Interesting views 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.
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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.”
It is perhaps a sign of the trouble the industry has got itself into that they are starting to sound like editorials that horrified them a few years ago, like this from Dr R.E.Ferner discussing the same issue eight years ago:
One answer would be to introduce a form of probation for newly licensed medicines, in which they are subject to careful scrutiny before they become available for all doctors to prescribe. A possible way to do this in Britain would be to allow the licensing authority to operate as before, but to decide separately whether a drug should be available for prescription within the NHS. That decision would necessarily require the manufacturer to show, on the basis of randomised clinical trials, that a drug was at least as effective as standard treatment. It would also permit the NHS to conduct its own trials into the costs and benefits of a newly licensed treatment, within the framework of NHS research. This would need some integration, since cost effectiveness is a matter for the health service, and safety a matter for the licensing authority, but that should be possible.