JAMA STANDS AGAINST MANDATED HPV VACCINE

Medical journal sides with HPV scientist

BY CINDY BEVINGTON
cindyb@kpcnews.net

CHICAGO — An editorial May 2 in what is considered the Bible of the medical profession vindicates a researcher who told this newspaper months ago that mandating the human papillomavirus (HPV) vaccine for young girls is “a great big public health experiment.”

The vaccine, Gardasil, offers protection against four of the more than 100 known HPVs, two of which scientists believe cause about 70 percent of cervical cancers.

Last week, The Journal of the American Medical Association (JAMA) took a public stand against legislation to mandate this vaccine. The article, “Mandatory HPV Vaccination: Public Health vs. Private Wealth,” was co-authored by Chicago-based JAMA editor Dr. Catherine D. DeAngelis and Washington, D.C.’s Georgetown University professor Lawrence O. Gostin. Gostin specializes in public health law.

Declaring it unethical to rush into mandates, the authors accuse Gardasil’s manufacturer, Merck & Co., of putting profits ahead of the safety of the 2 million girls and women in the U.S. who, if it were mandated, would receive the vaccine before the long-term effectiveness and safety of it had been determined.

(This blog author believes there is a deeper evil than just money at work)

Pointing out that the Federal Drug Administration’s approval of the vaccine was conditional upon Merck agreeing to further test the safety and effectiveness of it, the JAMA article says, “Making the HPV vaccine mandatory contributes to long-standing parental concerns about the safety of school-based vaccinations.”

In fact, legislating the vaccine now “could have the unintended consequence of heightening parental and public apprehensions about (all) childhood vaccinations,” the article adds.

The article also questions how vaccine recipients would be compensated in the event of their suffering adverse effects from it, since some courts may determine that the manufacturer would not be liable if the states mandated it.

The article also admonishes Merck, which could rake in billions of dollars from a mandated vaccine, for financing efforts to persuade states and public officials to mandate it. “Private wealth should never trump public health,” the article says.

Vindicated

Until the JAMA article came out, Diane Harper, a physician, scientist and professor at Dartmouth University Medical School in New Hampshire, who spent 20 years studying the virus and helping to develop a vaccine for it, had stood virtually alone among her peers in denouncing efforts to mandate the vaccine.

When she first interviewed with this newspaper, she said she’d tried to convince major print and broadcast media to “tell the whole story” about the vaccine and why she, as a lead researcher on it, believes it is premature to mandate it.

“But no one would listen,” she said. She said she was speaking out with this newspaper because “it was the only one willing to listen to the whole story.”

Answering questions by e-mail, Gostin said he was aware of Harper’s concerns. (DeAngelis sent word through an aide that she was unavailable for an interview.) He and DeAngelis were motivated to write the editorial, Gostin said, because of the states’ rush to mandate the vaccine before all of the safety and effectiveness data were collected and analyzed.

In place of mandates, Gostin’s and DeAngelis’ JAMA article encourages public education about HPV and routine, voluntary vaccination as part of a comprehensive package aimed at preventing the infection. It also suggests that a young girl’s assent to being vaccinated is as essential as her parents’ consent.

“As for work with the states, it is important to stress that the vaccine is an important public health innovation, but it is necessary to move carefully and deliberately, taking a science-based approach,” Gostin said in his e-mail. “I think that mandatory vaccination has its place, but should be a last resort only if it is clear that it would be safe, effective and in the public’s interest. That standard has not yet been met with HPV vaccination.”

Relieved

Tuesday, Harper was at a national conference of gynecologists in San Diego when she learned of the JAMA article. Acknowledging that she’d experienced some backlash because of her views — but declining to go into specifics — Harper said she felt relieved and excited that a publication as prestigious as JAMA was basically vindicating her and validating her views.

“I’m glad we are starting to get clarification in our communications, and in understanding the details of points that need to be considered for this vaccination,” Harper said. “The Associated Press has consistently miswritten, and consistently reported information that was not accurate about HPV. I have gone to them in New Hampshire several times for corrections, and they did correct a couple of things, but the last time they were unresponsive.”

So many people had questioned her because of her non-politically-correct stance on the issue that there were times when it looked like even her research was being doubted, she said, which made her position even more troubling. However, she stood behind her convictions.

“There is a lot of colleagial pressure to conform to the message, and be united in the message,” she said. “But I think we are too early in our knowledge of information to have just one message.”

She reiterated that this is “a wonderful vaccine,” and that this is an exciting time for medicine in this area. Today, the New England Journal of Medicine (NEJM) is publishing some HPV articles that she co-authored, and that should help explain what this vaccine can and cannot do, she said.

“But there are things we still don’t know about this vaccine,” she said. “For one thing, it takes 129 women to be vaccinated to prevent one case of CIN 2/3 (a type of cervical cell dysplasia), and that is important for people to know. It will be interesting now that the JAMA article is out, and the NEJM articles about Gardasil are published, what the public understanding will be.”

For more on this story and to read past stories in the HPV vaccine series, go to http://kpcnews.com/online_features/hpv_vaccine/ on the KPC Media Group Web site.

Last modified: Friday, May 11, 2007 12:55 PM EDT