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Healthy Skepticism Library item: 13506

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

Gibson BR, Suh R, Tilson H.
The US drug safety system: role of the pharmaceutical industry.
Pharmacoepidemiol Drug Saf. 2008 Feb; 17:(2):110-4
http://www3.interscience.wiley.com/cgi-bin/abstract/115807412/ABSTRACT?CRETRY=1&SRETRY=0


Abstract:

PURPOSE: Despite increasingly strident calls for improved drug safety in the United States, recent events underscore the continuing gap among manufacturers, regulators, patients, and physicians. In the period leading to the recent Institute of Medicine report on the future of drug safety, representatives from industry were given an opportunity to provide input into this report. In light of continuing concerns about drug safety and pending legislation, this original perspective provides an important context. METHODS: This work consolidates the views of representatives of individual pharmaceutical companies; the large industry trade associations, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) and the Biotechnology Industry Association (BIO); and those of the authors with regard to the industry role of drug safety in the United States. RESULTS: To ensure continued protection of the public’s health, manufacturers must recognize themselves as critical to ensuring safe products; maintain corporate safety functions separate from marketing functions; provide oversight by a senior medical executive; engage in structured epidemiological research, risk assessment, and risk communication; and mandate the formation and maintenance of an internal, interdisciplinary, senior level safety council. CONCLUSIONS: The importance of aggressive and accountable drug safety will only become more salient as the public and their elected representatives demand better accountability from industry. Individual corporations now have the opportunity to move first to counter perceptions of profit over safety and to ensure that their business practices adequately protect the public’s health. Copyright 2007 John Wiley & Sons, Ltd.

Keywords:
Adverse Drug Reaction Reporting Systems/organization & administration* Communication Drug Industry/organization & administration* Humans Pharmaceutical Preparations/adverse effects Product Surveillance, Postmarketing/methods* Risk Assessment/organization & administration United States

 

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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