Statins and The RX to OTC Switch Pipeline

As mentioned yesterday, the increase in the number of patent expirations set for the next few years indicates an opportunity for an increase in RX to OTC switches.  In March, I had a posting on the challenges in the current environment for switches. 

Essentially, in order for a drug to be a candidate for a switch, it must be

• Effective – that may seem obvious, but there are drugs that, after years on the market, don’t appear so hot.
• Safe – this is a wide open category and means that a person won’t hurt themselves in using the drug, even though theoretically a person can do a fair amount of harm to themselves with aspirin.
• Not prone to abuse – this means what you think it means
• Can be labeled – so that an average person can pick it up in the drug store and decide that he or she is the right patient for this drug and understands how to use it. 

The standard is that "the drug can be used without the intervention of a learned intermediary" – a phrase you can’t help loving.

While Xenical, a weight loss drug, recently got some indication that it may go OTC, in the past few years, there have been several failures in attempts to effect OTC switches.  Most notably,  a switch for acyclovir, for Flexeril and statins failed after two attempts.

Statins treat a condition, not a symptom.  But with Prilosec, which also treats a condition and offers a 14 day course of treatment, there is precedent for that.  However, statins treat a chronic condition.  Once you are on the statin, you are likely on it for good (ask President Clinton).    But cholesterol should be pretty easy for people.  You give them a number that they should have for their cholesterol, you tell them how much to take and monitor their progress – so what is the problem?

There are a couple of issues.  Different statins would seem to have different adverse event profiles.  However, more important, is the lack of ability on the part of the OTC patient to monitor the impact of the medication without going to the doctor.   If  they have to go to the doctor  to monitor their cholesterol, why not send them to the doctor to get the drug?

So OTC statins, despite the fact that they are theoretically a good idea for public health, probably aren’t possible until something in the environment changes – or until statin manufacturers can engage in studies that demonstrate that actual OTC use with access to some form of monitoring could be effected quite easily by millions of people.