Confidential report reveals: Big Pharma trying to stop long-term safety studies of ADHD drugs

A confidential document, now made public by a Swedish court, tells how pharmaceutical companies (calling themselves the “Consortium”) are trying to stop long-term safety studies of ADHD drugs (Ritalin, Concerta)

By Janne Larsson
March 5, 2010

The companies producing methylphenidate products (like Ritalin and Concerta) are normally competitors, marketing ADHD as a disease and the narcotic drugs as its solution. But when they are threatened with marketing restrictions they have a common interest.

If more scientific long-term studies would be done showing the harmful effects of the drugs it could lead to withdrawal from the market of this class of drugs. Therefore Big Pharma has to stop all such studies not written and controlled by themselves. The only studies they support are those conducted by paid researchers like psychiatry professors Joseph Biederman, Timothy Wilens and Thomas Spencer, where the outcome is known already from the beginning.

The European Commission has 27 May 2009, after a long review by the European Medicines Agency (EMEA), decided to issue warnings about methylphenidate drugs. The Commission has also decided that a number of long-term studies of good quality should be done to investigate different harmful effects of these drugs.

So for example the manufacturers were ordered to submit data how they could do long-term studies of psychiatric adverse effects (e.g. depression, hostility and psychotic reactions) and of cognitive effects (effects on learning, intellectual function) of the drugs. The answer from the pharmaceutical companies was a confidential report Feasibility Assessment of a Study of Long-term Effects of Methylphenidate on Cognition and Psychiatric Outcomes written 30 October 2009 – now made public by a Swedish court.

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