In the mid-2000s, Solvay Pharmaceuticals was developing an atypical antipsychotic called bifeprunox. As usual, the public relations for the drug overflowed with cheer and enthusiasm; a December 2006 article in PharmaTimes estimated that sales could generate as much as a billion dollars annually. But seven months later, the FDA rejected Solvay’s drug approval application.
Here is where things get interesting. In the non-approvable letter, the FDA apparently pointed to the weakness of the evidence that bifeprunox was effective in treating schizophrenia. But it also asked for more information about a patient who died while taking the drug in 2004. This was a Bulgarian patient with schizophrenia but no other health problems who went into a coma and died of hepatorenal failure only nine days after being given bifeprunox. The local investigator thought that the death was “possibly” related to bifeprunox, according to the Investigator’s Brochure, but Solvay continued with trials of the drug. Three years later, after the FDA asked for more information, Solvay officials went to Bulgaria, obtained an independent pathology report, and sent out a safety alert about the drug concluding that bifeprunox was linked to the death. The company soon shut down all bifeprunox studies. (You can see the safety alert here.)
The University of Minnesota was one of the sites where bifeprunox trials took place. In a local television segment last November, an anonymous patient detailed his harrowing experience on the drug. What is unclear is whether he or any other subjects in bifeprunox studies were ever told of all the risks the drug carried – especially the risk of hepatorenal failure that led to the suspension of the studies they had been enrolled in.
I am interested in hearing more about bifeprunox – from patients who were given the drug in clinical trials, from investigators who conducted the clinical trials, from IRB members who approved the trials, or anyone else with information about the drug. Given our history at the University of Minnesota, I am especially interested in subjects who took part in studies here, but I would also welcome calls or emails from anyone else with information about the drug. I can be found at the University of Minnesota Center for Bioethics.
Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.
Thank you for bringing this to people’s attention.
Crimes have been committed here. Once it was known that this drug could kill, continuing to administer it without precautions to people, some of whom died, would have been second-degree murder in many jurisdictions. A key phrase here is “a depraved indifference to human life.” Deaths don’t have to be directly intended for acts like this to be murder. If there is a risk of death that is recklessly disregarded, under circumstances that show this depraved indifference, this is a crime.
You might translate “depraved indifference to human life,” in ordinary language, to “I don’t give a damn if anyone dies.”
That happens over and over in situations like these. Our movement for human rights and justice in the mental “health” system must start raising the demand for criminal prosecution of criminal psychiatrists and drug company executives. It won’t be easy, and it won’t happen for a while, but lawsuits, with judgements paid for by the criminals’ insurance companies, just won’t change the situation. Why should they? The people who commit these outrageous acts pay no real price. Only the criminal law system can force these people to pay attention.