Two Wisconsin sisters have asked a federal court to find that a government-recommended vaccine is responsible for them losing the ability to conceive children.
At issue is Gardasil, a three-dose vaccine recommended for children 11 to 12 years old to prevent infection by certain strains of human papillomavirus (HPV) that are linked to genital and oral cancers.
The case of Madelyne Meylor, 20, and Olivia Meylor, 19, of Mount Horeb, Wisc., was presented last week to a special master with the vaccine program at the U.S. Federal Claims Court in Washington, D.C.
A decision from the special master is not expected until early 2014, attorney Mark Krueger said Monday.
The women say the premature ovarian failure they both experienced by age 16 was caused by the three doses of Gardasil they received in their young teens.
Details of their case — which may be the first to be heard by a special master — were not available for review, but medical and scientific witnesses testified last week why Gardasil was responsible for the rare loss of fertility, Mr. Krueger said.
Department of Justice attorneys, representing the Department of Health and Human Services, which promotes HPV vaccines, argued that Gardasil did not cause the women’s ovarian failure, Mr. Krueger said.
Gardasil manufacturer Merck & Co., said the drug’s safety and efficacy have been “studied in more than 25,000 females and males in clinical trials.”
The company said it studied reports of premature ovarian insufficiency (POI) after administration of Gardasil and “concluded that the evidence does not support a causal relationship to the vaccine.”
“There have been no reports of POI in the clinical trials with Gardasil,” Merck said in a statement.
Premature ovarian failure or insufficiency is a rare condition that strikes 1 in 1,000 women between the ages of 15 and 29 and 1 in 100 women between the ages of 30 and 39, according to Resolve, the national infertility association. The suspected causes of the condition include defects in reproductive organs, inherited disorders and exposure to anti-cancer drugs and treatments, Resolve said.
Women with ovarian failure can still be candidates for in-vitro fertilization using donor eggs.
The Meylor sisters tested negative for three genetic causes for their ovarian failure, according to a report Friday in the Wisconsin State Journal. The sisters have little or no chance of getting pregnant, but both believe they “could carry a baby conceived through infertility treatments,” the article said.
Mr. Krueger said the sisters believe the three shots of Gardasil triggered an autoimmune disease in them, based on the vaccine’s inclusion of substances designed to boost the human immune system.
These substances — called adjuvants — appear to cause side effects in some people, according to Israeli researcher Dr. Yehuda Shoenfeld, a specialist in autoimmune conditions, who testified on behalf of the Meylors last week. Dr. Shoenfeld has called the phenomenon “autoimmune syndrome induced by adjuvants” or ASIA.
According to the Wisconsin State Journal, the Justice Department rejects the ASIA argument, saying it has not been accepted in the medical community.
HPV is the nation’s most commonly transmitted sexual infection. Many HPV infections resolve themselves without ill effect, but a handful of HPV strains are linked to deadly genital and oral cancers, including cervical cancer.
Since 2007, the American Academy of Pediatrics has recommended that girls age 11 or 12 receive the HPV vaccine; last year, it recommended the shots for boys that age too. The vaccine is given to children before they begin having sex, since the vaccine can’t work against existing HPV infections.
In July, public health officials lamented the relatively low percentage of youths receiving the vaccine: In 2011 and 2012, only 35 percent of teen girls received the three shots of the vaccine, said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. Parental concerns about HPV shots are unwarranted, he said, because “no serious safety concerns have been identified.”
Judicial Watch, however, has tracked Gardasil outcomes — including two deaths that were compensated — based on a belief that the drug’s 2006 approval was “rushed through” because of political pressures, said Thomas Fitton, president of the watchdog group. “If an adult female wants to submit herself to the vaccination, that’s her choice,” Mr. Fitton said Friday. “But the idea that we would push this with children … It’s just a huge public health experiment. We shouldn’t have children being the guinea pigs.”
The National Vaccine Injury Compensation Program said that, as of Nov. 4, some 62 claims against an HPV vaccine have been compensated and 62 claims have been dismissed.
In addition to Gardasil, a GlaxoSmithKline product called Cervarix is available for HPV prevention.