Demystifying Medicine One Month at a Time


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.


  1. Darrel Stampley

    Way awesome, some great arguments! I appreciate you making these thoughts online, the rest of the site is also well done. Have a wonderful day.

  2. Health Blog

    Very cogent and straight to the point. Grand Rounds readers will enjoy this week.

  3. Janmar Delicana

    Dear Dr. Schumann,
    It’s a great pleasure to read your blog. I find your post very informative. I do believe that branded drugs are just over hyped and that generic drugs have the same efficacy compared with branded drugs.
    As a reader, I consider your writing to be a great example of a quality and globally competitive output.
    As a moderator for Physician Nexus (a community for physicians) I would like to share your genuine ideas and knowledge. With this you can gain 1000 physician readers on Nexus.
    We would love for you to visit our community. It’s free, takes seconds, and is designed for physicians only – completely free of industry bias and commercial interests.
    Janmar Delicana
    On behalf of the Physician Nexus Team

  4. GT, DO

    I enjoyed reading this, however I disagree somewhat on the use of generics. The FDA allows generics to alter in efficacy, anywhere up to 5%. If you are talking about a medication that has worked very well as a brand name, the generic might have different effects. Whether you are talking about a dose of Lipitor, which might not make much of a difference but HTN, or diabetes meds, which might. Until the FDA states that generics and brand names must have the same efficacy, sometimes going brand name to generics might not be such a great idea.

  5. Peter J Liepmann MD FAAFP

    In fact generics ARE the same. ALL manufacturers, whether it’s a generic maker, or the originator changing the size of the tablet, are required to test the new formulation in real people to make sure it yields the same blood levels the original drug did. SAME standards for original and generic manufacturer. Drugs with narrow dose ranges have tighter requirements- so the generic warfarin has to have less variation, just like the brand.
    There HAVE been problems over the years–like different batches of brand name drugs with narrow dose ranges having different potency –but the FDA has pretty much required that all drugs meet the same quality standards, and tightened those requirements where it needed to. This is a case where strict government regulation has worked really well.

    Now if we could just keep Congress from refusing to pay for the watchdog activity because it’s worked so well……

  6. Dr. Dalton

    It totally depends on the generic. I found that Synthroid, Lamictal, Zocor-just to name a few-are more effective (and less liver enzyme elevation with Zocor compared to simvastatin) in my practice. If you can link to this, it’s a wonderful podcast about generics. Basically, manufactuers aren’t overseen and the binders, fillers and colorants can make the affect the bioavailability of the drug. Public radio link:

  7. Barry Ursino

    In patients with severe coronary artery disease, amlodipine can increase the frequency and severity of angina or actually cause a heart attack on rare occasions.

  8. Ingrid Gordon, RN-BC

    Many years ago I worked at a nursing facility that care for head injured patients. Many of these folks had seizure disorders and were on brand name Dilantin and we had very few seizures. Then the pharmacy began to fill this RX with the generic form (it was cheaper). Suddenly our “stable” seizure folks started to have seizures. Labs were done and their drug levels had dropped. Our medical director ordered that they be switched back to brand name dilantin. The seizures stopped. Just my two cents worth.

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