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.
Such criticisms mark a stark turnabout for a product once hailed as a breakthrough. Cervical cancer is a scourge: 11,000 cases are expected to be diagnosed this year, and 4,000 women will probably die of the disease, says the National Cancer Institute. The vaccine could prevent more than 70% of such cases. But from Day One, Merck has been lambasted for tactics such as lobbying lawmakers to make vaccination mandatory. After a strong start in the first two years, Gardasil sales fell 5% in 2008 and second-quarter sales are down 18% from a year earlier.
Dr. Richard M. Haupt, who heads the Gardasil research program for Merck, defends the company's marketing. "Our goal is to act in the best interest of public health," he says, noting that many organizations have spent money to promote the cause. Should boys be vaccinated? Merck has given the FDA data showing Gardasil prevents 90% of HPV symptoms in men, but since related male cancers are rare, the main justification is to protect their partners from cervical cancer. (Gathering data is also dicey because even if there were a drop-off in cases after widespread male vaccination, Merck could never prove its vaccine deserved more of the credit than, say, improved screening.)
Glaxo, for its part, doesn't plan to market Cervarix to boys because it doesn't think the strategy would be worth the expense. The Centers for Disease Control estimates that vaccinating males would cost the health-care system at least twice as much per year of added life as it costs to vaccinate females.
As for payments to medical organizations, Glaxo, Merck, and their beneficiaries say their disclosures are adequate. Two recipients, the American College of Obstetricians & Gynecologists and the Society of Gynecologic Oncologists, say they put the money to many uses beyond endorsing a specific vaccine. Meanwhile, Merck's Haupt says the scandals are drawing attention away from what could be a public health boon. "I vaccinated both my daughters," says the father of four. And if Gardasil is approved for boys, he says, "I plan to vaccinate both my sons."