Cline symposium: Oklahoma law could force doctors to provide substandard medical care to women using medications to end a pregnancy

Jennifer Blasdell, J.D., is the Senior Director for Government Affairs at Physicians for Reproductive Health. Nancy Stanwood, M.D., M.P.H., is the Board Chair, Physicians for Reproductive Health; Chief of Family Planning Section, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine.

At stake in Cline v. Oklahoma Coalition for Reproductive Justice is the ability of a woman to use medications to end a pregnancy. Intertwined with that issue is the right of a clinician to provide the best and most up-to-date medical care to a patient. In 2011, the state of Oklahoma attacked access to medication abortion by passing a law that, on its face, bans the use of all medications to end a pregnancy. If such a law were to be upheld, it would mean that women would be denied access to a common, safe method of early abortion. Laws like the one at hand are not about the safety of abortion or protecting women; they are about limiting access to a safe and legal way to end a pregnancy.

Eighty-eight percent of all abortions in the United States occur early in pregnancy. There are two ways to end a pregnancy in the first trimester – a brief surgical procedure or a regimen of two medications. Each year, roughly 200,000 U.S. women use medications to end a pregnancy. The most widely used regimen is mifepristone (available in the United States as Mifeprex and also known as RU-486) along with misoprostol.  Mifepristone was approved for use by the U.S. Food and Drug Administration (FDA) in 2000 after years of study by the medical community.

The Oklahoma statute is so broad that it appears to ban the use of methotrexate, a medication used to treat ectopic pregnancies (a pregnancy that forms in the fallopian tube). An ectopic pregnancy can never develop into a normal pregnancy because it grows outside of the uterus. An untreated ectopic pregnancy will likely rupture, risking a woman’s health and life. Ectopic pregnancy is more dangerous than pregnancy and delivery, and prompt treatment is essential. It is unconscionable that Oklahoma would withhold an established and effective treatment for such a dangerous medical condition.

The U.S. Supreme Court has asked the Oklahoma Supreme Court for clarification on the breadth of this sweeping law and whether it also bans the use of methotrexate. Seemingly realizing that this broad ban will not pass constitutional muster, Oklahoma is arguing that its application is limited to regimens for mifepristone that differ from the FDA label approved thirteen years ago. Even if a court narrows the scope of the statute, it would still set a terrible precedent for health care in this country.

When the FDA approves medications for distribution in the United States, it approves labeling that contains information for clinicians, including the chemical composition of a drug, the mechanism of action, and the regimen upon which the approval is based.  All drugs approved for marketing in the United States have such a regimen in their label, but research and innovation do not stop once a drug is approved. The medications physicians use are continually studied to achieve better outcomes for our patients.  The regimens that result sometimes are termed “off-label,” but this is a misnomer – a better term is evidence-based, because the variations are firmly rooted in research and science.

Physicians are obligated by professional ethics to provide the best care possible to our patients. Why would we give more medication than necessary? Or require a woman to make an unnecessary trip to see a doctor when she is perfectly capable of following directions for administration? A law like the one in Oklahoma essentially replaces medical judgment with an ideologically driven political agenda. Do not be fooled by the law’s reliance on FDA labeling. The FDA does not practice medicine; doctors do. The medical community is constantly researching and improving how we care for patients, and physicians strive to provide our patients with the most up-to-date treatments.  This intrusion into the practice of medicine is offensive to doctors and the women for whom they care, and ominously threatening to scientific integrity.

Studies by U.S. researchers as well as the World Health Organization confirm that mifepristone is equally effective at lower dosages than the regimen in the 2000 label, meaning that a woman can take one pill as opposed to three pills. Studies also show that a woman can follow directions and take the second medication at home instead of returning to the clinic, doctor’s office, or hospital to be handed a pill. Lastly, researchers have found that mifepristone is safe and effective in the first nine weeks from the last menstrual period, two weeks beyond the original research given to the FDA. Study after study has established that these regimens are safe and effective. The results and findings have been published in peer-reviewed journals of the highest esteem, such as the New England Journal of Medicine and the American Journal of Obstetrics and Gynecology.  These evidence-based regimens have become standard medical practice in the U.S. and abroad. If clinicians were forced to follow the outdated label, they would be out of step with current practice.

We would never stand for this kind of interference in any other area of medicine. For example, most pediatric prescriptions are written for “off-label” evidence-based uses because we do not test medications on children. Beta blockers approved to prevent high blood pressure also treat heart failure effectively. Chemotherapy drugs studied and approved for one type of cancer are used safely for other types of cancer. There are thousands of examples of how health-care providers prescribe medications to meet the health needs of their patients based on the most up-to-date research, but differ from the regimen in the original FDA label in dosage, administration, or conditions treated.

Should Oklahoma’s arguments be accepted and upheld, doctors would be prohibited from using safe, scientifically based regimens for medication abortion. Instead, they would be limited to a protocol based on research conducted in the last century. In a nutshell, politicians would be able to order doctors to practice medicine based on old science and force practitioners to choose between providing substandard care or facing criminal penalties.

Anti-abortion advocates fought the approval of mifepristone in the U.S. and failed. They have tried unsuccessfully to convince the FDA to rescind the approval or put medically unnecessary restrictions in place. Attempts to restrict mifepristone through Congress have also failed.  Now, anti-abortion advocates have turned to state legislatures with the spurious claim that medication abortion is unsafe, even though they lack credible medical and scientific evidence.

Since 2000, more than 1.75 million U.S. women have used mifepristone to end a pregnancy.  Millions more women around the world have also taken mifepristone and it is available in thirty-nine countries including the United Kingdom, Germany, New Zealand, and Australia.  Mifepristone has an outstanding safety record; rates of infection and serious complications following a medication abortion are extremely low and deaths are very rare. For some women, using medications to end a pregnancy is safer and preferable to having a surgical procedure. For example, medication abortion may be medically indicated for women who are extremely obese, have large uterine fibroids, or have certain uterine anomalies. Women also decide to use medications because the abortion is more private.  This is particularly important to women who may be survivors of sexual violence and want a nonsurgical abortion. With medication abortion, women can also avoid anesthesia or sedation.

The FDA reports that it has been informed of eight deaths in the United States due to serious infections following the use of mifepristone/misoprostol since 2000, out of a total of 1.75 million women who have used mifepristone. Seven deaths have been attributed to Clostridium sordellii infection; one death has been linked to another clostridial organism, Clostridium perfringens. No causal relationship has been established between mifepristone, misoprostol, or the route of administration and these outcomes. Clostridium sordellii is a type of bacteria that in very rare cases causes toxic shock that is rapidly fatal. It has been identified as a cause of death following childbirth, miscarriage, menstruation, trauma, and surgery.

Very little is known about how or why Clostridium sordellii becomes lethal. All patients taking mifepristone are given detailed information about possible signs of infection and what to do should any concerning symptoms arise. Again, the risk of infection or any adverse event is extremely low. To compare, think about acetaminophen (Tylenol). We know that overdose causes liver failure and over 400 people die each year from taking too much acetaminophen, but it is considered a safe medication.

There is no legitimate scientific basis for restricting access to medication abortion. The science shows that these medications are safe and effective. Attacks on women’s access to safe abortion care like the statute in Oklahoma shock and outrage physicians. Politicians attempt to cloak these laws in rhetoric about safeguarding women, but the reality is that these laws take decision-making ability away from women by limiting their options and consequently endanger their health. The district court judge in this case recognized the danger posed by the statute and struck it down. Physicians who provide comprehensive reproductive health care to women across the country hope that as the Supreme Court considers this case, the Justices will recognize this law for what it is – an unjustified political intrusion into the practice of medicine that threatens the health and well-being of women across this country and forces health care providers to violate their ethics and practice outdated medicine.