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Healthy Skepticism Library item: 18609

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

Hao Y.
Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges.
Expert Rev Pharmacoecon Outcomes Res 2010 Aug; 10:(4):407-20
http://www.expert-reviews.com/doi/abs/10.1586/erp.10.45?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=ncbi.nlm.nih.gov


Abstract:

The US FDA has advocated the patient-reported outcome (PRO) draft guidance as the main vehicle for evaluating PRO-based labeling claims for oncology drugs. In addition, FDA-affiliated researchers have identified factors inhibiting acceptance of health-related quality of life (HRQoL)-based claims for oncology product labels. The views of the FDA on PRO claims are extensive and prescriptive. By contrast, the European Medicines Agency (EMA) has conducted authorizations without an explicitly defined approach for evaluating HRQoL data. A reflective paper released in 2005 offered only broad recommendations on HRQoL labeling claims. The different approaches between the two regulatory agencies partly stem from underlying, divergent organizational characteristics. Moreover, general issues inherent in PRO research in oncology trials including trial design, missing data, multiplicity of end points and inconsistent findings of HRQoL data are discussed.

 

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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