OTC Statins: How Safe is it to Swallow the Pill?

Recent industry buzz on Pfizer's alleged strategy to sell its cholesterol reducer-blockbuster drug, Lipitor as an over-the-counter (OTC) pill, reinforces debate on the safe compliance of prescription drugs when sold as OTC's, without prescription.

Industry watchers note that the tried and tested molecule Atorvastatin, popular as Pfizer's 'Lipitor' would be losing U.S. patent exclusivity this November. This might be Pfizer's trigger to rake in profits through the OTC mode by guarding Lipitor's current market presence, even as generics in the statin drug category gear to flood the market; replacing Lipitor when it goes off patent.

The Wall Street Journal reports that Pfizer would first have to conduct research showing that patients are able to follow instructions, understand related side-effects and contraindications before taking an OTC version of Lipitor. This would more often than not be without a doctor's prescription. It means that Pfizer will have to conduct studies that prove that consumers are independent enough to read, understand and assess the drug label correctly; also follow correct dosage guidelines, without physician interventions.

It is learnt that Pfizer has assembled a team to examine the feasibility of selling Lipitor as an OTC drug along with other options to salvage Lipitor's stake as it loses patient exclusivity this November.

This is not the first time that a drug in the branded segment has been manoeuvred for a switch to the OTC range. Pfizer's rival Merck & Co. has in the past tried to appease the U.S. FDA for its cholesterol-lowering drugs, Mevacor and Zocor, without success as they caused side effects in patients who tried to consume the drug without expert supervision.

Merck was unsuccessful with its statin category for OTC approval as one study revealed that almost one-third of patients who thought they should use Mevacor actually had less than 5 per cent risk of heart attack within 10 years. As reported by the Wall Street Journal, Patrick Ronan, a former chief of staff at the FDA, noted, "The statin switch is a difficult one and the arguments against the switch...have not and will not go away."

As per the 2008 article in the New England Journal of Medicine written by the chair of the FDA advisory committee, "...Some docs argue that increasing access to statins could prevent heart attacks and strokes, which in turn would lower health care costs. Overall, a study of an OTC Mevacor (Merck's statin) showed 30 percent of patients who thought they should take the drug actually had less than a 5 percent risk of a heart attack or other cardiovascular event in the next 10 years, and were therefore unlikely to benefit."

For drugs like statin, regular checks are necessary to determine the efficacy of the drug. It is done through tests on cholesterol and liver functioning, as per the drug label. This aspect might get lost if patients are left on their own to administer life saving drugs such as Lipitor without strict FDA approved guidelines.

The alleged step to sell statins as OTC drugs brings forth a study published in the American Journal of Cardiology in August last year. The study had suggested that fast-food restaurants could offset some of the cardiovascular effects of their meals by selling low-dose statins as OTCs. This could neutralize or minimize the occurrence of cardiac risks that is triggered by the intake of high dietary fat in fast food such as burgers. The study compiled by the Imperial College London, in 2010 was drawn from a meta-analysis of statins used for primary prevention of heart problems.

The study suggested that a "MacStatin" packet (with the tag "I'm neutralizin' it") could be handed out just like salt and ketchup packets, along with a leaflet advising people that the best way to cut heart risk is to eat well, exercise, stay trim and avoid smoking and to see a doctor "for complete advice."

While this concept is yet to take off, there have been guidelines in the UK that could enable patients to subscribe to OTC versions of statins under the guidance of trained Pharmacists. In fact, Merck, markets a non-prescription version of Zocor in the UK, where the pills are not directly sold as OTCs but managed by trained pharmacists, behind the counter.

One problem with administering OTC statins is that they are programmed to lower cholesterol, a condition that does not trigger symptoms and gets detected in patients through blood test alone. Efficacy of OTC prescriptions for cold or allergy can be noted as successful if the symptoms get neutralized, a person feels better or if a visible side-effect gets triggered.

But, lowering of cholesterol is a long term agenda and may be related to other conditions such as diabetes in many cases. In such patients, regular monitoring of blood samples is a must, followed by appropriate diet and exercise.

The proposed OTC switch by Pfizer could compliment government agencies' needs to fill in prescriptions for schemes such as Medicare where they could pay much less for a prescription medicine that currently costs between $4 and $5, per pill.

Pfizer's annual revenue through Lipitor sales is around $11 billion. As low-priced generic versions hit the market, Lipitor's' brand strength is likely to take a beating as a month's supply of Lipitor costs about $150 as against generics which costs about $10 per month in the US.

OTC or not, the tryst for statins continue, as another recent research published in the journal Neurology, proposed that statins may help reduce the risk of recurrent strokes in young people even if they do not have high cholesterol levels.

Study author Jukka Putaala, MD, PhD, a neurologist at Helsinki University Central Hospital in Helsinki, Finland, in a news release noted. "This study suggests that the drugs should be considered even when the cause of the stroke is unknown and the cholesterol levels are not high."

As new observations emerge on statins as a "miracle pill" for cardiac disorders, the FDA's directive on how the pill switch to OTC is prescribed is well worth the wait!