This is from CL Psych’s excellent blog – a word for word lift as he’s done the job so well there’s nothing to add, except to note the fact that these people should be ashamed to have been exposed:
Joseph Glenmullen’s testimony regarding GlaxoSmithKline’s burial of suicide data related to Paxil, which was discussed briefly across the blogosphere last week (Pharmalot, Furious Seasons, for example), was quite interesting in many respects.
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.
My main question in this post is how we are supposed to trust our “key opinion leaders” in psychiatry if they are willing to simply look at data tables from GSK (and others), then make pronouncements regarding the benefits and safety of medication without ever examining the raw data. To put this in layman’s terms, suppose an election occurs and candidate A wins 70% of votes while candidate B wins 30% of votes. As the vote counter, I then rig the results to say that candidate B won the election by a 55% to 45% margin. Suppose that the election certification board shows up later and I show them a spreadsheet that I created which backs up my 55% vote tally for candidate A. The election board is satisfied and walks away, not knowing that the vote counting was a sham. Obviously, the election board should have checked the ballots (the raw data) rather than simply examining the spreadsheet (the data table). In much the same way, these so-called thought leaders in psychiatry should have checked the raw data before issuing statements about Paxil.
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 findings.”
The 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.”
Attorney: “And — and you never questioned, did you, or did you not question the validity of the data in Table 8?”
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.
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.
March 22, 2008 at 11:39 pm
I haven’t been hurt as badly as many people who have taken Seroxat, but I would definitely welcome the sight of any psychiatrists airing their souls and apologizing for any such mistakes they had committed. If you are a medical person who believed a pharmaceutical rep and hurt me, I will forgive you, but only if you come away from the side of the criminals who deliberately hurt so many people. They fooled you once. Please don’t let them continue to make a chump out of you in your patients’ eyes. Your patients need you on their side. Please don’t be afraid.
March 23, 2008 at 3:45 am
I spoke to my GP last week , he is very aware of GSK and the promotion of Seroxat to kids..
His words were “what they did to those kids is horrifying” ..
March 24, 2008 at 7:11 am
I’m glad you found a doctor who will listen. (:
March 26, 2008 at 10:30 am
What they´ve done to some kids is truly horrifying.
Yesterday I had a phone call from a woman who told me about one of her grandchildren whose mother was on Seroxat when she was pregnant. The child, a little girl, screamed day and night for almost two years and her tiny body was shaking from what seemed like total despair. She wouldn´t sleep, didn´t want to eat and had breathing problems. She suffered from constant diarrhoea and was often dehydrated. She often had flu like symptoms, impetigo and other painful blisters in and around her mouth and asthma-like symptoms that didn´t respond to treatment. All medical tests were performed but came out normal and the doctors didn´t have a clue to what was wróng with her.
Her siblings all started to walk around the age of one but not this little girl. She couldn´t because her body was too unstable. When she was almost two years old, she finally took her first steps but took a long time to learn and when she walked, it didn´t look normal at all. Her little body was strangely limp and was swaying in all directions. She was senstive to sound and covered her ears with her hands as soon as the dog barked. When she tried to run, the other children laughed at her because she had problems controlling her muscles and limbs and it looked really strange.
The girl is now five years old. She is slightly more stable, walks better, can run with difficulty but gets easily exhausted and breathless and is often unnaturally tired. She has probles tolerating lots of foods but is not allergic according to tests. She still covers her ears to shut out loud noise. And the doctors still don´t have a clue. I do because I got exactly the same problems after exposure to Seroxat and another SSRI. The difference is that I had fifty years of normal health before it happened to me. This poor little girl has never known normal health. Her name is Molly, she is now five years old and my heart aches for her.
April 4, 2008 at 5:40 pm
That is so sad. I hope someone reading this will try to come up with a cure for the “medicine.”