New study about antidepressants – Big Pharma and medical agency working close together to save profits and careers

The new study, “A Regulatory Apologia - A review of placebo controlled studies of new-generation antidepressants”, claiming that antidepressants work well for all forms of depression should be seen in that light. It’s another good example of how alleged objective medical agencies work close together with the pharmaceutical industry and its paid psychiatrists to increase sales.

The study was announced in the journal of the Swedish Medical Association (Läkartidningen) April 15, 2008. In the article the longstanding advocate for antidepressant drugs Professor Björn Beerman from the Swedish equivalent to the FDA, the Medical Products Agency (MPA), promoted continued high level use of these drugs. Beerman did not believe in the data presented internationally and said (as many times before) “there is no doubt that the medication has effect and that this is independent of degree of depression”. He further stated that “the effect should be less good in milder depression, that we don’t believe in”.

In the article Beerman with pride announced the new study from the MPA; a study supposed to prove his statements. The study was said to be submitted for publication in the most prestigious medical journal on the planet, the Lancet.

But this part of the story needs to be told:

What Beerman didn’t say (April 15) was that the Lancet already, almost two weeks earlier, (April 4) had rejected the article – it was not to be published. The MPA then made another try, and submitted the data to the British Medical Journal (BMJ) – another journal with high impact. But the response was the same, the BMJ rejected the material.

So the agency – with its for Big Pharma so important “research message” – went directly to the manufacturers, or more correctly to a journal with an editor-in-chief who probably has meant more for the approval and sales of antidepressant drugs internationally than anyone else: The agency submitted its article to European Neuropsychopharmacology, with its editor-in-chief, Dr. Stuart Montgomery. And it was accepted.

For those not familiar with the work of Dr. Montgomery it can be said that he played a major role in helping Big Pharma to get new antidepressant drugs approved in the beginning of the 90-ties (despite that the actual data already at that time showed the drugs gave an increased risk of suicide).  He was also responsible for the famous concealment of Seroxat/Paxil severe withdrawal symptoms. Instead of accepting the clear withdrawal symptoms so that patients and doctors could be warned Dr. Montgomery and colleagues misclassified these symptoms as signs of recurring depression – needing more drug treatment.

So a study with the PR-message that antidepressants work well for all forms of depression would most likely be very welcome in the European Neuropsychopharmacology. And it was. One of the reviewers of the article made the point very clear, saying: “This meta-analysis is very timely in the situation when the recent meta-analysis of Kirsch et al. (2008) induced a lot of uncertainty about the efficacy of antidepressants, both in the psychiatric community as well as in public opinion.” It was recommended that the article should be published “without any delay, given the situation mentioned above [“uncertainty … in the psychiatric community as well as in public opinion”].”

The MPA and its counterpart FDA have done almost nothing to use the wealth of data in its files to show the actual suicide risks with antidepressants, and to warn doctors and the public. (See the newly unsealed extensive analysis by Dr. Joseph Glenmullen of GlaxoSmithKline’s hiding of Seroxat/Paxil suicide data, as an example of how the pharmaceutical industry can act, and how ineffective and silent a regulatory agency can be in questioning the data in the drug applications http://finance.senate.gov/press/Gpress/2008/prg061208a.pdf , 4MB.) The lack of positive drug effects has always been denied by the MPA. The ineffective system for postmarketing surveillance of adverse drug effects is putting the public at severe risk – yet it is allowed unchanged year after year. The often horrible withdrawal symptoms of antidepressant drugs have been explained away as signs of recurring depression – and thus transformed to evidence of positive drug effects; and this manipulation has been accepted by the regulatory agencies. The MPA and the FDA, supposed to protect the public, are agencies out of control, and see the pharmaceutical industry as their real clients.

It’s first in a situation, where independent analyses of data submitted to the FDA show no positive effect of antidepressant drugs compared to placebo, that the Swedish MPA puts all its “research resources” in action to prove the opposite. The eagerness for collaborating with Big Pharma in getting out a PR-message, to handle the “uncertainty about the efficacy of antidepressants, both in the psychiatric community as well as in public opinion”, is yet another example of betrayal of the real clients – the public.