Wednesday, April 4, 2012

Matt Herper Is -- Of Course -- Completely Right About Gardasil® (Both Good And Bad)

Forbes is running a very important piece on the case for HPV vaccination -- as well as against the undue politicization of the same (at least as to HPV vaccines), through legislative mandates -- all as a sub-rosa means to drive pharmaceutical profits.

Do go read all that Mr. Herper has written -- but here is a bit:

. . . .Merck bears more than a little responsibility for the negative response to Gardasil. When it was introduced in 2006, Merck was still reeling from the 2004 withdrawal of Vioxx and the resulting flood of lawsuits. Instead of going slow, as many of its own advisors recommended, Merck began an advertising push to raise awareness of the risks of HPV and began lobbying state governments to make Gardasil shots mandatory. Perry was the first to sign on. Virginia, which originally voted to make HPV vaccines mandatory, recently reversed the vote. Merck would have done better to take a stance like that of the American College of Obstetricians & Gynecologists, which strongly recommends HPV vaccines for 11- and 12-year-old girls but says they should not be mandatory. . . .

"It would not have been the way the old Merck would have done business," says David Kessler, who ran the Food & Drug Administration from 1990 to 1997. "It was a science-based company, not a marketing company. They would have been able to educate the medical community about the benefits, and the medical community would have adopted the product over time. . . ."

The company seems to agree. "Merck suspended our lobbying five years ago because our involvement became a distraction, and we believed the focus should be on the battle against cervical cancer," a [Merck] spokeswoman says. . . .

Merck's next-gen HPV vaccine -- reputed to cover more genotypes of the HPV virus -- is likely to be filed with FDA in late 2012. Let's hope the folks at Whitehouse Station do heed their lessons earlier learned -- on Gardasil®.


Anonymous said...

I clearly remember remarks Dick Clark made at a Town Hall event not long after the Gardasil approval. His explanation for the lobbying was that if the vaccine was not mandatory there would be an access issue. Once a vaccine is mandatory it becomes part of the shots needed to attend public schools, for instance. If a child didn't have health insurance the vaccination would be subsidized or even free as part of the mandatory series of vaccines required for school attendance.

I'm not saying this was correct or the right thing to do but it was how it was explained to the employee population at the time of the flap.

condor said...

Thanks Anon. -- I do think there is quite a bit of truth to all of that. It was my experience that the the strategic thinking on the best way to get a meningococcal vaccine (for example) widely distributed -- would have been to mandate it, for all. [That never happened in the US; but it did in the UK and the EU, eventually.]

I think the question I raise is where do we draw the line -- how young, and for what conditions -- as to a vaccine that prevents only a handful of the varieties of HPV transmission, and where in many cases it will not lead to any cancer.

It is my understanding that -- for the vast majority of boys, and for many many girls, too -- HPV clears itself -- without any chance of a cancerous aftershock.

I do not mean to appear callous, here -- but there is a small, but appreciable risk with any vaccine. For a 12 year old who is clearly not sexually-active (and thus, by definition CANNOT contract HPV), how deeply should the state intrude into a family's private medical decision?

Again -- greatly enjoying the depth of knowlege you are laying out here!

Do keep it up!


Anonymous said...

Condor, I agree, it is a conundrum to sort out at what age and if it really is worth vaccinating all when the vast majority will never suffer from being exposed to HPV.

I think the Forbes piece points out very well that the lobbying effort was motivated by marketing, something Merck has really never been very good at, imo. They were, indeed, about the science and all the way back to the famous George W. Merck quote, have been known more for education than for strong arming.

If Gardasil had been approved before the Vioxx withdrawal maybe the strategy wouldn't have been judged so harshly. No matter when it was released, however, it is clear that Merck underestimated the reaction parents would have to vaccinating children against potential disease states caused by sexual contact.

Anonymous said...

Children DO NOT have to be vaccinated in order to attend public schools. ... so tired of conversation about mandatory vaccination in order to attend school.

I do have another question that Merck never has answered ... why is it that some children that were vaccinated with the HPV vaccine have now contracted HPV infections? How is this possible if they were NEVER SEXUALLY ACTIVE? Hmmm? I believe Merck is indeed very good at marketing - just not at marketing the truth. ...