HPV Vaccine: the Problem Is the Lack of Informed Consent

TUCSON, Ariz., Sept. 20, 2011 /PRNewswire-USNewswire/ -- As opponents of Michele Bachmann try to bully her into backing down on the HPV vaccine, one essential question is not being addressed, states the Association of American Physicians and Surgeons (AAPS). Are recipients of the HPV vaccine giving fully informed consent?

"Simply giving patients a way to opt out is not enough," stated AAPS executive director Jane M. Orient, M.D. "Consent by patients should only occur after they have been fully informed of risks and benefits."

According to the Centers for Disease Control and Prevention (CDC) http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html, there had been more than 18,700 reports of medical problems following receipt of the Gardasil® (HPV) vaccine, as of this June. It is widely believed that adverse reactions are significantly under-reported.

The CDC describes most of these injuries as "non-serious," but that is misleading because of the CDC's narrow definition of "serious." A neurological or cognitive disorder would not be called "serious" by the CDC, unless it results in a "hospitalization, permanent disability, life-threatening illness, congenital anomaly or death."  

The CDC trivializes adverse effects when it declares: "The vast majority (92%) of the adverse events reports following Gardasil vaccination have included fainting, pain, and swelling at the injection site (the arm), headache, nausea, and fever." The many serious injuries associated with the HPV vaccine are not limited to those unpleasant reactions, but would include them.

Unlike many childhood vaccines, the HPV vaccine does not protect against a potentially fatal illness that any 9 year old might be exposed to at school. HPV is sexually transmitted, and could be completely avoided by refraining from sex with promiscuous partners.

Were those who have been injured by the HPV vaccine informed that the vaccine would probably never benefit them, but could seriously harm them instead? No, they were not.

Marketing messages show a poster girl tragically dying of cervical cancer, and an assertion that the vaccine is "very safe." What parent would want his little girl to die of cancer when a simple and safe (though very expensive) shot might prevent it?

Truly informed consent, however, would acknowledge that it's too soon to say how effective the vaccine is, or how long protection lasts, and that periodic screening, as with Pap smears, is both necessary and effective with or without Gardasil. The dozens of deaths and hundreds or thousands of serious reactions (such as paralysis or arthritis) associated with the vaccine might have been a coincidence. Or maybe not.

Parents and patients should also know that the vaccine manufacturer is immune from liability under special federal protection not available to most defendants.  Parents struck by the tragedy of an unnecessary vaccine inflicting life-changing injury on their child are left with struggling against the government for years to obtain a modicum of recovery from the stingy National Vaccine Injury Compensation Program (VICP). Because of this immunity and lack of accountability for harm they may cause, vaccine manufacturers have less incentive to make their products safer, or to test them more rigorously, or to make sure that recipients understand potential risks.

Michele Bachmann should not back down from her statements, or apologize for repeating a mother's claim that the vaccine caused cognitive problems, which can appear as mental retardation to a loving mom. Instead, the promoters of the HPV vaccine should limit its administration to only those who have given fully informed consent.

AAPS, a national organization representing physicians in all specialties, (www.aapsonline.org) was founded in 1943 to defend the sanctity of the patient-physician relationship.

SOURCE Association of American Physicians and Surgeons (AAPS)