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Healthy Skepticism Library item: 11858

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

Rock EP, Scott JA, Kennedy DL, Sridhara R, Pazdur R, Burke LB.
Challenges to use of health-related quality of life for food and drug administration approval of anticancer products.
J Natl Cancer Inst Monogr 2007 Oct; (37):27-30
http://jncimono.oxfordjournals.org/cgi/content/abstract/2007/37/27


Abstract:

The U.S. Food and Drug Administration (FDA) approves labeling claims of drug efficacy based on substantial evidence of clinical benefit demonstrated in adequate and well-controlled investigations. Patient-reported outcomes (PROs) may support marketing claims of clinical benefit, either alone or with other study endpoints. Health-related quality of life (HRQL) is a PRO that comprehensively measures patients’ reported health status. We present an overview of why HRQL-based efficacy claims have not to date been accepted by the FDA for inclusion in anticancer product labels. Persistent challenges to allowance of such claims include shortcomings in randomization and blinding of clinical trials, missing data, statistical multiplicity, and unclear intrinsic meaning of selected HRQL findings.

laurie.burke@fda.hhs.gov

Keywords:
PMID: 17951228 [PubMed - in process]

 

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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