As expected, a U.S. Centers for Disease Control and Prevention (CDC) advisory committee this week recommended expanding the use of the Gardasil vaccine, manufactured by Merck, to include boys and young men. The vaccine, which targets the human papillomavirus (HPV), previously has been recommended for girls, as a way to prevent cervical cancer caused by certain types of HPV. Gardsil use had already been approved by the FDA to treat boys in October 2009, although it was not yet given “recommended” status. The CDC reports that approximately 32 million doses of the vaccine have been distributed in the United States since the vaccine was initially approved in 2006.
While on the surface it would seem like a no-brainer to protect children against a virus that may cause cancer, some experts are cautioning the government to slow down where Gardasil is concerned. Since its launch in 2006, there have been more than 20,000 reports filed with the agency’s Vaccine Adverse Event Reporting System (VAERS), claiming serious side effects following the administration of the Gardasil vaccine. There also have been 92 reported deaths among girls who received the Gardasil vaccine.
Even one of the physicians who was a lead researcher in the development of Gardasil, Dr. Diane Harper, in 2009 expressed her concerns about the drug. She told an audience of medical professionals she feels the drug is “largely unnecessary,” as most HPV infections are cleared naturally by the body with no harmful effect. She pointed out that 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.
Among its reasons for recommending the expanded use of the HPV vaccine to boys, the CDC advisory panel said it hopes that by vaccinating both genders there will be a reduction of transmission of the virus back and forth. The panel also pointed to recent studies possibly linking HPV to penile and rectal cancers, as well as head and neck cancer.
Gardasil has been in the national spotlight lately as a result of comments made by U.S. presidential candidate Michelle Bachmann, who after a GOP presidential debate said a woman in the audience told her the drug caused her daughter to become “mentally retarded.” Medical experts said there is no evidence that Gardasil causes “mental retardation,” and brush off side effects as relatively minor, including fever, swelling at the injection site, and headache.
But thousands of parents claim that after receiving the Gardasil vaccine, which never completed Phase 3 clinical testing, their daughters suffered serious adverse events including Guillain Barre syndrome, lupus, seizures, rheumatoid arthritis, multiple sclerosis, among others. They argue children who receive the HPV vaccine are little more than “human guinea pigs.”