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.
While Wise has gone through the cumbersome process of getting licensed to practice medicine in about 20 states -- far more than your average M.D. -- 26 remain in which he cannot write prescriptions. (The numbers don't add up to 50 because of the states with OTC status and those with more flexible laws about prescriptions.) He has also decided that Getthepill.com will provide prescriptions only to patients 18 and older, even though many argue -- counter to the FDA's stated concerns -- that teenagers need easy access to E.C. as much, if not more, than adults do. "From a moral standpoint, I have no problem at all prescribing to younger patients," he says, noting that he does so -- along with plenty of counseling -- in his own practice. "But I realize that what we're doing already places us under increased scrutiny from medical boards, citizens and so forth, and we want to be cautious. So we made a difficult decision -- one not based on law, but just to make sure that we are able to continue the services that we provide -- that we're going to provide medical consults and prescribe EC only for legal adults." For minors and those in the 26 off-the-list states, Wise or his staff will at least try to guide them to a Planned Parenthood or other available resource.
Squeezing online clients in between and after his work commitments, Wise also takes follow-up calls or e-mails, talking patients through pregnancy scares or bouts of nausea (one of the drug's few side effects). "If I ever have a patient who comes back a second time needing emergency contraception, she always gets a phone call from me," he adds. "I'm not trying to make her feel guilty, obviously; I'm trying to make sure she does all she can to sort of replan her sexual activities so that she doesn't find herself in that situation again."
Wise makes himself available for such calls 24/362. The site is "closed" on Christmas and Thanksgiving, and from about 3 p.m. New Year's Eve to 3 p.m. New Year's Day -- but only because that's when pharmacies are closed. In the five years since the site's launched, he's taken one vacation -- sort of. "I had to get a hotel room right in the Grand Canyon, go out for a couple hours for a hike, come back up to check my e-mail, cellphone and pager," he says.
Who are all the women keeping him so busy? Why aren't they calling their own doctors? "First of all, it's actually surprising how many actually don't have a women's healthcare provider at all," says Wise. Some have changed jobs or insurance; some just don't have one. Other women simply find themselves unable to contact their provider (or college health service) over a weekend or holiday. Still others feel much more comfortable talking to Dr. Internet than to Dr. Disapproval. Remarkably, says Wise, there are doctors out there who still confuse emergency contraception with mifepristone, and refuse to dispense it. Then there are those, he says, who "give their patients an enormous guilt trip before prescribing the medication."
Wise cites one recent patient, a nurse at a small hospital who knew every doctor in town and felt uncomfortable approaching them "for fear she'd be judged in some way," he says -- for having unprotected sex, for having sex at all, for dodging the "consequences" when she does. "This is clearly a woman who has a provider, who has major access, who has good health insurance -- but because of the stigma that's out there, she chose to get the medication through us."
Dr. Joe DeCook is one doctor who does not prescribe emergency contraception, and who hopes Wise is careful when he does. "If he's going to give people this medication, he better give them informed consent, because [E.C.] doesn't hardly work," says DeCook, who is vice president of the American Association of Pro-Life Obstetricians and Gynecologists. DeCook cites several studies that appear to call the effectiveness of E.C. into question, and bemoans what he sees as a dearth of information on side effects on women and on pregnancies undetected before E.C. is taken. "It probably does prevent some pregnancies some of the time, but women are fertile for only about 36 hours a month," so it's unclear, he says, when the pill is actually doing its job -- and what it's doing to women's bodies when it's not.
Of course, given that emergency contraception (also often used: Lo/Ovral) is on the market in the first place, the FDA has already deemed it safe and effective. By and large, studies that question the drug's effectiveness find fault not with its medical properties but with the way the drug is presented and described to women -- and, indeed, with the stigmas that prevent them from asking for it when they need it.
Some physicians unfamiliar with Getthepill.com declined to comment on the Web site directly. But by reiterating the organization's support of over-the-counter status for Plan B, a spokesperson for the American College of Obstetricians and Gynecologists implied that if the drug should be available with no prescription at all, then a prescription from an online doctor would be more than sufficient.
Dr. Beth Jordan is willing to go further. "The fact that this site exists tells you something about the great need for it," says Jordan, medical director of the pro-abortion rights Association of Reproductive Health Professionals. "Any mechanism that makes emergency contraception more available is a good thing, so that women have timely access to a very time-sensitive reproductive technology." Jordan's only concern? "What about women who don't have the computer technology? We need over-the-counter access for them."
Having been the Web site's only doctor for five years, Wise is now considering the possibility of incorporating others who can prescribe in states where he's not licensed; doctors in Idaho and Kentucky have already offered their help. Expansion of the site's services in this way would reflect Dr. Wise's own transformation as its founder. "When I started this project I was doing it as a doctor. I viewed it as a huge unmet need, and I found a creative way to solve that problem," he says. "But as time has gone on and I've realized the politics involved in getting Plan B over-the-counter, frankly, I've become more of an activist."