Healthy Skepticism Library item: 2921

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

Dixon RB.
The current status of guidelines for clinical research from the viewpoint of the pharmaceutical industry.
J Clin Pharmacol 1977 Nov-Dec; 17:(11-12):691-6
http://jcp.sagepub.com/cgi/reprint/17/11/691

Abstract:

The guidelines for clinical research are here to stay. Even if they could, itis unlikely that industry sponsors would abolish them. Industry should heed the regulatory description of the guidelines as illustrations of acceptable standards, not as minimal requirements. In some cases, more than just the studies suggested in the guidelines may be required for an approvable new drug application. Hopefully, the Food and Drug Administration will continue to discuss with industry guidelines interpretations with respect ot individual drugs and to refer disputes to the advisory panels and not to adhere rigidly to the strictest interpretation.

Keywords:
*analysis/United States/trial design/ regulatory authorities/ new drugs/ drug company sponsored research/INFORMATION FROM INDUSTRY: REGULATORY AUTHORITIES/SPONSORSHIP: RESEARCH Drug Evaluation*/standards Drug Industry* Drug Therapy/adverse effects Humans 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