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Thursday, Nov 26, 2009
As the FDA stalls making Plan B emergency contraception available to women, a New Mexico doctor has stepped in to help -- now.
Nov 7, 2005 | Women have been waiting for more than two years for the FDA to grant over-the-counter status to Plan B, Barr Pharmaceuticals' brand of emergency contraception (keyword: emergency). On Aug. 26, in its latest non-move, the FDA -- ignoring recommendations from its own advisory panel in 2003 -- postponed indefinitely a decision on the matter, instead opening a period of "public comment" that ended Nov. 1. On Nov. 3, four frustrated members of Congress attempted an end run around the FDA, introducing a bill in the House that would allow over-the-counter sale of Plan B until the FDA makes a decision. Meanwhile, women have long been left scrambling for prescriptions -- and even for a pharmacy willing to fill them. Fortunately, however, one doctor in New Mexico -- having seen firsthand the vast demand for the medication as well as the roadblocks in its way -- has spent the last five years quietly making sure emergency contraception gets into the hands of women who need it, when they need it.
In 2000, Dr. Matt Wise launched the Web site Getthepill.com -- which provides prescriptions for emergency contraception -- as a short-term end run around the obstacles women face who are trying to get the drug. "We thought emergency contraception would be over-the-counter literally within months," he says. He assumed, therefore, that demand for the site's services would be short-lived. Five years later, however, Dr. Wise, 35, a practicing gynecologist by day, still may not be quitting his night job anytime soon.
"I would happily walk away from this project -- I mean, I'm hanging on by a thread here," says Wise, who hasn't taken an e-mail- and cellphone-free vacation since launching the site. "I've had state medical boards not happy with me, I've had pharmacists read me the riot act about how what I'm prescribing is wrong," he says. "The only thing keeping me in here is realizing that we're really making a difference -- at this point we've helped thousands of women. And it's part of a much bigger battle to get this stuff over-the-counter. We're not going to go anywhere until this medicine is widely available for patients."
Emergency contraception has been prescribed fairly commonly to women at risk of unintended pregnancy at least since the mid- to late 1990s. The medication typically consists of two pills, each containing a high dose of a hormone found in birth control pills, to be taken in sequence starting within 72 hours of unprotected sex. Not to be confused with mifepristone (the "abortion pill" formerly known as RU-486), E.C. is designed to avert pregnancy by preventing fertilization or implantation. It will not terminate an existing pregnancy.
Given that the drug's contraindications are few and that, when it's needed, time is of the essence, a prescription for emergency contraception does not require a face-to-face doctor's visit. In fact, the medical establishment and a majority of doctors take the position that the drug should require no prescription at all; it is already available over-the-counter in seven states, with Massachusetts soon to follow.
Despite the fact that E.C. is known to prevent, rather than induce, abortion, political opposition to emergency contraception remains powerful. The FDA's Aug. 26 postponement has been decried by many -- including two FDA experts who resigned in protest -- as "political." According to congressional staffers who saw an early draft of a Government Accountability Office report in response to the FDA's initial delay in May 2004, it suggests that the decision was actually made months before it was announced and involved an unusual number of top-level officials. The implication is that the process was guided more by internal machinations than by medical realities.
Back in 2000, when Wise was a medical resident at the University of North Carolina Hospital in Chapel Hill, one of his jobs was to answer the phone. "I was surprised by the number of calls from women with questions about emergency contraception," he says. "Since we were receiving that many phone calls in our small community from women with no doctor or insurance or who had encountered some sort of 'moral objection' to emergency contraception from doctors and pharmacists, I just thought, 'Gosh, on a nationwide basis there's got to be an enormous need.'"
Wise was inspired to try to help meet that need by one of his mentors, contraceptive expert Dr. David Grimes. Grimes, he says, had always told him, "Hey, if there's something out there you can do to help women that is morally and medically appropriate, you ought to be doing it."
Hence the Web site. Wise launched Getthepill.com with the help of his brother -- conveniently, a Web designer -- who created the site's architecture and its system for maintaining medical records. Three other people -- all family or close friends -- help answer phones and do other clerical work. The $24.95 prescription fee (separate from a pharmacy's price for the medicine) covers their salaries and all other operating costs; Wise derives his income only from his in-person gynecology practice. "When we started the site I had zero money -- I was in debt from med school! So we wouldn't have put this operation together if we couldn't have done it in a way that was very efficient," says Wise, who has actually declined offers of cash donations.
Getthepill.com logs 30 to 50 prescription requests or inquiries per day, most from women who have found the site via a search engine or a public health Web site; some college health services also recommend the site for use on weekends, when they're closed. Women seeking a prescription are asked to fill out a questionnaire designed, in part, to confirm that they are at risk of pregnancy -- but not already pregnant. (Plan B will not harm an existing pregnancy, says Wise, but it is a waste of time for a pregnant patient to use the drug.) "If patients get confused about when their last period was, I'll get on the phone with them and pull out my calendar and we'll try to do the best math we can to figure it out," says Wise. When a patient's need is confirmed, a prescription is called or sent in to the pharmacy of her choice. If a pharmacy or pharmacist turns out to be hostile to dispensing emergency contraception -- which happens once every other day or so, Wise says -- his staff goes back through their extensive database, which lists pharmacies across the country that they have used successfully, until they find a friendlier one.
