Merck 'Evergreens' Off-Patent Lipitor By Creating Combination Drug With No Additional Benefit

from the and-this-is-medical-innovation? dept

Big pharma often gets a rather rough ride here on Techdirt, what with its attempts to stop governments granting licenses for life-saving and low-cost generics in emerging countries, engaging in legal action to prevent drug safety information being released, and paying kickbacks to doctors. But sometimes you get the impression that drug companies really go out of their way to be disliked, as this great post by Josh Bloom on the Medical Progress Today site, pointed out to us by John Wilbanks, demonstrates:

[Merck] just received approval for the cholesterol-lowering combination drug Liptruzet -- a functionally similar (identical?) version of their own Vytorin, which is a combination of their statin Zocor and Schering's (now part of Merck) cholesterol absorption blocker Zetia (ezetimibe).

Liptruzet, ironically happens to be a combination of Zetia and atorvastatin (generic Lipitor). Yes -- Merck is substituting a former Pfizer drug for their own Zocor with combining it with Zetia to make a "new" medication with additional patent protection.
If it were just another case of trivial "innovation", the story wouldn't hold much interest. But there's something more here:
[Liptruzet] reduced LDL cholesterol more for patients who took Lipitor alone, but it did not reduce patients' chances of developing heart disease. Not surprisingly, this left some doctors to wonder why it was approved at all.
Bloom quotes an interesting comment on this from Philip Gelber, Chief Cardiologist at Cardiovascular Consultants of Long Island:
"The modern movement requires that drugs not just be safe and effective in their immediate goal, but to also show efficacy in improving outcomes. Cardiac medications should not just reduce the cholesterol count, but reduce the risk of heart attack and stroke as well." He continues, "There was, I'm sure, pressure by big pharma to get this approved, which by pairing it with another drug, would in effect restore blockbuster Lipitor back to branded status."
That is, this is a slightly unusual kind of "evergreening", applied this time to Lipitor, from Merck's rival Pfizer, but now off patent. Before that happened, Lipitor was the world's top-selling drug:
Over 14.5 years, the cholesterol-lowering medicine has made over $125 billion in sales, and has provided up to a quarter of Pfizer Inc.'s annual revenue for years.
Bloom goes on to explore the FDA's role in this surprising approval of a drug that offers no additional benefit over Lipitor, and notes that the agency doesn't come too well out of this business either. As he concludes:
This episode just plain smells bad on many levels. I get the feeling that just about everything except science is driving this, and this will be a black eye that Merck will be inflicting on itself and the rest of the industry.
In other words, it doesn't look as if the pharmaceutical industry's image is going to improve any time soon....

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Filed Under: evergreening, lipitor, no benefits, patents, pharma, pharmaceuticals
Companies: merck


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  1. identicon
    Pharma Worker, 10 Jul 2013 @ 12:46pm

    Patient Compliance

    Disclaimer: my mortgage is paid by Big Pharma.

    I will grant the 30,000 foot view of this looks sketchy, but the #1 problem facing the efficacy of medications is patient compliance. If we can take a regimen of pills a patient must take and combine them into 1 tablet, that in the end has tremendous positive outcomes.

    Yes, it may not look good in research - yep, taking X and taking Y gets the same result as taking XY. However, in the real world, a patient will NOT take X 3 times a day and Y 2 times a day, every day. If they can take a single pill once (or twice) daily, compliance goes through the roof and you have statistically better outcomes.

    You may not agree, and you may be compliant with your meds, but think of the 70 or 80 year old patient with that pillbox with dozens to take daily. Combining them makes a lot of sense. I hope this helps it make a little sense. Some people will always detest this practice, I get that, but it does have merit. You're very welcome to use the generic versions and take more pills daily. That's always an option.

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