You won’t believe who they’re trying to sell Gardasil to now

Third Time–No Charm

Merck said, “Please?” And the FDA said no.

Merck said, “Pretty please?” And the FDA said no.

Merck said, “Pretty please with sugar on it?”

We’re still waiting for the FDA’s final answer. If there’s a shred of rational thought, if there’s a shred of concern for consumer safety, agency officials will say no one last time.

But those big “ifs” couldn’t get much bigger.

Once again, the issue is Gardasil, Merck’s HPV vaccine.

The FDA allows Merck to market the vaccine to girls and women, ages 9-26. Late last year, the agency OK’d the vaccine for boys and men, ages 9-26, to help prevent genital warts.

But here’s what has my blood boiling today: Merck has been trying to get an FDA OK to market Gardasil to women, aged 27-45. Twice the company was rebuffed. But in the closing days of 2009, Merck executives submitted data from a four- year Gardasil study that (presumably) supports the claim that the vaccine is effective in the 27-45 age group.

NEVER MIND, of course, that a New England Journal of Medicine analysis found that Gardasil use is not cost- effective for young women 18 and older. The reason: The vaccine doesn’t prevent HPV when given to a woman who’s already sexually active.

And yet Merck pushes on. Well, you know, business is business. NEVER MIND, of course, that the FDA has received more than 15,000 adverse event reports for Gardasil use among girls. Those reports include over 1,000 severe reactions and 27 confirmed deaths.

Do you think those deaths weigh heavily on Merck executives? Come on… this is the company that aggressively marketed Vioxx long past the point when it became clear that the drug sharply increased heart attack risk. FDA officials estimate that Vioxx contributed to well over 27,000 heart attacks and sudden cardiac deaths.

But with a wave of a hand, Merck attorneys made thousands of Vioxx class action suits simply go away. They wrote a check for $5 BILLION and moved on.

A company with ethical standards like that (and a checkbook to match) would think nothing of promoting widespread use of an expensive and dangerous vaccine for women who don’t stand to benefit from it at all.

Speak your mind

Merck is responsible for most, but not all, of the Gardasil madness.

A couple of months ago, the CDC’s Advisory Committee on Immunization Practices (ACIP) added their own insanity to the mix.

The committee voted to recommend “permissive use” of Gardasil for boys. That is, the vaccine should not be regarded as necessary.

But that’s not the insane part. Here’s where it just gets loco…

The ACIP voted to recommend Gardasil for all boys who are eligible for Vaccines For Children–a government-funded program that provides vaccines for kids who are uninsured or eligible for Medicaid health insurance.

So the committee does NOT recommend the vaccine for all boys, but it’s all too happy to devote tax dollars so that boys with a financial need can be inoculated with this dangerous vaccine.

Want to put a stop to this madness?

You can start by taking a look at a video I made to highlight the pitfalls of Gardasil use.

Then you can use this link to write a note to the FDA Center for Drug Evaluation and Research.

Please join me in letting CDER know that we don’t want to see one more girl or boy put at risk with this absurd vaccine.

To Your Good Health,

Jenny Thompson

Sources:
“Merck Submits Data to Widen Gardasil Use” Pharmalot, 1/14/10, pharmalot.com
“U.S. Advisers Decline to Push Gardasil for Boys” Maggie Fox, Reuters, 10/21/09, reuters.com