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Because of politics, Potts adds, Mifeprex has drawn more regulatory fire than other drugs with higher adverse event rates. Potts recently published a study comparing the approval processes for birth control pills and Viagra, which has been linked to more than one hundred fatalities since its introduction in 1998. The professor rhetorically asks why DeMint and his cosponsors haven't taken interest in the drug with the higher death toll. "I think it's just part of the double standard in laws and behavior and attitudes towards male and female sexuality," he says. "If the man from South Carolina is going to be logical, he should take Viagra off the market tomorrow. He should have taken it off yesterday."
But the political forces behind the proposed ban insist mifepristone is a threat to public health. "It's a dangerous drug," says Wendy Wright, senior policy director for Concerned Women for America, one of the key lobbying groups behind Holly's Law. "Even if administered correctly, it still carries very high risks to women."
Last year CWA, along with the Christian Medical Association and the American Association of Pro Life Obstetricians and Gynecologists, submitted a lengthy "citizens' petition" asking the FDA to withdraw its approval of Mifeprex. The Christian lobbyists contend that 99 percent of Mifeprex users experience some sort of negative effects, whether they be relatively mild ones such as nausea and cramps, or more serious problems such as protracted bleeding. And, as with most drugs, there have been some horror stories, including a 21-year-old woman who had a nonfatal heart attack; two fifteen-year-olds who developed life-threatening infections; and a California woman who is suing her doctor and clinic, but not Danco, over severe bleeding and an infection that sent her to the emergency room.
The petition also criticizes the US clinical trial for not using a control group or including women younger than eighteen, although the drug can be distributed to teenagers. "That's not unusual in clinical trials in the US for any kind of medical product, because of various issues of parental approval," the Population Council's Arnold says of the age complaint.
Another section is devoted to showing how current clinical practice has diverged from the original trial protocols, in which ultrasound exams were required to check for ectopic pregnancies, and clinicians had to have admitting privileges for a hospital within an hour's drive in case a patient needed emergency treatment. The latter concern wasn't unique to pro-life activists, according to author Gorney: "The concern a lot of women's health people had -- people who had no problem with the morality of this -- was what about all the girls who aren't going to get back to the clinic, who are either too scared to go back, or don't have the transportation or have gotten the medication in some underground fashion?"
Mifeprex's critics point out that women end up having to self-diagnose, especially if they are taking the second half of the treatment at home -- thereby reducing the number of clinic visits from three to two. "The woman has to become her own doctor," Wright says. "She's experiencing pain and bleeding -- Holly to the point where she can't walk -- and she has to consider what it might be. If Brenda Vise, a 38-year-old nurse, couldn't diagnose herself, Holly didn't have a chance."
The CWA petition strongly implies that Planned Parenthood skirts the law by allowing women to self-administer the misoprostol. Yet this alternative regimen is "most definitely legal," says Dr. Vanessa Cullins, Planned Parenthood's vice president of medical affairs. "There is an extensive amount of studies in the literature that indicate that women taking the misoprostol at home is safe," she says.
Mostly, Wright's group focuses on bureaucratic procedure rather than medicine. Over and over, its petition alleges that the FDA breached its own rules in its rush to approve Mifeprex to appease the Clinton White House. And although the document was submitted to the FDA more than a year before Holly died, it easily could be mistaken for a rough draft of Holly's Law.
The interesting thing about Holly's Law, despite all the rhetoric about drug safety, is that DeMint's bill would do nothing to improve the safety of Mifeprex. It doesn't seek a clinical review, further trials, or any changes in how the drug is administered -- except that it not be administered.
Instead, mirroring the CWA petition, Holly's Law focuses on the timing of the FDA approval. "There are outside constituencies," says DeMint spokesman John Hart, "that helped get [Bill Clinton] elected -- Planned Parenthood, liberal groups that promote access to abortion -- and they expected this in return during his watch."
Both documents charge that undue pressure was brought to bear on the drug's inventors. In particular, they cite a letter from Shalala to Hoechst, giving a deadline by which she hoped to make the drug available. Both the CWA petition and Holly's Law also claim the FDA was so frustrated Danco wouldn't agree to the restrictions employed during the clinical trials -- the ultrasound and hospital-admitting privileges, among others -- that it employed Subpart H as a last-ditch mechanism to maintain control over a drug the White House was forcing onto the market. "The FDA buckled," Wright says. "Normally if a pharmaceutical company tried to pull tricks like this, the FDA would clamp down so hard -- they would say, 'Forget it. You're not getting approved, and neither are your next ten drugs.' But this was political, and Danco didn't have a next drug."
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