Healthy Skepticism Library item: 8100

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

FDA finalizes guidance on DTC broadcast ads
American Journal of Health System Pharmacy 1999 Sep 15; 56:1815

Abstract:

The final guidance on direct-to-consumer (DTC) advertising of prescription drugs issued by the U.S. Food and Drug Administration (FDA) addressing provision of product labeling is presented; regulations specify that DTC ads must include a statement conveying the product’s most important risk information (adverse effects and contraindications), in addition to either a brief summary or adequate provision for disseminating full product labeling. The final guidance states the following expectations for broadcast advertisements: that they are not false or misleading, that they present a fair balance of information about the drug’s benefits and risks, and that the major statement of risk information and all information about the drug’s approved use are included.

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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