The widespread stories about Pfizer trying to take Lipitor OTC bring up some important issues for drug companies trying to extend their statin brands to retail shelves. First, there is the concern about taking the doctor out of the direct decision chain to prescribe a drug for cholesterol reduction. Second, will consumers be able to know if they really need a statin, given the risks of such medicines? Third, how will consumers know if the cholesterol reductions are enough to gain the benefit of reduction of heart attack risk?
?Approving OTC Lipitor would be a good decision.? - Bob Ehrlich
Doctors have been removed from the Rx decision chain for many conditions. Heartburn and GERD is one of the most analogous. GERD is a serious condition and still we have OTC Prilosec, Zantac, Tagamet, and Pepcid on the store shelves. Many potent medications had once been prescription and now are OTC. Benedryl was Rx, as was Nasacort.
For statins, the regulatory resistance is a bit different. FDA will be concerned that managing cholesterol is more complicated than reducing excess acid or reducing inflammation of the nasal passages. Managing lipids has numerous components and sub-components. There are LDL, HDL, Triclycerides, and fluffy and dense lipids. While there may be complexities, Lipitor in the 10mg dose does get most people significant bad cholesterol reduction of about 40%. So, while consumers may not understand all the relationships between HDL, LDL and total cholesterol, the net effect of taking a 10mg pill is pretty good.
The second issue of risk/benefit is a tricky one. At the OTC likely dose of 10mg, serious side effects are very rare but muscle aches are possible. Will consumers be able to understand those risks and deal with them appropriately? Will they know what to expect do if they get those aches and pains?
Third, there is the issue of reaching a goal that is recognized by medical experts as the target level. Taking a 10mg pill for certain people may get them to goal, but for others it may be insufficient. It is hard to know whether some people who really need 20mg or 40mg would be under-dosed with an OTC version.
Taking all the issues above into account, it seems that the positives will outweigh the negatives. People that do not want to or cannot easily see a doctor, but know they have a fatty diet, may be more likely to take a statin if it is OTC. We also know that FDA will likely require a cholesterol blood test before being allowed to buy an OTC statin. Most likely, consumers would have to show the pharmacist test results that show high cholesterol before being allowed to buy Lipitor. So Lipitor would be BTC, (behind the counter) versus OTC on the open shelf.
Like it or not, we are entering an era where it will be more difficult to see a doctor. There is a serious doctor shortage on the horizon. Combine that with the millions of newly insured and we have an access problem. Government and society, for cost and access reasons, will want to make it easier for Americans to self treat and self fund their medical costs. I remember experts saying the H2 antagonists for GERD would never be approved for OTC. They were wrong and I think the time is right for OTC statins. Drug chains, supported by Pfizer, would likely offer free cholesterol tests so people buying OTC Lipitor would be aware of their cholesterol levels. The more people who are aware of their cholesterol level, the better it is for society. Once gaining awareness of high cholesterol, they will likely be counseled to test blood pressure and perhaps blood sugar levels as well. Retail medicine is the wave of the future and cholesterol is a good place to gain traction for retail diagnoses and treatment.
Given we allow retail sale of all sorts of OTC supplements that purport to lower cholesterol without clinical evidence, it seems reasonable to allow clinically proven Lipitor for the same purpose. Consumers will benefit from easy access to Lipitor and payers, both public and private, can pass the cost along to consumers.
In an ideal world, which we never have, doctors carefully screen everyone for all conditions needing treatment and then those people are monitored for correct dosing. In the new medially resource constrained world, self treatment is going to increase and we might as well offer as many OTC alternatives as is reasonably safe. I would be more concerned with the over use of OTC pain medications than I would with OTC Lipitor.
The net is approving OTC Lipitor would be a good decision and I hope FDA allows it.
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