Recent Developments

Another Tanning Myth Debunked

Despite some support for artificial tanning as a method of improving seasonal depression, one expert strongly refutes such beliefs. In a recent interview with Reuters Health, Dr. Michael Terman, director of the Center for Light Treatment and Biological Rhythms at New York-Presbyterian Hospital in Manhattan, noted that light therapy for the treatment of seasonal affective disorder (SAD) works through the eyes, not the skin, and is not dependent on ultraviolet waves. He added that even if artificial tanning did improve mood, the increased risk of skin cancer and ocular damage would outweigh its benefits. Dr. Terman says there are effective light devices for SAD treatment. He is associated with a website, www.cet.org, sponsored by the Center for Environmental Therapeutics that offers information on how to choose one.

Mortal Risk?
Recent findings indicate that topical tretinoin use in elderly patients may be associated with a risk of death. In a large, randomized trial, topical tretinoin therapy was associated with death, but investigators did not infer a causal association, because current evidence suggests it is unlikely (Arch Dermatol 145:18-24). The goal of the trial was to assess the relationships of topical tretinoin with all-cause mortality in a blinded randomized chemoprevention trial with two- to six-year follow-up. In the trial, 1,131 individuals, mean age 71 years, were randomly assigned to receive application of tretinoin 0.1%, or vehicle cream twice daily to the face and ears. Patients were excluded if they had a high estimated short-term risk of death. Due to an excessive number of deaths in the group receiving tretinoin, the intervention was terminated six months early.

New findings on AKs
Sequential treatment of multiple and recurrent actinic keratoses with diclofenac 3% gel followed by cryotherapy may be an effective approach to management, according to a new report (Clin Experimental Dermatol 34:33-35). Twenty-nine patients were reviewed in the trial, all of whom had more than five lesions (mean 8.2; range five to 12) and a long-term history of recurrence after repeated cryotherapy. After a first-line, 12-week treatment phase with diclofenac 3% gel alone, the number of AKs per subject was reduced to an average of 1.5 (range zero to five), with complete clearance of lesions in 21 cases. Patients showing incomplete response to the treatment then received liquid nitrogen ablation for all residual lesions, resulting in complete clearance of all cases. Importantly, patients had no AK recurrences for an average of 10 months (range six-20).

Another recent study examined the effects of topical imiquimod cream 5% on AKs. Applying the cream for 24 weeks may yield positive effects in the treatment of actinic keratoses (J Am Acad Dermatol). Researchers assessed 15 patients with actinic keratoses in a 28-week trial, each of whom applied topical imiquimod 5% cream to affected areas on one side of the body and a placebo cream to the opposite side once a week. Researchers assessed patients at 28 weeks, seven of whom had marked improvement or better on the actively treated areas, while only one patient had improvement in areas treated with placebo. Total number of lesions declined from an average of 1.93 to 1.47 on the actively treated side, while the numbers increased on the placebo side.

Lice Be Gone
Controlling head lice may be as simple as using the right shampoo. Researchers evaluated a novel coconut-derived emulsion shampoo in children with head lice and found it to be effective at controlling infestations (J Euro Acad Dermatol & Ven 23:67-69). In a school trial, pupils were treated on days zero and seven and checked on days eight and 15, and in a family trial, product was applied by parents three times in two weeks or used as a cosmetic shampoo and checked on days 14 and days 70. In the school trial, percentage cures at day eight were 61 percent and in the family trial, cure rate was 96 percent. Additionally, if the shampoo was subsequently used as a cosmetic shampoo, only one of 12 children became re-infested after 10 weeks.

Rethinking Networking
While researchers warned that readers should be cautious in attributing correlations in health outcomes of close friends to social network effects, they recently reported the identification of significant network effects in the acquisition of acne, headaches, and height. Of interest to dermatologists, having a friend with acne increased an individual's odds of having acne problems (odds ratio 1.62, 95% confidence interval 0.91 to 2.89) (BMJ 337:a2533). In the study of "network effects," researchers used statistical analyses common in network studies, such as logistic regression and longitudinal analyses, and found that while significant network effects were observed in the acquisition of acne, headaches, and height, the results became uniformly smaller and insignificant when adjusting for environmental confounders.

Gelling to Safety
Dapsone gel appears safe when applied topically to treat acne vulgaris (Arch Dermatol 144:1564-1570). Researchers evaluated the risk of drug-induced hemolytic anemia in 63 patients who had acne vulgaris, who were randomized to receive either 5% dapsone gel or vehicle. None of the reported adverse events included signs or symptoms of hemolytic anemia, and only eight patients reported any adverse events related to dapsone gel treatment. The number of patients who had a 1g/dL or greater decrease in hemoglobin level and the range of hemoglobin changes from baseline were similar between vehicle and dapsone gel treatment regimes at weeks two and 12, and all low hemoglobin levels remained close to normal range.

Approvals Up in '08
The Food and Drug Administration gave the thumbs up to 24 new drugs in 2008, more than any of the previous three years, according to The Wall Street Journal. The agency approved 18 drugs in 2007, 22 in 2006, and 20 in 2005. According to the Journal, the agency's high 2008 approval rate is "a consolation of sorts to an industry struggling with greater scrutiny, thousands of layoffs and thinning drug pipelines." Despite the higher number of green lights, delays in the approval process were more notable in 2008. The FDA resolves to reach a final decision on 90 percent of applications within the six- to 10-month time frame. However, the agency says it missed 32 out of 159 drug application deadlines, or 20 percent, through October 31, 2008.

According to a recent report from the Tufts Center for the Study of Drug Development, new drug development still takes an average of eight years. Although efforts by FDA to speed up the review and approval process led to an average review time of 1.1 years in the 2005-2007 period, the length of the clincal phase of development has increased, the Center reports.

Trends: Health Spending
The growth rate of US prescription drug spending in 2007 fell to its lowest level in three decades, according to an inflation-adjusted analysis of IMS data published last month. According to researchers, this decline in spending growth has created a "turning point" in healthcare with several implications:

• Prescription pharmaceutical costs are currently rising very slowly or even falling. In fact, prescription drug spending growth is now likely to be lower than any other major medical care sector.
• A decline in prescription sales growth may come at a cost. It could stifle or limit investment in research and development, the authors warn.
• Perhaps not suprisingly, the authors predict that achieving the much desired "balance between regulatory stringency and the introduction of innovative therapies will rise to the top of healthcare policymaker and industry agendas."
• Cost-sharing measures between payers and patients, used judiciously, are effective to limit the growth of future pharmaceutical spending.
• Enacting other more palatable measures may avoid the need to limit growth in drug spending levels "by limiting the uptake of new therapies."

—Health Affairs, 28(1): w151-w160