UK at heart of the great statin experiment, warns Drug and Therapeutics Bulletin

Main Category: Statins
Article Date: 04 Apr 2005 - 0:00 PDT

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The reclassification of the cholesterol-lowering drug simvastatin as the over-the counter product Zocor Heart-Pro for preventing heart attacks, was not based on robust evidence of clinical benefit, warns Drug and Therapeutics Bulletin (DTB).

DTB has also uncovered evidence that the medicines regulator (the Medicines and Healthcare products Regulatory Agency - MHRA) inaccurately reported the consultation which preceded the reclassification.

In the week when the Health Select Committee reports its Inquiry on the Influence of the Pharmaceutical Industry, DTB and Which? are calling for Government assurances that only when medicines are proven safe and effective for over-the-counter treatment will drug companies be allowed to sell them for such use.

Zocor Heart-Pro (simvastatin 10 mg daily) has not met these standards, as no trials have assessed the drug's long-term effectiveness in its target group - people likely to be at moderate risk of having a heart attack. The lack of such research raises serious questions about whether people are unknowingly wasting their money - around £170 per year - on a treatment that might not work.

Also, crucially, since people can be sold Zocor Heart-Pro without a detailed assessment that includes measurement of blood pressure and cholesterol levels, some could be wrongly classed and treated as being at only moderate risk of a heart attack, when in reality their risk is very much higher.

DTB also has evidence that the MHRA wrongly reported the consultation that preceded the drug's reclassification.

According to the MHRA, "about two thirds of respondents were in favour of the proposal". But DTB's analysis of the consultation submissions indicates that no more than 45 per cent of respondents could be classified as supporters of the proposal, even assuming the most liberal interpretation of being "in favour" of it.

Dr Ike Iheanacho, editor, DTB, said:

"The absence of any long-term efficacy trials for Zocor Heart-Pro in the target group means that people are, in effect, being used as guinea-pigs for such treatment, and being charged for this dubious privilege. It is also worrying that the consultation that preceded the drug's reclassification appears to have been inaccurately reported.

"These and other aspects of the way Zocor Heart-Pro became available set a poor precedent for future reclassifications of medicines for over-the-counter use.

"In our view reclassification should only proceed where there is unquestionable evidence of efficacy and safety and we hope this message is echoed in the forthcoming Health Select Committee report on the Inquiry into the Influence of the Pharmaceutical Industry."

Which?
2 Marylebone Road
London
NW1 4DF
http://www.which.co.uk

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