The HPV Vaccine Controversy
Shobha S. Krishnan
Ever since the FDA approved the human papillomavirus (HPV) vaccine in 2006, its introduction has been embroiled in a medical, social, cultural, and political controversy. This controversy has once again been rekindled in the recent Republican primary debates between Texas governor Rick Perry and Congresswoman Michele Bachmann from Minnesota, in which Bachmann emphatically stated that Merck's HPV vaccine, Gardasil, causes mental retardation.
As a physician, parent, and author of the award-winning book The HPV Vaccine Controversy: Sex, Cancer, God and Politics (Praeger, 2008), I feel compelled to comment on this issue.
A report presented by four different sources to the Advisory Committee on Immunization Practices (ACIP), an independent panel of experts that advises the Centers for Disease Control and Prevention (CDC) on vaccine policies, found no signals to link Gardasil directly to any of the serious adverse effects that have been publicized in the media.
To clarify this and help consumers make the best-informed decision before vaccinating, it is helpful to understand the difference between a side effect (caused directly by the vaccine) and an adverse effect (which usually occurs within six weeks after the administration of a vaccine but may or may not be related to the vaccine).
1) The most common side effects reported are pain followed by swelling and redness at the site of injection. These temporary symptoms usually resolve within a few days, as is the case with most other vaccines.
2) The number of adverse effects that link the HPV vaccines to the nervous system disorder Guillain-Barré Syndrome is around one to two out of every 100,000 cases-about the same as the number of cases that occur in the general population as a sheer coincidence or chance-and such disorders have the same statistical occurrence as the population at large that has not been vaccinated.
It is obvious that the greater the number of shots administered (as of June 22, 2011, 35 million doses of Gardasil had been distributed), the more likely the chance for these rare and unexpected events to occur. It should be noted that there is no report from the CDC of Gardasil resulting in mental retardation.
The HPV vaccine has established a decent track record at five years post-licensure. Based upon these current findings, the FDA strongly recommends vaccinating the target population: nine- to twenty-six-year-old females and males. The CDC will continue to be vigilant and monitor safety data on an ongoing basis. Nevertheless, it is helpful to remind ourselves that regardless of how well studies are conducted, gray zones of risk exist. The history of medicine has shown us that such unfortunate events do occur for unknown reasons, and research is underway to study if genetics and environmental factors have a role to play in such rare and serious events.
One should always balance the greater good with these potentially minimal risks when evaluating the advantages offered by new and emerging medicines. Scaremongering for personal political gain does not bode well for the education and welfare of the public. In the case of the HPV vaccine, it would be a shame if negative attention created by a few rare effects hampers the efforts to reach millions of women and men who risk losing their lives to HPV-related diseases, including cancers and particularly cervical cancer, both in our country and around the world.