Here’s the link to an article (written by investigative journalist Shelley Jofre) outlining the story of Glaxo and its infamous Study 329:
“UK-based GlaxoSmithKline (GSK), the second largest drug company in the world, which recorded 2006 sales of over $45 billion, had begun a series of clinical trials in the mid-1990s to test whether paroxetine would work in depressed children. Paroxetine had already been hailed as a wonder drug in adults as a treatment for everything from depression and stress to anxiety and even shyness. By the new millennium 100 million paroxetine prescriptions had been written worldwide, bringing in $2 billion a year for GSK and placing the antidepressant a close second to Prozac in popularity.
With the adult market sewn up, the company sought new ways to make money from the drug, or “life cycle management,” as the approach is known in the pharmaceutical industry. The U.S. Food and Drug Administration wanted to boost the number of medicines tested for children and had introduced an incentive that would give companies a six-month extension on their patent just for carrying out pediatric trials. For paroxetine alone that would be worth $1 billion. And if GSK could be the first company to prove its antidepressant was safe and effective for children, the rewards would be even higher, as paroxetine could become the market leader.
Hundreds of children were recruited from around the world to take part in three clinical trials. One group was given the drug, the other a placebo. They were randomized controlled trials (RCT) where neither the children nor their doctors knew whether they were taking the active drug or the placebo until the end of the study. This is widely accepted as the best way of working out whether a drug causes a particular effect: the gold standard in terms of evidence.
But the outcome of these the trials was not what GSK had been hoping for. Paroxetine proved no better than placebo. In the biggest trial, Study 329, which was conducted across several sites in the U.S., 11 of the 93 children who took paroxetine developed serious side-effects; seven had to be hospitalized. Significantly more had self-harmed or attempted suicide on the drug than on placebo.
The BBC (British Broadcasting Corporation) obtained confidential case reports from Study 329 which detail what happened to them:
“[13 days after starting paroxetine] the patient became very angry. He punched pictures, broke glass and sustained lacerations that required six sutures… he expressed hopelessness and possible suicide thoughts.”
“The patient began exhibiting symptoms of disinhibition, grandiosity and expansive mood around week four [after eight weeks] the patient became agitated and said she would kill herself.”
“[11 days after starting paroxetine] the patient was hospitalized for psychosis with auditory hallucinations and superficial cuts.”
Yet this was a drug that was supposed to make children happier and reduce the risk of suicide.
The company knew it had a problem. In an internal memo to senior executives in 1998 the product director for paroxetine admitted:
“The results of the studies were disappointing. The possibility of obtaining a safety statement from this data was considered but rejected. Consultation of the marketing teams confirmed that this would be unacceptable commercially.”
In other words, publishing the data in full would undermine the drug’s safety profile and put profits at risk. It took five years for this information to reach the public domain and only then as a result of the BBC investigation. In the intervening years doctors continued to prescribe a drug to tens of thousands of vulnerable children, ignorant of the fact that it had not been shown to work and was harmful to some”
Read the entire article here.
As well as being angry with Glaxo, I am just as annoyed with the drug company apologists who rant on about a “profitable anti-seroxat bandwagon” while they simply ignore the facts.
You can’t help asking what their angle is? – what do they have to gain by taking such a stance?