An impressive body of efficacy and safety data support use of Merck's ($MRK) blockbuster Gardasil, but HPV vaccines have lacked wider acceptance because of an ugly confluence of factors in U.S. culture that could end up costing people their lives.
In a Forbes article, Matthew Herper examines the amalgam of ills at play in the Gardasil saga. The vaccine has been used in millions of women to combat HPV, which is linked with cervical cancer. Yet HPV is believed to be a culprit in several tumors, including throat cancers in men who could get the virus from having sex, but the regulatory reality of getting an FDA green light for such use of the vaccine could take decades.
Gardasil and other vaccines have also suffered from the comments of politicians, according to Herper's article. Infamously, former Republican presidential candidate Michele Bachmann attacked the safety of Gardasil during her failed campaign with an anecdote about it causing someone's child to become mentally impaired. Such comments stoke fears about medicines and can overshadow the mountains of evidence that support their safety in the public eye.
And both Republicans and Democrats share blame for sapping FDA staffers trying to make scientific evidence, not politics, a gold standard for regulating products.
"If you look at both sides of the political spectrum I'm amazed and appalled by the lack of knowledge that's being put forward as knowledge," Robert Ruffolo, former head of research at Wyeth, told Forbes. "They're not scientists. They're not physicians. And many politicians will say almost anything during election season."
Merck and other pharma companies share some of the blame for cultural Kryptonite that can plague the use of lifesaving drugs, according to Herper's piece. The Whitehouse Station, NJ-based drugmaker's past sins during the Vioxx scandal and aggressive early marketing push for Gardasil during the previous decade appear to have weakened its credibility and its ability to advance Gardasil for patients who could benefit from the vaccine.
- read the Forbes article
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