Two sisters from Mount Horeb say a cervical cancer vaccine shut down their ovaries and almost certainly left them unable to get pregnant, a claim scheduled for a hearing Thursday and Friday in federal court in Washington, D.C.
Madelyne Meylor, 20, and Olivia Meylor, 19, say their premature ovarian failure came from the vaccine against human papillomavirus, or HPV.
It’s the first allegation that the vaccine caused the condition to reach a hearing through the National Vaccine Injury Compensation Program, said their attorney, Mark Krueger, of Baraboo.
Health officials recommend three doses of the vaccine against HPV, a sexually transmitted virus, for girls and boys ages 11 and 12 to protect against cervical cancer, throat cancer, genital warts and other conditions. Two brands are available: Gardasil, approved in 2006, and Cervarix, approved in 2009.
The vaccine injury program has awarded payments for HPV vaccine injuries in 68 cases for a total of at least $5.9 million, according to the federal government and Judicial Watch, a nonpartisan foundation. The program has dismissed 63 claims and 81 claims are pending.
About 22,000 adverse reactions from the HPV vaccine were reported nationally from June 2006 to March 2013, a period in which 57 million doses were distributed, according to the Centers for Disease Control and Prevention.
About 92 percent of the reactions, including the most common ones — fainting, dizziness and nausea — weren’t serious, the CDC said.
A 2011 study found that certain serious reactions — including seizures, stroke, potentially fatal allergic reactions and Guillain-Barre syndrome, an autoimmune disorder that can cause paralysis — were no more common among HPV vaccine recipients than in similar groups that didn’t get the vaccine, the CDC said.
The CDC and the Food and Drug Administration say the vaccine is safe and can help prevent many of the 18,000 cancers in women and 8,000 cancers in men caused by HPV each year.
But the Meylors said their Gardasil shots caused their ovaries to stop producing eggs. They also have premature menopause, marked by insomnia, night sweats and headaches, and almost certainly won’t be able to get pregnant, they said.
“I’ve always wanted a huge family, but I don’t know if that will be possible,” Madelyne said.
“People should look into the vaccine more and see if the benefits outweigh the risks,” Olivia said.
Madelyne, a UW-Madison junior, had her first menstrual periods at age 13, a few months before her first dose of HPV vaccine, according to a brief filed in her case.
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Her periods were irregular and became more irregular after the second dose. After the third dose, at age 15, her periods stopped.
In 2010, at age 16, she was diagnosed with premature ovarian failure.
Olivia, a UW-Platteville sophomore, received three doses of HPV vaccine before having her first period at age 15, according to a brief in her case.
She had just one more period the next month. At 16, she was diagnosed with premature ovarian failure.
Tests for three possible genetic causes of the condition were negative for both women. They are taking birth control pills or using patches as hormone replacement therapy.
Their doctor told Olivia she has no chance of getting pregnant and Madelyne has less than a 5 percent chance, they said. Both could carry a baby conceived through infertility treatments, they said.
Merck, which makes Gardasil, refers to the condition as premature ovarian insufficiency, or POI.
“Merck has reviewed the post-licensure reports of POI after administration of Gardasil and has concluded that the evidence does not support a causal relationship to the vaccine,” the company said in a statement. “The cases have been reported to the U.S. FDA and other regulatory agencies. There have been no reports of POI in the clinical trials with Garsadil.”
Dr. Yehuda Shoenfeld, from Israel, plans to testify that the Meylors’ condition is an autoimmune disease caused by substances in the HPV vaccine, called adjuvants, designed to boost the body’s immune response. The phenomenon is known as Autoimmune Syndrome Induced by Adjuvants, or ASIA.
“There may be many young women who have been affected in this way who don’t know it,” said Krueger, the attorney.
The government will argue that the Meylors have typical premature ovarian failure unrelated to the HPV vaccine, according to U.S. Department of Justice briefs filed in both cases.
ASIA “is a syndrome that was first proposed by Dr. Shoenfeld in an article he authored in 2010,” the briefs say. “ASIA is not accepted by the medical community at large.”
Krueger said he doesn’t expect a decision immediately after the two-day hearing.
Joen Meylor, the sisters’ mother, said she trusted her doctor that Gardasil was safe. But when both daughters’ ovaries failed, “I started digging on the Internet and realized how harmful that vaccine is,” she said.
Whether the hearing results in a payment, “at least they’re going to have to look at us and make a decision,” she said.