Oklahoma Gov. Mary Fallin signed a bill into law Tuesday that would place restrictions on medication abortion by mandating that providers follow outdated protocols for the delivery of the drugs that induce early abortion. The new law will take effect on November 1.
HB 2684, sponsored by Rep. Randy Grau (R-Edmond), would update restrictions on medication abortions originally put in place in 2011, but found unconstitutional in December. Grau said that the bill is essentially the follow-up to HB 1970, the 2011 law, and is meant to “[address] the concerns of the Oklahoma Supreme Court” by removing the language that created an effective ban on medication abortion in the state.
Responding to the news, Nancy Northup, president and CEO with the Center for Reproductive Rights, said in a statement that “Oklahoma politicians have yet again proven they are hell-bent on restricting women’s access to a safe and proven method of ending a pregnancy at its earliest stages, substituting their own ideologies for years of scientific research and the expertise of medical professionals worldwide.”
As noted in a report by the Guttmacher Institute, the current medication abortion regimen specified by the U.S. Food and Drug Administration (FDA) is outdated. FDA labeling and protocols are based on findings from the original application and data submitted by pharmaceutical companies for approval of specific drugs. Because of the administrative and bureaucratic hurdles required in the FDA approval process, existing labeling and protocols often lag well behind evolving scientific evidence on the use and dosages of a wide range of drugs. As a result, physicians and medical societies base their best practices on the actual science, and not the label. The original protocol used for medication abortion calls for much higher doses than are actually required to induce a safe, early abortion. The Guttmacher report underscores that requiring stringent adherence, the FDA-approved regimen “prohibits alternative, evidence-based protocols in wide use for at least the past decade” and prevents providers from “engaging in practices that are accepted as mainstream in other medical specialties.”
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The restrictions under HB 2684 are the same measures that have gone into effect in Arizona, where reproductive rights advocates have filed a pair of lawsuits challenging their legality on both the federal and state levels.
“Courts time and again have found these restrictions unconstitutional, and yet Oklahoma politicians refuse to give up their costly crusade of choking off access to safe, legal abortion care,” said Northup. “It should not take a series of court orders to convince these politicians to reevaluate their priorities and refocus their energy on making laws that truly protect women’s health, safety, and dignity.”
On June 28, just a day after the Supreme Court ruling, Texas published a revised draft of the pamphlet that must, by state law, be given to all people seeking abortion services. But the brochure still includes misleading information, reminding us that anti-choice politicians are still interfering in patient-provider interactions.
Reproductive health advocates cheered in March when the U.S. Food and Drug Administration (FDA) approved a revised label for abortion drug Mifeprex (mifepristone). We cheered again when the U.S. Supreme Court struck down central provisions of Texas law HB 2, which would have closed most of the state’s abortion clinics. Both of these were victories not just for access to abortion care, but also for health-care policies based on current evidence. However, on June 28, just a day after the Supreme Court ruling, Texas published a revised draft of the pamphlet that state law requires physicians to provide to all women seeking abortion services, reminding us that anti-choice politicians are still finding ways to interfere in patient-provider interactions.
Laws and regulatory actions of this kind, which require the use of biased and incomplete information, prevent health-care professionals from providing women with care that meets basic medical and ethical standards.
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State requirements that are at odds with up-to-date scientific or medical research are nothing new. Several states have passed laws requiring abortion providers to follow the FDA-approved label for Mifeprex. Those laws are currently in force in North Dakota, Ohio, and Texas, and have been halted by courts in Arizona, Arkansas, and Oklahoma. Before March, this meant that providers in those states had to follow the original Mifeprex label, which was based on clinical trials conducted in the 1980s and 1990s, and which didn’t encompass variations in practice used for years to make medication abortions safer and more accessible. These included lowering the dose of mifepristone from 600 mg to 200 mg; offering medication abortions for pregnancies of up to 70 days, rather than only through 49 days; and allowing the woman to take the second drug in the procedure (misoprostol) at home rather than requiring her to return to a provider’s office to swallow a pill. (For more on current science about medication abortion, see our white paper.) The new label reflects those changes and makes it easier for providers everywhere to offer evidence-based care.
Normally, providers’ use of approved drugs evolves as the evidence does. This is important because experience and research can show that it’s safe and effective to use drugs in different doses or for different conditions than what the label specifies. Providers can adopt these variations without waiting for a new label to be approved by the FDA by prescribing a drug off-label. For instance, the asthma medication albuterol (found in inhalers) is often prescribed off-label for chronic obstructive pulmonary disease due to substantial evidence supporting this off-label use. Drug manufacturers may apply to FDA for an updated label (particularly when insurers won’t cover drugs for off-label conditions), but they don’t have to do so.
However, a new Mifeprex label was important because some states were requiring abortion providers to adhere to the outdated label—in essence, telling providers that their practice could not evolve based on evidence, and denying women access to the care that’s been demonstrated to be safe and effective.
Much like laws requiring medication abortion providers to adhere to an outdated label, so-called informed consent laws requiring that a woman receive certain information before getting an abortion essentially substitutes the judgment of legislators for the judgment of health-care providers. In states like Texas, where a majority of the legislators are committed to a political agenda blocking access to abortion, this all too frequently means replacing scientific evidence with intentionally distorted information. When the Rutgers University Informed Consent Project asked anatomists specializing in embryological and fetal development to evaluate statements in the previously available version of Texas’s required pamphlet, they determined that 34 percent of the statements were either scientifically incorrect or misleading. (Preliminary findings on the revised draft suggest the accuracy hasn’t improved, project head Cynthia Daniels told the Texas Tribune.) True informed consent is a necessary and ethically valuable part of any medical process, but these types of laws subvert the true intent of consent when they require providers to give inaccurate or incomplete information under the guise of improving transparency.
Also problematic is what the revised Texas pamphlet still doesn’t say. The section on abortion risks reports the extremely low risk of death from abortion complications, but doesn’t mention the 2012 study that found the risk of death associated with childbirth to be 14 times higher than that from legal abortion. The pamphlet tells readers that “some women have reported” negative emotions, including depression, grief, and anxiety after abortions. However, it remains silent about rigorous, peer-reviewed research that compared outcomes for women who sought and received abortions to those who sought and were denied them. Those studies found no differences between the two groups in anxiety, depression, or post-traumatic stress disorder, and documented positive emotions, such as relief and reduced unhappiness, in those who obtained abortions. (See the Turnaway Study for details on this research).
Especially disturbing examples of legislators requiring providers to give women misleading information are laws passed in Arizona and Arkansas based on poorly supported claims that medication abortions can be “reversed” if a women decides to do so before taking the second drug. Such laws require physicians to provide a woman seeking a medication abortion with information about the possibility of “reversing” the procedure by taking another hormone to counter the mifepristone, despite the absence of reputable evidence that such “reversal” can occur. Requiring providers to give information like this, which is not borne out by human studies, conflicts with the responsibility of clinicians to do no harm.
The next step is for evidence-based medicine to meet with evidence-based legislating. It’s time for legislators to stop requiring health-care practices based on outdated or incomplete evidence, and instead focus on promoting health and high-quality health care for all.
A return to data should aid in dismantling other laws ungrounded in any real facts, such as Texas’ onerous "informed consent” law—HB 15—which forces women to get an ultrasound that they may neither need nor afford, and which imposes a 24-hour waiting period.
Whole Woman’s Health v. Hellerstedt, the landmark U.S. Supreme Court ruling striking down two provisions of Texas’ omnibus anti-abortion law, has changed the reproductive rights landscape in ways that will reverberate in courts around the country for years to come. It is no longer acceptable—at least in theory—for a state to announce that a particular restriction advances an interest in women’s health and to expect courts and the public to take them at their word.
In an opinion driven by science and data, Justice Stephen Breyer, writing for the majority in Whole Woman’sHealth, weighed the costs and benefits of the two provisions of HB 2 at issue—the admitting privileges and ambulatory surgical center (ASC) requirements—and found them wanting. Texas had breezed through the Fifth Circuit without facing any real pushback on its manufactured claims that the two provisions advanced women’s health. Finally, Justice Breyer whipped out his figurative calculator and determined that those claims didn’t add up. For starters, Texas admitted that it didn’t know of a single instance where the admitting privileges requirement would have helped a woman get better treatment. And as for Texas’ claim that abortion should be performed in an ASC, Breyer pointed out that the state did not require the same of its midwifery clinics, and that childbirth is 14 times more likely to result in death.
So now, as Justice Ruth Bader Ginsburg pointed out in the case’s concurring opinion, laws that “‘do little or nothing for health, but rather strew impediments to abortion’ cannot survive judicial inspection.” In other words, if a state says a restriction promotes women’s health and safety, that state will now have to prove it to the courts.
With this success under our belts, a similar return to science and data should aid in dismantling other laws ungrounded in any real facts, such as Texas’ onerous “informed consent” law—HB 15—which forces women to get an ultrasound that they may neither need nor afford, and which imposes a 24-hour waiting period.
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In Planned Parenthood v. Casey, the U.S. Supreme Court upheld parts of Pennsylvania’s “informed consent” law requiring abortion patients to receive a pamphlet developed by the state department of health, finding that it did not constitute an “undue burden” on the constitutional right to abortion. The basis? Protecting women’s mental health: “[I]n an attempt to ensure that a woman apprehends the full consequences of her decision, the State furthers the legitimate purpose of 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.”
Texas took up Casey’s informed consent mantle and ran with it. In 2011, the legislature passed a law that forces patients to undergo a medical exam, whether or not their doctor thinks they need it, and that forces them to listen to information that the state wants them to hear, whether or not their doctor thinks that they need to hear it. The purpose of this law—at least in theory—is, again, to protect patients’ “mental health” by dissuading those who may be unsure about procedure.
And make no mistake: The exam the law requires is invasive, and in some cases, cruelly so. As Beverly McPhail pointed out in the Houston Chronicle in 2011, transvaginal probes will often be necessary to comply with the law up to 10 to 12 weeks of pregnancy—which is when, according to the Guttmacher Institute, 91 percent of abortions take place. “Because the fetus is so small at this stage, traditional ultrasounds performed through the abdominal wall, ‘jelly on the belly,’ often cannot produce a clear image,” McPhail noted.
Instead, a “probe is inserted into the vagina, sending sound waves to reflect off body structures to produce an image of the fetus. Under this new law, a woman’s vagina will be penetrated without an opportunity for her to refuse due to coercion from the so-called ‘public servants’ who passed and signed this bill into law,” McPhail concluded.
There’s a reason why abortion advocates began decrying these laws as “rape by the state.”
If Texas legislators are concerned about the mental health of their citizens, particularly those who may have been the victims of sexual assault—or any woman who does not want a wand forcibly shoved into her body for no medical reason—they have a funny way of showing it.
They don’t seem terribly concerned about the well-being of the woman who wants desperately to be a mother but who decides to terminate a pregnancy that doctors tell her is not viable. Certainly, forcing that woman to undergo the painful experience of having an ultrasound image described to her—which the law mandates for the vast majority of patients—could be psychologically devastating.
But maybe Texas legislators don’t care that forcing a foreign object into a person’s body is the ultimate undue burden.
After all, if foisting ultrasounds onto women who have decided to terminate a pregnancy saves even one woman from a lifetime of “devastating psychologically damaging consequences,” then it will all have been worth it, right? Liberty and bodily autonomy be damned.
But what if there’s very little risk that a woman who gets an abortion experiences those “devastating psychological consequences”?
If the purpose of informed consent laws is to weed out women who have been coerced or who haven’t thought it through, then that purpose collapses if women who get abortions are, by and large, perfectly happy with their decision.
Scientific studies indicate that the vast majority of women don’t regret their abortions, and therefore are not devastated psychologically. They don’t fall into drug and alcohol addiction or attempt to kill themselves. But that hasn’t kept anti-choice activists from claiming otherwise.
It’s simply not true that abortion sends mentally healthy patients over the edge. In a study report released in 2008, the APA found that the strongest predictor of post-abortion mental health was prior mental health. In other words, if you’re already suffering from mental health issues before getting an abortion, you’re likely to suffer mental health issues afterward. But the studies most frequently cited in courts around the country prove, at best, an association between mental illness and abortion. When the studies controlled for “prior mental health and violence experience,” “no significant relation was found between abortion history and anxiety disorders.”
But what about forced ultrasound laws, specifically?
Science has its part to play in dismantling those, too.
If Whole Woman’s Health requires the weighing of costs and benefits to ensure that there’s a connection between the claimed purpose of an abortion restriction and the law’s effect, then laws that require a woman to get an ultrasound and to hear a description of it certainly fail that cost-benefit analysis. Science tells us forcing patients to view ultrasound images (as opposed to simply offering the opportunity for a woman to view ultrasound images) in order to give them “information” doesn’t dissuade them from having abortions.
Dr. Jen Gunter made this point in a blog post years ago: One 2009 study found that when given the option to view an ultrasound, nearly 73 percent of women chose to view the ultrasound image, and of those who chose to view it, 85 percent of women felt that it was a positive experience. And here’s the kicker: Not a single woman changed her mind about having an abortion.
Again, if women who choose to see ultrasounds don’t change their minds about getting an abortion, a law mandating that ultrasound in order to dissuade at least some women is, at best, useless. At worst, it’s yet another hurdle patients must leap to get care.
And what of the mandatory waiting period? Texas law requires a 24-hour waiting period—and the Court in Casey upheld a 24-hour waiting period—but states like Louisiana and Florida are increasing the waiting period to 72 hours.
There’s no evidence that forcing women into longer waiting periods has a measurable effect on a woman’s decision to get an abortion. One study conducted in Utah found that 86 percent of women had chosen to get the abortion after the waiting period was over. Eight percent of women chose not to get the abortion, but the most common reason given was that they were already conflicted about abortion in the first place. The author of that study recommended that clinics explore options with women seeking abortion and offer additional counseling to the small percentage of women who are conflicted about it, rather than states imposing a burdensome waiting period.
The bottom line is that the majority of women who choose abortion make up their minds and go through with it, irrespective of the many roadblocks placed in their way by overzealous state governments. And we know that those who cannot overcome those roadblocks—for financial or other reasons—are the ones who experience actual negative effects. As we saw in Whole Woman’s Health, those kinds of studies, when admitted as evidence in the court record, can be critical in striking restrictions down.
Of course, the Supreme Court has not always expressed an affinity for scientific data, as Justice Anthony Kennedy demonstrated in Gonzales v.Carhart,when he announced that “some women come to regret their choice to abort the infant life they once created and sustained,” even though he admitted there was “no reliable data to measure the phenomenon.” It was under Gonzales that so many legislators felt equipped to pass laws backed up by no legitimate scientific evidence in the first place.
Whole Woman’s Health offers reproductive rights advocates an opportunity to revisit a host of anti-choice restrictions that states claim are intended to advance one interest or another—whether it’s the state’s interest in fetal life or the state’s purported interest in the psychological well-being of its citizens. But if the laws don’t have their intended effects, and if they simply throw up obstacles in front of people seeking abortion, then perhaps, Whole Woman’s Health and its focus on scientific data will be the death knell of these laws too.