I have been tapped once again as an expert in the ongoing saga of Accutane and psychiatric side effects, this case involving a 15-year-old boy who committed homicide in Colorado after he became psychotic while taking a generic version of Accutane, which is isotretinoin, this brand was Claravis. You can read about the case here including quotes from me and read more of my writings on the behavioral effects of Accutane here. Accutane was taken off the market in 2009 by the Hoffmann-LaRoche Pharmaceutical Company. It now requires a rigorous registry by doctor, patient and pharmacist, and has dropped to less than 5% of its prior use for the treatment of acne. It is chemically similar to the active form of Vitamin A, which was linked to psychosis in both North Pole explorers and Eskimos who ate polar bear, walrus and seal liver which has extremely high levels of Vitamin A. There is also a wealth of neuroscience evidence that Accutane affects the brain as well as multiple reports in the literature. And more salient is the fact that after 20 years this issue never goes away. I am constantly made aware of more tragic cases related to this drug.
Roche itself has known for years that Accutane can cause depression. A scientist working for the company from Switzerland named Dr. Peter Schifferdecker said exactly that in a report about 20 years ago. Marketing executives from the American branch of the company in Nutley, New Jersey, headed by a Vice President named John McClane, “re-wrote” the report to “enhance” it, removing the reference to the association. In France in 1998 Roche warned about the risk of suicide, although in Nutley there was no alert given to the FDA. Nutley claimed they had nothing to do with the French company and knew nothing about the warnings, which was completely false, as there were a flurry of emails across the Atlantic, and all of the subsidiaries of Roche are subordinate to the main company in Basel, Switzerland. Incredibly, John Mclane actually came to meet with me in my office at Yale University in 1999 when he saw that we were advertising for a study to look at the effects of Accutane on the brain. I thought at the time that he was a drug rep. I asked him to provide medication, which was going for about $2,000 for a full course of treatment at the time (common practice for researchers on drug effects) but he declined, telling me I should give up my study since it was a waste of time, they had already established there was no link. He gave me articles funded by his company.
I wrote about all of this and my experiences as an expert witness in the Accutane suicide and depression cases in my book The Goose That Laid the Golden Egg. Statements by the lawyers involved in current and previous litigation that I was excluded as a witness in those cases are wrong. In the case of Charles Bishop who flew a plane into a building in Tampa, Florida, claiming he was working with Osama Bin Ladin (i.e., clearly psychotic) I was allowed to testify about the psychiatric effects of this drug, but the family of the victim dropped out of the case after various entities tried to portray them as crazy trailer trash. At the time I wondered if this was related to behind-the-scenes efforts by the drug company to discredit the family for their own financial gain.
I was excluded in a lower court in a case in New Jersey where a teenager killed himself on the drug, at a time when the drug company knew there were cases of suicide but they failed to alert the Food and Drug Administration (FDA). This was overturned by the New Jersey Supreme Court. The case was set for trial but did not go forward. Think Harvey Weinstein. The lawyers also said that I had been accused of scientific misconduct and “reprimanded” by Emory University. The fact is that Roche spent millions of dollars on experts trying to get our paper showing that Accutane decreases function in a part of the brain called the orbitofrontal cortex that is known to be linked to depression retracted, and that my university did a thorough investigation, and found no evidence of fraud and did not recommend a retraction, only a single line correction about a minor issue that did not change our conclusion that Accutane affects brain function. The fact is that the paper still stands in The American Journal of Psychiatry despite their efforts to make it otherwise to save what at the time was their billion dollar a year drug for pimples. And cases of depression, suicide, violence, psychosis, and aggression on the various generic forms of Accutane, including Claravis, Myorisan, and others, continue to accumulate.
To those that argue there is no association between Accutane and its various generic equivalents and suicide, depression, psychosis and violence, I have only one question. Why then don’t these cases ever stop?