JAMA: Gardasil safe, but promos questionable

The latest issue of JAMA delivered a mixed blessing to Merck's Gardasil. In a headliner study published by the Journal of the American Medical Association, the side effects of the human papillomavirus shot were deemed reasonable. Serious adverse events cropped in up those who got the vaccine--including some 32 deaths and two cases of Lou Gehrig's disease--but there's no evidence the shot actually caused them. The most common complications were fainting and clot risk.

Overall, there were 54 adverse event reports for every 100,000 doses, and some 6 percent of those were serious. "We feel confident recommending people get the vaccine; the benefits still outweigh the risks," Dr. Barbara A. Slade, lead author and a medical officer with the Centers for Disease Control and Prevention, told the New York Times. The company sent out a release touting the news: "We are pleased that the study published by JAMA today further reinforces the safety profile of Gardasil," Merck's Richard Haupt said in a statement.

That's the good stuff. The not-so-good: JAMA asks in an editorial whether any level of risk is appropriate in the case of HPV vaccination. "I wouldn't accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she's older, she'll never get cervical cancer," the editorial's author, Dr. Charlotte Haug, told the Times.

And another JAMA study dropped a bombshell: Merck gave money to three medical societies to fund their promotion of Gardasil. Researchers from Columbia University said the American College Health Association, the American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncologists used Merck funding on educational materials and lectures that offered lopsided information about the vaccine's risks and benefits. "I think what happened here was that marketing and medical education got blurred," co-author Sheila Rothman told the Washington Post. "This shows how [Merck was] able to influence physicians," Diane Harper of the University of Missouri, who helped test the vaccine, told the paper.

Merck, however, says that the $750,000 it gave to those three groups was intended to help them develop "independent" information for their membership. "[O]ur activities with these societies were done in an appropriate and independent manner," Haupt said. The groups themselves say the funding didn't affect the content of their materials or programs.

- see the Merck release [1]
- check out the NYT story [2]
- get more [3] from the Washington Post
- read the news [4] from FirstWord
- find the AP story [5]

Related Articles:
Gardasil, Cervarix face FDA next month [6]
Merck readies back-to-school Gardasil push [7]
Merck's Gardasil protects against strains not in vax [8]
CDC: Side effects not linked to Gardasil [9]
Gardasil "remarkably safe," despite anaphylaxis [10]