The Little Pill that Could

In the mid-1990s, the abortion wars were at a fever pitch over the impending approval of RU-486. Time magazine called it “The Pill that Changes Everything,” The New York Times Magazine dubbed it a “little white bombshell,” and anti-abortion leaders said over and over that this drug was dangerous because it would make having an abortion “as trivial as taking aspirin.” Pro-choicers, for their part, were invigorated by the possibility of giving women another abortion option, one they hoped would let them largely bypass abortion clinics and the attendant protestors at the gates.

But for all the controversy about mifepristone, the active drug in RU-486, there wasn't much attention paid to the fact that many doctors were already providing abortions in pill form using a drug called methotrexate, which had been FDA-approved for years as a treatment for cancer, arthritis, and Crohn's disease. Because methotrexate was useful in many more ways than abortion, it was more loosely regulated and readily available. And because the methotrexate was approved for a variety of illnesses, it was politically impossible for anti-abortion groups to push the FDA to revoke its approval.

“Nobody's trying to get that drug off the market,” says Beth Jordan, medical director for the Association of Reproductive Health Professionals. “We want to see mifepristone enjoy that same place on the market. If the science is there.”

That's why, even before mifepristone was FDA-approved as an abortion pill, pro-choice groups began supporting research into whether the drug can be used to treat depression, cancer, and reproductive system disorders. So far the results are encouraging. In November, one researcher attracted considerable press when she released findings that she had successfully used mifepristone to treat breast cancer in mice. The announcement gave pro-choicers hope that they were a step closer to pushing for FDA approval for a use other than abortion.

Although only about 10 percent of the 1.29 million abortions performed in the United States every year use the medication method, the battle over the drug has been particularly bitter. While a woman must obtain mifepristone at a clinic, the actual abortion happens in the privacy of her home. Currently, medication abortion is common in many countries where the procedure is illegal, because it's decidedly less risky than using a wire hanger. In fact, in the absence of a doctor, it's the safest and easiest way for a woman to perform a do-it-yourself abortion. Which is another reason why pro-choice groups would like it approved for alternate uses and see its availability increase. If abortion were ever outlawed in the United States, mifepristone would become perhaps the most important -- and the most common -- abortion option.

It took pro-choice activists 12 years to get the abortion pill -- of which mifepristone is one of two components -- approved by the FDA. Though it had been used in some European countries since the early 1980s, American abortion politics caused the drug's European makers to shy away from patenting and marketing the drug here. After a series of hang-ups, clinical trials were completed in the late 1990s and the FDA agreed to consider approval. Despite objections from anti-abortion groups and conservative congressmen, mifepristone was FDA-approved for abortions in September 2000. (More recently, the drug came under renewed scrutiny when at least four women died of a rare bacterial infection after taking the pill. The anti-abortion movement seized on the deaths to push for a ban on mifepristone. But after two more people died of the same rare bacteria, many experts questioned mifepristone's role in the deaths.)

Given the politics at play, it's not surprising that mifepristone is one of the most strictly regulated drugs in America. As a concession to the anti-abortion movement, the FDA gave the drug a “Phase 4” classification. This means that, even with a doctor's prescription, you can't get it at a pharmacy. The drug can only be dispensed by a licensed physician, who must order each $500 dose directly from the manufacturer. The restriction also prevents doctors from prescribing mifepristone off-label, a common and legal practice generally considered safe if supported by research. With Phase 4 drugs, the doctor needs special permission from the FDA, which it will only grant if a patient faces a life-threatening illness such as cancer. For a painful but not lethal condition such as uterine fibroids, for which studies have shown mifepristone is sometimes the best treatment, doctors have no way to legally prescribe it.

A great deal, therefore, rides on the outcome of research into mifepristone's other uses: Jordan hopes the drug's connotation will change from “abortion drug that can treat cancer” to “cancer drug that's also used in abortions.” But here too, abortion politics have stymied the effort. Due to the drug's political significance, researchers are cautious about studying it -- two breast cancer researchers in Canada who were studying mifepristone received death threats from anti-abortion activists. And because mifepristone is not a patented drug, none of the major pharmaceutical companies stands to gain financially by expanding the number of uses for which it's FDA-approved. This means finding private funders, many of whom don't want to touch a hot-button drug.

“I feel that everything here has gone slower than we would have thought,” says Feminist Majority President Eleanor Smeal. “We have this terrible political battle going on that has made everything more difficult.”

Government agencies have quietly funded a handful of the mifepristone studies, even though President Bush is on record as opposing the FDA's decision to approve the drug. Most of the money comes from private individuals and foundations, with women's groups like the Feminist Majority providing logistical support. A University of Rochester study that has been going on for more than a year is showing that the drug holds great promise in treating uterine fibroids, and Stanford University is testing its effectiveness on clinical depression and schizophrenia. In November, Dr. Eva Lee at the University of California, Irvine, got substantial media attention for her finding that mifepristone may successfully combat genetically linked breast cancer.

Organizations like the Feminist Majority openly acknowledge that while they are thrilled at these medical findings, they're even more excited at the political promise. Jim Sedlak, vice president of the American Life League (ALL), opposes the research for the same reasons. “They are desperately looking for a way to justify this product so that if abortion is made illegal in the U.S., they can still sell this product and claim it is for something else,” he says, noting that all would oppose FDA approval of the drug for any new purpose -- even if it could save the lives of women with breast cancer. That position probably won't find great public appeal -- in fact, the pro-choice movement is banking on it.

Ann Friedman is the associate web editor of The American Prospect.

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