A Study of Statins

J0227757 There is perhaps no better candidate in the pipeline for an RX to OTC switch than for statins.  Statins lower cholesterol dramatically and therefore one can intuit – they would lower the rate of heart disease in this country if they were more widely available.

There is a problem with that, as evidenced by past failed attempts to take statins OTC by Bristol-Myers Squibb and Merck, and that is the fact that people who have high cholesterol have no way to monitor their levels at home.  One of the basic tenets of an OTC switch is that people are able to use the drug without the intervention of a learned intermediary, i.e. a physician.  Therefore, until someone links an OTC switch to a home cholesterol monitoring capacity, then the OTC availability of statins seems in question.

But another concern is one of safety.  Statins provide an enormous amount of benefit by lowering cholesterol.  For some, however, there are side effects that could be serious.  That, however, is true of many drugs that are OTC today.

This is why it is interesting that a new Web site has been started regarding statins to log adverse events solely related to their use.  The site is The Statin Effects Study.  It is sponsored by the University of California at San Diego.  The study is being overseen by the Beatrice A. Golomb, M.D., Ph.D.  Unfortunately it would appear that the results are not real time, we apparently cannot view what people are saying.  But undoubtedly, the results of this study will be influential in seeing whether or not statins are a good candidate for an OTC switch. 

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