Over the past few weeks you have most likely seen – unless you work at the White House – the undercover videos released by David Daleiden and the Center for Medical Progress, which show various Planned Parenthood employees discussing the harvesting and sale of fetal organs and body parts. The negotiations caught on camera suggest that these transactions are not at all unusual for the organization nor are they limited to these few incidents but are, in fact, systemic throughout the organization. This suggests that Planned Parenthood, which performs about 330,000 abortions a year in the United States, has found a way to make abortion even more profitable.
Note (9/4/2015): The author wishes to acknowledge an error in the originally published version of this article. Due to a mistake in interpretation the cost of patient care at a Community Health Center (CHC) was stated as $1.67 per patient per year rather than the obviously much-larger $1.67 per patient per day. The original article cited by CLI was comparing the much-lower per diem cost of CHCs relative to the cost of hospital inpatient care, emergency room visits, and other alternatives. The reallocation of the current Planned Parenthood funding of $528.4 million in annual spending from federal, state and local government sources would finance care for an additional 866,869 women if the $1.67 per diem cost claimed by CHCs is used. Other CHC documents suggest that full access to current fiscal year discretionary funds plus another $3.6 billion from the mandatory Health Center Fund could establish CHC capacity for another 11 million patients, a figure that suggests an even lower per diem cost than $1.67. Even at $1.67 per day, a full reallocation of the $528.4 million could serve a minimum of 31 percent of Planned Parenthood’s unique annual client base of 2.8 million individuals. A $528.4 million reallocation represents 41 percent of Planned Parenthood’s current budget. The calculation presumes that the annual cost per patient for women of childbearing age in a CHC is the same as the overall per patient average in a CHC, and that Planned Parenthood’s per diem per patient cost for the transferred services equals the full CHC per patient cost, which is unlikely given the much wider scope of CHC services. Mr. Donovan sincerely regrets the error.
In the wake of the spreading scandal over the sale of human organs extracted from unborn children, members of Congress are calling for the end of federal funding of Planned Parenthood. A first attempt in the U.S. Senate to do this failed on Monday of this week, but a dozen more Senators voted for the cut-off than did so the last time it was considered, in 2011. A cut-off would be condign punishment for an elite institution long given to dismissive responses to evidence of ethical misconduct, but the latest charges are hardly the only reason to wean this mega-wealthy nonprofit from the federal dole. In truth, the stand-alone Planned Parenthood facility is obsolete.
To view as PDF, please see “Abortion World Leaders”
The United States is second in the world in number of abortions each year. If Planned Parenthood were included for comparison, it would rank sixth in the world in number of abortions carried out annually; and the International Planned Parenthood Federation would be fourth in the number of abortions carried out per year.
|England and Wales||189,800|
Annual abortion numbers for countries 2008, PP USA 2013, IPPF 2014
 Most recent verifiable data for international abortion numbers, 2008 from: Sedgh G et al., Legal Abortion Worldwide in 2008: Levels and Recent Trends, International Perspectives on Sexual and Reproductive Health 37, 84, 2011; Sedgh G et al., Legal Abortion Worldwide in 2008: Levels and Recent Trends, Perspectives on Sexual and Reproductive Health 43, 188, 2011; PP USA 2013 information accessed at: http://www.sba-list.org/sites/default/files/content/shared/12.31.14fact_sheet_pp_2013_2014_annual_report.pdf; IPPF 2014 numbers from: Table 1 in http://www.ippf.org/sites/default/files/ippf_apr2014_15_web_4.pdf
Last Thursday Alaska Governor Bill Walker announced that he would use his executive authority to expand Alaska’s state Medicaid program under the federal Affordable Care Act. Walker’s proposal would extend Medicaid eligibility to all Alaskans earning less than 133 percent of the poverty line. Walker reported that he sent a letter to the Alaska legislature’s Budget and Audit Committee, giving legislators the required 45-day notice of his plan. The committee can make recommendations, but Walker said he has legal authority to move forward without the legislature’s approval.
How many babies prenatally diagnosed with Down syndrome (DS) are aborted in the United States each year? Well, we don’t know. While new data suggesting lower numbers has recently been published, we continue to see most often in print a statistics of 90% – 92%. While that certainly draws attention to the horrifying reality that the majority of children prenatally diagnosed with DS are aborted, it is not accurate. That number relies on a 1999 European study with little data drawn from the U.S. There are good reasons for advocates to use the best data available to raise awareness of the problem that exists in the link between prenatal diagnosis and abortion.
British Members of Parliament recently voted to clarify the status of sex-selection abortion under the Abortion Act of 1967. The MPs voted, 181-1, in favor of banning sex-selection abortion under the British abortion statute. Sex-selection abortion has been a topic of intense focus among legislators after investigators exposed doctors agreeing to perform abortions solely based on a baby’s undesired gender.
A new report released October 1 by abortion rights groups, Center for Reproductive Rights (CRR) and Ibis Reproductive Health, claims that the more laws regulating abortion a state has, the poorer the state performs in health outcomes for women and children. A brief look at the methodology employed, however, reveals a built-in subjectivity from which correlations and results are drawn, effectively stacking the deck to support the authors’ narrative.
The non-partisan congressional watchdog agency, Government Accountability Office (GAO), released a new report late September 15 confirming that: 1,036 federally subsidized plans cover elective abortion; insurance consumers were frequently not informed of this coverage before enrolling; and plan issuers are not billing elective abortion coverage separately despite a legal requirement.
Now, four and a half years since the Affordable Care Act’s passage and nearing the end of its first year of implementation, concerns over elective abortion coverage in health insurance exchange plans continue to be dismissed by the current administration. In addition to the evident lack of transparency over which plans cover this “benefit,” the Charlotte Lozier Institute (CLI) has now also found that the ACA provision that is supposed to separate funds used for elective abortions from other taxpayer payments in federally subsidized health insurance exchange plans is largely inoperative.
A federal judge on August 31 issued a “limited” temporary restraining order on a Louisiana abortion health and safety law that would have gone into effect September 1. The Unsafe Abortion Protection Act (HB 388), or Act 620, requires doctors at abortion facilities to have admitting privileges at a hospital within 30 miles in case a need for emergency care arises.
Liberty can be explained in a handful of words; deprivations of liberty usually require thousands. That is the case with the latest iteration of the accommodations permitted under the Obama Administration’s preventive services mandate, which was published on Friday, August 22. The Obama Health and Human Services (HHS) Department issued its latest rulemakings designed to ensure that the employees of the vast majority of religious nonprofits, as well as those of businesses like Hobby Lobby, can obtain zero-cost contraceptives, abortifacients and sterilization via their employers’ insurance plans.
Download PDF here: The Women’s Health Protection Act of 2013: The Sweeping Impact of S. 1696
United States Senator Richard Blumenthal introduced S. 1696 on November 13, 2013. Cosponsors of the bill currently include Senators Baldwin, Boxer, Schatz, Hirono, Harkin, Whitehouse, Sanders, Schumer, Murray, Gillibrand, Cantwell, Murphy, Brown, Warren, Tester, Menendez, Heinrich, Coons, Markey, Merkley, Shaheen, Mikulski, Booker, Feinstein, Stabenow, Wyden, Franken, Klobuchar, Cardin, McCaskill, Begich, Baucus, Durbin, Walsh, and Levin.
S. 1696 proposes a federal law that would be titled “The Women’s Health Protection Act of 2013.”
If enacted in current form, S.1696 would jeopardize or outright invalidate a wide range of State and Federal abortion-related regulations. In particular, S. 1696:
- Could Be Interpreted to Impose a Heightened Burden of Proof on Many if Not Most Abortion Laws Ever Enacted
- Would Trump 20-Week Laws in a Very Large Percentage of Cases
- Would Create a Special Protection in Federal Law for Sex-Discrimination Abortion
- Would Jeopardize Laws Limiting Performance of Abortions to Licensed Physicians
- Would Authorize Federal Court Attacks on Abortion Clinic Health and Safety Standards that Protect Women
- Could Have the Effect of Deterring Health and Safety Inspections of Abortion Clinics
- Would Jeopardize Limits on Late Abortions
- Would Jeopardize Prohibitions on Taxpayer-Funded Abortion—Including the Hyde Amendment—as well as Abortion Training
- Would Jeopardize Health and Safety Regulations Governing the Use of Abortion Drugs
- Would Jeopardize Health and Safety Regulations Governing the Practice of Telemedicine Abortion
- Would Jeopardize Sonogram and Fetal Heartbeat Test Requirements
- Would Jeopardize Mandatory Reflection Periods that the U.S. Supreme Court Has Upheld
- Could Be Interpreted to Trump State and Federal Conscience Protections
S. 1696 does not apply to laws regulating physical access to clinic entrances, requirements for parental consent or notification before a minor may obtain an abortion, insurance coverage of abortion, or partial-birth abortion.
Brief Overview of S. 1696
S. 1696 contains eight sections. Section 4 contains the substantive provisions of S. 1696. Section 4 is titled “Prohibited Measures and Actions.”
Section 4 contains three basic types of prohibitions. One type of prohibition involves direct prohibitions. A second type of prohibition involves conditional prohibitions. A third type of prohibition involves a heightened burden of proof that must be satisfied if a showing of prima facie unlawfulness is made.
The standards for making a prima facie showing of unlawfulness and, where such a showing is made, for satisfying the heightened burden of proof are set forth in Section 4(b). Section 4(b) requires extended analysis. Analysis of Section 4(b) follows in a separate section of this paper titled “S. 1696 Could Be Interpreted to Impose a Heightened Burden of Proof on Many if Not Most Abortion Laws Ever Enacted.”
A brief restatement of the other two types of prohibitions, direct prohibitions and conditional prohibitions, follows here.
Direct prohibitions include Section 4(a)(6), Section 4(c)(1), Section 4(c)(2), Section 4(c)(3), and Section 4(c)(4).
- Under Section 4(c)(1), “[a] prohibition or ban on abortion prior to fetal viability” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(c)(4), “[a] measure or action that prohibits or restricts a woman from obtaining an abortion prior to fetal viability based on her reasons or perceived reasons or that requires a woman to state her reasons before obtaining an abortion prior to fetal viability” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(a)(6), “[a] requirement that, prior to obtaining an abortion, a woman make one or more medically unnecessary visits to the provider of abortion services or to any individual or entity that does not provide abortion services” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(c)(2), “[a] prohibition on abortion after fetal viability when, in the good-faith medical judgment of the treating physician, continuation of the pregnancy would pose a risk to the pregnant woman’s life or health” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(c)(3), “[a] restriction that limits a pregnant woman’s ability to obtain an immediate abortion when a health care professional believes, based on her or his good-faith medical judgment, that delay would pose a risk to the woman’s health” is “unlawful and shall not be imposed or applied by any government.”
Conditional prohibitions include Section 4(a)(1), Section 4(a)(2), Section 4(a)(3), Section 4(a)(4), Section 4(a)(5), and Section 4(a)(7). In each of the following restatements emphasis is added to the conditional clause in the prohibition.
- Under Section 4(a)(1), “[a] requirement that a medical professional perform specific tests or follow specific medical procedures in connection with the provision of an abortion, unless generally required for the provision of medically comparable procedures,” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(a)(2), “[a] limitation on an abortion provider’s ability to delegate tasks, other than a limitation generally applicable to providers of medically comparable procedures,” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(a)(3), “[a] limitation on an abortion provider’s ability to prescribe or dispense drugs based on her or his good-faith medical judgment, other than a limitation generally applicable to the medical profession,” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(a)(4), “[a] limitation on an abortion provider’s ability to provide abortion services via telemedicine, other than a limitation generally applicable to the provision of medical services via telemedicine,” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(a)(5), “[a] requirement or limitation concerning the physical plant, equipment, staffing, or hospital transfer arrangements of facilities where abortions are performed, or the credentials or hospital privileges or status of personnel at such facilities, that is not imposed on facilities or the personnel of facilities where medically comparable procedures are performed” is “unlawful and shall not be imposed or applied by any government.”
- Under Section 4(a)(7), “[a] requirement or limitation that prohibits or restricts medical training for abortion procedures, other than a requirement or limitation generally applicable to medical training for medically comparable procedures,” is “unlawful and shall not be imposed or applied by any government.”
The term “medically comparable procedures” appears in Section 4(a)(1), Section 4(a)(2), Section 4(a)(5), and Section 4(a)(7). S. 1696 fails to define the term “medically comparable procedures.” How courts interpret that term will have considerable significance for the legal effects created by the four provisions where the term appears. A brief treatment of the term here will facilitate analysis of those four provisions throughout the paper.
Some parties will argue, correctly, that no “procedure” is “medically comparable” to abortion. As the Supreme Court has explained, “Abortion is inherently different from other medical procedures, because no other procedure involves the purposeful termination of a potential life.” However, applying this understanding to S. 1696 would render ineffective the four provisions of S. 1696 where the term appears. And that approach would violate “one of the most basic interpretive canons, that [a] statute should be construed so that effect is given to all its provisions, so that no part will be inoperative or superfluous, void or insignificant.” It is the “duty” of courts “to give effect, if possible, to every clause and word of a statute.” “[E]ach word in a statute should [carry meaning].” In addition to these general rules, Section 5 of S. 1696 commands courts to “liberally construe” the provisions of S. 1696 to effectuate its purposes. Analysis of S. 1696 as currently drafted should be based upon the assumption that courts interpreting it are likely to conclude that one or more procedures are, within the meaning of S. 1696, “medically comparable” to abortion. Moreover, because Section 3(1) of S. 1696 defines the term “abortion” to include “any medical treatment, including the prescription of medication, intended to cause the termination of a pregnancy,” courts interpreting the term “medically comparable procedures” must consider procedures that would be “medically comparable” to medication abortions, surgical abortions, or both, depending on the particular use of the term in each of the four provisions where it appears.
Finally, a few additional notes will help to understand the potential scope and impact of S. 1696.
First, S. 1696 would apply to both State and Federal laws. Section 4(a) and Section 4(c) both refer to unlawful restrictions that “shall not be imposed or applied by any government.” Section 3(3), in turn, defines the term “government” to include “a branch, department, agency, instrumentality, or individual acting under color of law of the United States, a State, or a subdivision of a State.” Government restrictions subject to S. 1696 would include, as set forth in Section 4(e), statutory and other restrictions whether enacted or imposed prior to or after the date of enactment of S. 1696.
Second, as set forth in Section 4(d), S. 1696 does not apply to “laws regulating physical access to clinic entrances, requirements for parental consent or notification before a minor may obtain an abortion, insurance coverage of abortion, or the procedure described in section 1531(b)(1) of title 18, United States Code.” Section 1531(b)(1) of title 18 of the United States Code describes the procedure known as partial-birth abortion.
Third, Section 5 is titled “Liberal Construction.” It states, “In interpreting the provisions of this Act, a court shall liberally construe such provisions to effectuate the purposes of the Act.” Section 2(b) is titled “Purpose.” It states that the “purpose” of S. 1696 is “to protect women’s health by ensuring that abortion services will continue to be available and that abortion providers are not singled out for medically unwarranted restrictions that harm women by preventing them from accessing safe abortion services.”
Fourth, Section 3 of the Act defines seven terms including “abortion,” “abortion provider,” “government,” “health care professional,” “pregnancy,” “state,” and “viability.” Section 3 does not define other terms used in S. 1696 including “health,” “medically unnecessary,” “good-faith medical judgment,” and “medically comparable procedures.”
S. 1696 Could Be Interpreted to Impose a Heightened Burden of Proof on Many if Not Most Abortion Laws Ever Enacted
Section 4(b) of S. 1696 would make certain measures and actions unlawful unless, as set forth in Section 4(b)(4), the government “establishes, by clear and convincing evidence” that the measure or action “significantly advances the safety of abortion services or the health of women” and the safety of abortion services or the health of women “cannot be advanced by a less restrictive alternative measure or action.” Plaintiffs such as Planned Parenthood could trigger this heightened burden of proof by establishing a prima facie case that a measure or action is unlawful under Section 4(b). To establish a prima facie case of unlawfulness, plaintiffs would need to make only one of two showings. Under Section 4(b)(2)(A) plaintiffs could make a prima facie case of unlawfulness by showing that the measure or action “singles out the provision of abortion services or facilities in which abortion services are performed.” Or under Section 4(b)(2)(B) plaintiffs could make a prima facie case of unlawfulness by showing that the measure or action impedes access to abortion services based on “one or more” of seven factors set forth in Section 4(b)(3).
The potential scope of Section 4(b) would be extremely wide and, depending on the facts of the case and how courts interpreted certain provisions of Section 4(b), could reach an extensive range of State and Federal abortion-related laws and regulations. For every measure or action that would fall within the scope of Section 4(b), the government would be required, under Section 4(b)(4), to demonstrate, by clear and convincing evidence, that the measure or action “significantly advances” the safety of abortion services or women’s health and is the least restrictive way of doing so. Failure to satisfy this heavy burden would result in the measure or action being enjoined under S. 1696, as set forth in Section 6(c). Further, under Section 6(d), S. 1696 would force taxpayers to pay the costs of litigation for plaintiffs such as Planned Parenthood who prevail or even “substantially prevail” in actions brought under S. 1696.
Heightened Burden of Proof Under “Singles Out” Clause of Section 4(b)(2)(A)
Section 4(b)(2)(A) provides the first of the two methods for triggering the heightened burden of proof. Section 4(b)(2)(A) provides that a plaintiff can make a prima facie showing of unlawfulness by demonstrating that the challenged measure or action “singles out the provision of abortion services or facilities in which abortion services are performed.”
Section 4(b)(2)(A) yields at least two potential interpretations. The first potential interpretation is that a law “singles” out abortion services and therefore triggers the heightened burden of proof by specifically addressing the subject of abortion either by itself or with one or more other subjects. Under this interpretation abortion laws would be subject to the heightened burden of proof even if they merely applied a general standard to a matter involving abortion but did so in a “measure” or “action” that addressed abortion specifically. Under this interpretation of Section 4(b)(2)(A) any law, regulation, or government action specifically addressing abortion would be subject to the heightened burden of proof and would be upheld only upon a demonstration, made by clear and convincing evidence, that the measure or action significantly advanced the safety of abortion services or the health of women and did so in the least restrictive way possible.
The second approach to interpreting “singles out” is not as formalistic but would still be very broad. Under the second approach, potential interpretations of “singles out” include that a measure or action “singles out” abortion services or abortion facilities if that measure or action applies a standard to abortion services or abortion facilities that is not applied to any other services or facilities, that is not applied to all other similarly situated services or facilities, or that is applied to some or all other similarly situated services or facilities but with certain variations in the abortion context. Though not as extreme as the first approach to interpreting “singles out,” this second approach would likewise jeopardize a wide range of abortion-related regulation.
Under either interpretation, the “singles out” standard would significantly distort regulatory approaches to abortion-related issues at both the State and Federal levels. In some instances, laws that regulate abortion might simply be designed to elevate the standards of abortion services or abortion facilities to the standards achieved by other regulated health care providers and facilities. In many cases, however, laws that regulate abortion might take into account and reflect the unique nature of abortion in the life of women and their unborn children, in the practice of medicine, and in society as a whole. In the words of the U.S. Supreme Court, abortion is a “unique act” and “inherently different” from other medical procedures. Therefore it is no surprise, as explained by a Federal appeals court, that “[t]he rationality of distinguishing between abortion services and other medical services when regulating physicians or women’s healthcare has long been acknowledged by Supreme Court precedent.” Indeed, even as a general rule, aside from the particular and unique nature of abortion, policymakers might conclude that the most uniform method of regulating medical procedures is to regulate them differently according to the unique issues presented by the procedures or practice area. Non-ideological, evidence-based standards of care and practice that make sense in one context might very well be unjustified, irrational, or even counterproductive in another context. Even if abortion were not unique in the field of medicine and in society as a whole, regulating abortion based on the particular issues it presents would simply correspond with a sensible approach to regulating for public health and safety in general.
S. 1696 runs against this commonsense approach. Instead of allowing for a flexible, evidence-based approach to regulating abortion-related issues based on the unique issues abortion presents, S. 1696 would impose a broad, indiscriminating burden that, ironically, would “single out” abortion for special protections under the rubric of targeting measures that “single out” abortion.
Heightened Burden of Proof Under “Impedes” Clause of Section 4(b)(2)(B) and Seven Factors Described in Section 4(b)(3)
Section 4(b)(2)(A) provides the first method for establishing a prima facie case of unlawfulness under S. 1696. Section 4(b)(2)(B) provides the second method.
Under Section 4(b)(2)(B) a plaintiff may make a prima facie showing of unlawfulness by demonstrating that the measure or action challenged “impedes women’s access to abortion services based on one or more of the factors described in” Section 4(b)(3). Section 4(b)(3), in turn, sets forth seven factors “for a court to consider in determining whether a measure or action impedes access to abortion services.” The Section 4(b)(2)(B) showing may be made based on “one or more” of these factors.
Section 4(b)(2)(B) fails to clarify the relationship between Section 4(b)(2)(B) and Section 4(b)(3). Courts could conclude that, for the purpose of establishing a prima facie showing of unlawfulness under Section 4(b)(2)(B), a measure or action “impedes” access to abortion, without any further factual showing, so long as it comes within the meaning of “one or more” of the factors described in Section 4(b)(3). Or courts could conclude that, to establish a prima facie case under Section 4(b)(2)(B), plaintiffs must show that a measure or action, in fact, impedes access to abortion and, separately, comes within the meaning of “one or more” of the factors described in Section 4(b)(3). The first reading would be broader than the second reading. However, even the second reading could produce a broad scope of application depending on the interpretation courts gave to the term “impedes,” especially in the light of Section 5, which commands courts to “liberally construe” provisions of S. 1696 to “effectuate” its purposes. Analysis of S. 1696 should be based on the broadest, not the narrowest, potential interpretations of its provisions. But either understanding of the relationship between Section 4(b)(2)(B) and Section 4(b)(3) could produce a sweeping scope of application.
The Section 4(b)(3) factors “for a court to consider in determining whether a measure or action impedes access to abortion services” for purposes of Section 4(b)(2)(B) include:
- Section 4(b)(3)(A) states “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment.”
- Section 4(b)(3)(B) states “[w]hether the measure or action is reasonably likely to delay some women in accessing abortion services.”
- Section 4(b)(3)(C) states “[w]hether the measure or action is reasonably likely to directly or indirectly increase the cost of providing abortion services or the cost for obtaining abortion services (including costs associated with travel, childcare, or time off work).”
- Section 4(b)(3)(D) states “[w]hether the measure or action requires, or is reasonably likely to have the effect of necessitating, a trip to the offices of the abortion provider that would not otherwise be required.”
- Section 4(b)(3)(E) states “[w]hether the measure or action is reasonably likely to result in a decrease in the availability of abortion services in the State.”
The potential scope of regulation covered by these factors would be enormous. In particular, two of the Section 4(b)(3) factors, Section 4(b)(3)(A) and Section 4(b)(3)(C), are so broadly worded that they could be interpreted to reach a potentially very large swath of abortion-related regulation. These provisions provide astonishing “trump cards” for abortion providers to challenge a host of abortion regulations based on potentially nothing more than the assertion that the regulation “interferes” with the provider’s ability to provide abortion services “in accordance with” her or his “good-faith medical judgment” or would be “reasonably likely” to increase, “directly or indirectly,” the cost of providing or obtaining an abortion. The potential effects of these provisions are so broad that the provisions could even result in heightened judicial scrutiny of State and Federal laws that have nothing to do with abortion services directly but that somehow “interfere” with an abortion provider’s “ability” to “render services” “in accordance with” her or his “good-faith” medical judgment or increase the costs, “directly or indirectly,” of providing or obtaining an abortion. At a minimum these provisions would provide a statutory basis for generating a huge amount of litigation.
S. 1696 Would Trump 20-Week Laws in a Very Large Percentage of Cases
Twenty-week laws prohibit elective abortion, subject to specified exceptions, at or after 20 weeks of pregnancy. Several States have enacted 20-week laws in recent years and the U.S. House of Representatives passed a national 20-week bill in 2013.
Twenty-week laws protect unborn children from suffering pain. The 20-week bill passed by the U.S. House of Representatives found that “there is substantial medical evidence that an unborn child is capable of experiencing pain at least by 20 weeks after fertilization, if not earlier.” Twenty-week laws also advance women’s health. According to Americans United for Life, “[A] woman seeking an abortion at 20 weeks is 35 times more likely to die from abortion than she was in the first trimester” and at “21 weeks or more, she is 91 times more likely to die from abortion than she was in the first trimester.”
S. 1696 would trump State 20-week laws in a large percentage of cases. Section 4(c)(1) states that a “prohibition or ban on abortion prior to fetal viability” is unlawful and shall not be imposed or applied by any government. Section 3(7) of S. 1696 defines viability as “the point in a pregnancy at which, in the good-faith medical judgment of the treating health care professional, based on the particular facts of the case before her or him, there is a reasonable likelihood of sustained fetal survival outside the uterus with or without artificial support.” In most instances a 20-week law will apply before viability occurs. Twenty weeks can be measured in different ways including from the first day of the last menstrual cycle (LMP) and from the point of fertilization. (“The LMP age is the post-fertilization age, plus two weeks.”) Viability can occur at 20 weeks post-fertilization age; in the current state of medical technology, however, viability will occur later than 20 weeks post-fertilization age in a very large percentage of cases. Where a 20-week prohibition on elective abortion applies before viability occurs, S. 1696 would trump the 20-week rule and require the availability of elective abortion.
Other provisions of S. 1696 would threaten 20-week laws whether those laws applied before or after viability. Section 4(c)(2) makes unlawful “[a] prohibition on abortion after fetal viability when, in the good-faith medical judgment of the treating physician, continuation of the pregnancy would pose a risk to the pregnant woman’s life or health.” S. 1696 does not define the term “health.” If courts construe the health exception set forth in Section 4(c)(2) more broadly than the health exception set forth in a particular 20-week law, either on the ground that S. 1696 contemplates a very broad understanding of the term “health” or reserves that determination to the “good-faith medical judgment” of the abortionist, then S. 1696 would reduce the effective scope, potentially significantly, of that 20-week policy.
In addition, Section 4(b)(2)(B) imposes a heightened burden of proof on any measure or action that “impedes” access to abortion services based on “one or more” of the factors described in Section 4(b)(3). The Section 4(b)(3) factors include Section 4(b)(3)(A), “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment.” Some courts might rule that 20-week laws “interfere” with the ability of doctors to provide abortions “in accordance with” their “good-faith medical judgment.” States would then be forced to establish by clear and convincing evidence that such laws “significantly” advanced the safety of abortion services or the health of women and did so in the least restrictive way possible. The heightened burden of proof imposed by Section 4(b) makes no allowance for States’ interest in protecting unborn children from pain.
Section 2(a)(4) of S. 1696 states that “bans on abortions prior to viability” are “blatantly” unconstitutional. That assertion misleads. In a much noted 2013 ruling a Federal appellate court struck down as unconstitutional a State law prohibiting elective abortion at 20 weeks in LMP age. But the U.S. Supreme Court has never decided a challenge to a 20-week law. And there are substantial reasons to believe that the Court might very well uphold 20-week laws as constitutional. However, if S. 1696 became law, the Court would have no occasion to decide that constitutional question. As a general rule, federal courts “will not pass upon a constitutional question . . . if there is also present some other ground upon which the case may be disposed of. . . . Thus, if a case can be decided on either of two grounds, one involving a constitutional question, the other a question of statutory construction or general law, the Court will decide only the latter.” Because S. 1696 would trump 20-week laws even if the Constitution permits 20-week laws, in a legal challenge to 20-week laws courts would not decide the constitutional question. S. 1696 would effectively freeze further jurisprudential developments regarding the constitutional validity of 20-week laws.
S. 1696 Would Create a Special Protection in Federal Law for Sex-Discrimination Abortion
S. 1696 would protect the practice of sex-discrimination abortion, race-discrimination abortion, and disability-discrimination abortion. Sex-discrimination abortion is when an abortion is conducted because of the sex of the unborn child. Race-discrimination abortion is when an abortion is conducted because of the race of the unborn child. Disability-discrimination abortion is when abortion is conducted because the unborn child suffers from a condition such as Down syndrome.
Several States have already enacted regulations addressing the practice of abortions based on the sex, race, or disability of the child or one or more of those bases of discrimination. And more States might enact similar legislation in coming years. According to Americans United for Life, in 2013 “at least 16 States considered measures to prohibit abortion based on the child’s sex, race, and/or diagnosed genetic abnormality.”
S. 1696 would wipe out State laws prohibiting the practice of discrimination abortion. Section 4(c)(4) makes unlawful “[a] measure or action that prohibits or restricts a woman from obtaining an abortion prior to fetal viability based on her reasons or perceived reasons or that requires a woman to state her reasons before obtaining an abortion prior to fetal viability” (emphasis added).
Section 4(c)(4) is a clear-cut prohibition on laws that prohibit the practice of sex-selection abortion as well as abortions performed for the reason of the child’s race or genetic condition such as Down syndrome. S. 1696 would write a special protection into the U.S. Code for discriminating against unborn children on any ground, including sex, race, and disability.
S. 1696 Would Jeopardize Laws Limiting Performance of Abortions to Licensed Physicians
The U.S. Supreme Court has made, in its own words, “repeated statements” that “the performance of abortions may be restricted to physicians.” However, S. 1696 would jeopardize the ability of the States to restrict the performance of abortions to licensed physicians.
Section 4(a)(2) of S. 1696 makes unlawful “[a] limitation on an abortion provider’s ability to delegate tasks, other than a limitation generally applicable to providers of medically comparable procedures.” S. 1696 does not define the term “medically comparable procedures,” but Section 3(1) defines abortion to include surgical abortion procedures as well as medication abortion procedures that involve a patient consuming prescription drugs. If a court concluded that any procedure involving a patient consuming prescription drugs was “medically comparable” to abortion, then the potential reach of the “generally applicable” requirement in Section 4(a)(2) would be enormous. Under this interpretation Section 4(a)(2) would have the perverse effect of forcing States to require nondelegation in contexts where such a policy is irrational, counterproductive, or even dangerous as a condition of restricting abortion procedures to only licensed physicians. As a practical matter this application of S. 1696 would likely increase the number of women undergoing abortion-related procedures performed by nonphysicians.
In addition, Section 4(b)(2)(B) imposes a heightened burden of proof on any measure or action that impedes access to abortion based on “one or more” factors described in Section 4(b)(3). The Section 4(b)(3) factors include Section 4(b)(3)(A), “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment.” The term “abortion provider” is defined by Section 3(2) as “a health care professional who performs abortions.” The term “health care professional,” in turn, is defined by Section 3(4) as “a licensed medical professional (including physicians, certified nurse-midwives, nurse practitioners, and physician assistants) who is competent to perform abortions based on clinic training.” By definition laws that restrict the performance of abortion to licensed physicians would “interfere” with the ability of the nonphysicians described in Section 3(4) to perform abortions. If courts conclude that a prohibition on performing abortions interferes with the ability of those nonphysicians “to provide care and render services” “in accordance with” their “good-faith” medical judgment, as set forth in Section 4(b)(3)(A), then States would be forced to establish, by “clear and convincing” evidence, that laws restricting the performance of abortion to licensed physicians “significantly advance” either the safety of abortion services or the health of women and do so in the least restrictive way possible.
Health and safety regulations restricting the performance of abortion to licensed physicians would also suffer jeopardy under Section 4(b)(3)(B), Section 4(b)(3)(C), and Section 4(b)(3)(E).
S. 1696 Would Authorize Federal Court Attacks on Abortion Clinic Health and Safety Standards that Protect Women
The trial of abortionist Kermit Gosnell raised public awareness about the health and safety hazards threatening women at too many abortion clinics. The Susan B. Anthony List has compiled a list of reported allegations or established findings that includes items such as clinics with drugs decades past their expiration dates, mishandling of fetal tissue, a broken defibrillator, preparing to use unsterilized instruments on patients, patients that were regularly lying down in corridors and sometimes vomiting, a doctor conducting examinations with unwashed hands, blood-stained medical equipment, failure to disinfect recovery cots between each patient use, improper sedation and failure to resuscitate a patient who went into cardiac arrest, improper use of syringes, failure to test staff for rubella and TB, leaving the head of an aborted baby inside a mother’s womb, dead insects inside the facility, a mother who died as a result of hemorrhage following a surgical abortion, holes in a leaky ceiling, blood dripping from a sink p-trap in a room used by patients, the remains of aborted children being discarded in dumpsters, no oxygen available for patients, no emergency call system, insufficient or nonexistent narcotic logs, noncompliance with requirements regarding maintenance of sterile environments and sterile pre-operation handwashing, one doctor scrubbing his hands in a sink used for processing fetal remains, failure to provide local anesthesia causing patient experience of extreme pain, patients who tried to stop the abortion procedure and were restrained or subjected to the procedure anyway, failure to provide adequate protection for privacy, fraudulent billing practices, a situation where paramedics had to hand-lift a patient from a narrow doorway and down several steps because the clinic lacked a gurney-accessible entrance, failure to diagnose a tubal pregnancy, needles on the floor, and failure to clean exam tables between abortions.The compiled list includes instances of women suffering complications from abortion or even dying.
According to Americans United for Life (AUL), in 2013 “[a]t least 17 States considered measures mandating various health and safety standards for abortion clinics” and “[n]ew laws were enacted in Alabama, Indiana, North Carolina, North Dakota, and Texas.” AUL reports that “Alabama and Texas now require abortion clinics to meet the same patient care standards as facilities performing other outpatient surgeries.” Similarly, in 2013 “at least 15 States considered legislation delineating qualifications for individual abortion providers.” According to AUL, “Alabama, North Dakota, Texas, and Wisconsin enacted measures requiring abortion providers to have admitting privileges at a local hospital, while Louisiana and North Dakota now require that abortion providers be board certified in obstetrics and gynecology.”
S. 1696 would threaten State laws regulating the health and safety of abortion clinics and the qualifications of abortion doctors. Section 4(a)(5) makes unlawful “[a] requirement or limitation concerning the physical plant, equipment, staffing, or hospital transfer arrangements of facilities where abortions are performed, or the credentials or hospital privileges or status of personnel at such facilities, that is not imposed on facilities or the personnel of facilities where medically comparable procedures are performed.” In some cases, state laws regulating the health and safety of abortion clinics might simply have the effect of raising standards for the practice of abortion to the same standards imposed and observed by other facilities. In these cases, state officials might be able to defend health and safety measures as lawful under S. 1696. However, the process would be expensive, and success would not be guaranteed. S. 1696 fails to define the term “medically comparable procedures” and it is uncertain how courts would interpret that provision. Well-reasoned, carefully-tailored health and safety regulations could be struck down because they fail to satisfy the Section 4(a)(5) condition as applied by a single unelected federal judge. Even in cases where the State eventually prevailed, a federal judge might temporarily enjoin the health and safety regulations pending litigation. At a minimum, S. 1696 would create a statutory basis for entangling state health and safety regulations in federal court litigation.
In addition, even if States prevailed under Section 4(a)(5) by demonstrating that regulations governing the health and safety standards of abortion clinics and abortion doctors were the same as regulations governing the facilities or personnel of facilities where “medically comparable procedures” are performed, those regulations would still be subject to challenge under Section 4(b), which imposes a heightened burden of proof on certain measures and actions.
Section 4(b)(2)(A) imposes a heightened burden of proof on any measure or action that “singles out” the provision of abortion services or the facilities where abortion services are performed. S. 1696 fails to define the term “singles out” but commands courts to “liberally construe” provisions of S. 1696. If a court construed the term “singles out” to encompass any legislation or regulation specifically addressing abortion, even where such legislation or regulation merely raised abortion-related health and safety standards to the same standards applied in other contexts, then health and safety regulations designed to protect women could fall unless the State established by “clear and convincing” evidence that the regulations “significantly” advanced either the safety of abortion services or the health of women and did so in the least restrictive way possible.
Section 4(b)(2)(B) imposes a heightened burden of proof on any measure or action that impedes access to abortion based on “one or more” factors described in Section 4(b)(3). Those factors include Section 4(b)(3)(A), “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment.” Some abortion doctors might argue that regulations requiring them to become board certified in obstetrics and gynecology or to qualify for admitting privileges at a local hospital “interfere” with their ability to provide abortion services “in accordance with” their “good-faith” medical judgment. Upon such a showing States would be forced to satisfy the heightened burden of proof imposed by S. 1696 or those health and safety regulations would fall.
The Section 4(b)(3) factors also include Section 4(b)(3)(C), whether the measure or action is “reasonably likely” to “directly or indirectly” increase the cost of providing abortion services and Section 4(b)(3)(E), whether the measure or action is “reasonably likely” to result in a “decrease in the availability” of abortion services in the state. Providing safe, clean, hygienic abortion facilities with doctors who can obtain admitting privileges at local hospitals and obtain board certification in obstetrics and gynecology probably costs more money than providing inadequate, unhygienic, and dangerous abortion facilities with underqualified doctors. It is almost certain that complying with health and safety regulations will “directly or indirectly” increase the cost of providing abortion services. And if some abortion providers stop providing abortion services because they lack the ability or choose not to obtain admitting privileges or board certifications or to comply with other health and safety regulations then those regulations would also likely trigger the provision regarding a “decrease in availability” of abortion services. Under either showing, S. 1696 would jeopardize State regulations providing for the health and safety of women unless the State managed to satisfy the stiff burden of proof imposed by S. 1696.
S. 1696 Could Have the Effect of Deterring Health and Safety Inspections of Abortion Clinics
Inspections of abortion clinics are a vital tool for enforcing health and safety standards designed to protect women who choose to undergo abortion. However, S. 1696 could have the effect of deterring inspections of abortion clinics.
Section 4(b) of S. 1696 imposes a heightened burden of proof on any measure or action that “singles out” abortion services or facilities. S. 1696 fails to define the term “singles out.” If a court concluded that a law authorizing inspections of abortion clinics or a particular safety inspection “singled out” abortion services or facilities, then the State would be forced to establish, by clear and convincing evidence, that the inspection law “significantly” advanced the safety of abortion services or the health of women and did so in the least restrictive way possible.
In the end State officials might persuade a court that a law authorizing health and safety inspections of abortion clinics is valid under S. 1696. Even if a court concluded that a law authorizing inspections of abortion clinics “singled out” the provision of abortion services or the facilities where abortions are provided, State officials might establish through clear and convincing evidence that inspection laws significantly advance the safety of abortion services or the health of women and do so in the least restrictive way possible.
However, even where the State was able to sustain a law authorizing inspections of abortion clinics, the mere threat of litigation could deter State officials from putting the inspection law into practice. Section 4(b) applies to “measures” and “actions.” S. 1696 fails to define either of those terms, but courts could interpret either “measures” or “actions” to include inspections of abortion facilities, not just the laws that authorize those inspections.
If challenged to defend a practice of inspection in Federal court, State officials would likely offer the same arguments in defense of a particular inspection or plan of inspection that it offers in support of a law authorizing those inspections. However, litigation is costly, distracting, and time consuming. Even where government officials have carefully studied applicable standards and received legal counsel about appropriate actions, there is no guarantee a court will reach a favorable outcome. Further, S. 1696 would force State governments to pay the costs of litigation, including reasonable attorney and expert witness fees, to Planned Parenthood or other plaintiffs that prevail or even only “substantially” prevail in a challenge brought under S. 1696. The combination of these factors could produce a deterrent effect that leads to fewer safety inspections of abortion clinics.
More, in jurisdictions with fewer financial resources, the marginal increase in potential cost of defending abortion clinic inspections under S. 1696 might produce an even greater deterrent effect than in jurisdictions with greater financial resources. If so, then any effect of S. 1696 making abortion clinics more dangerous could fall disproportionately on women who seek access to abortion in jurisdictions with fewer financial resources yet nevertheless continue to depend on the protection of the law for enforcing at least minimum standards of safety and care.
S. 1696 Would Jeopardize Limits on Late Abortions
The Supreme Court of the United States has declared that after viability a State may proscribe abortion “except where it is necessary, in appropriate medical judgment, for the preservation of the life or health of the mother.”This rule is often referred to as the “health exception.”
The scope of the health exception required by the U.S. Supreme Court has been subject to debate. If the term “health” is construed broadly, for example, to include any psychological, social, or emotional impact whatsoever, the exception has the effect of making abortion available throughout all of pregnancy without meaningful restriction.
Some States have crafted health exceptions that include physical but not psychological health and other States might not specify whether health exceptions to post-viability abortion restrictions include mental health. Further, some States require “that a second physician certify that the abortion is medically necessary in all or some circumstances.”
S. 1696 would jeopardize the ability of States to establish meaningful health exceptions to restrictions on late abortion.
Section 4(c)(2) of S. 1696 makes unlawful “[a] prohibition on abortion after fetal viability when, in the good-faith medical judgment of the treating physician, continuation of the pregnancy would pose a risk to the pregnant woman’s life or health.” S. 1696 fails to define the term “health” but instructs courts to “liberally construe” provisions of S. 1696. Some courts might liberally construe the term “health” to encompass psychological health and even other factors such as socio-economic circumstances. Alternatively, courts might conclude that, instead of defining the scope of the health exception set forth in Section 4(c)(2), Congress reserved that determination to the “good-faith medical judgment” of the treating physician. In practice, and because S. 1696 does not define the term “good-faith medical judgment,” this interpretation of Section 4(c)(2) could produce substantially the same effect as expansively construing the term “health” to include psychological and even other factors.
In addition, Section 4(b)(2)(B) imposes heightened scrutiny on measures that impede access to abortion based on one or more factors described in Section 4(b)(3). Section 4(b)(3) factors include Section 4(b)(3)(A), “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment.” Abortion providers could argue that a health exception that does not provide for consideration of psychological, economic, social or other factors “interferes” with their ability to “provide care and render services” in “accordance” with their “good-faith medical judgment.” If a court agreed, then a State would be forced to establish by clear and convincing evidence that its health exception “significantly” advanced the safety of abortion services or the health of women and did so in the least restrictive way possible. Late abortion can be dangerous to women, but health and safety are not the only legitimate goals of abortion regulation. For example, “the government has a legitimate, substantial interest in preserving and promoting fetal life.” To the extent that carefully tailored post-viability health exceptions are designed to advance the government’s “substantial interest” in preserving and promoting the life of unborn children, it is reasonable to expect that at least some courts would conclude that the policy does not satisfy the required burden of proof.
In addition, S. 1696 would almost certainly wipe out regulations requiring the involvement of a second physician in post-viability abortions. Section 4(c)(2) makes unlawful “[a] prohibition on abortion after fetal viability when, in the good-faith medical judgment of the treating physician, continuation of the pregnancy would pose a risk to the pregnant woman’s life or health” (emphasis added). Even if courts construed “health” narrowly to coincide with the most stringent definition of “medical necessity” provided by the law of a State, Section 4(c)(2) restricts such judgments to “the” treating physician. The use of the definite article “the” in Section 4(c)(2) would likely result in the invalidation of regulations requiring the involvement of a second physician in late abortions. Furthermore, Section 4(a)(6) makes unlawful “[a] requirement that, prior to obtaining an abortion, a woman make one or more medically unnecessary visits to the provider of abortion services or to any individual or entity that does not provide abortion services.” S. 1696 does not define the term “medically unnecessary.” If the regulation requiring involvement of a second physician resulted in an extra visit to “any individual or entity” and those visits were adjudged to be “medically unnecessary,” then the second physician requirement likely would be struck down.
If S. 1696 were construed to require an expansive health exception or invalidate regulations requiring involvement of a second physician in late abortions, then S. 1696 would effectively freeze further litigation regarding the constitutional standards that apply to those issues. As a general rule, federal courts “will not pass upon a constitutional question . . . if there is also present some other ground upon which the case may be disposed of. . . . Thus, if a case can be decided on either of two grounds, one involving a constitutional question, the other a question of statutory construction or general law, the Court will decide only the latter.”
S. 1696 Would Jeopardize Prohibitions on Taxpayer-Funded Abortion—Including the Hyde Amendment—as well as Abortion Training
U.S. Supreme Court precedents establish that governments “need not commit any resources to facilitating abortions.” However, S. 1696 would jeopardize the ability of both the State and Federal government to prohibit the use of taxpayer funds for the purpose of performing abortions and training in abortion procedures.
Section 4(d) states that S. 1696 does not apply to “insurance coverage of abortion.” Therefore, State and Federal prohibitions on taxpayer funds for elective abortions in the context of insurance coverage would survive the application of S. 1696. However, S. 1696 would continue to apply to prohibitions not subject to the “insurance coverage” exclusion.
Federal law provides several examples of prohibitions, or purported prohibitions, on elective abortion in taxpayer-funded programs. In each case the prohibition would be subject to jeopardy under S. 1696, as set forth below, so long as courts ruled the prohibition did not fall within the meaning of “insurance coverage” as that term is used in Section 4(d).
The Hyde Amendment and Medicaid. The “Hyde Amendment” is a federal policy that prohibits certain federal funds, including funds appropriated for the Medicaid program, to be used for elective abortion. “In the years before the Hyde Amendment was first enacted by Congress in 1976, Medicaid was required to pay for about 300,000 abortions a year.” Under the Hyde Amendment Medicaid funds may no longer be used for elective abortion.
As explained above, Section 4(d) states that S. 1696 does not apply to “insurance coverage.” Therefore, a threshold question would be whether Medicaid funds subject to the Hyde Amendment fall within the meaning of the term “insurance coverage” as that term is used in S. 1696. Plaintiffs seeking to challenge the Hyde Amendment restriction on Medicaid funds might argue, for example, that because Medicaid is a public entitlement program it is not “insurance coverage.” Plaintiffs might also argue, more fundamentally, that Congress knows how to draft abortion rights legislation that unambiguously protects restrictions on taxpayer funded abortion and chose not to do so here. In 1993, U.S. Senate Bill 25, the Freedom of Choice Act of 1993, was reported to the Senate with language stating that “[n]othing in this Act shall be construed to . . . prevent a State from declining to pay for the performance of abortions . . . .” Plaintiffs could argue that the omission of similarly unambiguous language in S. 1696 supports the understanding that S. 1696 does not and was not intended to exclude Medicaid funds subject to the Hyde Amendment from application of S. 1696.
Given the ambiguity of S. 1696 as currently drafted, it is impossible to predict how courts confronted with challenges to Hyde Amendment restrictions on Medicaid funds would interpret the term “insurance coverage.” Federal courts sometimes interpret statutory terms in unpredictable and counterintuitive ways. See, e.g., National Federation of Independent Business v. Sebelius, 132 S. Ct. 2566, 2596 (2012) (concluding that “what is called a ‘penalty’ here may be viewed as a tax”). Analysis of S. 1696 in its current form should be based on the possibility that courts would conclude that the Hyde Amendment restrictions on Medicaid funds fall outside the meaning of the term “insurance coverage” as used in S. 1696 and therefore within the scope of any applicable prohibitions imposed by S. 1696. The same approach applies to taxpayer funds subject to the three prohibitions described in the following paragraphs.
The Hyde Amendment, Executive Order 13535, and PPACA-Funded CHC Programs. The Patient Protection and Affordable Care Act (PPACA) creates a Community Health Centers Fund and makes appropriations for the support of Community Health Centers (CHCs). One question is whether CHCs may, or even must, provide abortion services in programs receiving PPACA funds.
On March 24, 2010, one day after he signed the PPACA, President Obama issued Executive Order 13535. In the Executive Order President Obama stated that the Hyde Amendment, which prohibits abortion in certain federally funded programs, would apply to CHC programs receiving PPACA funds. “Under [PPACA], the Hyde language shall apply to the authorization and appropriations of funds for Community Health Centers under section 10503 [of PPACA] and all other relevant provisions. I hereby direct the Secretary of HHS to ensure that program administrators and recipients of Federal funds are aware of and comply with the limitations on abortion services imposed on CHCs by existing law.”
Debate ensued about whether Executive Order 13535 effectively prohibited abortion in PPACA-funded CHC programs. One analysis, for example, argued that the Hyde Amendment does not apply to PPACA-funded CHC programs, PPACA does not independently prohibit CHCs from providing abortions in PPACA-funded programs, absent a statutory restriction courts are likely to interpret PPACA to require abortion in PPACA-funded CHC programs, and the President of the United States lacks the constitutional authority independently to prohibit abortion services where courts rule that abortion services are required by PPACA in PPACA-funded CHC programs.
If the Hyde Amendment or Executive Order 13535 or both sources of law prohibit abortion services in PPACA-funded CHC programs, then that prohibition would be subject to jeopardy under S. 1696, as set forth below.
Title X Family Planning Programs. Title X of the Public Health Services Act “provides federal funds for project grants to public and private nonprofit organizations for the provision of family planning information and services.”Organizations receiving Title X funds include Planned Parenthood. Federal law currently prohibits Title X funds from being used in programs where abortion is a method of family planning.
The Mexico City Policy. The Mexico City Policy was first instituted by President Reagan in 1984. The policy “required nongovernmental organizations to agree as a condition of their receipt of Federal funds that such organizations would neither perform nor actively promote abortion as a method of family planning in other nations.” Following the Reagan Administration, President George H.W. Bush continued the policy, President Clinton rescinded the policy, President George W. Bush reinstated the policy, and President Obama rescinded the policy. The question is whether S. 1696 would jeopardize the ability of a future president to reinstate the policy.
In several ways S. 1696 would jeopardize not only these and any other Federal policies but also similar State policies that prohibit taxpayer funds from being used to support abortion outside the context of “insurance coverage.”
Section 4(c)(1) makes unlawful “[a] prohibition or ban on abortion prior to fetal viability.” On its face Section 4(c)(1) appears to address measures that would make unlawful the performance of abortion prior to fetal viability. Prohibitions on taxpayer-funded abortion do not make abortion unlawful, they merely restrict abortion in programs receiving taxpayer funds. However, Section 5 commands courts to “liberally construe” provisions of S. 1696 to “effectuate” its purposes. Some courts might conclude that prohibitions on abortion in taxpayer-funded programs constitute a “prohibition” within the meaning of that term as used in Section 4(c)(1). Under this interpretation, prohibitions on elective abortions in taxpayer-funded programs would be invalid when applied before viability, which is when most abortions take place.
Section 4(a)(3) makes unlawful “[a] limitation on an abortion provider’s ability to prescribe or dispense drugs based on her or his good-faith medical judgment, other than a limitation generally applicable to the medical profession.” Providers subject to restrictions attached to taxpayer funds might argue that those restrictions create a “limitation” on their ability to prescribe or dispense drugs that does not apply generally to other health care professionals. S. 1696 does not define the term “limitation” but S. 1696 commands courts to “liberally construe” provisions of S. 1696 to effectuate its purposes. Similarly, organizations that wish to have their employees provide abortions in programs covered by restrictions attached to taxpayer funds, or individuals seeking services in those programs, might argue that they are “aggrieved” by the alleged violation of Section 4(a)(3). Section 6(b)(1) of S. 1696 creates a private right of action for any individual or entity aggrieved by an alleged violation of S. 1696.
Section 4(b) would provide additional bases for challenging prohibitions on taxpayer funding for abortion. Section 4(b) imposes a heightened burden of proof on certain measures or actions.
Section 4(b)(2)(A) imposes a heightened burden of proof on any measure or action that “singles out” the provision of abortion services. If a court concludes that the restrictions on abortion attached to taxpayer funds “single out” the provision of abortion services, then those policies could be enforced only by establishing, through “clear and convincing evidence,” that they “significantly” advance the safety of abortion services or the health of women in the least restrictive way possible.
In addition, Section 4(b)(2)(B) imposes a heightened burden of proof on any measure or action that impedes access to abortion based on “one or more” of the seven factors described in Section 4(b)(3). Those factors include Section 4(b)(3)(A), “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment.” Abortion providers subject to restrictions attached to taxpayer funds could argue that those policies “interfere” with their ability to “provide care” and “render services” in “accordance” with their “good-faith” medical judgment. Similarly, organizations that wish to have their employees provide abortions in programs covered by restrictions attached to taxpayer funds, or individuals seeking services in those programs, might argue that they are “aggrieved” by the alleged violation of Section 4(b). Section 6(b)(1) of S. 1696 creates a private right of action for any individual or entity aggrieved by an alleged violation of S. 1696.
The Section 4(b)(3) factors also include Section 4(b)(3)(C), “[w]hether the measure or action is reasonably likely to directly or indirectly increase . . . the cost for obtaining abortion services.” Abortion providers subject to restrictions attached to taxpayer funds, or individuals seeking services in those programs, might argue that not providing abortion in programs covered by those policies would “indirectly” increase the cost for obtaining abortions by reducing the availability of abortion in general or the availability of free or subsidized abortion in particular. Section 6(b)(1) creates a private right of action for any individual or entity aggrieved by an alleged violation of S. 1696 and Section 6(b)(2) expressly authorizes medical professionals to commence an action on behalf of the professional’s patients who might be adversely affected by an alleged violation of S. 1696.
Prohibitions on taxpayer-funded abortion subjected to the heightened burden of proof under either provision of Section 4(b) would fall unless the government established by clear and convincing evidence that those policies “significantly advanced” either the safety of abortion services or the health of women and did so in the least restrictive way possible. Abortion can be dangerous to mothers, but health and safety are not the only legitimate goals of abortion regulation. For example, “the government has a legitimate, substantial interest in preserving and promoting fetal life,” the government is “permitted to enact persuasive measures which favor childbirth over abortion, even if those measures do not further a health interest,” and “the government may ‘make a value judgment favoring childbirth over abortion, and . . . implement that judgment by the allocation of public funds.’”To the extent that prohibitions on taxpayer funded abortion are designed to advance a policy choice “favor[ing] childbirth over abortion” rather than a health interest, it is reasonable to expect that courts would conclude that the policy does not satisfy the one-sided burden of proof imposed by S. 1696.
Taxpayer-Funded Abortion Training
S. 1696 would also jeopardize prohibitions on using taxpayer funds for abortion training. Section 4(a)(7) makes unlawful “[a] requirement or limitation that prohibits or restricts medical training for abortion procedures, other than a requirement or limitation generally applicable to medical training for medically comparable procedures.” Section 5 commands courts to “liberally construe” the provisions of S. 1696. Applying Section 5, courts might conclude that a policy prohibiting taxpayer funds for abortion training is a “requirement” or “limitation” within the meaning of Section 4(a)(7) and that such a policy “restricts” medical training for abortion procedures. In this reading, State governments would not be permitted to prohibit taxpayer funds from being used for abortion training unless they also prohibited taxpayer funds from being used for training in “medically comparable procedures.” Because S. 1696 fails to define the term “medically comparable procedures” and commands courts to “liberally construe” the provisions of S. 1696, courts could give the term “medically comparable procedures” such a broad construction that, as a practical matter, no State would choose to attempt to satisfy the “generally applicable” standard required to prohibit taxpayer funding for abortion training.
In addition, Section 4(b)(2)(A) imposes a heightened burden of proof on any measure or action that “singles out” the “provision of abortion services.” Section 5 commands courts to “liberally construe” S. 1696. Applying Section 5, a court might construe the phrase “provision of abortion services” to include the training required to provide such services. Under this interpretation a restriction on using taxpayer funds for abortion training would likely be considered a measure that “singles out” the provision of abortion services and is therefore subject to a heightened burden of proof. In this outcome such a policy would stand only if the State established by “clear and convincing evidence” that its policy “significantly” advanced the safety of abortion services or the health of women and that the measure or action was the least restrictive means of doing so.
Abortion can be dangerous to mothers, but health and safety are not the only legitimate goals of abortion regulation. For example, “the government has a legitimate, substantial interest in preserving and promoting fetal life,” the government is “permitted to enact persuasive measures which favor childbirth over abortion, even if those measures do not further a health interest,” and “the government may ‘make a value judgment favoring childbirth over abortion, and . . . implement that judgment by the allocation of public funds.’” However, to the extent prohibitions on using taxpayer funds for abortion training are designed to advance the government’s interest in “promoting fetal life” or policies that “favor childbirth over abortion” rather than a health interest, it is reasonable to expect that at least some courts would conclude that prohibitions on taxpayer funding for abortion training do not satisfy the one-sided burden of proof imposed by S. 1696.
S. 1696 Would Jeopardize Health and Safety Regulations Governing the Use of Abortion Drugs
Medication abortion is distinct from surgical abortion. Surgical abortion involves removing the child from the womb through suctioning or with instruments such as forceps. Medication abortion involves the mother ingesting drugs that disrupt the pregnancy and cause the unborn child to be expelled from the womb.
For medication abortion the Food and Drug Administration has approved the use of the drug known as Mifeprex (mifepristone). Mifeprex is administered in conjunction with a drug known as misoprostol and, as set forth in the label approved for Mifeprex, involves three steps. First, the mother receives a dose of Mifeprex (mifepristone).Second, the mother receives a dose of misoprostol. Third, the woman “must “return” to the provider about 14 days after she has taken Mifeprex to be sure she is well and that the life of the unborn child has been successfully terminated. These drugs are sometimes referred to as the Mifeprex regime, the RU-486 regime, or just RU-486.
The FDA approved Mifeprex under a regulation providing for “restrictions to assure safe use” and the labeling approved for Mifeprex includes extensive health and safety guidelines. For example, Mifeprex is “not approved” for “ending later pregnancies.” Women should “not take” Mifeprex if “[i]t has been more than 49 days (7 weeks) since your last menstrual period began.” In addition, the labeling approved for Mifeprex expressly contemplates that women will undergo each of the three steps in the Mifeprex regime—including the dosage of misoprostol administered in the second step— “at your provider’s office.”
Furthermore, as set forth in a document available on the FDA website, the FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) “is necessary” for Mifeprex to ensure that the “benefits” of the drug outweigh the “risks of serious complications.” As set forth in the REMS abortion providers wishing to provide Mifeprex must first sign a Prescriber’s Agreement stating they satisfy certain qualifications and will follow certain guidelines.The Prescriber’s Agreement expressly states that, “[u]nder Federal law,” Mifeprex “must be” provided by or under the supervision of a physician who meets certain qualifications including the “[a]bility to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.” The Prescriber’s Agreement also informs providers that they “must” provide Mifeprex “in a manner consistent with” guidelines that include the statement that “[t]he patient’s follow-up visit at approximately 14 days is very important to confirm that a complete termination of pregnancy has occurred and that there have been no complications.”
In addition to health and safety guidelines required or approved by the U.S. Food and Drug Administration, many States have adopted health and safety regulations that govern the performance of medication abortion. Texas, for example, recently enacted health and safety regulations that, subject to a specified exception, require that the administration of the abortion-inducing drug “satisfies the protocol tested and authorized by the United States Food and Drug Administration as outlined in the final printed label of the abortion-inducing drug.” The Texas health and safety regulations also require that the person who administers the abortion-inducing drugs be a physician,that before the physician administers the abortion-inducing drug the physician examine the pregnant woman and document the gestational age and intrauterine location of the pregnancy, and that the physician or physician’s agent schedule a follow-up visit for the woman to occur not more than 14 days after the administration of the abortion-inducing drug and during this visit confirm that the pregnancy is completely terminated and assess the degree of bleeding. Other States, while not specifically requiring conformance to FDA-approved guidelines, restrict performance of abortion to licensed physicians or require the physician prescribing abortion medication to be in the presence of the patient.
Documents available on the FDA website set out the potential adverse events associated with Mifeprex. In 2000 the FDA approved labeling for Mifeprex that stated that adverse events following the administration of Mifeprex and misoprostol in trials included abdominal pain, uterine cramping, nausea, headache, vomiting, diarrhea, dizziness, fatigue, back pain, uterine hemorrhage, fever, viral infections, vaginitis, rigors (chills/shaking), dyspepsia, insomnia, asthenia, leg pain, anxiety, anemia, leucorrhea, sinusitis, syncope, endometritis/salpingitis/pelvic inflammatory disease, decrease in hemoglobin greater than two g/dL, pelvic pain, and fainting. In 2005 the FDA approved labeling for Mifeprex that stated that adverse reactions reported during the post-approval use of Mifeprex and misoprostol include allergic reaction (including rash, hives, itching), hypotension (including orthostatic), lightheadedness, loss of consciousness, post-abortal infection (including endomyometritis, parametritis), ruptured ectopic pregnancy, shortness of breath, and tachycardia (including racing pulse, heart palpitations, heart pounding). In 2009 the FDA approved labeling for Mifeprex that stated that “[n]early all of the women who receive Mifeprex and misoprostol will report adverse reactions, and many can be expected to report more than one such reaction.”In 2011 the FDA reported that post-marketing reports of adverse events that occurred among patients who had taken mifepristone for abortion included 14 deaths, 39 instances of blood loss requiring transfusion, and 256 instances of infection including 48 instances of severe infection.
Threats to State Regulations
S. 1696 would jeopardize the ability of States to impose health and safety regulations governing the use of abortion-inducing drugs. Section 4(a)(3) of S. 1696, for example, makes unlawful “[a] limitation on an abortion provider’s ability to prescribe or dispense drugs based on her or his good-faith medical judgment, other than a limitation generally applicable to the medical profession.” S. 1696 fails to explain what kind of limitation on the ability to prescribe or dispense drugs that applied to the Mifeprex regime would also qualify as generally applicable to the medical profession. One potential interpretation of Section 4(a)(3) would be that only an across-the-board ban on off-label uses of all FDA-approved drugs would both restrict off-label uses of the Mifeprex regime and qualify as generally applicable to the medical profession. Under this interpretation States would face a perverse dilemma. States would be forced either to permit abortion providers to subject women to potentially dangerous off-label uses of the Mifeprex regime or to ban all off-label uses of all FDA-approved drugs even though in many cases prescribing FDA-approved drugs for off-label uses might significantly promote patient health. Faced with this choice it seems unlikely that many, if any, States would impose regulations that advance the health and safety of women by requiring administration of the Mifeprex regime according to FDA-approved guidelines.
Other provisions of S. 1696 would also threaten the ability of States to regulate the use of abortion-inducing drugs for health and safety. Section 4(a)(1), for example, makes unlawful “[a] requirement that a medical professional perform specific tests or follow specific medical procedures in connection with the provision of an abortion, unless generally required for the provision of medically comparable procedures.” S. 1696 fails to define what procedures would be “medically comparable” to the Mifeprex regime. If a court ruled that any procedure involving a patient consuming prescription drugs was “medically comparable” to the Mifeprex regime then the State would be prohibited from requiring abortion providers to determine the gestational age of the unborn child, determine whether a pregnancy was ectopic, test for continued pregnancy, and schedule follow-up tests unless those same tests or procedures were required in every situation involving a patient consuming prescription drugs. Faced with this dilemma it seems unlikely that many, if any, States would impose regulations providing for women’s health and safety in the administration of abortion-inducing drugs.
Other provisions of S. 1696 that would jeopardize those regulations include Section 4(b)(2)(A) and Section 4(b)(2)(B). Both these provisions impose a heightened burden of proof on certain measures and actions.
Section 4(b)(2)(A) imposes a heightened burden of proof on any measure or action that “singles out” the provision of abortion services. As with several other key terms, S. 1696 fails to define the term “singles out.” If courts conclude that health and safety regulations governing the use of abortion-inducing drugs “single out” abortion then States would be required to establish, by clear and convincing evidence, that those regulations significantly advance either the safety of abortion services or the health of women and do so in the least restrictive way possible.
In addition, Section 4(b)(2)(B) imposes a heightened burden of proof on any measure or action that “impedes women’s access to abortion services based on one or more of the factors described in” Section 4(b)(3). Section 4(b)(3), in turn, describes several factors that could apply to prohibitions on potentially dangerous off-label uses of the Mifeprex regime, including Section 4(b)(3)(A), “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment,” Section 4(b)(3)(C), “[w]hether the measure or action is reasonably likely to directly or indirectly increase the cost of providing abortion services or the cost for obtaining abortion services (including costs associated with travel, childcare, or time off work),” and Section 4(b)(3)(D), “[w]hether the measure or action requires, or is reasonably likely to have the effect of necessitating, a trip to the offices of the abortion provider that would not otherwise be required.” Between these three provisions S. 1696 would jeopardize regulations restricting the use of Mifeprex to cases of early pregnancy, restricting the performance of abortion to licensed physicians, requiring the prescribing physician to be in the presence of the patient, requiring women to take each step of the Mifeprex regime at the provider’s office, and requiring providers to schedule a follow-up visit at 14 days. For each regulation subjected to heightened scrutiny under S. 1696, States would be required to establish, by clear and convincing evidence, that the regulation significantly advances either the safety of abortion services or the health of women and does so in the least restrictive way possible.
Threats to Federal Regulations
In addition to threatening the ability of States to regulate procedures involving abortion-inducing drugs, S. 1696 could threaten the ability of the FDA to regulate abortion-inducing drugs. As described in Section 4(e), S. 1696 applies to “government restrictions on the provision of abortion services, whether statutory or otherwise, whether enacted or imposed prior to or after the date of enactment of the Act” (emphasis added), and Section 3(3) defines “government” to include a department or agency acting under color of law of the United States. The FDA approved Mifeprex under a regulation providing for “restrictions to assure safe use.” Under this regulation, if the FDA concludes that a drug can be safely used “only if distribution or use is restricted,” then the FDA “will require” postmarketing restrictions such as “[d]istribution conditioned on the performance of specified medical procedures.”
A review of the regulatory history of Mifeprex reveals that, in fact, the FDA determined that a Risk Evaluation and Mitigation Strategy [REMS] “is necessary” for Mifeprex to ensure that the “benefits” of the drug outweigh the “risks of serious complications.” As set forth in the REMS, abortion providers wishing to provide Mifeprex must first sign a Prescriber’s Agreement stating they satisfy certain qualifications and will follow certain guidelines. The Prescriber’s Agreement expressly states that, “[u]nder Federal law,” Mifeprex “must be” provided by or under the supervision of a physician who meets certain qualifications including the “[a]bility to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.” The Prescriber’s Agreement also informs prescribers that they “must” provide Mifeprex “in a manner consistent with” guidelines including the statement that “[t]he patient’s follow-up visit at approximately 14 days is very important to confirm that a complete termination of pregnancy has occurred and that there have been no complications.”
Plaintiffs could argue that the REMS approved by the FDA for Mifeprex is a “measure or action” within the meaning of Section 4(b) of S. 1696. If a court concludes that the guidelines and requirements set forth in the REMS “single out” abortion services under Section 4(b)(2)(A), “interfere with” an abortion provider’s ability to render services in accordance with her or his “good-faith” medical judgment under Section 4(b)(2)(B) and Section 4(b)(3)(A), or are “reasonably likely” to either “directly or indirectly” increase the cost of providing abortion services under Section 4(b)(2)(B) and Section 4(b)(3)(C), then the FDA would be required to demonstrate, through clear and convincing evidence, that its regulation significantly advances the safety of abortion services or the health of women and does so in the least restrictive way possible.
S. 1696 might even authorize pharmaceutical companies that manufacture abortion drugs to challenge FDA regulations in Federal court. Section 6(b)(1) creates a “private right of action” for “[a]ny” individual or “entity” that is “aggrieved” by an “alleged” violation of S. 1696. Pharmaceutical companies might argue that measures or actions taken by the FDA with respect to abortion drugs violate S. 1696 and that the pharmaceutical companies are “aggrieved” by these “alleged” violations. In this scenario pharmaceutical companies that manufacture abortion drugs would be accorded special treatment and the FDA would face additional obstacles in fulfilling its mission of “protecting the public health.”
S. 1696 Would Jeopardize Health and Safety Regulations Governing the Practice of Telemedicine Abortion
“Telemedicine abortion” is where a woman procures a medication abortion without meeting in person with a physician. Rather a woman “meets” with a physician using a teleconferencing technology such as Skype. The abortion drugs are then dispensed remotely by the physician pushing a button that opens a box containing the drugs. This procedure is sometimes referred to as “webcam abortions.”
The practice of telemedicine abortion has raised safety concerns centered around the failure of physicians to attend to the patient in person. One State-level board of medicine, for example, recently concluded that “[t]he practices used by physicians who prescribe and administer abortion-inducing drugs using telemedicine are inconsistent with the protocols approved by the U.S. Food and Drug Administration (FDA) and the manufacturer of the drugs.” In particular, “A physical examination of the patient in telemedicine settings is not being performed by the physician who prescribes and administers the abortion-inducing drugs . . . .”
Sound reasons exist for deciding that drug-induced abortion procedures should be performed by a licensed physician who is physically present with the woman. For example, States might reasonably conclude that requiring a physician to be physically present strengthens the physician-patient relationship. Abortion is unlike any other decision a woman will make. It is “fraught with consequences” for both the woman as well as her unborn child. A strong physician-patient relationship benefits women who, when considering abortion, must first understand the procedure, how it will affect their child, and what health consequences they are likely to face during the course of the procedure, immediately following, and longer term.
In addition, States might reasonably conclude that physicians, as opposed to nonphysicians, should conduct a physical examination before conducting a medication abortion. According to labeling approved by the FDA women should not take Mifeprex if more than 49 days have passed since their last menstrual period began or if they have an ectopic pregnancy. Before providing Mifeprex providers must complete a “Prescriber’s Agreement” that certifies they meet certain qualifications and will follow certain guidelines. The Prescriber’s Agreement specifically states that, “[u]nder Federal law,” Mifeprex “must” be provided “by or under the supervision” of a physician who is able to “assess the duration of pregnancy accurately” and “diagnose ectopic pregnancies.” A physical examination by a physician can be used to confirm and properly interpret any ultrasonic findings as well as help to identify whether a woman experiences conditions where administering the Mifeprex regime will not be effective or requires additional caution. Requiring a physician to be present can help to ensure that ultrasonic findings are reliable and properly interpreted and that a physical examination is available to all women who might benefit from closer personal attention by a licensed medical doctor.
Moreover, States might reasonably conclude that requiring a licensed physician to be present contributes to patient safety throughout the course of the Mediprex regime. In particular, the follow-up visit at about 14 days is “very important.” Before providing Mifeprex providers must complete a “Prescriber’s Agreement” that certifies they meet certain qualifications and will follow certain guidelines. The Prescriber’s Agreement specifically states that “[t]he patient’s follow-up visit at approximately 14 days is very important to confirm that a complete termination of pregnancy has occurred.” The 14-day follow-up visit is also “very important” to confirm that “there have been no complications.” “Complications” associated with the Mifeprex regime are a very real possibility: Labeling approved by the FDA in 2009 openly stated that “[n]early all of the women who receive Mifeprex and misoprostol will report adverse reactions, and many can be expected to report more than one such reaction.” It is no surprise, therefore, that the Prescriber’s Agreement expressly requires Mifeprex to be provided by or under the supervision of a physician who meets certain qualifications including the “[a]bility to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and [be] able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.”States might reasonably conclude that requiring that a licensed physician be present throughout the Mifeprex regime increases the standard of care provided during the abortion procedure.
S. 1696 would jeopardize the ability of States to require medication abortions to be provided in person by a licensed physician. For example, Section 4(a)(4) makes unlawful “[a] limitation on an abortion provider’s ability to provide abortion services via telemedicine, other than a limitation generally applicable to the provision of medical services via telemedicine.” Under this provision, any requirement that doctors provide abortion services in person, rather than remotely using teleconferencing technology, would be unlawful unless the same requirement was imposed across the board for every health care service. Of course such a requirement would effectively ban the practice of telemedicine altogether. If telemedicine advances patient wellbeing and public health in many contexts, then it is unlikely States would be willing to enact an across-the-board ban on all telemedicine services in order to impose tailored safety measures in the abortion context specifically. In this scenario S. 1696 would, as a practical matter, likely clear the way for providers such as Planned Parenthood to increase the practice of telemedicine abortion.
In addition, Section 4(a)(2) of S. 1696 makes unlawful “[a] limitation on an abortion provider’s ability to delegate tasks, other than a limitation generally applicable to providers of medically comparable procedures.” Depending on how courts interpreted the term “medically comparable procedures” this provision, as a practical matter, could threaten the ability of States to require physicians to personally examine women before and during the course of abortion procedures. Furthermore, Section 4(a)(3) makes unlawful “[a] limitation on an abortion provider’s ability to prescribe or dispense drugs based on her or his good-faith medical judgment, other than a limitation generally applicable to the medical profession.” Depending on how courts applied the term “generally applicable to the medical profession,” this provision, as a practical matter, could jeopardize regulations requiring adherence to certain procedures in administering the Mifeprex regime, including in-person examinations and mandatory follow-up visits, that were not also required for the prescription and dispensation of every other drug.
In addition, Section 4(b) of S. 1696 would likely impose a heightened burden of proof on any attempt by a State to require a licensed physician to conduct an in-person examination and personally supervise women undergoing medication abortion.
Section 4(b)(2)(A) imposes a heightened burden of proof on any measure or action that “singles out” the provision of abortion services. If courts conclude that regulations requiring a licensed physician to be physically present during a medication abortion “single out” abortion services, then the State would be required to establish by clear and convincing evidence that the regulations “significantly advance” the safety of abortion services or the health of women and that they do so in the least restrictive way possible.
Similarly, Section 4(b)(2)(B) imposes a heightened burden of proof on any measure or action that impedes access to abortion based on “one or more” of the seven factors described in Section 4(b)(3). The Section 4(b)(3) factors include Section 4(b)(3)(A) and Section 4(b)(3)(C). Section 4(b)(3)(A) makes as a factor “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment.” This provision provides a powerful trump card to challenge health and safety regulations requiring a licensed physician to be physically present with women undergoing medication abortion. Section 4(b)(3)(C) makes as a factor “[w]hether the measure or action is reasonably likely to directly or indirectly increase the cost of providing abortion services.” If requiring licensed physicians to be present with patients means that abortion services cost more than when physicians simply “teleconference in” from an iPhone or other device, this provision would further jeopardize regulations governing the practice of telemedicine abortion.
S. 1696 Would Jeopardize Sonogram and Fetal Heartbeat Test Requirements
Several States require abortion providers, before providing an abortion, to conduct an ultrasound and to share or offer to share the sonogram with the mother. In addition, some States require abortion providers, before providing an abortion, to test or offer to test for fetal heartbeat and to offer the mother the opportunity to view or listen to the heartbeat of her unborn child.
Sonogram and fetal heartbeat tests advance two important public policy interests. First, they advance women’s health by strengthening the informed consent process before undergoing an abortion. “[I]t seems unexceptionable to conclude some women come to regret their choice to abort the infant life they once created and sustained,” and “reducing the risk that a woman may elect an abortion, only to discover later, with devastating psychological consequences, that her decision was not fully informed” is a legitimate legislative purpose. Second, sonogram and fetal heartbeat test requirements advance the State’s legitimate interest in protecting the life of unborn children. “[T]he government has a legitimate, substantial interest in preserving and promoting fetal life,” and it cannot “be doubted that most women considering an abortion would deem the impact on the fetus relevant, if not dispositive, to the decision.”
S. 1696 jeopardizes the ability of States to require abortion providers, before performing an abortion, to produce a sonogram, to test for fetal heartbeat, and to share or offer to share the medical information obtained by those procedures with the mother. Section 4(a)(1) makes unlawful “[a] requirement that a medical professional perform specific tests or follow specific medical procedures in connection with the provision of an abortion, unless generally required for the provision of medically comparable procedures.” S. 1696 does not define the term “medically comparable procedures.” Because Section 3(1) of S. 1696 defines abortion to include medication abortion as well as surgical abortion, a potentially wide range of procedures could be adjudged as “medically comparable” to abortion. For example, medication abortion involves a patient consuming a prescription drug. If a court concluded that abortion was “medically comparable” to any treatment involving a patient consuming a prescription drug, then States would not be permitted to require ultrasound and fetal heartbeat tests before abortion unless they required those same tests before any procedure involving a patient consuming a prescription drug. In this scenario it is unlikely that, as a practical matter, many if any States would seek to defend or enact laws imposing ultrasound and fetal heartbeat test requirements before conducting abortion.
In addition, Section 4(b) of S. 1696 could be interpreted to impose a heightened burden of proof on laws requiring sonogram and fetal heartbeat tests. Section 4(b)(2)(A) imposes a heightened burden of proof if a measure or action “singles out” the provision of abortion services. As with several key terms, S. 1696 fails to define the term “singles out.” If a court concludes that sonogram and fetal heartbeat test requirements “single out” abortion, then States would be forced to satisfy the heightened burden of proof imposed by Section 4(b).
Similarly, Section 4(b)(2)(B) imposes a heightened burden of proof if a measure or action impedes access to abortion services based on “one or more” of seven factors set forth in Section 4(b)(3). Those factors include Section 4(b)(3)(A), “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment,” Section 4(b)(3)(B), “[w]hether the measure or action is reasonably likely to delay some women in accessing abortion services,” and Section 4(b)(3)(C), “[w]hether the measure or action is reasonably likely to directly or indirectly increase the cost of providing abortion services or the cost for obtaining abortion services.” Depending on the facts of the case and how certain key terms are interpreted, any of these provisions could provide a basis for subjecting sonogram and fetal heartbeat test requirements to the heightened burden of proof.
The heightened burden of proof imposed by Section 4(b) requires States to establish, by “clear and convincing” evidence, that a challenged law “significantly advances” either the safety of abortion services or the health of women and does so in the least restrictive way possible. Sonogram and fetal heartbeat test requirements advance women’s health by reducing the likelihood of experiencing potentially “devastating psychological consequences” from later realizing that a decision to choose abortion “was not fully informed.” However, health and safety are not the only legitimate goals of abortion regulation. For example, “the government has a legitimate, substantial interest in preserving and promoting fetal life,” and the government is permitted to further its “legitimate goal of protecting the life of the unborn by enacting legislation aimed at ensuring a decision that is mature and informed, even when in so doing the State expresses a preference for childbirth over abortion.” However, the heightened burden of proof imposed by Section 4(b) makes no allowance for such interests. If courts applied the Section 4(b) burden of proof and ruled that the health interests advanced by sonogram and fetal heartbeat test requirements were insufficient to satisfy that burden, then those requirements would fall.
S. 1696 Would Jeopardize Mandatory Reflection Periods that the U.S. Supreme Court Has Upheld
In the 1992 Planned Parenthood v. Casey case, the U.S. Supreme Court upheld a law requiring that a physician provide a woman with certain information at least 24 hours before performing an abortion. The Court upheld the mandatory reflection period even though it could result in women having to make a second trip to the abortion provider. Today roughly half the States mandate a reflection period, most often 24 hours, before a woman may subject herself and her unborn child to an abortion.
S. 1696 would jeopardize the type of mandatory reflection period that the U.S. Supreme Court upheld in Casey. Section 4(a)(6) makes unlawful “[a] requirement that, prior to obtaining an abortion, a woman make one or more medically unnecessary visits to the provider of abortion services or to any individual or entity that does not provide abortion services.” States could argue that mandatory reflection periods are “medically necessary,” but, as with several key terms, S. 1696 fails to define that term. If courts interpreted the term “medically unnecessary” to include visits for the purpose of informing consent to the abortion procedure, then S. 1696 would make unlawful mandatory reflection periods that begin upon the conclusion of such a visit.
Mandatory reflection periods might also be jeopardized by provisions of S. 1696 imposing a heightened burden of proof on certain measures. Section 4(b)(2)(A) imposes a heightened burden of proof if a measure or action “singles out” the provision of abortion services. As with several key terms, S. 1696 fails to define the term “singles out.” If courts rule that a mandatory reflection requirement “singles out” abortion by addressing abortion specifically, even if similar requirements are imposed separately on other but not all medical procedures, then mandatory reflection periods such as those upheld by the U.S. Supreme Court in Casey would be subjected to a heightened burden of proof.
Similarly, Section 4(b)(2)(B) imposes a heightened burden of proof if a measure or action impedes access to abortion services based on “one or more” of seven factors set forth in Section 4(b)(3). Those factors include Section 4(b)(3)(A), “[w]hether the measure or action interferes with an abortion provider’s ability to provide care and render services in accordance with her or his good-faith medical judgment,” Section 4(b)(3)(B), “[w]hether the measure or action is reasonably likely to delay some women in accessing abortion services,” Section 4(b)(3)(C), “[w]hether the measure or action is reasonably likely to directly or indirectly increase the cost of . . . obtaining abortion services (including costs associated with travel, childcare, or time off work),” and Section 4(b)(3)(D), “[w]hether the measure or action requires, or is reasonably likely to have the effect of necessitating, a trip to the offices of the abortion provider that would not otherwise be required.”
The heightened burden of proof imposed by Section 4(b) requires States to establish, by “clear and convincing” evidence, that a challenged law “significantly” advances either the safety of abortion services or the health of women and does so in the least restrictive way possible. Reflection periods advance women’s health by “ensuring a decision that is mature and informed,” but health and safety are not the only legitimate goals of abortion regulation. For example, “the government has a legitimate, substantial interest in preserving and promoting fetal life,” an interest that a required period of reflection can help to advance. However, the heightened burden of proof imposed by Section 4(b) makes no allowance for such interests. If courts applied the Section 4(b) burden of proof and ruled that the health interests advanced by required reflection periods were insufficient to satisfy that burden, then those requirements would fall.
S. 1696 Could Be Interpreted to Trump State and Federal Conscience Protections
Federal laws as well as laws in many States protect individuals and institutions that conscientiously object to participating in abortion. S. 1696 could trump these laws.
Section 4(b) imposes a heightened burden of proof on certain measures and actions. Where a conscience protection law was subjected to the heightened burden of proof under S. 1696, the government would be forced to establish by “clear and convincing” evidence that the conscience protection law significantly advanced the safety of abortion services or the health of women and did so in the least restrictive way possible.
Several provisions of Section 4(b) could be interpreted to subject conscience protection laws to a heightened burden of proof.
Section 4(b)(2)(A) imposes a heightened burden of proof on any measure or action that “singles out” the provision of abortion services or the facilities where abortion services are provided. Some conscience protection laws, such as the federal Religious Freedom Restoration Act, apply generally without singling out particular subject matter. But some conscience protection laws specifically protect conscience in the area of abortion services. The Federal “Church Amendment,” for example, specifically protects conscientious objection involving abortion and sterilization.Similarly, the Federal “Danforth Amendment” creates conscience protections for abortion and no other subject matter, and conscience protection laws in some States take a similar approach. If a court concluded that these or similar laws “singled out” abortion within the meaning of Section 4(b) then those laws would fall unless the government satisfied the high burden of proof imposed by S. 1696.
In addition, Section 4(b)(2)(B) imposes a heightened burden of proof on any measure or action that impedes access to abortion based on “one or more” factors described in Section 4(b)(3). Those factors include Section 4(b)(3)(E), “[w]hether the measure or action is reasonably likely to result in a decrease in the availability of abortion services in the State,” Section 4(b)(3)(C), “[w]hether the measure or action is reasonably likely to directly or indirectly increase . . . the cost for obtaining abortion services (including costs associated with travel, childcare, or time off work),” and Section 4(b)(3)(B), “[w]hether the measure or action is reasonably likely to delay some women in accessing abortion services.”
Where plaintiffs make a prima facie showing of unlawfulness under either Section 4(b)(2)(A) or Section 4(b)(2)(B), the government can defend by establishing by clear and convincing evidence that the challenged policy significantly advances either the safety of abortion services or women’s health and does so in the least restrictive way possible. However, this test gives no weight to the government’s interest in protecting religious freedom and right of conscience. Therefore, S. 1696 could have the effect of undermining essential legal protections for health care professionals and institutions that conscientiously object to participating in abortion.
As set forth in a brief submitted to the U.S. Supreme Court on behalf of amici curiae including the Charlotte Lozier Institute, the United States enjoys a “long- and well-established tradition of recognizing the need for abortion-related conscience rights and protecting those rights in federal law.”
In Roe v. Wade, for example, this Court cited abortion-related conscience protections embraced by the American Medical Association (“AMA”). In describing the history of AMA viewpoints regarding abortion, the Court cited an AMA resolution that described abortion coldly as “‘a medical procedure’” but also stated that “‘[n]either physician, hospital, nor hospital personnel shall be required to perform any act violative of personally-held moral principles.’” Similarly, in Doe v. Bolton, the companion case to Roe, this Court cited abortion-related conscience protections provided by Georgia law. “These provisions obviously are in the statute,” the Court wrote, “in order to afford appropriate protection to the individual and to the denominational hospital.”
Then, just months after this Court decided the Roe and Doe cases, Congress passed federal legislation commonly referred to as the Church Amendment, which protects abortion-related conscience rights of both individuals and institutions. Senator Ted Kennedy, who would become known for his vocal support of abortion rights, spoke in favor of the Church Amendment during debate in the Senate, and Members of Congress overwhelmingly supported the legislation. In enacting the Church Amendment, “Congress quite properly sought to protect the freedom of religion of those with religious or moral scruples against . . . abortions.”
Since Congress passed the Church Amendment in 1973, the principle of conscientious objection has been repeatedly affirmed and, today, federal law contains several protections for rights of conscience in the context of abortion.
Similar protections exist in many States.
Because the burden of proof imposed by S. 1696 gives no weight to the government’s interest in protecting conscience in the abortion context, S. 1696 would jeopardize protections for religious freedom and conscience secured by State and Federal laws unless in effect, those protections were saved by some other law such as the Free Exercise Clause of the First Amendment to the U.S. Constitution.
Thomas M. Messner is a Legal Policy Fellow at the Charlotte Lozier Institute.
 Harris v. McRae, 448 U.S. 297, 325 (1980).
 Corley v. United States, 556 U.S. 303, 314 (2009) (internal quotations omitted).
 United States v. Menasche, 348 U.S. 528, 538-39 (1955) (internal quotations omitted).
 Ransom v. FIA Card Servs., N.A., 131 S.Ct. 716, 724 (2011).
 Planned Parenthood of Se. Pennsylvania v. Casey, 505 U.S. 833, 852 (1992).
 Harris v. McRae, 448 U.S. 297, 325 (1980).
 Greenville Women’s Clinic v. Bryant, 222 F.3d 157, 173 (4th Cir. 2000).
 See Guttmacher Institute, State Policies in Brief: State Policies on Later Abortions (July 1, 2014), http://www.guttmacher.org/statecenter/spibs/spib_PLTA.pdf; Betsy Johnson, Momentum for Late-Term Abortion Limits, Charlotte Lozier Institute (Aug. 5, 2013), https://lozierinstitute.org/momentum-for-late-term-abortion-limits/; Pain-Capable Unborn Child Protection Act, H.R. 1797, 113th Cong. (2013), available athttps://beta.congress.gov/bill/113th-congress/house-bill/1797?q=%7B%22search%22%3A%5B%22pain-capable%22%5D%7D.
 Pain-Capable Unborn Child Protection Act, H.R. 1797, 113th Cong. (2013), available athttps://beta.congress.gov/bill/113th-congress/house-bill/1797?q=%7B%22search%22%3A%5B%22pain-capable%22%5D%7D. See National Right to Life, Pain of the Unborn, http://nrlc.djcweb.net/abortion/fetalpain/ (last visited July 12, 2014) (view sources listed under heading “The Scientific Evidence”).
 Mississippi Women Better Protected as Governor Signs Historic Legislation, Americans United for Life (Apr. 23, 2014), http://www.aul.org/2014/04/mississippi-women-better-protected-as-governor-signs-historic-legislation/.
 The District of Columbia Pain-Capable Unborn Child Protection Act: Hearing on H.R. 3803, Before the Subcomm. on the Constitution of the H. Comm. On the Judiciary, 112th Cong. 65 (2012) (Testimony of Colleen A. Malloy, M.D., Assistant Professor, Division of Neonatology/Department of Pediatrics, Northwestern University Feinberg School of Medicine), available at http://judiciary.house.gov/_files/hearings/printers/112th/112-118_74261.PDF.
 Isaacson v. Horne, 716 F.3d 1213 (2013), cert. denied, 134 S. Ct. 905 (2014). Note existence of additional litigation at Guttmacher Institute, State Policies in Brief: State Policies on Later Abortions (July 1, 2014), http://www.guttmacher.org/statecenter/spibs/spib_PLTA.pdf.
 See Randy Beck, State Interests and the Duration of Abortion Rights, 44 McGeorge L. Rev. 31 (2013); Randy Beck, The Essential Holding of Casey: Rethinking Viability, 75 UMKC L. Rev. 713 (2007).
 Ashwander v. Tennessee Valley Auth., 297 U.S. 288, 347 (1936) (Brandeis, J., concurring).
 Ariz. Rev. Stat. Ann. §§ 13-3603.02 (Westlaw 2011) (sex, race); 720 Ill. Comp. Stat. 510/6(8) (Westlaw 2008) (sex); Kan. Stat. Ann. § 65-6726 (West 2013) (sex); N.C. Gen. Stat. Ann. § 90-21.121 (sex); N.D. Cent. Code Ann. § 14-02.1-04.1 (Westlaw 2013) (sex, disability); Okla. Stat. Ann. tit. 63, § 1-731.2 (Westlaw 2010) (sex); 18 Pa. Cons. Stat. Ann. § 3204(c) (Westlaw 2008) (sex).
 Mailee R. Smith, 2013 State Legislative Sessions: Unabashedly Pro-Life and Pro-Woman, in The Women’s Protection Project 17, 18 (Americans United for Life, 2014), http://www.aul.org/wp-content/uploads/2014/03/Defending_Life_Book_FINAL_4-WPP.pdf.
 Mazurek v. Armstrong, 520 U.S. 968, 974 (1997) (per curiam).
 Guttmacher Institute, State Policies in Brief: An Overview of Abortion Laws, (July 1, 2014), http://www.guttmacher.org/statecenter/spibs/spib_OAL.pdf (stating that “39 states require an abortion to be performed by a licensed physician”).
 Susan B. Anthony List, Fact Sheet: Abortion Industry Negligence Nationwide, http://www.sba-list.org/sites/default/files/content/shared/07.24.13_updated_version_abortion_clinic_violations_fact_sheet.pdf.
 Mailee R. Smith, 2013 State Legislative Sessions: Unabashedly Pro-Life and Pro-Woman, in The Women’s Protection Project 17, 18 (Americans United for Life, 2014), http://www.aul.org/wp-content/uploads/2014/03/Defending_Life_Book_FINAL_4-WPP.pdf.
 See Tex. Health & Safety Code Ann. § 245.010 (West 2013) (“[T]he minimum standards for an abortion facility must be equivalent to the minimum standards adopted under Section 243.010 for ambulatory surgical centers.”); Ala. Code § 26-23E-9 (2014) (“An abortion or reproductive health center shall be classified as ambulatory health care occupancy and shall meet all standards in the NFPA 101 Life Safety Code 2000 edition, or such standards in any later edition of the NFPA 101 Life Safety Code that the Board of Health may adopt for facilities classified as ambulatory health care occupancy.”). Further, the model legislation proposed by AUL specifically contemplates that health and safety standards imposed on abortion clinics will be linked to the standards already imposed on similar entities already regulated by State law. See Americans United for Life, Abortion Patients’ Enhanced Safety Act § 4(b), http://www.aul.org/wp-content/uploads/2013/12/Model-Legislation.pdf.
 Roe v. Wade, 410 U.S. 113, 164 (1973).
 Guttmacher Institute, State Policies in Brief: State Policies on Later Abortions (July 1, 2014), http://www.guttmacher.org/statecenter/spibs/spib_PLTA.pdf. In an opinion issued in 1998 Justice Thomas wrote, “The vast majority of the 38 States that have enacted postviability abortion restrictions have not specified whether such abortions must be permitted on mental health grounds.” Voinovich v. Women’s Medical Professional Corp., 118 S.Ct. 1347, 1349 (1998) (Thomas, J., dissenting).
 See State Policies in Brief: State Policies on Later Abortions, supra. At least two States require involvement of a second and third physician. See Mont. Code Ann. § 50-20-109(2)(a)-(b) (2014); Va. Code Ann. § 18.2-74(b) (West 2009).
 Gonzales v. Carhart, 550 U.S. 124, 126 (2007).
 Ashwander v. Tennessee Valley Auth., 297 U.S. 288, 347 (1936) (Brandeis, J., concurring).
 Webster v. Reprod. Health Servs, 492 U.S. 490, 511 (1989).
 Compare Consolidated Appropriations Act, 2014, Pub. L. No. 113-76, div. H (Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2014), tit. ii (2014) (providing for “grants to states for medicaid”), with id., tit. v, § 506 (providing that “[n]one of the funds appropriated in this Act, and none of the funds in any trust fund to which funds are appropriated in this Act, shall be expended for any abortion”), and id., § 507(a) (providing for exceptions to general prohibition).
 Anthony Picarello and Michael Moses, Office of the General Counsel of the United States Conference of Catholic Bishops, Legal Analysis of the Provisions of the Patient Protection and Affordable Care Act and Corresponding Executive Order Regarding Abortion Funding and Conscience Protection 2 (Mar. 25, 2010), available athttp://www.usccb.org/about/general-counsel/upload/Healthcare-EO-Memo.pdf.
 The Freedom of Choice Act of 1993, S. 25, 103d Cong. § 3(b)(2) (as reported to the Senate on Apr. 29, 1993).
 See Patient Protection and Affordable Care Act, 2010, Pub. L. 111–148, tit. X, § 10503.
 Exec. Order No. 13,535, 75 Fed. Reg. 15,599 (Mar. 24, 2010).
 Exec. Order No. 13,535, 75 Fed. Reg. 15,599 (Mar. 24, 2010).
 See Picarello & Moses, supra note 35, at 1–4.
 Abortion Facts, Abortion and Title X: What Health Care Providers Need to Know, National Abortion Federation, https://www.prochoice.org/about_abortion/facts/abortion_title_x.html (last visited July 8, 2014).
 The Case for Investigating Planned Parenthood 14, Americans United for Life (July 7, 2011), available athttp://www.aul.org/wp-content/uploads/2011/07/PPReport_FULL.pdf (describing Planned Parenthood as “Title X’s largest recipient”).
 42 U.S.C.A. § 300a-6.
 George W. Bush, Memorandum on Restoration of the Mexico City Policy, for the Adm’r of the United States Agency for Int’l Dev. (Jan. 22, 2001), http://www.gpo.gov/fdsys/pkg/WCPD-2001-01-29/pdf/WCPD-2001-01-29-Pg216.pdf. Accord Planned Parenthood Fed’n of Am., Inc. v. Agency for Int’l Dev., 915 F.2d 59, 61 (2d Cir. 1990) (quoting Policy Statement of the United States of America at the United Nations International Conference on Population (Second Session) Mexico, D.F., August 6-13, 1984, at 4-5, and providing details of how policy was implemented); John Blane & Matthew Friedman, Mexico City Policy Implementation Study (Nov. 21, 1990),http://pdf.usaid.gov/pdf_docs/PNABG765.pdf. The policy includes exceptions for abortions in cases of rape, incest, or threat to the mother’s life. See Blane & Matthew, supra, at 3; Memorandum for the Administrator of the United States Agency for International Development: Restoration of the Mexico City Policy, 66 Fed. Reg. 17,303 (Mar. 28, 2001), http://www.gpo.gov/fdsys/pkg/FR-2001-03-29/pdf/01-8011.pdf.
 See Daniel Briggs, The Mexico City Policy, Americans United for Life (Apr. 23, 2010), http://www.aul.org/2010/04/the-mexico-city-policy/
 Gonzales v. Carhart, 550 U.S. 124, 126 (2007).
 Planned Parenthood of Se. Pennsylvania v. Casey, 505 U.S. 833, 886 (1992) (plurality).
 Rust v. Sullivan, 500 U.S. 173, 192–93 (1991) (quoting Maher v. Roe, 432 U.S. 464, 474 (1977)) (explaining that “[h]ere the Government is exercising the authority it possesses . . . to subsidize family planning services which will lead to conception and childbirth, and declining to ‘promote or encourage abortion’”).
 In 2011, Arizona passed a bill that prohibited public monies or tax monies from being “expended or allocated for training to perform abortions.” H.R. 2384, 50th Leg., 1st Reg. Sess. (Ariz. 2011), 2011 Ariz. Legis. Serv. Ch. 55 (West). In 2011 the U.S. House of Representatives passed a measure that would have limited certain funds for being used to provide “training in the provision of abortions.” H.R. 1216, 112th Cong. (1st Sess. 2011).
 Gonzales, 550 U.S. at 126.
 Casey, 505 U.S. at 886 (plurality).
 Rust, 500 U.S. at 192–93 (quoting Maher, 432 U.S. at 474).
 See, e.g., Gonzales, 550 U.S. at 134–40.
 Details on Mifeprex can be accessed on the U.S. Food and Drug Administration’s Drugs@FDA’s webpage, which is available at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.
 U.S. Food and Drug Admin., Medication Guide: Mifeprex, available athttp://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf.
 See Danco Laboratories, LLC, Dep’t of Health and Human Servs. Supplemental Approval Letter (NDA 020687/S-014) (June 8, 2011), http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020687s014ltr.pdf; Applications for FDA Approval to Market a New Drug, 21 C.F.R. § 314.520 (2014).
 Medication Guide: Mifeprex, supra note 55.
 See Supplemental Approval Letter, supra note 58.
 Risk Evaluation and Mitigation Strategy (REMS): NDA 20-687 Mifeprex § II.B.1.a, http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM258412.pdf.
 Prescriber’s Agreement, in id.
 Guttmacher Institute, State Policies in Brief: Medication Abortion (July 1, 2014), http://www.guttmacher.org/statecenter/spibs/spib_MA.pdf.
 Tex. Health & Safety Code Ann. § 171.063(2) (Westlaw 2013).
 Id., § 171.063(1).
 Id., § 171.063(c).
 Id, § 171.063(e).
 State Policies in Brief: Medication Abortion, supra note 66.
 Mifeprex Tablets Label 13 (Rev. 4 2009), http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020687s015lbl.pdf.
 Id. at 11.
 RCM 2007-525, NDA 20-687, Mifepristone U.S. Postmarketing Adverse Events Summary through 4/30/2011 (July 7, 2011), http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM263353.pdf. Creating even more cause for alarm, the FDA openly admitted that “information gaps” prevented establishing “with certainty” the “causal” relationship between Mifeprex and these adverse events. Id.
 See Supplemental Approval Letter, supra note 58; Applications for FDA Approval to Market a New Drug, 21 C.F.R. § 314.520.
 21 C.F.R. § 314.520(a).
 See Supplemental Approval Letter, supra note 58.
 REMS, supra note 63, at § II.B.1.a.
 Prescriber’s Agreement, in id.
 About FDA: What We Do, Food and Drug Administration, http://www.fda.gov/aboutfda/whatwedo/ (last visited July 8, 2014).
 See, e.g., Cheryl Sullenger, “Planned Parenthood Halts Webcam Abortions at Tenth Iowa Facility,” July 8, 2014, Lifenews.com, http://www.lifenews.com/2014/07/08/planned-parenthood-halts-webcam-abortions-at-tenth-iowa-facility/.
 Iowa Board of Medicine, Iowa Board of Medicine’s Statement on Adopted and Filed Rule ARC 1034C (Sept. 27, 2013), https://medicalboard.iowa.gov/Board%20News/2013/Board%20issues%20statement%20on%20adopted%20rule%20ARC%201034C%20-%20092713.pdf.
 Id. The brief cited in this footnote and the preceding footnote was submitted in a case in which a state court entered an order of temporary stay pending judicial review. See Ruling on Motion to Stay Pending Judicial Review of Agency Action and Declaratory Judgment and Injunctive Relief, Planned Parenthood of the Heartland, Inc. v. Iowa Bd. of Medicine (Iowa District Court for Polk County 2014) (No. CVCV046429). The court expressed some doubt about regulations governing the practice of telemedicine issued by the Board, see id. at 14-15, but stated that “the Court makes clear that this ruling is extremely narrow in scope” and “does not, in any way, decide the merits of Petitioners’ constitutional and other claims,” id. at 5.
 Planned Parenthood of Se. Pennsylvania v. Casey, 505 U.S. 833, 852 (1992).
 U.S. Food and Drug Admin., Medication Guide: Mifeprex, available athttp://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf.
 Mifeprex Tablets Label, supra note 72, at 11. The current label was approved on June 8, 2011, and is available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf.
 Medication Guide: Mifeprex, supra note 55.
 Guttmacher Institute, State Policies in Brief: Requirements for Ultrasound (July 1, 2014), http://www.guttmacher.org/statecenter/spibs/spib_RFU.pdf.
 See Ark. Code Ann. § 20-16-1303(a) (West 2013); Ind. Code (2014) §§ 16-34-2-1.1(a)(1)(I), 16-34-2-1.1(a)(3)(B)(ii), 16-34-2-1.1(b)(2); La. Rev. Stat. Ann. § 40:1299.35.2(D)(2)(a), amended by 2014 La. Sess. Law Serv. Act 602 (West); Miss. Code Ann. § 41‑41-34(1)(a), (b) (West 2007); N.C. Gen. Stat. § 90-21.85(a)(2) (2011), invalidated in part by Stuart v. Loomis, 1:11-CV-804, 2014 WL 186310 (M.D.N.C. Jan. 17, 2014); N.D. Cent. Code Ann. § 14-02.1-05.1(1) (West 2013), invalidated by MKB Mgmt. Corp. v. Burdick, 954 F. Supp. 2d 900 (D.N.D. 2013); Ohio Rev. Code Ann. § 2919.191(B)(1), (2) (West); Okla. Stat. Ann. tit. 63, § 1-745.14(B) (West 2012); Tex. Health & Safety Code Ann. § 171.012(a)(4)(D) (West 2011).
 Gonzales v. Carhart, 550 U.S. 124, 159 (2007).
 Planned Parenthood of Se. Pennsylvania v. Casey, 505 U.S. 833, 882 (1992) (plurality).
 Gonzales, 550 U.S. at 126.
 Casey, 505 U.S. at 882 (plurality).
 Id. at 882 (plurality).
 Gonzales, 550 U.S. at 126.
 Casey, 505 U.S. at 883 (plurality).
 Id. at 881–87 (plurality).
 Id. at 885–86 (plurality).
 Guttmacher Institute, State Policies in Brief: Counseling and Waiting Periods for Abortion (July 1, 2014), http://www.guttmacher.org/statecenter/spibs/spib_MWPA.pdf.
 Casey, 505 U.S. at 883 (plurality).
 Gonzales, 550 U.S. at 126.
 See, e.g., Mark L. Rienzi, The Constitutional Right Not to Kill, 62 EMORY L.J. 121, 147–52 (2012).
 42 U.S.C.A. § 2000bb-1 – 2000bb-4.
 Id., § 300a-7.
 Id., § 238n.
 See Rienzi, supra note 107, at 148–49 (stating that “virtually every state in the country has some sort of statute protecting individuals and, in many cases, entities who refuse to provide abortions” and that “[s]ome states expressly limit this protection to the practice of abortion, which is treated specially”).
 Brief of Amici Curiae Women’s Public Policy Groups and a Coalition of Female State Legislative and Executive Branch Officials in Support of Nongovernment Parties 8, Burwell v. Hobby Lobby Stores, Inc., 573 U.S. ___ (2014),available at http://www.sba-list.org/sites/default/files/content/shared/01.28.14_womens_policy_groups_and_coaltion_of_female_state_legislative_and_executive_branch_officials_13-354_356_bsac.pdf.
 Id. at 8–9 (internal citations omitted).
 See Rienzi, supra note 107, at 148–49 (stating that “virtually every state in the country has some sort of statute protecting individuals and, in many cases, entities who refuse to provide abortions”).
Click here for PDF version: Abortion Funding Limits- 6-23-14- Update
Update on Abortion Coverage Limitations: States Take Action
(Current as of June 2014)
With the passage in 2010 of the Patient Protection and Affordable Care Act (PPACA) and the individual mandate, which forces every American to purchase government-approved insurance plans or pay a penalty, came another mandate which many see as an unprecedented threat to their liberty.
Buried within the individual mandate is the “abortion premium mandate.” This mandate requires that all who are enrolled in insurance plans which cover elective abortion must pay a separate premium which serves as a direct abortion subsidy. This mandate could potentially leave many Americans stuck between a rock and a hard place as they must choose between following their consciences and providing for the healthcare needs of their families.
In March 2012, the Department of Health and Human Services issued a final rule regarding the healthcare exchanges. Despite the Hyde Amendment, the annual appropriations limitation which bars federal funds from being used to pay for most abortions, Section 1303 of PPACA prescribes a mechanism for plans that use a separate surcharge in order to cover elective abortions for each enrollee. The surcharge can only be described to the customer during enrollment and the insurance plans may advertise the total cost of the plan while not making known the abortion charge.
The law required that new exchanges be functional by January 1, 2014 for use by individuals, families and employers who can begin enrolling on October 1, 2014. However, the Obama Administration has relaxed the employer portion of the mandate, which requires companies of a certain size to provide coverage for all of their full-time (30 hours or more) employees under a plan that meets federal standards. The individual portion of the mandate, which requires individuals and families to enroll in a qualified plan by the first of the year, has not been delayed, even though the majority of states have not established their own exchange and instead will be subject to a federally run exchange or a “partnership” exchange jointly managed by the state and federal government.
The overall effect of the law to date has been to increase costs, reduce the number of qualified insurers, and induce employers to limit worker hours or drop employee coverage altogether as a cost-containment measure.
Meanwhile, with these rules set in place and churning employer and individual options, a growing number of statesare moving to bar abortion funding in their exchanges so that they can stop public dollars from being used to subsidize or extend coverage of abortion. Twenty-three states have taken action as of September 2013 to prevent elective abortion from being included in plans offered via their exchanges. Along with states that have prohibited abortion funding via Medicaid, or via state employee insurance and private insurance plans, these states are trying to insure that their rights as states and their citizens’ rights of conscience will be protected.
Because of state resistance, the role of federally financed exchanges, and so-called partnership exchanges, looms ever larger. As of mid-June, key information regarding abortion coverage options in plans offered through state exchanges remain decidedly opaque. Numerous attempts by the Charlotte Lozier Institute to ascertain whether policies offered through state exchanges included abortion coverage found that information was not freely available.
In addition, the PPACA directs the federal Office of Personnel Management to negotiate contracts with at least two insurers to offer multi-state plans (MSPs) that will be available in every state exchange. The law requires that at least one of these two plans exclude abortion coverage beyond the exceptions permitted under the annual Hyde amendment governing appropriations for the U.S. Department of Health and Human Services. Under the final rule governing MSPs issued by OPM on March 11, 2013, a multi-state plan may not offer coverage of non-Hyde abortions in any state where such coverage is prohibited under state law (currently 23 states). Until HHS reveals details about MSP contracts in the other states, how the department will implement PPACA’s abortion rule remains unclear, although the prevailing opinion is that the Obama Office of Personnel Management is likely to include one or more MSPs offering elective abortions under the same secretive surcharge procedure outlined above.
As all of these issues converge, abortion coverage will no doubt continue to be a highly contested issue as each state attempts to apply PPACA to their system. The new law and the liberty of the American people are in a precarious balancing act. In an attempt to preserve their liberty, it is likely Americans will continue to call on their states and on members of Congress to take action in order to stop coerced funding of abortion via the new exchanges.
State Abortion Funding Limits
|STATE||Public Funding for Indigent||States Employee Insurance||Exchanges||Private Plans|
|District of Columbia||X|
|TOTAL:||34 states prohibit public funding of abortions for indigent women.||19 states restrict abortion coverage in insurance plans for public employees.||25 states prohibit coverage in plans offered through the exchanges.||8 states have laws restricting insurance coverage of abortion in private insurance plans.|
 Though a state-Supreme Court decision in 2002 required Arizona to fund “medically necessary” abortions in its Medicaid program, very few abortions are actually paid for by the state (e.g., only 13 in 2010).
 Acccording to data from the Guttmacher Institute, in 2001 and 2006, less than 0.2% of all abortions performed on Illinois residents were funded by Medicaid. Similarly, according to data from the Illinois Department of Public Aid, every year from 1994 to 2002, less than 1% of abortions performed on Illinois residents were paid for by Medicaid.
 Specifically prohibits partial birth abortion.
 Permanently enjoined by court order
Jennifer Lahl, founder of the Center for Bioethics and Culture and an award-winning film director, recently released her latest documentary entitled Breeders: A Subclass of Women? The new film examines the harmful consequences of surrogacy. Breeders concludes her three-part film series on sexual reproductive technologies. The first installment, Eggsploitation (California Independent Film Festival Best Documentary, 2011), highlighted the risks for women in selling their eggs, and was followed by Anonymous Father’s Day (2012) which featured the stories of men and women conceived as a result of sperm donation.
Download PDF here: American Reports Series IMPROVING JOYFUL LIVES
Down syndrome is a highly complex genetic condition, but it is also a highly complex sociological phenomenon that is iconic in its significance to questions regarding quality of life, selective abortion, and the extent and legitimacy of research into medical treatment to enhance cognition in the intellectually disabled. As technologies of prenatal screening and diagnosis become more sophisticated, Down syndrome provides an initial test of how society will respond to difference and disability. It has been shown that peer support, as well as accurate and balanced information that exposes the positive experiences of those with Down syndrome and their families, can influence a woman’s choice regarding whether to continue her pregnancy.Therefore, it is critical that federal and state laws be expanded to require that this information be provided upon receiving a prenatal diagnosis of Down syndrome. Also, advocates should work to expand prenatal nondiscrimination legislation that is consistent with other federal laws intended to protect the disabled. While research to improve the lives of those living with Down syndrome has progressed rapidly, federal funding for Down syndrome research lags considerably behind other similar genetic disorders.Research to improve birth outcomes and quality of life over the life span will certainly improve the message given with a prenatal diagnosis and discourage the termination of Down syndrome pregnancies.
In the United States, approximately 6,000 individuals are born each year with Down syndrome (trisomy 21).The live birth incidence is about one in 700.i Down syndrome is the most common genetic cause of intellectual disability, with the U.S. population estimated to be between 250,000 and 400,000 people, and the worldwide population at six million.
Down syndrome is a highly complex genetic medical condition; it is also a highly complex sociological phenomenon that is iconic in its significance to questions regarding quality of life, selective abortion, and the extent and legitimacy of research into medical treatment to enhance cognition in the intellectually disabled. Iconic, because Down syndrome provides the initial test of how society responds to difference and disability when offered increasingly sophisticated means of prenatal screening technologies in a pro-abortion culture.
The most recent study of abortion following a confirmed prenatal diagnosis of Down syndrome showed that, depending on several factors such as time of prenatal diagnosis, geographical region, ethnicity and religious belief, abortion rates range from 61% to 93% in the United States.ii In France, where prenatal screening has been enshrined in public policy, the rate increases to at least 96%.iii
With such a high termination rate, research done by Dr.Brian Skotko, co-director of the Down Syndrome Program at Massachusetts General Hospital, is particularly striking. He has shown that:
- 99% of people with Down syndrome are happy with their lives
- 97% of people with Down syndrome like who they are
- 99% of parents said they love their child with Down syndrome
- 5% of parents felt embarrassed by their child
- 97% of brothers/sisters,ages 9-11,said they love their sibling iv
Individuals and families living with Down syndrome overwhelmingly report satisfaction with their lives, but the majority of parents continue to elect abortion following prenatal diagnosis.The contrast presented in these two sources raises critical questions about how prenatal diagnosis is delivered, the perception of support for the intellectually disabled and their families, and the stigma that still remains regarding intellectual disability.
This paper will present a short history of the disability and suggest possible reasons for this stark dichotomy. It will also offer suggestions for how policymakers and advocates might work to create a future where true acceptance and inclusion may be realized for all those conceived with Down syndrome– not just the current minority who are allowed to live.
Modern History of Down Syndrome
Cause and Discovery
Most typically, Down syndrome is caused by an error in meiotic cell division (usually the mother’s oocyte), called a “nondisjunction,” in which the 21st chromosome fails to divide. At conception when the parents’ gametes fuse to create the new unique individual, this individual has three chromosomes 21 rather than the typical two,or a total of 47 human chromosomes in every cell of the body. The presence of an extra chromosome 21, with its full complement of genetic activity, creates a severe metabolic disturbance resulting in mild to moderate intellectual disability, distinctive physical traits, and often more or less serious associated medical conditions,e.g., cardiac defects, leukemia, gastrointestinal issues, various autoimmune disorders, and several others.v
In 2% – 4% of conceptions, not all cells are affected and the trisomy is restricted to certain cell lines creating a mosaic effect.vi “Mosaic” Down syndrome is typically less severe in its effect than a full trisomy. A third type of Down syndrome, “translocation,” results when part of the 21st chromosome breaks off and attaches to a different chromosome. The usual complement of 46 chromosomes remains in these individuals, but because a fragment of chromosome 21 becomes attached to another chromosome, the individual may express some characteristics of the Down syndrome phenotype.
A genetic description of Down syndrome is a fairly recent development. It was first developed in 1958 by Dr. Jérôme Lejeune, a medical doctor and researcher working in Paris, and subsequently published in 1959 by the team of Jérôme Lejeune, Marthe Gautier,and Raymond Turpin.vii The identification of the genetic cause of Down syndrome was made possible with the introduction of a new technique that, for the first time, allowed the observation of individual chromosomes under a microscope. Lejeune, using slide preparations prepared by his associate Gautier, was able to enlarge a photograph of an individual’s chromosomes, called a karyotype, and cut and paste them together by size to identify the supernumerary chromosome on the 21st pair.
Lejeune’s discovery was revolutionary in its importance for the future of modern medicine. Until then it had been commonly believed that Down syndrome was due to some fault of the parent. Many believed that it was caused by a venereal infection and even that it was contagious. These children- children because few lived to adulthood- were kept hidden or placed in institutions because they were a source of shame for their families.
John Langdon Down was the first to apply the term “mongoloid” to those exhibiting the common physical and intellectual features of trisomy 21 in his work, Observations on an Ethnic Classification of Idiots, published in 1866. To quote his text:
The number of idiots who arrange themselves around the Mongolian type is so great, and they present such a close resemblance to one another in mental power, that I shall describe an idiot member of this racial division, selected from the large number that have fallen under my observation.viii
Down’s term “mongoloid” originated in the medical vocabulary as a descriptive term, along with other terms for the intellectually disabled such as “idiots,” “imbeciles,”and“dullards,” but crossed over into common parlance where it gained pejorative implications in the 20th century. Due to its inaccuracy and racial overtones, the term “mongoloid” fell into disrepute in the medical community by the mid-20th century. On April 8,1961, two years after the publication of the paper describing the genetic origin of “mongolism” by the Lejeune team, a group of 19 prominent scientists, including Lejeune, submitted a letter to the Lancet urging the scientific community to abandon the term. Of five suggested alternatives, the editor of the Lancet himself settled on the term “Down syndrome” which has continued in use more prominently to the present day.1 The medically descriptive term, “trisomy 21,”which was preferred by Lejeune, is only used in the United States in reference to those cases of Down syndrome that result from full meiotic nondisjunction, and not mosaicism or translocation.
The use of language applied to those with intellectual disabilities reveals social attitudes that are often disparaging of those living with intellectual disability. The Campaign to End the R-Word ix (“Retard”) was launched in 2009 as a grassroots youth movement to defend those with intellectual disability from ridicule, and is evidence that discriminatory language and attitudes remain a challenge to overcome.
Medical Progress and Life Expectancy
Life expectancy for those living with Down syndrome has increased dramatically from nine years of age in 1929 and 12 years in 1949 to over 60 today. A marked increase in life expectancy occurred in the 1950s with the introduction of antibiotics to fight respiratory infections which had previously been a common cause of death due to compromised immune systems exacerbated by institutionalization and the spread of infection among residents. The ability to treat cardiac defects also factors as a cause for increased longevity. Almost half of babies born with Down syndrome have congenital heart defects, the most common being atrioventricular septal defects. A recent study has shown that infants born with Down syndrome who receive surgical treatment for cardiac defects now fare better than their typically developing peers with the same condition.x
When Lejeune discovered that an extra copy of the 21st chromosome caused Down syndrome, he believed that a “cure” would one day be possible. Over 50 years later, the biological effects of trisomy 21 are much better understood, and clinical trials have even begun on potential drug therapies to improve cognition and memory, but a cure for Down syndrome is not considered possible.
Adding to the already acknowledged complexity of Down syndrome, an April 2014 article published in the journal Nature showed evidence that an extra copy of the 21st chromosome has a downstream effect on some 182 genes on chromosomes other than the 21st. The research team led by Dr. Stylianos Antonarak is at the University of Geneva Medical School had the opportunity to study gene expression of monozygotic twins, one of which had trisomy 21 and the other not. Their findings reinforced the suspected complexity of the genetic anomaly: an additional chromosome disrupts gene expression of the entire human genome, and not only the genes that reside on the 21st chromosome.
The Current Status of Research to Address Intellectual Disability in Those Living with Down Syndrome
Advances in Research to Improve Cognition in Down Syndrome
The primary targets for researchers investigating treatments for Down syndrome are cognition, memory, and speech. Very recently we have seen unprecedented developments in these areas, and especially in the link between Down syndrome and Alzheimer’s disease.2 As of the writing of this paper, three clinical trials have been initiated by pharmaceutical companies:
- In 2011 the Roche Pharmaceutical Company began an early-stage clinical trial to investigate the safety of a drug called RG1662, and to obtain data indicating its possible effectiveness in improving cognition.xi Following a successful phase 1 trial, Roche has now initiated a phase 2 trial to evaluate the drug’s efficacy in improving learning, memory, and language ability. This is an international, multi- site trial with nine clinical sites participating in the U.S.xii Interesting to note, the phase 1 trial involved individuals from 18– 30 years of age. Phase 2 has lowered the recruitment age to 12 years, indicating that the initial trial showed substantial tolerability of the drug in the target population.
- In September 2013 Elan Corporation announced the first dosing of a patient in a phase 2a clinical trial with their drug, ELND005, orscyllo-inositol.xiii Scyllo-inositol is a drug thought to potentially reduce aggregation of beta-amyloid that is the product of the APP (amyloid precursor protein) gene located on chromosome 21. In this study, however, participants must not show evidence of dementia and the target is scyllo-inositol’s effect on cognition and not memory.
- Balance Therapeutics, a new Australian pharmaceutical company, has initiated a clinical trial it is calling the “Compose Study,” for “Cognition and Memory in People with Down Syndrome”.xiv The study is investigating the safety and efficacy of a compound called BTD-001 to improve memory, language, and learning in persons with Down syndrome. BTD-001 is a form of drug that has been available since the 1920s to treat respiratory infections and dementia in the aged. The investigators have seen that the drug has potential to affect the brain signaling pathways by activating non-performing connections.
In addition, AC Immune has partnered with Genentech to identify and conduct a clinical trial on an antibody that they hope will effectively create an immune response against the development of beta amyloid.xv Other drugs are currently in the research and clinical trial pipelines, but the investment of these pharmaceutical companies is strong evidence of the current therapeutic potential for treatments to improve the lives of those living with Down syndrome.
In addition to these three industry-based clinical trials, smaller trials are also being conducted and financed privately. The Jérôme Lejeune Foundation has funded a clinical trial in Spain investigating the efficacy of a polyphenol in green tea called epigallocatechin gallate (EGCG) and its effectiveness in regulation of the DRK1A gene that is overexpressed in individuals with Down syndrome.xvi Data will be published at the end of 2014. The Jérôme Lejeune Institute in Paris is also conducting a clinical trial funded by the Jérôme Lejeune Foundation on 256 patients aged six to 18 months to investigate the efficacy of folinic acid and thyroxine hormone on improving psychomotor development of infants with Down syndrome.xvii The trial will conclude in 2017.
Researchers claim that even a decade ago young researchers were discouraged from pursuing a career investigating Down syndrome. Five years ago, clinical trials were unheard of. The accelerated pace of research in the last three to five years is a strong indication that therapeutic treatments may soon offer hope to those now living with Down syndrome and their caregivers.
Advances in Understanding the Neurobiology of Down Syndrome
Researchers would be unable to develop drugs to improve the lives of those living with Down syndrome without significant developments in the understanding of the neurobiology of Down syndrome. Very recently unparalleled advances have taken place in basic science. Animal models that imitate Down syndrome, such as the Ts65Dn mouse produced by Jackson Labs,xviii3 and the ability to create induced pluripotent stem cell (iPS) lines from patients with Down syndrome have given researchers the ability to work with model systems to test their hypotheses more effectively.
Three of the more startling and recent developments in basic science will serve to illustrate the present level of achievement of researchers in advancing the understanding of Down syndrome. Two of these discoveries were hailed in the media as being a “cure” for Down syndrome, but the investigators were quick to clarify that they are not cures, but rather one more important step in understanding that may someday soon lead to therapeutic applications.
- In July 2013 Dr. Jeanne Lawrence, a researcher at the University of Massachusetts, published an article in the journal Nature xix showing that it is possible to silence the extra 21st chromosome completely by inserting a copy of the XIST gene (the gene which silences the X chromosome in men and the second copy of X in women) into the third copy of chromosome 21 in an iPS cell line generated from a somatic cell of a patient with Down syndrome. Hailed by the media as a “cure” for Down syndrome, Dr.Lawrence was more circumspect. She observed that “[t]he silencing of trisomy 21 by manipulation of a single gene in laboratory cells surmounts the first major obstacle to development of potential ‘chromosome therapy.’” She expressed the hope that “for individuals living with Down syndrome, this proof-of-principle (would open up) multiple exciting new avenues for studying the disorder…and bring into the realm of consideration research on the concept of ‘chromosome therapy’ in the future.”xx In the short term, what Dr.Lawrence and her lab created was a valuable tool to better understand the effect of Down syndrome on the whole genome. With the insertion of XIST, she also inserted a doxycycline “switch” that enabled her to turn on and off the extra chromosome, allowing her to test the down stream effect of an additional copy of a whole human chromosome on the entire genome.
- In September 2013 a research team led by Dr. Roger Reeves at the Johns Hopkins University School of Medicine published an article in the journal Science xxi showing that a single injection of a sonic hedgehog4 pathway agonist at birth completely normalized cerebellar development and function of the hippocampus in the brains of developing Ts65Dn mouse pups that lasted into adulthood, an astonishing discovery. Dr. Reeves warned that the treatment would likely have unintended effects in humans such as increasing the risk of cancer, but indicated his study highlighted the important role of the sonic hedgehog pathway in cerebellar development.xxii His results suggested a possible approach that might someday lead to therapeutic treatments to improve cognitive function in Down syndrome. Individuals with Down syndrome have a cerebellum approximately 60% the size of the typical population and reduced hippocampal function that accounts for deficits in long-term memory.
- As previously mentioned, in April 2014 a research team led by Dr. Stylianos Antonarakis at the University of Geneva Medical School in Geneva, Switzerland published their findings on a study of monozygotic twins in the journal Nature.xxiii In this rare set of twins, one had a full trisomy 21 and the other was typical. The most accepted theory has been that the Down syndrome phenotype is the result of the over expression of genes on chromosome 21. These researchers proved that the perturbations exist across the entire genome and raised the question whether the Down syndrome phenotype is the result of single genes or too much DNA. If it could be discovered that it is due to single genes that regulate expression of other genes, then Down syndrome research could instantly be propelled light years ahead of where it is now. That question is next to be addressed by Dr. Antonarakis’ lab.
Improving Birth Outcomes
Medical research has made incredible strides toward improving the lives of those living with Down syndrome, but even more exciting are advances that have taken place in investigating prenatal therapies to improve birth outcomes.
Two research teams, one at Tufts University in Boston and the other at the University of Bologna, have published evidence that shows prenatal drug treatments improve birth outcomes in mice. Dr. Diana Bianchi’s lab at Tufts has shown that fetuses with Down syndrome are subject to substantial oxidative stress in the second and third trimester of development. Her investigations into the use of antioxidant therapies delivered in utero have had astounding results in the Ts1Cje mouse.xxiv As she has stated: “It would be very exciting if prenatal screening for T21 could create an opportunity to provide fetal treatment and ultimately improve neurocognition in DS. Preliminary experiments in mouse models suggest that prenatal treatment of DS is an achievable goal.”xxv
Dr. Renata Bartesaghi’s lab at the University of Bologna has published on the administration of fluoxetine5 prenatally from day 10 to delivery, and then giving a dose of 5-bromo-2-deoxyuridine 2 days after birth. Compared with the untreated mice, those that had received prenatal fluoxetine saw their “precursor proliferation and cellularity… fully restored throughout all brain regions.” Additionally, “The recovery of proliferation potency and cellularity was still present in treated Ts65Dn 45-day-old mice. Moreover, embryonic treatment restored dendritic development, cortical and hippocampal synapse development and brain volume. Importantly, these effects were accompanied by recovery of behavioral performance.”xxvi Of substantial concern, however, is the safety of this particular drug, especially when administered to human fetuses in utero.
The particular significance of these studies is that they show the very real potential that exists for reversing the neurodevelopmental deficits associated with Down syndrome that begin during fetal development. Success in this particular area of research could have a transformative effect on the decision parents face following a prenatal diagnosis of Down syndrome, a decision that now strongly favors abortion.
A significant impediment to more rapid progress in identifying treatments for Down syndrome has been funding. The National Institutes of Health (NIH) has received harsh criticism from the Down syndrome community for their meager spending on Down syndrome in their extramural research portfolio. A mere $22 million was appropriated in 2010, but in the 2014 and 2015 (est.) budgets, $19 million will be spent on Down syndrome research.xxvii If that allocation is compared to other disabilities on a per capita basis, Down syndrome receives a fraction of support. The comparison commonly cited is with research for cystic fibrosis. $80 million has been allocated for 2014/2015 fora population of approximately 30,000 people. That is approximately $2,666 per person as compared to $76 per person for Down syndrome using a population of 250,000 for the calculation. The most common genetic cause of intellectual disability is one of the worst funded in the NIH research portfolio.The burden of funding, then, is with private foundations that rely on the generosity of their donors to support research that will improve the lives of a significant number of the population.
In spite of low funding levels, in recent years the National Institute of Child Health and Human Development (NICHD) at the NIH under the leadership of Dr.Yvonne Maddox has shown tremendous support for Down syndrome research and care. Dr. Maddox Initiated the NIH Down Syndrome Consortium to gather together representatives from the Down syndrome research and advocacy communities, and with Consortium assistance she has launched DS-Connect, an online contact registry to which individuals living with Down syndrome can subscribe to be notified of upcoming clinical trials.
Prenatal Diagnosis and Abortion
Prenatal diagnosis and selective abortion have emerged since the 1970s as two sides of the same coin. The technique of creating a karyotype from human cells to identify Down syndrome was first developed in France and published by Lejeune, Gautier and Turpin in 1959. In 1968 it was discovered that fetal cells in amniotic fluid could be used to generate a karyotype that would identify Down syndrome as early as the 16th week of pregnancy. With that discovery, social attitudes toward Down syndrome rapidly shifted toward seeing it as something that could, and often should, be avoided. Following the U.S. Supreme Court 1973 decision in Roe v. Wade, which created a constitutional right to abortion, some began to question whether society had an obligation to use abortion to purge the human race of disease and disability.
From the beginning of the debate over prenatal diagnosis and abortion, Down syndrome has been a focal point of competing arguments over how we view and respond to disability. Harry Harris, in his 1974 book, Prenatal Diagnosis and Selective Abortion,xxviii said that prenatal diagnosis had provided a new objective in medicine, and that the new objective was not the nature of the technique, but rather the objective at which the diagnosis is aimed. He went on that the object of prenatal diagnosis is “to find out whether the foetus has some defined abnormality which will inevitably lead to the birth of a defective infant and, if so, to abort the foetus. ”Of course, the example of an “abnormality” that he used in his argument was “mongolism.” He mentioned Jérôme Lejeune’s opposition to abortion on the grounds that it was unethical and immoral, but continued to say that most human geneticists disagreed with Lejeune’s position because it “dismisses too easily the welfare of afflicted families and the general social good.”
Far from an isolated perspective, Harris’s view was promoted by Dr. Joycelyn Elders, who became the U.S. Surgeon General during the Clinton administration. Dr. Elders was the first public figure to advocate for the abortion of Down syndrome babies. She was quoted in 1990, when she was Arkansas State Health Director, that “[a]bortion has had an important, and positive, public-health effect” because it has reduced “the number of children afflicted with severe defects.” To provide an example to support her claim, she stated, “The number of Down’s syndrome infants in Washington State in 1976 was 64 percent lower than it would have been without legal abortion.”xxix
Elders’ position, it could be argued, has become enshrined as a best practice in medical genetics and obstetric care. A poll of the members of the American College of Obstetricians and Gynecologists (ACOG) conducted in 1995 revealed that 63% of the members who responded believed abortion was a justifiable treatment option for fetal anomalies compatible with life. Ninety percent believed abortion was justifiable for uniformly fatal fetal anomalies.xxx Even more recently, a 2013 poll, the results of which were published in the Journal of Intellectual and Developmental Disabilities, showed that almost one in four patients who had received a positive prenatal diagnosis for Down syndrome said their medical professional was insistent that they terminate their pregnancy.xxxi ACOG now recommends that all women, regardless of maternal age, be offered prenatal screening for aneuploidy(trisomies), either by screenings or invasive testing such as amniocentesis. This recommendation, combined with the prevailing attitude toward birth defects in the medical community, would seem to encourage the option for abortion following a positive result. As the now-deceased disabilities rights activist, Adrienne Asch,has stated, prenatal diagnosis “is not a medical procedure to promote the health of the fetus. It is a procedure to give prospective parents information to decide whether or not to eliminate a possible future life.”xxxii
Defining Abortion Statistics
Determining what this information portends in terms of the actual number of abortions of Down syndrome pregnancies in the U.S. is difficult. The most commonly recited abortion statistic in the U.S. is 92% termination following a positive prenatal diagnosis for Down syndrome; however,it is not likely an accurate statistic.This number is derived from a study published in 1999 that reviewed 10 studies on Down syndrome published between 1980 and 1998.xxxiii Only three of those studies were from the United States; the most recent was from 1988 and comprised only 77 of the 5,035 patient cases reviewed.
In 2012 a new review of the literature on abortion following prenatal diagnosis was published.xxxiv After applying a rigid exclusion criterion to 308 potential publications, 24 articles were accepted by the authors to include in their review, including population- based,hospital-based, and anomaly-based studies. Their analysis of the literature showed that termination rates following prenatal diagnosis vary according to a number of factors such as maternal age, race and ethnicity, and gestational age, but the range averages from 67%- 85%.6 Of particular interest,however,is the finer analysis of the study. In hospital-based studies, they noted that one publication showed higher termination rates associated with earlier gestational age, i.e., 93% at 16 weeks gestation or less, as compared to 85% at 17 weeks or greater.The implication of this finding is of particular concern given that the newest methods of prenatal screening are able to return a result as early as 10 weeks of gestation, 7 well within the first trimester, and at a point in pregnancy when there may be less maternal attachment and inhibition regarding termination.
As evidence of the ambiguity of abortion statistics following prenatal diagnosis,the Natoli study revealed some positive trends. Compared to the earlier Mansfield study, Natoli, et al. suggested that selective abortion for Down syndrome in the U.S. declined through the 1990s and early 2000s. The authors of another study, however,offer a differently nuanced view. They claim that the Down syndrome birthrate declined sharply following passage of the Americans with Disabilities Act in 1990, and only began to rebound in 1995 and almost reach its previous level by 2002.xxxv Possible reasons for this decline and reemergence of Down syndrome births will be discussed in a later section.
Of note, the authors of the Natoli study present analyses of data from 20 registries in the International Clearinghouse for Birth Defects Surveillance and Research that indicate abortion rates after Down syndrome diagnosis in North America are lower than in Europe and Australia.xxxvi Perhaps U.S. advocacy efforts to improve the quality of life and acceptance of those living with Down syndrome have been successful. One can only hope this trend will continue and not be offset by the availability of early prenatal diagnosis using new and sophisticated noninvasive prenatal screening tests.
Dr. Brian Skotko has given an overall impression of what these statistics mean with regard to the Down syndrome population in the United States and abroad. His research shows that due to prenatal testing, “[T]he worldwide birth incidence of DS has actually decreased from what it could have been by 2–18% per year,” and that “in the USA, there would have been a 34% increase in the number of babies born with DS between 1989 and 2005, in the absence of prenatal testing. Instead, there were 15% fewer babies born, representing a 49% decrease between the expected and observed rates.”xxxvii Indeed, in 2008 the population statistics of those living with Down syndrome in the United States were revised downward from 400,000 to 250,000.xxxviii
Whatever statistics one might choose to cite, it is clear that the majority of women who receive a prenatal diagnosis of Down syndrome choose to terminate their pregnancy. Whether the number is 50%, or 93%, it is a staggering social problem reflective of society’s attitudes toward and perception of disability in general, specifically intellectual disability, and especially in a category of disability so easily targeted. Those living with Down syndrome cannot hide their disability; they wear it on their faces and are easy targets for fear and discrimination.
Fueling concerns about the future of expanded prenatal testing, a number of high-profile wrongful birth lawsuits have succeeded in U.S.courts and abroad.
In 2012 a Portland, Oregon couple was awarded $2.9 million in a court case in which they claimed that they would not have allowed their child to be born had they known she would have Down syndrome.xxxix They claimed that the doctors were “negligent” in their prenatal care. The family had initially sued for $7 million to cover the cost of providing for their child over the course of her lifetime.
In December 2013 a jury awarded another couple $50 million when they claimed that had they known their child would be born with a severe genetic defect, an unbalanced chromosomal translocation, they would have chosen to abort.xl They have sued both the medical practice and Laboratory Corporation of America, the company they claim missed the translocation in reading the test.
The success of these wrongful birth lawsuits relates back to the legal precedent established in the New York courts in 1978. In the case, Becker v. Schwartz, the couple claimed to have not been adequately informed of the risk for Down syndrome in older mothers nor offered an amniocentesis.xli For the first time, a court acknowledged hardship imposed by medical negligence in failing to provide an opportunity to abort a child, and awarded the cost of raising their child through its lifetime.
The potential impact of these wrongful birth lawsuits on influencing prenatal testing guidelines cannot be overlooked. If doctors can be held liable for not offering prenatal diagnosis, or for “missing” a genetic anomaly, then risk exposure for insurance companies is increased and prenatal testing becomes free and encouraged. Important questions are then raised regarding a physician’s freedom to practice medicine according to conscience, prenatal diagnosis for the purpose of abortion becomes a right, and contemporary expectations of childbirth lead to parents’ increasingly presumed right to choose which babies are allowed to come into the world. The way that these questions are resolved around Down syndrome now will prepare the ground for management of future cases as prenatal diagnosis becomes increasingly sophisticated, less expensive, and more broadly and simply available.
In the short time since noninvasive prenatal screening tests have been commercially available (October 2011), the tests have been expanded to the point where manufacturers now claim the ability to identify not just aneuploidy, but also DiGeorge, cri-du-chat, Prader-Willi/Angelman, and 1p36 deletion syndromes.xlii Advanced microarray testing that will be able to do whole genome genetic analysis of fetal cells in maternal blood is in development. These tests could potentially replace amniocentesis and chorionic villus sampling, both of which carry a risk of miscarriage, and safely identify at nine weeks into a pregnancy most known genetic abnormalities.8
Given the success of litigation for wrongful birth recommendation of prenatal testing for all women by ACOG, provision for prenatal testing as part of the “Women’s Preventive Services Guidelines” contained under the “Affordable Care Act,”9 and the evident self-interest insurance companies have in reducing exposure to the financial liability of providing coverage for the birth of a medically challenged child, it is critical that protections be put into place for children who are emotionally victimized by their parents’ legal complaints that they did not have the option to abort them. Tort reform efforts should be initiated to limit incentives for these persons to sue their health care providers.
Rep. Stephen Palazzo (R) from Mississippi introduced such legislation, H.R.4698, on May 21,2014 with the intent to prohibit certain wrongful birth and wrongful life civil actions.xliii
Attempted Legal Protections of the Unborn with Disabilities
The landmark disabilities legislation in the United States is called the Americans with Disabilities Act (ADA). The act was signed into law by President George H.W. Bush in 1990 and then broadened by President George W.Bush when he signed into law the ADA Amendments Act of 2008. The ADA was intended to have the same effect of ending discrimination based upon disability as the Civil Rights Act of 1964 had for racial minorities..xliv10 The ADA reflects important truths about the dignity of disabled persons that can also be invoked in the context of opposing the practice of disability-based abortion.
Lawmakers are beginning to address the issue of disability-selective abortion. A bill banning disability-selective abortions was signed into law in North Dakota on March 26, 2013. After challenging the law in the courts, the Fargo-based Red River Women’s Clinic, with assistance from the Center for Reproductive Rights, dropped their opposition without prejudice to the provision to ban abortions because of sex or disability citing that they don’t perform abortions for those purposes anyway. The bill had also attempted to ban all abortions after six weeks. That six-week ban was blocked by a federal district court judge who called it “clearly invalid and unconstitutional.”xlv
Similar legislation failed earlier this year in South Dakota where a ban on both sex- selective and disability-selective abortions was attempted in 2014. HB 1240 failed which would have prohibited disability-selective abortions, but the ban on sex- selective abortions was sustained.
Legislation was also introduced in Indiana in the 2013 legislative session that would have prohibited sex-selective and disability-selective abortions. The legislation would have made the knowing provision of an abortion for these reasons a Class-C felony in the state but the bill died in committee.
In a brief filed on behalf of the Jérôme Lejeune Foundation, Saving Downs, and the International Down Syndrome Coalition, the Bioethics Defense Fund has argued that the U.S. Supreme Court “has never endorsed a right to abort children only because they have been detected to have a disability.” In the 1992 Planned Parenthood v. Casey decision, the Bioethics Defense Fund brief argues, the Supreme Court “repeatedly premised its reaffirmation of abortion rights in terms of the right to terminate an unintended pregnancy….[The Supreme] Court has never framed the protected abortion decision as whether to bear or abort a particular child based on identified traits of genetic variation, disability, or other health condition.” According to the Bioethics Defense Fund brief, the Court’s decision in Casey “formulated the abortion decision as one confronting a woman ‘when the woman confronts the reality that, despite her attempts to avoid it, she has become pregnant’– not when she accepts a pregnancy at first, but then comes to perceive the child she is carrying as defective.”xlvi
Down Syndrome Prenatal Education– Legislation
The link between prenatal testing and abortion raises significant questions around informed consent that have not yet been adequately addressed, but that are important to ensuring that families are aware of the liabilities and benefits of testing, and certainly before they act upon it to end the life of their child. Adrienne Asch and David Wasserman, writing in the “Virtual Mentor,” a publication of the American Medical Association, outlined those issues as follows:
- When is the best time to introduce the subject of testing;
- What type of information about the tests do prospective parents want or need;
- What is the proper balance between medical information and information on nonmedical aspects of life with a particular disease or disability;
- How can the perspectives of people living with the conditions and their families best be included; and
- How can uncertainty about the applicability of general information to a specific child and family situation be conveyed?xlvii
This article by Asch and Wasserman makes several excellent observations that can provide talking points and inspiration for those working to pass legislation that protects families and secures the safety of children prenatally diagnosed with a disability. Research shows information now supplied following prenatal diagnosis is biased, outdated, narrow, inaccurate and clinical;xlviii and, as has been previously stated, this information comes from a profession which prefers termination in the case of disability. Informed consent give parents an opportunity to look on their child as an individual person living with a disability, and not as a person who will be consumed with a disability. Studies show that helping parents see disability in the context of a full human life will influence their response to a prenatal diagnosis.xlix
Acknowledging that the way prenatal testing is offered and the results explained do not adequately ensure informed consent, Senator Sam Brownback and the late Senator Ted Kennedy introduced into the U.S.Senate the Prenatally and Postnatally Diagnosed Conditions Awareness Act in 2007. The act was intended to “increase the provision of scientifically sound information and support services to patients receiving a positive diagnostic test for Down syndrome, or other prenatally or postnatally diagnosed conditions.”l The act was passed by the Congress and signed into law by President George W.Bush on October 8,2008. Unfortunately, the bill has not been funded due to disagreement between prolife and prochoice legislators over how the topic of abortion would be handled in the materials accepted for distribution.
Advocates view the Kennedy-Brownback bill as a good first step, but one that falls short of addressing a key moment, and that is before the test is offered to the patient, providing information on potential outcomes in advance of a result. Prenatal screening tests are most often given as part of routine prenatal care, as recommended by ACOG, with no understanding by women of potential outcomes, or even the purpose for which the tests are being offered. An unanticipated result can place women in a position of vulnerability to the influence of their health care provider. Asch and Wasserman provide evidence that many women would decline prenatal testing altogether if they were adequately informed before the test is given of the rewards and challenges of raising a child with a disability.
In the absence of funding for the Kennedy-Brownback bill, advocates in various states have pursued legislation with the same intent. To date, six states have passed their own versions of prenatal education legislation intended specifically to require information regarding the positive outcomes of giving birth to a child with Down syndrome. Those states are: Virginia (Virginia Code 54.1-2403.01.B), Missouri (Revised Statutes,191.923), Massachusetts (H 3815, 2012), Kentucky (SB 34, 2013), Delaware (HB 214, 2014), and Maryland (SB 654, 2014). Legislation is currently pending in the following states:
- Louisiana (H.B. 1058). Passed both houses of legislature on May 20, 2014 and awaiting governor’s signature
- New Jersey (A 3233). Introduced May 22, 2014
- Ohio (HB552). Introduced May 19, 2014
- Oklahoma (SB586, 2013). Introduced Feb. 5, 2013, referred to committee
- Pennsylvania (HB2111/SB1339). Passed in the House of Representatives on May 6, 2014, and awaiting vote in Senate
The Louisiana legislation (H.B.1058) introduced in 2014 includes a unique and controversial element. H.B.1058 requires that all resource materials provided to women not mention abortion as an option following a positive prenatal diagnosis for Down syndrome. Using a prenatal discrimination argument, the language of the bill states that information must be provided that “[d]oes not engage in discrimination based on disability or genetic variation by explicitly or implicitly presenting pregnancy termination as a neutral or acceptable option when a prenatal test indicates a probability or diagnosis that the unborn child has Down syndrome or any other health condition.” Opponents argue that states cannot limit information on legally permissible procedures. This provision was signed into law by Governor Bobby Jindal on May 30, 2014 and is nearly certain to be challenged incourt.li
The National Down Syndrome Society (NDSS) provides a “Prenatal Information State Law Tool kit” for those wishing to propose legislation in their states. The tool kit includes model legislation, sample press releases, and samples of testimonies.lii
Down Syndrome Prenatal Education– Resources
States continue to pass laws nation wide which require the provision of a list of peer supports and up-to-date, evidence-based, written information to those who receive a prenatal diagnosis of Down syndrome. However, the currently available resources are few.
The most widely available and well-presented resource is Understanding a Down Syndrome Diagnosis, available at www.lettercase.org and from the National Center for Prenatal and Postnatal Down Syndrome Resources of the Human Development Institute at the University of Kentucky. The preparation of this small booklet was assisted by representatives from the National Society of Genetic Counselors, the American College of Medical Genetics, ACOG, the National Down Syndrome Society, and the National Down Syndrome Congress. With those endorsements, it qualifies under the emerging legislation as a peer-reviewed resource. Critics of the Lettercase Booklet, as it is commonly called, question its acknowledgement of abortion as a choice many families make. The primary authors defend that decision, stating that it is the only way they could have obtained the endorsement of the medical community that is essential in promoting distribution to doctors and genetic counselors who will then place it in the hands of those receiving a prenatal diagnosis of Down syndrome. The small section on “Pregnancy Termination” is intentionally placed in counter point to the much larger section on “Adoption” which appears on the opposing page.
The National Center also publishes Diagnosis to Delivery: A Pregnant Mother’s Guide to Down Syndrome, and will soon have available Coping with Loss for parents who have lost their pregnancy or newborn child. The Center also maintains two web sites in addition to their portal at www.DownSyndromeDiagnosis.org: one site is www.BrighterTomorrows.org, which provides comprehensive resources for expectant parents and training modules for physicians, and the other is www.DownSyndromePregnancy.org, a website with a blog for women who are pregnant and expecting a baby with Down syndrome. All resources from the National Center for Prenatal and Postnatal Down Syndrome Resources are available in both English and Spanish.
In 2012 the Global Down Syndrome Foundation and the National Down Syndrome Congress together published a small pamphlet, available in print and online at www.downsyndrometest.org, that they hoped would “eliminate confusion at a time when advice and guidance can vary dramatically from doctor to doctor and counselor to counselor, and where there was previously no accessible, consistent resource for women and families.”liii The authors have stated that self-advocates11 resent abortion being mentioned in resources provided to women who have received a prenatal diagnosis for Down syndrome; consequently, this resource makes no mention of abortion as an option following prenatal diagnosis. The sponsoring organizations initially arranged for Sequenom Center for Molecular Medicine, the first company to make commercially available a prenatal screening test to identify aneuploidy in cell-free DNA in maternal blood in October 2011, to share printing costs and distribute the pamphlet along with orders for the MaterniT21 test. The current status of that arrangement is not known.
In addition to these two print and online resources, various organizations provide informational support for women who have received a prenatal diagnosis of Down syndrome. Be Not Afraid (www.benotafraid.net) is an organization whose ethical principles are informed by the teachings of the Catholic Church. They provide a referral service that connects parents with a peer minister for those who have received an unexpected prenatal diagnosis. Other organizations provide online information and support such as the Down Syndrome Diagnostic Network (http://www.dsdiagnosisnetwork.org), the International Down Syndrome Coalition (www.theidsc.org), and others available online. Many individuals who staff these organizations consider themselves prolife, but prefer to be seen as “pro- information” and use “non-directive” language in counseling those who contact them to engage those who may be considering termination. Individuals who believe that prenatal counseling should discourage abortion have criticized this “non- directive”approach. Counselors, however, defend their approach by saying that women considering abortion will avoid any resource they believe is attempting to deny them the option to abort.
The Education and Training of Health Care Professionals
In the aforementioned study on parental experiences in receiving a Down syndrome diagnosis (Goff), negative experiences outnumbered positive experiences 2.5 to 1. The reasons listed for these negative experiences included the health care provider’s insistence on termination, the communication of negative stereotypes of individuals with Down syndrome, a lack of available information, and a perceived lack of compassion shown by the physician and staff.liv These findings were not surprising. In a survey conducted by the Special Olympics, 81% of medical school students said they do not get any clinical training regarding individuals with intellectual disabilities.lv Forty-five percent of ACOG fellows and juniors reported their residency training as “barely adequate or nonexistent,” and only 28% of ACOG fellows felt “well qualified” to provide genetic counseling.lvi
The response of medical professionals to those who receive an unanticipated prenatal diagnosis of Down syndrome is key to the decision women make regarding birth or abortion. In a 2007 study done in the Netherlands, 97% of women who chose to terminate their pregnancy following a prenatal diagnosis of Down syndrome claimed they had chosen to abort a baby they had wanted until receiving the diagnosis. Their motivations for termination were based on misunderstandings of the disability and included as reasons: a belief the child would never be able to function independently (92%), a consideration that the abnormality was too severe (90%), the burden for the child himself of having the disability would be too heavy (83%), uncertainty about the consequences of the disability were too great (78%), and the burden for other children in the family would be too heavy (73%).lvii
These reasons given for termination lie in stark contrast to the real, lived experiences of families who have accepted a child with Down syndrome into their homes. A summary of those statistics was provided at the beginning of this paper. These reasons reveal a perception of Down syndrome that is uninformed by the reality of the lived experiences of thousands of families– a reality those professionally bound to the principle of informed consent should be obligated to communicate.
The incidence of abortion of children with Down syndrome is inseparably tied to the promotion of prenatal screening. If the statistics on the number of abortions following a prenatal diagnosis of Down syndrome is to change, five key elements must be addressed with regard to the delivery of the diagnosis and care of patients:
- Standardized practice guidelines should be promulgated among medical professionals regarding how best to deliver a prenatal and postnatal diagnosis of Down syndrome and other genetic intellectual disabilities.12
- Accrediting agencies must require that health care professionals, as part of their medical education, be trained in how to deliver complete and consistent information free of personal bias against disabilities and to care for individuals with intellectual and developmental disabilities.
- Prenatal information resources, similar to those listed above, must continue to be developed that are linguistically and culturally appropriate.
- Legislation should be enacted and enforced nationwide requiring that when women are given a prenatal diagnosis of Down syndrome, at the same time they are provided a list of peer-support organizations in their area, and accurate, up-to- date, evidence-based information on the outcomes of delivering a child with Down syndrome.
- Public education efforts must continue regarding the value of individuals living with Down syndrome.
Research has confirmed that the “overall impression of the families and children with Down syndrome is one of normality.”lviii However, historically research has focused on the negative aspects, or a “deficit framework” of disability as a “life stressor.”lix The challenge advocates face is restructuring the framework of disability to one of acceptance and love through the provision of accurate information, and the experience of families who find that having a child with a disability increases their mutual love and sense of resilience.
This paper began and will conclude by pointing out the discrepancy between experiences of those living with Down syndrome and their families, and the negative stereotype of Down syndrome that is still deeply embedded in culture. That stereotype leads to the harshest form of discrimination against individuals with Down syndrome: selective abortion following prenatal diagnosis in a majority of cases.
The Down syndrome community is an incredibly diverse one with a wide range of abilities and disabilities. Families who live with Down syndrome and those who have no experience with Down syndrome are more similar than different. Public and many private schools welcome children with Down syndrome; they are able to learn to their capacity; they are often employed; and some now attend special college programs, live independently or in group homes, and even marry.
So what can be done in the face of increasingly sophisticated means of prenatal diagnosis, and as parents are offered the opportunity to become increasingly selective of the lives they accept into their families? This paper has attempted to show that getting accurate information to women and their partners is key in the near term if we are to rescue from abortion those prenatally diagnosed with a disability.
Jérôme Lejeune, however, would have said that “the only way to save them is to cure them.” He believed that research would one day resolve the metabolic disorder caused by an extra 21st chromosome and remove the fear and stigma of Down syndrome in the minds of parents and the community. It has been shown in this paper that research has made incredible progress toward that goal in a short period of time. Those living with Down syndrome have mild to moderate intellectual disability. It may soon be possible to improve cognition in those living with Down syndrome enough to ensure employment and independence for many. It may also soon be possible to restore neurological development before birth, radically changing even the best story that can now be given to women who receive an unexpected prenatal diagnosis of Down syndrome. It is critical that NIH funding levels be increased to support science that is just now translating into therapeutic trials to improve the lives of those living with Down syndrome.
Abortion is not the preference of families that receive a prenatal diagnosis of Down syndrome, but is chosen because of fear of an uncertain future, grief over the loss of an image parents had in mind for their child and their family, concern that their child will suffer, concern over a lifetime of managing health issues, and other similar concerns, most of which can be dispelled by the experiences of families living with Down syndrome. The value of peer support following prenatal diagnosis cannot be overestimated. As one parent commented in the Goff study, “Talking to parents of kids with DS and meeting beautiful children with DS helped us to be comforted that our son would be just like any other child.”lx
The lives of those living with Down syndrome have been improved radically since the genetic cause was discovered in 1958. The challenge remains, however, to use legislative means to break through barriers to communication, often created by the medical community, so that quality of life, both for the individual and the family, is communicated in an accurate and effective way. By this means this final and most deadly bastion of discrimination can fade into the past along with the institutions which once housed these children to keep them far from the general population.
Footnotes From Text
1 For an in-depth discussion of the naming of Down syndrome, see David Wright, Downs: The History of a Disability.
2 The amyloid precursor protein (APP) gene responsible for the development of the amyloid plaques and neurofibrillary tangles that are neurological features of Alzheimer’s disease is located on the 21st chromosome. All individuals with trisomy 21 have an extra copy of the APP gene and therefore will develop the neurological features of Alzheimer’s disease by age 40. Almost all will experience the onset of dementia by age 60. This phenomenon has brought attention to the Down syndrome community by those working to develop treatments for Alzheimer’s disease. Since it is known that all individuals with Down syndrome will develop the neurological features of Alzheimer’s disease, they are the ideal control population for researchers.
3 The mouse chromosome 16 most replicates the chromosomes found on human chromosome 21. Importantly, mice are an effective, but incomplete model of trisomy 21. They do not completely reproduce the full human chromosome 21, but rather 65 genes on a critical segment of the chromosome. Other mouse strains have also been developed to investigate gene dosing in Down syndrome. Using mouse models, researchers are also able to “knock-in” or “knock-out” specific genes to study their effect in depth.
4 Sonic hedgehog, first identified in fruit flies, is a protein that signals the growth of limbs, fingers, and organization of the brain in the developing fetus. It also controls the division of adult stem cells in adults and has been implicated in the development of some cancers.
5 Fluoxetine is commonly known by the trade name Prozac.
6 See the publication for a breakdown of statistics by each study category.
7 These include so-called “non invasive prenatal screening tests” (NIPS) that identify cell-free DNA from the fetus in the mother’s blood and then subject it to micro array analysis for trisomies 21,18,13,and some X-linked chromosomal disorders. These technologies are heavily promoted by their manufacturers-Sequenom (MaterniT21), Ariosa (Harmony), and Illumina/Verinata (Panorama) and they claim a sensitivity range between 99.1% and 99.9% with very low false positive rates.
8 Cell Scape Corporation is one company developing a non invasive test they call “Clarity.” See detailed information at their website, http://www.cellscapecorp.com/.
9 Under the Final Rules of the “Women’s Preventative Services Guidelines,” recommendations supported by the Health Resources and Services Administration that are not specifically mentioned in the Guidelines must be covered without any cost-sharing requirement.
10 It has been suggested by some authors that the immediate effect of the ADA was, at least with consideration of abortion, an increase in termination rates following prenatal diagnosis. Fox and Griffin suggest that there were two consequences of the ADA. Immediately after passage, they claim it may have “promoted disability-selective abortion if social interactions reinforced negative attitudes toward people with disabilities, or if the media portrayed people with disabilities as incurring undesirable costs for society. Their data suggests that with no increase in prenatal diagnosis, birth rates fell from 1989 to 1995 by between 13 and 18 per 100,000 births, adding controls for other demographic and medical variables. This information is provided only to suggest another parallel between civil rights legislation and the ADA, and that is that public attitudes are not necessarily changed with protective legislation. In the years between 1998 and 2002 birth rates of children with disabilities increased, but did not reach their pre-ADA levels.
11 Self-advocates are individuals living with Down syndrome who speak publicly to raise awareness of their disability and to show the capabilities of those living with Down syndrome.
12 Practice guidelines have been developed by The National Society of Genetic Counselors and are available at their website at www.nsgc.org. The guidelines reinforce the principles expressed in the 2008 Kennedy–Brownback bill with regard to balancing positive and negative outcomes, but are insistent that “feelings about having a child with Down syndrome dictate the conversation that follows regarding options, ”which include termination, and that non directive, non-judgmental language be used in counseling. The stated purpose of the guidelines is to “uphold patient autonomy regarding reproductive choices.” Understanding the radical and destructive choice that is abortion, the guidelines could have benefited by less neutrality and more opportunity to introduce couples to families who have children with Down syndrome.
Summary of Recommendations
1. Funding and enforcement of the Kennedy-Brownback Prenatally and Postnatally Diagnosed Conditions Awareness Act of 2008 should be a top priority. Concern over the possibility of information being provided that mentions abortion should not impede passage of legislation that will place in women’s hands information on positive outcomes. As this paper has shown, research supports the claim that when positive information is provided with appropriate peer supports, the incidence of abortion is reduced.
2. In the absence of funding for Kennedy-Brownback, advocates should work at the state level to pass legislation similar to that which has been passed in other states mentioned in this paper. Each state’s sensitivity regarding abortion should be considered in proposing legislation. The desire to include language or provisions that discourage abortion should not place at risk passage of legislation that would be a positive force toward reducing the incidence of abortion following prenatal diagnosis.
3. NIH funding levels for Down syndrome research should at least equal funding for similar intellectual disabilities. Fragile X syndrome is the most common form of inherited intellectual disability and could serve as a first benchmark to increase funding for Down syndrome. The number of people living with fragile X is unknown, so a per capita suggested level cannot be given. Funding for fragile X syndrome, however, has increased since 2010 from $25 million to $30 million while funding for Down syndrome has decreased from $22 million to $19million.lxi
4. Advocates should introduce and advocate for prenatal nondiscrimination legislation in states that would protect children prenatally diagnosed with Down syndrome from abortion. The argumentation in the amicus brief presented to the Supreme Court by the Bioethics Defense Fund (cited above) on behalf of the Jérôme Lejeune Foundation and two other advocacy organizations can serve as a model for arguing the legitimacy of such legislation. Americans United for Life also provides model legislation that can be used by those wishing to introduce legislation banning disability-selective abortion.lxii
5. Support should be given for tort reform legislation proposed by Rep. Stephen Palazzo, or other forthcoming legislation, that limits liabilities of physicians in wrongful birth lawsuits.
*Mark Bradford is President of the Lejeune Foundation USA.
i U.S. Centers for Disease Control, “Facts about Down Syndrome,” http://www.cdc.gov/ncbddd/ birthdefects/downsyndrome.html.
ii Jaime L Natoli, et al. “Prenatal Diagnosis of Down Syndrome: A Systematic Review of Termination Rates (1995–2011)”. Prenatal Diagnosis, 32 (2012): 142-153.
iii Jean-Marie Le Mené. “La trisomie est une tragédie grecque 1 ” Genetique February 2009. Accessed at http://www.genethique.org/?q=fr/synthese-fr/110.
iv Brian G. Skotko, Susan P. Levine, Richard Goldstein, “Self Perceptions from People with Down Syndrome.” American Journal of Medical Genetics Part A 155 (2011) 2360–2369.
v National Institute of Child Health and Human Development, “What conditions or disorders are commonly associated with Down syndrome?” https://www.nichd.nih.gov/health/topics/down/conditioninfo/Pages/associated.aspx.
vi International Mosaic Down Syndrome Association, “MDSFAQs,” accessed at http://www.imdsa.org/mdsfacts.
vii Lejeune, Gautier, Turpin. “Les chromosomes humains en culture de tissus.” CR Hebd Seances Acad Sci. 1959 Jan 26; 248 (4): 602–603.
viii J. Langdon H. Down, “London Hospital Reports,” 3: 259-262, 1866 accessed at http://www.neonatology.org/classics/down.html.
ix See http://www.r-word.org.
x Jacqueline M. Evans, MD, PhD et al. “Association Between Down Syndrome and In-Hospital Death Among Children Undergoing Surgery for Congenital Heart Disease: AUS Population Based Study.” CIRCOUTCOMES. 113.000764.
xii See, http://www.clinicaltrials.gov/ct2/show/NCT01920633term=%22down+syndrome%22+roche&rank=1.
xiii See http://www.clinicaltrials.gov/ct2/show/NCT01791725?term=%22down+syndrome%22+elan&rank=1.
xiv See http://compose21.com/study.htm
xv Scrip Intelligence, “AC Immune and Genentech partner on first-in-class Alzheimer’s antibody.” Accessed online, June4, 2014 at http://acimmune.com/content/img/pages/20120619_ScripReprint.pdf
xviii See http://jaxmice.jax.org/strain/001924.html
xix Jun Jian, et al., “Translating dosage compensation to trisomy 21,” Nature 500 (2013): 296–300
xx Reneé Mirkes. “Prospective Chromosome Therapy for Down Syndrome: Hopes, Fears, Ethics,” Catholic World Report (January 10, 2014). Quoted from a no longer existing online source at “Genomic Editing and IncRNAs Team Up Against Down’s Syndrome,” posted August 20,2013, at http://epigenie.com/aid-for– downs-syndrome-symptoms-may-soon-exist/ [last accessed on 12/1/13].
xxi Ishita Das, et al., “Agonist Therapy Corrects Structural and Cognitive Deficits in a Down Syndrome Mouse Model”. Sci. Transl. Med. 5, 201ra120 (2013).
xxii “Experimental Compound Reverses Down Syndrome-Like Learning Deficits in Mice,” last accessed May 7, 2014. http://www.hopkinsmedicine.org/news/media/releases/experimental_compound_reverses_down_syndrome_like_learning_deficits_in_mice
xxiii Audrey Letourneau, et al., “Domains of genome-wide gene expression dysregulation in Down’s syndrome,” Nature 508 (2014): 345-350
xxiv The Diana Bianchi Lab: Prenatal Treatment of Down Syndrome. Accessed May 8, 2014. http://sackler.tufts.edu/Faculty-and-Research/Faculty-Research-Pages/Diana-Bianchi
xxv Faycal Guedj, and Diana W. Bianchi. “Noninvasive prenatal testing creates an opportunity for antenatal treatment of Down syndrome.”PrenatalDiagnosis33(2013):617
xxvi Sandra Guidi, et al., “Prenatal pharmacotherapy rescues brain development in a Down’s syndrome mouse model”. Brain 137 (2014): 380-401. Quote from the summary accessed online on May 7, 2014. http://brain.oxfordjournals.org/content/137/2/380
xxvii NIH Research Portfolio Online Reporting Tools. Estimates of Funding for Various Research, Condition, and Disease Categories. http://report.nih.gov/categorical_spending.aspx
xxviii Harry Harris, Prenatal Diagnosis and Selective Abortion. (London,1974)
xxix Quoted in Tucker Carlson, “Eugenics American Style” Weekly Standard, December 2, 1996, p. 20
xxx Denise Cavenaugh, et al. “Changing Attitudes of American Ob/Gyns on Legal Abortion, ”The Female Patient 20 (1995)
xxxi Nelson Goff, et al. “Receiving the initial Down syndrome diagnosis: a comparison of prenatal and postnatal parent group experiences.” Journal of Intellectual and Developmental Disabilities 6 (2013)
xxxii Quoted in Elizabeth Weil, “A Wrongful Birth?”. New York Times Magazine, March 12, 2006 accessed on May 14, 2014 at http://www.nytimes.com/2006/03/12/magazine/312wrongful.1.html?pagewanted=all
xxxiii Caroline Mansfield, Suellen Hopfer and Theresa M. Marteau on behalf of European Concerted Action. “Termination Rates after Prenatal Diagnosis of Down Syndrome, Spina Bifida, Anencephaly, and Turner and Klinefelter Syndromes: A Systematic Literature Review.” Prenatal Diagnosis 19 (1999): 808–812
xxxiv Jaime L. Natoli, et al., “Prenatal diagnosis of Down syndrome: a systematic review of termination rates (1995–2011). ”Prenatal Diagnosis 32 (2012): 142 –153
xxxv Dov Fox and Christopher L. Griffin, Jr. “Disability-Selective Abortion and the Americans with Disabilities Act.” Utah Law Review 3 (2009): 876
xxxvi Natoli, p 150
xxxvii Brian G. Skotko, “With New Prenatal Testing, Will Babies with Down Syndrome Slowly Disappear?” Archives of Disease in Childhood 94 (2009): 823–826
xxxviii “Key Findings: Prevalence of Down Syndrome in the United States,” accessed on June 2, 2014 at http://www.cdc.gov/ncbddd/birthdefects/features/key-findings-down-syndrome-prevalence.html
xxxix Olivia Kandranjian, “Parents Get $2.9 Millionin Down Syndrome Girl ‘Wrongful Birth’ Lawsuit,” ABC News, March 10, 2012. Accessed June 30, 2014 at http://abcnews.go.com/blogs/health/2012/03/10/parents-get-2-9m-in-down-syndrome-girl-wrongful-birth- suit/.
xl Carol M. Ostrom, “$50m awarded over birth defect; test said baby would be OK,” The Seattle Times, December 11, 2013. Accessed on June 30, 2014 at http://seattletimes.com/html/localnews/2022438460_geneticverdictxml.html. xli46NY2d401(1978).
xlii See MaterniT21™ Plus accessed on May 14, 2014 at http://laboratories.sequenom.com/maternit21plus/maternit21-plus-better-results-born-better-science
xlv “Judge Dismisses Part of Legal Challenge to N.D. Abortion Law.” Accessed on May 22, 2014 at http://www.thenewamerican.com/culture/faith-and-morals/item/16551-judge-dismisses-legal-challenge-to– nd-abortion-law
xlvi Accessed online at http://www.bdfund.org/reply-blog?p=1061
xlvii Adrienne Asch, PhD and David Wasserman, JD. “Informed Consent and Prenatal Testing: The Kennedy-Brownback Act.” Virtual Mentor, American Medical Association Journal of Ethics 11 (2009) 721– 724. Accessed on June 3, 2014 at http://virtualmentor.ama-assn.org/2009/09/oped1-0909.html
xlviii A. Lippman and B.S. Wilfond. “Twice-told tales: stories about genetic disorders.” American Journal of Human Genetics 51 (1992): 936-937
xlix Asch and Wasserman
l S. 1810 (110th): Prenatally and Postnatally Diagnosed Conditions Awareness Act, 100th Congress, 2007 – 2009. Accessed online on June3, 2014 at https://www.govtrack.us/congress/bills/110/s1810/text
li “BDF Amendment Prohibits Disability-Selective Abortion Discrimination in State-Sponsored Down Syndrome Materials,” May 30, 2014. Accessed on June 24 at http://www.bdfund.org/reply-blog?p=1061.
lii Available at http://www.ndss.org/Advocacy/Advocacy-Programs/NDSS-Government-Affairs– Committee-GAC-Program/NDSS-Prenatal-Information-State-Law-Toolkit/
liii “Global Down Syndrome Foundation, National Down Syndrome Congress Publish Hallmark Prenatal Testing Pamphlet for Pregnant Women.” Accessed on June 4, 2014 at http://www.globaldownsyndrome.org/news-community/press-releases-2/2012-press-releases/global-down– syndrome-foundation-national-down-syndrome-congress-publish-hallmark-prenatal-testing-pamphlet-for- pregnant-women/
liv Goff, 453.
lv Special Olympics, “Changing attitudes, changing the world: The health and healthcare of people with intellectual disabilities.” Accessed online June 4, 2014 at http://www.specialolympics.org/uploadedFiles/LandingPage/WhatWeDo/Research_Studies_Desciption_Pages/policy_paper_Health.pdf
lvi J. Cleary-Goldman, et al. “Screening for Down syndrome: Practice patterns and knowledge of obstetricians and gynecologists.” Obstetrics and Gynecology 107 (2006): 11–17.
lvii Korenromp, et al. “Maternal decision to terminate a pregnancy after a diagnosis of Down syndrome,” American Journal of Obstetrics and Gynecology 196 (2007): 149, e1–149. e11.
lviii C. Cunningham. “Families of children with Down syndrome: What we know and what we need to know.” Down Syndrome Research and Practice, 4 (1996): 93. Quoted in Goff, p 446.
lix Goff, 446
lx Goff, et al., 453
lxi See http://report.nih.gov/categorical_spending.aspx for NIH funding categories and allocations
lxii Available at http://www.aul.org/wp-content/uploads/2012/01/Sex-Selective-and-Genetic-Abnormality-Ban-2012-LG.pdf
Recent updates to official medical guidelines in the United Kingdom regarding specialization in sexual and reproductive health now bar doctors and nurses, with religious or moral objections to proscribing abortion inducing drugs such as the morning after pill, from receiving specialist professional qualifications.
An abortion clinic in Toledo, Ohio is claiming that an agreement made with the University of Michigan Health System puts the clinic in compliance with state law requiring Ohio abortion providers to have a transfer agreement with a local hospital.
This week the United Nations Commission of Inquiry on Human Rights in North Korea released a report detailing the harrowing human rights atrocities being perpetrated by the North Korean dictatorship upon its people. North Korea has been essentially cut off from the rest of the world since the ceasefire was declared in the Korean War. This new report commissioned by the Human Rights Council pulls the curtain back on this intensely secretive nation and confirms many of the reports of horrific abuses that have long been mentioned in conjunction with the North Korean regime. In the words of the report, “The gravity, scale, and nature of these violations reveal a state that does not have any parallel in the modern world.”
Last Wednesday marked the 41st anniversary of the Roe v. Wade. This monumental Supreme Court decision was commemorated, as it has been every year since, by tens of thousands of Americans marching along the National Mall to the steps of the Supreme Court, this year trudging through arctic conditions. The annual March for Life stands out in the minds of those who have witnessed it on account of the sheer size of the crowd that comes every year as well as their youth and vitality.
On November 29, the day after Thanksgiving, the U.S. Centers for Disease Control and Prevention (CDC) released their 2010 Abortion Surveillance report to the public. The annual report is composed of statistical data and analysis documenting induced abortions in the States. The report revealed that there was a total of 765,651 abortions in 2010 – a 3% decrease from the figure CDC reported in 2009. This number also represents the lowest abortion total reported by the CDC since 2001.
On December 11, 2013, Secretary of Health and Human Services Kathleen Sebelius, in response to a question from Rep. John Shimkus (R-IL), testified on Capitol Hill that abortion coverage information in insurance plans is “available for every customer,” and that “it is on the website.” After the testimony the Charlotte Lozier Institute undertook to research a variety of plan documents for health insurance plans on the federal exchange to discern which ones do and do not cover abortion. Here is a list of the Summary of Benefits and Coverage documents CLI has gathered from a survey of states whose marketplaces are operated by the federal government. Most do not reveal any information on whether the plan covers abortion.
This Tuesday, December 10, which is interestingly enough Human Rights Day, the European Parliament once again voted on the controversial Report on Sexual and Reproductive Health and Rights, which would classify abortion as a fundamental human right. Despite the intense lobbying of the proposed legislation’s supporters, the measure was once again rejected by Members of the European Parliament (MEP’s).
Editor’s Note: The following is an excerpt from the brief amicus curiae of Americans United for Life (AUL) in Conestoga Wood Specialties Corporation v. Sebelius, in support of a petition for writ of certiorari in the U.S. Court of Appeals for the Third Circuit. The brief was filed on behalf of seven medical and bioethics groups in the United States. The text below refers to “Petitioners” (Conestoga) and “Respondents” (the Obama Administration in the form of Secretary of Health and Human Services Kathleen Sebelius and others).
The case involves the preventive services mandate (the “Mandate”) from the U.S. Department of Health and Human Services under the Affordable Care Act, and the question presented is whether the federal government may compel a commercial enterprise with religious or conscientious objections to certain drugs and devices used to prevent conception and/or induce early abortions to provide or arrange for insurance coverage of such drugs and devices for its employees. The brief is excerpted here because of its clear and concise framing of evidence and arguments regarding the abortion-inducing mode of action of various drugs and devices that are involved in this and related litigation across the United States.
The Charlotte Lozier Institute (CLI) thankfully acknowledges the permission of AUL to reprint this excerpt. CLI has edited the excerpt only to renumber footnotes and to remove headings required for a legal brief that are not necessary for presentation as an independent article. For more information about AUL and to obtain a full copy of this amicus brief and related materials, visit www.aul.org.
A New, Distinct Human Organism Comes into Being at Fertilization
It is undisputed that a new, distinct human organism comes into existence during the process of fertilization. Scientific literature states the following:
• “The fusion of sperm and egg membranes initiates the life of a sexually reproducing organism.”
• “The life cycle of mammals begins when a sperm enters an egg.”
• “Fertilization is the process by which male and female haploid gametes (sperm and egg) unite to produce a genetically distinct individual.”
• “The oviduct or Fallopian tube is the anatomical region where every new life begins in mammalian species. After a long journey, the spermatozoa meet the oocyte in the specific site of the oviduct named ampulla, and fertilization takes place.”
• “Fertilization – the fusion of gametes to produce a new organism – is the culmination of a multitude of intricately regulated cellular processes.”
The government’s own definition attests to the fact that life begins at fertilization. According to the National Institutes of Health, “fertilization” is the process of union of two gametes (i.e., ovum and sperm) “whereby the somatic chromosome number is restored and the development of a new individual is initiated.” Thus, in the context of human life, a new individual human organism is initiated at the union of ovum and sperm. One textbook similarly explains: Human development begins at fertilization when a male gamete or sperm (spermatozoon) unites with a female gamete or oocyte (ovum) to produce a single cell – a zygote. This highly specialized, totipotent cell marked the beginning of each of us as a unique individual.
Thus, a new human organism is created before the developing embryo implants in the uterus – i.e., before that time at which some people consider a woman “pregnant.” Respondents [HHS] and their amici have at times tried to blur this distinct line with semantics of when “pregnancy” begins. Relying on a definition of pregnancy that begins at “implantation,” Respondents argue that “emergency contraceptives” are not “abortifacients.” However, this is a nonresponse to the concern that a drug or device can work after fertilization, by blocking the implantation of a developing human embryo. Such drugs might not end a “pregnancy” under Respondents’ definition, but it does end the life of a unique human being. What Petitioners [AUL et al.] – and Amici – conscientiously oppose is not simply the ending of a “pregnancy,” but this ending of human life.
Drugs and Devices Defined by the FDA as “Emergency Contraception” Have Post-Fertilization Mechanisms of Action
Drugs and devices with post-fertilization (i.e., life-ending) mechanisms of action are included in the FDA definition of “contraception.” Even though these drugs or devices may end a developing, distinct human being’s life by preventing implantation, they are labeled by the FDA as “contraception.” However, referring to such drugs as “contraception” is deceiving in that it infers only the prevention of fertilization. But the FDA’s criterion in categorizing a drug as “contraception” is whether a drug can work by preventing “pregnancy” – which the FDA defines as beginning at “implantation,” not fertilization.
Thus, drugs that interfere with implantation – which occurs after fertilization and the creation of a new human organism – are categorized as “contraception.” Promoting the Mandate, Respondent Kathleen Sebelius, Secretary of Health and Human Services (HHS), admitted that the FDA’s definition of “contraception” extends to blocking the implantation of an already developing human embryo: “The Food and Drug Administration has a category [of drugs] that prevent fertilization and implantation. That’s really the scientific definition.” Respondent Sebelius stated that under the new Mandate, “[t]hese covered prescription drugs are specifically those that are designed to prevent implantation.” Respondents know and admit that these drugs work after fertilization.
In his most recent study on “emergency contraception,” Dr. James Trussell, whose research on “contraception” is cited by the FDA, states: “To make an informed choice, women must know that [emergency contraception pills] . . . may at times inhibit implantation. . . .” Although an advocate of “emergency contraception,” Dr. Trussell believes that the scientific difference between a drug that prevents fertilization of an egg and one that may also prevent implantation of a unique human organism is significant enough that it must be disclosed to a potential user. He has also stated that these post-fertilization effects “should certainly be [acknowledged and] celebrated, because without them the [contraceptive] method would not provide as much benefit as they do.” In other words, if fertilization has occurred, the method provides “benefit” by preventing implantation.
Strikingly, Dr. Warren Wallace, a physician at Northwestern University Medical School who has “prescribed emergency contraceptives,” and who was called to testify in support of a law restricting rights of conscience protections for the prescription of “emergency contraception,” testified that “there is a new unique human life before” the implantation of an embryo.
Moreover, a new drug classified by the FDA as “emergency contraception” – Ulipristal Acetate (ella) – is actually an abortion-inducing drug, because it can kill an embryo after implantation. An understanding of these post-fertilization mechanisms of action, discussed below, demonstrates that “emergency contraception” can end the life of an already developing human organism.
Plan B Can Prevent Implantation
In 1999, the FDA approved the distribution of the drug known as Plan B. Although called “emergency contraception,” the FDA’s labeling acknowledges that Plan B can prevent implantation of an already developing human embryo. Further, the FDA states on its website, “[i]f fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation).” The same explanation is provided by Duramed Pharmaceuticals, the manufacturer of Plan B One-Step.
Under Respondents’ Mandate, Petitioners are forced to pay for Plan B, despite its life-ending effect on already formed unique human organisms, in violation of Petitioners’ genuinely held religious beliefs.
Ulipristal Acetate (ella) can prevent implantation or kill an implanted embryo. In 2010, the FDA approved the drug Ulipristal Acetate (ella) as another “emergency contraceptive.” Importantly, ella is not an “improved” version of Plan B; instead, the chemical make-up of ella is similar to the abortion drug RU-486. Like RU-486, ella is a selective progesterone receptor modulator (SPRM) – “[t]he mechanism of action of ulipristal (ella) in human ovarian and endometrial tissue is identical to that of its parent compound mifepristone.” This means that though labeled as “contraception,” ella works the same way as RU-486. By blocking progesterone – a hormone necessary to build and maintain the uterine wall during pregnancy – ella can either prevent a developing human embryo from implanting in the uterus, or it can kill an implanted embryo by essentially starving it to death. Put another way, ella can abort a pregnancy, whether you define “pregnancy” as beginning at fertilization or at implantation.
Studies confirm that ella is harmful to a human embryo. The FDA-approved labeling notes that ella may “affect implantation” and contraindicates use of ella in the case of known or suspected pregnancy. A study funded by ella’s manufacturer explains that SPRMs (drugs that block the hormone progesterone), “including ulipristal acetate,” can “impair implantation.” While the study theorizes that the dosage used in its trial “might be too low to inhibit implantation,” it states affirmatively that “an additional postovulatory mechanism of action,” e.g., impairing implantation, “cannot be excluded.”
Thus, ella has the potential to destroy a human embryo. At the FDA advisory panel meeting for ella, Dr. Scott Emerson, a professor of Biostatistics at the University of Washington and a panelist, raised the point that the low pregnancy rate for women who take ella four or five days after intercourse suggests that the drug must have an “abortifacient” quality.
In short, ella goes beyond any other “contraceptive” approved by the FDA at the time of the Affordable Care Act’s enactment. By approving ella as “contraception,” the FDA removed, not simply blurred, the line between “contraception” and “abortion” drugs because ella can work by ending an established “pregnancy.”
Further, though “indicated” for contraceptive use, mandated coverage for ella opens the door to the funding (through health insurance) of purposeful off-label abortion usage of the drug. Already, ella is available for sale online, where a purchaser need only fill out a questionnaire to obtain the drug, with no physician or pharmacist to examine the patient, explain the risks in person, or verify the identity and intentions of the purchaser. Thus, contrary to their religious and conscientious beliefs, Petitioners are required to pay for ella – an abortion-inducing drug – under Respondents’ mandate.
Intrauterine Devices May Also Prevent Implantation
Copper Intrauterine Devices (IUDs) are heavily promoted as another form of “emergency contraception.” IUDs can block the implantation of a human embryo after fertilization.
In his study on “emergency contraceptives,” Dr. Trussell concludes that “[i]ts very high effectiveness implies that emergency insertion of a copper IUD must be able to prevent pregnancy after fertilization.” Put another way, IUDs are so effective because they do not just prevent conception – they can kill an already developing human embryo. Once again, under Respondents’ Mandate – and contrary to their religious and conscientious beliefs –Petitioners are required to pay for devices that can kill human embryos.
 See, e.g., Condic, When Does Human Life Begin? A Scientific Perspective (The Westchester Institute for Ethics & the Human Person Oct. 2008), http://bdfund.org/wordpress/wpcontent/uploads/2012/06/wi_whitepaper_life_print.pdf; George & Tollefsen, EMBRYO 39 (2008).
 Marsden et al., Model systems for membrane fusion, CHEM. SOC. REV. 40 (3): 1572 (Mar. 2011) (emphasis added).
 Okada et al., A role for the elongator complex in zygotic paternal genome demethylation, NATURE 463:554 (Jan. 28, 2010) (emphasis added).
 Signorelli et al., Kinases, phosphatases and proteases during sperm capacitation, CELL TISSUE RES. 349(3):765 (Mar. 20, 2012) (emphasis added).
 Coy et al., Roles of the oviduct in mammalian fertilization, REPRODUCTION 144 (6): 649 (Oct. 1, 2012) (emphasis added).
 Marcello et al., Fertilization, ADV. EXP. BIOL. 757:321 (2013) (emphasis added).
 National Institutes of Health, Medline Plus Merriam-Webster Medical Dictionary (2013), http://www.merriamwebster.com/medlineplus/fertilization (emphasis added).
 Moore & Persaud, THE DEVELOPING HUMAN 16 (7th ed. 2003) (emphasis added).
 For an overview of how the definition of “pregnancy” has changed, see Gacek, Conceiving Pregnancy: U.S. Medical Dictionaries and Their Definitions of Conception and Pregnancy, FRC INSIGHT PAPER (Apr. 2009), http://downloads.frc.org/EF/ EF09D12.pdf.
 Wallace, Health and Human Services Secretary Kathleen Sebelius Tells iVillage “Historic” New Guidelines Cover Contraception, Not Abortion (Aug. 2, 2011), http://www.ivillage.com/ kathleen-sebelius-guidelines-cover-contraception-not-abortion/4- a-369771 (emphasis added).
 Id. (emphasis added).
 Trussell et al., Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy (Office of Population Research at Princeton University June 2010).
 Raymond et al., Embracing post-fertilisation methods of family planning: a call to action, J. FAM. PLAN. REPROD. HEALTH CARE (2013), http://press.psprings.co.uk/jfprhc/september/jfprhc 100702.pdf.
 Transcript of Bench Trial at 91-92, 111, Morr-Fitz, Inc. v. Quinn, 2012 IL App. (4th) 110398 (Ill. App. Ct. Sept. 20, 2012).
 Plan B Approved Labeling, http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021045s011_Plan_B_PRNTLBL.pdf.
 FDA, FDA’s Decision Regarding Plan B: Questions and Answers (updated Apr. 30, 2009), http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm.
 Duramed Pharmaceuticals, How does Plan B One-Step work? (2010), http://www.planbonestep.com/faqs.aspx (explaining that Plan B can work “by preventing attachment (implantation) to the uterus (womb)”).
 Harrison & Mitroka, Defining Reality: The Potential Role of Pharmacists in Assessing the Impact of Progesterone Receptor Modulators and Misoprostol in Reproductive Health, 45 ANNALS PHARMACOTHERAPY 115 (Jan. 2011).
 See Gacek, Conceiving Pregnancy, supra.
 European Medicines Agency, Evaluation of Medicines for Human Use: CHMP Assessment Report for Ellaone 16 (2009), http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Public_assessment_report/human/001027/WC500023673.pdf.
 ella Labeling Information (Aug. 13, 2010), http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf.
 Glasier et al., Ulipristal acetate versus levongestrel for emergency contraception: a randomized non-inferiority trial and meta-analysis, 375 THE LANCET 555 (Jan. 2010).
 In the Glasier study, “follow-up was done 5-7 days after expected menses. If menses had occurred and a pregnancy test was negative, participation [in the study] ended. If menses had not occurred, participants returned a week later.” Considering that implantation must occur before menses, the study could not, and did not attempt to, measure an impact on an embryo prior to implantation or even shortly after implantation. ella was not given to anyone who was known to already be pregnant (upon enrollment participants were given a pregnancy test and pregnant women were excluded from the study). The only criterion for ella “working” was that a woman was not pregnant in the end. Whether that was achieved through blocking implantation, or killing the embryo after implantation, was not determinable.
 See Transcript, Food and Drug Administration Center for Drug Evaluation and Research (CDER), Advisory Committee for Reproductive Health Drugs (June 17, 2010), http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM218560.pdf.
 See Department of Health and Human Services, Birth Control Methods (Nov. 21, 2011), http://www.womenshealth.gov/publications/our-publications/fact-sheet/birth-control-methods.pdf (“If fertilization does occur, the IUD keeps the fertilized egg from implanting in the lining of the uterus.”).
 See Trussell, Emergency Contraception, supra (emphasis added).
Yesterday the U.S. Court of Appeals for the Fifth Circuit issued an order that allows a recently enacted Texas abortion regulation to take effect. The case is called Planned Parenthood v. Abbott and it was filed by several Planned Parenthood entities and similar organizations.
Here are three things you need to know about the case.
On Tuesday of this week, the European Parliament will vote on a measure that classifies abortion as a fundamental human right.
The measure was scheduled for a vote after the European Parliament’s Committee on Women’s Rights and Gender Equality issued a draft report last month discussing sexual and reproductive health and rights.
On Tuesday of this week, the European Parliament will vote on a measure that classifies a measure that classifies abortion as a fundamental human right.
The measure was scheduled for a vote after the European Parliament’s Committee on Women’s Rights and Gender Equality issued a draft report last month discussing sexual and reproductive health and rights. View More
More than a week into the enrollment period for health insurance via the federal-state insurance exchanges, whether existing plan options include elective abortion remains anything but clear. Under Obamacare, a cluster of Multi-State Plans (MSPs) are likely to include elective abortion coverage in 27 states. In each of those states, at least one MSP is required under federal law to exclude elective abortion coverage so that individual subscribers can select an option that squares with this element of conscience. But how to tell an elective-abortion plan from one that does not include it?
The news came of the United Kingdom this past week that the Crown Prosecution Service (CPS) rules that it would not be in the “public interest” to prosecute two doctors who agreed to arrange illegal sex-selective abortions. This ruling was made despite the fact that prosecutors admit that there is more than enough evidence to take these doctors to court for violating the law.
On January 1, 2014 state health exchanges, or the federal or “partnership” versions that will operate in their stead in a narrow majority of states, are required by law to be up and running. By October 1, 2013 consumers are supposed to be able to begin researching and comparing insurance options in these exchanges. Delays in the implementation of the Affordable Care Act are evident in nearly all areas of the law, including a feature called “multi-state plans” (MSPs) that are designed to be phased in over a four-year period for every state in the Union. Despite provisions of law including the Hyde Amendment governing appropriations for abortion; the Hyde-Weldon amendment barring discrimination against physicians, insurers, institutional providers and others with respect to their policies regarding providing, referring or paying for abortion; and the language governing the MSPs themselves, the Obama Administration and abortion funding advocates seem bent on pursuing numerous avenues for the ACA, and MSPs in particular, to make public abortion subsidies available to tens of thousands of girls and women of childbearing age. Here is how.
Multi-state health plans were created under Section 1334 of the Affordable Care Act. The law provides for a minimum of two such plans in each state, one of which must be a nonprofit plan. The MSPs were a late substitute for the idea of a public option, a fully government-run plan that would have competed with – and, many advocates hoped, eventually supplanted – privately sponsored plans. Instead, the MSPs will be offered by heavily regulated private sector insurers operating under contracts these insurers directly sign with OPM. “Multi-state” is another word for “national” and the degree of regulation of plan content, control of medical-loss ratios, and other factors ensure that these plans will operate more like regulated utilities than truly private insurance.
Beginning in 2014, the MSPs are to be phased in over a four-year period. The ACA requires approved plans to be available in at least 60 percent of the states in the first year (30 states), 70 percent in the second year (35 states), 85 percent in the third year (presumably 43 states), and 100 percent in the fourth year (2017). One core rationale for these plans is to increase “competition” in the state exchanges, a goal in dramatic tension with the concept of heavily regulated plans, which by their heft and complexity are likely to be offered by only a handful of the largest health insurance companies in the country. In order to aid this regulated competition, the MSPs will have to offer price advantages that may well flow from the fact that their administrative (including promotional) costs will be borne by the taxpayer through the Office of Personnel Management. Both the companies and the Obama Administration have incentives to maximize participation in these plans.
What these advantaged plans will do with respect to abortion coverage is not yet fully clear. However, Section 1334(a)(6) of the ACA states that:
In entering into contracts under this subsection, the Director [of OPM] shall ensure that with respect to multi-State qualified health plans offered in an Exchange, there is at least one such plan that does not provide coverage of services described in section 1303(b)(1)(B)(i). (Emphasis added).
The cited section refers to the ACA’s description of the Hyde Amendment regarding abortions that may be covered: those for reasons of rape and incest and a narrow set of conditions regarding physical threat to the life of the mother.
The ACA also included a provision, Section 1303(a)(1), making clear that state legislatures, some of which already had laws in place barring every health insurer in the state from offering abortion in any plans marketed and sold there, could adopt new opt-out legislation barring plans that cover elective abortions from participation in their state’s exchanges. Five states adopted this exchange abortion limit in 2010, and since then the number of states doing so has grown to 23. Twenty-seven states and the District of Columbia currently have no such limitation.
On March 1 of this year, the Office of Personnel Management issued its final rule on the MSPs, acknowledging that a decision by a state to exclude abortion-covering plans from its exchange will apply to any and all MSPs offered in that particular state. Section 800.602(b) of the rule, titled “State Opt-Out,” simply says, “An MSP may not offer abortion coverage in any State where such coverage of abortion services is prohibited by State law.” That states can block all qualified insurers, including MSPs, from their exchanges if they cover elective (non-Hyde) abortions is clear. But a strong case can be made that Section 1303(b)(1)(B)(1)’s reference to excluding abortion coverage can be read, in conjunction with other provisions of federal health law, to forestall the Obama Administration from seeking to compel any private insurance company to include elective abortion in its MSP.
A July 22, 2013 article in Roll Call reported on an email from the HHS Center for Medicare and Medicaid Services (CMS) to the article’s author, quoting an unnamed CMS source to the effect that “the multistate plans will help [CMS to] ‘ensure that in each exchange, there is at least one plan available that covers abortions beyond those allowed by the Hyde Amendment and at least one plan that does not cover abortions beyond those permitted by the Hyde Amendment’.” (i.e., rape, incest or danger to the woman’s life) But the ACA says nothing about such “ensuring” of abortion coverage in states where it is not precluded by state law. In fact, Section 1303(b)(1) of the ACA states that “[n]otwithstanding any other provision of this title (or any amendment made by this title) . . . nothing in this title (or any amendment made by this title), shall be construed to require a qualified health plan to provide coverage of services described in subparagraph (B)(i) or (B)(ii) [elective abortion] as part of its essential health benefits for any plan year; and . . . the issuer of a qualified health plan shall determine whether or not the plan provides coverage of services described in subparagraph (B)(i) or (B)(ii) as part of such benefits for the plan year.” (Emphasis added)
This is exactly the type of “thumb on the scale” that the Obama Administration can be expected to apply to the ACA and to MSPs in order to drive the states that permit elective abortion in their exchanges or reluctant insurers wishing to participate in those exchanges to do something (provide abortion coverage under the unprecedented “segregated funding” scheme) they not only may not wish to do but are explicitly protected from being required to do in their MSP. Another way to place this thumb on the scale, for example, would be through the “Navigators” program, a separate stream of ACA funding that Planned Parenthood and similar entities are receiving that could be diverted to efforts to enroll girls and women in MSPs that include elective abortion and to discourage them from enrolling in plans that omit it.
Estimating how many girls and women will likely enroll in plans that cover elective abortion under the ACA is a complex and, absent details on MSP contracts, caveat-ridden business. We can, however, arrive at a reasonable estimate of the size of the pool of women of reproductive age (15-44) who will gain eligibility for such plans in the coming years. The Charlotte Lozier Institute has reviewed numbers compiled by the Henry J. Kaiser Foundation in 2010 for a paper titled “Access to Abortion Coverage and Health Reform.” The Kaiser paper estimates the number of currently uninsured girls and women age 15-44, by state, who are either likely to newly qualify for Medicaid or to qualify for premium credits in the state exchanges.
While state policies continue to develop and more states could conceivably block elective abortion in their exchanges, at present the majority of states (27) and the District of Columbia do not exclude elective abortion coverage from their exchanges. A smaller number of states (17) permit elective abortion coverage, using state funds, in their Medicaid programs. The vast majority of these states (13) do so as a result of state court rulings that are less protective than the Hyde amendment policy upheld by the U.S. Supreme Court governing federal funds. The table below includes the numbers and percentages compiled by the Kaiser Foundation and applies them to states that allow elective abortion in state exchanges or fund elective abortion through their Medicaid program, or both. The calculations were done by the Lozier Institute working with this 2008-2009 data. Note that the figures represent a maximum number of girls and women who may gain abortion coverage; in reality, the percentage of currently uninsured girls and women who will choose an MSP with elective abortion over an MSP that excludes this coverage is unknown.
Table 1: Estimates of Currently Uninsured Women and State Abortion Funding Policies
|State||Funds Medicaid Abortions||Exchange Allows Plans with Elective Abortion||Number of Uninsured Women Age 15-44||Percent of Currently Uninsured Women Age 15-44 Potentially Eligible for Federal Assistance in 2014 Medicaid Exchanges||Total Women Gaining Potential Abortion Coverage|
|District of Columbia||X||17,640||32%||5,645|
Total: 8,181,305 5,574,435
X – voluntarily funding abortion (not under court order).
How many abortions might, maximally, be funded through this expansion of the pool of girls and women who have insurance coverage for this procedure? Any calculation must take into account the fact that only a fraction of women who have abortions have private insurance coverage for the procedure and are willing to use that coverage for this personally and ethically sensitive purpose. According to a Guttmacher Institute study, only 30% of girls and women who had abortions in 2008 had private insurance for the procedure. Of those who did have private insurance, only about one-third actually used that insurance to pay for the abortion. While Guttmacher cites high co-pays and deductibles as a factor for limited use of the insurance, it seems more likely that, since an abortion paid for with cash would be more costly in any event, the low usage rate of private insurance for abortions has less to do with expense (as Guttmacher acknowledges) as with intense feelings about not disclosing abortion to third parties, even insurers. Overall, only about 12 percent of U.S. abortions were paid for with private insurance in 2008. 
It could be argued that expanding private coverage of abortion will therefore have a small impact on the public subsidies for abortion, but it is by no means certain that today’s funding patterns will remain unchanged, as the heart of the abortion funding debate under ObamaCare, as with every other public program or private policy on the subject, is whether it represents a health practice or the unwarranted destruction of human life that is injurious to all involved. ObamaCare’s conflicting policies represent a step, partial but by no means full, toward treating abortion as a basic medical treatment that should be no more controversial than dental hygiene or pap smears.
Overall, CLI’s analysis concludes that some 5.57 million girls and women potentially gain coverage for abortion under ObamaCare, split roughly equally between Medicaid expansion and exchange insurance that covers elective procedures. If 2% of all women of childbearing age have abortions each year, an estimated 111,500 girls and women who will have abortions in coming years will have new coverage in effect for them. If only one third of the girls and women who are newly privately covered for elective abortions proceed and file for them, an additional 18,397 abortions will be paid for each year under ObamaCare’s exchange expansion. Publicly funded abortions, on the other hand, could rise by as much as 53,600 – with roughly half of that increase occurring in New York and California, two states with high existing abortion rates. Taken together, the data suggest that ObamaCare’s annual net increase in insured abortions that are either fully publicly funded through Medicaid or heavily subsidized through the exchanges could be as high as 71,000 to 111,500, depending on how many girls and women forego insurance and pay out-of-pocket.
These numbers are estimates at the outset of a dynamic process. Robert Moffit, Director of the Center for Health Policy Studies at the Heritage Foundation, argues that the MSPs will ultimately be a significant factor not in ensuring competition but in reducing it by exercising the advantages granted to them by OPM promotion and support. “What this does, “Dr. Moffit told Kaiser Health News, “is it will give larger plans an expanded market share. My view is you will see an acceleration of this consolidation in health insurance markets over time.” Whether or not this is an intentional result of this form of “public option,” the implementation of ObamaCare could have a profound effect on the ability of millions of Americans to avoid participating indirectly in subsidizing abortions through public programs or quasi-private plans. A taxpayer may have an individual plan that does not cover elective abortion, but his or her tax dollars will be increasingly flowing to public and private plans in other states that reimburse for abortions at a higher rate than previously seen in American health care. Moreover, the ability to avoid the companies that sponsor these plans may decrease over time as they grow in size and continue to curry favor from a government that views abortion as a form of therapy.
Charles A. Donovan is the President of the Charlotte Lozier Institute
 42 U.S.C. 18054.
 “Patient Protection and Affordable Care Act; Establishment of the Multi-State Program for the Affordable Insurance Exchanges,” Office of Personnel Management, 45 CFR Part 800; March 11, 2013; at https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-04954.pdf (September 17, 2013).
 Rebecca Adams, “The Question of Abortion Coverage in Health Care Exchanges,” Roll Call, July 22, 2013, at www.rollcall.com/news/the_question_of_abortion_coverage_in_health_exchanges-226547-1.html?pg=2 (emphasis added).
 “Access to Abortion Coverage and Health Reform,” Henry J. Kaiser Foundation, Table 2, State Level Estimates of Percent of Uninsured Women Ages 15-44 Likely to Qualify for Federal Assistance Under the Patient Protection and Affordable Care Act,” October 30, 2010, at http://kff.org/womens-health-policy/issue-brief/access-to-abortion-coverage-and-health-reform/ (September 17, 2013).
 Harris v. McRae, 448 U.S. 297 (1980).
 http://www.guttmacher.org/media/inthenews/2011/01/19/index.html (“Memo on Private Insurance Coverage of Abortion,” Guttmacher Institute, January 19, 2011)(viewed September 13, 2013).
 Julie Appleby, “National Health Plans, Designed to Spur Competition, May Be Unavailable in Some States Next Year,” Kaiser Health News, July 5, 2013. http://www.kaiserhealthnews.org/Stories/2013/July/05/multistate-national-health-insurance-plans-exchange-marketplace.aspx (September 13, 2013).
 The 10 largest private insurance plans in the country are United (noncommittal at this date on abortion coverage through the MSP but expected to do so where permitted), Wellpoint, Kaiser, Aetna, Humana (has indicated it will not do an MSP), HCSC, Coventry Corp., Highmark, Independence Blue Cross, Blue Shield (has submitted a plan for 31 states that covers abortion where permitted), and Cigna. See (http://health.usnews.com/health-plans/national-insurance-companies).
Amid the firestorm in Texas politics on the legislative vote to ban abortions after 20 weeks and increase regulation of the health and safety of clinics that perform abortions (despite a failed filibuster, a successful mob takeover of the statehouse, and now a special session of the legislature), national attention has turned to these laws that create a time barrier on late-term abortions.
This week in Ireland, the final vote on proposed abortion legislation is expected to take place. The Dáil is expected to hear and discuss proposed amendments to the divisive bill, though Taoiseach Enda Kenny has made it clear that one of the most contentious portions of the bill — legalized abortion on the grounds of suicidality — will not be removed from the proposed legislation.
In a fascinating new webinar sponsored by Heartbeat International and the Charlotte Lozier Institute, CLI adjunct scholar Dr. Elizabeth Johnson gave a fascinating presentation on induced abortion and the subsequent risk of pre-term birth. In her talk, Dr. Johnson describes the serious public health concerns of pre-term birth and discusses the growing body of research on the topics as it relates to both clinical practice and a woman’s informed consent.
Last week, a fascinating new research paper was released which demonstrates that mothers and babies in Ireland are safer there and receive better care than they would in the neighboring United Kingdom, in spite of the fact that abortion remains illegal in Ireland. The paper, entitled Maternal and Neonatal Health and Abortion: 40 Year Trends in Great Britain and Ireland, was authored by CLI Adjunct scholar Byron Calhoun, MD, as well as John M. Thorp MD, and Patrick S. Carroll, MA. It was published in the American Journal of Physicians and Surgeons.
When Melinda Gates announced the Gates Foundation’s expanded commitment to contraception, she made certain to spell out that this commitment did not embrace abortion or population control. Successful pursuit of this “middle road” Gates thinks should cause “no controversy” has frustrated both those who oppose government-run efforts focused on contraception and those who believe any reproductive health program that does not include abortion fails women.
Last Saturday, in Dublin, an estimated 40,000 people came out to stand in opposition to legalized abortion-on-demand in Ireland. The abortion issue has simmered in Ireland for years, but the tragic death of Savita Halappanavar in October 2012 has pushed the issue to the forefront of national debate.
*Editor’s Note: Last week Dr. Henry Morgentaler, whose medical practice and activism led to the legalization of abortion in Canada, died at age 90. Andrea Mrozek reflects on Morgentaler’s impact on Canadian women and families.
There’s some irony in the passing away of Dr. Henry Morgentaler. Regrettably, Morgentaler, whose name will forever be connected with opening Canada up to abortion on demand, cannot be celebrated. Making abortion mainstream is something few can celebrate.
1/21/2013: Charlotte Lozier Institute President Chuck Donovan discusses the importance of accurate and reliable abortion reporting in the states at the New York Times.
This past Friday, March 8, marked International Women’s Day. The observance, quite admirably, draws attention to the social, political, and economic struggles of women throughout the world as well as the plethora of human rights abuses committed against them. There is no doubt that women have made and continue to make vital contributions to society and every day we seem to make substantial gains in the global arena. However, it quite often seems that, throughout most of the world, to be a woman is to be born already facing an almost insurmountable struggle and, in many cases, a life of tragedy.
The Maryland Office of Health Care Quality is investigating the tragic death of 29-year-old Jennifer Morbelli, who died after a suspected late-term abortion procedure performed at a controversial abortion clinic in Germantown, Maryland. They are right to do so. However, a more comprehensive response is warranted from the wider obstetrical and medical community. Americans should be outraged by the paucity of evidence-based information regarding abortion procedures and complications in the United States.
A new poll released by the Chiaroscuro Foundation in New York reveals that the majority of New Yorkers support sensible restrictions on abortion and oppose proposed changes to current law which would considerably expand abortion in the state. This poll, which surveyed both pro-choice and pro-life New Yorkers, has been released at a time of great tension in the abortion debate in New York, as Governor Andrew Cuomo (D) unveiled the Reproductive Health Act last month.
For years abortion advocates and researchers have been asserting that an abortion is in fact safer than carrying a pregnancy to term. They contend that pregnancy is a long process and the chance of complications during the gestational period and birth is significantly higher than complications resulting from the abortion procedure. However, a study released this past week demonstrates that this claim is not entirely valid. New research, which takes into account the full reproductive histories of the women involved, illustrates that, compared to women who delivered their babies, women who had an early- or late-term abortion have significantly higher mortality rates within one to ten years of the event.
A recent pretrial hearing of Fort Hood shooter Major Nidal Hasan provides the opportunity to again raise the question as to why prosecutors are not seeking justice for all the victims of the 2009 massacre.
At the hearing, attorneys for Hasan again confirmed their client’s willingness to plead guilty to 13 counts of premeditated murder and 32 counts of attempted premeditated murder.
However, under federal law and the Uniform Code of Military Justice (§919a Article 119a), there was a 14th victim – the unborn child of Army Private Francheska Velez, herself killed in the shooting.
The 2004 Unborn Victims of Violence Act (UVVA)makes the killing or injuring of an unborn child during the commission of a crime a criminal offense, and allows for the prosecution of an individual who, intentionally or not, kills or injures an unborn child.
This is exactly what happened during the Fort Hood massacre (and, incidentally, during the Aurora theater shooting, albeit Colorado is one of the minority of states that do not have an unborn victims’ law); it is a clear instance of what originally prompted lawmakers to pass UVVA. According to a witness, Pvt. Velez’s last words before dying were, “My baby, my baby.”
Despite the UVVA, prosecutors are refusing to hold Hasan responsible for the shooting death of that baby. Pvt. Valez’s child may have been unborn but not, in the eyes of the law, unrecognized. It makes no difference to the applicability of the UVVA that a gun was used in this crime, but that fact only heightens the irony of the present circumstance.
Pvt. Valez’s last words and last concern were for the child she was carrying. Prosecutors owe it to her memory to seek justice for that child as for all the victims of the Fort Hood shootings.
Gene Tarne is a Senior Analyst at Charlotte Lozier Institute.
Download PDF here: American Report Series ABORTION REPORTING LAWS
National and state abortion reporting laws and policies in the United States are a patchwork that falls far short of fulfilling the potential of this information to inform and guide public policy. The composite picture they reveal is at once impressionistic and incomplete, non-contemporaneous and of limited use in providing a true and timely rendering of the impact of public policies and attitudes on the reality of abortion in the United States. Like an observer of the night sky, analysts seeking to understand the real-time status of abortion in the United States are forced to look at sketchy and incomplete information whose origin, like light from the stars, varies by age and quality.
In this era of Internet technology and nearly instant reporting of all sorts of data, this patchwork need not be the rule, nor need policymakers accept such incomplete information as a given. Moreover, policymakers can and must be aware of the biases inherent in the current system of gathering and disseminating data about one of the most morally fraught questions in public life. Getting current and unfiltered information and having the advantage of multiple interpretations of its meaning should be a topic of the highest priority for state and federal attention. Moreover, in the age of the Internet, neither gathering nor disseminating useful, current, and patient-protective cumulative data need be a costly enterprise.
Consider the example of Minnesota. Abortion reporting there is conducted on a relatively timely basis and at low cost to the state treasury. While some states with large numbers of abortions – for example, California and Maryland – have not produced a public, statewide abortion report in years or do not publish one at all, Minnesota’s Department of Health implements a state law passed in 1998 that requires it to release a compilation of data for the previous calendar year by July 1 of the following year (see http://www.health.state.mn.us/divs/chs/abrpt/abrpt.htm). These reports allow the state legislature and interested citizens to track and analyze state abortion trends and document decreases in abortion, presumptively a consensus objective in public policy. The 2011 annual report states that its production cost, including printing and staff time, was only $4,000 in 2012.
Across the spectrum of views about the legal status of abortion throughout the duration of pregnancy, a wide range of commentators have urged public policies that would render the practice rare. An examination of state and federal reporting policies makes clear, nonetheless, that the system now in place is poorly suited to determine whether or not, in fact, abortion is becoming significantly less frequent and to what degree, especially in year-over-year comparisons where published data is delayed, non-existent, or available only from a single source with a history of close ties to the industry itself. Uniformity of data across the states is severely lacking, as is the completeness of information even regarding such elementary questions as the potential shift underway between surgical abortions and chemically induced procedures.
Moreover, the laws generally take little advantage of advances in the ease and timeliness of reporting that are offered by the development of the Internet. While a few states have adopted legislation that facilitates and encourages the compilation of flash reports on basic abortion data within their jurisdictions, the vast majority of states deploy longer timelines to obtain information that would be of great value to policy makers in assessing the short- and long-term impacts of other state laws regarding abortion or even of wider trends in the economy or cultural factors that may be influencing the recourse to abortion. Changes in public policy on abortion reporting could ameliorate this situation without massive cost to taxpayers and with continued regard for individual medical privacy, an area in which legitimate concerns exist regarding inadvertent release of sensitive patient information.
The Federal Role: Delays and Doubts
First, a word about national abortion reporting. Since 1969, four years before the Supreme Court legalized abortion nationwide, the U.S. Centers for Disease Control (CDC) have published an annual report on the incidence of abortion in the United States. This report is based on data submitted by the majority, but by no means all, of the political jurisdictions in the United States. In 2009, for example – the most recent year for which CDC has published a report – CDC requested abortion reports from 52 jurisdictions, that is, the 50 states, the District of Columbia, and New York City. Forty-eight of these jurisdictions provided data to the CDC (one fewer than 2008), but only 45 of them have consistently done so since 1999, restricting the trend analysis CDC is able to perform. The submission of these reports by the states, D.C., and New York City is completely voluntary.
Besides the CDC, the only other source for national abortion data in the United States is the private, independent nonprofit Guttmacher Institute. Named for the president of the Planned Parenthood Federation of America from 1962-74, Alan F. Guttmacher, M.D., the Institute obtains survey data directly from abortion providers, including those with which it was formerly affiliated as the research arm of Planned Parenthood. This history has permitted the Institute to obtain information that, though voluntarily submitted like that from the CDC’s reporting areas, is far more complete than the federal data. The average undercount for CDC data is shown in Table 1. While the undercount has diminished
by since 1999, it remains substantial at nearly 32%, a figure virtually unchanged since 2003. Compare this to the U.S. Census net over count for 2000, which is estimated at 0.5%, and to CDC-Guttmacher abortion count differentials in the 1990s, which were as low as 13%.
With the exception of several jurisdictions described below that have sharply increased the quality and speed of their abortion reporting, the amount of progress made in providing better information about abortion and women’s health over the past 15 years is startlingly small. Some locales have even seen sharp diminutions in the completeness and reliability of their information. A useful special report on the federal and state roles in abortion reporting published in 1998 (Saul), stemming from the debate over partial-birth abortion and questions about the prevalence of late-term abortion in the United States, found that “the quality of CDC’s information is primarily compromised by the unevenness of reporting in the states.” At the time of the special report, for example, only 17 states had moved to include non-surgical (medical) abortions as specifically reportable events in their reporting process; today, according to the current study, the number is at least 38, leaving perhaps a quarter of the jurisdictions without mandatory tracking of this growing phenomenon.
The last significant attempt at the federal level to produce more uniform and useful information about abortion was abandoned by the National Center for Health Statistics (NCHS) nearly two decades ago. The NCHS attempted to move from the states’ aggregate abortion reporting to a system of contracts that would have relied on the NCHS’s U.S. Standard Report of Induced Termination of Pregnancy. The maximum number of states adopting the standard report was only 15 and the effort ended in 1993 due to a lack of adequate funding and, one may infer, flagging federal commitment to data collection, a continuing concern with respect to other social indicators at the national level. The remainder of this report is devoted to a fresh look at state abortion reporting policies, with special attention to recent steps that several states have taken to improve their data collection and dissemination, and to provide recommendations for state and federal policy changes to extend these improvements as a way of monitoring, among other questions, whether, and why, abortion is becoming more or less rare in the United States.
In November 2011, we began gathering information about abortion reporting data for each of the 50 states, the District of Columbia and New York City. The abortion reporting forms, also known as Reports of Induced Abortions or Reports of Induced Terminations of Pregnancy (ITOPs), are completed by the abortion provider or a representative of the abortion-providing facility. The forms supply general data about the patient, the procedure, and the facility for statistical purposes. Certain states also require additional information regarding the developing child, complications due to the abortion procedure, the abortion provider, as well as various additional areas of interest. The abortion-providing facility collects the data and sends it into the state at regular intervals. Most of the states use this information to produce an annual report, and most states make these reports available to the public at a regular if often delayed basis. The state then has the option to send the aggregate report to the CDC for compilation in its annual report to the nation, which is typically published up to three years after the close of the calendar year covered by the state reports.
We commenced the collection of data by researching the web sites of each state or jurisdiction’s Health Department, Office of Health Statistics, or Office of Vital Records to see if the state’s abortion reporting form and annual reports were readily available online. After locating several online, we began an effort at information collection via telephone and e-mail. While wading through public offices was often a slow process, this method proved much more effective. The official responsible for abortion reporting was asked for a copy of the state’s abortion reporting form as well as the state’s most recent abortion report or abortion statistics. We were able to obtain information from the vast majority of states. While seven states (Montana, Rhode Island, California, Wyoming, New York, Pennsylvania and Hawaii) indicated they will not release their abortion reporting forms to non-abortion providers, others (such as New Hampshire and Maryland) simply do not collect abortion data at all.
The abortion reporting forms were then examined and categorized across common elements on a set of spreadsheets so that each state could be compared. The categories analyzed for each state were: 1) The general features of abortion reporting laws; 2) characteristics of mother; 3) characteristics of the pregnancy/developing child; 4) doctor and physician Information. Arraying the information in this way allowed for the comparison of state policies across a wide variety of factors affecting where abortions are performed, when in pregnancy they are done, who is having abortions in the United States, and what we do and do not know about this medical procedure. Overall, our research tallied nearly 40 discrete data points that the states inquire about or that typify the laws and policies governing this information collection. The variation among the jurisdictions is significant, with a handful gathering little or no information at all. A few jurisdictions gather very detailed information that allows evaluation of abortion incidence even by zip code, although most jurisdictions restrict their published information to statewide or county-by-county tallies. Data in Tables 2 and 4-6 is current through April 2012.
General Features of Abortion Reporting Laws and Policies
Turning first to the general features of state laws and policies (Table 2), the number of states that have mandatory reporting policies has grown slightly since 1998, when mandatory reporting was already widespread but not universal. In 1998, 36 states had mandatory reporting laws, three mandated reports via regulatory policy, and six jurisdictions (five states plus the District of Columbia) had voluntary reporting policies. Arizona, in particular, moved in 2010 from a regulatory policy on abortion data collection to one of the more useful and effective statutory schemes. Jurisdictions that continue to make abortion reporting voluntary include, however, several that report some of the highest abortion rates in the United States, significantly affecting the quality and utility of national abortion data through public sources. These jurisdictions are California, the District of Columbia, Maryland, New Jersey, and New Hampshire. Most of these states rank among the top ten nationally in their abortion rates: California (6th), the District of Columbia (4th), Maryland (5th), New Jersey (3rd), and New Hampshire (31st-tie).
States also vary considerably in the amount and timeliness of information they make available to the public. Concerns about the potential risks of retaliation against abortion providers or violation of the medical privacy of women obtaining abortions have played a role in debates over the scope and specificity of abortion reporting. Measures to protect the privacy of patients are invariably included in state abortion reporting laws, and the constitutionality of statutes including mandatory reporting provisions without identifiers has been repeatedly upheld by the U.S. Supreme Court. More attention has been and should be given to increasing the accuracy and completeness of abortion reporting, reducing the cost of collecting and publishing the information, making it accessible to the public through venues like the Internet, and pointing the way toward cross-state comparability and consistency. These goals are achievable without compromising protection of private medical information.
Our survey touched upon use of the Internet and the speed of publication of both annual and, less often, month-over-month data on abortion, a particularly significant development that could assist both private and public entities in designing and evaluating laws and educational campaigns to reduce the incidence of abortion. Forty-four of the 50 states compile and publish annual reports providing an array of information, most commonly the total number of abortions, the gestational age of the developing child, the number of previous abortions, the abortion method, and the provider type. The six states that publish no annual reports again include some with the highest abortions rates in the country (California, New Jersey, Connecticut, and Maryland). New Hampshire, with a low abortion rate according to privately compiled data, is reviewing its abortion-data policies and has set up a legislative study committee to review its current policy. Massachusetts and Florida collect data and will provide raw information on request but publish no reports. The District of Columbia publishes an annual report, and New York City publishes one of the nation’s most comprehensive annual reports on a relatively swift timetable.
As noted above, the CDC and the Guttmacher Institute annual reports are current only up to 2009 and 2008, respectively. Because the CDC relies on voluntary data provided by the states after the conclusion of the reporting year, this report necessarily lags the slowest of the states in their reporting timetable. Accelerating state reporting would itself be a significant step in potentially shortening the time period before the CDC surveillance summary is compiled and released. Of the states that publish annual reports, as of November2012, only nine had released their reports for 2011. Eighteen states had released reports for 2010, eleven had released reports for 2009, and six more had released reports no more recent than for 2008.
Minnesota, Arizona and New York City offer examples of effective reporting that is done in a timely and useful way. Minnesota’s abortion reporting law requires the submission to the legislature and release of an annual summary report for each year no later than July of the following year. Consistent reports that allow review of state trends have been available since adoption of the reporting law in 1998 and the state Department of Health web page is organized for clarity and ease of use. Arizona’s first reporting law became effective in July 2010. It relies on electronic filing of reports, also limiting its cost. The report requires information on abortion occurrence by county, and state officials can make available on request a monthly tally of abortions just 15 days after the end of each month. Monthly tallies of abortions in Arizona are available for year-over-year comparison through the month of October 2012 (see Table 3).
New York City’s abortion reporting law provides detailed information by zip code, which enabled the Chiaroscuro Foundation of New York to prepare an extraordinary online city map documenting the high abortion rate in the city over time.
The Internet offers significant advantages in facilitating the rapid filing of abortion reports and publications of those results at lower costs for the states. Despite this, only a tiny minority (5) of the states utilize Internet reporting to expedite and simplify the process.
Compliance with Abortion Reporting Laws
A detailed examination of provider compliance with abortion reporting laws is beyond the scope of this paper. According to the most recent annual abortion incidence report from the Guttmacher Institute, whose surveys of providers reach many more institutions and individuals than state and federal agencies, the private-sector undercount of all U.S. abortions was estimated to be 3-4 percent in the early 1990s and the undercount is likely to have become “more pronounced” over the last decade. The reasons cited were the growth of non-surgical abortions and the hypothesized reluctance of entities that perform a small number of abortions to identify themselves, even in an industry-originated survey. The percentage of abortions not reported to state agencies and therefore not available for public scrutiny and analysis is certainly multiples higher, not only because of the voluntary policies of major jurisdictions but also because of uneven or poor compliance with even mandatory policies in some states.
An investigation by the Chicago Tribune published in June 2011 documented what it termed “many gaps in a surveillance system viewed as crucial to protecting” women. The review found that the number of abortions reported to the state under its 1975 reporting law was between 7,000 and 17,000 fewer per year than the number privately reported to Guttmacher. The number of providers reporting in Illinois was only two-thirds of the 37 providers identified by Guttmacher as operating in the state. Moreover, nearly 4,000 of the state reports for individuals lacked information on complications of abortion. Illinois reported 54,920 abortions to Guttmacher in 2008; complications information, therefore, may be missing in 20-38 percent (4,000 reports missing data plus 7,000-17,000 cases unreported to the state at all) of the abortion cases in the state.
Because one major goal of any reporting system is to track the number and type of medical complications and to identify practitioners with high rates of injury to women and girls, the lack of information in so many instances frustrates one of the law’s most basic purposes. The underreporting of maternal mortality under various reporting regimes has been widely discussed, with estimates of “missed” maternal mortality ranging in one study from 22% in France to 93% in Massachusetts. The inability to ascertain the contribution of various medical conditions to maternal deaths, combined with inaccurate or incomplete reporting of the incidence of induced abortion – in other words, the lack of both reliable numerators and denominators – makes calculation of the relative safety or danger of induced abortion and delivery impossible. A 2005 study that compared two American states with Finland and France using an enhanced method of identifying maternal deaths, involving an expert panel review of individual birth and death records, did not examine the role of induced abortion because only one of the four jurisdictions, Finland, “has a register of induced abortions that allows a systematic identification of women during the year after an induced abortion[.]”
Illinois is one of the minority of American states that includes complication reporting on its standard form, and the law allows for criminal penalties on providers who intentionally fail to submit accurate and complete reports. Despite this fact and the absence of so many mandated reports, the state Department of Public Health has never, according to the Tribune, sought disciplinary action against any abortion provider. It is reasonable to hypothesize that those providers with less-qualified or non-qualified personnel are those most likely to experience higher complication rates and avoid reporting.
The lack of enforcement of existing reporting laws by public health agencies has been problematic elsewhere as well. Delaware has the highest abortion rate in the nation according to the Guttmacher Institute, higher even than New York State. In 2005, Delaware reported 5,150 abortions to Guttmacher, but the total dramatically increased in 2007 and 2008 – reaching 7,070 in the latter year. But Delaware’s Department of Health and Social Services reported only 4,603 abortions in 2008, a figure 65 percent lower than Guttmacher’s estimate. Guttmacher has reportedly said that the state’s official undercount is due to failure of a single abortion clinic in the state to provide accurate data. Most of the unreported abortions at this facility, which may have been operated by a physician charged with murder in Pennsylvania, were carried out on non-Delaware residents. Delaware’s recent history of having an abortion rate twice the national average and the potential for a high number of women traveling into Delaware from out-of-state for abortions heightens concern about accurate data collection and clinic safety there. Delaware did not furnish data to the CDC for its 2009 report.
The undercount of abortions in the District of Columbia is likewise dramatic and of public concern. According to Guttmacher (2008), the District of Columbia experienced sharp declines in total abortions from 2000 onward, falling by more than half from that year (9,800) to 2007 (4,160), a period in which the national abortion volume decreased by roughly 7 percent. In 2009, the last year for which data is available for the District of Columbia, the city’s abortion total surged a stunning 28.7%. It seems probable that an increase of this size did not actually occur, but rather that the numbers reported for the immediately preceding years under the capital city’s voluntary reporting law represent a large undercount. Public funding of elective abortion did resume in the District of Columbia in late 2009, but this occurred late in the year and could not account for the higher total.
Other explanations for the increase elude District of Columbia officials. In response to an inquiry for this report, a city official in the Department of Health observed that in the early 2000s “several facilities that provided the Department of Health with abortion [data] either closed or no longer reported data” under the city’s completely voluntary system. The official further stated that an attempt to obtain answers from facilities that perform a “large number of abortions” failed because “there was high staff turnover and no one could fully explain what was going on.” City birth data, she noted, decreased only slightly at the same time. One possibility is that a large proportion of the unexplained decrease in abortions in the 2000s simply represents underreporting and that the increase in 2009 is a reflection of abortion reporters’ perceived or actual comfort zone with a friendly Congress and national administration.
Other Voluntary Reporting Jurisdictions
The states that make abortion reporting voluntary and do not publish annual public reports are few in number but sizable in terms of the number of abortions involved. For 2008, the most recent year for which the Guttmacher Institute has released the results of its annual private survey, the six states without public reporting (California, Connecticut, Maryland, New Hampshire, New Jersey, and Wyoming) totaled 322,960 of the estimated national total of 1,212,350 abortions – more than one quarter (26.6%) of the entire national count. Inability to access data from these states in a timely and reliable way casts considerable doubt on assertions about general abortion trends in the United States as well as about more particular issues of health, age, abortion safety and demographics of concern to policymakers and the public.
Moreover, because reporting is a minimally burdensome responsibility common to medical practices of all types, the lack of government interest in accumulating and publishing significant information can foster a laissez-faire approach to abortion incidence generally. Officials in Maryland responded to a request for this paper by noting that the state had ceased to collect data in 2006 and has published no reports in recent years, citing unreliability of the information they were receiving. State officials suggested that inquiries about abortion in the state be directed to the private Guttmacher Institute. The state ranked fifth highest in its abortion rate in 2008, according to Guttmacher, and in recent years has become an East Coast haven for late-term abortions.
Characteristics of the Mother
Information on the characteristics of women obtaining abortions is relatively uniform among the states (Table 4), and the form recommended by the U.S. Centers for Disease Control reflects a well-developed consensus about the kind of information most useful to policymakers and researchers that can be collected at the time of the abortion. The CDC requests that states provide it with aggregate (not individual) information on the following characteristics of girls and women having abortions: age, ethnicity, race, marital status, number of previous births, number of previous abortions, and maternal residence (state, reporting area, or foreign nation). The CDC acknowledges, however, that the level of detail it “receives on the characteristics of women obtaining abortions varies considerably from year to year and among reporting areas.” This challenge was among the reasons CDC developed a reporting handbook for abortion that was published in 1998, but in the absence of mandated federal data collection the states can develop and have developed their own reporting forms.
Despite this variation in reporting forms, the number of jurisdictions (states plus the District of Columbia) collecting maternal information is high across several categories (See Table 3): age (41 states), number of prior births (41), prior abortions (40), marital status (38), state of residence (40). Most states capture additional information that CDC does not request for its surveillance summaries: county of residence (40 states) and education level (35). Beyond these categories, states collect relatively little data from abortion providers, in keeping perhaps with ongoing concerns about the privacy of individual medical records. While release of such records is forbidden by law and inhibited by the small number of government officials who have access to them, occasional release of identifying information has occurred in the past due to invasions of privacy by activist organizations.
These issues were addressed again recently in Arizona, which adopted an abortion reporting law in 2010 that basically codified the existing regulatory policy of the state Department of Health. One abortion provider recommended that the law permit the reporting entity to omit most if not all of the standard CDC maternal data if the provider reasonably believed that the information could lead to the disclosure of an individual’s identity. The legislature rejected affording providers this high level of discretion and decided instead to maintain the range of data collection, add information about the specific medical justification for the abortion, include harsh penalties for anyone found to have disclosed individual data, and exclude residential information below the county level. Public disclosure of the aggregate information mirrors substantially the aggregate data compiled and published by the CDC from other reporting areas across the country.
Characteristics of the Pregnancy and Abortion Procedure
The 50 states and two smaller jurisdictions covered by this paper, the District of Columbia and New York City, collect a variety of information about characteristics of the pregnancy and the abortion method chosen to end the developing life. Several points are captured by nearly every jurisdiction we examined (see Table 5), including the date of the abortion, the probable gestational age of the developing life, and the abortion method employed by the facility. Other characteristics were less commonly reported and a number of factors of potential policy and research significance were only rarely covered by state laws. For example, just 16 states require information on abortion complications to be included in each report filed with the state and, of these, only eight states publish summary information about abortion complications in their annual report. This data will necessarily have significant limitations given the fact that complications do occur away from the abortion facility and in the absence of follow-up by the abortion facility, but an initial reporting requirement when a complication occurs and is known to the facility is sensible.
Viability, the ability of the child to live outside the womb on its own albeit with artificial assistance, is also an area in which state reporting laws require very little. Only six of the 50 states ask about the pathological evidence of the extrauterine survival potential of the unborn child when a late-term abortion has been performed. These states are Indiana, Kansas, Louisiana, Utah, Missouri and Nebraska. Only five states – Florida, Indiana, Kansas, Nebraska, and Oklahoma – inquire about the medical reason for the abortion if, in fact, the child was found to be viable. In at least two other states, Illinois and Massachusetts, fetal viability data is not requested on the reporting forms despite laws requiring the collection and reporting of such data for at least some abortions.
Informed consent, maternal mortality, and follow-up care are also areas in which state reporting exists but is very spare. While informed consent laws for abortion are commonplace nationwide, only seven states (Idaho, Nebraska, Oklahoma, South Carolina, South Dakota, Utah, and West Virginia) inquire on their standard reporting form whether informed consent was obtained before the abortion procedure was carried out. Only Texas, Maryland, Michigan and Utah inquire about maternal mortality from abortion. The definition of maternal mortality includes factors related to pregnancy and childbirth where the death occurs up to a year after the maternal event, and thus would include a number of deaths that would not be associated in public records with induced abortions due to a lack of information and a variety of terminological issues . Researchers who have conducted reviews of maternal mortality statistics using records-linkage methods have uncovered more deaths than reported in the Centers for Disease Control’s surveillance system. The CDC itself acknowledged these problems in 1986 in a published paper on maternal mortality and there appears to have been little progress in resolving these issues.
Follow-up care is an exceedingly rare topic in state abortion reporting. Only Oregon inquires about whether a follow-up visit was recommended and whether the visit took place and where it took place (i.e., in the facility, at a hospital, or in a doctor’s office). With the increase in drug-induced abortions (Arizona, for example, reports a 25.7 percent increase in non-surgical abortions from 2008 to 2009 and Delaware reports that non-surgical abortions have risen from 2.1 percent of abortions in 1997 to 18.4 percent in 2007), follow-up visits are more important than ever to ensure that the pregnancy has ended and a surgical abortion is not needed. Use of mifepristone now stands behind only suction curettage as the most common or preferred method of abortion in the United States.
Finally, state abortion reports reveal very little information about minor children’s recourse to abortion and whether or not in these cases parental notice was given or the abortion facility assisted the minor in obtaining a judicial bypass. Under current court rulings states that have adopted parental notice or consent laws must provide a method whereby the minor and clinic personnel or other adults can obtain a judge’s ruling whether or not she is mature enough to consent to an abortion without parental knowledge or permission. Knowing how often parents are notified in these instances and what percentage of cases involve judicial bypasses might be valuable to policymakers wishing to evaluate the operation of such laws and how often they result in parental consultation in the abortion decision. Only nine states have abortion reporting forms that ask about parental notification and judicial bypass utilization.
Providers and Facilities
States also gather a variety of data on abortion providers (see Table 6) as they seek accurate information about where abortions are taking place and who is performing them. The vast majority of states require that the facility where the abortion is performed be identified, or at the very least they ask for the facility’s identification code. However, this is not an explicit standard for every state and certain states, such as New Mexico, do not require it. Should women encounter a pattern of problems at a particular facility with complications such as infection, bleeding, perforation of the uterus, or gastrointestinal pain following abortion, it would be beneficial that the facility be identified so that the problem could be addressed in order to better safeguard women’s health.
|Doctor and Physician Information|
|Attending physician||Abortion facility||Type of abortion facility|
|IL||Physician license number required||X|
|IA||Healthcare Provider code|
|KS||Physician ID code||Provider ID code|
|MN||Physician ID code||Facility Reporting Code||X|
|MO||Physician license number required||X|
|WA||X||Facility ID Number|
Similarly, it would be constructive for states to pinpoint the types of facilities where abortions are being performed. Seven states listed in Table 5 require that the type of facility (such as clinic, hospital, doctor’s office, etc.) be noted. Access to this information would assist in determining what sort of facilities women are going to in order to obtain an abortion and what access they have to proper medical care during and after the procedure. Additionally, this information would help determine where the best possible care is taking place with fewer complications, better follow-up care, and better access to informational and counseling services.
While the patients always remain anonymous, several states require information regarding the person who is performing the abortion. They ask for their name, or at least their provider identification code, and require that they sign off on the report. A handful of states are particularly thorough (South Dakota requests not only the name of the abortion provider but also his or her license number, specialty, and any professional sanctions). Collection of this information would be valuable to ensure that women are receiving the best and safest care possible from licensed physicians and that the information that is being reported is confirmed by the doctor.
The public interest in the characteristics of women and girls obtaining abortions, in the record of physicians and other personnel performing them, and in the nature of the developing child and the reasons for and means of its destruction is a compelling reason for gathering complete and consistent data about abortion. Moreover, there exist a strong public interest in and consensus about making abortion a rare event regardless of its legal status in the nation. The only appropriate way to gather and assess this information is through public health agencies that impartially reflect this public interest, do not serve the policy objectives of any private participant in debates over abortion, and can act with public accountability to amass objective data while protecting both patient privacy and individual health.
In the four decades since Roe v. Wade delivered a shock to the nation’s legal system regarding elective abortion, states have responded with a variety of means, some carefully considered and thorough, others passive and nearly neglectful, to the need for accurate information about abortion. The resulting situation, a slowly produced and voluntary national report from the CDC, a similarly delayed but more comprehensive report from a private entity associated with legal abortion, and a patchwork of state laws and policies, denies citizens, researchers and policymakers the advantages of prompt and thorough information that could guide debate and action toward the best possible outcome for mothers and the children they help beget and bear. More consistency among state laws is an overall goal worthy of support, as is the objective of ensuring that abortion information is gathered and made available in annual statistical reports in the small number of states, with high abortion volumes, that now make no public reports at all.
Beyond these recommendations in principle, the following steps, relatively low-cost and well-modeled by states and locales conducting effective reporting, could make a dramatic difference in what Americans know about abortion and the progress being made, or not being made, in reducing this practice in our nation.
- Congress should direct and fund the Centers for Disease Control to contract with each of the 50 states and U.S. territories to gather data for a national abortion report to upgrade the Surveillance Summaries issued now. The current voluntary reporting form could be substantially retained to ease the administrative burden of a new national reporting scheme and allow comparison of data year over year. The data CDC collects under this system, which would take up anew the initiative abandoned by the National Center for Health Statistics in 1993, would neither replace the state reports nor obviate the additional data states have chosen and will choose to collect regarding abortion within their jurisdictions. Congress should also stipulate that the national report appear within one calendar year from December 31 of the year being tabulated and provide adequate funds to assure this result.
- Each state should be encouraged to adopt the goal of publishing aggregate statistical data on abortion on a timely basis, including a monthly “flash” report and an annual report that is released no later than six months after the close of the previous calendar year. The monthly report could be as straightforward as a table of total abortions by county that is released within weeks of the end of the month. Publication of this data could greatly assist policymakers and private sector actors as they devise, test and evaluate education and public health strategies for making abortion less common and ultimately rare. Annual reports with greater detail can be produced, as the state of Minnesota has consistently shown, within a reasonable time frame after the year in which the abortions occurred. By July 1 of the following year, each of the 50 states and the District of Columbia should publish an annual report for the preceding year. An Internet-based system for gathering data can sharply reduce the cost of this data collection and publication.
- With the growing role of medical (that is, drug-induced or non-surgical) abortions across the nation, all states should revise their statutes to make clear that the same reporting standards that apply to surgical procedures and the facilities that perform them also apply to pharmacologically induced abortions. The requirement should apply to non-physicians in the small number of states that permit nurse-midwives or other non-physician medical personnel to perform abortions, and it should apply as well to any institution that employs a physician out-of-state or out-of-country who prescribes drugs for chemical abortion. Attempts to lower standards of care for drug-induced abortion are likely to continue as the number of physicians willing to perform or supervise abortions continues to decrease. 
- Weak compliance with abortion reporting laws is a continuing problem that has vitiated the accuracy of abortion reports in many states, even to the point of persuading public officials in Maryland and the District of Columbia to discount the utility of the reports or cease collecting them altogether. Among the states, only Michigan includes on its abortion reporting form a notice to the effect that failure to provide the required information is a misdemeanor punishable by imprisonment of not more than one year or a fine of not more than $1,000, or both. Congress has the authority to direct the District of Columbia to conduct thorough and timely abortion reporting and to provide the funds necessary to complete and publish a useful report on an annual basis. The frequency of changes in abortion clinic personnel does not justify failure to comply with abortion reporting requirements. The collapse of abortion reporting in a state like Maryland should preferably be redressed by the General Assembly in the exercise of its public responsibility. Congressional support for a national reporting system worthy of the name could provide incentive for states with dismal records to participate in accumulating more information. If necessary, however, Congress could impose reasonable financial disincentives on the handful of states that willfully fail to accumulate such vital statistics.
- Finally, abortions involving minors and the operation of parental notice laws deserve more attention. Only eight states collect information on whether a judicial bypass was sought for a minor child requesting an abortion when that minor is unwilling or unable to notify a parent or obtain parental consent for the abortion to be performed. Advocates of parental notification laws have generally presumed that notice or consent would not be routinely waived through any “rubber-stamp” process of judicial bypass that does not take into account the importance of parental involvement in minors’ health care decisions. Abortion providers state that parental consultation is encouraged and often obtained, but there is a lack of data to substantiate this observation. All 50 states and the District of Columbia should require abortion clinics in their jurisdictions to report on the number of legal minors seeking abortions without parental notice or consent, the number who obtain judicial bypasses (where such statutes exist), and the number who inform their parents or are accompanied by them to the abortion.
Improving national abortion data collection in the United States should be a priority concern for state and federal policymakers in the years ahead. Experience has demonstrated that more thorough and more swiftly produced information can be obtained and published at lower cost and with full protection of individual privacy. Swifter and more accurate data can facilitate information campaigns of all kinds that pursue the goal of reducing abortion and ultimately making it rare in the United States, assisting policymakers in adopting the best approaches that protect both women and the children they carry.
*Updated January 10, 2013
 “Induced Abortions in Minnesota January-December 2011: Report to the Legislature, July 2012,” Minnesota Department of Health, at http://www.health.state.mn.us/divs/chs/abrpt/abrpt.html (viewed December 4, 2012) The report is published in accord with MN Statutes, 145.4131 – 145.4136.
 Speaking in Steubenville, Ohio, in February 2008 on behalf of the presidential candidacy of his wife Hillary Clinton, former President Clinton reiterated remarks first made in 1992 and said, “”Even though she as a woman did not believe we should overturn Roe v. Wade, she said – and she said again at the outset of this election – that every abortion is a tragedy and they should be more rare, but safe and legal. And I agree with her.” Aaron Lewis, “Bill Clinton Responds to Anti-Abortion Rights Activists,” CBS News Politics, February 18, 2008, at http://www.cbsnews.com/8301-502443_162-3842338-502443.html. See also Suzanne Malveau, “Obama questioned on abortion, why he is a Christian,” CNN Politics, September 28, 2010, at http://articles.cnn.com/2010-09-28/politics/obama.tough.question_1_late-term-abortion-abortion-debate-president-barack-obama?_s=PM:POLITICS (viewed December 27, 2011).
 By “flash report” the authors mean preliminary data on abortion volume by county or other reasonable governmental unit that can be compiled and released on a monthly basis to yield a look at short-term trends. The report would not substitute for the annual, detailed reports that most states compile that look at the many maternal and other factors discussed in this paper.
 Robert Goldenkoff, Director, Strategic Issues, U.S. Government Accountability Office, Testimony before the Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security, Committee on Homeland Security and Governmental Affairs, U.S. Senate (September 23, 2008) at http://www.gao.gov/assets/130/121237.html (April 18, 2012).
 Henshaw, SK, Abortion Services in the United States, 1995-96 Family Planning Perspectives; in Saul, Rebekah, Abortion Reporting in the United States: An Examination of the Federal-State Partnership, Special Report, Family Planning Perspectives, Vol. 30, No. 5, September/October 1998, 244-47.
 Naturally, with variations in the data regarding total abortions as large as they are, substantial differences between other factors collected by the CDC and Guttmacher also occur. For 2008, for example, CDC found that 14.6% of abortions were carried out by non-surgical means while Guttmacher registered a higher percentage – at 17. The CDC undercount of the percentage of non-surgical abortions is at least 14% for this important indicator.
 The collection of detailed data on marriage and divorce was suspended at the national level in 1996, for some of the same reasons cited apropros abortion (budgetary concerns and limitations on the quality and comparability of the state data). See the National Center for Health Statistics comment at http://www.cdc.gov/nchs/mardiv.htm (May 2, 2012).
 The New York City Department of Health and Mental Hygiene maintains its own detailed data on abortions occurring within city limits and publishes it as a subset of its annual report on vital statistics. See http://www.nyc.gov/html/doh/html/vs/vs.shtml (May 15, 2012).
 States that did not provide copies of their abortion reporting forms are listed in the tables as such but not included in tallies for particular report characteristics. For this reason, there is some discrepancy in numbers between this report and other published summaries, though this is not a result of inaccuracy in the information presented. The Lozier Institute continues to seek copies of state abortion forms and will update this report as they are received.
 Jones, Rachel K, and Kooistra, Kathryn, “Abortion Incidence and Access to Services 2008,” Perspectives on Sexual and Reproductive Health 2011: 43(1):41-50. Guttmacher Institute (Washington, D.C.). This is the successor publication to the journal Family Planning Perspectives.
 Wyoming, with the nation’s lowest abortion rate at 0.9 per 1,000 women age 15-44 (Guttmacher 2008), does not publish an annual abortion report.
 Annmarie Timmins, “House holds senate bills as a ‘price’: GOP in conflict across chambers,” Concord Monitor, April 26, 2012, at http://www.concordmonitor.com/article/325990/house-holds-senate-bills-as-price?CSAuthResp=1335980228%3Ajdme524b90trbp8cu2mthah633%3ACSUserId%7CCSGroupId%3Aapproved%3A07DA8441CD5FB94CAE0FCCD7F41D4BEF&CSUserId=94&CSGroupId=1 (May 2, 2012).
 See http://www.nyc41percent.com/ (May 2, 2012).
 Jones, Rebekah K. and Kooistra, Kathryn, op. cit.
 Megan Twohey, “State abortion records full of gaps: Thousands of procedures not reported to health department,” Chicago Tribune, June 16, 2011 at http://articles.chicagotribune.com/2011-06-16/news/ct-met-abortion-reporting-20110615_1_abortion-providers-fewer-abortions-national-abortion-federation (April 20, 2012).
 Deneux-Tharaux, et al., “Under-reporting of Pregnancy-Related Mortality in the United States and Europe,“ Obstetrics and Gynecology, Vol. 106, No. 4, 684-92, October 2005.
 Jones, Rebekah, K, and Kooistra, Kathryn, op cit.
 Steven Ertelt, “Gosnell Abortion Center May Have Faked Delaware Abortion Report,” LifeNews.com, February 4, 2011; at http://www.lifenews.com/2011/02/04/gosnell-abortion-ctr-may-have-faked-delaware-abortion-report/ (April 20, 2012).
http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6108a1.htm?s_cid=ss6108a1_w (December 5, 2012).
 Joe Danielewicz, “Maryland drops charges against doctors over late-term abortions,” Reuters, March 7, 2012 at http://www.reuters.com/article/2012/03/08/us-abortion-maryland-idUSTRE82626720120308 (April 23, 2012).
 Karen Pazol, PhD, et al., “Abortion Surveillance – United States, 2008” Surveillance Summaries, November 25, 2011 (Centers for Disease Control and Prevention); at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6015a1.htm?s_cid=ss6015a1_w (April 30, 2012).
 States that require abortion complication reporting are (states that include this information in their annual reports are shown in bold): Arizona, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Michigan, Nebraska, North Dakota, Ohio, Oregon, Utah, Washington and Wisconsin.
 Donna J. Harrison, M.D., “Removing the Roadblocks from Achieving MDG5 by Improving the Data on Maternal Mortality: How Faulty Definitions of ‘Abortion,’ ‘Safe Abortion,’ and ‘Unsafe Abortion’ in Reproductive Health Indicators for Global Monitoring Lead to Miscalculating the Causes of Maternal Mortality.” International Organizations Research Group Briefing Paper No. 5, May 1, 2009; at http://www.c-fam.org/docLib/20090514_Removing_the_Roadblocksfinal.pdf (April 23, 2012).
 Suzanne R. Trupin SR, Moreno C. Medical Abortion: Overview and Management. MedGenMed 4(1), 2002 [formerly published in Medscape Women’s Health eJournal 7(1), 2002]. Available at:
http://www.ncbi.nlm.nih.gov/pubmed/11965218 (May 4, 2012).
 Alabama, Alaska, Arkansas, Idaho, Oklahoma, South Carolina, South Dakota, West Virginia and Wisconsin.
 See the “ICMA Information Package on Medical Abortion,” International Consortium for Medical Abortion, at http://www.medicalabortionconsortium.org/articles/for-policy-makers/default/?bl=en (May 1, 2012). The ICMA calls for “Health care setting requirements intended for surgical abortion [ ] to be updated so that medical abortion can be provided in primary care settings by general practitioners, nurse-midwives[,] family planning nurses and other mid-level providers.”
 See SB 1338, introduced in the California State Senate, at http://leginfo.ca.gov/pub/11-12/bill/sen/sb_1301-1350/sb_1338_cfa_20120423_113919_sen_comm.html. “The purpose of this bill is to clearly provide that nurse practitioners, nurse midwifes or physician assistants will not be subject to criminal liability for performing an abortion by medication or aspiration.”
Preterm birth is one of the most significant challenges facing the field of obstetrics and remains a considerable public health issue. For years, concerns have been raised about a potential association between frequently performed induced abortion procedures and preterm delivery in subsequent pregnancies. Such concerns have been largely ignored in mainstream U.S. medical literature and are unknown to wider public opinion. However, a growing body of worldwide evidence suggests that the association between preterm birth and history of induced abortion is indeed credible. Several clinically relevant, recently published studies deserve widespread attention and should inspire renewed reflection on public health implications.
Every year in the United States, more than half a million babies are born prematurely, prior to 37 weeks gestation. In 2007, this represented 12.7% of the babies born in the United States. Preterm birth is associated with considerable problems, including significant infant morbidity and mortality, parental stressors, and financial burden. Preterm delivery is a complex obstetrical complication with many contributing factors and potential causes. Many factors related to a woman’s risk of preterm delivery are outside a patient’s control. In contrast, modifiable risk factors, those that can be altered or eliminated to reduce a woman’s risk of preterm delivery, remain the subject of intense study and some debate in obstetrics.
In the decades following legalization of abortion in the U.S. and several European countries, considerable debate has ensued regarding the consequences of induced abortion for future pregnancy outcomes. Historically, obstetricians have considered abortion procedures to be risk factors for subsequent adverse pregnancy outcomes, including preterm birth. In 1979, the World Health Organization reported that a history of abortion correlated with an increased risk of second-trimester pregnancy loss, even after demographic characteristics such as smoking and maternal weight were controlled
Today, induced abortion is one of the most common gynecological procedures performed on women. According to the U.S. Census Bureau, relying on both survey research and unpublished data from the Guttmacher institute, 1.2 million abortions were performed in the United States in 2007, and that number has grown over the past six years. Many women begin their reproductive experience with an abortion prior to subsequent childbearing. Thus, the extent to which induced abortions affect subsequent pregnancy outcomes is a public health concern.
Despite this, within the U.S. medical literature, induced abortion has largely been ignored as a risk factor for preterm birth. Informed consent for abortion procedures does not routinely mention future preterm delivery or other adverse pregnancy outcomes as possible risks of the procedures. Reasonable doubt regarding the association initially arose in the first decades following abortion legalization in the United States. At that time, several studies either reported no association between abortion and adverse outcomes in subsequent pregnancies or demonstrated conflicting results. However, many of these early studies suffered from small sample sizes, short follow-up timeframes and other methodological limitations. Studies published in European journals periodically raised the issue and reiterated findings of an association of varying degrees between preterm delivery and a history of induced abortion. While popular belief remains among many American obstetricians that preterm birth and induced abortion history are unrelated, a mounting body of worldwide literature suggesting the contrary is gaining greater attention and acceptance.
In 2011, it was openly acknowledged in The American Journal of Obstetrics and Gynecology that a growing body of large, population-based studies have credibly shown elective pregnancy terminations in the first and second trimesters to be associated with an increased risk of subsequent spontaneous preterm birth. In 2009, a large literature review was published on the subject in the British Journal of Obstetrics and Gynecology. Study findings were based on results analyzed from 37 studies, spanning 40 years. The study concluded that a single induced abortion was associated with a 36% increase in odds of subsequent preterm birth. More than one induced abortion was found to nearly double a woman’s odds of preterm birth.
In 2012, two additional large, population-based studies examining this subject were published in the European literature, one in Human Reproduction and the second in The British Journal of Obstetrics and Gynecology. Both are widely read, well-respected journals within the worldwide obstetrics community, and both studies reported results showing increased risk of preterm birth following induced abortion.
Finland’s National Institute for Health and Welfare conducted the study published in Human Reproduction, which included over 300,000 first-time mothers with a singleton birth over a 12-year time period. Researchers reported that, after adjusting for confounding background variables such as maternal age, socioeconomic and marital status, smoking and previous miscarriages, women with a history of one or more induced abortions showed increased odds of delivering prior to 28 weeks gestation in a future pregnancy. The odds of very preterm delivery increased with repeated induced abortions and ranged from a 20% increase after one induced abortion to a 278% increase following three or more induced abortions. The odds of preterm delivery prior to 37 weeks were reported at a 35% increase and were seen only among mothers with three or more induced abortions.
Also published in 2012 in The British Journal of Obstetrics and Gynecology was a national, register-based study performed in Scotland, this time using over 26 years of data from over 650,000 births. The study reported that, after adjustment for numerous potential confounding background variables, a history of one induced abortion increased the risk of spontaneous preterm birth by 37%. Researchers did not find further increased risk in women with more than one induced abortion.
Just what do these results mean practically? Literature and media reports of odds ratios and relative risks may sound impressive, but they can be confusing for patients and can be challenging for clinicians to interpret and apply in medical management decisions. It is important to note that increases in risk can sound impressive, yet have little clinical relevance for individual patients or societal groups if the initial risk or the overall incidence of the risk-increasing factor is low.
Because the risk of preterm delivery among first-time mothers is relatively low (reported as 5.6% in the Finnish study for instance) compared to the overall birth rate, some consider the increased risk of preterm delivery following induced abortion as reported in these studies to be small in practical terms. Others have gone so far as to say that women should not be alarmed by such results. However, such clinical opinions are being openly debated in the current literature. When considering procedures as frequently performed as induced abortion, even small associated increases in the risk of poor subsequent birth outcomes could have significant public health implications. For instance, the preterm delivery odds increase of 30-40% seen in many of the above studies is comparable to the risk observed due to other accepted preterm birth risk factors, such as maternal age greater than 35, and higher than the risk associated with factors like low pregnancy weight and heavy smoking. Smoking-cessation programs for pregnant women are rightly considered to be an important means of reducing preterm birth, yet they are shown to reduce the preterm birth rate by 16-31%, which is less than the rate decrease seen from avoiding induced abortion, as predicted by the above studies).
It must be noted that observational studies like the ones noted here, no matter how large and well-controlled, cannot prove causality. However, as reported in these studies, the increased risk of preterm birth and other adverse subsequent pregnancy outcomes following induced abortion is both clinically relevant and important from a public health perspective. Health care professionals should be informed about the potential risks of induced abortion on subsequent birth outcomes and women considering abortion should be given this information as part of the process of obtaining informed consent.
Elizabeth Ann M. Johnson, M.D. is a Fellow, Program for Human Rights and Health, University of Minnesota School of Public Health.
Steven Calvin, M.D., is Clinical Associate Professor Department of OB/GYN & Women’s Health, Co-chair of the Program in Human Rights and Health in the School of Public Health, University of Minnesota.
A very disturbing story has recently come to light as it has been revealed that 491 babies were born alive during botched abortion procedures in Canada and then left to die in its immediate aftermath. These deaths took place between the years 2000 and 2009.
The tragic news of the death of an expectant mother in Ireland has drawn worldwide attention in a way, it is safe to say, deaths of other expectant mothers (like Tonya Reaves, who died as a result of a botched abortion at Planned Parenthood last July) have not. The death of Savita Halappanavar is worthy of the closest scrutiny, because she and her family, as well as every expectant mother in Ireland, has a right to know if the sequence of events that led to her death was a case of medical malpractice or neglect, a result of the Irish law on abortion, a result of misapplication of that law, an admixture of these factors – or even unavoidable.
Today, October 11, the United Nations marks the first annual International Day of the Girl Child. The observance was formally adopted by the U.N. General Assembly on December 19, 2011 as an official day on which to raise awareness of the situation of girls across the globe. The institution of this day is a decidedly positive symbol. Young girls worldwide face a multitude of obstacles, such as poverty and a lack of education, which can prevent them from fulfilling their human potential. Additionally, a plethora of problems face young girls in developing countries as well as in prosperous nations that violate their human rights every day on a massive and frightening scale. A day such as this can call attention to the very real concerns facing girl children throughout the world. With any luck, that attention will bring about much needed action to protect these little girls.