Data on Harms Are Not Reflected in Clinical Study Reports; But Can Be Recovered, Says Peter Gøtzsche

Kermit Cole
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Data on adverse events in clinical study reports may not accurately represent underlying patient data, according to two pilot studies in the British Medical Journal, the first from a team lead by Peter Gøtzsche analyzing unredacted clinical study reports and protocols from the European Medicines Association before it closed in 2011.  The team is finding that clinical study reports contain extensive data on major harms that are not made available in journal articles and trial registry reports.

Maund, E., Tendal, B., Hróbjartsson, A., Lundh, A., Gøtzsche, P. Coding of adverse events of suicidality in clinical study reports of duloxetine. British Medical Journal. June 4, 2014; 348:g3555. doi: 10.1136/bmj.g3555

Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. British Medical Journal. June 4, 2014; 348:g3510 doi: 10.1136/bmj.g3510

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Kermit Cole
Kermit Cole, MFT, founding editor of Mad in America, works in Santa Fe, New Mexico as a couples and family therapist. Inspired by Open Dialogue, he works as part of a team and consults with couples and families that have members identified as patients. His work in residential treatment — largely with severely traumatized and/or "psychotic" clients — led to an appreciation of the power and beauty of systemic philosophy and practice, as the alternative to the prevailing focus on individual pathology. A former film-maker, he has undergraduate and master's degrees in psychology from Harvard University, as well as an MFT degree from the Council for Relationships in Philadelphia. He is a doctoral candidate with the Taos Institute and the Free University of Brussels. You can reach him at [email protected]

2 COMMENTS

  1. They will constantly claim there are not big risks associated with this or that psych drug or that these drugs are “safe and effective” while the existing data is biased, incomplete and in big parts unreliable. Clinical trials and drug development should be taken from the hands and funding by pharmaceutical companies.

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