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....

Follow me @glynmoody on Twitter or identi.ca, and on Google+

Hide this

Thank you for reading this Techdirt post. With so many things competing for everyone’s attention these days, we really appreciate you giving us your time. We work hard every day to put quality content out there for our community.

Techdirt is one of the few remaining truly independent media outlets. We do not have a giant corporation behind us, and we rely heavily on our community to support us, in an age when advertisers are increasingly uninterested in sponsoring small, independent sites — especially a site like ours that is unwilling to pull punches in its reporting and analysis.

While other websites have resorted to paywalls, registration requirements, and increasingly annoying/intrusive advertising, we have always kept Techdirt open and available to anyone. But in order to continue doing so, we need your support. We offer a variety of ways for our readers to support us, from direct donations to special subscriptions and cool merchandise — and every little bit helps. Thank you.

–The Techdirt Team

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


Reader Comments

Subscribe: RSS

View by: Thread


  1. icon
    Chris Rhodes (profile), 9 Jul 2013 @ 7:24am

    Re: Re: Re:

    Yes, but he was implying through sarcasm that this was an example of the free market not regulating itself, when patents themselves are artifacts of government regulation.

Add Your Comment

Have a Techdirt Account? Sign in now. Want one? Register here



Subscribe to the Techdirt Daily newsletter




Comment Options:

  • Use markdown. Use plain text.
  • Remember name/email/url (set a cookie)

Follow Techdirt
Essential Reading
Techdirt Deals
Report this ad  |  Hide Techdirt ads
Techdirt Insider Chat

Warning: include(/home/beta6/deploy/itasca_20201215-3691-c395/includes/right_column/rc_promo_discord_chat.inc): failed to open stream: No such file or directory in /home/beta6/deploy/itasca_20201215-3691-c395/includes/right_column/rc_module_promo.inc on line 8

Warning: include(): Failed opening '/home/beta6/deploy/itasca_20201215-3691-c395/includes/right_column/rc_promo_discord_chat.inc' for inclusion (include_path='.:/usr/share/pear:/home/beta6/deploy/itasca_20201215-3691-c395:/home/beta6/deploy/itasca_20201215-3691-c395/..') in /home/beta6/deploy/itasca_20201215-3691-c395/includes/right_column/rc_module_promo.inc on line 8
Recent Stories
.

This site, like most other sites on the web, uses cookies. For more information, see our privacy policy. Got it
Close

Email This

This feature is only available to registered users. Register or sign in to use it.