HPV and Corporate Welfare
by Ryan McMaken
by Ryan McMaken
Efforts continue in state legislatures across the country to force twelve-year old girls to submit to a regimen of vaccines for certain strains of the Human Papilloma Virus, or HPV. This drive to coerce families into submitting to yet another state-mandated round of vaccinations has illustrated just how reckless legislators can be with the health of citizens while bringing to the fore the immense power exercised by drug companies supposedly regulated by the FDA.
Almost as soon as the FDA approved the new vaccine, legislators immediately began drafting bills to create new state mandates requiring the vaccination of 12-year-old girls with the HPV vaccine Gardasil before being admitted to school. The vaccine, produced by Merck & Co. costs $360 for the series of three shots, and, if it becomes mandated by states, Merck has stated that it hopes to generate as much as $3 billion in annual sales from Gardasil.
The politicians who have been bringing the legislation forward naturally present the state mandate as a women's health issue, using the usual nanny-state rhetoric about saving the masses from themselves while providing us all with a valuable public health lesson. Such rhetoric, unwelcome and authoritarian as ever, was this time worthy of added condemnation in that it is part of a massive corporate welfare scheme on an unprecedented scale.
In February, it became clear the meteoric rise of Gardasil in the minds of lawmakers is in fact the result of little more than a massive lobbying campaign initiated by Merck & Co. in which states would be convinced to mandate the vaccine. State tax-revenues would then be used to supplement the high cost of the vaccine for low-income families, thus providing Merck with a healthy portion of those billions in Gardasil sales care of the U.S. taxpayer.
Indeed, the connection between the allegedly selfless actions of lawmakers and the direct benefit to Merck & Co. was so obvious, that public opposition forced Merck to cease its lobbying campaigns (at least the more overt parts) in February. By then, the Texas legislature was already acting to rescind an executive order handed down by Texas governor Rick Perry which would pump $50 million of state money into Merck's coffers in the first year alone.
Perry, in fact, accepted a $5,000 "donation" from Merck on the very same day he met with Merck about the executive order. Perry's chief of staff is now a lobbyist for Merck.
Perry and other accommodating politicians met with opposition from right-wing groups like Focus on the Family, parent groups, and medical organizations like the American Academy of Pediatrics. The claims being made by Merck and its mouthpieces about the safety and effectiveness of the new vaccine turn out to be based on rather shaky ground, adding even more credence to the arguments of critics that both Merck and the Food and Drug Administration were more interested in greasing the skids for Merck & Co. than anything else.
In its May/June issue, Mothering magazine, a publication that can only be described as required reading for the midwife-neo-hippie-organic-food-extended-breastfeeding crowd (hardly Focus on the Family's natural ally) published a scathing anti-Gardasil article warning readers about the thoroughly inaccurate claims being buttressed by both Merck and the FDA.
The article notes that while Merck sought to up revenues by setting the government-mandated vaccination age at 12, it turns out that all the long-term serious testing of the vaccine's safety and effectiveness had only been done for women age 15 and older. Merck claims that some studies had been done on girls age 10 to 15 years, but such studies are neither published nor peer-reviewed, so all we have is Merck's word that the vaccine is safe for the younger age group, and any member of the public seeking to read such studies is simply out of luck. The FDA's press release on the vaccine however (undoubtedly drafted by a Merck public relations staffer), clearly gives the impression that full testing has been done for the younger age group.
Indeed, when the FDA approved the vaccine in June 2006, it recommended that it be administered to females between the ages of 9 and 26, in spite of the discrepancy in the research. Also troubling is the fact that, in a study published in the Journal of the American Medical Association [the Feb 28 issue, in an article by Dr. Eileen F. Dunne, et al.], only 3.4% of HPV infections detected in subjects of the study were of the strains that Gardasil provides protection against. Add this to the fact that no data exist on the prevalence of HPV among girls younger than 14 and that most girls age 14 to 19 do not have HPV, the political campaign to force parents to vaccinate their 12-year-old daughters is billions spent on a vaccine that protects against only 3.4 percent of all HPV cases for a population with an unknown prevalence of HPV in the first place. Other recent studies have also shown that the benefits of the vaccine have been exaggerated.
In other words, Merck will benefit mightily from a costly public health program of unknown safety and benefit in the long term, or even in the short term. What we do know, is that it will cost the taxpayers billions in addition to subjecting them to yet another coercive government invasion of privacy and family prerogatives.
What the whole ongoing episode illustrates is that phenomenon known to political scientists as "regulatory capture" in which the big players in the regulated industries are the ones who end up writing the regulations. This was the case with the railroads and the interstate commerce commission and it was the case with the airlines and the Civil Aeronautics Board. And now, it is the case with Merck and the FDA. Regulated industries are smart enough to recognize that the regulator can be used not only to limit competition by preventing entry into the market, but in the case of pharmaceuticals especially, the federal regulators are an invaluable partner in convincing the public that certain drugs are safe, even when they're not.
The FDA has made it clear that it is willing to approve pretty much anything as long as the pharmaceutical companies employ enough lobbyists to make sure it happens. The recent debacle with Vioxx (also produced by Merck) shows that the FDA serves little purpose other than to approve the drugs that the drug companies think it should approve, and to provide cover for irresponsible publications like The New York Times which apparently thinks that if the FDA likes it, it must be good.
Meanwhile, cheap, effective remedies for various ailments like medicinal marijuana or even less expensive imported drugs of all kinds are ferociously opposed by the Bush administration and by the Congress. Federal police are kicking in doors in California to harass legal users of marijuana (legal under California state law), while governments simultaneously shove unproven vaccines like Gardasil down everyone's throats. And all the while, the FDA finds the enthusiastic help of toadies like The Nation's Katha Pollitt who is desperate to believe that all opposition to the vaccine is coming only from so-called right-wing nuts who oppose the vaccines for mere religious reasons.
It is hard to imagine how the recklessness and corruption of the FDA, and the substantial political clout of some pharmaceutical companies could be better illustrated than the recent drive for massive state-funded HPV vaccination programs. The movement benefited greatly from the unquestioning "women's health" lobby for whom a press release from a government agency is apparently infallible, but for some responsible publications and activists, the benefits are hardly crystal clear.
Yet even if the vaccine were the greatest medical development since penicillin, the political enthusiasm over Merck's lobbying drive makes it clear that few organizations are more thoroughly unqualified to dictate health care options to families than legislatures and the FDA.
May 18, 2007
Ryan McMaken [send him mail] teaches political science in Colorado.
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