An Oklahoma law banning off-label use of abortion pills goes to the Supreme Court.
The U.S. Supreme Court recently accepted a case Cline v. Oklahoma Coalition for Reproductive Justice,challenging Oklahoma’s regulation of the abortion drug Mifeprex commonly known as mifepristone, RU-486, or The Abortion Pill.
The case is an appeal by the state of Oklahoma from a ruling by its Supreme Court striking down a 2011 law that requires prescribing physicians to follow the FDA’s protocol for administering the Mifeprex abortion pill regimen using a combination of two drugs; mifepristone and misoprostol.
The Oklahoma law does not ban the use of the Mifeprex regimen, nor does it ban any abortion before or after 49 days gestation. It simply requires that the medical abortion regimen be administered in the way deemed safest by the FDA. The Act imposes no obstacle or undue burden to women seeking access to an abortion.
Monty Patterson's Participation in the Case
As part of this Supreme Court case, I submitted an “Affidavit of Monty Patterson, father of Holly Patterson” in support of the “Brief of Women and Families Hurt by RU-486.”
My daughter, Holly Patterson, tragically died in 2003, seven days after the initial start of her 7-week-old pregnancy termination from a massive infection known as Clostridium sordellii toxic shock syndrome that was associated with a medically induced abortion.
Planned Parenthood prescribed my teenage daughter an unapproved, off-label RU-486 medical abortion regimen touted to be equally as safe an effective as the FDA protocol. Holly, barely 18-years-old, took advice from her provider and was persuaded to choose their alternative medical abortion regimen.
Holly did not receive accurate and truthful information concerning medical abortion in order to make an informed decision about her safe reproductive healthcare.
Since my daughter’s death, I have researched and studied the risks of mifepristone and misoprostol medical abortion and have built an educational website http://abortionpillrisks.org/ that discusses and details the facts that reveal significant safety concerns for women who consider an early pregnancy termination.
In the past 13 years, since FDA approval of RU-486, there have been an alarming number of serious health complications and injuries to women, including death.
The FDA has evaluated these injuries and deaths and publicly reported the off-label uses of the Mifeprex regimen has resulted in serious or sometimes fatal adverse events.
Personally, I do not believe any medical abortion pill regimen using mifepristone and misprostol to terminate early pregnancy is safe.
My focus is not to be pulled into the larger national abortion debate that has divided the United States into pro-choice and pro-life camps.
The United States Supreme Court has made it landmark decision on the issue of abortion. Women have certain legal rights to access and reproductive health care choices under the law.
With the legalization of abortion, a woman and her family should therefore be entitled to all the facts and risks to properly make informed decisions that are in their best interest, safety, health and welfare. This includes the choice of medical abortion with the drug regimen of mifepristone and misoprostol.
Abortion providers are promoting the use of unapproved off-label medical abortion regimens that may not have received the same degree of scientific scrutiny as the FDA approved mifepristone protocol. This problem needs to be addressed.
I have made it my focus to help educate women, families, researchers, even health care professionals to become informed of the facts and health risks of medical abortion to terminate an early pregnancy.
Significant issues of concern to me are: What are acceptable medical abortion practices? How are medical abortion providers exposing women to unnecessary health risks to already a potentially dangerous procedure?
The issue of legalized medical abortion should not be in question, but the issues of safe medical abortion protocol(s) and practices remain to be answered.
Off-Label Loopholes and Practices
Special interest groups and abortion providers have been taking advantage of huge loopholes in our drug regulatory system. Once medical abortion was approved by the FDA in 2000 and put on the market, there is absolutely nothing to prevent any abortion provider from using an alternative drug regimen in any manner, in any dose, for any patient he or she chooses. The drug’s labeling contains the indications approved by the FDA and these alternative uses are called "off-label" use of drugs.
Medical Abortion advocates contend that “doctors use drugs off-label all the time!” Organizations like Planned Parenthood are taking matters into their own hands when it comes to the use of medical abortion with mifepristone and misoprostol on their women patients. Sometimes these patients are teenage adolescents as young as 14 years old.
Common off-label usage of drugs in general does not prove it is a good idea, especially where safe medical abortion practices are critical to a woman’s health. Should medical abortion providers continue to promote their off-label prescribing as they continue to gain more confidence in what has been a serious mistake resulting in thousands of injuries and at least 14 deaths?
Medical abortion advocates claim off-label uses are not considered experimental to patients because their regimens have been “demonstrated by scientific research to be safer and more effective.”
Who makes the decisions if the medical abortion industry-sponsored research is sound scientific evidence? Who are these scientific bodies? Is it an organization of professionals trying to protect the special interests of their members?
Medical abortion providers using unapproved off-label regimens represents both a cavalier disregard for the safety of women and a total lack of faith in the U.S. Food and Drug Administration’s drug regulatory system.
Isn’t the whole purpose of FDA approved on-label use to provide assurances to the patient there is sound scientific evidence?
Providers Ignore FDA Public Health Advisories
The argument that the approved FDA protocol is an “old guideline” and considered to be “bad medicine” does not appear to be embraced by FDA officials.
The FDA has published Mifeprex “Public Health Advisories” when women have been seriously injured or suffer fatal consequences as a result of Mifeprex off-label medical abortion practice. These advisories state that the safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intra-vaginally has not been recognized or accepted by the FDA.
The FDA continues to stand by the Mifeprex protocol they evaluated and publicly remind abortion health care professionals of the approved Mifeprex dosing regimen.
Medical abortion practitioners continue to ignore every FDA Public Health Advisory. They continue to use modified regimens, by increasing the gestational age limit, shortening the process, decreasing their costs, changing the dosing regimen, decreasing physician oversight by allowing women to administer misoprostol at home (instead of at the provider's clinic) and reducing the number of patient’s return visits back to the clinic. Some practitioners advise their patients to repeat misoprostol dosing to try to improve on abortion success rates.
These practitioners have turned their off-label regimens into the “Do it Yourself” at home procedure where women are shouldering the responsibility for their own health, safety and well-being.
Making The Case For Safety
Medical abortion rights advocates are trying to make the case that off-label regimens are a safety improvement over the current FDA protocol. They oppose any action where providers may be required to prescribe three-times-more Mifeprex, essential for pregnancy termination, than they think is called for. No matter if it violates FDA approved protocol.
What about the off-label prescribing of the second drug misoprostol?
Is it considered a safety improvement for abortion providers to double the dose of buccal or vaginally administered misoprostol to further induce labor and increase contractions to expel the embryo and placental tissues? Further, additional doses of misoprostol may be prescribed for incomplete abortion complications.
Misoprostol carries its own boxed warnings, but they can’t be found in the Mifeprex drug labeling or the Patient Agreement and Medication Guide. Why aren’t providers informing women about uterine rupture that has been reported when misoprostol is administered to induce labor beyond the eighth week of pregnancy?
Providers have increased medical abortion gestation age limits from 7 weeks to 9 weeks to make it available to more women. Is that another safety improvement?
Mifeprex is being prescribed at a 1/3 reduced dose because medical abortion providers understand the cost benefits of misoprostol over Mifeprex. Mifeprex is expensive but misoprostol is a very cheap and readily available. To increase profits, misoprostol is used by providers as the predominant abortifacient agent in the regimen (not mifepristone) to terminate early pregnancy.
Medical evidence points to the fact that off-label uses of Mifeprex have resulted in more serious adverse health events, including death, than the FDA-approved regimen.
Medical abortion rights advocates claim this action is about punishment and discrimination against women who seek Mifeprex to induce medical abortion. Did the FDA have that in mind when they approved the drug sponsor’s application for distribution and prescribing of Mifeprex?
The off-label prescribing of medical abortion drug regimens has resulted in disastrous health consequences for thousands of women. Every recorded U.S. death, as in the case of Holly Patterson, has been a result of off-label Mifeprex and misoprostol use to terminate early pregnancy.
Medical abortion can be an unpredictable and dangerous alternative, especially when abortion providers choose to ignore and circumvent the FDA approved protocol.
Medical Opinion Or Evidence?
FDA's approval of mifepristone is supposed to be based on controlled studies and independent analysis of data by qualified doctors and scientists designated to review and monitor clinical medical research.
If abortion researchers and providers believe they have regimens that are “safer and more effective” than the one approved by the FDA in 2000, then they should submit them to the U.S. Food and Drug Administration, along with their unbiased and so-called "evidence-based" studies, for rigorous FDA review and evaluation. Obviously, they haven’t, and don’t intend to do so.
After all, shouldn’t women deserve quality information to ensure the medical community has all of the available facts on which to base medical abortion treatment decisions that aren't biased, industry-sponsored and motivated by profit and market expansion?
If medical abortion advocates, providers, and their researchers were really looking out for the best interest of women's reproductive health care, this contentious debate requiring a U.S. Supreme Court decision may have been avoided.
Monty L. Patterson is the father of Holly Patterson and creator of the Abortion Pill Risks website, where this article was originally published.