Idaho judge's decision endorses dangerous 'off-label' use of RU-486, abortifacients
March 14, 2013, (National Right to Life News) - There was a lot wrong with U.S. District Court Judge B. Lynn Winmill decision last week overturning Idaho’s Pain-Capable Unborn Child Protection Act (PCUCPA). However what caught my attention, as someone who has followed the tragic history of chemical abortifacients in the U.S. for many years, was how uncritically Judge Winmill seems to have bought the abortion industry’s propaganda on the abortion pill and how poorly he appears to understand the all too real risks. (For background, see http://nrlc.cc/Wb1KXr and http://nrlc.cc/Wb1tne])
In late 2010, Jennie Linn McCormack, a mother from Idaho with three living children, finding herself pregnant again, took some abortifacient pills her sister ordered over the Internet. Ms. McCormack took the first pill on December 23 and the rest sometime in the next few hours. After cramping that night, she delivered a dead child the next day, Christmas Eve, in her bathroom, along with a “great deal of blood” (Myrtle Beach Sun-News, 1/3/13).
Though McCormack at various times gave estimates of the baby’s age as being anywhere from 4 weeks to 25 weeks, police who investigated said the child displayed “fully formed facial features, tiny fingernails, hair” (Los Angeles Times, 6/17/12). As mentioned in our 3/7/13 NRL News Today story, the most likely age was between 18 and 21 weeks.
McCormack was charged under an Idaho law making it illegal for anyone other than a health care professional to be involved in an abortion. Though the original case was dismissed, McCormack and her lawyer, Richard Hearn, a non-practicing physician who says he’d like to provide chemical abortions, sued to challenge that law and the Pain-Capable Unborn Child Protection Act, which prohibits abortions once the child is capable of experiencing pain—20 weeks after fertilization.
In the process of defending his decision to strike down PCUCPA, Winmill makes a number of claims that demonstrate a disturbing lack of interest or understanding of the real risks associated with chemical abortifacients.
Judge Winmill accurately notes that [in September of 2000] the U.S. Food and Drug Administration (FDA) approved a protocol. Under that protocol, on the first day, 600 milligrams of mifepristone (three pills of RU-486) is given to a mother who is no more than 49 days gestation [actually 49 days after a woman’s last menstrual period], followed by 400 micrograms of misoprostol given two days later. (Misoprostol is a prostaglandin that induces delivery of the dead baby.)
Winmill mentions that the FDA protocol involved taking the mifepristone orally, but does not add that it also directed that the misoprostol be taken by mouth. He does not mention that the FDA also expected women to return for both the second visit (when the misoprostol is administered) and for a third visit, two weeks from the first, to confirm the completion of the abortion.
Immediately after summarizing his truncated version of the FDA protocol, Winmill makes this statement.
Following FDA approval, additional clinical trials led to the development of mifepristone-misoprostol regimens that differ from the FDA-approved protocol. These new regimens reduce side effects, and make medical abortions cheaper, safer, and faster.
Winmill then goes on to mention such variations as extending the cut-off date to 63 days LMP, adding that “The medical community” recognizes the off-label use (uses not officially approved by the government) of other chemical abortifacient combinations such as methotrexate (ordinarily used to treat ulcers) and misoprostol or misoprostol alone.
Click "like" if you are PRO-LIFE!
Winmill makes it sound as if the FDA is okay with such off-label use. He offers that the agency regulates only the marketing and distribution of the drugs, not medical practice, and writes that after the FDA approves a drug, doctors may prescribe drugs for purposes, in doses, and using protocols other than that approved by the FDA (unless there is some state law in place to the contrary). Winmill quotes an FDA document that says the “FDA itself recognize the value and propriety of off-label use” and again cites “medical community’s” recognition of off label use.
A great many important medical and historical details are missing in this presentation.
Winmill shows no evidence of having real knowledge of the significant history behind the altered protocols. Winmill says that “Following FDA approval, additional trials led to the development of mifepristone-misoprostol regimens that differ from the FDA-approved protocol...”(italics added).
The truth is that these “new regimens” were largely developed on the basis of “additional trials” that took place before, not “following” FDA approval, and these were unsuccessful in getting the FDA to modify its protocol in the ways the industry had in mind.
And who is this “medical community” that Winmill offers as endorsing these new protocols?
Winmill cites guidelines, developed in part by Mitchell Creinin, notorious chemical abortifacient researcher, that were published by the American College of Obstetricians and Gynecologists (ACOG), the same group that couldn’t bring itself to support a ban on Partial-Birth Abortion.
And who do the Creinin and ACOG cite in their guidelines? Why, that would be a veritable Who’s Who of the abortion industry. These are folks whose history has long been to experiment with dangerous new chemical abortifacients, minimize the risks, cut as many corners as possible, and to challenge whatever minimal safeguards might be put in place.
Among the modifications pushed in these studies were altered doses of the two drugs, extending the cutoff date past 49 days, and having women take the second drug at home.
It is true that in a packet sent out by the National Abortion Federation (NAF) shortly after RU-486’s approval, NAF counsels would-be chemical abortionists (in language strangely anticipating that used in Winmill’s opinion) that “The FDA has recognized that alternative evidence-based uses of drugs by clinicians is often appropriate and may represent the standard of practice.”
But both NAF and Winmill ignore what an FDA official told the Wall Street Journal shortly after approval: “People should use the product according to the approved regimen.” The official said that if the distributor wanted to change the dosage or the label (official instructions on how the drug is to be used), it should submit new data to the FDA for review (Wall Street Journal, 10/30/2000).
The FDA explicitly rejected the modification pushed by the pills sponsors before approval to allow women to take the second drug at home, rather than having to return to the clinic. In a memo to the sponsor of the application, the FDA said “data provided by the Population Council supporting home use was re-reviewed and found not to provide substantial evidence for safety and efficacy.” It is deviation from the protocol now widely practiced.
It should also be noted, that despite Winmill’s declarations of the safety of these new off-label protocols, there is real dispute in the abortion industry as to whether vaginal self-administration of the misoprostol, the second drug in the process many are now taking at home, is really safe. Some speculate that this modification may be at least partly responsible for the rare infections that have killed a number of RU-486 patients (LA Times, 8/15/05, NRL News, May 2006)
Also, despite what Winmill says, chemical abortions are NOT cheaper than surgical abortions performed in the same time frame. According to figures published by the Guttmacher Institute in 2009, the average cost for a surgical abortion at ten weeks was $451. Chemical abortions, such as those done with RU486, averaged slightly more, at $483.
How have abortionists cut chemical abortion costs? By ignoring the FDA protocol, reducing the dose of mifepristone from three pills (cost $90 each) to one and doubling the dose of the misoprostol which is only a couple of dollars, at most. With the modified dosages, chemical abortions cost less than they would have cost under the FDA protocol, but they still cost more than standard surgical abortions–meaning that they still do not represent any overall savings.
The ACOG guidelines that Judge Winmill cites do indeed suggest altering the dosages and extending the cutoff date to 63 days. But a good portion of his decision is spent discussing the ways in which Idaho laws would “interfere” with McCormack lawyer/doctor Richard Hearn’s expressed desire to offer chemical abortions “through the second trimester” and “outside a clinical or hospital setting.”
There have been studies using misoprostol and mifepristone, or the prostaglandin misoprostol alone for second trimester abortion, but the idea that these could be managed remotely by a non-practicing physician dabbling in a field other than the ones in which he is trained seems beyond the pale of even the National Abortion Federation (NAF). While NAF does allow for second trimester chemical abortions, their guidelines only state that they consider this method “safe and effective” “in appropriate clinical settings by trained clinicians.”
NAF says that those doing these abortions need to be “capable of surgical management… including a clinician who can perform a timely curettage for retained placenta or bleeding,” and says such “must be available until post-abortion discharge.” Furthermore, they say that “A clinician must be available for emergency care from initiation of cervical pretreatment until post-abortion discharge.” They indicate that a physical exam should be performed and that gestational age must be verified by ultrasonography.
The idea that a woman should or could safely do this on her own or only with some doctor she consults over the Internet is totally inconsistent with NAF Guidelines. NAF says that “Once regular contractions have been confirmed, patients must be observed by a health care worker trained to monitor contractions and expulsion.” NAF also says that “Completion of the procedure must be verified and documented by the operator.”
Furthermore, though the FDA has a general policy discouraging Internet purchases, it specifically warns “Do Not Buy Mifeprex over the Internet” (“Mifeprex” is the U.S. trade name of mifepristone or RU-486) and adds that:
You should not buy Mifeprex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others).
Mifeprex has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.
Winmill’s opinion is not that of someone familiar with the real and serious risks associated with chemical abortions.
The idea that the abortion drugs are safe, that the time limits and the dosages and the protocol can be casually tinkered with; that they can be safely administered by a lawyer who has not practiced medicine since 1997 and who is not an Ob-GYN; or even worse, by someone ordering the drugs off the Internet and administering these to herself, is contradicted by the stark reality disclosed in a April 30, 2011 FDA memo. That memo reported 14 deaths associated with use of mifepristone in the U.S., over 2200 ‘adverse events,” and at least 612 hospitalizations for women dealing with such issues as infections, blood loss requiring transfusions, and ectopic pregnancy.
Keep in mind that these were probably perfectly healthy pregnant women who ended up in the hospital fighting for their lives only after taking these “safe” drugs. And most of those were under the supervision of, if not a responsible doctor, at least a trained one that should have at least counseled or examined them.
If the vision of Judge Winmill, Jennie McCormack, her lawyer/one-time doctor, and all the abortion pill pushers in the medical establishment comes to fruition, the numbers of women who will join the corpses already piling up from this killing pill will be staggering.
This article originally appeared on National Right to Life News and is reprinted with permission.