FDA Advisory Committee Member Backs Review of RU 486 Abortion Drug
by Paul Nowak
LifeNews.com Staff Writer
December 3, 2003
Washington, DC (LifeNews.com) — Dr. W. David Hager, a member of the FDA Advisory Committee For Reproductive Health Drugs, has endorsed a review of the abortion drug that resulted in the death of California teenager Holly Patterson.
Hager discussed the drug and Patterson’s death in an interview with LifeNews.com.
"I obviously feel that the drug should be reviewed," Dr. Hager, a doctor and professor of obstetrics and gynecology at the University of Kentucky, said.
Earlier this month a spokesman for the FDA said it was "aggressively investigating" Patterson’s death.
In addition, the FDA and Danco Pharmaceuticals, the distributor of the drug, are considering and must respond to a citizen’s petition filed last year by The American Association of Pro-Life Obstetricians and Gynecologists, The Christian Medical Association, and Concerned Women for America.
Their petition encourages Mifeprex to be withdrawn from the market until adequate analysis of its safety is completed.
According to Dr. Hager, a response has not yet been received regarding the petition. He supports the idea of a review of the abortion drug and assisted in the preparation of the petition.
"If the petition is not the stimulus then I would support legislation that accomplishes the same," Hager said.
Hager expressed his views as a physician on the abortion drug mifepristone, commonly known as RU-486.
"Mifepristone is one of two medications in the regimen marketed as Mifeprex which also includes the drug misoprostol," explained Dr. Hager. "Mifepristone is an anti-progesterone which acts at the level of the lining of the uterus to interfere with normal blood supply to the implanted infant/placenta and kill the baby. Misoprostol then acts to stimulate uterine contractions to cause the dead baby and placenta to be expelled from the mother’s body via the vagina."
Holly Patterson, the 19-year-old who was given mifepristone by a Planned Parenthood office in California and died from complications, didn’t use the second drug. She was too sick to complete the procedure by taking misoprostol, Hager said.
According to the autopsy report, Patterson died of sepsis. Dr. Hager explained how mifepristone was involved and said the abortion drug indirectly caused her death.
"Sepsis means the dissemination of infection through the blood stream," Hager told LifeNews.com. "Bacteria spread from [the uterus] into the veins and lymphatics to other parts of her body."
"When a person becomes infected in this way, antibiotics may stop the process if the diagnosis is made early enough and the right antibiotics are administered," Hager explained. "Holly was so sick when she arrived at the hospital that she could not be saved. Thus, although sepsis was the direct cause of her death, mifepristone was the indirect cause."
Monty Patterson, Holly’s father, also agrees that the FDA should re-examine the safety of the abortion pill, and said he and his wife feel an obligation to inform other young women of the "grave dangers" of the drug.
They have openly endorsed federal legislation that would suspend the FDA’s approval of the drug pending a Congressional review.
While Patterson met the FDA guidelines for the gestational age at which the drug could be administered, Planned Parenthood officials admitted that they did not follow the guidelines on how it should be administered. Despite the confession, they were not apologetic, and said the regulations were more restrictive then necessary.
"The FDA put those restrictions on how it should be used because they concluded that was the safest way for women to use it," said Wendy Wright, senior policy director for Concerned Women for America. "The fact that it’s being used differently is very worrisome."
According to a report from the Washington Post, though the FDA says it doesn’t condone the misuse of the abortion drug, it says state agencies are responsible for overseeing any derivations from the guidelines.
Though dangerous, the drug remains popular.
Danco Laboratories, the manufacturer and distributor of mifepristone, said sales of the drug increased by 43 percent in fiscal 2003 over the year before. In Europe, the drug is responsible for 15 to 30 percent of all abortions, though that level hasn’t been reached here.