One important aspect that needs public airing is how key opinion leaders in psychiatry were used by GSK to help allay fears that Paxil might induce suicidal thoughts and/or behaviors. When GSK issues statements indicating that Paxil is not linked to increased suicide risk, many people will think “Gee, of course GSK will say Paxil is not linked to suicide – it’s their product, after all.” But when purportedly independent academic researchers make the same claims regarding the alleged safety of Paxil, then people tend to think “Well, if these big-name researchers say it’s safe, then I suppose that there’s no risk.” But what if GSK simply hands these big-name researchers (aka “key opinion leaders") charts with data, and then the “independent” researchers go about stating that Paxil is safe? Mind you, the researchers in question don’t see the actual raw data – just tables handed to them from GSK – in other words, they simply take GSK’s word that the data is accurate. In essence, these researchers are serving as information conduits for GSK.
But wait a second, what if the charts and data tables handed to them by GSK are not an accurate representation of the raw data; what if GSK is lying? Well, of course, it turns out that GSK was lying in a big way for several years. This post will not go into depth on the suicide data, as it has been covered elsewhere (1, 2, 3 ) -- even GSK now admits that Paxil is related to an increased risk of suicidality.
What did these key opinion leaders say about Paxil? Some quotes from Glenmullen's testimony follows, based upon documents he obtained in GSK's archive. Here's what David Dunner (University of Washington) and Geoffrey Dunbar (of GSK) reportedly said at a conference
Suicides and suicide attempts occurred less frequently with Paxil than with either placebo or active controls.John Mann of Columbia University, regarding how data were collected:
We spent quite a bit of time gathering data from various drug companies and formulating it into the publication of the committee's findingsThe committee he references is a committee from the American College of Neuropsychopharmacology, the same organization that issued a dubious report blessing the use of antidepressants in kids.
More from Mann, after being asked if he saw raw data or just data summarized in tables:
To be perfectly honest, I can't recall how much of the statistical raw data we received at the time that we put these numbers together...No, I think we all went through the tables of data that were provided at the time.To use the analogy from above, the election board did not actually see the ballots. Stuart Montgomery is next. He was an author, along with Dunner and Dunbar, on a paper in the journal European Neuropsychopharmacology that stated:
Consistent reduction in suicides, attempted suicides, and suicidal thoughts, and protection against emergent suicidal thoughts suggest that Paxil has advantages in treating the potentially suicidal client.Did Dunner see any raw data?
Dunner: I didn't see the raw data in the case report forms. I did see the tables. I work with the tables. The tables came before any draft, as I recall. We -- we created the paper from the tables.The above-mentioned paper that gave a clean slate to Paxil? According to a GSK document examined by Glenmullen, it was used by GSK to help convince physicians that they need not worry about Paxil inducing suicidality.
Attorney: And -- and you never questioned, did you, or did you not question the validity of the data in Table 8?
If you are an academic researcher, and you simply take data tables from drug companies then reproduce them in a report and/or publication, you are not doing research -- you are laundering information. People think that you have closely examined the data, but you have not, and you are thus doing the public a disservice.
I am unaware of any of the above researchers ever issuing a public apology. I can respect the context of the times; researchers may not have been aware of how pharmaceutical companies fool around with data in the early 90's. So if anyone wants to issue a mea culpa, I'd respect such an apology, but I have a feeling that not a single one of the above named individuals (nor this guy) will make an apology. Instead, it will be more business as usual, as these key opinion leaders, knowing who butters their bread, will continue to launder information and tell the public that everything will be fine and dandy if they just take their Paxil, Seroquel, or whatever hot drug of the moment is burning up the sales charts.