Pharma sez: we can find the good but not the bad effects

This continues to amaze me. The pharma companies say they cannot perform a study on the side effects of their adhd drugs because the children patients have too many other problems. So the question is: if that is true then how can they claim beneficial effects for their products.

taken from Ed Silverman’s blog Pharmalot: http://tiny.cc/WxgHH


A confidential report issued last fall by Novartis on behalf of several drugmakers that sell ADHD meds concludes it isn’t feasible to conduct an observational, comparative long-term study to validate a signal of adverse psychiatric or cognitive outcomes from the long-term use of methylphenidate in children and adolescents with ADHD. Methylphenidate is sold as Ritalin and Concerta, for instance.

The 18-page report, which recently began circulating on the Internet, was compiled in response to a requirement issued last year by the European Commission to conduct such a study after the Committee for Medicinal Products for Human Use expressed concerns about safety issues, including sudden death, cerebrovascular disorders and psychiatric disorders as well as the effects on growth (see here).

However, the manufacturers – which refer to themselves as a consortium and include Johnson & Johnson and Shire – conclude a study isn’t feasible. Why? Comorbidity. “It is well established that ADHD co-occurs with other psychiatric disorders, including disruptive behavioral disorders such as oppositional defiant disorder, conduct disorder; and mood disorders such as depression, bipolar disorder; and anxiety disorders.” In other words, adverse events may be explained by other psychiatric disorders, such as bipolar disorder, for which still other meds may be needed.

“The difficulty (in conducting a feasibility study) stems, in part, from the fact that the endpoints of interest are part of the natural course of the disease, may also be related to the severity of the ADHD symptomatology and the overall psychiatric condition of the patients and the resulting treatment needs, leading to confounding by indication,” according to the report. Interestingly, the report cites various studies by Harvard University’s Joseph Biederman, who is credited with spearheading a big increase in the number of kids diagnosed with bipolar disorder, but was accused by a US Senator of failing to fully disclose payments from drugmakers, including J&J (see here and here).

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