With the patent for Lipitor expiring, Pfizer is considering selling an OTC version of the statin.
It’s generated a firestorm of debate, with doctors speculating on the impact for patients.
According to Pharmalot, “an OTC version would allow Pfizer to capture some of the sales that will be lost when the Lipitor patent expires in November. In fact, Pfizer execs recently changed their mind about the possibility of selling the consumer healthcare unit, since the division allows them to market OTC versions of prescription meds and generated needed cash flow.”
Furthermore, as health care costs continue to spiral out of control, there is a certain appeal to an OTC statin drug, which certainly will cost less than then current $4 to $5 a pill that Lipitor costs.
Most physicians are against the move. Several years ago, Merck tried the same tactic with Mevacor, which the FDA denied. According to a study in the New England Journal of Medicine, people who thought they should be on a statin really shouldn’t have been, and furthermore, “cholesterol does not generate symptoms that would prompt patients to make informed decisions about dosing or benefits.”
Cardiologist Dr. Wes goes against the grain, and says that the FDA should allow Pfizer to sell Lipitor OTC:
Let Lipitor go over-the-counter. Give patients the benefit of the doubt regarding their intelligence and offer them an opportunity to drive down prices by having more options for their lipid management. Let them follow their own lipid and hepatic panels with home testing. I know it will be hard not to send all those electronic prescriptions via electronic medical records to all those pharmacy benefit managers in charge of all of those pharmacies out there, but maybe this is exactly the innovation our health care system needs to cut costs.
Internist Matthew Mintz, however, disagrees, calling the move a cash grab by Pfizer at the expense of patient safety:
The reason why Pfizer wants Lipitor OTC is for one reason: to make more money. They can argue that cardiovascular disease is the number one killer in the US, and by having Lipitor OTC, it will be available to more patients. However, because statins require blood work and medical consultations, the risk of harm to patients outweighs the potential benefits of greater availability.
I can see valid points from both sides. That said, I think it’s unlikely that the FDA would approve OTC Lipitor. Not much has changed since the FDA rejected OTC Mevacor years ago. Patients still cannot make informed decisions as to when to take a statin, and high cholesterol doesn’t generate symptoms like, say, allergies. That’s why you can’t compare a potential OTC Lipitor with Allegra, Zyrtic or Claritin.
Finally, patients on statins are supposed to be monitored periodically for muscle pain and liver function. Although there are some patients who will be diligent in getting that done, I’m not hopeful that most will.
From an economics standpoint, OTC Lipitor would theoretically provide price competition, and can be a game-changer in bending the statin drug cost curve. That’s certainly appealing in this age of deficits and runaway health spending.
But that, by itself, isn’t reason enough to recommend an OTC version of Lipitor.
Kevin Pho is an internal medicine physician and on the Board of Contributors at USA Today. He is founder and editor of KevinMD.com, also on Facebook, Twitter, Google+, and LinkedIn.
