Thursday, December 06, 2007

Seroquel for Everything and Academic Spokespeople

Part 1. Seroquel for Depression and Anxiety. AstraZeneca is slowly rolling out the PR for Seroquel as a treatment for depression and generalized anxiety disorder. At something called the 7th International Forum on Mood and Anxiety Disorders, AstraZeneca (via academic frontman Stuart Montgomery) has trotted out data from their latest clinical trials which purportedly show that Seroquel beat placebo for depression and GAD. Here's a quote from the detached, independent, non-conflicted academic author, Stuart Montgomery...
Dr. Stuart Montgomery, Imperial College School of Medicine, University of London and author of the [depression] monotherapy study, said: These study results are remarkable -- all of the doses of SEROQUEL XR examined provided improvements in MDD and GAD symptoms. Results from further studies that are still ongoing will add to our understanding of SEROQUEL XR in these conditions.
What is remarkable is not that 'Quell had a slight advantage over placebo but that an "independent" academic psychiatrist is willing to pimp Seroquel so blatantly. It would appear that Dr. Montgomery is aware of who is putting butter on his bread. Finding a modest to perhaps moderate advantage for a drug over a placebo in treating depression and/or anxiety is far from remarkable, given that there are dozens of drugs and psychotherapies that have demonstrated similar or better efficacy. Then again, it is remarkable that Seroquel is related to increased risk of diabetes (1, 2, 3, 4), which is likely not the case for competing depression treatments. Of course, since the movement has now started to treat depression with antipsychotics (1, 2), perhaps we will see many people with depression moving toward an increased risk of diabetes. It might be worth noting that on the MADRS, which was the measure of depression reported in the press release, one question is regarding eating -- the more you eat, the better your score. So an antipsychotic linked to weight gain is set to do well in that those who eat a lot will score better on this item, which is then taken as a sign that they are less depressed.

I've been tracking the Seroquel for everything bandwagon for some time now (1, 2, 3, 4) and I can't wait to see where this is headed next.

Part 2. The Academic Salesperson. As Krusty the Klown might say, "I heartily endorse this event and/or product"...

Here are some other Stuart Montgomery quotes from press releases:

"Agomelatine is an interesting and potentially very valuable antidepressant that is effective in both moderate and severe depression", says Professor Stuart Montgomery from the Imperial College School of Medicine in London. "The new agent has a unique mode of action, improves sleep without affecting daytime alertness and its efficacy is not compromised by sexual side effects, tolerability problems or discontinuation symptoms.
Escitalopram (Lexapro)
"These results are important because they show we have a treatment at our disposal which is effective without sacrificing the good side-effect profile obviously preferred by patients," commented study author Professor Stuart A. Montgomery, Imperial College School of Medicine, London, United Kingdom. "The ideal combination for any first line treatment is good efficacy and good tolerability - this study shows that escitalopram has all the potency of the non selective SNRIs combined with the good tolerability of the conventional SSRIs," he concluded.
Lexapro (again)
“This consistent advantage really came out as a surprise,” marvelled Prof Montgomery. “These are shocking data that no one was expecting”. He added: “At that stage we already knew that there was something special about the drug”.

Finally, Prof Montgomery mentioned results coming from further studies that he referred to as “staggering” – these were decisive in establishing Lexapro’s long term effectiveness in treating both GAD and SAD.
One more piece on Dr. Montgomery may be of interest to readers (via The Guardian ):
A leading figure in the world of psychiatry gave a pharmaceutical company advice on how to get its new drug approved while he was sitting on the committee which was deciding the licence application.

An internal memorandum from Pfizer, the world's largest drug company, says Stuart Montgomery would be happy to become a paid adviser and declare an interest to the Committee on the Safety of Medicines (CSM) once the drug, an antidepressant to rival Prozac, had been through the licensing process.

Read the whole article and see what you think.

When Dr. Montgomery or other key opinion leaders with similar conflicts of interest speak, we are supposed to view them as independent expert researchers whose enthusiastic product endorsements are based purely based on science. The manner in which every drug company trot out eager academic spokespeople is a sign that academic medicine has become rotten to the core.


Anonymous said...

Way back when, Stuart Montgomery, then of St. Mary’s hospital medical school in London was co-author of a paper bigging up Paxil.

See below:

Dr. David Dunner of the University of Washington’s Department of Psychiatry admitted he “ghostwrote” an article that appeared in the March 1995 issue of the journal European Neuropsychopharmacology (EN) on behalf of pharmaceutical manufacturer SmithKline-Beecham (which has since merged with GlaxoWellome to become Glaxo-Smith-Kline, or GSK). Dunner had purportedly analyzed the data of clinical studies involving GSK’s antidepressant and anti-anxiety drug Paxil and concluded that it is less likely to lead to suicidal thoughts than the older antidepressant imipramine or a placebo(sugar pill).

Dunner never looked at any of the data but he was still listed as an “author” of the article.

Meanwhile, Dr. David Healy of the University of Wales Department of Psychological Medicine presented a different analysis of this same data during the Paxil trial [of 2001]. The family of Wyoming resident Donald Schell, 60, sued GSK in federal court after Schell shot his wife, daughter, granddaughter and then himself to death in 1998 after two days on Paxil. Healy testified on behalf of the plaintiffs. He argued GSK’s internal records demonstrated that there is a substantially increased suicide risk for patients put on Paxil. The jury agreed with the plaintiff’s position that Paxil was primarily responsible for Schell’s actions and awarded them $6.4 million in June of [2001]. The judge in the case rejected GSK’s challenge of Healy’s testimony and sent them packing to a federal appeals court in Denver in August.

A suicide warning has since been put on the label for the drug, not here in the United States, but in Britain, where it is known as Seroxat.

Dunner’s record also includes eight statements of significant financial interest. The most significant with regard to the Paxil clinical trial data is a disclosure he made in 1998. The disclosure was made regarding an application for a clinical trial dealing with Paxil in which Dunner would serve as an investigator at his Center for Anxiety and Depression. His Confidential Statement to the Vice Provost for Research states, “My involvement with SmithKlineBeecham (the pre-Glaxo merger owner of Paxil) involves being a member of the international advisory board related to paroxetine (Paxil).” In other words, Dunner’s name appeared in the EN article not as an independent scientist but most likely as a part-time employee of the manufacturer of Paxil. This conflict of interest is not mentioned in the EN article.

Anonymous said...

Great job.

This sickens me.....


CL Psych said...


Thanks for the additional info.


Thanks for the feedback and for linking it on your site. It is indeed very disheartening...