The Magazine

A Merck-y Business

The case against mandatory HPV vaccinations.

Mar 12, 2007, Vol. 12, No. 25 • By MICHAEL FUMENTO
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Yet if the Gardasil inoculation sends a message about intercourse, it also sends a much stronger message about Pap smears. Why bother when one is already protected (mostly) from the big danger, cervical cancer? Psychology must be considered as well as physiology.

The usefulness of detection programs is enhanced by the long latency time from HPV infection to cancer. According to physician Mark Spitzer, a gynecologist at New York Methodist Hospital, in a small minority of women, "viral persistence may result in the development of a carcinoma in situ lesion [remaining within the cervix] about 8 or 9 years later. The transition from carcinoma in situ to microinvasive cancer takes a long time, since the median age of microinvasive cancer is approximately 41, or about 12 years older than carcinoma in situ. The median age of [potentially lethal] invasive carcinoma is not for another 7 years after that."

Do the math. After an initial latency period of, say, 8 months (but possibly "many years or decades"), add an additional 8 years, plus 12 more years, plus 7 more years before we have a life-threatening, invasive carcinoma--28 years total. That's why the age bracket with the highest rate of death from cervical cancer is 45-54 and the second highest is 55-64. HPV is generally a young woman's disease; cervical cancer generally that of older women. Averages, of course, are just that. Some will develop the cancer sooner and others later. But once you realize we're talking about an almost three-decade-long period that doesn't begin until the woman first has intercourse and becomes infected, the speed with which politicians are trying to foist these mandates upon parents seems unwarranted.

Indeed, cervical cancer could conceivably be a thing of the past before today's young vaccine candidates reach middle age. As computers become more powerful--with developments such as Intel's "teraflop chip," Hewlett-Packard's nano-chip, and even quantum computing--drug and biologic testing will be transformed, made vastly faster and more effective. Yet as long ago as 1999, a CDC representative testified before Congress that with then-current medical technology and heightened awareness of the need for Pap smears, cervical cancer was "nearly 100 percent preventable."

So why such urgency on the part of lawmakers? Maybe it reflects urgency on the part of Gardasil's maker, Merck & Co. Last December, at a briefing on Wall Street, the president of global human health at Merck, Peter Loescher, remarked that he stresses "speed, speed, speed" in a product launch. That may be because another HPV vaccine, Cervarix from GlaxoSmithKline, was submitted to the European Union for approval about a year ago, and GSK is expected to submit it to the FDA this year.

Moreover, in January GSK announced a head-to-head clinical trial against Gardasil, indicating it believes it may have a superior product. In any event, Cervarix would certainly cut into the profit margin of Merck's vaccine, which, at $360 for the series of three inoculations, is the most expensive vaccine available.

To that end, "Merck is bankrolling efforts to pass state laws across the country," according to the Associated Press. The Baltimore Sun was the first to report that Women in Government, a national advocacy group of female state legislators that's been lobbying hard for mandatory Gardasil vaccinations, has been taking Merck money. "In addition to vaccination mandates, Merck supports measures that would require private insurers and Medicaid to cover the cost of the vaccine," said the Sun. The paper also relayed the estimates of Wall Street analysts: "The vaccine is expected to reach $1 billion in sales next year, and state mandates could make Gardasil a mega-blockbuster drug within five years, with sales of more than $4 billion."

The AP meanwhile reported it obtained documents showing Gov. Perry's chief of staff met with key aides about Gardasil the same day its manufacturer donated money to Perry's campaign. That day, Merck's political action committee forked over $5,000 to Perry and $5,000 total to eight state lawmakers.

"It's not the vaccine community pushing for this," physician Martin Myers, director of the National Network for Immunization Information, told the Sun. Myers, former head of the federal National Vaccine Program Office, added, "Many of us are concerned a mandate may be premature, and it's important for people to realize that this isn't as clear-cut as with some previous vaccines."

Finally, in the face of all this bad publicity, Merck announced it would stop lobbying for mandatory vaccination.