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Manipulations with antidepressants-research

By Dr. Marcel de Roos, Psychologist PhD, the Netherlands

Dick Bijl, a Dutch medical doctor and epidemiologist, has been for 22 years the chief editor with “Het Geneesmiddelenbulletin”. This is a Dutch independent governmental magazine which informs impartially about medications to doctors, pharmacists, patients and students. He has read tens of thousands international articles about drug research and he has published many scientific articles.

In his book “Antidepressiva en depressie” he describes how the pharmaceutical industry tries every trick in the book to embellish their products, and how they mislead scientific magazine editors, regulatory authorities, doctors and patients. Editors and peer-reviewers are totally not equipped against this, and admission authorities like the American FDA and the European EMA are typically controlled by doctors and researchers who have strong ties with the pharmaceutical industry. Even worse, these authorities are primarily financed by the pharmaceutical industry. And they frequently select (former) top administrators from the FDA and EMA to come and work for them.

Antidepressants are big business, and in the stock markets the pharmaceuticals are seen as highly profitable blue chip companies. Since the financial interests are astronomical, you can imagine that the pharmaceutical industry will do almost anything to safeguard their profits.

You can’t measure depression; there exists no blood test, x-ray or scan for it. So the only way to determine the level of depression is with a self-questionnaire, usually the Hamilton Depression Rating Scale (HAM-D). The range of the scale is from 0 – 52 points. A difference of one point (!) between patients who received an antidepressant and those who had a placebo is seen as statistically significant (if both groups are big enough, say a few hundred patients).

For example in a research study, patients with a serious depression have a mean HAM-D score of 20. The group that takes antidepressants goes for instance from 20 to 12 and the group with the placebo from 20 to 13. This difference of one point is statistically significant if your study group is big enough.

But no one, neither a doctor nor a patient, will be able to experience this one point difference as a clinical improvement. A CLINICAL significant difference should be at least three or four points. But antidepressants are officially registered when they have a STATISTICAL significant difference (one point) with placebo tablets. We know from several meta-analyses that antidepressants only “work” with people with a very serious depression, but they work only a little bit in the sense that people say they feel a bit better.

The registration authorities approve antidepressants if manufacturers can show two studies (which the manufacturers finance and control!) with a statistical significant difference. The manufacturers often have nine or ten studies but for the approval there need only be two positive in terms of efficacy. If eight out of ten studies have no efficacy then the drug will be accepted on the basis of two positive studies.  .

In 2015 independent researchers have done a re-analysis of a published study in 2000 about antidepressants with children and adolescents. By means of a court order they had access to all the data that the manufacturer hadn’t published. The re-analysis showed that the antidepressants showed no efficacy with children and adolescents, and there were considerable side-effects.

There exists no “chemical imbalance in the brain” and this and the “serotonin reuptake” story (people are encouraged to believe that depression is caused by a deficiency of serotonin as in the analogy with diabetes and insulin) are just clever marketing concoctions of the pharmaceutical industry, there is no scientific medical proof for this.

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