Manufacturer of autism drug Risperdal may have hidden some adverse effects from FDA
The informational autism website SpectrumNews.com reported in August 2015 that a leading manufacturer of the widely used autism drug risperidone omitted data on the drug’s side effects from a 2003 study. The article cites evidence presented during a lawsuit against Janssen Pharmaceuticals.
Risperidone, marketed by Janssen as Risperdal, is one of only two drugs approved for autism. The Spectrum News article also describes growing criticism from doctors and researchers aimed at Janssen for its alleged ethics breach.
The drug, originally developed as an antipsychotic for adults with schizophrenia in 1993, was deemed unsafe for prepubescent children because it can boost levels of prolactin, a hormone that helps new mothers produce milk. The website notes that elevated prolactin levels are linked to a range of side effects, including gynecomastia, or growth of breasts, in men and boys.
Janssen’s risperidone troubles began with its 2003 Risperdal study, where it stated that it did not find a link between elevated prolactin levels in boys and gynecomastia (or other side effects) that could result from excess prolactin.
In 2006, the U.S. Food and Drug Administration approved risperidone for easing irritability in children with autism, which sometimes manifests as aggressive outbursts. But, according to Spectrum News, the FDA acknowledges the drug can have dangerous side effects, including severe weight gain. The drug’s label includes a warning that some boys may develop gynecomastia.
Then came the part of the story that is typical after a pharmaceutical company and the FDA agree that a drug is sufficiently safe. In 2013, Janssen settled a lawsuit brought by the FDA for $2.2 billion that alleged Janssen aggressively marketed Risperdal between 2002 and 2003 for unapproved uses, including in children with autism.
Individual lawsuits followed, including one from a now-20-year-old man with autism who grew size 46DD breasts after taking Risperdal between 2002 and 2006, according to the website. In February, a Philadelphia jury awarded him $2.2 million.
Spectrum News says documents introduced as evidence against Janssen in this case include an early manuscript of the 2003 study that includes two data tables missing from the published version.
The study, backed by Janssen, was designed to ferret out potential adverse effects of long-term risperidone use. A team of researchers from Janssen and elsewhere looked at data from 700 children who took risperidone. They reported that prolactin levels rose in these children over the first two months of treatment but returned to normal by five months.
The news site also notes that the researchers reported some incidences of what they preposterously called “SHAP,” or “Side effects Hypothetically Attributable to Prolactin.” (Pharma loves its acronyms, especially when they stand for euphemisms!)
These adverse effects include gynecomastia, but the study concluded that “there was no direct correlation between elevated prolactin and ‘SHAP’.” As SpectrumNews.com points out, the data in the previously missing tables introduced in the latest lawsuit directly contradict this finding.
A professor of psychiatry and behavioral sciences at the University of Washington in Seattle, who was not involved with the study or the lawsuits, commented on these problems to Spectrum News: “This is disheartening on many levels. Scientific misconduct is scientific misconduct. I honestly don’t see any difference between withholding something in a deliberate attempt to influence the findings and just making it up.”