On January 17th, 2008, the prestigious New England Journal of Medicine, published a landmark paper by Eric Turner and others:
“Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy”.
This paper showed that among 74 FDA registered studies of antidepressants, 31% were not published. 37 studies showing positive results were published, while studies showing negative or questionable results were, with three exceptions, either not published (22 studies) or published in a way that (the authors conclude) erroneously conveyed a positive outcome.
This means that if one were to read the literature, one would believe that 94% of the trials conducted were positive. In contrast to the published literature, the study authors, who reviewed all the FDA studies, found a 51% rate of positive trials. And finally, the ‘effect size’ (useful for making clinical decisions, effect size is a measure of the strength of the relationship between two variables such as mood improvement and the use of a medication) reported from journal reports were often larger than the data on file with the FDA justified. The numbers were inflated.
Now, I am waking to the fact that there is a long-term historical pattern. Despite the periodic real advances in medicine over the centuries, facts demonstrate that this field dons the mask of science on a pretty regular basis.
Here is a brief tour of the evidence:
a) In the 60’s birth control pills were promoted as a hormonal way to eliminate unwanted pregnancies. The fact is that birth control pills are made of conjugated equine estrogen: these are not human hormones, they are horse hormones. Millions of women were given a foreign substance misrepresented as a hormone. Anyone who has knowledge of chemistry knows that if you move or change a single atom in a molecule its biological activity changes very dramatically. So while these substances are equine hormones, for humans these are xeno-hormones, or foreign hormones. It is nearly 50 years later that “medical scientists” decided to look in a serious way at the effect on women’s health and were surprised by the damage being done. In this case gynecologists, backed by industry and politicians wore the mask of science.
b) For about 30 years, the HPA axis (hypothalamic-pituitary-adrenal axis) has been a focus of research in psychiatry, since it seems to be a core part of the way the body transduces psychosocial stress into depression. A steroid called dexamethasone has been given to people in an attempt to tease out the function and dysfunction of the HPA axis. Did I say steroid? Oops. Guess what. This steroid is actually synthetic. All of the studies on the HPA axis in depression have been done using a synthetic steroid. So, you must be wondering, what’s the big deal? I was at a conference on ‘mood and corticosteroids’ last June. A parade of scientists came across the stage, each one touting their issue, their study, their perspective. Finally, one researcher was presenting, and I could tell this guy was a ‘take-no-prisoners’ seeker of truth. So I asked him: “Do you think it matters that all of the HPA axis studies are done using dexamethasone as their steroid, when it is foreign to the human body, when the human body makes hydrocortisone, not dexamethasone?” He pulled the mask of science and exposed the dark shadow underneath:‘When you look at which genes are turned off and which genes are turned on by the two compounds (hydrocortisone, the natural human corticosteroid vs dexamethasone), there is some overlap, but overall there is a wide difference in their metabolic and genetic effects.’ Doesn’t that matter if we are studying the natural function of the HPA axis? ‘It’s a matter of convenience’, he said. dexamethasone can be dosed once per day, rather than 3-4 times per day. Who said science should be easy?