Merck Is On The Defensive Over Gardasil, Again

Merck Is On The Defensive Over Gardasil, Again

September 15th, 2011 // 1:20 pm @

These are trying times for the Merck c-suite. For the past week, their Gardasil vaccine has been in the news every day, but not for very good reasons. First, Texas Governor Rick Perry is attacked by his rivals for the Republican presidential nomination for accepting Merck donations leading up to his controversial decision to unilaterally mandate Gardasil for school-age girls.

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Then, Congresswoman Michele Bachmann not only lambasts Perry for the contributions and the fact that his former chief of staff was by then a Merck lobbyist, but she told the NBC Today show that one mother approached after her the debate the other night to say her daughter was vaccinated and suffered “mental retardation.” Bachmann then says Gardasil can have “very dangerous side effects.” The rhetoric feeds into the overall debate over vaccine safety. UPDATE: For instance, the American Academy of Pediatrics called her comment a “false statement” .

But there is more. A group of parents who formed a non-profit called SaneVax to publicize side effect concerns about Gardasil a few days ago announced that an independent lab examined 13 vials and found evidence of genetically modified HPV DNA, which the group asserts poses a potential hazard. A Merck spokeswoman dismissed the report, although by then, SaneVax widely publicized the findings and also wrote FDA commish Margaret Hamburg to again urge the agency to review the vaccine.

The continual negative comments and stories prompted Merck last night to take the unusual step of issuing a news release to insist that Gardasil is safe and effective. “The facts are clear,” Merck maintains. The vaccine was approved five years ago to protect against various strains of the human papillomavirus in girls and women ages 9 to 26. HPV can lead to cervical cancer, which is why federal health officials subsequently endorsed its use.

But even before the FDA issued its approval, Gardasil was causing a fuss. Social conservatives and some parents expressed concern that vaccination would be interpreted by teenagers as a green light for premarital sex. Merck then complicated its own cause by conducting a surreptitious marketing campaign to encourage state officials nationwide to require mandatory vaccination.

Nonetheless, the issue shows no sign of abating. A recent uproar emerged in California, for instance, over legislation amid reports that many of the legislators who voted in favor of a bill that would remove parental consent for vaccinating children 12 and older against sexually transmitted diseases had received money from Merck (read this).

Now, Merck is left on the defensive and this comes at a difficult time. In general, the drugmaker has struggled to resume production on some vaccines and Gardasil, in particular, has been wobbling along. Last year, Gardasil sales slowed considerably, from $1.4 billion in 2008 to $988 million.For the first half of this year, though, Gardasil revenue has climbed about 10 percent, to $490 million, from a year earlier.

Nonetheless, teenage vaccination rates for the HPV vaccine are trailing the other two vaccines recommended for teens and pre-teens. and the FDA recently rejected refused to approve the use of the Gardasil vaccine for preventing HPV in women ages 27 to 45, a market the drugmaker has been counting on to boost revenue .

Source: Pharmalot


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