More from the Evelyn Pringle here. The entire article can be read here Trail Of Paxil Suicides Leads To Glaxosmithkline.
Glaxo needed to find a way to ‘use’ Study 329 – you know, the one that showed Paxil wasn’t safe and didn’t actually work in children. Enter Drs. Keller and Ryan. By using opinion leaders in the field, academics who everybody looks up to, doctors would be far more influenced to prescribe Paxil than they would be if approached by Glaxo salespersons.
At the time, the name of Dr Martin Keller, a professor of psychiatry at a prominent university in the US was apparently worth a lot to drug makers and specifically Glaxo. In a single year, Panorama reports, Dr Keller earned a half a million dollars from drug companies, including Glaxo.
Study 329 was finally published in the July 2001, Journal of the American Academy of Child and Adolescent Psychiatry, with Dr Keller’s name as the lead author (with Dr Neal Ryan and Dr Karen Wagner), but Keller’s actual input has been seriously questioned. In one memo, Dr Keller thanked a ghost writer from a PR firm hired by Glaxo for preparing the manuscript stating: “You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me…”
The study drew criticism from around the world: one letter to the Editor by Professors, Dr Jon Jureidini and Dr Anne Tonkin, from Adelaide, Australia, stated: “We believe that the Keller et al. study shows evidence of distorted and unbalanced reporting that seems to have evaded the scrutiny of your editorial process. Given that the research was paid for by GlaxoSmithKlien it is tempting to explain the mode of reporting as an attempt to show the drug in the most favorable light. Given the frequency with which it is cited in other scientific papers, at conferences and educational functions, and in advertising, this article may have contributed to the increased prescribing of SSRI medication to children and adolescents.”
Another highly critical editorial was published on June 12, 2004, in The Lancet, which stated in part that Glaxo “appears to be floundering in the semantic depths. While it has been earnestly parsing the meaning of ‘suicidal thinking and acts’ and ‘publicly,’ it appears to have forgotten what lies behind those words – people.”
By 2004 even the European Medicines Agency (EMA) and the FDA were in on the Act – the FDA ordering the re-evaluation of all SSRI studies… including 329.
A February 4, 2004, email from another highly paid Glaxo academic, Dr Neal Ryan, to fellow Study 329 authors, Dr Karen Wagner and Dr Keller, illustrates their alarm over the FDA’s order for drug companies to re-evalute all SSRI studies. The email states:
FDA made each company go line by line through absolutely all documentation of all kids in all their studies. This is where 4 more subjects in our joint study fell out, unfortunately all the Paxil group. Don’t know severity or more information about this yet.
In a curious Glaxo email titled, ‘Study 329 Update,’ to Dr Ryan, Dr Wagner and Dr Keller, the investigators who supposedly reviewed the data and authored the report, a GSK employee wrote: “We want to update you, as investigators on Study 329, about additional potential pediatric suicidality cases that were recently discovered. In a manual review of all SAE narratives and ‘trauma’ cases, 10 additional events potentially suggestive of intentional self injury, suicidal ideation, or suicide attempt were identified. Four of the 10 events occurred in study 329, all in the paroxetine group. Consequently, this could potentially change the number of paroxetine suicide-related adverse events for that study from 6 to 10.” “These cases,”the email states, “included among those undergoing blinded review by Dr. Wagner, Dr. Ryan, and Dr. Apter for the pediatric suicidality manuscript.”
This message apparently caused Dr Ryan to panic because he was being contacted by reporters. In an email response he stated:
“With your email yesterday (appended below) about 4 additional ‘events’ in Study 329 on the Paxil arm, those of us involved in writing the recent letter to the reporter asking about details of our article need very very quickly to get absolutely as much information as you have and understand what part of this we need to pass on to her. Otherwise we are in the challenging position of sending her a good-faith effort at directly answering her questions that we find very shortly thereafter is no longer the most complete information available to us and which therefore might appear misleading.”
“Can we get a much fuller explanation in email?” Dr Ryan asks. “Should we quickly set up a conference phone call?”