Big Pharma Blocks Studies of Long Term ADHD Drug Effects While FDA and EMEA Dither

The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) dither while Big Pharma blocks studies into long term effects of ADHD drugs—unless, of course, they’re produced by their own pet (and very highly paid) researchers, such as Joseph Biederman, Timothy Wilens and Thomas Spencer. Hanging in the balance are the health and futures of millions of children.

FDA Findings and Nonaction

On 3 March 2006, the FDA reported on serious concerns about ADHD drugs⁽¹⁾, including documentation that they can induce psychotic behavior in children, as follows:

The most important finding of this review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors, at usual doses of any of the drugs currently used to treat ADHD. Current approved labeling for drug treatments of ADHD does not clearly address the risk of drug-induced signs or symptoms of psychosis or mania (such as hallucinations) in patients without identifiable risk factors, and occurring at usual dosages. In addition, current labeling does not clearly state the importance of stopping drug therapy in any patient who develops hallucinations, or other signs or symptoms of psychosis or mania, during drug treatment of ADHD. We recommend that these issues be addressed.

It has been more than four years since this memo was sent to the Director of the Office of New Drugs, the Director of the Office of Pediatric Therapeutics, the Acting Deputy Director of the Office of Pediatric Drug Development, and the Deputy Director of the Division of Drug Risk Evaluation. At this point, it appears that nothing has come of it.

EMEA’s Request and Hiding of the Response

On 22 June 2007, the Committee for Human Medical Products (CHMP), an EMEA agency, sent a request to Big Pharma companies that manufacture ADHD drugs containing methylphenidate, the active ingredient in the drugs named above. They were asked to outline how they could produce studies on certain long term effects of these drugs, including adverse cognitive outcomes and adverse psychiatric outcomes.

The result was a response by a Consortium (self-described) of Big Pharma companies, including Novartis, Johnson & Johnson, Shire, Medice, and Laboratorios Rubió on 30 October 2009⁽²⁾. It has become publicly available only by order of a Swedish court.

Rest of the story…