The Pharmaceutical Journal
Vol 274 No 7344 p411
9 April 2005

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DTB claims that simvastatin reclassification was flawed

The way in which simvastatin became an over-the-counter medicine was “flawed” and represents a “poor model” for future POM to P switches, according to Drug and Therapeutics Bulletin (2005;43:25).

In the April issue of DTB, the rationale for reclassifying simvastatin 10mg is reviewed and several concerns about the process are raised. In particular, DTB claims that the Medicines and Healthcare products Regulatory Agency exaggerated the proportion of favourable responses made to the public consultation.

After analysing 80 of the 100 responses, DTB says that 31 per cent offered at least some support, 35 per cent clearly opposed it and the rest offered no clear opinion either way. “Even if all 20 of the withheld responses are assumed to have been in favour of the reclassification, only 45 per cent of all respondents at most could be described as supporting the proposal,” says DTB. At the time, the MHRA reported that “about two thirds of respondents were in favour of the proposal”. A spokeswoman for the MHRA refuted the suggestion that the consultation was misrepresented. She said the decision to reclassify simvastatin 10mg was taken following advice from the Committee on Safety of Medicines, which had full access to all responses to the consultation.

DTB also suggests that the reclassification was not based on robust evidence. No published clinical studies have determined the effect simvastatin 10mg has on coronary heart disease morbidity or mortality and extrapolations made from meta-analyses may be over-optimistic in their predictions, it says. “As a result, the UK population has, in effect, now been enrolled in a large experiment without adequate monitoring of benefits or risks.”