by: Natural News Editors
In 2001, GlaxoSmithKline published a trial in children and adolescents, study
329.1 This study reported that Paxil (Seroxat) was effective with minimal side effects, and it was widely believed and cited, no less than 184 times by 2010, which is remarkable. However, the trial was fraudulent. We know this because the Attorney General of New York State sued the company in 2004 for repeated and persistent consumer fraud in relation to concealing harms of Paxil,2 which opened the company’s archives as part of a settlement. (Story from RadCliffeHealth.com.[PDF])
Glaxo lied to its sales force, telling them that trial 329 showed ‘REMARKABLE Efficacy and Safety’,3 while the company admitted in internal documents that the study didn’t show Paxil was effective. The study was negative for efficacy on all eight protocol-specified outcomes and positive for harm. These indisputable facts were washed away with extensive data manipulations, so that the published paper, which – although it was ghostwritten – had 22 ‘authors’, ended up reporting positive effects.3,4 The data massage produced four statistically significant effects after splitting the data in various ways, and it was clear that many variations were tried before the data confessed. The paper didn’t leave any trace of the torture; in fact, it falsely stated that the new outcomes were declared a priori.
For harms, the manipulations were even worse. The internal unpublished study report that became available through litigation showed that at least eight children became suicidal on Paxil versus one on placebo. This was a serious and statistically significant harm of Paxil (P = 0.035). There were 11 serious adverse effects in total among 93 children treated with Paxil and two among 87 children treated with placebo, which was also significant (P = 0.01, my calculation; the paper didn’t say that this difference was statistically significant). This means that for every 10 children treated with Paxil instead of placebo, there was one more serious adverse event (the inverse of the risk difference, 11/93 – 2/87, is 10). However, the abstract of the paper ended thus:
‘Conclusions: Paroxetine is generally well tolerated and effective for major depression in adolescents.’
An early draft of the paper prepared for JAMA didn’t discuss serious adverse effects at all! JAMA rejected the paper, and later drafts mentioned that worsening depression, emotional lability, headache and hostility were considered related or possibly related to treatment. The published paper did mention the serious adverse effects, but only headache in one patient was considered by the treat- ing investigator to be related to paroxetine treatment. I have my doubts about whether the treating investigators really made these decisions. As the adverse events were reported to the company and appeared in earlier drafts, it’s more likely that it was people employed by Glaxo that interpreted the drug’s harms so generously. In the published paper, five cases of suicidal thoughts and behaviour were listed as ’emotional lability’ and three additional cases of suicidal ideation or self-harm were called ‘hospitalisation’.
At least three adolescents threatened or attempted suicide, but this wasn’t described in the paper. Its first author, Martin Keller, wrote that they were terminated from the study because of non-compliance.2 There were other issues the published paper said nothing about. For one of the suicidal teenagers, the treating psychiatrist asked a researcher involved with the study to break the blind, which he refused although the protocol provided for this. Another ‘non-compliant’ teenager ingested 82 tablets of paracetamol, which is a deadly dose. Most curiously, another teenager was enrolled with the same trial number as the suicidal one, although this should be impossible, but perhaps the new patient took what remained of the study drug? This raises the uncomfortable question whether some patients who had fared badly were excluded from the trial. When the FDA demanded the company to review the data again, there were four additional cases of intentional self-injury, suicidal ideation or suicide attempt, all on paroxetine.
Keller is some character. He double-billed his travel expenses, which were reimbursed both by his university and the drug sponsor. Further, the Massachusetts Department of Mental Health had paid Brown’s psychiatry department, which Keller chaired, hundreds of thousands of dollars to fund research that wasn’t being conducted. Keller himself received hundreds of thousands of dollars from drug companies every year that he didn’t disclose. A social worker found a computer disc in the hallway and opened it to see to whom she should return it. She realised that adolescents were listed as if they had been enrolled in a study, which wasn’t true. It seemed they were made up, which would have been tempting given that $25 000 was offered by the drug company for each vulnerable teenager. The president of a chapter of the National Alliance for the Mentally Ill, supposed to be a patient advocacy group but heavily supported by big pharma, lectured for patients and their relatives on drug company money, which he didn’t reveal, and the honoraria were whitewashed.2
Read the entire study at RadCliffeHealth.com.[PDF]
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