By Albert Samaha
By Steve Weinstein
By Devon Maloney
By Tessa Stuart
By Alison Flowers
By Albert Samaha
By Jesse Jarnow
By Eric Tsetsi
The Population Council, which was set up almost 50 years ago by John D. Rockefeller III to address the problem of overpopulation, had a seemingly simple mission for mifepristone: to conduct a U.S. clinical trial, file a new drug application with the FDA, and arrange for a manufacturer and distributor in this country. But nothing having to do with mifepristone happens quite so smoothly. The first attempt at raising money to launch the drug played out like a bad B-movie. Patent securely in hand, the Council proceeded to hire Joseph Pike, a shady, disbarred lawyer, to raise funds for the drug. After Pike went public with having a criminal record, a legal mess between the Population Council, Pike, and other investors ensued, eating up almost two years of time when mifepristone might have been fighting its way toward American women.
Most people chalk up the Pike chapter of the RU-486 story to unfortunate circumstances rather than politics. But while bad luck clearly had something to do with the choice of a petty criminal to head a sensitive medical project, the dearth of better business partners that led to that choice can be tracedonce againback to abortion politics. Mifepristone promises to be in great demand; one-third of the more than 1.3 million abortions in the United States are performed in the first 49 days of pregnancy, and so could be done with RU-486. With the cost of the whole regimen, doctors' visits and all, expected to be about the same as surgical abortion (which averaged $316 in 1997, when statistics were last tallied), this could mean a profit of tens of millions of dollars for whoever is willing to produce and market the drug. Yet fear of protests and boycottsnot to mention bombings and shootingshas meant that big pharmaceutical companies won't go near it with a 10-foot test tube.
The same is true for investors. "You have no idea how frightened people are to contribute money," says Richard Hausknecht, medical director of Danco, a group of investors that formed to market RU-486. "The company that's doing this is tiny," Hausknecht says of Danco. "It's literally a mom-and-pop store." Without bigger, wealthier sources, Danco has been operating on a shoestring budget, which may partly explain its snail's pace toward approval. For many bigger potential financial backers, the business is simply too volatile. "If you're an investment banker, even if your heart's in the right place, your wallet's not," says Hausknecht. "They're afraid [approval] is just not going to happen."
Bankrollers aren't the only ones afraid mifepristone will never happen. Since 1997, when the Population Council ousted Pike and rearranged its investment team, the ball has mostly been in the Food and Drug Administration's court. And women have been waiting and waiting, and waitingfor the agency to hit it back. The FDA seemed poised to approve the drug in '96, when the agency issued its first letter declaring mifepristone safe and effective. But then it requested additional information. And shortly after, the Hungarian company that had agreed to manufacture the drug in the U.S. pulled out, derailing the process.
Since then, times at the FDA have been somewhat turbulentthe agency has spent much of that period without a commissioner and under scrutiny for approving drugs both too quickly and too slowly. And mifepristone has faced one delay after another. First, it was supposed to be approved in 1998. Then, it seemed likely to get the nod at the end of '99, but when that time came, the agency instead issued another set of questions. Most recently, FDA watchers were sure RU-486 would be approved by the beginning of this year. But in February, the agency once again asked for more information and then announced its new September deadline.
This last might have been just another in the line of frustrating delays if not for news leaked at the same time to The Washington Post: The FDA was considering imposing restrictions that could snuff out the potential of RU-486. We now know mifepristone may be limited to physicians who are specially trained to use it and also have admitting privileges in hospitals within an hour of their offices. Perhaps the most stifling of the FDA's proposed restrictions would allow only doctors who have fulfilled the special training required to provide surgical abortions to prescribe mifepristone.
If pro-choice advocates didn't think politics were mucking up a supposedly scientific process before, there now seem few other possible explanations. "Since there is no scientific basis, it has to be about restricting access to this medication that holds the promise of making early abortion available without violence and harassment," says Wendy Chavkin, professor of public health and OB-GYN at Columbia University. Chavkin calls the proposed restrictions "unheard of." And several medical organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Medical Women's Association, have also weighed in against the restrictions as an intrusion into the practice of medicine.
To understand how extreme these restrictions are, realize thatwith very few exceptionsthe FDA has no say as to who gets to prescribe drugs. The agency doesn't require doctors to be able to do bypass surgery in order to prescribe heart medications. A dermatologist could prescribe it if he or she felt like it. For that matter, a dermatologist could also prescribe Viagra, the drug for erectile dysfunction, which took far less time to gain FDA approval, despite the fact that it can cause heart problems.