When Lipitor Goes Generic

When the world's leading cholesterol-lowering "statin" drug, Lipitor, goes generic tomorrow, doctors will bear the brunt of the conversion with little information about what the new drug will cost for their patients.

This, of course, is the plan.

Even the Wall Street Journal which has an excellent "user's guide" to making the switch from name-brand to generic Lipitor offers little help as it mentions "co-pays" rather than actual drug cost:

How much cheaper will generic Lipitor be?

Insurance copayments should drop considerably, if patients are getting Lipitor or atorvastatin on the generic tier of their health plans. Currently, Lipitor has been on a higher, branded tier for prescription drugs. Copays for branded drugs average either $29 or $49 depending on the tier, according to Kaiser Family Foundation. Copays for generics average $10.

In addition, Ranbaxy Laboratories Ltd, one of the generic manufacturers of generic Lipitor, won concessions to maintain elevated prices for 180 days from the government (a la our own Food and Drug Administration while the Federal Trade Commission stands idly by complaining how consumers are gouged with this arrangement) to assure prices stay high a bit longer.

But if we forget the insurers and copays, how much will the generic drug actually cost consumers?

No one will tell you.

That's because everyone else has to make sure they make their cut first. Pharmacy benefit managers, the leeches attached to nearly every prescription written today, have to strong-arm their position in the ever-competitive pharmaceutical profit by "pre-negotiating" prices for consumers wed to even more insurance plans with varying deductibles and co-pays.

Even Pfizer, not wanting to exclude itself from the profits inherent to such a non-transparent system is offering it's own "generic version" through Watson Pharmaceuticals. Theoretically it would be good for the public to have multiple generic manufacturers competing for generic Liptor's market, driving prices down. However, this natural self-regulating market function cannot occur to the benefit of consumers due to the blocking of actual drug price comparison.

Insisting on tranparent retail pricing of the medication's pre-insurance costs would greatly facilitate consumer choice of statin in the doctor's office. Someday, one could imagine a Consumer Reports spreadsheet in the same way they rate appliances and automobiles.

But then again, it seems we can't do that because it would serve the function of weeding out our hidden pharmaceutical middlemen.

-Wes

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.

-Wes

Statins, Cognitive Effects, and Gender Bias

It's surfaced again: the effects of statins (specifically atorvastatin or Lipitor) on the cognitive functioning of the brain. Today's Wall Street Journal quotes Dr. Orli Etingin, vice president of New York Presbytarian Hospital who states "This drug makes women stupid." He goes on to say:

"I've seen this in maybe two dozen patients," Dr. Etingin said later, adding that they did better on other statins. "This is just observational, of course. We really need more studies, particularly on cognitive effects and women."

Now is this about the drug? Or is this about supporting research for women? Why would women be affected and not men? Are not our brains made of the same cholesterol-based myelin mush? Or is their a societal bias against men who must never become confused or depressed? Certainly, the relative benefits of statins for reducing acute coronary syndromes has been well-studied, but the challenge with measuring cognitive effects of these medications (or any other medication) are considerable and less conducive to increasing sales. So I would ask that before we bias these statements toward women, we also consider statins' effects on men, too.

Better yet, before panicking, we should consider that this cogitive effect might just be a side effect of the medicine, just like nausea, muscle aches, or any other side effect, and appears reversible if the drug is stopped. Doctors and patients alike should look at it this way and not generate undue anxiety over this news while carefully considering the risks of recurrent heart injury to cognitive decline. Only then with such a careful assessment can recommendations be made to the risks and benefits of these medications in an individual patient.

Well, I better warn my office staff today - no doubt we'll be hearing the phones ring like crazy...

-Wes

Ref: More info at: www.statineffects.com.

Pfizer: Coming Clean on Lipitor

Seems Pfizer admitted to the SEC that its superiority data regarding Lipitor (atorvastatin) over Zocor (simvastatin) was overstated. They might have the same efficacy rate. It seems they were forced to reconsider their claims:

The error was discovered while researchers were re-analyzing the data at the request of an expert who was reviewing the manuscript, which had been submitted for publication in a journal. (Pfizer senior vice president Michael) Berelowitz declined to name the publication.

Hmmm. I'm intrigued. There must me something going on here. Why would Pfizer suddenly decide to come clean and surrender their profits to generic simvastatin? Could people be on to their techniques?

-Wes

Reference: Wall Street Journal's Health Blog