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.
These laws, along with many others that interfere with abortion care, are enacted amid claims that they are designed to benefit women. The evidence, however, contradicts those claims. As U.S. Supreme Court Justice Stephen Breyer wrote in his majority opinion striking down the provisions of the Texas law, the requirements imposed by the state “vastly increase the obstacles confronting women seeking abortions in Texas without providing any benefit to women’s health capable of withstanding any meaningful scrutiny.” Noted Supreme Court analyst and New York Times reporter Linda Greenhouse wrote that in this decision “evidence-based medicine meets evidence-based law.”
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.