Acne Drug Controversy Ignites Turf Battle Over Prescribing Images of scarred faces and deformed babies have dominated recent media coverage of Accutane. But for primary care doctors, the underlying story is how patients might be diverted away from them and toward specialists.
In the wake of claims that the acne drug may have caused many more birth defects than previously suspected, the FDA is weighing several proposals for curtailing its use. Among them are:
* permitting only dermatologists or specially trained physicians to prescribe Accutane (isotretinoin, Hoffmann-La Roche),
* requiring a second opinion,
* stipulating that fertile women use it only if an obstetrician-gynecologist has certified that they aren’t pregnant and are using contraception, and
* legally limiting use to patients with severe cystic acne that has failed all other treatments.
Freedom to prescribe. If the FDA adopts these proposals, some fear that primary care doctors will lose their freedom to prescribe drugs and refer patients according to their own best judgment.
As it stands, “any physician can prescribe any drug that he or she darn well pleases,” says teratologist John W. Larsen Jr. If the FDA takes the unprecedented step of limiting Accutane use to dermatologists, Dr. Larsen says he can imagine a new medical world in which only ob-gyns are authorized to prescribe birth control pills. “Wouldn’t that be a nice little accounts receivable stiumulator?” comments Dr. Larsen, a professor of ob-gyn and genetics at George Washington University.
Patients–particularly those in rural areas–also standard to lose if drug prescribing is limited. Dr. Ken Evans practices family medicine in Shattuck, Okla., a town of 1,500 near the Texas border. “My nearest dermatologist is 120 miles away,” he told MWN. He hasn’t used Accutane in his practice so far, but he says other family doctors in the area have. He strongly opposes any move to restrict the use of Accutane or other approved drugs. If family physicians “maintain their skills and ability” in dermatology, “I see no reason why they shouldn’t write Accutane,” said Dr. Evans, chairman of the American Academy of Family Physicians’ committee on drugs and devices.
Testimony. In April, the FDA’s advisory committee on dermatologic drugs heard presentations by physicians, consumer advocates, government researchers, and the manufacturer concerning the drug’s unique benefits for cystic acne patients and its powerful effects on the unborn. They heard charges that physicians have prescribed Accutane too freely and claims that the drug may be implicated in 900 to 1,300 birth defects instead of the 62 reported to the FDA since 1982.
The committee endorsed the idea of limiting Accutane’s distribution but left the details up to policymakers inside the FDA. The agency’s general counsel is examining the legal pitfalls of restricting distribution of an approved drug. Any steps the FDA takes must be consistent with “the Food, Drug, and Cosmetics Act and other acts that give us authority,” spokesman Brad Stone told MWN.
Pregnancy warnings. Roche representatives laid out voluntary steps they will take regarding women of reproductive age. The company’s aim is to “reinforce the message” about proper drug indications and teratogenicity, according to Carolyn R. Glynn, Roche’s director of public policy and communications. Starting in June, Accutane will be shipped with new package inserts and labeling and with pregnancy warnings on each individually wrapped capsule.
But the most surprising element in Roche’s preventive package was the company’s offer to pay for second opinions and an ob-gyn consultation for women at risk of becoming pregnant. Glynn said this is an “unprecedented” offer by a pharmaceutical company. Its price tag is impossible to guess–FDA scientists estimate that about 1,000 young women seek treatment for severe, recalcitrant cystic acne each year, but Roche puts the number at 27,000 to 43,000.
“Pregnancy tests, consultations, and second opinions would amount to about $200 per patient, and the total cost of the drug to the patient is $400 to $500 for the five-month treatment,” says Dr. G. Thomas Jansen, who practices dermatology in Little Rock, Ark., and is president of the American Academy of Dermatology.
Roche’s generosity would no doubt stand them in good stead in the courtroom, and the price could be right. Industry critic Sidney Wolfe told the FDA advisory committee that the company has paid “$1 million settlements” in Accutane-related lawsuits.
The concerns of F. Hoffmann-La Roche & Co., the Swiss parent of the U.S. firm, go far beyond the immediate issues of acne and birth defects. They have about 10 related compounds currently in development.
Dr. Jansen calls Roche “a class company” and says that their offer to underwrite consultations and second opinions involves altruism as well as a concern with profits.
Dr. Jansen told MWN that he left the FDA committee hearing in Washington with a clear mandate from representatives of the FDA, CDC, and Roche. He was told to work closely with dermatologists, pediatricians, and ob-gyns. Family physicians and internists “simply did not figure into any of the discussions” about managing Accutane’s future, he said.
This oversight has outraged some family doctors who don’t believe that dermatologists should have exclusive rights to Accutane or that ob-gyns should have a corner on special reimbursement from Roche.
Mandatory referral. If those proposals become reality, they will constitute “mandatory consultation,” objects Dr. Chris Unger, a family physician in Bethesda, Md. Patients will be deprived of access, and physicians will lose some of their autonomy.
Family doctors must exercise caution in “prescribing drugs every day that are risky during pregnancy,” Dr. Unger told MWN.
Dr. Unger calls Accutane “a blessing” for patients with severe, disfiguring cystic acne and says he has prescribed it for male patients after hygienic measures and less potent drugs have failed. If he had an 18-year-old female patient with cystic acne, he says he “would get a dermatology consult by telephone” from a nearby specialist and that he wouldn’t start Accutane without a negative pregnancy test.
Other specialists don’t necessarily want primary care doctors removed from the Accutane loop. Though Dr. Wolfe urged the FDA committee to restrict the drug to board-certified dermatologists, the president of the AAD disagrees. If a physician is well informed about “treatments that must be given before isotretinoin is considered, then I don’t care what that person is called,” Dr. Jansen said.
The American College of Obstetricians and Gynecologists will work out a “reasonable description” of an Accutane consultation with the FDA or other groups, says Dr. Harold A. Kaminetzky, ACOG’s director of practice activities. But family physicians and others who routinely offer contraceptive services “know what to do,” he told MWN.
Drug of last resort. Regardless of specialty, doctors interviewed by MWN agree on two points: Accutane is a highly teratogenic agent that should be prescribed only as a last resort, and it should stay on the market. “It’s better to go through the complexities of referral, testing, and education than to withhold the drug categorically,” Dr. Kaminetzky said.
Dermatologists don’t want to go back to the “bad old days,” when they administered long-term teratogenic doses of antibiotics and vitamin A and repeatedly incised and drained cysts before injecting them with steroids. That approach typically brought about only a 50% improvement, said Dr. Jansen.
Traditionally, custom rather than law has curtailed the use of specific agents, he noted. Hospital privilege committees sometimes restrict methotrexate and other powerful cytotoxics to oncologists. But dermatologists are still free to use methotrexate for intractable psoriasis, as are rheumatologists, who prescribe it for some forms of arthritis.
The FDA could take the unprecedented step of limiting Accutane use to dermatologists or giving ob-gyns veto power over prescriptions written by colleagues in other specialities. If that happens, the agency may be flirting with the Philadelphia model of crisis control, in which an entire neighborhood burned during a police raid on two houses. If the Accutane firestorm spreads to other drugs, primary care doctors expect themselves and their patients to get burned.