Letter to Senator Barbara Mikulski: HPV Vaccine Concerns

The following letter was sent by Dr. William Reichel, Georgetown University School of Medicine:

June 12, 2011

Dear Senator Mikulski,

As a physician and past researcher at the National Institute of Health (NIH), I am writing to your office because of my personal concern over the trail of tragedies left in the wake of people making decisions to follow CDC guidelines regarding the FDA approved quadrivalent HPV (qHPV) vaccine, Gardasil. We were led to believe that Gardasil “can prevent most cases of cervical cancer….” and “it can also prevent vaginal and vulvar cancer…” [1] Millions of trusting people around the world submitted to the administration of the qHPV vaccine believing it to be “very safe” and effective [1]. However we now learned that in clinical trials, the efficacy of Gardasil to prevent cervical cancer was never validated under the FDA fast track drug program. Furthermore, post-licensure monitoring of Gardasil as required by law to determine if Gardasil indeed reduces the incidence of cervical cancer or precancer caused by relevant HPV genotypes has also not occurred.

I have attached a copy of a letter to Dr. Laura Markowitz at the CDC which documents the concerns in detail. Validation of the efficacy of Gardasil would require a reliable, science-based DNA sequencing test to properly analyze HPV genotypes. Although this reliable method of analysis is the gold standard, it has not been implemented. Consequently, there is no valid scientific evidence that Gardasil can prevent cervical, vaginal or vulvar cancer.

Gardasil is known to be associated with a high incidence of potentially serious side effects which are also documented in the letter. It is imperative that the CDC institute a reliable post-licensure monitoring system nationwide immediately to determine if the benefits of mass vaccination of young women against HPV infection for cervical cancer prevention do in fact outweigh the risks of vaccination. We request that your office follows up to ensure that the CDC acts immediately to comply with the law in the interests of public health and safety. There is also no cost benefit to paying for a vaccine that is not effective. If there is no reliable method of monitoring HPV vaccinations for disease impact, there should be no marketing of HPV vaccines.

Thank you very much for your prompt attention to this issue and I look forward to hearing from you.

Sincerely,

[1] CDC. Vaccine Information Sheet: HPV Vaccine- Gardasil. May 3, 2011.

http://cdc.gov/vaccines/pub/vis/downloads/vis-hpv-gardasil.pdf. Accessed May 23, 2011.