Healthy Skepticism Library item: 9825

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

Lo Re V 3rd, Strom BL.
The role of academia and the research community in assisting the food and drug administration to ensure U.S. drug safety.
Pharmacoepidemiol Drug Saf. 2007 July; 16:(7):818-25
http://www3.interscience.wiley.com/cgi-bin/abstract/114210443/ABSTRACT?CRETRY=1&SRETRY=0

Abstract:

PURPOSE: Academia can play a prominent role in the drug safety arena, unique from that of industry, and a clearer articulation of how it could positively influence the current system is needed. We sought to examine ways that academia could expand its role in U.S. drug safety. METHODS: An ad hoc meeting of academic experts in drug safety and risk management was convened at the Institute of Medicine (IOM) in Washington, D.C.

METHODS: An ad hoc meeting of academic experts in drug safety and risk management was convened at the Institute of Medicine (IOM) in Washington, D.C.

RESULTS: Academia should develop a stronger partnership with the Food and Drug Administration (FDA) to increase research on regulatory issues and public health questions and facilitate the prioritization of critical issues on drug safety. Such a collaboration could also facilitate the development of a network of academic centers of excellence in pharmacoepidemiology to address drug safety and risk management questions from a public health standpoint in a timely fashion. The development and testing of methodologic innovations on drug safety should also be encouraged.

CONCLUSIONS: Greater partnership between academia and the FDA could facilitate the prioritization of important issues on drug safety, allow more research questions on drug safety to be answered in a timely fashion, promote the development of networks for answering these questions, and help generate additional research ideas, ultimately providing enormous benefit to the public health.

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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