On 13 February 1998 60-year-old Donald Schell of Gillette, Wyoming, took two guns and shot his wife and daughter and 9-month-old granddaughter dead. Each victim took at least at least three shots to the head. Afterwards, Schell turned one of the guns on himself and ended his life. All this took place two days after Don Schell began taking Paxil for sleep problems.
Paxil is an antidepressant, one of a class of drugs known as Selective Serotonin Reuptake Inhibitors, or SSRI’s. The generic name for Paxil is paroxetine. In the UK, paroxetine is marketed as Seroxat.
Series:
Part 1: “I tried killing myself thirty times”
Part 2: “Remarkable efficacy and safety”
Part 3: “An effective drug treatment”
Part 4: The Ghost Writer
Part 5: It's shameful"
Surviving family members filed suit against SmithKline Beecham, the manufacturer of Paxil. (By the time the case went to trial, SKB had merged with Glaxo Wellcome to form GlaxoSmithKline, at the time the largest drug company in the world.) Plaintiffs retained psychiatrist David Healy as an expert witness. Doctor Healy examined the secret files of GSK and found the company had carried out studies – never made public – in which as many as one out of four healthy volunteers given Paxil experienced symptoms such as mental turmoil, restlessness, and nightmares, often after just a few days on the drug. Dr. Healy testified that Paxil had caused Don Schell, who had no previous history of violent behavior, to slaughter his own family.
Not surprisingly, Charles Preuss, attorney for GSK, disagreed. He argued that depression, not Paxil, caused Schell to carry out the killings. “Paxil is an effective drug treatment,” he averred. Noting that Don Schell had been taking the drug for only two days, he argued “The real tragedy is that Paxil didn’t have a chance to do its job and save lives. Paxil could have saved four lives in Gillette.” Jurors didn’t buy his argument, and awarded surviving family members $6.4 million.
On 13 October 2002, the British news program Panorama aired the documentary “Secret of Seroxat,” presented by BBC reporter Shelley Jofre, who noted that some patients who tried to stop taking paroxetine suffered withdrawal symptoms far worse than the conditions that led them to take the drug in the first place. These symptoms included headaches, muscle pain, sweating, trembling, visual distortions, thoughts of self-harm, and “head shocks.” Producers were subsequently deluged with emails from viewers claiming to have been harmed by paroxetine. One missive after another told of hallucinations, self-harm, nightmares about murdering children, violence, suicide, and homicide. Panorama, which had never before repeated a topic, subsequently aired three more episodes about the drug.
Meanwhile, earlier that year GlaxoSmithKline had submitted data regarding the safety and effectiveness of Paxil in pediatric populations to the FDA, which offered drug companies a six-month patent just for studying the effects of their products in children, even if safety and effectiveness was not demonstrated. Such an extension had the potential to be worth hundreds of millions of dollars to GSK.
On October 10, 2002, the FDA replied to GSK’s application for a patent extension, asking for more information. On May 22, 2003, GSK responded, submitting data to the FDA that showed that Paxil doubled the rate of suicidality in children in its trials. On June 20, the FDA issued a warning that no one under the age of 18 should be prescribed Paxil.
The following September, Dr. Healy along with statistician Chris Whitaker published a meta-analysis of randomized clinical trials of nine antidepressants, including Paxil, and found that these drugs caused a two-fold increase in suicide attempts and a whopping four-fold increase in actual suicides.
Or as Dr. Healy put it, graphically and succinctly, “When it comes to dead bodies in current psychotropic trials, there are a greater number of them in the active treatment groups than in the placebo groups. This is quite different from what happens in penicillin trials or trials of drugs that really work.”
In January of 2004, the Canadian Medical Association Journal obtained a secret document from the Central Medical Affairs team of GSK which concerned Study 329 along with another trial sponsored by GSK, Study 377. This document had been obtained by the California law firm Baum Hedlund, which had filed numerous lawsuits against GSK on behalf of plaintiffs claiming to have been harmed by Paxil. Baum Hedlund passed the document on to Panorama, which passed it on to Dr. Healy, who in turn passed it on to the CMAJ. The document noted that the data from these trials were “insufficiently robust” to support the use of Paxil in pediatric depression, and recommended GSK “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.” Regarding the publication of results from Study 329, the missive advised “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.”
The CMAt memo came to the attention to Rose Fierstein, a prosecutor working for Eliot Spitzer, then Attorney General for the State of New York. Spitzer’s office filed suit against GSK for fraud in concealing negative information about Paxil. This was the first lawsuit ever filed by a public official against the drug industry. GSK, while not admitting any wrongdoing, agreed to pay $2.5 million to settle the case and to post the results of its clinical trials on a website.
Doctor Steve Nissen of the Cleveland Clinic analyzed the data for GSK’s diabetes drug Avandia, and concluded the drug was causing thousands of people to suffer heart attacks. His findings, published in 2007 in the New England Journal of Medicine, caused the FDA to place severe restrictions Avandia, although the drug was never taken off the market.
Meanwhile bad news for GSK and the drug companies in general continued to pile up on other fronts. Faced with an avalanche of case reports of suicidal and homicidal violence associated with antidepressants, the FDA convened an emotional hearing on the subject, and on September 16 2004 an FDA advisory committee voted 15-8 to mandate a black-box warning on all antidepressants, informing consumers that these drugs increase the risk of suicidality in children and adolescents. In 2007 this warning was extended to adults up the age of 25.
The saga of Study 329 continued. On January 29, 2007, the fourth Panorama episode about Paxil aired. Titled “Secrets of the drug trials,” the show painted a disturbing picture of corporate venality on the part of GSK.
Next: The Ghost Writer
List of Sources
Kelly, R. 1998. Slaying suspect is one of dead. Wyoming Tribune-Eagle February 16 1998.
Orr, B. 2001. Antidepressant lawsuit begins in Cheyenne. Wyoming Tribune-Eagle May 22 2001.
Orr, B. 201. Paxil verdict: $6.4 million. Wyoming Tribune-Eagle June 7 2001.
Healy, D. 2014. Study 329. Retrieved 7 September 2015.
AP 2003. US issues warning on child use of Paxil. New York Times June 20 2003.
Healy, D. and C. Whitaker 2003. Antidepressants and suicide: Risk-benefit conundrums. Journal of Psychiatry and Neuroscience 28:331-337.
Bass, A. 2008. Side Effects: A Prosecutor, a Whistleblower, and a bestselling Antidepressant on Trial. Algonquin Books.
Kondro, W., and B. Sibbald 2004. Drug company experts advised staff to withhold data about SSRI use in children. Canadian Medical Association Journal 170:783.
Harris, G. 2004. Spitzer sues a drug maker, saying it hid negative data. New York Times June 3 2004.
Meier, B. 2004. Two studies, two results, and a debate over a drug. New York Times June 3 2004.
Meier, B. 2004. Glaxo plans public listing of drug trials on web site. New York Times June 19 2004.
Meier, B. 2004. Glaxo to begin posting drug trial results. New York Times September 1 2004.
Meier, B. 2004. For drug makers, a downside to full disclosure. New York Times May 23 2007.
Goode, E. 2004. Stronger warning is urged on antidepressants for teenagers. New York Times February 3 2004.
