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Merck launched its new cervical cancer vaccine with a major advertising and lobbying blitz, and pushed to make the drug mandatory for all 11- to 12- year-old girls. Cervical cancer, caused by the sexually transmitted human papillomavirus (HPV), affects 10,000 women in the United States every year, and kills 3,700. The toll is far greater in the developing world, where women lack diagnostic Pap tests.
Gardasil may well be what Merck claims: a lifesaving vaccine that protects against key HPV strains without any significant side effects. Because the drug is most effective on unexposed populations, the FDA recommends vaccinating girls as young as nine – before they are sexually active.
Merck – along with Women in Government (WIG), a recipient of Merck funding – went one step further, advocating mandatory vaccination. WIG has introduced bills in 20 states; in Florida, Merck helped write the legislation. In Texas, brushing aside abstinence junkies and the legislature, Gov. Rick Perry issued an executive order requiring vaccination for all girls entering the sixth grade unless parents opt out.
The stealth timing (late on Friday, just before Super Bowl Sunday), politics (Perry is a pro-abstinence Christian Conservative), and speed of Perry’s order (just months after the FDA approved the vaccine and before all the data have been published) raised questions. It soon emerged that the WIG state director is the mother-in-law of Perry’s current chief of staff, and his former chief of staff is now one of Merck’s three Texas lobbyists. The governor received $6,000 from Merck’s political action committee.
While Perry’s pace is suspect, Merck’s is transparent. If Gardasil becomes routine, the $360 course will generate annual sales of $3.2 billion by 2010. This potential windfall has led cynics to dub the push the “Help Pay for Vioxx” program. Before Merck withdrew the arthritis drug in 2004, it may have caused almost 28,000 deaths, according to FDA estimates. In one Texas liability trial, lawyers produced documents and e‑mails from Merck scientists discussing Vioxx’s potential heart risks as early as 1997, more than two years before it went on the market.
In the meantime, people will have to weigh the risks of trying a new vaccine. While there are good reasons for women to take Gardasil – especially if they lack access to regular Pap tests – there are also solid reasons for waiting before making it mandatory. (They do not include the paranoid belief that all vaccines are evil, or the worry that protecting against an STD encourages girls – already undeterred by fear of AIDS, pregnancy, fumbling teenage foreplay, eternal damnation, or being labeled a slut – to indulge in unbridled sex.)
“The safety of new agents cannot be known with certainty until a drug has been on the market for years,” according to a 2002 study in the Journal of the American Medical Association. “Serious ADRs [adverse drug reactions] commonly emerge after Food and Drug Administration approval.” Reacting to outrage over Vioxx and other drug safety debacles, the FDA announced on Jan. 30 that it will eventually require comprehensive safety reviews of new drugs 18 months after their introduction.
For now, assurances of efficacy and safety are only as good as the data on which they are based. While more than 20,000 women between ages 16 and 26 took part in trials, the sample of 9- to 15-year-old girls was small – only 1,184. And since no participants have been followed for more than five years, long-term effects remain unknown.
“The published data looks great, but at the very least, I would like to see efficacy data among 11- and 12-year-olds, which won’t emerge until they are sexually active,” says Karen Smith-McCune, a professor of obstetrics and gynecology at the University of California, San Francisco.
It also takes time to assess whether data are comprehensive and reliable, and mirror real-world conditions. Merck outsourced some of its Gardasil trials to Contract Research Organizations (CROs) in the developing world, including JayaJan Pharmaceutical Research in India. CROs are part of a $14 billion industry that recruits subjects and runs trials for Big Pharma. Conflicts of interest can arise when CROs are paid royalties only after a drug is approved rather than getting a set fee independent of results, or when CROs believe favorable findings will lead to future contracts. Merck spokesperson Amy Rose refused to specify how, or even if, the company oversees CROs.
The FDA – hobbled by underfunding, politicization and dependence on Big Pharma money – has few resources to assess foreign trials and relies on drug companies. Even U.S. studies are subject to manipulation, as when researchers simply exclude unfavorable trials from those submitted to the FDA.
Of course, none of this means that Gardasil is unsafe. Few things in medicine are guaranteed, and odds are good that the HPV vaccine is a life-saving breakthrough. But consumers, activists, health professionals, and parents wanted the option of waiting for more data. The mighty PR stink they raised smothered Merck’s lust for an instant blockbuster. On Feb. 20, the company announced it would immediately stop lobbying state legislatures to make vaccination mandatory.
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