Dermatologists and Statistics
Apparently, dermatologists are lacking when it comes to appropriately using statistical methods and interpreting resultsbut not any more so than physicians in other specialties, according to a recent review of studies in the Archives of Dermatology and the Journal of the American Academy of Dermatology by researchers at Wake Forest University. They found that 38% (59) of 155 articles that used statistical analyses either had errors in the methods or omissions in reporting of results. They reviewed original studies from January through December 2003. Twenty-two studies erred in use of a statistical test, thus possibly changing the validity of results; 41 presented results incorrectly, and 4 had errors in both test use and presentation. Thirty-eight were in the Journal of the American Academy of Dermatology and 21 were in the Archives of Dermatology. To reduce errors, perhaps all papers should be reviewed by a statistician before submission, and statistics training should be added to dermatology residency programs, suggested the authors. The paper was published in the June 2006 Archives of Dermatology.
Supplement Side Effects
Dietary supplement makers and producers of over-the-counter drugs would be required to report serious adverse events to the Food and Drug Administration within 15 business days, under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3456), currently pending in the U.S. Senate. Events would include death, a life-threatening experience, hospitalization, disability, or a birth defect. Retailers would not be required to report the events. The bill was introduced by strange bedfellows: Sen. Orrin Hatch (R-Utah), who crafted the 1994 Dietary Supplement Health and Education Act (DSHEA), which is widely seen as a loophole for the products, along with two frequent critics of DSHEA: Sen. Tom Harkin (D-Iowa) and Sen. Richard Durbin (D-Ill.). The proposal also has the backing of consumer advocates such as Consumer Reports and the Center for Science in the Public Interest, and of industry groups, including the Consumer Healthcare Products Association, the American Herbal Products Association, the Council for Responsible Nutrition, and the National Nutritional Foods Association. The bill could be on a fast track to approval; it was accepted and reported out of the Senate Health, Education, Labor and Pension Committee earlier this summer and now will go before the full Senate.
Postmarketing Study Failure
The Food and Drug Administration is doing a poor job of ensuring that pharmaceutical companies live up to postmarketing study commitments, according to a new report by the Department of Health and Human Services' Office of Inspector General. Among the findings: that the FDA can't easily identify if the studies are progressing or what stage they are in; and that monitoring postmarketing studies "is not a top priority at FDA." The IG reviewed new drug applications from 1990 to 2004; 48% of those applications had at least one postmarketing study commitment. Drugmakers are required to submit annual status reports. The IG found that 35% of the reports that should have been submitted in fiscal 2004 were missing or had no information on the study commitments. The IG noted that the FDA has limited enforcement power in this area, but suggested that the agency require more, and more relevant, information from drugmakers. In response, FDA said it could not do that without additional regulations, but agreed that it needed to do more to improve its monitoring and to ensure that commitments are honored and that annual reports are thorough.
Part D Drug Price Increase
The advocacy group Families USA says almost all the plans participating in Medicare Part D drug coverage raised prices from November 2005 to April 2006 for pharmaceuticals frequently used by seniors. The data are compiled from pricing reports submitted to the Center for Medicare and Medicaid Services. All the plans raised prices for Zocor (simvastatin), and most did so for Fosamax (alendronate), Actonel (risedronate), Nexium (esomeprazole), and Norvasc (amlodipine). The median price increase for the top 20 drugs used by seniors was 3.7%, said Families USA. Increases for Celebrex (celecoxib), Lipitor (atorvastatin), and Aricept (donepezil) were 6%. During the November-April time period, the median price increases for the Part D plans "were virtually identical to changes in manufacturer prices as measured by average wholesale price (AWP)," according to the report. "This means that Part D plans are doing essentially nothing to contain the fast-rising prices by the drug industry," said Ron Pollack, executive director of the group, in a statement. CMS, however, said that its analysis showed that Part D plan prices rose 3.6% on average while AWPs rose 4.1%, resulting in savings to taxpayers.