Don't Hold Your Breath Waiting for OTC Lipitor

Pfizer CEO Ian Read surprised investors at his November 1 earnings report when he said the company will eventually sell the world's best-selling drug, Lipitor, over the counter (OTC) just like aspirin. The comment raised the likelihood that Pfizer would retain some of its vast Lipitor revenues.  But follow-up interviews suggest that it will be much harder to bring Lipitor over the counter than Read let on and will not happen for several years at least.

Lipitor currently generates over $9 billion revenue for Pfizer each year, and much of that will disappear when the product loses patent exclusivity at the end of this month.  By selling Lipitor without a prescription, Read raised the possibility Pfizer could keep some of that vanishing revenue.

Speaking to investors, Read said, "Clearly there is an intent at some point to have an OTC version of Lipitor in the marketplace."  While that impressed many observers, one Pfizer executive, put forward by the PR department, claimed instead they merely "are considering an OTC version of Lipitor as an option."

Two other Pfizer insiders say Read and others recognize that getting FDA approval for OTC Lipitor will require overcoming "a large number of hurdles."  These include convincing the FDA that a system will be in place to make sure only people who need Lipitor will get it.  Pfizer will also face the challenge of demonstrating that people who buy and use Lipitor without a prescription will be regularly checked for side effects, such as muscle damage.

These Pfizer folks, who requested their names not be used, say that an OTC Lipitor launch does not appear even a possibility for 2012.  They say 2013 also "seems unlikely."  One executive with direct involvement in the matter states, "the FDA will want more data," including "real world data" drawn from actual consumer behavior.

The Pfizer executives spoke on the condition of anonymity because Read's statement, according to one, was basically just an effort "to show investors the company has tactical plans in place for making up some of the enormous revenue that will disappear once Lipitor goes generic."  They do not want to be seen as possibly hindering that attempt to appease anxious investors.

One Pfizer executive claims the media spotlight on a possible Lipitor switch from prescription-only to OTC is actually distracting.  She sees the availability of a non-prescription Lipitor as only one "possible addition" to their larger, ongoing effort at making health care more easily available.

Some of Pfizer's current programs for that purpose include support for training pharmacists on patient counseling.  Another Pfizer-sponsored activity, the Kansas City Collaborative, involves assisting human resources personnel at mid-sized companies to design more effective, employee benefit programs.

One Pfizer insider said that CEO Read's statements to investors are sometimes "very exuberant," but the company's subsequent actions tend to be far more conservative.  He pointed to Read's statement in March that Pfizer may divest up to 40% of its business operations.  To date it has offered to sell only its infant nutritionals and animal health businesses.  Together the two units account for just 9% of Pfizer's sales.

Several sources outside Pfizer believe the likelihood of ever receiving FDA approval to sell Lipitor without a prescription remains quite small.  Dr. Dan Hussar, a professor of pharmacy at the University of the Sciences in Philadelphia, says physicians and their medical associations will oppose making Lipitor available without prescription because many community pharmacies currently cannot conduct proper screening and monitoring.

Hussar believes pharmacists can take on the responsibility if they are properly trained and if they work in a practice setting that supports the effort.  For Pfizer to bring this about, "it would require them to make a large commitment to community pharmacy, but doing it just for Lipitor isn't practical and it could potentially antagonize physicians."

The FDA has a history of preventing cholesterol-lowering statin drugs like Lipitor from going over the counter.  In 2000 an FDA advisory board recommended against approving an OTC version of Merck's Mevacor.  In 2005 another advisory board rejected the same request for Mevacor when Merck and Johnson & Johnson proposed it.  The FDA also turned down a third Merck proposal to sell non-prescription Mevacor in 2008.

Among the reasons the FDA ruled against an OTC Mevacor was that over 75% of consumers in Merck's study misdiagnosed their own need for a cholesterol medication.  In an interview,  Daiva Shetty, an FDA medical officer, said "only 10% who bought Mevacor" in an actual-use study met the FDA-approved criteria for using it.

In late 2004 another cholesterol-lowering drug from Merck, Zocor, was approved for non-prescription sale in Great Britain.  In contrast to the US, however, where drugs either do or don't require a prescription, Britain also maintains a third class, behind-the-counter, meaning a dispensing pharmacist must qualify consumers that want to purchase a drug classified with that designation.

Physicians and pharmacists that studied the UK's Zocor experience found much to dislike about the process.  Derek Stewart, a pharmacy professor at Robert Gordon University in Aberdeen, Scotland, surveyed British primary care physicians in 2009.  He found the majority "do not support the decision to let community pharmacists dispense Zocor behind the counter" because patients that obtain it that way aren't adequately monitored.

According to the American Medical Association, patients on drugs such as Mevacor, Zocor and Lipitor require regular clinical exams and laboratory blood tests.

Charles Ganley, the director of the FDA's Division of Over-the-Counter Drug Products, says that with only two, highly unusual exceptions, the agency "never approved anything behind the counter" and new legislation would be needed to create such a classification.

Some community pharmacists in this country claim that with adequate training, they can perform the services needed to monitor patients taking cholesterol-lowering drugs.  Training and a system to support their efforts are key requirements.  Several years ago, the Government Accountability Office concluded that pharmacist counseling at the time was too "infrequent and incomplete" to offer a worthwhile benefit.

Hussar, for example, believes a system of Electronic Medical Records (EMR) would help pharmacists to see if patients have any condition that indicates they should avoid Lipitor.  If someone were approved to take a cholesterol-lowering drug, an EMR system would let the pharmacist communicate easily with the person's physician to recommend a lab test, an office visit or some other course of action.

To check out more Check Up items go to www.philly.com/checkup.