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Bruce Psaty and the risks of calcium channel blockers
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  • Published on:
    Postmarketing surveillance for adverse drug effects

    Dear Editor

    Doctors Santiago, Debanne, and Neuhauser correctly point out the frequent deficiencies in post-marketing surveillance of newly marketed drugs.[1] Because of aggressive marketing to physicians and direct-to- consumer advertising in the US, a new drug can now have very rapid dissemination, exposing large populations in a short time. Passive surveillance with ambiguous definitions of adverse effects may ofte...

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    Conflict of Interest:
    None declared.
  • Published on:
    Tracking adverse events in randomize control trials the lack of agreement among regulatory instituti

    Dear Editor

    We need to do a better job of keeping track of potential side effects when designing randomized clinical trials (RCTs). Consider a RCT for a new drug tested for the main, or first order effect, the reduction of hypertension. Power calculations are carried out so that meaningful differences between the drug users and the controls can be detected on this effect. Second order effects, mortality in this case, a...

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    Conflict of Interest:
    None declared.