This is my first feature article written for the now defunct Cincinnati, OH alternative weekly
, published November 10-16 1995, issue #374. At the time mifepristone, or RU-486, had not been FDA approved and it was unclear if or when it ever would be. FDA finally did
the drug September 28, 2000 - just over five years after publication.
While the article is old and contains some outdated information, the fact that RU-486 is getting recent media attention for
after use might generate some interest. Should the FDA revoke approval for RU-486, methotrexate is a known safe alternative as an abortofacient. Given that over ten years after writing this article methotrexate still hasn't been approved by the FDA as an alternative drug induced abortion, when it continues to be used for a wide variety of other ailments, only shows that FDA unwillingness to approve drug induced abortion is a political and not a medical decision. Should RU-486 be taken off the market, off-label prescription of this drug for abortion may once again be considered as a viable option by physicians.
Physicians at the University of Cincinnati Hospital have recently prescribed and used a safe and effective drug to terminate some problematic pregnancies - news which may come as a surprise to many. In the context of the fierce national debate in this country about the moral ramifications of abortion, a presidential executive order during the Reagan and Bush administrations stalled FDA approval of RU-486, commonly known as the French abortion pill. Physicians here in America, however, were able to identify a pharmacological abortion procedure which relies on drugs already approved by the FDA.
Methotrexate, a drug used in cancer chemotherapy and the treatment of rheumatoid arthritis, and misoprostol, often prescribed for the treatment of ulcers, will successfully terminate an early term pregnancy ninety-six percent of the time when the two drugs are used in conjunction. That's according to a study published in the August New England Journal of Medicine by New York gynecologist Dr. Richard U. Hausknecht of the Mount Sinai School of Medicine.
Hausknecht's finding is based on a study of 178 women with unwanted pregnancies, all of whom had conceived less than 63 days before admittance to the study. After receiving a mixture of methotrexate and misoprostol, 171 of the 178 aborted successfully, experiencing no significant side effects or complications, seven of the women required a surgical abortion procedure.
Dr. John Merson, a specialist in obstetrics and gynecologist (Ob/Gyn) at UC Hospital has used methotrexate to terminate ectopic pregnancies. There are potentially life-threatening pregnancies in which a fertilized egg may implant itself in one of the fallopian tubes leading to the uterus.
"The danger is that ... the fallopian tube can rupture and cause serious hemorrhaging," says Mershon. However, Mershon does not perform elective abortions and makes a clear distinction between medical necessity of pregnancy termination in these cases and abortion by personal choice.
Cindy Feldhaus, founder of the local Women Exploited by Abortion (WEBA), is a staunch opponent of abortion. A registered nurse with Saint Elizabeth's Medical Center in Northern Kentucky for 24 years with a Ph.D. in Psychology from Boston University, Feldhaus concurs with the decision to terminate pregnancy in such cases by means of the drug procedure.
"Medication used for the health and well being of an individual ... is perfectly sound treatment," says Feldhaus, when the fetus "has no chance [to] survive."
IT Works, But Is It Safe?
Surgery - not he methotrexate method - remains the procedure of choice for dealing with ectopic pregnancies. Dr. Mershon, however, hopes such drugs will one day supplant the standard surgical procedure. Methotrexate is commonly used today only after the failure of a surgical pregnancy termination to remote off of the tubal prenatal tissue, and for what are called persistent ectopic pregnancies. Mershon says improved diagnostic techniques are key to the drug treatment becoming common practice.
"If there is residual tissue within the tube, these people are then ideal candidates for methotrexate treatment," he says. "Because ultrasound techniques are getting better and better, it may be possible in the near future to ultrasound a patient and make the diagnosis without surgery. Then, tubal pregnancy becomes a medial disease."
All of this presuppose, of course, that a pair of drugs which the FDA originally approved for the treatment of cancer and arthritis are safe when used as an alternative to surgical abortion. Dr. Hausknecht made a point in various interviews and press conferences following publication of his study that, before they begin prescribing methotrexate and mifoprostol for elective abortion, he would prefer physicians wait until he finishes a wider study of the procedure using at least 1500 patients. However, any licensed physician can legally prescribe these drugs for this purpose - right now. In fact, many drugs approved for one specific application are commonly and conscientiously prescribed by doctors for other purposes. It's called using a drug "off-label."
One example of a drug often used by physicians in off-label applications is Prozac. In spite of the fact that the FDA approved Prozac specifically only for treatment of depression, psychiatrists and doctors currently prescribe it for such varied complaints as sleeplessness, obsessive compulsive disorder and weight control. Once a drug has been FDA approved, physicians have significant leeway in prescribing it for their patients. In some situations, there may be some uncertainty about whether a physician's malpractice insurance would cover a lawsuit brought by a patient who responds poorly to drugs which were prescribed off-label. However, in the case of drugs such as Prozac, with widespread use and well known side effect, even those constraints do not apply.
As with Prozac, methotrexate has an extensive and well documented safety history. It is so well established in the pharmaceutical industry, it can be obtained in generic form. When taken in large multiple doses, such as for cancer treatment, methotrexate can cause severe side effects, such as hair loss, nausea, vomiting, diarrhea, liver damage, and mouth and skin ulcers. These side effects decrease in frequency and severity when the doses are smaller, such as in the treatment of rheumatoid arthritis. Dr. Michael Luggen, a specialist working in the departments of Immunology and Internal Medicine of the UC Medical Center, has extensive experience with methotrexate. According to Luggen, up to 75 percent of the UC patients with rheumatoid arthritis have taken, or are currently taking, methotrexate, and he considers it a safe and valuable medical tool in his battle against that disease.
"I've fount it very safe," says Luggen, "I've found it to be the most effective treatment available for arthritis, in comparison to other available treatments."
In his treatment, Luggen administers many doses over a period of time in an attempt to control the swelling of patients' arthritis. When methotrexate is used to terminate a pregnancy, however, only a single, relatively small dose is required. Dr. Mershon confirms that it seems methotrexate-induced abortion is at least as safe as surgical [abortion] procedure, and [surgical abortions] are extremely safe procedures.
Dr. Mershon refuses to discuss the use of the drug procedure for elective abortions, but he does indicate that there is little technical difference between using methotrexate to terminate ectopic pregnancies and using it as a standard elective abortion. "[The] general principals are the same," says Mershon, [they're] a very, very, similar process."
Comparing RU-486 to Methotrexate
Drug-induced abortion became a reality in 1982, when Dr. Etienne-Emile Baliew, a French researcher and physician at the pharmaceutical company, Roussel Uclaf, discovered that mifepristone, an antiprostaglandin, was over 95 percent effective in safely terminating a woman's pregnancy. Baliew's discovery resulted in RU-486 - and a torrent of heated debate over its application.
It took Roussel Uclaf six years to test RU-486 and bring it to market in France. In 1989, after the French government announced that the final testing and approval process was nearly finished, Roussel Uclaf, responding to widespread public protest in the predominantly Catholic country, decided to hold RU-486 off the market, stating that they didn't want to engage in a moral debate. Within 48 hours, however, the French Health Minister, Claude Evin, forced Roussel Uclaf to agree to put the drug on the open market as soon as government approval was granted.
"RU-486 [has become] the moral property of women," Evin argued.
The American government, however, followed a very different path. The Reagan administration actively prevented the FDA's testing of RU-486 by banning import of the drug, a policy sustained by the [George H. W.] Bush administration.
During his 1992 election campaign, Bill Clinton promised to end that ban. However, Roussel Uclad, wary of the virulence of anti-abortion protests, refused to license and sell RU-486 here until late 1993, when the French company ceded all rights for sale of the drug in this country to The Population Council, a non-profit agency. Even this group is leery of protesters. The organization recently announced it will not provide RU-486 to pharmacists, even if physicians are willing to prescribe the drug. Instead, The Population Council will make the drug available directly to physicians qualified to perform surgical abortions.
RU-486 functions slightly differently than methotrexate, but the results are the same. RU-486 works by blocking progesterone, a hormone produced naturally during pregnancy. This causes the lining between the fetus and the uterine wall to break down, disrupting growth of the placenta. Methotrexate, on the other hand, blocks folic acid, the B-vitamin which is necessary for cell reproduction. Without folic acid, cells can't divide. Since an embryo is in a constant state of rapid cell division and growth, this deprivation effectively terminates fetal development.
Both misoprostol and prostaglandin cause uterine contractions and are only used to expel the fetus for several days after the original ingestion of RU-486 or the injection of methotrexate. In France, Roussel Uclaf recently recommended discontinuing prostaglandin in favor of misoprostal in conjunction with RU-486.
The Population Council is working with the FDA to test RU-486 at twelve undisclosed locations here in America. But FDA approval even under the best of circumstances can take many years, and it's unclear when - or if - RU-486 will become available to the American public.
Methotrexate, by contrast, is already FDA-approved, and has a long history of use within the medical community. When these factors are combined with the low price for the drug in its generic form - it is significantly less expensive than RU-486 - it becomes clear methotrexate represents a new challenge for anti-abortion forces.
Is It Really Available?
Barbara Rinto, executive director of the local Planned Parenthood Center in Mt. Auburn, has been following the evolution of drug-induced abortion technology and confirms that methotrexate offers a distict economic advantage over RU-486. However, even though it is no more illegal for a physician to prescribe methotrexate for an elective abortion than for treating arthritis or cancer, don't expect to walk into your doctor's office - or your abortion clinic - and get a shot of the drug any time soon. Planned Parenthood decided to wait until the FDA approved methotrexate specifically for elective abortions. In fact, with regard to methotrexate induced abortion Rinto says, "We don't expect to use it in the near term or in the near future."
Dr. Mershon is even less enthusiastic about methotrexate's potential future use for elective abortions.
"Nobody is currently doing this off-label," says Mershon, "there is a lot of opposition to this." However, though he says he himself doesn't know of any, Mershon concedes some doctors may be using drug-induced abortion methods due to a lack of surgical facilities. Rinto also worries some physicians won't wait for FDA approval.
"I expect there will be some physicians who will use this covertly," says Rinto. "Some physicians, who are practicing in rural areas, might use this technique out of a lack of facilities." To women who might have an interest in trying the procedure, Rinto offers this advice: "I would urge women who want to use this to contact those clinical trials currently testing this drug."
Rinto also reiterates Dr. Haushknects's warning to physicians, that they should wait until further studies are complete before using the drug for elective abortions. Unlike Dr. Mershon, however, Rinto expects widespread availability once FDA studies are complete.
These cautions aside, nothing prevents your family doctor from prescribing this drug right now. And in rural areas where a woman may have to travel several hundred miles to find surgical abortion facilities, many doctors might be tempted to prescribe and administer methotrexate as an alternative.
After nearly ten years of successfully stalling RU-486, American abortion opponents suddenly find they must confront a drug-induced abortion technology. Clearly, methotrexate has the potential of forcing a radical reevaluation of the tactics, if not the moral assumptions, of each side in the anti-abortion/pro-choice debate. How will abortion foes deal with a procedure which would make abortion a walk-in procedure available at any small town doctor's office?
The Debate Rages Locally
Cindy Feldhaus opposes all elective abortions, calling it "the contractual taking of an unborn child's life." Against such arguments, of course, many in the pro-choice movement point to the large number of illegal abortions before Roe vs. Wade, and to the many women who died or suffered permanent physical damage because of non-sterile facilities or ignored practitioners. Such considerations, however, do not change Feldhaus' view that abortion destroys the life of a child and the life of the mother.
"Once a child is conceived, the woman is the mother of a living human being, or she chooses to be the mother of a dead child," she says.
Each year, Feldhaus provides psychological counseling to about 2,000 area women who have had to deal one way or the other with an unwanted pregnancy. She helps them find ways to take care of their baby after birth, provides referral services for adoption agencies, and also provides a comforting shoulder for women who become depressed after having abortions.
"Women who have had abortions are out there quietly suffering," she says.
Barbara Rinto also has plenty to say about the importance of abortion availability - for individual women and for society as a whole. She also stresses the safety of the standard surgical procedure as compared to carrying a pregnancy to term. Rinto cites a study published in Family Planning Perspective by the Allen Guttenmacher institute, an organization conducting reproductive health research and affiliated with Planned Parenthood. The 1990 study concludes that a surgical abortion is eleven times safer than carrying a pregnancy to term - twice as safe as taking a few doses of penicillin. Rinto has learned the importance of making her point with stark figures.
"The opposition wants to frighten women about the dangers of surgical abortions when in fact they are very safe," Rinto explains. While she supports research and development of a pharmacological abortion alternative, Rinto strongly believes in the continued importance and viability of surgical abortions.
"These drugs work best for early pregnancies," says Rinto, "but for those who need later abortions because of not recognizing a late pregnancy, say, and for those who the drugs have not worked, surgical abortions will still need to be available."
But once either methotrexate or RU-486 becomes widely available, it is probable many women will opt for the drug induced method over surgery. In France, once RU-486 became available, 85 percent of those women who requested abortions chose the drug alternative.
Rinto knows that the anti-abortion camp in this country will react to the expansion of abortion technology.
"They're extraordinarily frustrated by RU-486 [and methotrexate]. These drugs make it very difficult for them to stop medical abortions," she says. But Rinto also offered an olive branch to her adversaries on the other side of the issue.
"They're never going to eradicate abortion unless they work with us on prevention," Rinto predicts. "But even then, there will be some women who will need abortions." If Rinto is sincerely eager to work with anti-abortion activists like Cindy Feldhaus, however, she is probably in for a disappointment.
"Concerning the opposition, I don't see gray when it comes to the death of a child," says Feldhaus by way of response to Rinto's proposition. "Prevention of abortion is the ultimate goal," according to Feldhaus, one she prefers to reach "by reinstating the moral values of chastity, self-respect, and the sanctity of life."
A Short Walk Up To Planned Parenthood
In the course of researching this article, I went to pick up a press packet Rinto left for me at their front desk of the Mt. Auburn Planned Parenthood. Outside the building at four o'clock on a Wednesday afternoon, it was quiet, without a single protester picketing the facility. Even so, the level of security was impressive, and for good reason. After several shootings of Planned Parenthood physicians and staff around the nation, the organization isn't taking any chances.
Cameras cover the main entrance and foyer. Surrounded by a metal frame, a think pane of glass, which I can only assume is bullet proof, separates the main desk from the entry room. A few comfortable chairs dot the room, but this barren area is obviously designed to either let people inside or keep them out.
The receptionist, a large burly man, wore a polo shirt with an image of the American flag wrapped around it like some star spangled armor. While seated at his desk, he pressed a button and padded the press packet through a secure metal chute, never once considering whether to let me in. He didn't smile. I looked around the brick and carpet trying to record a mental image of the place - and noticed a small basket filled with multi-colored condoms.
My business completed, I walked back outside, looked around a bit, and finally noticed a sign attached to the large metal gate surrounding the building. It read:
NO TRESPASSING. PRIVATE PROPERTY. PREMISES FOR USE BY PATIENTS AND STAFF ONLY. NO SOLICITING.
I was mildly irritated to realize my palms had become sweaty with nervous apprehension. I wiped them on my jean jacket and left.
Text Copyright ©1995 J. Maynard Gelinas.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 2.5 License.