Merck responds to Gardasil criticism

NEW YORK — Attacks on a human papillomavirus vaccine made amid an increasingly caustic Republican presidential primary battle have drawn a response from the manufacturer.

During a CNN/Tea Party Express debate in Tampa, Fla., Monday night, Rep. Michele Bachmann of Minnesota criticized Texas Gov. Rick Perry for signing a 2007 executive order mandating that girls be vaccinated against HPV with Merck & Co.'s Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant). Following the debate, Bachmann told "Fox News" that a woman had approached her and said the vaccine had caused "mental retardation" in her young daughter.

Bachmann did not support the claim with scientific evidence, and no studies have linked Gardasil with mental retardation. HPV causes genital warts and also can cause cancer, particularly cervical cancer, which about 12,000 women in the United States develop each year, according to Merck.

"The facts about Gardasil are clear," read a statement released by Merck on Tuesday that did not directly reference the debate or either of the candidates. "The efficacy and safety of Gardasil was established in clinical trials in thousands of patients. Since its approval in 2006, the vaccine has been given to millions of girls around the world. Merck remains strongly committed to preventing cervical cancer."

Meanwhile, the American Academy of Pediatrics offered a more direct response.

“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," AAP president O. Marion Burton said. "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."