Exploring the disconnect between what is effective and safe, and the rules. (Photo: Getty Images)
Medical abortion, or the non-invasive administration of oral medication to terminate a pregnancy in the first trimester, is a procedure for those who learn early on that they are pregnant and elect not to carry the pregnancy to term. In fact, a new study shows that a regimen for medical abortion — which would only involve a woman having to go in to the doctor twice, compared with three times under the current FDA rules — is effective and safe.
Yet, medical abortion is the least-used form of abortion, accounting for only 16.5 percent of all abortions in the United States.
A Look At The Options
There are two general types of abortion available to women seeking to terminate a pregnancy. The more common and widely known kind is surgical abortion, which involves either aspiration or dilation and evacuation, commonly referred to as D&C, both of which involve in-office optional sedation and a suction machine that gently empties the uterus through a tube inserted through the cervix. The other type is medical abortion (sometimes referred to as medication abortion), which uses a combination of oral medication to trigger miscarriage in early pregnancy.
Medical abortion has been FDA-approved since 2000, and was known by one of the drugs used in the process, RU-486, while it was being developed. Women who have a medical abortion take the first pill of the procedure in their health care provider’s office, and then take an antibiotic. Next, they take a second pill one to two days later.
Current FDA regulations necessitate multiple visits to a physician’s office, once for a consult session and then once for supervised administration of the initial dose of 600 milligrams of mifepristone, followed by another visit one to two days later for supervised administration of 400 micrograms of misoprostol. (Note: the consult visit and the visit to receive the first dose of mifepristone don’t have to be separate visits according to the FDA, just per some state laws.)
A fourth visit is then required to ensure that abortion in complete. (While an antibiotic is not required, Planned Parenthood Federation of America uses antibiotics, and they can be administered any time between the first pill of mifepristone and the second pill of misoprostol.)
New Study Shows Efficacy Of A Different Medical Abortion Regimen
A new study in the journal Contraception, however, shows evidence of the efficacy and safety of medical abortion utilizing an initial dose of 200 milligrams of mifepristone followed by home administration of 800 micrograms of misoprostol one to two days later up to 63 days of gestational age. This regimen was shown to have an efficacy of 97.7 percent.
While the original studies on medical abortion, as used to set the existing FDA protocol, only included women up to 49 days, or seven weeks, of gestational age, current data now include women through 63 days, or nine weeks, of gestational age. Furthermore, several factors from the original FDA protocol make the process of medical abortion more difficult on women than the evidence-based protocols suggest they need be.
With each 200-milligram dose of mifepristone costing approximately $90 a pill, only having to take one pill (200 milligrams) instead of three (600 milligrams) makes medical abortion more accessible. Also, while the FDA protocol necessitates patients to take both medicines for a medical abortion at the prescribing physician’s office, in the evidence-based regimens, the patients can take the first medication (mifepristone) in the office and then the second one (misoprostol) at home, making for one less visit to the office for a woman.
This investigation was a joint research project by Planned Parenthood Federation of America, Planned Parenthood Los Angeles, and Princeton University and shows that evidence-based medication abortion protocols are safe and effective — even more so than the original FDA protocols express. The study looked at 13,000 women who received medical abortions at Planned Parenthood Los Angeles health centers over a five-year period.
Per the new Planned Parenthood and Princeton study, the success of this evidence-based dosage and home administration was not only nearly 98 percent successful, but was between 96.5 percent and 98.8 percent successful regardless of age, ethnicity, socio-economic status or gestational age.
How Changes To The Regimen Reflect Medical Understanding
As noted by the American Congress of Obstetrics and Gynecology (ACOG), evidence-based protocols such as this are encouraged as they improve on the existing FDA protocols for medical abortion “in terms of expense, safety, speed, and adverse effects.”
“We now know, based on well over a decade of solid research in the United States, that there are several changes to the regimen that make it more effective, an option for more women, and less of a burden on women,” study researcher Deborah Nucatola, MD, senior director of medical services at Planned Parenthood Federation of America and associate medical director for research at Planned Parenthood Los Angeles, tells Yahoo Health.
What is on the label of a medicine is the best evidence that was available at the time of its approval, but as our medical knowledge and evidence evolves, a package label doesn’t necessarily evolve with it, she adds.
“As a result, it is critical that health care providers be able to practice according to the best medical evidence, not laws passed by politicians reading a 15-year-old package label,” Nucatola says. “ [P]oliticians should not be passing legislation requiring providers to dispense medication according to outdated protocols when we have newer and better evidence-based protocols now.”
State Restrictions Around Abortion
Many states, however, have introduced laws severely restricting the availability and accessibility of medical abortion, despite its safety and effectiveness. The pills used for medical abortion are not available at pharmacies. And at present, 16 states regulate that the pills must be administered under the direct supervision of the prescribing physician while three states require that medication abortion be administered only according to the current FDA protocols. Both the American Congress of Obstetrics and Gynecology (ACOG) and the American Medical Association (AMA) have spoken out against such laws.
In a 2013 statement issued following an amicus brief jointly filed by the two organizations opposing a Texas law that sought to restrict abortion access, ACOG and the AMA said: “Legislators should not block advances in medical care by prohibiting physicians from incorporating the best, and most current, scientific evidence into their patient care. Requiring physicians to follow a protocol that is scientifically proven to be inferior to other regimens is an unwarranted intrusion in the physician-patient relationship.” (The Texas law was ultimately overturned by the Supreme Court this fall.)
In 2011, Oklahoma passed a state law that was found to be unconstitutional by the state’s Supreme Court that, depending on its interpretation, “either bans all medical abortions” or “requires doctors who do medical abortions…to follow the FDA protocol.”
Laws such as the one proposed in Oklahoma — and currently in effect in North Dakota, Ohio and Texas — might seem logical on paper: It might make sense that a doctor to be required to follow the FDA protocols for a given medication. And yet, research on medications continue long after they receive FDA approval, allowing physicians to then base how they prescribe the drug on a case-by-case basis, determined by each patient’s medical history and needs. Legislation that seeks to restrict the interactions that a given doctor has with a given patient thus seems to be only motivated by those who worry medical abortion is “too easy,” and thus use these kinds of restrictions as a backdoor policy for overall limiting abortion access.
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