The UK government appears to be in favor of releasing this drug for OTC use. A similar proposal in the U.S. was turned down by the FDA a few years ago, after physician groups strenuously objected. The rationale for releasing OTC simvastatin is outlined in a public proposal, released by the UK government in their solicitation of comments.
The proposal suggests that a single 10 mg dose of simvastatin should be considered by individuals who are at moderate risk for heart disease. These would include all men 55 or older, and men 45 - 55 and women over 55 who have at least one risk factor. Such people have a 10-year risk in the range of 10 - 15% for developing serious cardiovascular disease. Further, many studies have shown that reducing LDL levels reduces that risk - indeed, there is no level of LDL where reducing levels even lower is not associated with lowered risk. The proposal further notes that in the large number of patients treated with simvastatin to date (over 73 million patient-years of experience) the drug in the proposed dosage has an excellent safety profile.
Since any reduction in LDL reduces risk, the proposal notes that it is not necessary to follow LDL levels in people electing to take the OTC drug - though a preliminary cholesterol measurement is needed to screen out people whose cholesterol levels are very high, and who thus ought to be treated under a doctor's supervision.
DrRich Comments:
Cynics will no doubt point out that the UK government, with this proposal, is just trying to save money. Saving money is clearly a factor, since a) patients pay for OTC drugs out of their own pockets, even in Great Britain, and b) reducing the incidence of cardiovascular catastrophes - which this proposal will do - will save the national health care agency lots of bucks.Others (doctors) will argue that this proposal inappropriately takes preventive medicine out of the hands of physicians, where it belongs, and places it into the hands of the unwashed masses, where much harm will be done through the public's ignorance, and the general failure of the large majority of the public to become doctors. This, indeed, is the argument American doctors used successfully with the FDA.
DrRich thinks the British proposal is compelling. It will end up preventing disabling heart disease and saving lives, and it will help to empower patients to take more responsibility for their own health. If doctors were actually good at employing preventative measures that are simple to use and that have been shown to be effective, they might have a reasonable point. But doctors have largely failed in this arena.
Besides, in any system that coerces doctors to engage in covert health care rationing (such as in the U.S. and Great Britain,)anything that empowers patients to protect themselves has to be a good thing.
