In the most comprehensive safety study since its approval, the CDC reports that Gardisil isn't more dangerous than other vaccines. However, Merck promoted Gardasil by providing undisclosed funding to associations while ignoring poor women most at risk for cervical cancer.
Yesterday, CDC and FDA researchers published an analysis of the side effects associated with the human papillomavirus vaccine - which has been linked to 32 deaths since 2006 - in the Journal of the American Medical Association (JAMA). As of June 1, 23 million doses of Gardasil have been distributed, and there was an average of 53.9 complaints filed with the government for every 100,000 vaccine doses, which ABC News reports is similar to the number of complaints filed for other vaccines.
Experts say the complaint data is limited because anyone can file one and the reports are not verified, but only 6.2 percent of the reported complaints were considered serious and lead to hospitalization, permanent disability or death. Compared to other vaccines, users of Gardasil were more likely to report fainting or blood clots, but the JAMA study showed 90 percent of the 56 women who reported developing blood clots had other risk factors like smoking, being overweight, or using oral contraceptives. "Although the number of serious adverse events is small and rare, they are real and cannot be overlooked or dismissed without disclosing the possibility to all other possible vaccine recipients," Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at University of Missouri told ABC News, "The rate of serious adverse events is greater than the incidence rate of cervical cancer."
The FDA and CDC continue to recommend the vaccine for women ages 9 to 26, but now the consensus in the medical community is that doctors need to be more educated about the risk of cervical cancer and the vaccine's side effects. Dr. Joseph Zanga, chief of pediatrics at the Columbus Regional Healthcare system in Columbus, GA, told ABC News that HPV infections may clear up on their own and that routine pap smears are still the best prevention against cervical cancer. He added:
"Perhaps the most important, currently missing 'warning' is that the vaccine may not be forever... we know that it protects for 5-7 years so that a girl getting the series at [age] 11-12 will enter the time of her most likely sexual debut unprotected but believing herself to be."
But finding unbiased information on Gardasil's side effects may have been complicated by the vaccine's manufacturer. A separate article published in the Journal of the American Medical Association reported that at least three medical associations promoted the vaccine using money provided by Merck. The analysis of the pharmaceutical company's marketing techniques by Columbia University public health experts revealed that the American College Health Association, the American Society for Colopscopy and Cervical Pathology, and the Society of Gynecologic Oncologists used the same strategies as Merck to promote the vaccine and did always not disclose that they were accepting money from the company, The Washington Post reports. Merck and the three medical societies say it was not inappropriate for the groups to each accept about $200,000 to $300,000 from the drug company because they money funded education programs about the vaccine but didn't influence their content.
In the JAMA article the Columbia researchers say that the medical societies used arguments that were very similar to Merck's marketing approach, which downplayed the vaccine's potential side effects and overemphasized the threat of cervical cancer to adolescents. According to the American Cancer Society, 11,000 women in the U.S. develop cervical cancer every year, and 4,070 die from it, but USA Today reports that many of the deaths are among poor white women in Appalachia, black women in the South, and Latinas along the Texas-Mexico border. Since cervical cancer can be detected by regular pap smears, these women without access to medical care are most likely to die from it. Dr. Sheila Rothman, the article's co-author, wrote that Merck "practically ignored" these at risk groups, and focused instead on the message that all women are equally at risk, helping the company reach as many customers as possible.
A representative for Merck said that there are several programs that make the vaccine available to poor women, but the JAMA report says these facts were not emphasized in the medical society's marketing material, which often failed to mention that they received Merck funding. "It screeched the message, 'all women are at equal risk, protect yourself from cervical cancer, and this is the way to do it,'" said Rothman, "The fact that the medical societies repeated this message is what concerns us."
Gardasil HPV Vaccine Faces Safety Questions [ABC News]
Medical Groups Promoted HPV Vaccine Using Drug Company Money [The Washington Post]
Report: HPV Vaccine May Be Going To The Wrong Women [USA Today]