Healthy Skepticism Library item: 12178

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

De Vries R, Elliott C.
Why disclosure?
J Gen Intern Med 2006 Sep; 21:(9):1003-4
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=16918750

Abstract:

In March 2006, 6 previously healthy research subjects in London were nearly killed in a Phase 1 trial of an investigational monoclonal antibody called TGN1412. Shortly after being given the investigational drug, the subjects developed multisystem organ failure and were rushed to an intensive care unit at a nearby hospital.1 The subjects had been promised £2000 ($3500) apiece upon completion of the trial, which was conducted by a Contract Research Organization called Parexel.2 According to its website, Parexel partners with clients “to accelerate time-to-market, control development costs, reduce risk, and maximize return on investment.”3

It is phrases like “maximize return on investment” that should be troubling to potential research subjects. The TGN1412 study is only one among a number of recent industry-funded clinical trials where financial interests have arguably placed research subjects at risk…

Keywords:
Publication Types: Comment Editorial MeSH Terms: Adolescent Adult Child Clinical Trials as Topic*/adverse effects Clinical Trials as Topic*/ethics Clinical Trials as Topic*/mortality Conflict of Interest/economics* Disclosure* Ethics, Business Humans

Notes:

Comment on:
J Gen Intern Med. 2006 Sep;21(9):901-6.

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