Bioethicists Offer $11,000 for Proof of HPV Vaccine Story

More Than $100,000 in Subsequent Pledges

Nick Mulcahy

September 15, 2011

September 15, 2011 (UPDATED September 16, 2011) — A pair of bioethicists have challenged US Representative Michele Bachmann (R-MN) to provide proof that vaccination for human papillomavirus (HPV) causes mental retardation. And both are offering money for the evidence.

Earlier this week on the Today Show, Ms. Bachmann said that after the recent Republican presidential candidate debate in Tampa, Florida, a crying woman approached her and said that her daughter received the HPV vaccine and developed "mental retardation" thereafter.

Steven Miles, PhD, a professor of bioethics at the University of Minnesota in Minneapolis, said that he will pay $1000 to have the medical records related to Bachmann’s story released for review by a medical professional, according to a report in the Star Tribune newspaper.

In addition, Arthur Caplan, PhD, a professor of bioethics at University of Pennsylvania in Philadelphia and a Medscape advisor and video blogger, has upped the stakes.

In an email sent to USA Today, Dr. Caplan confirmed that he is offering $10,000 for the same proof.

"If she can produce a case…of a woman who became 'retarded' (her words) due to HPV vaccine, I will donate that [$10,000] to a charity of her choice. She must donate $10k to a charity I pick if she fails to do so," he wrote. The case must be verified by medical professionals and be revealed in the next week, Dr. Caplan said.

Today, Dr. Caplan told Medscape Medical News that since the news of his challenge, he has received a flood of offers that total "as much as $150,000" to increase the reward money. However Dr. Caplan said that he is not taking the money and that he has made his "point" with his original offer.

The bioethicists' money-backed challenges are the latest development in a whirlwind of media coverage that have been spawned by Ms. Bachmann's account of a distraught mother and her critical comments about HPV vaccination during Republican party debate.

During the debate, Ms. Bachmann criticized Texas governor Rick Perry for his executive order that would have required mandatory vaccination of appropriately aged state schoolgirls against HPV.

"To have innocent little 12-year-old girls be forced to have a government injection through an executive order is just flat-out wrong," Bachmann said, according to National Public Radio. "Little girls who have a potentially dangerous reaction to this drug don't get a mulligan," she said. "You don't get a do-over."

Ms. Bachmann also criticized Governor Perry for his financial ties with Merck, the manufacturer of the HPV vaccine Gardasil.

The American Academy of Pediatrics (AAP) reacted strongly to Ms. Bachmann's comments about the dangers of HPV vaccination.

"The American Academy of Pediatrics would like to correct false statements made in the Republican presidential campaign that HPV vaccine is dangerous and can cause mental retardation," O. Marion Burton, MD, the president of the AAP, said in statement released this week. "There is absolutely no scientific validity to this statement. Since the vaccine has been introduced, more than 35 million doses have been administered, and it has an excellent safety record."

Several groups, including the AAP, the Centers for Disease Control and Prevention, and the American Academy of Family Physicians, all recommend that girls receive HPV vaccine around age 11 or 12, Dr. Burton said.

"That's because this is the age at which the vaccine produces the best immune response in the body, and because it's important to protect girls well before the onset of sexual activity," Dr. Burton explained. "In the U.S., about 6 million people, including teens, become infected with HPV each year, and 4,000 women die from cervical cancer. This is a life-saving vaccine that can protect girls from cervical cancer."

Safety and HPV Vaccination

Currently, there are 2 licensed HPV vaccines in the United States. Gardasil (Merck) was approved by the US Food and Drug Administration (FDA) in 2006, and the vaccine protects against HPV types 6, 11, 16, and 18. Gardasil is indicated for use in girls and women from age 9 to 26 years, as well as for use in boys and young men. Cervarix (GlaxoSmithKline) was approved by the FDA in 2009 and protects against HPV types 16 and 18. Cervarix is indicated for girls and women from age 9 to 25 years.

"Clinical trials and monitoring data show that both vaccines are very safe," according to the Centers for Disease Control Web site.

The CDC indicates that approximately 35 million doses of Gardasil have been distributed in the United States.

As of June 22, 2011, the US Vaccine Adverse Event Reporting System (VAERS) received a total of 18,727 reports of adverse events following Gardasil vaccination, including 17,958 reports among females. Of the total number of VAERS reports, 92% were considered to be nonserious, and 8% were considered serious.

Nonserious adverse events have included fainting, pain, and swelling at the injection site (the arm), headache, nausea, and fever.

Serious adverse event reports include 68 deaths among individuals who have received Gardasil.

Thirty-two of the total death reports have been confirmed and 36 remain unconfirmed. In the 32 reports confirmed, "there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination," according to the CDC.

Serious adverse events also include Guillain-Barré syndrome (GBS), a rare neurologic disorder that causes muscle weakness. "There has been no indication that Gardasil increases the rate of GBS above the rate expected in the general population, whether or not they were vaccinated," the CDC Web site indicates.

The CDC Web site has much less information about Cervarix. As of June 2011, there have been 39 VAERS reports of adverse events following Cervarix vaccination in the United States. The majority of these reports (97%) were considered to be nonserious.


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