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. icon
    Anonymoose Custard (profile), 9 Jul 2013 @ 9:51am

    This tells me we need to change the drug approval process.

    Clearly, the FDA is at fault for a lot of this, and the Patent Office is clearly at fault for allowing the patent to be extended in this way.

    What needs to happen, in my mind, is that the structure of the approval process needs to be inverted a little: When a pharma comes to the FDA with a new drug, making claims that it improves over another drug, then the FDA should have the resources from its own budget to perform the study and evaluation for efficacy, safety, etc., and then if the drug doesn't meet expectations, then the pharma should pay a fine for wasting the FDA's time, in addition to getting the approval denied.

    In this way, the impetus is less on producing more drugs to extend patents and massive earnings and more on making more efficacious and safer drugs.

    Getting rid of the shareholders' opinions in this matter would also be of great benefit.

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