Pharmaceutical

Did Bachmann overblow Gardasil side effects? What are the risks?

Michele Bachmann 100x100 Did Bachmann overblow Gardasil side effects? What are the risks?In this week’s GOP Presidential debate, candidate Michele Bachmann criticized Governor and presidential candidate Rick Perry for his attempt to mandate the use of in his state. Gardasil, manufactured by Merck, is promoted as a preventive treatment against (HPV), a sexually transmitted virus linked to the development of . Following a public outcry in the state of Texas, the mandate was overturned. Bachmann objected to the mandate for political reasons, but also expressed concerns that any parent might feel about being required to give their child a relatively new vaccine, about possible adverse side effects.

But in at least two news interviews after the debate, Bachmann told reporters Gardasil was linked to mental retardation as a possible side effect. She says she received this information from a parent she spoke with after the debate, whose child had received the . This account left medical experts scratching their heads, as mental retardation is not listed among the currently reported in connection with Gardasil.

The controversy is leaving many wondering, did Bachmann simply misunderstand the adverse event described to her by a young girl’s distraught mother, or is she trying to sensationalize her story? Perhaps even more importantly, what are the risks associated with Gardasil?

Since Gardasil’s introduction in 2006, the Vaccine Adverse Event Reporting System () has received more than 20,000 reports of adverse side effects related to Gardasil. These reports do include serious adverse side effects including Guillain Barre syndrome, , , rheumatoid arthritis, multiple sclerosis, among others. There also have been 92 reported deaths among girls who received the Gardasil vaccine.

In 2009, Dr. Diane Harper, one of the lead researchers in the development of two HPV vaccines, told an audience of medical professionals that in her opinion Gardasil is actually largely unnecessary. Almost all HPV infections are cleared naturally by the body’s immune system without harmful effect, she pointed out. In fact, Harper says, the rate of cervical cancer in the U.S. is so low, that vaccination is not expected to reduce the rate of cervical cancer in the U.S. at all.

Add to that, the vaccine has not been proven to last more than 5 years. In order for there to be true prevention, the vaccine would have to last a lifetime. For the target audience, 11-12-year-old girls, the vaccine is not likely to last long enough to protect them when they do become sexually active. However, cervical abnormalities that may indicate a risk of cervical cancer are still easily detectable through the use of regular pap smears. And, unlike Gardasil, pap smears have no risk of adverse event and cost only a fraction of the cost of Gardasil.

Despite the questions, by October 2009 the FDA had expanded the use of Gardasil in the U.S., approving it to treat boys and young men ages 9-26 for the prevention of genital warts, throat and anal cancers linked to HPV, as well as to curtail the spread of HPV. The (CDC) reports that approximately 32 million doses of the vaccine have been distributed in the United States since about September 2006.

Though Michele Bachmann’s attempt to point out the risks of Gardasil may not have been artful, she should be applauded for her attempt to spotlight the problems with Gardasil. Gardasil is a vaccination that is costly, potentially dangerous, and likely ineffective at preventing cancer. The cost and the risk of injury far outweigh any benefits. Rather than encouraging vaccination, the wiser course would be to proceed with great caution in the vaccination of young girls and boys.