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Cervical Cancer Vaccines and Industry Influence

When the manufacturer of the cervical cancer vaccine announced that it will stop lobbying for mandatory vaccination of schoolgirls, my students reacted with jeers. “So what?” said one, “They’ve already achieved their goals.”

So young, so cynical – but not necessary inaccurate. After all, Merck has spent years, and millions, preparing the market for Gardasil. Merck’s extensive educational campaigns have effectively raised awareness of the existence of human papilloma virus (HPV) and the link between HPV and cervical cancer. And bills requiring mandatory vaccination are pending or being drafted in about 20 states.

Texas led the way when Governor Rick Perry mandated vaccination of sixth-grade girls by executive order, but parental protests and media attention caused the state legislature to overturn the mandate on March 13. Merck’s links with Perry are certainly newsworthy. During his re-election campaign, Governor Perry accepted a total of $6,000 from Merck. Mike Toomey, a Merck lobbyist, is Perry’s former chief of staff, and the current chief of staff held an “HPV Vaccine for Children Briefing” on the same day Merck donated $5,000 to Perry’s campaign. Merck also donated a total of $5,000 to eight state lawmakers.

According to the San Antonio Express News, Merck also donated $50,000 to a Republican Governors Association fundraising dinner hosted by Perry. Apparently Merck has donated the same amount to this dinner annually for the past six years. Merck has supported the dinner for so long, some say, that Perry’s enthusiasm for the vaccine is not a result of Merck’s support. But the longstanding support could just as well be seen as evidence that Merck has been trying for a long time to gain political influence. Typically, the ground is laid for marketing new therapeutics many years before a product hits the market.

Newsday has reported that in New York State, Merck laid out more than half a million dollars in lobbying costs and donations to key officials. Between 1999 and 2006, Merck donated $106,000 ($33,400 to Democratic accounts and $72,600 to Republican accounts) – to  committee “housekeeping accounts.” That sum includes $10,000 to the New York Republican State Committee. Housekeeping accounts are supposed to be used for office overhead expenses, such as telephones, but tracking the use of such donations is difficult.

Undoubtedly other state legislators have received donations, and Merck has also donated an undisclosed sum to Women in Government, an advocacy group composed of women who are state lawmakers.

But isn’t this a case where corporate and public health goals align? Maybe. Or maybe not. Let’s review a few facts. Cervical cancer begins with precancerous changes detectable by Pap smear; it is very slow-growing and completely curable at most stages. The biggest risk factor for cervical cancer isn’t having HPV; it’s never having had a Pap smear.

There are more than a hundred types of HPV, most of which are harmless. Some (especially types 6 and 11) cause genital warts, a medically trivial condition, and others (especially types 16 and 18) contribute to cervical cancer. HPV is extremely common; about a quarter of the population is infected and about 3% are infected with strains that are associated with cancer.

However, most women with HPV, even cancer-associated strains, never develop cervical cancer. Most never even develop abnormal cells. In fact, most people with HPV cure themselves. About 70% of women test negative for the virus a year after diagnosis, and about 90% test negative after two years. About 10% of women infected with HPV stay infected, and those women are at highest risk for progression to cervical cancer.

Because cervical cancer is so slow-growing, cervical cancer screening is vitally important. Deaths from cervical cancer are a marker of failure in a health system. No woman, anywhere, should die of this disease. Vaccines won’t end cervical cancer, or even the need for Pap smears (remember, vaccines only work in those not yet affected, and they don’t cover all cancer-causing strains). If women substitute vaccinations for Pap smears, cervical cancer rates could go up instead of down.

The condemnation leveled at Merck’s marketing efforts is deserved, but should not obscure the fact that vaccines against cervical cancer are a public health breakthrough with the potential to save many lives worldwide. These vaccines can reduce the incidence of an entirely preventable cancer, and we’ve got few enough of those.

More than 80% of cervical cancer cases occur in underserved, resource-poor populations. In the United States, there are 6.6 cases of cervical cancer per 100,000 white women, and 10.5 cases/100,000 among African American women. (Rates are higher in the rural South and in some cities.) But these rates are dwarfed by cervical cancer rates in other countries. In parts of Africa, Central and South America, and Micronesia more than 50 cases occur per 100,000 women.

Merck’s heavy-handed legislative push may be an effort to corner the market before its competition, Glaxo Smith Kline’s Cervarix, reaches the market. Merck’s vaccine protects against about 70% of cancer-causing HPV strains; GSK’s version purportedly protects against 80% of cancer-causing strains (but provides no protection against genital warts).

Ironically, the exposure of Merck’s lobbying may inhibit rather than encourage widespread use of cervical cancer vaccines. There are good public health reasons for widespread, even mandatory vaccination, primarily that the vaccines are effective before exposure, and HPV viruses are common enough that many people are exposed within two years of first intercourse. The problem with leaving the decision to parents is that parents are notably ignorant about when their kids start having sex. Mandatory vaccination would take away the burden from parents of considering the possibility that their children might have sex at age 16, or 14, or 12.

Merck isn’t the only company lobbying legislatures, or launching education campaigns aimed at maximizing uptake of profitable therapies. But the lesson we should take from the exposure of Merck’s marketing efforts is that public health policy should never be orchestrated by corporations.

And to all those state legislatures out there considering mandatory vaccination: Table the discussion. Start over. There’s time to gather more data on the effects of this vaccine in young girls. There’s time to grill people about their conflicts of interest and to exclude testimony from anyone who has accepted money from Merck or GSK. There’s time to recuse legislators who have accepted money from voting. There’s time to consider the costs (about $360 for a three-shot regimen, and some physicians charge double or triple that) and the likelihood that prices will come down once Cervarix is approved. Remember, Pap smears are still necessary. How are cervical cancer screening programs in your state?

Cervical cancer is uncommon in the United States. This is not an emergency; this is not SARS. Listen only to public health people without conflicts of interest. There’s time for a discussion – but ban industry from the room in which any decisions on public health are made.

– Adriane Fugh-Berman

For more information about HPV, see:

D. Saslow et al., “American Cancer Society Gui(HPV) Vaccine Use to Prevent Cervical Cancer and Its Precursors delines for Human Papillomavirus,” CA: A Cancer Journal for Clinicians57 (2007): 7-28.

Centers for Disease Control, “Human Papillomavirus: HPV Information for Clinicians,” November 2006, accessed February 10, 2007.

Published on: March 15, 2007
Published in: Health Care Reform & Policy, Public Health

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