Whenever the US Food and Drug Administration approves a new medication, they list a specific treatment protocol derived from the studies they used in their assessment.
In September 2000, the FDA approved mifepristone, commonly referred to as RU-486, for manufacture and use in the United States. RU-486 is a pill used in combination with another drug, misoprostol, to induce an abortion without surgical intervention. The FDA’s approval was based on clinical trials in which patients whose pregnancies had advanced no longer than 49 days received an oral dose of 600 mg of RU-486, followed two days later by an oral dose of 0.4 mg of misoprostol.
In 2004, Ohio passed a law which stated that medical providers must follow the FDA protocol when prescribing mifepristone. Sounds perfectly legit, right?
After a drug has been approved by the FDA, in the absence of additional state-level regulation, doctors are permitted to prescribe that drug in different medical situations and to employ different dosages and delivery protocols for the drug than those initially approved by the FDA. This practice, known as “off-label” use, is not barred by federal law or FDA regulations. As a result of research conducted following FDA approval of RU-486, an off-label protocol was developed in which doctors administer a 200 mg oral dose of RU-486 followed three days later by 0.8 mg of misoprostol to patients whose pregnancies have progressed as long as 63 days. This off-label regime was adopted by the Planned Parenthood clinics in Cleveland, Columbus and Cincinnati and by other providers of abortion services in Ohio.
Research on a drug doesn’t grind to a halt after FDA approval. Quite the opposite, in fact: the influx of people using the drug creates a surge in the data about that drug’s dosage and side-effects, and can open up new treatment protocols for related conditions. Much as what happened with birth control pills, mifepristone was later found to be as effective in lower doses that triggered fewer side-effects. As a bonus, decreased doses also mean less drug needs to be manufactured and thus cheaper pills.
So a proposal that seemed to protect patients actually harmed them, as it had the gall to demand pregnant people pay more for higher drug doses than they needed, and barred them from off-label usage that may also have been safe and effective. The Ohio legislature can’t claim to be ignorant of this, as those two quotes above are from a 2009 Sixth-Circuit Supreme Court ruling that OK’d their legislation, though the law would continue to be blocked by the courts until 2011; during seven years’ worth of litigation, expert witnesses testified to all of the points I’ve mentioned above several times over.
The consequences of ignoring expert advice have come to pass.
This study finds that while the provision of medication abortion was still safe and effective in Ohio, the 2011 law change was associated with greater need for additional intervention, more visits, more side effects, and higher costs for women who have medication abortions.
Additionally, we observed a trend of declining use of medication abortion, which is consistent with other analyses of state-level data from Ohio and with experiences in Texas after a similar law was passed there. This decline is opposite to national trends, where medication abortion is increasing as a proportion of all abortions.
The law increased the logistical burdens on women who have medication abortions. Between February 2011 and March 2016, women needed to make a minimum of four visits instead of two, resulting in potential increases in transportation and childcare costs and more time away from work and school. In recent years, the number of facilities in Ohio has decreased from 14 to 8, and some providers had stopped providing medication abortion as a result of this law. Thus, many women who prefer this abortion method needed to travel further to obtain it. More than 10% of the patients in our sample travelled over 50 mi to get to the abortion provider; for women having to make four visits, this adds up to more than 400 mi travelled. The requirement of misoprostol administration in the provider’s office also led to cases of vomiting and other side effects beginning on the journey home.
The increased rate of side effects in the postlaw period may be due to the higher dose of mifepristone and the oral route of misoprostol administration. Previous studies report higher rates of nausea and vomiting and more severe bleeding with 600 mg versus 200 mg of mifepristone. While the misoprostol dose in the postlaw period was lower, clinical trials have demonstrated that oral administration is associated with higher rates of gastrointestinal effects, nausea, vomiting, and diarrhea than vaginal administration.
Yet again, we find the anti-choice movement’s claims of protecting women to be outright lies, in the face of clear evidence. In this case, however, there’s a welcome twist: in a rare move, the FDA updated their recommended protocols for mifepristone to match clinical practice, effectively removing the claws from these unhealthy laws.