Contents: The Hippocratic Oath Basic Press Release Catholic News Press Release



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RU-486


CONTENTS:

  1. The Hippocratic Oath

  2. Basic Press Release

  3. Catholic News Press Release

  4. Candidates Comments

  5. History of RU-486 in the U.S.



  1. The Hippocratic Oath

I SWEAR by Apollo the physician, and Aesculapius, and Health, and All-heal, and all the gods and goddesses, that, according to my ability and judgment, I will keep this Oath and this stipulation to reckon him who taught me this Art equally dear to me as my parents, to share my substance with him, and relieve his necessities if required; to look upon his offspring in the same footing as my own brothers, and to teach them this art, if they shall wish to learn it, without fee or stipulation; and that by precept, lecture, and every other mode of instruction, I will impart a knowledge of the Art to my own sons, and those of my teachers, and to disciples bound by a stipulation and oath according to the law of medicine, but to none others. I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to any one if asked, nor suggest any such counsel; and in like manner I will not give to a woman a pessary to produce abortion. With purity and with holiness I will pass my life and practice my Art. I will not cut persons laboring under the stone, but will leave this to be done by men who are practitioners of this work. Into whatever houses I enter, I will go into them for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption; and, further from the seduction of females or males, of freemen and slaves. Whatever, in connection with my professional practice or not, in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret. While I continue to keep this Oath unviolated, may it be granted to me to enjoy life and the practice of the art, respected by all men, in all times! But should I trespass and violate this Oath, may the reverse be my lot!




  1. Press Release, Courtesy of Reuters

By Lisa Richwine

WASHINGTON, Sept 28 (Reuters) - U.S. health officials on Thursday approved a pill that causes an abortion early in pregnancy, clearing the way for its sale after 12 years of political battles and delays that kept it off the U.S. market.

In a move hailed by abortion rights groups as "the beginning of a new era" that might increase privacy and boost access to abortion, the Food and Drug Administration cleared the pill, known as RU-486, or mifepristone. The drug debuted in France in 1988, but abortion opponents fought its entry into the United States.

The pill will be sold under the brand name Mifeprex by Danco Laboratories, a private firm set up to distribute and market the product. Fears of anti-abortion violence and boycotts kept big drug makers from pursuing the pill. The identity of the current manufacturer has been kept secret.

Mifepristone should be available in about one month, Danco's medical director, Dr. Richard Hausknecht, said.

"This important step will have ever-lasting and important benefits," Hausknecht said at a news conference. The company has not announced a price for mifepristone.

Opponents said they would work to discourage use of the drug, and the decision split the presidential candidates, with Democrat Al Gore approving and Republican George W. Bush calling the decision "wrong."

DRUG BLOCKS HORMONE



Mifepristone causes an abortion by blocking a hormone needed to sustain pregnancy. Under the regimen approved by the U.S. Food and Drug Administration, mifepristone would be given within 49 days of a woman's last menstrual period and be followed two days later by misoprostol, a drug that causes uterine contractions.

Women need to return for an exam two weeks later to find out whether the pregnancy has been terminated. The drug combination works in about 95 percent of cases without surgery. Most patients will have some side effects, such as cramping or bleeding.

While disapproving of the decision, Bush did not say he would ban the pill if he became president. His father, President George Bush, forbade the import of the pill in 1989.

"I fear that making this abortion pill widespread will make abortions more and more common, rather than more and more rare. As president, I will work to build a culture that respects life," Bush said in a statement.

Bush's Democratic rival, Vice President Al Gore, said he was pleased with the action.

"Today's decision is not about politics but the health and safety of American women and a woman's fundamental right to choose," Gore said in a statement.

CLEARANCE TOOK FOUR YEARS

The clearance, more than four years after the initial application for approval, came after a careful review of clinical trials in the United States and France as well as scrutiny of the manufacturer, FDA Commissioner Jane Henney said in an interview.

"The decision was not difficult to make when you look at the science," Henney said.

Women who receive the drug will be given a pamphlet that explains how to use it and cautions about possible side effects. About 1 percent of patients in clinical trials had bleeding so severe they needed surgery, the FDA said.

Abortion rights groups cheered the news. The final approval was a "total victory for U.S. women," Eleanor Smeal, president of the Feminist Majority Foundation, said. "At long last, science trumps anti-abortion politics," she added.



Gloria Feldt, president of Planned Parenthood, said mifepristone's U.S. arrival marked the "beginning of a new era" in which women and doctors might have more privacy from protesters and access to abortion might widen.

President Bill Clinton, speaking to reporters before a Cabinet meeting, also said the decision was a medical and not political one. Clinton had ordered the FDA to promote the study and licensing of the drug in 1993.

EXPERTS WANTED TO BE SURE

"It ought to be treated as the scientific and medical decision it was. ... They took so long to try to make sure they were making a good decision," Clinton said.

Abortion opponents denounced the approval.

"The Clinton-Gore administration, which claimed it wanted to make abortion rare, has embraced an abortion pill that will result in more abortions and new risks to women," said Laura Echevarria, a spokeswoman for the National Right to Life Committee.

Others said the public had a right to know where the pill was being made and whether a report that the manufacturer was in China was true.

About 1 million women undergo surgical abortions in the United States each year.

Passion against abortion is so high that clinics have been bombed, and doctors and clinic workers have been harassed and killed by the movement's radical elements. Concerned about possible retaliation, the FDA was keeping the names of the scientists who reviewed the drug secret, Henney said.

PEACEFUL OPPOSITION PLANNED

Groups that oppose abortion said they planned to use peaceful means to discourage the pill's use, including highlighting possible side effects.

Under FDA rules, prescribers must be prepared to provide or refer women to surgical procedures in cases of severe bleeding or an incomplete abortion.

The final approval comes after years of obstacles.

French maker Roussel-Uclaf donated U.S. rights in 1994 to the Population Council, a New York-based nonprofit group that funded clinical trials of the drug.

The FDA deemed mifepristone safe and effective in 1996. But the group still had to work out manufacturing and distribution issues before mifepristone could hit the market.

The drug's approval follows by two years that of the "morning-after pill," a high dose of birth control pills that can prevent pregnancy when taken up to 72 hours after sex.




  1. Press Release, Courtesy of Zenit (Catholic News)

U.S. AGENCY APPROVES SALE OF ABORTION PILL

RU-486 Likely Made in China, Reports Say

WASHINGTON, SEPT. 28, 2000 (ZENIT.org). - The federal Food and Drug

Administration announced today it had approved marketing of the RU-486

abortion pill in the United States.

"The Clinton-Gore administration, which claimed it wanted to make abortion

rare, has embraced an abortion pill that will result in more abortions and



new risks to women," commented Laura Echevarria, spokeswoman for the

National Right to Life Committee. It appears from published reports that

the drug will be imported from the People's Republic of China.

Echevarria noted the widely broadcast "inaccurate references to RU-486 as a

'morning-after pill' or as a drug that causes expulsion of a 'fertilized

egg.'" "In reality," she said, "this method involves administration of two



potent drugs, and frequently produces profuse bleeding, in order to kill a

human embryo who is 2 to 5 weeks old."The U.S. patent holder, the

Population Council, and its for-profit Danco Laboratories will step up a

marketing and public-relations campaign "aimed at swiftly building market

share," according to a revealing report that appeared in the Sept. 5 Wall

Street Journal.
4. Bush, Clinton and Gore Comments, Courtesy of Bloomberg
Washington, Sept. 28 -- The following are comments by Republican presidential candidate George W. Bush, his Democratic rival, Vice President Al Gore, and President Bill Clinton on the U.S. Food and Drug Administration's approval of mifepristone, the abortion pill known as RU-486, after a seven- year effort by the Clinton administration and women's groups to bring the drug to the U.S. The drug will be sold to prescribing physicians, not pharmacies, by the closely held Danco Group.

Bush:

``I think the FDA's decision to approve the abortion pill RU- 486 is wrong,'' the Texas governor said in a statement. ``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. As president, I will work to build a culture that respects life.''



Gore:

``I think it's up to the woman,'' Gore said in an appearance on ''Larry King Live'' on CNN. ``I support the FDA's approval, assuming it's safe for the woman, and that's what they decided today.''



Clinton:

``This administration treated that issue as purely one of science and medicine,'' Clinton told reporters at the White House. ``And the decision to be made under our law is whether the drug should be approved by the FDA on grounds of safety. And I think that they have bent over backwards to do a lot of serious inquiries.''

``The FDA is basically doing its job. It's now done its job. And I regret that some members of the other party apparently have already tried to politicize it.''

Clinton added that Dr. Bernadine Healy, who was the National Institutes of Health director under Bush's father, President George H.W. Bush, ``said that she agreed with the decision of the FDA.''

``It ought to be treated as the scientific and medical decision it was, and we should respect the fact that it was a nonpolitical inquiry and that they took so long to try to make sure they were making a good decision,'' Clinton said.

Sep/28/2000 22:13 ET

Copyright 2000 Bloomberg L.P.


  1. History of RU-486 (From WebMD)

Brief History of the Abortion Pill in the U.S.

A Long, Bumpy Road to Approval

By Denise Mann
WebMD Medical News


Reviewed by Dr. Pamela R. Yoder

To illustrate the long, embattled road toward approval, WebMD has put together a time line of the milestones and roadblocks in the fight to approve RU-486, both here and abroad:



  • 1980 -- Researchers at Roussel-Uclaf, a French pharmaceutical company, develop mifepristone (RU-486).

  • 1983 -- The FDA issues a testing permit to the Population Council, a nonprofit group, to conduct trials of mifepristone as an early abortion method.

  • 1988 -- RU-486 is approved in France, but distribution is halted in response to protests. The French Minister of Health intervenes and orders the company to return the drug to the market. Anti-abortion rights groups then threaten to boycott Hoechst A.G. (Rousell-Uclaf's parent company).

  • 1989 -- In response to pressure from the Bush Administration and others, the FDA bans the importation of RU-486 for personal use. Hoechst says it won't market or distribute the drug outside of France to appease groups against abortion rights.

  • 1990 -- Leading scientists testify before Congress that the FDA import ban has hindered research on the broad medical benefits of RU-486, including treatment for some cancers, HIV, and uterine tumors, and for inducing labor.

  • July 1992 -- An American woman named Leona Benten issues the first direct challenge to the FDA import ban when U.S. Customs seizes the drug from her as she returns from Europe. However the U.S. Supreme Court refuses to hear her case or order the FDA to overturn the ban.

  • Jan. 1993 -- President Clinton asks the FDA to re-examine its import ban.

  • Sept. 1993 -- The Institute of Medicine suggests that an expedited new drug application be submitted to the FDA for the use of RU-486 as a method of early abortion.

  • 1994-1995 -- Roussel-Uclaf gives the Population Council the U.S. patent rights for RU-486. Clinical trials involving 2,100 women begin.

  • March 1996 -- The Population Council submits a drug application to the FDA for RU-486 as an early abortion method.

  • July 1996 -- An advisory arm of the FDA recommends approval of RU-486 as a safe and effective early nonsurgical method of abortion.

  • Sept. 1996 -- The FDA issues an "approvable letter" for RU-486 for early abortion, when used with misoprostol, a drug that causes uterine contractions to expel the embryo. The letter states that the two-drug combination is safe and effective when used under close medical supervision but notes that additional information is needed on the manufacturing process and labeling before a final decision is made.

  • Feb. 1997 -- A major roadblock: The European manufacturer responsible for producing RU-486 in the U.S. cancels its contract with the Population Council -- delaying the drug's introduction in the U.S. indefinitely.

  • April 1997 -- A study in The New England Journal of Medicine shows that RU-486, when used in combination with a type of drug called a prostaglandin (misoprostol), medically terminates 92% of pregnancies when taken within 49 days of conception.

  • June 1998 -- An amendment to a bill is passed that bans the FDA from using funds to test, develop, or approve any abortion drug.

  • Sept. 1998 -- The Clinton administration opposes the amendment.

  • Oct. 1998 -- The ban is deleted from the bill.

  • Feb. 2000 -- The FDA postpones approval of RU-486 until certain questions about the manufacturing and distribution of the drug are answered.

  • Sept. 28, 2000 -- RU-486 is approved by FDA as a method of early medical abortion


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