Political Intrigue in Merck's HPV Vaccine Push

Feb. 22, 2007— -- The manufacturer of Gardasil, the first-ever vaccine shown to prevent cervical cancer, is facing growing opposition to the product's widespread use among pre-teen girls.

But many of the problems are political, not medical. According to documents obtained by The Associated Press, Texas Gov. Rick Perry's chief of staff met with key aides about the human papillomavirus vaccine the same day drug giant Merck & Co, the manufacturer of the vaccine, donated several thousand dollars to his campaign.

Chief of staff Deirdre Delisi's calendar shows she met with the governor's budget director and three members of his office for an "HPV Vaccine for Children Briefing" on Oct. 16, according to The AP report. That same day, the documents show, Merck's political action committee donated $5,000 to Perry and $5,000 total to eight state lawmakers.

The revelation may provide ammunition to those in many states who oppose mandatory vaccination campaigns for pre-teen girls. On Wednesday, a House committee voted to rescind Perry's executive order requiring vaccination for girls in Texas.

Meanwhile, conservative family groups in Minnesota have criticized similar proposed requirements there, maintaining that such a plan would encourage promiscuity.

And in Connecticut, state health officials say they are concerned similar proposed legislation would be premature, citing a lack of available safety data.

The developments have added a new round of political heat that Merck had sought to avoid. Merck announced Feb. 20 that it would suspend its own campaign urging states to implement mandatory vaccination programs for pre-teen girls with its human papillomavirus vaccine.

In its announcement, Merck said it made the move to avoid having its campaign take attention away from the bills being drafted in several states that would make the vaccine mandatory for pre-teen girls.

"We … do not want any misperception about Merck's role to distract from the ultimate goal of fighting cervical cancer, so Merck has re-evaluated its approach at the state level and we will not lobby for school requirements for Gardasil," said Mary Elizabeth Blake, senior director of public affairs for the Merck vaccine division, in a prepared, e-mailed statement.

Blake added in the statement that the company would continue to advocate for educational campaigns around the vaccine and cervical cancer.

Some women's health experts say the move is a step in the right direction.

"I think we have been down this road before with an early polio vaccine preparation, the swine flu vaccine in the '70s, and the first and possibly second generation rotavirus vaccines," said one vaccine specialist who preferred to remain anonymous. "The public needs time to consider the safety of this vaccine. Politicians and drug companies need to stay in the waiting room and out of the examining room," the specialist said.

"My impression is that [the move] will defuse a lot of the heated public debate on what the real purpose of the vaccine is," said Dr. Kenneth Haller, assistant professor of pediatrics at the Saint Louis University School of Medicine. "The fact that Merck was pushing on this did cause a distraction from the issue.

"By pulling back and allowing the vaccine to go through the normal route, this will allow, over time, for greater public acceptance."

Haller said the fact that rival GlaxoSmithKline is currently developing a similar vaccine, possibly slated for release this year, may have been the motivating factor behind Merck's aggressive promotion.

Aggressive Promotion May Have Hurt Public Perception

"I think that Merck has been pushing it so hard that [the company's efforts] have perhaps been viewed negatively by the public," said Dr. Mark Groshek of Kaiser Permanente Colorado's Departments of Pediatrics.

"If this reduces the distraction, then I'm glad for that, because people really need to think about this. For all girls, vaccination really does make sense."

However, since the vaccine was approved only last year, some public health experts feel the push for mandatory vaccination may be coming too soon.

"I am in favor of having all girls receive Gardisil, but I do think that it is a little premature for this vaccine to be made mandatory," said Dr. Tanya Remer Altmann of the Community Pediatric Medical Group in Westlake Village, Calif.

"It is still a fairly new vaccine, most pediatricians are losing money giving it -- I know I am in my office -- and parents are still adjusting to the idea. I think they should give it a few years."

HPV Vaccine 'Still Valuable'

Gardasil, the first -- and currently only -- vaccine of its kind on the market, protects against the human papillomavirus. Researchers have connected the sexually transmitted infection to cervical cancer, which kills between 3,000 and 4,000 women annually.

"This is still a very valuable vaccine," Groshek said. "There are enough people who aren't affiliated with the company to say that it is effective and important."

"The important thing here is to look at the purpose of the vaccine," Haller said. "At this point, 3,000 to 4,000 women die every year because of cervical cancer. This vaccine has the potential to prevent 70 percent of these deaths."