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November 26, 2004

On New Medicines and Drug Safety, Comments and the Story

Topics: Clinical Pharmacology

In the way of an update of sorts to our previous post on "Rosuvastatin pharmacokinetics in heart transplant recipients administered an antirejection regimen including cyclosporine," we see that there is the following post from Black Triangle  on "New medicines and drug safety" on some interesting comments from Tom McKillop at Astra Zeneca:

SIR TOM McKILLOP, chief executive of Astra Zeneca, has called for a radical shake-up in the way new medicines are made available to patients in an effort to tackle mounting public concern about drug safety...

McKillop proposed that the industry should adopt a system of conditional approval, whereby new drugs would be closely monitored for side effects after receiving their initial marketing licence.

McKillop said this could prevent some of the controversies that have battered the pharmaceutical industry in recent years. It would prevent innovative - and therefore potentially risky - new medicines being indiscriminately prescribed by inexpert general practitioners.

The full side-effect profile of new medicines is often not seen until they have been taken by hundreds of thousands of patients - far more than participate in clinical trials.

McKillop said: "It's difficult to go from a clinical trial setting, where you are dealing with a very well-informed group of physicians and carefully selected patients who have given informed consent, to a situation where you have doctors with less information prescribing the drug to a wider body of patients who have given no informed consent."  Read More at Black Triangle...

Posted by Hyscience at November 26, 2004 11:03 PM

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