Saturday, June 28, 2008

Bad News--Other Countries Also Have FDAs of their Own

The ever-alert Jon Judeidini sent this link out through the Healthy Skepticism network:

This is a news article and not a medical journal publication, but the claim is that the Swedish pharmaceutical regulatory agency, their version of the US FDA, is colluding with psychiatrists who are well known to be heavily beholden to the pharmaceutical industry, to publish a study that purports to show that antidepressants really do work very well and that studies that seem to indicate that they are little if any better than placebo are bunk. The article was of such stunning scientific quality that the two journals to which it was first submitted, Lancet and BMJ, both rejected it forthwith. The study then experienced a soft landing at European Psychopharmacology (I guess psychopharmacology on that continent is different from everywhere else, requiring a separate journal) , edited by Dr. Stuart Montgomery. According to the reporter, Dr. Montgomery is apparently the European version of our own Dr. Charles Nemeroff (see previous post, Dr. Montgomery was described as being almost singlehandedly responsible for previously concealing data on the paroxetine withdrawal syndrome.

Now, just to be up front about the whole matter, I would like to go on record as admitting that I have somewhat the same reaction as the Swedish psychiatrists who are in bed with Pharma. In my years of practicing family medicine, during which I wrote a lot (in hindsight probably way too many) of scripts for newer-generation antidepressants, I did see a number of patients who had very significant therapeutic responses. In the best cases, they stated that they felt like their normal selves again for the first time in years. For this subgroup of patients, it might have been a placebo effect for all I could know scientifically, but it was a darn impressive placebo effect if so. I also saw a number of cases where the drugs did not work or seemed to stop working after about 6 months; and I saw a good many cases where the patient complained that the side effects ("I feel like a zombie" was a pretty common way to express them) were as bad or nearly as bad as the depressive symptoms. So my own very limited clinical experience is inconsistent with the notion that these drugs are no good at all. It is consistent with the assertion that the side effects of these drugs have been chronically underreported in the literature as well as in the curbside conversation of my colleagues, in both psychiatry and in primary care.

Anyway, back to Sweden--I suppose one element of incurable romanticism among Americans is that we imagine that other countries are wiser than we are and have solved many of the problems that continue to plague us (like providing universal health care). So it is sad to realize that other advanced countries have their own versions of the same issues with "regulatory capture" that we do in the U.S.

1 comment:

Anonymous said...

Some remark for you who don’t now Sweden or Swedish.

The reporter writing the transworldnews article is known for his connection to the scientology movement in Sweden.

The article he refers to is'n really about the mpa but about the publication biases where the mpa states that they known about the problem and even published about this problem before. What they question is the statement that antidepressant drugs have no more effects than placebo, something that not even the recently published papers agree with, just the clinical significance.

I’m not defending the mpa’s publication or their methodology, just put the article and the criticism in a perspective.