Michele Bachmann’s Mostly Right About the HPV Vaccine

“Little girls who have a negative reaction to this potentially dangerous drug don’t get a mulligan,” Republican presidential hopeful Michele Bachmann said about the controversial HPV vaccine at a Sept. 12 debate. “They don’t get a do-over. The parents don’t get a do-over.”

Bachmann’s comments on the HPV vaccine have struck a nerve in this country. Unfortunately, the media has focused almost exclusively on her unsubstantiated claim, which she’s since rolled back on, that the vaccine may lead to “mental retardation.” Bachman’s other points about the vaccine have gone largely overlooked by the national media, which isn’t all that surprising since they’ve failed to seriously report on this issue for the past four years.

“To have innocent little 12-year-old girls be forced to have a government injection through an executive order is just flat out wrong,” Bachmann said at the debate. Her comments were directed at Gov. Rick Perry, who, in 2007, signed an executive order that made Texas the first state in the country to mandate the HPV vaccine for sixth grade girls. Shortly thereafter, Texas became the first to undo its mandate when the state legislature overturned Perry’s order.

Appearing on the “Today Show” the morning after the debate, Bachmann continued to raise the issue. “It’s very clear that crony capitalism could have likely been the cause [for the mandate] because the governor’s former chief of staff was the chief lobbyist for this drug company,” she said.

Indeed, Mike Toomey was paid between $260,000 and $535,000 from 2005 to 2010 to lobby on behalf of Merck. With his unprecedented access to Perry, Toomey was just the person Merck was looking for in 2005. (Presently, “Mike the knife” is hard at work on a super-PAC, Make Us Great, which allows him to collect unlimited corporate campaign contributions for his former boss’s presidential run.)

As Merck’s stock was falling ever-lower with each report linking the painkiller Vioxx to heart complications, Merck’s HPV vaccine, Gardasil, was rushed to market in record time. Speaking to investors on Wall Street in Dec. 2006, a Merck executive laid out the company’s top priorities for a product launch: “speed, speed, speed.”

With other companies nipping at their heels, Merck moved fast to take advantage of the narrow window in which they’d have the only HPV vaccine on the market. In so doing, Gardasil became the blockbuster they so badly needed.

Gardasil may prove to be even more profitable than Vioxx, in no small part because Merck is unlikely to face costly lawsuits even if its HPV vaccine proves to be harmful. As a result of a 1986 law passed by Congress, liability for vaccine injuries was substantially shifted away from manufacturers to the state.

This is no small matter for Merck, which withheld information from the Food and Drug Administration showing that Vioxx was associated with increased heart complications. In late 2007, Merck agreed to pay $4.85 billion to settle 27,000 lawsuits brought against the company in regards to Vioxx. (For the full story, read Tom Nesi’s “Poison Pills.”)

In his Nov. 18, 2004 testimony before the U.S. Senate Finance Committee, Dr. David Graham, safety officer for the FDA, said of Vioxx:

“We are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world. We are talking about a catastrophe that I strongly believe could have – should have – been largely or completely avoided. But it wasn’t, and over 100,000 Americans have paid dearly for the failure.”

Amazingly, no higher-ups at Merck went to jail. It feels like this massive loss of American life never happened. The press moved on. The event went down the memory hole. Then, with the company’s stock falling, Merck somehow managed to escape skepticism when it announced that it had found the cure for cancer – cervical cancer, that is.

The full Gardasil vaccination consists of three shots, and at $120 per shot, it’s the most expensive vaccine ever recommended by the FDA. Post-approval, Merck needed to generate sales, so it pushed state governments to mandate the HPV vaccine (i.e. Gardasil).

The Perry/Toomey executive order in conservative Texas got things off to a strong start. Virginia and D.C. soon followed. But then Merck hit a road block and in the last four years no other state has required the HPV vaccine.

Here in D.C., a group of us worked to stop the mandate. As part of that effort, I wrote a report in 2007 which called into question the legitimacy of Merck’s testing:

“[S]ome (most?) of Merck’s testing for Gardasil was outsourced to Contract Research Organizations (CROs) who may be paid royalties once a drug is approved, rather than a set fee. Thus, CROs have an interest in seeing results come out a certain way. One of the CROs Merck used for testing Gardasil is JayaJan Pharmaceutical Research in India. Merck spokeswoman Amy Rosen refused to comment on how, or even if, Merck oversees the testing conducted by the CROs.”

In a must-read expose in Vanity Fair, journalists Donald Bartlett and James Steele pull back the curtain on Big Pharma’s shady practices, including the use of CROs. The award-winning duo wrote:

“Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and ‘mistakes’ can end up in pauper’s graves?”

Aside from the use of CROs, there are other serious questions regarding the testing of Gardasil. Dr. Diane Harper, a leading researcher of the HPV vaccine who received funding from Merck, called Gardasil’s use on females under the age of sixteen “a great big public health experiment,” due to the lack of testing on the age group.

Even Merck admits that it’s unknown whether the vaccine offers any long-term protection. “The duration of immunity following a complete schedule of immunization with Gardasil has not been established,” the company states in their medical literature.

It’s unclear why doctors often fail to convey this uncertainty, but instead push Gardasil on their patients with an intensity that is alarming. “It was hard to find a doctor willing to forego the vaccine,” said Kate Straus of Wellesley, Mass., who chose not to get her daughter vaccinated. “As far as I can tell, Ellie was the only girl in her class of 320 in this affluent neighborhood who did not get the series of Gardasil shots.”

In excess of 35 million doses of the HPV vaccine have been given out in the U.S. This couldn’t have happened without doctors pushing it. They tell us the HPV vaccine is necessary in order to prevent against cervical cancer. The funny thing is that we already know how to prevent cervical cancer and have been doing so for years.

With annual Pap smears, pre-cancerous cells can be detected and removed before the disease takes hold. Due to increased availability of Pap smears, U.S. deaths from cervical cancer have fallen precipitously over the last several decades, and it’s conceivable they could become a thing of the past. The way to get there is clear: ensure that all women have access to high-quality, annual Pap smears.

But Merck has a problem with this proven solution: they can’t make billions off of it. So they hired the PR giant Edelman to convince America that Gardasil was the answer to cervical cancer.

The Center for Media and Democracy’s PRWatch described the “One Less” direct-to-consumer advertising campaign:

“The upbeat commercials feature young women and girls engaged in a variety of activities – playing soccer, shooting baskets, skateboarding, drumming, and dancing – saying that they want to be ‘one less statistic,’ ‘one less woman who will battle cervical cancer.'”

The “One Less” ad campaign was an unparalleled success. Medical Marketing and Media wrote, “Merck’s Gardasil team cleaned up [the 2008] Phame Awards, winning honors for Best Branded TV, Best Branded Print and Best Integrated Campaign on the strength of its ‘One less’ campaign.”

Pharmaceutical Executive Magazine chose Gardasil as its 2006 Brand of the Year and wrote:

“The morning of Merck’s annual analyst meeting dawned bright and crisp. At the podium inside the drug giant’s Whitehouse Station, NJ, headquarters last December, CEO Richard Clark was beyond buoyant. ‘We executed every aspect of this launch flawlessly,’ he said about Gardasil, crowing most loudly about the speed with which the pioneering HPV vaccine made it onto state guidelines and won formulary coverage… [T]he rollout of what the media has dubbed ‘the first cancer vaccine’ has cast a halo over Merck, which was badly bruised by the recent fallout from its Vioxx withdrawal and ensuing litigation. But Gardasil is Merck at its best.”

Bachmann is right, this is crony capitalism. It’s a shame that it took four years and an ambitious right-winger in order for the truth about Gardasil to be said on national television with any consistency. “The question is,” Bachmann asked, “is it about life, or was it about millions of dollars or potentially billions for a drug company?”

* This piece was edited slightly since its original posting.

Check out the trailer for the upcoming documentary, “One More Girl”

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Related stories:
Is D.C.’s HPV Vaccine Mandate a Mistake? (A Discussion with Emily Tarsell) 1/28/11
D.C.’s HPV Vaccine Mandate Is “A Great Big Public Health Experiment” 5/4/11
Is Councilmember David Catania Fit for Office? 5/10/11

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