Personal Injury Law

Merck Pays for Favorable Gardasil Opinion

By Jane Akre

$750,000

Merck & Co paid for a favorable medical opinion from three medical associations to promote Gardasil, according to a published report.

The August 19 Journal of the American Medical Association (JAMA) reports that Merck dished out a total of $750,000 to the American College Health Association, the Society of Gynecological Oncologists, and the American Society for Colposcopy and Cervical Pathology, reports the Washington Post.

The medical groups would then launch an educational campaign promoting use of the cervical cancer drug almost identical to the marketing done by Merck for the drug.

The JAMA article is written by Sheila M. Rothman of Columbia University's Mailman School of Public Health in New York, and her husband, David Rothman.

"I think what happened here was that marketing and medical education got blurred," said Rothman to the Post.

The Rothmans report that medical societies maximized the threat of cervical cancer to adolescents, while downplaying the risks of the vaccine.

As of May 1, there were 13,758 reports of adverse events linked to Gardasil, among the more than 24 million doses given.

The medical societies began promoting the HPV vaccinations more than one year before clinical trials were published.

'How could anyone be so certain about the effect of the vaccine?' asks an accompanying editorial. The net benefit of the HPV vaccine to a woman is uncertain considering the potential risk, concludes Dr. Charlotte Haug, of the Norwegian Medical Association.

The American Society of Colposcopy and Cervical Pathology encouraged doctors to persuade state and federal agencies to help pay for the vaccine and to impose mandates for use.

The governor of Texas mandated Gardasil use among young girls shortly after it was marketed by Merck in June 2006, but the state legislature reversed the mandate, UPI reports.

Others also believe Merck is aggressively pushing the vaccine inappropriately. Dr. Diane Harper, of the University of Missouri at Kansas City, helped Merck develop Gardasil. She has since criticized the company's activities and feels the drug was not adequately tested on young females it is intended for.

"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 to the Washington Post. "This shows how they were able to influence physicians."

James Turner, president of the American College Health Association says the Gardasil is the 'greatest prevention tool in women's health since the invention of the Pap smear.'

Merck believes the money is provided for education but did not influence opinion.

Merck spokesman, Richard Haupt tells the Washington Post, 'We provided grants that allowed them to develop, independent of Merck, their own information that was distributed to their membership.' "Our activities with these societies were done in an appropriate and independent manner."

Merck acknowledged that the company provided $199,000 to the American College Health Association; $300,000 went to the American Society for Colposcopy and Cervical Pathology; and $250,000 to the Society of Gynecologic Oncologists.

Gardasil is given to young women beginning at age 11 up to age 18, before they become sexually active to combat four types of human papillomavirus, two that cause cervical warts and two that cause about 70 percent of cervical cancers.

An accompanying JAMA editorial says there are more than 100 different types of HPV and the current vaccine targets only two strains that can led to cancer, HPV -16 and 18. Dr. Haug reports that 79 percent of women will be infected over their lifetime, with almost all HPV infections cleared by a woman's immune system.

The editorial also points out that immediately after Gardasil approval in June 2006, the U.S. recommended routine vaccination of girls ages 11 and 12. Phase 3 trials of the HPV vaccine were not reported until May 2007.

And while more long-term studies were called for, none have been published since then. #

Full post as published by InjuryBoard on August 19, 2009 (boomark / email).