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"Do you believe in magic in a young girl's heart?"

 - John Sebastian, The Lovin' Spoonfuls, 1965

 

Pfizer announced its intention to attempt a switch of Lipitor from prescription to non-prescription status coincident with its pending patent expiry despite several failed attempts at FDA to switch a statin.  The professional community voices diverse opinion on the wisdom of doing so.  We attempt to sort out the argument...

Pfizer's patent on Lipitor expires in November, 2011.  Unless discussions with FDA and clinical trials are already complete there is little chance for OTC Lipitor to enter the market in time to staunch the loss of cash flow from this $11 billion dollar product.  The fundamental debate around OTC statins is whether this disorder can exist as an OTC indication.  But this is not the first time this disorder has been up for debate and verdict.  The first was in 2000 when FDA rejected Merck (Mevacor) and Bristol (Prevachol) and more recently in 2008 with Merck again with Mevacor.  This proposition, that cholesterol prevention and management can be done by the consumer, is a hard sell precisely because it takes the OTC consumer on a wild ride into the realm of prevention using a blinded, uncontrolled vehicle.  Agreeing to move medical management in this direction would be a precedent encouraging blind self-diagnosis and self-treatment without supervision.

 

The fundamental axiom of OTC drug approval is whether the consumer is able to self-diagnose and self-treat.  In the case of the prevention of silent conditions the answer to the first depends on access to cholesterol testing services or devices; and the second is a tenuous "maybe".  We offer the following perspectives:

1. Compliance:  Perhaps the least talked about but most important issue.  Leaving aside other issues the compliance rate for a consumer-initiated program of prevention of a silent condition will be poor.  Compliance will depend on the economic environment, hierarchy of household needs, educational attainment, and cost.  Daily dosing over time will erode, particularly with no oversight, feedback, or value added.
2. Clinical Effectiveness:  There is no existing clinical trial, nor pre-market approval process, that can adequately predict the outcome of this switch.  The wild cards of who purchases, what there status is, how they use it, how long they comply, etc. makes the free market the only way to judge the safety and effectiveness of this intervention and reveal low probability events.
3. Safety:  Much has been made about the side effect profile of statins including rhabdo, muscle weakness, liver toxicity, pregnancy, diabetes, etc.  The bigger issues are what is not talked about:  risk of haphazard treatment in high risk users; risk of cavalier dose escalation to increase "effectiveness"; and, added risk to healthy users who do not need this drug.
4. Cynical Cost Shifting:  Another less talked about result of a statin switch is the off-loading of substantial cost from insurers to the consumer.  While the pharmacoeconomics of a switch would save payers (increasingly the US taxpayer) substantial cost its effect would be to weaken the population efficacy of the treatment by excluding those who need the drug but can't afford it, further isolating them from care.

 

If statins were to switch there would be two drivers of awareness and trial:  consumer advertising and physician recommendation.  This leads to a rather odd reality, that the retail shelf becomes a venue for picking up a drug product "prescribed" by a doctor, or a place to experiment with a preventative drug without knowing its cost/benefit, or value.  The former is now common place for previous Rx/OTC switches for allergy and heartburn, but both are symptomatic conditions with a perceptible benefit; the latter is more a kin to the hype of the vitamin/supplement shelf.

 

As a libertarian proposition making useful products freely available to the consumer seems like a good idea.  In reality the benefit of those products may be elusive and the risk palpable, particularly the risk of having little sustained effectiveness.  However, as much as we like to "believe in magic" the reality of good prevention will be further determined by the economic and social standing of those who seek out this product.  It's unclear what the overall improvement in the public health might be.  If consumers with hypercholesterolemia are "lost to follow up" who's to say that cardiovascular prevention may even decline.

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