A Conspiracy of Silence: The Suppressed Evidence about Anti-Depressants

Multinational Monitor, July-August 2004 | Go to article overview

A Conspiracy of Silence: The Suppressed Evidence about Anti-Depressants


An interview with Charles Medawar

Charles Medawar is the executive director of the London-based Social Audit, a British public interest group Medawar is a specialist on medicines policy and corporate accountability. Social Audit's work on anti-depressants helped bring to widespread public attention the risks and side effects of anti-depressants, and drug regulators' failure to ferret out these hazards. Medawar is the co-author with Anita Hardon of Medicines Out of Control: Antidepressants and the Conspiracy of Goodwill.

Multinational Monitor: How effective are the blockbuster anti-depressants?

Charles Medawar: If you look at the performance of these drugs in large populations, you get a very consistent pattern. These drugs are generally shown to be more effective than a placebo, a dummy drug, but the data for large populations disguises the reality as most individuals would experience it.

I suspect what happens with these drugs is that a relatively small proportion of people--perhaps 10 to 15 percent--will find the drugs to be extremely effective. Another small proportion of a comparable size will find the drugs quite unacceptable and intolerable, and a small proportion of those would find them potentially dangerous. For the vast majority of users--perhaps as high as 80 percent--it would make very little difference whether they took one of the drugs or a placebo, The other thing one can say about the measured performance of these drugs is that in spite of the different mechanisms of action--some drugs for example work on the serotonin system, and others do not--there are no measurable differences in effectiveness. Considering the claims made for the different kinds of anti-depressants, that seems astonishing.

I also have to add a caveat to the first point I made. The evidence that shows these drugs to be more effective than placebo comes from published trials. What has become clear as a result of the investigations surrounding the anti-depressant crisis is that a good deal of evidence is not published. In other words, the drug manufacturers are publishing the trials that demonstrate positive results and often not publishing the results of trials which do not show positive results.

There is an outstanding example of this in relation to the FDA's efficacy requirement--that the sponsor of the drug (the manufacturer) should produce evidence from two trials demonstrating greater effectiveness than placebo. Because of the relatively weak effect of the anti-depressants, it seems that the manufacturers normally conduct eight studies of drug against placebo in order to come up with two positive results. I'm sure the four or five or six trials that demonstrate no difference between drug and placebo are submitted to the regulators, but they are identified as something else, for example, safety studies. The trials which do not demonstrate effectiveness are not submitted to satisfy that particular requirement of the FDA, and the FDA apparently has no objection to this. What should happen is a meta-analysis of all trials conducted to the same protocol--to take account of the results of all the studies done, and not simply the ones most favorable to the manufacturer.

MM: What are the risks and dangers of using these drugs?

Medawar: The risks are very unpredictable--you really don't know who is going to experience what in advance. The risks are compounded by the fact that the manufacturers, essentially for marketing reasons, tend to recommend a single uniform dosage for everyone. A one-size-fits-all basis is extremely convenient for marketing, but seems quite inappropriate, considering what we know about the subtleties and variations of individual response. And in extreme cases, the consequences may be very serious.

Albeit 15 years too late, the authorities have also now acknowledged that there are major risks of dependence--when you want to stop taking the drug, you can't because of sometimes severe withdrawal effects. …

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