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Healthy Skepticism Library item: 14841

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

Poole D, Bertolini G, Garattini S.
Errors in the approval process and post-marketing evaluation of drotrecogin alfa (activated) for the treatment of severe sepsis.
Lancet Infect Dis 2009 Jan; 9:(1):67-72
http://linkinghub.elsevier.com/retrieve/pii/S1473-3099(08)70306-2


Abstract:

Regulatory agencies take responsibility for the safety and efficacy of the drugs they license. Over the past few years, however, several serious failings in the approval procedure have raised widespread concern that the present process of drug regulation is inadequate to guarantee the defence of public health. We discuss the approval process of drotrecogin alfa (activated), a non-antibacterial drug for the treatment of severe sepsis. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) approved drotrecogin alfa following a phase III trial that showed efficacy of the drug. However, on the basis of subgroup analyses, the drug was licensed only for use in part of the study population. This methodology is contrary to guidelines established by the FDA and EMEA themselves. According to these guidelines, analyses of non-predefined subgroups do not provide sufficient evidence for drug approval. Although the results of several post-marketing trials raised doubts about the efficacy of drotrecogin alfa, both regulatory agencies passively accepted the reassuring interpretations of sponsored investigators and of the manufacturing company itself. The recent requirement of a confirmatory trial by the EMEA without recalling the drug from the market is the latest inconsistent step taken by the agency. The case of the approval and post-marketing evaluation of drotrecogin alfa, we believe, shows that the current drug regulation system needs reforming.

 

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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