Pfizer and research misconduct in Zoloft clinical trials

Many thanks to Aubrey Blumsohn for this piece about Pfizer. He writes about a clinical trial for the SSRI Zoloft in the early 1980s.

Research misconduct (scientific fraud) is the violation of the standard codes of scholarly conduct and ethics in scientific research. It includes all forms of intentional distortion of the research process or reckless disregard of that process that place the scientific record at risk. It also includes the violation of informed consent, and improper use of information derived from the assumption of risk by other humans.

This link will take you to Scientific Misconduct where you can see copies of a couple of documents – in one 1983 document Pfizer reported that a patient had been taken off Zoloft (an antidepressant) during a clinical trial. The portion of the report that had been in the public domain (and presumably also with the FDA) from 1983 to 2004 indicated only that the patient was taken off the drug because of “treatment failure and nausea, anorexia and painful urination.”

However this explanation would seem at odds with the true clinical trial record which indicates that the patient had been withdrawn at day 11 of the trial because of thoughts of killing himself and others : “[The patient] began to verbalize feelings of killing other people and then himself.”

I suppose that could be translated as “treatment failure”…


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