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Healthy Skepticism Library item: 9249

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

Kesselheim AS, Mello MM.
Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.
Health Aff (Millwood) 2007 Mar-Apr; 26:(2):483-91
http://content.healthaffairs.org/cgi/content/full/26/2/483


Abstract:

Pharmaceutical manufacturers have long considered results collected from drugs’ clinical trials to be confidential information or trade secrets, even after submission to the Food and Drug Administration (FDA). We describe FDA policies regarding disclosure of clinical trial data and evaluate how courts have interpreted the Freedom of Information Act in cases seeking access to unreleased information. Recent examples of approved drugs later found to have dangerous side effects show the importance of complete dissemination of safety information. We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs.

Keywords:
Publication Types: Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Review MeSH Terms: Access to Information* Biomedical Research/legislation & jurisprudence* Clinical Trials* Confidentiality/legislation & jurisprudence* Disclosure Drug Approval Drug Industry/legislation & jurisprudence Drug Toxicity* Humans Policy Making Product Surveillance, Postmarketing United States United States Food and Drug Administration

 

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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