Drugs/ Medication "Mifepristone" - Ru486 term paper 17157

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Overview:

The medication "mifepristone" was invented in France by Dr. Etienne-Emile Baulieu in 1980. It is widely know as "RU-486" throughout North America. The letters is taken from the initials of the pharmaceutical company Roussel-Uclaf. The "486" is an arbitrary lab serial number. 1 It was first introduced in France, where it is called Mifegyne. ® It has been used, in combination with prostaglandin medication, to induce abortions in about 500,000 women over almost 2 decades.

Over the last fifteen years, dozens of clinical studies on RU-486 have been conducted with thousands of women in over 20 countries, including France, Britain, Spain, Germany, the Netherlands, Switzerland, the U.S., Scandinavia, and the former Soviet Union. 11 In 1999, mifespristone was approved for marketing in Austria, Belgium, Denmark, Finland, Germany, Greece, Israel, the Netherlands and Spain. 15 Danco Laboratories, the U.S. distributor expected to be selling the pill in that country by the end of 1999. 11 That did not happen; FDA finally approved the pill for U.S. distribution on 2000-SEP-28. It will be distributed under the name "Early Option Pill."

Regulation Difficulties:

In late 1988, Roussel-Uclaf started distribution of the drug in France. But they withdrew it after some of its personnel had received death threats. The French government forced the company to return RU-486 to the market. Claude Evin, the French health minister called "RU-486 the moral property of women, not just the property of the drug company."

Pro-life pressure on the U.S. Food and Drug Administration caused them to ban the importation of RU-486 into the United States until 1993. Boycotts were organized against Roussel-Uclaf, its parent company, and its American affiliates.

A non-profit, New York-based group, Population Council obtained patent rights to the pill in 1994-MAY. A clinical trial was conducted in 1994-5. Following a Food and Drug Administration hearing in 1996, the FDA Advisory Committee recommended that the FDA approved mifepristone in combination with misoprostol as a safe and effective way to end pregnancies up to 7 weeks. The FDA issued an statement in 1996-SEP, stating that mifespristone is safe and effective. However, it asked that the Population Council and its licensee provide additional information.

Under pressure from anti-abortion groups, Hoechst AF of Germany halted distribution everywhere except in England, France and Sweden. In 1997, they stopped production entirely, and gave their rights to a new French company, Exelgyn.

In 1998, Abortion Rights Mobilization manufactured and distributed small test quantities of the drug in the U.S. A spokesperson said "We keep our place secret because of the danger that someone will throw a bomb through the window...It's sad, but that's the way it is."

In 1997-APR, the Canadian rights to distribute the pill were assigned to Exelgyn. The Canadian government does not approve drugs unless they permission is first sought from Health Canada by the manufacturer. This has not happened. However, with the increase in violence against abortion clinics and abortion providers, the provincial government of British Columbia has been pressuring the federal government to approve RU-486 for use in Canada. The federal government responded in early 1998 by sending a letter to Exelgyn, indicating that the political climate in Canada was such that their pill would get a fair hearing. 7

On 1998-JUN-24, the U.S. House passed a bill to bar approval of RU-486 by the Food and Drug Administration. The vote was 223 to 202. Tom Coburn (R-OK) said that if the pill were approved, it would be "killing babies". Also, he said that it would violate the FDA's directive of approving drugs that are "safe and effective." The bill was never signed into law.

The medication is expected to be generally available in the U.S., with the exception of Wal-Mart pharmacies *abo_walm.htm*, by late 2000-OCT. It will be distributed by Danco Laboratories under the name "Mifeprex." It is still undergoing clinical trials in Canada.

Safety

An essay on an unofficial Roman Catholic web site comments: "As far as safety is concerned, complete cardiovascular collapse and death immediately following administration of RU486 has been reported in the European medical literature." 8 This is a true statement; it describes the only fatality that has occurred to a woman taking RU486. However, it does not tell the full story. RU-486 is a safe method to terminate a pregnancy, as long as it is not used on women with any of three contraindications -- a history of:

heavy smoking,

heart problems, or

high blood pressure.

After extensive use in Europe, one fatality occurred to a woman who should never have been given the pill, because all three contraindications applied to her. In addition, an older form of prostaglandin was injected in her case. This is no longer used in France and elsewhere; misoprostol is now used in combination with RU486. One death in 500,000 compares very favorably with the fatality rate if the pregnancies had been allowed continued to term. Trials have been conducted in 20 countries, including France, Germany, the Netherlands, Scandinavian countries, the former Soviet Union, Spain, Switzerland, the UK, and the U.S. The U.S. trial was concluded on 2,100 women who had been pregnant fewer than 7 weeks.

One source 1 compares the safety of various alternatives in North America:

RU-486: 1 death in 200,000 abortions (this number has since grown to 500,000)

Vacuum aspiration abortion: 1 death in 200,000 abortions

Childbirth 1 death in 14,300 pregnancies

Illegal abortions 1 death in 3,000 abortions

How it Works

In the U.S. RU-486 is to be taken within than 49 days after the start of the last menstrual period. It is an antiprogestin. It binds itself to progesterone receptors on the wall of the uterus thus blocking the effect of the woman's natural progesterone. This triggers the shedding of the uterine wall, much like a normal period. RU-486 also opens the cervix, and causes mild contractions which help expel the embryo. The initial dose often causes some nausea, headache, weakness, diarrhea and/or fatigue. It is sometimes taken at home; other times it is taken at a clinic.

One or two days later, the woman takes a prostaglandin pill, typically misoprostol. This causes her cervix to soften and dilate. Contractions of her uterus begin. French studies showed that in 54% of the time, the embryo is expelled within 4 hours. In another 22% of the time, it is expelled within 24 hours. She is observed in a clinic for 4 to 6 hours. The medication causes bleeding and deep cramps. Some days later, she returns again for an examination to confirm that the abortion was complete.

It works about 95% of the time. It is most effective in the first 7 weeks of pregnancy. After 9 weeks, it is less effective and the side-effects are more severe. Bleeding can last up to 9 days (compared with about 5 days for a surgical abortion). Approximately 1% of women will have heavy bleeding which requires additional treatment. The medication totally fails to cause an abortion in about 1% of the women; about 2 to 3% of women experience an incomplete abortion. They require a follow-up surgical abortion. About 0.1 to 0.2% of the women experience excessive bleeding and require a blood transfusion. 10 Four women of the 2,100 who took part in the initial trials lost sufficient blood to require a transfusion. 17

It is not a simple procedure; it has unpleasant side effects. But many women find it more acceptable than an a conventional early-pregnancy elective abortion which involves surgical intervention and perhaps a one day recovery period. In mid-1998-JUL, the Population Council in New York NY released the results of a survey of 2,121 women who had taken RU-486. Half of the women had previously had a surgical abortion. 77% of those women rated RU-486 "more satisfactory." 90% would prefer the pill if they had another abortion and would recommend it to others.

Author S. Boyd cited a report published in the Journal of the American Medical Women's Association. The report listed a number of reasons why many women interviewed from "various races, ethnicities, education levels and socioeconomic backgrounds" preferred RU-486 over a surgical abortion:

It seemed more like a natural miscarriage.

It was helpful to have a partner or friend with them during the abortion; this is not allowed at most abortion clinics.

Medical abortion counselors spend twice as much time with women as do the counselors for surgical abortion, giving women more time to ask questions and further solidify their abortion decision.

One study participant said: "The fact that you insert [misoprostol] yourself is a feeling like ... this is my choice ... my decision. There's so much more power in it." 19

Reaction by Pro-Life Groups:

Pro-life groups and individuals generally believe that life (in the form of an ovum and sperm) become a human person *abo_when.htm* at the instant of conception. Thus, they regard RU486 as a medication that murders a human child. The pill has thus been universally condemned by pro-life groups. Some refer to it as the "French death pill.''

One of the reasons for their strong opposition to RU-486 is that it has the potential to relocate abortion services from the relatively few urban clinics where the procedure is now conducted. It could become available in untold thousands of doctor's offices. Rural residents could have convenient access to abortions for the first time. Pro-life groups would no longer be able to picket locations where abortions were performed.

An editorial in the Vatican newspaper, which is thought to reflect the beliefs of Pope John Paul II, referred to RU-486 as the "pill of Cain: the monster that cynically kills its brothers.''

The Family Research Council described the clinical trials of RU-486 as "experimenting on 2100 pregnant American women." The New Jersey Right to Life organization publishes an essay on their web site 2 which says, in part: "For the most part, RU-486 is a relatively untested drug...To support the drug in this country would be irresponsible on our part. The US public does not favor most abortions and they support the harmful physical and emotional effects of the RU-486 drug even less." [Author's note: It is difficult to support these assertions. This pill has been previously tested extensively in Europe. It has been routinely used in France and China since 1989, and in the UK and Sweden since the early 1990's.]

Judy Brown, spokesperson for the American Life League in Stafford, VA commented "It is a clinical study that is testing a chemical to destroy a child in the womb. This should be astounding to people and society - that we are willing to test a pill to kill children." 3

Christopher Slattery, of the Legal Center for the Defense of Life in New York NY commented: "There's a chance women will see this as an easier, less expensive, and less physically traumatic abortion, and may be attracted to it...I'm worried that we're going to turn more health-care practitioners into killers...Any time you turn the heart and soul of an individual, it's hard to get them back. They're doing the Devil's work, and it's going to be hard to win them to the cause of life.''

Martha Kleder, staff writer for Focus on the Family wrote an essay about RU-486 in early 2000-JAN at the time that Rhode Island became the final state to approve the use of prescription drugs for abortion. She quoted some pro-life leaders:

Rev. Joseph Howard, of the American Bioethics Advisory Commission who said: "What they essentially do is they prevent progesterone from binding and starve the fetus to death, because it cannot live without an adequate level of progesterone." [Author's note: Actually, regulations require that RU-486 only be taken up to about 5 weeks after conception, at a time when the products of conception are called an embryo, not a fetus. Howard's description is somewhat deceptive. The phrase "starve the fetus to death" would imply to many readers that the embryo would suffer pain as it experienced a lingering, agonizing death. This is not true. An embryo has no sensory organs, no developed brain and is unable to feel hunger or any other form of pain *abo_pain.htm*.]

Steve Sanborn, spokesperson for the American Life League was critical of RU-486. He said: "Oftentimes, women will be expelling their own children in their own living room or their own bathroom and sitting there faced with that baby. I can't imagine what kind of 'convenience' that's going to be for them."

Reaction by Pro-Choice groups:

These groups appear to be heavily in favor of the widespread use of RU-486:

Abortions with a RU-486/misoprostol can be done very soon after conception. The embryo can be removed before it develops any human features. But woman has to wait before having a conventional surgical abortion until about 6 or 7 weeks gestation. By that time, the embryo has almost lost its tail. The face is mammalian but somewhat pig-like. By 8 weeks, the embryo's face resembles that of a primate but is not fully human in appearance. 4

RU-486 would be of particular benefit in developing countries, where a lack of physician and clinics makes a conventional abortion dangerous. "The National Academy of Sciences estimates that 20 million abortions are performed illegally or unsafely each year worldwide, causing 100,000 or more deaths." Many of those lives could be saved with RU-486, because it normally requires no surgery. 5

In North America, it would make abortion much more private; it would become an arrangement between a woman and her personal doctor. Rural women could obtain abortions from their physician instead of traveling long distances to and from an urban clinic.

Many women consider a medical abortion to be far less invasive than a surgical abortion. "Studies showed that many women preferred it over other methods." 5

Recent developments:

1999-JUL-7, Europe: The German government has ended the ban on the sale of RU-486 in that country. Under European Union regulations, they would have had to present reasons to maintain the ban; they could find none. This action was an election promise of the current government which replaced the Christian Democrat party in 1998-SEP. Roman Catholic Archbishop Joachim Meisner of Cologne said that the decision was illegal. He called RU-486 a "murder pill." 9 Robert Sassone, director of the World Life League commented: "Those who kill via RU-486 treat humans not yet born as non-persons. The chemical means of killing these babies is disquietingly similar to the mode of killing with the gases used by the Nazis." Seven other European countries also legalized RU-486.

1999-AUG-25: Switzerland: A pro-life group in Switzerland, Swiss Aid for Mother and Child (ASME) has appealed to a Swiss court to overrule the decision of the Inter-Cantonal Office for Control of Medicines (OICM), and thus prevent the introduction of RU-486 to that country.

2000-FEB-14: USA Pro-life activity: Focus on the Family, a Fundamentalist Christian organization, predicted that RU-486 would be available by prescription as early as 2000-APR. They are concerned that many physicians who had not done surgical abortions in the past will now prescribe RU-486. "Focus" reports that: "As the FDA finalizes protocols for dispensing the drug, pro-life advocates are appealing to public outrage and for prompt recall by Congress." 14

2000-APR-2: USA Poll: The Gallup Organization completed a public opinion survey on RU-486. The question was: "Would you, personally, favor or oppose making RU-486 -- an abortion pill -- available in the United States as a prescription drug?" The result was: 39% favored the availability of the pill; 47% were opposed. This is a reduction in support since their 1996-JUL survey, when the results were 43% favor and 44% opposed. The same question was asked both times. 20

2000-JUN-12: USA: RU-486 regulations: According to Family News in Focus, and EWTN News, the Food and Drug Administration is considering regulations that would require Doctors prescribing RU-486 to:

Be part of a national registry.

Be trained in providing surgical abortions.

Have admitting privileges at a hospital within a one-hour trip of their offices. 16

Perform follow-up studies on their patients.

2000-JUN-27: Canada: Clinical trials of RU-486 began on JUN-27 in Vancouver, and were scheduled to begin about JUL-10 in Toronto. Trials will also be held in two other provinces. Possibly in reaction to these trials, Dr. Garson Romalis was stabbed in the back near his office on JUL-11. He is the same abortion provider who survived an assassination attempt in 1994 when an anti-abortion terrorist shot him in the leg. This time, Dr. Romalis' injuries are not life threatening. A spokesperson from the B.C. Pro-life Society disassociated her organization from this act of violence. A spokesperson for the Pro-Choice Action Network expressed frustration at the level of violence that abortion providers must live with. One day later, the physician who is conducting the RU-486 trials in Vancouver received a death threat. On JUL-13, the Vancouver Police received a phone call from a terrorist allegedly representing the Baby Liberation Army. He warned abortion providers to watch their back -- an apparent reference to the stabbing of Dr. Romalis.

2000-JUL-13: USA Congressional action: A bill to prevent the Food and Drug Administration from developing, testing or approving RU-486 failed in the House of Representatives by a vote of 182 to 187. The vote may have been distorted by the absence of about 60 members of congress whose return to Washington was delayed by storms in the Midwest. According to its sponsor, Rep. Tom Coburn (OK-R), the bill would "limit the expenditure of federal funds by the Food and Drug Administration in their efforts to approve drugs whose sole purpose is to terminate life." Scott Weinberg, spokesperson for the American Life League commented: "It was a good amendment, and it just shows you the state of the nation. We have the FDA involved in abortion providing. We have the Supreme Court effectively legalizing infanticide. I mean, for crying out loud, what is going on in America?."

2000-SEP-28: USA: RU-486 approval: FDA gave its approval to RU-486. It will be called the "Early Option Pill." Distribution should begin by the end of 2000-OCT. Due to concern about anti-abortion violence, the FDA has increased security in some of its offices. The names of the medical officers who reviewed the drug are being kept secret. The FDA has passed a number of regulations concerning this drug:

They require that each woman who will be given Mifepristone will receive a "MedGuide" brochure. It will explain eligibility requirements, and the probable side effects. It will also stress that she must make three trips to the doctor during the procedure.

It will only be available from physicians who are trained to determine the duration of pregnancy accurately, and to detect ectopic (tubal) pregnancies.

A doctor who prescribes the medication who are qualified to perform a surgical abortion if needed, or who have made prior arrangements for a competent surgeon to provide an abortion.

Reactions were not long in coming:

Judie Brown of the American Life League said: "We will not tolerate the FDA’s decision to approve the destruction of innocent human persons through chemical abortion."

Dr. Stanley Henshaw, a senior fellow at the Alan Guttmacher Institute, commented: "I think it will be a great benefit to women." He estimates that the 90% of women who live outside of major cities and had no close access to abortion services will be able to use this pill.

Dr. Benson Harer, Jr., of the Riverside County Regional Medical Center in Moreno, CA said: "We’re very happy about it. It’s probably long overdue. I think it will greatly expand the ability of women to have abortions without having to travel great distances." 17

Former presidential candidate Gary Bauer said that the approval is "a payoff by the Clinton administration to the abortion radicals."

Ann Stone of Republicans for Choice favored the ruling; she said: "It’s about time. I’m celebrating." 18

NARAL President Kate Michelman said: Mifepristone's approval is one of the most significant advances in women's reproductive health that we have seen in decades. Its approval today is yet another milestone on the long road to women's reproductive freedom and equality in this country...The FDA's action today opens doors long closed to American women, but the benefits of mifepristone will reach far beyond the realm of reproductive freedom and choice. The potential mifepristone holds for the treatment and possible eradication of numerous diseases could mean an end to the suffering of millions of Americans.. George W. Bush has...stated his opposition to mifepristone and has said he would be 'inclined not to accept' the FDA's ruling if it approved the drug. Al Gore supports the approval of mifepristone."

2000-OCT-5: Philippines: According to CWNews: The Philippine Daily Inquirer reported that "Health Secretary Alberto Romualdez was quoted earlier as saying that RU-486 is not an abortive drug....He was reported as saying that if the drug's manufacturer filed for registration with the Bureau of Food and Drugs, the application would be treated like any other and would not be blocked." Msgr. Pedro Quitorio, spokesperson for the Philippine [Roman Catholic] Bishops' Conference, noted that anyone taking RU-486 is automatically excommunicated. "Ipso facto excommunication. It does not have to be announced anymore. It is automatic."

2000-OCT-9: USA: Federal bill to restrict RU-486: Representative Tom Coburn (R-OK) has introduced a bill, the "RU-486 Patient Health and Safety Act" which would set into law some of the FDA's regulations. A similar bill is being introduced into the Senate by Tim Hutchinson (R-AR). The bill appears to be based on some inaccurate beliefs about RU-486: that the second, prostaglandin, pill is caustic, that it causes serious birth defects, and that the complication rate of RU-486 is 5%. 21

2000-OCT-13: USA: Pro-life groups object to country of origin of RU-486: According to Catholic World News Briefs on this date, some U.S. pro-life groups are concerned that Mifeprex will be manufactured in China. In an apparent reference to China's forced abortion policy, Judie Brown, president of American Life League commented: "The Clinton Administration has teamed up with the world's most infamous baby-killer -- Communist China -- to produce the abortion chemical, RU-486," said "No wonder the FDA tried to keep secret the source of these baby-destroying chemicals." [Author's note: Actually, it was Danco Laboratories who negotiated the contract with a Chinese pharmaceutical company. No North American company would agree to manufacture Mifeprex, fearing terrorist attacks on their facilities by anti-abortion activists, boycotts of all of their products by pro-life groups, and lawsuits.]

What will happen now?

Nobody knows, for certain, what changes will happen to abortion provision in the U.S. Some indication can be obtained from experience in other countries:

Total number of abortions: The total in France, Sweden and the UK did not increase when RU-486 was introduced. Some women simply switched methods from a surgical abortion to this pill.

Convenience: Women who live in rural areas will be able to obtain abortions much more easily.

How often used: About 20% of abortions in France are induced with this pill; the rates are 17% in Sweden and 6% in England. The National Abortion Federation estimates that two-thirds of abortion providers expect to use the drug. 17 With the high level of violence and threatened violence at abortion clinics, many women in the U.S. might try to obtain Mifepristone from their family doctors rather than seek a surgical abortion.

Presidential election: Approval happened only a few weeks before the presidential elections. There is some speculation about the effect that the decision will have on the campaign. Al Gore was pleased with the drug's approval: "I think the majority, the overwhelming majority, of the American people will support it." He added that if Republicans try to ban RU-486, "it will be an issue. I strongly support a woman’s right to choose; my opponent wants to take that away, he’s made that clear." George W. Bush disagreed: "I think the FDA’s decision to approve the abortion pill RU-486 is wrong. People on both sides of the abortion issue can agree that we should do everything we can to reduce the number of abortions, and I fear that making this abortion pill widespread will make abortions more and more common, rather than more and more rare."

References:

Childbirth by Choice Trust has a very complete and balanced article on U-486 at: *http://web.idirect.com/~cbctrust/RU486.96.html*

Steve Ertelt, "The Dangers of RU-486," available at: *http://www.prolife.org/ultimate/upl5.html*

L.M.Krieger "RU-486 abortion pill still not widely available in the U.S." San Francisco Examiner, 1998-JAN-27

Stages of Fetal Development *abo_fetu.htm*, an essay on this Web site.

Aaron Zitner, "The RU-486 Saga," The Boston Globe, 1997-NOV-23

Ted Gerk "The RU-486 Files" at *http://www.ru486.org/* has many hyperlinks to articles and reports on RU-486

Anne McIlroy, "Canada approaches abortion-pill maker," The Globe and Mail, 1999-MAR-12, P. A10.

Brian Kopp, "Anti-Catholicism: Politically Correct bigotry of the 1990's," Yellowstone Information Services at: *http://www.yellowstoneinfo.com/*

"Germany clears ban on abortion pill," Charisma News Service, reprinted by Maranatha Christian Journal at: *http://www.mcjonline.com/news/news3219.htm*

Tom Carney, "'Abortion pill' test goes awry for one patient," Des Moines Register, 1995-SEP-21. Online at: *http://www.ru486.org/ru3.htm*

"Pros and cons of abortion pill," Toronto Daily Star, 1999-JUL-19.

Martha Lkeder, "RU-486 to affect abortion debate," at: *http://www.family.org/cforum/fnif/news/a0009130.html*

Carl Sagan, "Billions and Billions", Random House, New York NY (1997), Pages 163-179

Dave Clark, "RU-486: A bitter pill," Focus on the Family, at: *http://www.family.org/cforum/fnif/news/a0009682.html*

Letter to this website from the Population Council, 2000-MAY-25. Their web site is at: *http://www.popcouncil.org*

Dave Clark, "FDA could offer RU-486 restrictions," Focus on the Family, at:*http://www.family.org/cforum/fnif/news/A0011782.html*

"FDA approves abortion pill in United States," MSNBC, 2000-SEP-28, at: *http://www.msnbc.com/news/467301.asp*

Tom Curry, "FDA decision has political impact," *http://www.msnbc.com/news/469014.asp*

S. Boyd, "Give us liberty: The approval of RU-486 isn't about morals, it's about optons," Salon.com at: *http://www.salon.com/mwt/feature/2000/09/18/medical_abortion/index.html* (This may be a temporary posting)

"Abortion Issues," Gallup Organization, at: *http://www.gallup.com/poll/indicators/indabortion.asp*

Martha Lkeder, "Lawmakers try to protect women from RU-486," Focus on the Family, at: *http://www.family.org/cforum/fnif/news/A0013218.html*

Word Count: 4298

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