Bioethicists are demanding proof the vaccine for human papillomavirus caused mental retardation -- a charge leveled by Republican presidential hopeful Michele Bachmann.
It's not often bioethicists get involved in presidential politics but one offered $1,000 and a second offered $10,000 for access to the medical records so they can be evaluated independently.
During last week's GOP debate, the conservative Minnesota congresswoman said it's wrong for the government to force young girls to get the HPV vaccine and then followed up in two broadcast interviews -- on Fox and NBC -- saying a mother attending the debate said her daughter suffered mental retardation after receiving the vaccine.
"She has to verify the validity of the claim because these claims have enormous impact and people make medical decisions based on statements like these ...," said Dr. Steven Miles, a professor at the University of Minnesota Medical School who offered $1,000 for the records.
Arthur L. Caplan, a professor of bioethics at the University of Pennsylvania in Philadelphia, upped the ante and offered Bachmann, R-Minn., a $10,000 donation to a charity of her choice is if she can produce the details of the case in one week.
"The results must be verified by three medical experts we both agree on, but if she fails to do so, she must donate $10,000 to a charity of my choice," Caplan told UPI.
"There is so much misinformation on vaccines and politicians and celebrities should not add to it. They have a responsibility that what they say is accurate and not just repeat something they heard."
In 2006, the FDA approved the HPV vaccine Gardasil for girls and women ages 9 to 26 for the prevention of cervical cancer caused by two types of HPV that cause 70 percent of cervical cancers. Of the more than 150 types of HPV, more than 40 can be spread through sexual contact.
HPV is the most prevalent sexually transmitted disease in the United States with an annual incidence of 6.2 million new infections, the CDC said.
In 2011, more than 12,000 U.S. women are expected to be diagnosed with cervical cancer, with more than 4,000 expected to die, the National Cancer Institute advised.
"Before a vaccine is approved by the government, vaccines undergo a rigorous and extensive development program in the laboratory, as well as animal studies and human clinical trials, to determine their safety and effectiveness," said Rita Chappelle, a press officer at the U.S. Food and Drug Administration.
Bachmann could have checked whether mental retardation is one of the listed side-effects of the HPV vaccine with a phone call or a check of the CDC Web site (http://wonder.cdc.gov/vaers.html).
Jeff Diamond, a public affairs specialist at the CDC, said a search for reports of mental retardation following administration of Gardasil or Cervarix (another HPV vaccine) turned up no such reports as of July 12.
A CDC-FDA survey analyzed 12,424 reports of adverse events resulting from more than 23 million doses administered nationally since the HPV vaccine was first licensed in June 2006 through Dec. 31, 2008.
The findings, published in 2009 in the Journal of the American Medical Association, were not that different from what was seen in the safety reviews of other vaccines recommended for a similar age group for meningitis and Tdap -- diphtheria, pertussis and tetanus -- and based on the review of the available information, the benefits of the HPV vaccine outweighed risks.
Since the HPV vaccine was approved, 94 percent of reported adverse events have been minor, the CDC said. The most common were fainting, pain and redness at the vaccine site, dizziness, nausea and headache.
The CDC said the 32 deaths among vaccine recipients were attributed to other causes, including diabetes, viral illness, illicit drug use and heart failure.
Side affects aside, the vaccine also has become tangled in the hot-button issue of teen sexual promiscuity, with some parents concerned mandatory vaccinations impinge on parental rights and worried that giving it to their young daughters may lead to earlier sexual activity.
Sex is the real "elephant in the room any time you bring up the HPV vaccine," Dr. Jennifer Ammons, a pediatrician and member of the Lancaster County (Pa.) Immunization Coalition, told Lancaster Online in an article posted Saturday. For parents with strong religious beliefs, dealing with the sexual issues leading to the diseases the vaccine prevents can be difficult, she said.
"They believe their child is not going to have sex before marriage, and their child's [future] partner is not going to have sex before marriage," she said.