Generics

Later this year, the nation’s top selling drug–Lipitor–will lose its patent protection. Soon thereafter, generic drug manufacturers will compete to market a low cost version of the drug.

How low?

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The price will drop in the neighborhood of 90%. Makes you wonder why the cost is so high in the first place. Manufacturers justify it as the price of innovation. Patent exclusivity allows pharmaceutical firms to recoup their investments in research and development (and marketing).

To complicate matters, once the patent expires it’s not quite a free-for-all. For complicated legal reasons, a single generic manufacturer is given a six month window of exclusivity before the drug can be manufactured in the ‘public domain.’

This means that the price is certain to drop (if the generic manufacturer clears its legal hurdles), but not by the massive amount it will once there are lots of other manufacturers competing.

I mention this story for two reasons:

First, the company that makes brand-name Lipitor, Pfizer, is causing controversy by applying to sell its version of the drug over-the-counter (meaning available without a doctor’s prescription). Critics accuse the company of a naked cash grab, arguing that Pfizer is simply trying to extend their product’s market share dominance.

There’s a nice summary of the controversy from mega-medical blogger KevinMD. Link here.

No doubt many of you have opinions about generics–ranging from “I always choose them since it’s the most cost-effective strategy” to “Never. I don’t trust anything less than brand name. I don’t like being forced into generics by my insurer. Isn’t this why I have insurance in the first place?” [Patients have said that to me many times.]

The other reason I offer the story is to let you in on a secret of the medical profession. Get ready:

[sotto voce] Doctors like generics. We believe in them. In general, we find it ludicrous to pay the differential for brand name drugs. Claims about the superiority of brand name drugs are just so much smoke and mirrors. Don’t believe the hype.

Having said that, here are a couple of stories to keep us all on our toes:

Some drugs actually aren’t the same. For example, it’s been generally accepted that there are differences in the way brand name blood thinner Coumadin is metabolized versus it’s generic ‘equivalent,’ warfarin. So the absolute I just gave you about docs always favoring generics isn’t absolutely true.

Then try this on: Patients get confused when they’re on a generic and suddenly it switches. Happens all the time. Pharmacies get huge bulk discounts on the pills they sell. Next year, when you go for that refill on your amlodipine or metformin (the first a very common blood pressure medicine, the second the most common oral medicine for diabetes), the pill could easily change size, shape and color. But it’s for all intents and purposes the same thing. The only difference is the ‘inert’ stuff in the pills, what are called congeners.

But it is darn confusing when this happens. And even though the ‘active’ ingredient, the actual drug, is supposedly safe and effective, there are anecdotes of things going wrong. I had a patient on the blood pressure medicine lisinopril for years. She tolerated it well, and it worked to control her blood pressure. We were both happy.

Sure enough, her pharmacy changed her pills from round white ones to oblong pink ones. After the third dose, she had a major allergic reaction called angioedema. [Her face, tongue, and lips swelled up.] Luckily, with treatment, she got better and no further harm was done. Coincidence? We’ll never know. One thing we know: no more lisinopril for her.

So, that’s this week’s debate. Where do you fall on generics vs. brand name?

Apparently, it’s no contest. A vast majority of Americans prefer generics and believe that they are safe and effective. Scott Hensley at NPR’s Shots blog has a nice post about this trend.