Healthy Skepticism Library item: 2400

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

Helft PR, Ratain MJ, Epstein RA, Siegler M.
Inside information: Financial conflicts of interest for research subjects in early phase clinical trials.
J Natl Cancer Inst 2004 May 5; 96:(9):656-61
http://jncicancerspectrum.oxfordjournals.org/cgi/content/full/jnci;96/9/656

Abstract:

In recent years, several research subjects have told us that they had bought or intended to buy stock in the companies sponsoring the clinical trials in which they were enrolled. This situation has led us to ask what, if any, are physician-investigators’ scientific, ethical, and legal responsibilities concerning research subjects who choose to buy stock in the companies sponsoring the clinical trials in which they are participating. Although the scope of this problem is unknown and is likely to be small, this commentary examines the scientific, ethical, and legal concerns raised by such activities on the part of research subjects enrolled in early phase clinical trials. In addition, this commentary also outlines the basis for our opinion that research subjects involved in an early phase clinical trial should avoid the financial conflicts of interest created by trading stock in the company sponsoring the clinical trial.

Keywords:
Publication Types: Review Review, Tutorial MeSH Terms: Clinical Trials, Phase I*/economics Clinical Trials, Phase I*/ethics Clinical Trials, Phase I*/legislation & jurisprudence Conflict of Interest* Drug Industry*/economics Drug Industry*/ethics Drug Industry*/legislation & jurisprudence Drugs, Investigational*/adverse effects Drugs, Investigational*/economics Drugs, Investigational*/standards Ethics, Research* Humans Information Dissemination*/ethics Information Dissemination*/legislation & jurisprudence Informed Consent Physician-Patient Relations Research Subjects*/economics Research Subjects*/legislation & jurisprudence Research Support* United States Substances: Drugs, Investigational

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909