AAD Fires Back on Indoor Tanning
The American Academy of Dermatology is launching a public service campaign to communicate the risks of indoor tanning. The target audience is 16- to 29-year-old women, according to the AAD. This group is being chosen because the data show that 70% of indoor tanners are women in that age group, and melanoma is increasing faster among women than men in that age range. The "Indoor Tanning Is Out" campaign includes print, television, and radio ads. The campaign comes on the heels of an ad blitz in New York, Boston, Washington, Chicago, San Francisco, Seattle, and Pittsburgh sponsored by the Indoor Tanning Association. That campaign claimed there is no compelling scientific evidence linking tanning to melanoma.
Tanning Industry Ties Cited
The Indoor Tanning Association also recently found its ties to a Boston University researcher, Dr. Michael F. Holick, scrutinized by the Wall Street Journal. Dr. Holick has published numerous articles on vitamin D deficiency, including a review in the New England Journal of Medicine in 2007 (N. Engl. J. Med. 2007;357:26681), in which he suggested using tanning beds "in moderation" as a source of replenishment. The article was supported by grants from the National Institutes of Health and also the UV Foundation, which is a nonprofit arm of the Indoor Tanning Association. Dr. Holick and his research are prominently featured on the UV Foundation's Web site. In a video on the site, he again suggests the use of tanning beds in moderation. The Wall Street Journal reported that the New England Journal said that Dr. Holick properly disclosed his funding source and his potential conflicts.
Stiefel Buys Atlean Maker
Stiefel Laboratories Inc. has acquired ABR Invent and ABR Development, two French companies that developed Atlean, an injectable dermal filler. Atlean is made up of tricalcium phosphate particles suspended in a hyaluronic acid gel. The product was granted a CE marking in 2006, and is currently sold in France and Italy. The Coral Gables, Fla.-based Stiefel said it plans to launch Atlean in other European nations, Asia, Latin America, and the Caribbean in the next 18 months. The company will also eventually seek Food and Drug Administration approval, the company reported in a press release.
Generic Fluorouracil Cream Halted
Spear Pharmaceuticals Inc. has agreed to at least temporarily cease sales, marketing, and shipment of a generic fluorouracil cream 5%. Valeant Pharmaceuticals International, which makes the brand Efudex cream 5%, sued the FDA to challenge the agency's denial of Valeant's citizen's petition. The petition challenged the agency's approval of the generic. The company said that the FDA should not approve a generic that had not been tested head to head against Efudex in patients with superficial basal cell carcinoma. The agency said that generics needed to be tested only against actinic or solar keratoses. The FDA requested a 2-week stay of Valeant's lawsuit, which was granted.
Low Postmarketing FDACompliance
The FDA has issued its annual summary report of how pharmaceutical and biologic manufacturers are doing on meeting their commitments to conduct postmarketing studies. According to the agency, 76% of drug makers and 81% of biologic makers had met their commitment as of September 30, 2007. There were 136 drug makers and 54 biologic manufacturers with open postmarketing commitments as of that date. A closer look at the FDA data shows that only 12% of drug studies were completed or terminated with a final report submitted to the FDA that year. In all, 20% of biologics met that goal. Manufacturers are required to report annually on the status of safety, efficacy, pharmacology, and nonclinical toxicology studies required by the FDA, or to report that they have committed to conduct at the time of approval or after approval.
Disciplinary Actions Decline
The number and rate of serious disciplinary actions against physicians have decreased for the third consecutive year, according to Public Citizen's annual ranking of state medical boards. The advocacy group said the analysis indicates that many states are not living up to their obligations to protect patients from bad doctors. Since 2004, the number of serious disciplinary actions against doctors has decreased 17%, resulting in 553 fewer serious actions in 2007 than in 2004. Taking into account the increasing number of U.S. physicians since 2004, the rate of serious actions has fallen 22% since then, when calculated per 1,000 physicians, according to Public Citizen. The annual rankings are based on data from the Federation of State Medical Boards.