Thursday, August 04, 2011

When Drugs Go Off the Radar

With the news that Pfizer is considering the possibility of making Lipitor (atorvastatin) over-the-counter (OTC), the FDA suddenly becomes "concerned:"
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.

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.
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.

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.



Lisa said...

Thank you for having faith in the intelligence of your patients. But I find it mildly disturbing that all those tests that I take for doctors really don't mean anything.

Anonymous said...

This has more to do with Pfizer's need to keep the Lipitor users on the Pfizer med, instead of the upcoming generics. Wonder how the FDA and Pfizer would react to all manufacturers being allowed to sell OTC with the name "generic Lipitor". Bet your stethoscope Pfizer would fight it tooth and nail.

Tim Hulsey, MD said...

Emmy, "all those tests" are done because the doctor has to order a set of tests that are all done on the same blood specimen to get the one she/he wants, not because they are just ordering a bunch of tests.
Wes, heaven forbid that you would suggest that we or our patients could better handle our own problems without the control of the ruling elite! Obviously, we don't have enough intelligence for that. All we have enough intelligence for is to defend ourselves in court, because, no matter how many decisions are taken away from us or how little we get paid for carrying them out, WE KEEP ALL OF THE LIABILITY!!
Did I mention that I HATE SOCIALISTS!!

Eric Rph said...

I think this is a longshot at best, and a dangerous one. Patients barely understand statin therapy now as a prescription. The host of problems from self-treating a chronic condition like cholesterol with powerful statins is risky and potentially more costly. Just think, if OTC Lipitor became available, insurance companies would immediately stop covering statins, and likely tests associated with their correct use.

Neal Lippman, M.D. said...

Interesting link to personal injury firm Anapol Schwartz. In the "FAQ" on Zocor, in response to the question as to what to do if you are taking Zocor 80 mg, they actually advise you to "immediately discontinue use of the drug" and "seek a second opinion from a different medical professional."

I'm very surprised that a law firm would actually advise, on their website, that someone stop taking a medication that was prescribed for them without having _first_ obtained a medical opinion on that action.

Neal Lippman, M.D. said...

Oh yes - I meant to point out in my comment that the most recent FDA advisory on Zocor specifically states that patients taking Zocor 80mg should "NOT stop taking their medication unless told to by their medical professional" (emphasis added).

Why in the world would a law firm issue medical advice on their website, especially advise that specifically contradicts the FDA's recommendations?