Last year a prominent editorial and article in JAMA questioned the medical arguments for vaccination, as well as the ethics of aggressive marketing campaigns from pharmaceutical companies (2009;302:795–6, 781-6). “If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to women is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened,” wrote Dr. Charlotte Haug, editor-in-chief of the Journal of the Norwegian Medical Association.
In their article, Sheila Rothman, Ph.D., and David Rothman, Ph.D., of Columbia University, New York, noted that in 2006, Merck's Gardasil “was named the pharmaceutical 'brand of the year' for building a 'market out of thin air.'”
Alan Cassels, a drug policy researcher at the University of Victoria (B.C.), was critical. “It's not a slam dunk that if you get the HPV vaccine you'll be prevented from developing cancer,” he said in an interview. He compared the vaccine to cholesterol-lowering drugs. “Yes, we can prove that a drug lowers cholesterol, but the question is whether it prevents heart attacks and strokes. So, while the HPV vaccine may prevent transmission of the virus, will that really result in [fewer] cancers? We won't know for 10 or 20 years down the road.”
Given the uncertainty of benefit, or the duration of efficacy, Mr. Cassels cautioned that the risks of any intervention should be minimal, which is not the case with the HPV vaccine.
As of Jan. 31, 2010, there were 49 U.S. reports of death among females who had received Gardasil, according to the Centers for Disease Control and Prevention. Twenty-eight of these reports have been confirmed and 21 remain unconfirmed. In the 28 confirmed reports, “there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine,” according to a CDC statement.
Disclosures: Merck sponsored the symposium. Dr. Fisher disclosed that he has been a consultant for Merck, Boehringer Ingelheim, and Bayer. Dr. Plante reported having no conflicts of interest.