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CDC, FDA review HPV vaccine adverse events
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The rate of adverse events associated with the 23 million doses of the HPV vaccine Gardasil is similar to the rate that Merck officials expected in prelicensure trials, but there may be an increased risk of fainting and developing blood clots more often than those receiving other vaccines, according to a study published this week in The Journal of the American Medical Association.
The Vaccine Adverse Event Reporting System received 12,424 reports of adverse events following distribution, a rate of 53.9 reports per 100,000 doses distributed, according to the CDC and FDA officials that authored the study. The researchers said they could not be certain whether the vaccine was to blame for the adverse events, adding that most of the girls may have been more vulnerable to developing clots because they were overweight or on birth control pills.
Charlotte Haug, MD, who wrote an editorial that JAMA published with the CDC paper, said that it is important to carefully weigh the risks and benefits before using any vaccine, and she said, “prospective, controlled studies will be able to distinguish the true harmful effects of the HPV vaccine.”
Meanwhile, public health experts at Columbia University are charging in a paper in the same journal that Merck officials may be indirectly influencing physicians to use the vaccine by providing grants to some medical organizations which then train physicians who in turn speak about HPV vaccination.
At least three medical associations, the American Society for Colposcopy and Cervical Pathology, the American College Health Association and the Society of Gynecologic Oncologists, distributed education materials using virtually the same strategy that Merck employed in its marketing campaign for the vaccine, according to the analysis, led by Sheila M. Rothman, PhD, of Columbia University's Mailman School of Public Health in New York.
Stewart Massad, MD, assistant secretary for the American Society for Colposcopy and Cervical Pathology, said that while Merck did provide funding for their educational activity, he said several other companies contributed as well.
“We tried to find federal or nonprofit funding and no one is interested in funding education about proprietary products,” Massad said. “Unfortunately, it is a monopoly at this point, because there is no other approved HPV vaccine in the United States. Because we recognize the risk for bias, all materials were reviewed by people who don’t accept funding from the industry.”
The Society of Gynecologic Oncologists and the American College Health Association did not immediately return a request for comment.