Fresh controversies are heating up over the marketing of products to prevent cervical cancer
August 28, 2009
By Arlene Weintraub
The U.S. Food & Drug Administration is gearing up to make critical decisions about two controversial vaccines. On Sept. 9 an FDA advisory committee will consider whether Merck (MRK)’s Gardasil, given to girls to prevent cancer-causing human papilloma virus (HPV), should be approved for use in boys, who can be HPV carriers. The same panel will also advise the agency on whether it should allow a new HPV vaccine, GlaxoSmithKline (GSK)’s Cervarix, to enter the U.S. market. The FDA doesn’t have to follow its panels’ recommendations, but it usually does.
Sales of Gardasil to prevent cervical cancer hit a respectable $1.4 billion last year, but they are already starting to slump, and fresh controversies could pour more cold water on this whole class of vaccines. Ever since Gardasil was approved in 2006, health-care watchdogs have griped that Merck has been overselling the vaccine’s cancer-beating power without having a full understanding of potential long-term risks. On Aug. 19, Columbia University professors Sheila M. and David J. Rothman published an article in the Journal of the American Medical Assn. blasting the company for paying grants to medical organizations that are strong advocates for vaccination. “Telling every mom she needs to get her daughters vaccinated to protect them from cancer is creating a market out of thin air,” David Rothman says. “They’re already protected” through regular pap smears, he adds.