By Rob Stein
Washington Post Staff Writer
Tuesday, August 18, 2009 4:00 PM
At least three medical associations promoted a vaccine that protects against a sexually transmitted virus using funds provided by the vaccine's manufacturer, according to a new analysis being published in Wednesday's issue of the Journal of the American Medical Association.
The groups -- the American College Health Association, the American Society for Colposcopy and Cervical Pathology, and the Society of Gynecologic Oncologists -- promoted Gardasil, a vaccine against a virus that can cause cervical cancer, using virtually the same strategy that Merck employed in its marketing campaign for the vaccine, the analysis concluded.
"I think what happened here was that marketing and medical education got blurred," said Sheila M. Rothman of Columbia University's Mailman School of Public Health, who co-authored the article with her husband, David J. Rothman of the school's Center for Society and Medicine.
Critics of Merck's aggressive marketing efforts said the analysis is the latest evidence that the company is pushing the vaccine inappropriately.
"This clearly shows how Merck was able to influence opinion leaders in the medical field to promote the vaccine without presenting any of the downsides," said Diane M. Harper of the University of Missouri at Kansas City, who helped test the vaccine for Merck but has criticized the company's activities. "This shows how they were able to influence physicians."
Merck acknowledged that the company provided $199,000 to the ACHA, $300,000 to the ASCCP and $250,000 to the SGO, but officials with the company and the three medical groups disputed suggestions that they acted inappropriately. They said Merck provided funding for education efforts about the vaccine but did not influence the content of the groups' programs.
"We provided grants that allowed them to develop, independent of Merck, their own information that was distributed to their membership," said Richard Haupt, who heads the program responsible for the vaccine at Merck Laboratories. "Our activities with these societies were done in an appropriate and independent manner."
Gardasil protects against the human papillomavirus, which causes genital warts and can lead to cervical cancer. Although hailed by many health experts, the vaccine has been highly controversial since winning Food and Drug Administration approval in 2006.
Social conservatives worried that providing the vaccine to young girls would encourage sexual activity. The company subsequently came under heavy criticism for an aggressive campaign to make the vaccine mandatory for school attendance -- a campaign the company later abandoned.
Other critics have raised questions about the vaccine's long-term effectiveness and cost-effectiveness and whether the vaccine may cause serious side effects. Merck, the FDA and the Centers for Disease Control and Prevention, however, have repeatedly said there is no evidence that the vaccine is unsafe.
In a second paper published in the medical journal, the CDC analyzed more than 12,000 reports of adverse events among recipients of the vaccine and concluded that there is no evidence that any of the serious side effects were caused by the vaccine. While more women who received the course of three vaccines experienced blood clots, other factors such as the use of birth control pills may be to blame, the researchers said.
Harper said the analysis could not rule out uncommon risks from the vaccine, but Haupt praised the findings as confirmation of the vaccine's safety.
The Rothmans, however, charge that the three medical societies relied on company funding to promote the use of the vaccine using arguments that mimicked the Merck's approach, which they said de-emphasized the downsides of the vaccine and oversimplified the risk from cervical cancer.
The American Society of Colposcopy and Cervical Pathology's program went so far as to encourage doctors to help persuade "states and federal agencies to pay for the vaccine" and to impose "mandates for use" of the vaccine, the pair write.
The Society of Gynecologic Oncologists' "teaching materials omitted cautionary qualifications" about the vaccine, the Rothmans write. And the American College Health Association's efforts included sponsoring a webcast viewed by 350 members and sending e-mails to college and university students urging them to get vaccinated.
"They seem to be repeating the marketing message of Merck," the Rothmans write. "If the societies are just repeating the drug companies' message they are not really educating. They are blurring the line between educating and marketing."
But spokespeople from the three groups said that they disclosed the funding source for their activities and that their efforts underwent independent scientific review.
"I consider the HPV vaccine the greatest prevention tool in women's health since the invention of the Pap smear," said American College Health Association President James Turner. "We're just trying to prevent a disease that occurs in thousands of college students every year."