Paxil/Seroxat – ‘information laundering’

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?”

Dunner: “No”

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.

Seroxat can be a killer – so says South Cumbria Coroner

SOUTH Cumbria coroner Ian Smith will contact drug authorities because he fears people are killing themselves after taking antidepressants.

Mr Smith is to write to the Committee on the Safety of Medicines – an independent advisory body on the quality and safety of medicines – following the inquest into the death of Nigel Woodburn.

Mr Woodburn drove into a tree just four days after being prescribed controversial antidepressants.

The retired bank manager, of Bardsea Green, was killed at the wheel of his car on June 16, minutes after confessing to his wife he’d had suicidal thoughts. He had been prescribed Citalopram after becoming depressed through ill health.

His heart-broken family said they were not aware of the suicide risks associated with antidepressants until the issue was highlighted at Mr Woodburn’s inquest this week.

Mr Smith told Tuesday’s inquest he knew of several other suspected suicides involving the same group of antidepressants, known as selective serotonin re-uptake inhibitors (SSRIs).

He said: “I have to say this is probably the fifth, if not sixth inquest I’ve heard within a period of three years when somebody either just going on to Citalopram or Seroxat, or coming off it, have killed themselves one way or another, totally out of the blue, totally without expectation, without a history of suicidal thoughts in the past.”

Mr Woodburn’s stepson, Gareth Salton, said: “I want people to understand the effects these drugs have.

“I want people to know it isn’t just something you read about in the national media.”

On the morning of his death, Mr Woodburn, 68, told his wife Rita he’d been thinking of killing himself.

“Even at that time I wasn’t unduly concerned,” she said.

“I didn’t think for a minute he was going to do anything silly.”

Mrs Woodburn went to ring her son, Gareth, and when she returned to the sitting room her husband had gone and the car was missing.

He travelled a short distance, in his pyjamas and dressing gown, along the A5087 coast road before crashing into a tree.

Collision investigator PC Philip Murray confirmed tyre tracks on the grass verge were consistent with rolling wheels, which indicates brakes weren’t applied.

Consultant histopathologist at Furness General Hospital, Dr Marek Witkowski, said the cause of death was a head injury.

Mr Woodburn had also suffered a ruptured aorta, which Dr Witkowski said raised questions about whether this caused the accident or happened upon impact.

Mr Smith said: “I think it is highly unlikely this man, who had just expressed for the first time in his life thoughts about suicide, should just by chance have had the ruptured aorta which caused the accident.”

Mr Smith returned a narrative verdict that Mr Woodburn died in a road vehicle collision.

He added: “I think what happened to Mr Woodburn was in part as a result of the drugs he was taking. There has been publicity about these drugs recently, particularly relating to younger adults, and it does seem to me it’s something that needs to highlighted.”

After the inquest, Mr Salton, 40, added: “I want people to know how awful these drugs are, and that when friends and family are put on these drugs to recognise what might happen, so they don’t go through the nine months of self-recrimination that this family has.”

Coroner’s officer Liz Gaskell stressed that anybody concerned about these antidepressants must consult their GP.