The New England Journal of Medicine published an editorial Thursday in which two obstetricians contest the efficacy of Merck's cervical cancer vaccine Gardasil and advise policymakers, doctors and parents to take a "cautious approach" to vaccination. The journal also published results of a Merck-financed clinical trial of Gardasil, a drug that attacks two kinds of the human papillomavirus (HPV 16 and 18) believed to be responsible for 70% of cervical cancers. The study found Gardasil 98% effective at preventing precancerous lesions related to HPV 16 and 18 among previously uninfected women, but its efficacy dropped to 44% when the subject group included previously infected women and to 17% when all precancerous lesions were taken into account. George F. Sawaya, M.D. and Karen Smith-McCune, M.D. claim in their NEJM editorial that although the vaccine could ultimately have "profound public health benefit," questions remain unanswered about Gardasil's overall effectiveness, the length of time protection will last, and possible side effects. Other scientists have already suggested the billions expected to be spent on Gardasil might be better spent on Pap smear testing for low-income women. Merck pushed state legislatures to make vaccination a school requirement for 11- and 12-year-old girls before being pressed to withdraw the campaign in February. In related news, Glaxosmithkline Thursday reported that it has applied for FDA approval for Cervarix, its own cervical cancer vaccine. If approved, Cervaris will be Gardasil's first competitor.
Sources: HPV Vaccination — More Answers, More Questions [New England Journal of Medicine], Wall Street Journal
Commentary: Merck Pressured to Halt HPV Vaccine Lobbying • Mandatory Vaccination with Merck's Gardasil Raises Eyebrows • Vaccines Suffer from Poor Public Image
Stocks/ETFs to watch: Merck & Co., Inc. (MRK). Competitors: GlaxoSmithKline plc (GSK), Bristol-Myers Squibb Co. (BMY), Pfizer Inc. (PFE), Sanofi-Aventis (SNY). ETFs: Pharmaceutical HOLDRs (PPH), iShares Dow Jones US Pharmaceuticals (IHE)
Conference call transcripts: Q1 2007
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