Merck Deliberately Hid Gardasil Link to Autoimmune Disorders, Says Former FDA Consultant
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A former FDA regulatory consultant says Merck failed to adequately warn the public that its Gardasil HPV vaccine could be linked to postural orthostatic tachycardia syndrome (POTS) and other autoimmune-related conditions, according to a public court filing. The expert report, released after Merck settled hundreds of Gardasil lawsuits, alleges the company had sufficient evidence to strengthen the vaccine’s safety warnings years earlier but chose not to do so.
A pharmaceutical regulatory expert says Merck failed to adequately warn the public that its Gardasil HPV vaccine could be linked to postural orthostatic tachycardia syndrome (POTS) and other autoimmune-related conditions, according to a public court filing.
The expert report, released after Merck settled hundreds of Gardasil lawsuits, alleges the company had sufficient evidence to strengthen the vaccine‘s safety warnings years earlier but chose not to do so.
Since Merck’s highly profitable Gardasil vaccine first came on the market in 2006, the list of side effects on the label has grown.
Over time, Merck added reports of dizziness, fatigue, fainting and other conditions. And eventually, the label noted that there had been postmarketing reports of autoimmune diseases, motor neuron disease, transverse myelitis and other conditions.
The collection of symptoms — along with evidence from animal studies, Merck’s own clinical trials, case reports submitted to the company and published scientific literature — all indicated that Gardasil could cause autoimmune disorders and postural orthostatic tachycardia syndrome (POTS) in some individuals.
Yet the company never warned the public about these risks, according to regulatory affairs specialist Stephen Amato, Ph.D., a professor and department chair of Graduate Regulatory Affairs and Life Science at Northeastern University and former U.S. Food and Drug Administration consultant with decades of experience in pharmaceutical regulation.
Amato concluded that Merck should have added stronger warnings about possible autoimmune-related adverse events, including POTS, to the Gardasil label.
In his declaration to the court, Amato said that Merck listed POTS symptoms on the label as individual adverse events, when the drugmaker should have warned about the condition itself.
A warning is a higher level of precaution that would more effectively alert the public to a possible causal relationship between Gardasil and POTS and other autoimmune disorders.
“Merck continued to add other symptoms of POTS to postmarketing sections of its labels, but never a Warning of POTS; rather Merck merely added what appeared to be a random collection of symptoms without ever connecting them to one another,” he wrote.
Amato said federal regulations require manufacturers to update warnings when there is “reasonable evidence of a causal association,” even if a causal relationship has not been definitively proven.
He said that by January 2011, Merck either knew or “should have known” that there was reasonable evidence of a causal connection between Gardasil and autoimmune reactions, including POTS.
Merck has consistently maintained that Gardasil is safe and effective.
Amato’s findings are detailed in an expert report submitted as evidence in a lawsuit against Merck by Jennifer Robi, a California woman who alleged the Gardasil vaccine permanently disabled her.
Robi and hundreds of other plaintiffs recently settled with Merck on confidential terms. The expert reports submitted during the case are now public.