Thursday, May 7, 2009

The Gardasil Campaign Picks Up Some of Merck’s ‘Hit List’ Strategies.

It’s a classic case of, if you’re not white-hot with rage, you’re sure as heck not paying attention.

Last month The Australian reported that Julian Burnside QC (Queen’s Counsel) had produced in court internal Merck emails that contained a ‘hit list’ of doctors, researchers and academics it needed to neutralize or discredit. In some cases it was noted that a doctor had already been neutralized. “We may need to seek them out and destroy them where they live,” it read. (One can only assume that the advice was not meant to be taken Mafia-style.)

Why discredit these people? Because they had criticized Vioxx or Merck.

Now it turns out that New Zealand’s Health Ministry may have picked up a few tips from Merck.

Just to refresh your memory, the Merck e-mails were presented in a class-action lawsuit against Merck over its anti-inflammatory drug Vioxx. Julian Burnside also produced evidence that Merck had attempted to intimidate researchers with implied threats of funding cut-offs or withdrawn academic appointments. An infuriated James Fries, professor of medicine at Stanford University, had apparently written to Merck back in 2000 to complain about the way it had treated some of his researchers who had been critical of Vioxx.

“Even worse were allegations of Merck damage control by intimidation…This has happened to at least eight (clinical) investigators ... I suppose I was mildly threatened myself…”

Specific incidences of intimidation included one of Fries’ colleagues’ belief that his position had been put in jeopardy, and phone calls to another alleging his “anti-Merck” bias. Fries apparently told Merck that it had been ‘systematically playing down the side effects of Vioxx’ and that its behavior "seriously impinges on academic freedom."

"In every possible way the company exerted itself to present the impression to the world at large that Vioxx did not provide any increased cardio risk ... when (a) it probably would and (b) it probably did," the letter went on to say.

So, on to Gardasil and New Zealand’s Ministry of Health.

New Zealand is having a bit of a problem with implementing its country-wide Gardasil vaccination program. The 3-shot HPV vaccine is being administered through schools, and 78 schools, about 5 percent, have declined to take part.

Furthermore, New Zealand’s self-described “leading health and fitness magazine” Fitness Life produced an article critical of Gardasil because, according to the publisher, the drug had been heavily promoted by a glowingly positive Ministry of Health and Merck, and no-one had publicly discussed potential long-term effects.

The article was publicized with a billboard in the middle of Auckland. The Ministry of Health promptly filed a complaint with the Advertising Standards Authority (ASA) on the grounds that both billboard and article were “misleading, deceptive, and irresponsible.”

The magazine countered that it would be deceptive and irresponsible to “only talk Gardasil up, regardless of possible side-effects…The advertisement and article were commissioned with a keen sense of social responsibility and with the hope that, by asking entirely valid questions, we are opening the floor to fresh debate on an issue that is of great importance to families and their daughters.”

Fair enough. The ASA agreed on all counts and threw out the MoH’s complaint.

Now, here’s where it gets interesting.

The MoH’s next cannon-ball was a written response to the article, available online, from the Immunisation Advisory Center.

After an unprofessionally snarky introduction, it counters some errors, such as a statement in the Fitness Life article that Gardasil contains a dead virus (it’s neither dead nor alive; it in fact uses a new genetically-engineered process that produces “virus-like particles”). It clears up some “confusions” and reiterates the CDC’s stance that, regardless of VAERS data (which is raw and often unverified data, both under-reported and over-reported) Gardasil “has not been found to increase the risk of any of the serious conditions (other than anaphylaxis) noted in Wheaton’s article.”

I’m certainly not opposed to correcting statements of fact. As a writer, I do my damndest to get my facts straight, and I’m happy to correct any factual error that I might make. I get positively crabby, actually, when people do the Chinese-whispers thing with some fairly outrageous suggestions—and that certainly has been known to happen with Gardasil. Because Fitness Life is not online, I have no clue what the article actually said.

But what sticks in my craw, apart from the pettish tone of the response, is the rather blatant attempt to shut down debate.

And what really, truly sticks in my craw like a bowling ball in a drinking straw. is the little zinger at the end.

“A note on Diane Harper: After involvement with Merck and Gardasil clinical trials, Diane Harper disappeared and was found working for GSK on the Cervarix clinical trials. Her position on Gardasil may not be neutral.”

Wow. That comes straight out of Merck’s playbook.

I don’t know Harper from Adam. But I’ve liked the seemingly very realistic and sensible statements I’ve heard from her. She has said, pretty much, that Gardasil is a great vaccine that is very valuable for most women, BUT that it was marketed too aggressively, introduced too rapidly, and could be a no-no for people with a family or personal history of auto-immune disorder. In other words, she’d have liked to see Merck and medical authorities proceeding a little more cautiously with a brand-new vaccine. Which sounds completely reasonable to me.

Oh wait. It’s partially critical.

So let’s discredit her.

Yep. Sounds like good old New Zealand has been getting some advice from Merck.

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