Merck's HPV Vaccine: A Mandatory Lesson Learned

What a week it’s been for advocates — and critics — of the HPV vaccine.

Acknowledging that its lobbying efforts have only hurt its cause, Merck this week announced it would stop campaigning to get states to mandate the use of its new vaccine against the human papillomavirus, which can cause cervical cancer. But the announcement did little to quash debate surrounding Merck’s influence and the general safety of the vaccine.

On Thursday, Texas Gov. Rick Perry, who already signed an executive order making the vaccine mandatory for sixth-grade girls — though the Texas legislature is anxious to overturn it — had to defend his order in light of reports that his chief of staff had met with aides about the vaccine on the same day that Perry’s campaign received $5,000 from Merck’s political action committee. Perry’s relationship with Merck was already questioned since the governor’s former chief of staff is now a Merck lobbyist.

Also on Thursday, a group of Texas families filed a lawsuit to block the executive order.

Merck, which manufactures Gardasil, currently the only FDA-approved vaccine, has been working to promote widespread vaccination with the support of state lawmakers — including Women in Government, a national association of state legislators. Critics note that an executive from Merck’s vaccine division sat on Women In Government’s business council last year, and the group receives funding from Merck (along with other phamaceutical companies).

NPR’s “Morning Edition” on Thursday covered the resentment against Merck’s “steamroller effort,” with medical experts raising concerns about setting up distribution protocols and long-term safety. (Listen here.)

More than 20 states have drafted bills calling for mandatory inoculation (with the usual opt-out provisions) of pre-teen girls. The vaccine was approved for girls and women age 9 to 26. It is most effective if given before females become sexually active and have not acquired any of the four HPV types covered by the vaccine.

Some states are re-thinking legislative efforts to mandate the vaccine, reported NPR. But other states, like Vermont, are not changing course.

GlaxoSmithKline is also working on a vaccine and, according to this story published in The New York Times Feb. 17, “Analysts see a potential $5 billion a year market for H.P.V. vaccines, and some say that Merck is intent on inoculating as many girls as possible before the introduction of Glaxo’s product, which could become available this year.”

Indeed, with the billions Merck stands to reap from the vaccine — a series of three shots that cost a total of $360 per person — some cynics have called the HPV vaccine the “Help Pay for Vioxx” program, referring to the arthritis drug Merck withdrew from the market after studies linked to it a higher risk of heart attacks and strokes.

Merck’s president for vaccines, Margaret McGlynn, insists Merck is motivated by the potential for eradicating the disease. “Each and every day that a female delays getting the vaccine there is a chance she is exposed to human papilloma virus,” McGlynn told the New York Times.

Other public health advocates have noted that while Gardasil may well be a life-saving vaccine, the timing of the vaccination push and the speed by which it is being promoted has produced a daunting backlash. “The decision to make this mandatory this early has created a significant controversy over things that have nothing to do with the vaccine,” said Dr. Joseph A. Bocchini, chairman of the committee on infectious diseases of the American Academy of Pediatrics.

The CDC estimates that about 15 percent of the population is infected with HPV. Most women with HPV, however, will not develop cervical cancer and most will find that they test negative for the virus a year after a diagnosed infection. Around 10 percent of women with HPV stay infected, and it is these women with persistent infections who are at highest risk for developing cervical cancer.

Regular screening and follow-up treatment of cancerous and/or pre-cancerous tissue is highly successful, so even those women with persistent infections rarely get cervical cancer. The periodic screening and follow-up care are absolutely necessary, however. The U.S. rate of infection is 7.2 per 100,000 nationally — higher among black and Hispanic women — and there were 3,700 deaths from cervical cancer in 2006.

Of concern is whether public funding that is now allocated to cervical cancer screening and follow-up care will be diverted to the provision of the HPV vaccine. Some public health experts have cautioned that any HPV vaccine mandate should be tied to a guarantee that cervical cancer screening will be made accessible to all women at the same time. Others have argued that money would be better spent providing expanded healthcare for women.

“It is important to note that low income women and women who do not have health insurance are most at risk because they are less likely to get regular Pap smears,” writes Lucinda Marshall in Dissident Voice. “Since the vaccine does not eliminate the need for regular Pap smears, it would appear that a far more appropriate and cost effective first step would be to make regular gynecological healthcare available for all women regardless of income and medical insurance, particularly since this step by itself would go a long way in reducing the few cases of cervical cancer that still occur in this country.”

As the HPV vaccine receives more scrutiny, it remains imperative that we continue to critique those whose objections are rooted in misguided attempts to connect the vaccine with promoting sexual activity. Skim any discussion board on this issue and you’ll come across commenters who argue that promiscuous women bring the virus on themselves, or that it’s inappropriate to mandate the vaccine for women who intend to remain virgins until marriage.

In Illinois, State Sen. Debbie Halvorson, the Democratic majority leader, is in favor of a bill calling for 11- and 12-year-old girls to be vaccinated. She also said publicly that she had the virus, prompting a contributor to the conservative blog Illinois Review to question whether the state senator’s time would be better spent discussing her sexual history than advocating for a bill to prevent cancer.

The post defies logic. But Halvorson shows she’s got moxie, telling The New York Times: “I’m offended by their ignorance, but if I have to take a hit to educate people, I’m willing to do it.”