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Physician-scientist urges improved drug regulation to ensure heart safety of non-heart drugs
Date:12/28/2007

be standardized for all observers before the drug is administered to any patient. (Currently, for drugs not intended for heart problems, cardiovascular effects often are assessed only minimally, generally in later phases of drug development. And, the definition of adverse events is left up to each observer individually, limiting the strength of conclusions about cardiovascular safety.)
  • Regulatory bodies should be given the authority to mandate continuing evaluation of drug effects, even after approval for marketing. This will allow updates in drug labeling to increase the precision with which doctors and patients can know the relation of benefit and risk, enabling the best decisions about selection of treatment strategies.
  • Regulatory bodies should be empowered to withdraw approval if mandated post-marketing studies are not performed. Currently, the FDA, for example, does not have such authority.
  • If the drug is likely to be used by people who have relatively high cardiovascular risk (as, for example, might be the case with a drug for arthritis), at least one study of the drug's beneficial effects should be carried out among such patients, not only in low risk people as is now commonly the case.
  • Analysis plans should be designed to incorporate all data collected during development, including results of so-called observational studies (which do not employ randomization to eliminate study bias, and which do not employ "control" groups for comparison) in order to increase statistical power to find problems if they exist. Currently, this kind of analysis plan is not usually employed.

    Dr. Borer's presentation was made at the recent annual meeting of the European Society of Cardiology in Vienna, and was drawn in part from his article in the Aug. 2007 issue of the European Heart Journal. This paper summarizes the conclusions of a group of co-authors -- including cardiologists, biostatisticians, FDA and EMEA (European Medicines Agency H
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  • Contact: Emily Berlanstein
    eab2007@med.cornell.edu
    212-821-0560
    New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College
    Source:Eurekalert

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