Dermatology World May 2012 Supplement : Page 17
indication for the registration of men. It doesn’t provide us any detail on the epidemiology of the use of istotreti-noin, they’re at no risk of getting pregnant, and whether or not we register them, they can still give their medi-cine away if they want to,” Dr. Maloney said. “Some of the logic was letting men know that they couldn’t give their medicine to their girlfriend, for example. But it has signi cant costs to the health care system to register men, so I think that’s an area where we should continue to work and see if we can somehow eliminate some of those costs.” Former Academy President Stephen P. Stone, MD, who co-authored an editorial on iPLEDGE with Dr. Maloney in the Journal of the American Academy of Dermatology (2011;65:418-9), said that at present, the iPLEDGE program is running with relative smooth-ness, especially compared to the furor that met its launch during his presidential year. From the perspec-tive of those in charge of the program, he said, it may not prove worthwhile to signi cantly alter it at present. “I think there are still some dermatologists who feel it should be changed and liberalized a great deal,” Dr. Stone said. “But I’m not sure that it will be done. There is certainly a vested interest on the part of people who participate in the program to maintain it running smoothly. And I think that quite frankly there is a con-cern if we change too much, it will increase the risk of pregnancies. Another question is how much it will cost to make these changes. Still, it makes no sense to in-clude males in the program at this point.” MEASURABLE RESULTS While many aspects of iPLEDGE and isotretinoin are hotly debated, one fact that remains at the center of the debate is that the program has not been able to sig-ni cantly decrease the number of fetal exposures per year. This, according to Dr. Maloney, implies that the program has reached something approaching a baseline minimum. “The failures are failures of compliance, either with taking birth control pills, or with using two barrier methods,” Dr. Maloney said. “We just haven’t seen that number budge signi cantly through all of the FDA’s programs. It’s always been 120 plus or minus ve, seven, two — and we can’t seem to break that number.” While the fetal exposure numbers may not have changed, Dr. Stone said, there is a visible di erence “I reference the article by Popescu in the Archives of Dermatology (and my own comment there), that a critical number is the ‘number needed to treat’ of 2977 (I say 2900 generally), meaning we need to treat 2977 people to get one case of ulcerative colitis,” Dr. Mostow said. “I use a line I borrowed from the epidemiologist David Savitz, PhD, stating that the one thing we know for sure is that this product will not prevent or cure any of the side effects that are reported in the literature. It can be a tough decision, and I acknowledge that with parents and patients. All of this being said, most people appreciate the honest approach and many decide to proceed.” Aware of the litigious nature of isotretinoin treatment, Dr. Mostow has patients or their parents sign an additional form outlining each of the potential side effects that he discusses with patients, and takes extra time to address each of the concerns that patients may have. In all, Dr. Mostow said, the vast majority of patients are thankful that isotretinoin is available as a means of treatment. That, he said, is the most consistent side effect of isotretinoin in his office. SUPPLEMENT TO DERMATOLOGY WORLD // May 2012 17
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