Pledging for Accutane
An irresponsible pregnancy, once just a source of personal shame, will soon be a recordable national offense--that is, if it occurs while taking the acne drug Accutane. Last week, the Food and Drug Administration released iPLEDGE, the Web-based program for doctors, patients, and pharmacists designed to toughen up distribution of this strong drug because it can cause severe birth defects.
The pregnancy problem has bedeviled Accutane makers for years, and the physician counseling and pregnancy tests required for each prescription have made this threat well known to users. Still, each year, with roughly 1 million prescriptions written, the FDA estimates at least 120 women take the drug while pregnant, prompting many to have abortions. No one questions the goal of reducing these ill-conceived pregnancies to zero, but iPLEDGE, mandatory by year-end, doesn't look as if it will get us there.
Compliance with iPLEDGE intrudes on the doctor-patient relationship, and the national registry, however "confidential," looks more like a public confessional. Doctors, for their part, must pledge that they know how to treat acne, know about Accutane's birth-defect risk, and know how patients can avoid pregnancies. They must also pledge to register every patient, enter the primary and secondary methods of birth control of all females of childbearing potential (unless they swear to abstinence), and record the results of regular pregnancy tests, which must be performed by federally certified laboratories, not at-home kits. They also must ensure monthly counseling sessions on pregnancy prevention.
Patients must sign on to iPLEDGE, too, getting a personal identification number in order to fill their prescriptions. They must verify online or by phone that their doctors counseled them and obtained pregnancy tests, and every month patients must repledge the two forms of birth control they are using. Those who get pregnant anyway agree to be queried by an agent of iPLEDGE.
Sign and date. But before they get that far, patients must initial 25 pledges on two consent forms. The first, for females, is pregnancy related, such as pledge No. 11: "I must stop taking isotretinoin [Accutane] right away and call my doctor if I get pregnant, miss my expected menstrual period, stop using birth control, or have sexual intercourse without using my two birth control methods at any time."
The second consent form is gender neutral. It includes pledges about not sharing Accutane with anyone and informing doctors about their own or their family's mental illnesses. (Although a link is by no means proved, some tie Accutane to depression or suicidal thoughts.) Doctors, patients, and parents or guardians of those under 18 must then date and sign the documents and retain a copy.
There is good reason patients are willing to jump through these hoops. The drug is close to miraculous at clearing up the scarring, inflamed, and pus-filled cysts and nodules that cover the face, neck, and back of severe-acne sufferers. And there is reason doctors sign on. As Allison Vidimos, chair of dermatology at the Cleveland Clinic, puts it: "It's intrusive, but we accept it since we were fearful that our patients would be deprived of treatment they desperately need." She stresses that Accutane is a one-of-a-kind remedy for a severe disease that peels, washes, lasers, and antibiotics just don't touch. The FDA, caught in a tussle between needy patients and those wanting the drug off the market, accepted iPLEDGE as a compromise to improve behavior.
It's hard to legislate personal behavior. And patients are sensitive about their sex lives and histories of mental illness, especially if Big Brother might be watching. Women will resist entering their number in a national database of unintended pregnancies and abortions. It's also hard to fathom who would call up their docs to confess pledge violations. And what are doctors to say? "You flunk. Call iPLEDGE and fess up." That, to put it mildly, doesn't make for a good doctor-patient relationship. Instead, how about pumping up the consent form, adding more-frequent counseling and pregnancy tests, and spot auditing? Use the same resources and good intentions, but keep it inside the doc's office.
The road to hell is paved with good intentions. I fear the well-meant iPLEDGE will bring guilt, lies, and misdemeanors but no fewer pregnancies or consequent abortions.
This story appears in the September 5, 2005 print edition of U.S. News & World Report.