Magazine article Insight on the News

Safety of RU-486 Is Questionable

Magazine article Insight on the News

Safety of RU-486 Is Questionable

Article excerpt

The FDA's accelerated approval of the abortion-inducing drug RU-486 without thorough testing is under fire by critics of the drug who say the FDA broke its own rules.

Six years ago, "newly unemployed" by a corporate downsizing, Lee Knowlen discovered that she was about to become a single mother -- and amid other stressful troubles she decided to have an abortion. Knowlen heard that the U.S. clinical trials for RU-486, or mifepristone, were then under way. She knew about the drug from the time she had spent living in Europe, where the chemical abortifacient already was in use. So she agreed to become part of the U.S. trials.

Knowlen tells Insight that her use of the experimental drug was a "success." Nevertheless, she grieved for her aborted child, and sought comfort in a formal grieving ceremony with her partner.

This deep ambivalence toward RU-486 had marked the stunning controversy over the drug since efforts began to legalize its use, an end finally achieved by proponents when the U.S. Food and Drug Administration (FDA) gave its formal approval on Sept. 28, 2000. Opponents charged that the approval process had been aborted by politics and ideology, putting it into a special accelerated category of drugs intended to make them available to dying patients, and by passing usual safety concerns and legal liability.

Pro-choice advocates and the Population Council hailed the approval as a long-awaited victory in the battle for women's rights. Opponents of abortion were furious. "Never before has the FDA approved a drug intended to kill people," said Rep. Tom Coburn, R-Okla. And it was a matter of some concern that FDA had approved the use of the controversial drug on the basis of a couple of foreign studies and a single U.S. clinical trial.

Newspapers and networks nonetheless were quick to cheer the potential benefits of RU-486; the Washington Post broke the story on Oct. 12, 2000, that the drug would be manufactured for the U.S. market by the state-owned Hua Lian Pharmaceutical factory in the People's Republic of China. Oddly, no one thought it important enough to report how RU-486 so quickly had moved from that clinical trial to the physician's practice at the very end of the Clinton administration.

In its Sept. 28, 2000, approval letter for mifepristone from an unnamed FDA official to Sandra P. Arnold, vice president of the Population Council, the FDA says the drug was approved for marketing "under 21 CFR 314 Subpart H," otherwise known as the accelerated-approval process. For a drug to qualify for such acceleration it "must provide meaningful or therapeutic benefits over existing treatments" and must be used to treat a serious or life-threatening illness.

In short, the Subpart H process is permitted only to allow speedy approval of experimental drugs whose safety cannot be established but the dangers of which are outweighed by the threat of a patient's current illness. To date, 0nly 30 drugs have been approved under Subpart H, with more than half of them providing treatment for HIV/AIDS patients and others for treatment of cancer (see "New Drug Approvals" p. 18).

Without such an approval the manufacturers would be held to strict liability for drugs that by their nature are incapable of being made safe and huge lawsuits likely would result to make distribution financially risky or impossible. According to tort specialists, such lawsuits might arise anyway.

Brad Clanton, counsel for the House Judiciary subcommittee on the Constitution, is one who has serious reservations about the ramifications of mifepristone's approval under Subpart H. "It's an accelerated process for approving drugs for people who are basically dying or are going to have some serious deformity if they don't get something [treatment] right away," Clanton says. "It was basically created for AIDS patients."

Clanton believes that the medical history of mifepristone invalidates the drug's approval under Subpart H because FDA rules require that the drug be intended to treat a serious or life-threatening disease or illness and that it provide meaningful therapeutic benefit over existing treatment. …

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