OTTAWA — Results are starting to come in on the use of the RU-486 abortion pill, and they didn't look good.
The Canadian government refused in May to publicly disclose results from its investigation of a woman who died during a trial of the abortion drug RU-486 in 2001.
After the woman died on Sept. 1, 2001, an initial report blamed a rare infection, not the drug. The Vancouver abortionist who gave the woman the drugs, Ellen Wiebe, was sent results from a new investigation, but the information was not released to the public.
Meanwhile, women who take it continue to report pain and suffering.
After taking RU-486 last year, a Los Angeles County woman lapsed into unconsciousness and was hospitalized.
The woman, 34-year-old Danlin Tang, and her husband, Alfred, are suing Family Planning Associates Medical Group and Dr. Soon Chon Sohn, both of Los Angeles County, and a number of unnamed clinic workers alleging they were professionally negligent. They say she suffered from septic shock, massive blood loss, severe anemia, acute respiratory failure and infection.
Tang went for an abortion at the clinic on May 28, 2002, according to her attorney, Michael Saint-George of the David R. Denis law firm. She was briefly examined and given the first part of RU-486 — a two-part drug regimen that aborts babies in the first seven weeks of pregnancy. A clinic staff member then allegedly spoke on the telephone to Tang's friend, who acted as a translator to explain to Tang, in Cantonese, how to self-administer the second part of the drug combination vaginally at home the following day.
Four hours after taking the second part of the drug mixture the next afternoon, Saint-George said, Tang began to bleed profusely.
“They gave her an instruction sheet to take home, which said to call if she bled in excess of soaking one large maxi pad.” When her friend called the clinic later, “definitely she was bleeding in excess of that amount,” Saint-George said.
But clinic staff said the bleeding was normal for the procedure. And on May 30, when Tang continued to bleed and began vomiting and losing consciousness, the family members called the clinic repeatedly.
“They were told again that the loss of blood was a normal reaction and there was no need to bring her in,” Saint-George said. “They said to put a damp towel on her forehead.”
On the afternoon of June 3, when Tang was unconscious and unresponsive, she was taken to Garfield Medical Center where, the lawsuit alleges, she was treated for septic shock, massive blood loss, severe anemia and respiratory failure. According to Saint-George, she required a transfusion and emergency surgery and her condition, as one doctor noted in her file, was “critically ill with grave prognosis.”
“This poor girl almost died,” Saint-George said. “It was a major effort by the medical doctors that saved her.”
Clinic staff violated basic safety protocols in not seeing Tang after her abortion, he said. “They should not have abandoned her.”
Tang's case argues professional negligence but it also maintains that clinic staff did not adequately inform her (especially because she did not speak English well) about its risks before she chose the RU-486 regimen.
Officials at Family Planning Associates Medical Group did not return calls seeking comment about the lawsuit, which the court will not hear until early 2004, but Saint-George said they have filed papers denying the allegations.
Saint-George said the case could be amended to also include defendants such as Danco Laboratories, the maker of mifepristone or Mifeprex (the first drug in the combination), and Pfizer, the company that manufacturers Cytotec, the drug used to expel the fetus.
At least one other lawsuit in the country alleges a botched chemical abortion.
Brenda Vise, a 38-year-old Hamilton County, Tenn., pharmaceutical representative, died Sept. 12, 2001, five days after beginning RU-486. A $15 million lawsuit by her estate against the Volunteer Women's Medical Clinic in Knoxville, Tenn., and two doctors at the clinic alleges she died of a massive infection stemming Pfrom a ruptured ectopic pregnancy the clinic workers failed to diagnose.
Vise's lawsuit also alleges she contacted the clinic “multiple” times as she experienced severe pain and bleeding, but staff there told her her symptoms were “normal and routine.”
In April 2002, Danco Laboratories sent physicians a letter acknowledging that three women (including Vise) had suffered ruptured ectopic pregnancies, and two other patients, 15-year-olds, had suffered bacterial infections following administration of RU-486.
A sixth woman, 21 years old, suffered a heart attack three days after taking the drug combination.
Danco denied the “adverse events” were directly linked to their drug, but it is likely there are many more unreported complications because reporting is a voluntary practice by physicians.
Susan Cruzan, spokeswoman for the Food and Drug Administration, which keeps a tab on reports, would not say how many adverse events have been associated with RU-486 so far.
RU-486's supporters are unruf-fled by the known injuries to women.
“The medication is extraordinarily safe and effective,” said Dr. Beverly Winikoff, former director of reproductive health for the Population Council, the group that led the movement to have RU-486 approved by the FDA.
“Compare this to the safety records of other drugs,” Winikoff added. “Look at Viagra for men. There were a dozen deaths within the first couple months. You don't hear anything about that. Even penicillin is lethal in rare circumstances. Even aspirin can be fatal.”
While abortion advocates continue to liken RU-486 to antibiotics and aspirin, pro-life critics are finding more and more evidence of the drug's risks to women.
A coalition of conservative groups representing a half-million members has documented evidence that the FDA repeatedly violated its own safety protocols in allowing RU-486 on the U.S. market in September 2000.
Concerned Women for America, the American Association of Pro-Life Obstetricians and Gynecologists and the Christian Medical Association filed a petition to the FDA last August alleging that the agency fast-tracked RU-486 approval because of pressure from the abortion lobby.
The 90-page petition, based on hundreds of internal FDA documents and e-mails acquired through Freedom of Information requests, cites instances, for example, where the FDA permitted “tainted data” from French trials of the drug.
The FDA's own reports had found “pages missing from the case records ... underreported side-effects [such as] a patient bleeding with two subsequent [suction procedures]; convulsions reported as fainting; and an expulsion that was actually a surgical evacuation.”
The petition also charges the FDA failed to ensure that safety protocols used in the experiments, such as routine ultrasound, also be used in clinics.
And, the petitioners allege, one safety standard was simply set aside.
The Pediatric Rule demands that drugs to be used on adolescents or children be tested on them first.
“When the FDA considered abolishing the Pediatric Rule last March, Sen. Hillary Clinton strenuously objected,” said Wendy Wright of Concerned Women for America, a pro-family organization. “Yet, for mifepristone, the FDA ignored this regulation.”
“The citizen petition lays out irrefutable evidence that the FDA violated numerous safety regulations and shows how women have suffered because of it,” Wright said. “The only way to correct this is for the FDA to withdraw its illegal approval of mifepristone.”
Even Wright admitted that outcome is unlikely at this point, especially because it is probable some of the same FDA officials who approved RU-486 will review the petition.
Dr. Janet Woodcock of the FDA's Center for Drug Evaluation and Research has told the petitioners the FDA is examining their allegations but is delayed (three months beyond the six-month mandated response time) “given the complex science and policy issues raised.”
As President Bush has said about reversing the Clinton administration FDA approval of RU-486: “Once the decision's made, it's been made ... unless it's proven to be unsafe to women.”
Celeste McGovern writes from Portland, Oregon.