No scientific evidence backs Rep. Michele Bachmann's second-hand story of HPV vaccine causing mental retardation. Our research reveals that 35 million doses of the vaccine have been administered, without a single reported case of mental retardation. A total of four cases of a disorder involving inflammation of the brain have been reported, but a panel of scientists found there was insufficient evidence to establish that the vaccine caused those.
The Republican presidential candidate has repeatedly related an anecdote about a post-debate encounter with a woman who told her a vaccine promoted by Texas Gov. Rick Perry has left her daughter mentally retarded. In fact, federal health officials say they've received no reports of mental retardation following an injection of the vaccine. Based on experience from tens of millions of doses already administered, they find the vaccine to be safe and effective as a deterrent against a sexually transmitted disease that can lead to cervical cancer, which takes 4,000 lives a year. And that's backed up by the American Academy of Pediatrics, which has denounced Bachmann's statements.
Bachmann first raised the issue about the vaccine at a Republican debate sponsored by CNN and the Tea Party Express on Sept. 12. She attacked Perry for issuing an executive order in 2007 requiring 11- and 12-year-old girls to get the a vaccine designed to protect against cervical, vulvar and vaginal cancers caused by human papillomavirus (HPV).
Bachmann criticized the executive order as a "violation of a liberty interest" and questioned the motivation for Perry's decision, noting that Perry's former chief of staff was a lobbyist for Merck, the maker of the vaccine Gardasil, and that Merck donated thousands to Perry's campaign.
Bachmann was right about the former staffer-turned-lobbyist and the political donations from Merck. But Bachmann drew rebuke from many health officials for her claim that Gardasil was a "potentially dangerous drug." The Food and Drug Administration and Centers for Disease Control and Prevention both have concluded that Gardasil is "a safe and effective vaccine." We discussed some of the extensive studies that underpin the FDA and CDC's decision in our coverage of the debate.
However, in the hours after the debate, Bachmann doubled down on her assertions about the supposed dangers of the vaccine. Several times on national TV she related an anecdote about a post-debate encounter with a weeping woman who told her the vaccine caused her daughter to suffer mental retardation.
Bachmann first relayed the anecdote in a post-debate interview with Greta Van Susteren of Fox News:
Bachmann, Sept. 12: "The problem is, it comes with some very significant consequences. There’s a woman who came up crying to me tonight after the debate. She said her daughter was given that vaccine. She told me her daughter suffered mental retardation as a result of that vaccine. There are very dangerous consequences. It’s not good enough to take, quote, “a mulligan” where you want a do-over, not when you have little children’s lives at risk."
The following morning, Bachmann repeated the story in an interview with Matt Lauer on NBC's "Today" show.
Bachmann, Sept. 13: "Well, I will tell you that I had a mother last night come up to me here in Tampa, Florida, after the debate. She told me that her little daughter took that vaccine, that injection, and she suffered from mental retardation thereafter. It can have very dangerous side effects.
The mother was crying when she came up to me last night. I didn’t know who she was before the debate.
This is the very real concern and people have to draw their own conclusions."
After an extensive review, the FDA approved Gardasil in 2006 for use in females age 9 to 26. But since then, the FDA and CDC have kept tabs on any side effects reported for Gardasil — as it does with all vaccines – through the Vaccine Adverse Event Reporting System (VAERS). Since coming on the market, Merck has distributed more than 35 million doses of the vaccine in the U.S. There have been no reports of anyone suffering mental retardation as a result of receiving the Gardasil vaccine.
In August, a committee of experts convened by the Institute of Medicine, after extensive review of published scientific research on vaccine safety, released a report that took a comprehensive look at the adverse events for a number of vaccines, including HPV.
The IOM panel concluded "the evidence is strong and generally suggestive" of a causal relationship between the HPV vaccine and anaphylaxis. Anaphylaxis is a severe allergic reaction that can cause cramping, difficulty breathing or swallowing, hives, nausea or fainting. (Doctors are advised to observe patients for a short period after injection, in case one of these rare allergic reactions takes place.) There was no evidence proving a causal relationship between the HPV vaccine and any other adverse event.
We spoke to Dr. Joseph Bocchini, chairman of the Department of Pediatrics at the Louisiana State University Health Sciences Center – Shreveport. He's also a member of the CDC's Advisory Committee on Immunization Practices and chairs the ACIP's HPV working group.
Of the 35 million doses of HPV that have been distributed, Bocchini said there have been 19,000 reports of adverse events — most of them described as "non-serious." But that doesn't mean the vaccine caused any of them. To determine a causal relationship requires a large and thorough database study to determine whether the events are happening more frequently than one would expect to see without the vaccine.
"The evidence is that there is no serious risk to the use of this vaccine," Bocchini said. "Its safety record is very strong."
The IOM did note there were four published reports of Acute Disseminated Encephalomyelitis (ADEM). That is a neurological event that could potentially lead to a decrease in mental capabilities, Bocchini said. It's possible, he said, that the unidentified woman who spoke to Bachmann — if she was someone who didn't have the correct medical terms at her disposal — might have been referring to ADEM, although that it not the same thing as mental retardation.
Even still, the IOM concluded there was insufficient evidence, based on the small number of reports, to establish any kind of causal relationship between the HPV vaccine and ADEM. It said: "The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and ADEM."
"There is no vaccine that I'm aware of that's been associated with a significant likelihood of damage being done to the neurological systems that would affect brain function," Bocchini said.
The president of the American Academy of Pediatrics, O. Marion Burton, also released astatement to "correct false statements" made by Bachmann.
Burton, Sept. 13: "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. 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.
The American Academy of Pediatrics, 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. 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. 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."
Bachmann's comments were also condemned by the Global and Regional Asperger Syndrome Partnership in a statement to Politico.
GRASP spokesman Evan Siegfried, Sept. 13: "Congresswoman Bachmann's decision to spread fear of vaccines is dangerous and irresponsible. There is zero credible scientific evidence that vaccines cause mental retardation or autism. She should cease trying to foment fear in order to advance her political agenda."
In an interview on Sept. 13, Sean Hannity of Fox News played a clip of Bachmann relaying the anecdote about Gardasil causing the woman's daughter to suffer mental retardation, and he asked her directly about it.
"Is that one of the side effects of this? Because I've not heard that," Hannity said.
"I have no idea," Bachmann said, before relaying the anecdote yet again.
"I am not a doctor, I'm not a scientist, I'm not a physician," Bachmann said. "All I was doing is reporting what this woman told me last night at the debate."
However, Bachmann has repeatedly cited the anecdote in the context of her assertion that the vaccine is potentially dangerous. And there is no scientific evidence to back that up.
– Robert Farley