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The study was not designed to say whether isotretinoin treatment caused these effects, or even whether they were more common among isotretinoin patients than in the rest of the American population. As Guanglei Hong, a professor and health-statistics expert at the University of Chicago who was not involved in the study, told me in an email, the data do not “provide any insight on whether the drug increased or decreased mental health issues because this analysis did not include a comparison group.”
But Mostaghimi believes that the results are still worth considering. The drug’s “greatest burden may actually be on emotional lability and anxiety,” he says, even though those effects “weren’t things that we’ve really as dermatologists been focused on when we assess these patients.” His findings, he contends, might signal that dermatologists are overlooking major side effects.
Isotretinoin is strictly controlled through an FDA program called iPledge, which requires patients to visit their dermatologist once a month in order to receive their prescription. Isotretinoin can cause serious birth defects, so women capable of bearing children have to commit to using two methods of birth control while taking the drug and submit to monthly pregnancy tests. Dermatologists also commonly require their isotretinoin patients to get a monthly blood test.
Mostaghimi hopes that dermatologists can take advantage of that monthly check-in to screen their patients for the less acknowledged conditions that he found reported in the FDA database. “I should probably be not only looking for signs and symptoms of psychiatric disturbance and challenges, but really trying to take advantage of those meetings to try to identify patients that need help and connect them to people who can help them,” he says.
But adding more screening demands on top of the existing iPledge requirements could be a nightmare for some patients. In its current iteration, iPledge can already create significant obstacles to acne treatment. The journalist Sabrina Imbler recently described in Gay Magazine how the program can demean queer women by policing their compliance with birth-control methods they don’t need. According to Mostaghimi, the program has been grappling with how to handle the needs of transgender patients for a few years now. And a study he published in March found that nonwhite isotretinoin patients were about 50 percent more likely to end their treatment early than their white counterparts—and that patients were most likely to identify iPledge-related requirements as the reason they delayed or interrupted their treatment. (The FDA declined to comment on the new paper.)
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Adewole Adamson, a professor of internal medicine at the University of Texas at Austin and the web editor of JAMA Dermatology, is adamant that more people should have access to isotretinoin. “Accutane is one of the most satisfying drugs to give to patients,” he told me. “It really transforms how patients feel about themselves.” Indeed, it’s difficult to argue that the medication is ineffective: In one study, more than a third of patients who go on isotretinoin never experienced an acne relapse; less than a quarter required another round of the drug. Because of that, he said, dermatologists can’t yet be sure whether adding even more hoops for isotretinoin patients to jump through would be a good thing. “We have to be careful in rushing to change practice without more rigorous studies, because of these other potential consequences of burdening patients,” he said.