FDA Faces Questions Over RU-486 Deaths

WASHINGTON — Two more women have died after undergoing chemically induced abortions, bringing the total number of deaths in North America to seven. This recent news has prompted an official from the U.S. Conference of Catholic Bishops to call once again for the passage of the RU-486 Suspension and Review Act (also known as Holly’s Law in memory of one of the women who passed away).

“How many more healthy women must die before the agency takes a close second look at RU-486?” Deirdre McQuade, director of planning and information at the Pro-Life Secretariat, said.

Holly’s Law, introduced by Sen. Jim DeMint, R-S.C., calls for the Government Accountability Office to review the FDA’s original approval process of mifepristone (Mifeprex), one of two drugs used in a chemically induced abortion. When the drug was approved in 2000, it was fast-tracked under a special provision of the Federal Food, Drug and Cosmetic Act, intended to be used only for medications that treat life-threatening illnesses.

“When the Clinton administration rushed RU-486 to the market in the waning days of its tenure, many medical professionals expressed alarm about the FDA’s corner-cutting and lax safety standards for RU-486,” DeMint said. “Tragically, those concerns have been proven to be well founded.”

Mifepristone, produced by Danco Laboratories, is administered up to 49 days after conception. It blocks the production of progesterone, a hormone needed to maintain a pregnancy, Dr. Kathleen Raviele, vice president of the Catholic Medical Association, said. The woman takes a second drug, misoprostol, a few days later to cause contractions that expel the unborn child.

In the previously reported fatalities, four of the women died of a severe infection (sepsis) and tested positive for the bacteria Clostridium sordellii. Symptoms included nausea, vomiting, diarrhea and abdominal pain, which are all also side effects of the abortion drugs. “When a woman calls the clinic or a doctor, she may be dismissed as having symptoms from the drugs or the abortion,” Raviele said.

The FDA has not yet confirmed whether the two most recent deaths also were a result of sepsis, but did issue a health advisory on March 17 warning of the risk and instructing physicians to treat symptomatic patients with the proper antibiotics. They also asked that misoprostol be given orally instead of vaginally, which is how it was administered to the four deceased women. RU-486 does carry a “black-box” warning, McQuade said, adding, however, that the FDA’s overall reaction has been “weak.”

“Put yourself in the position of a woman desperate enough to be seeking an abortion. Most women are not going to stop and read all of the side effects,” she said.

What ‘Treatment?’

Upon hearing of the most recent deaths, Planned Parenthood released an open letter to clients. “If you are a woman undergoing mifepristone medication abortion at a Planned Parenthood health center, you should attend scheduled follow-up appointments and contact us at any time with questions and concerns,” Dr. Vanessa Cullins, Planned Parenthood vice president of medical affairs, wrote, adding that none of the fatalities has been directly attributed to the drug.

Planned Parenthood denied a request from the Register for an interview.

McQuade reacted to the phrase “medication abortion.”

“Medication makes it sound like aspirin or Tylenol. They call it a treatment. For what? Is pregnancy a disease?” she said, questioning also whether many women return to their abortion provider as instructed. “Many women don’t want to go back to where they got their abortion pills. Follow-up care is on the shoulders of women going through a tough time,” McQuade said.

The burden of the abortion itself also is shifted to women.

“The woman is aborting herself. She is putting the pills in her mouth. This is very different from thinking this is a medical procedure that the doctor is doing to me. … The child is no better than trash and [often] goes down the toilet, which will really have a profound effect on the woman doing this,” Raviele said.

Abortionists have realized that surgical abortions also “affect staff more profoundly than was anticipated,” said Father Frank Pavone, director of Priests for Life, adding that fewer and fewer abortionists want to perform the procedure. “Hence the drive for more personal and private means to get children out of the way,” he said.

The FDA will co-sponsor a workshop in May designed to discuss Clostridial disease, including the infection that followed the mifepristone abortions.

Meanwhile, the FDA is waiting for congressional confirmation of Andrew von Eschenbach as commissioner. His nomination sparked new controversy over a separate drug, known commonly as the “morning-after” pill, emergency contraception or Plan B, because it is taken shortly after having “unprotected sex.”

Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., have said they will block the nomination process until the FDA issues a decision as to whether Plan B can be offered over the counter. “For more than two years, the FDA has dragged its feet on making a decision, putting ideology over science,” they said in a joint statement.

Reacting to the news, Father Pavone said that science exists to serve humanity and cannot be separated from moral considerations.

“To invoke science to justify threats to human life is to turn the purpose of science upside down,” he said, adding that a nomination process should be held “hostage” only if a fundamental human right is threatened. “It is not a fundamental human right to have the ‘morning-after’ pill sold over the counter. On the other hand, the right to life is a fundamental human right.”

In addition, studies have shown the availability of drugs over the counter can lead to a increased risk of sexually transmitted diseases, Raviele added. There is the added factor that women could be taking the ‘morning-after’ pill multiple times. “We don’t know the long-term effects of taking it repeatedly.”

Monta Hernon is based in

La Grange Park, Illinois.

Abortion Pill at a Glance

— RU-486 was developed by French pharmaceutical company Rousel-Uclaf in 1980 and approved in that country in 1988. It prevents the fertilized egg from clinging to the uterine wall. A prostaglandin is used 48 hours later to set off contractions that expel the embryo.

— The drug combination was approved by the Clinton-era FDA in September 2000 and has been marketed in the U.S. under the names Mifeprex and Early Option by U.S. manufacturer Danco Laboratories.

— There have been several U.S. deaths related to use of the drugs, notably that of Holly Patterson, an 18-year-old from California who died in 2003.

— Deirdre McQuade of the United States Conference of Catholic Bishops called again in March for Congress to suspend the FDA’s approval of the drug.