But Pfizer likely faces an uphill battle because the U.S. Food and Drug Administration has previously rejected the idea of allowing over-the-counter versions of cholesterol drugs in the same class as Lipitor—known as statins—because of concerns that consumers aren't able to properly use the drugs without a doctor's guidance.Yes, this is the same FDA that has promoted direct-to-consumer advertising on TV and radio suddenly becoming "concerned" that patients might not make the right decisions about taking their medications.
FDA spokeswoman Shelly Burgess said prior research on proposed over-the-counter statins hasn't proven that most consumers will make correct decisions about taking the drugs. But she said the agency is open to discussing OTC statins, as long as companies are ready to demonstrate that consumers will make the right decisions.
Mixed messages, anyone?
People only have so much money these days, so willful consumption of a relatively expensive OTC drug like Lipitor will likely only occur if (1) people feel they really need it and (2) if it proves to be affordable relative to the co-pay they have to pay from an insurer's plan. Pfizer realizes that most doctors consider their medication to be relatively safe. I suspect most cardiologists would agree with that sentiment.
Recently, doctors have seen the FDA overreach in clinical care. Their concerns about rhabdomyolysis with statins are important, but cardiologists like myself are baffled when the FDA makes random restrictions to the milligram dose of simvistatin when used in conjunction with other medications like Amiodarone: are there really any data supporting the use of limiting simvistatin use to 10 mg instead of 20 mg in their most recent recommendations? If so, where? Why did they change their earlier recommendation that 20mg was okay with Amiodarone? Or are they, instead, trying to minimize a side effect in the name of safety without data without balancing the possible incremental detriment to cardiovascular outcomes? I would venture that their recommendations like this that carry little clinical data subject doctors to greater individual liability risks compared to the greater risk of toxicity to their patients.
The FDA further notes that patients don't take Lipitor for symptoms, which is true. But I would venture that patients are probably smart enough to realize that if they start developing muscle aches after starting this drug, they are likely to stop the drug. Further, patients are paying for an increased percentage of their health care bill these days and that trend is likely to continue. Costs will drive compliance, and the best way to reduce costs is by market competition.
As far as liver toxicity with these drugs is concerned, the odds of seeing an elevated lipid panel on an asymptomatic patient on chronic Lipitor therapy is low. Certainly if it is found, stopping the drug might avert disaster. But the truth be known, when cardiologists see asymptomatic patients on Lipitor for their annual physicals, hepatic blood panels are drawn more for their defensive value against litigation than for their patients' clinical need. We justify this as "smart medicine" because we occassionally find an abnormality. But statistically, many "abnormal" lab tests are not acted upon clinically because "clinically" we know many of these "abnormals" are actually false positive abberations of the testing itself. In fact, when we do a panel of 10 chemistries from a single blood test, the odds that one of them will be abnormal can approach as much as 5%. Here's the truth: blood tests aren't perfect, either, so doctors practice clinical "judgement."
So I say, 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.
And who knows? Maybe our patients will actually do better for themselves than we give them credit for.