Two Wisconsin women are in federal court today, alleging that Gardasil caused them to go into early menopause and become infertile, but doctors say such claims aren't rooted in science.
Madelyne and Olivia Meylor, of Mount Horeb, Wis., claim that the vaccine against cancer-causing human papillomavirus, or HPV, caused primary ovarian failure in both of them. The sisters are 20 and 19 years old, respectively.
"There is nothing about this particular vaccine that would make this at all plausible," said Dr. Kim Gecsi, who directs the ob/gyn clerkship program at University Hospitals Case Medical Center in Cleveland. "There is nothing hormonal in Gardasil or anything anti-hormonal in Gardasil -- nothing that should encourage the body to stop producing ovarian hormones."
Like the flu shot, the Gardasil vaccine contains an inactive virus, triggering an immune response in the patient, Gecsi said. This immune response includes the production of antibodies specifically taught to fight HPV, so if a live virus ever gets into the patient's body, her immune system can fight it off.
Merck, the maker of Gardasil, conducted Gardasil safety and efficacy testing in more than 25,000 people before the drug was approved by the Food and Drug Administration, said Merck's executive director of vaccine medical affairs and policy, John Grabenstein. Researchers did not find instances primary ovarian failure to be linked to Gardasil.
Since then, 125 million doses of Gardasil have been administered worldwide, he said.
"We've not found any reason to believe there's a cause-effect relationship" between the vaccine and ovarian failure, Grabenstein said.
The Meylor sisters originally filed their claim in November 2010, and their case is being heard today at the Special Masters at the U.S. Court of Federal Claims. The court's decision will determine whether the Meylors receive a settlement from the government's Vaccine Injury Compensation Program.
The Vaccine Injury Compensation Program has received 212 claims against HPV vaccines, including 11 deaths, according to program records. (Gardasil is one of two HPV vaccines.)
Of those claims, 63 were dismissed and 68 received compensation of some kind. The rest are pending. Two deaths prompted compensation from the program.
"Please note that a settlement is not an admission by the United States or the Secretary of Health and Human Services that the vaccine caused the petitioner's alleged injuries, and, in settled cases, the court does not determine that the vaccine caused the injury," said David Bowman, a spokesman for the Health Resources and Services Administration, which runs the program.
Although most vaccine claims are settled in court, 10 of the 68 were settled by the Special Masters at the U.S. Court of Federal claims, where the Meylor sisters' claim is being heard today, Bowman said.
"Since this is not a recognized adverse effect, the judges will have to make a decision about that," said Dr. William Schaffner, chairman of preventive medicine at Vanderbilt University Medical Center in Nashville, Tenn. "There's no scientific basis for it."
The vaccines against HPV appear to be working, according to a study by the Centers for Disease Control and Prevention, which found that a single dose cuts HPV risk by 82 percent. Since the arrival of HPV vaccines -- Gardasil and Cervarix -- HPV infection rates among girls aged 14 to 16 have dropped by 56 percent, according to the study.
HPV has been implicated in more than 28,000 cancers, including 12,000 cervical cancers, according to the CDC. "It's a vaccine that prevents cancer," Gesci said. "This is a huge public health benefit we've been given for the last eight years. It really is amazing to me, the controversy that comes from it."
Dr. Jennifer Ashton, a senior medical contributor for ABC News and a practicing ob-gyn, said the most common symptoms are redness around the injection site and fainting.
Some patients will have allergic reactions, which can happen in any vaccine, Gesci said.
"As with any vaccine, the doctor and the patient have to balance and assess the risks versus the benefit versus the alternative," Ashton said.
The attorney representing Madelyne and Olivia Meylor was not immediately available for comment.