Where The Boys Are: Merck, Gardasil And HPV

Pharmalot by Ed Silverman

where-the-boys-are1In the midst of ongoing controversy over HPV vaccines, the Advisory Committee on Immunization Practices, which advises the US Centers for Disease Control and Prevention, voted unanimously to recommend routine use of Merck’s Gardasil in boys as young as 11 years old. The vaccine fights human papillomavirus, which causes genital warts and oral, penile and anal cancers in men and cervical cancers in women.
Two years ago, Gardasil was first approved for in males between ages 9 and 26 to combat two HPV strains that can cause genital warts, so the new recommendation greatly expands the population, although the ACIP previously suggested vaccination was suitable for boys. As for females, the Merck vaccine was originally approved in 2006 to protect against four HPV strains that can lead to cervical and other cancers in girls and women in the same age range.
The move comes just weeks after Gardasil took center stage in the Republican presidential primary campaign. Texas Governor and GOP candidate Rick Perry backpedaled on a 2007 decision to mandate Gardasil for school-age girls, and his ties to Merck at the time became campaign fodder. Later, rival candidate Michele Bachmann claimed Gardasil causes brain damage (see here and here).
The ruckus reflected concerns over side effects, long-term benefits and views of social conservatives, who fear vaccination will give teenagers a green light to premarital sex. This last issue was debated in California over the past several months, where a bill was introduced that removed parental consent for vaccinating children 12 and older against sexually transmitted diseases. Earlier this month, California Governor Jerry Brown signed it into law, but not before the debate raised charges that Merck engaged in the sort of surreptitious lobbying that was conducted when Gardasil was approved in 2006 (back story).
This is the second bit of good news that Merck has received this week about Gardasil. Early-stage research found evidence of a link between HPV infection and heart disease in women who have no other risk factors. The study appeared in the Journal of the American College of Cardiology (see here).
Last year, Gardasil sales slowed considerably, from $1.4 billion in 2008 to $988 million, although for the first half of this year, revenue climbed about 10 percent, to $490 million, from a year earlier. Besides controversy, cost has also been a factor – Gardasil costs about $360 for a three-course dose. The drugmaker will welcome the increased sales that come with the ACIP recommendation, given that 13,000 jobs are in the process of being eliminated. In fact, Merck employees in numerous locations this week are being notified of pending layoffs.

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