How can Merck look itself in the mirror?

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Josh Bloom in Medical Progress Today

The pharmaceutical industry does many wonderful things, yet most people regard it as one step below head lice on the food chain.

This week, Merck, with some questionable help from the FDA, gave more ammunition to industry critics, who typically maintain that the industry contributes little innovation, and is simply concerned with profits.

For the most part, this criticism is biased and uninformed, but this time I'm siding with the critics. Because Merck is trying something that is as good an example of marketing without innovation as you'll ever see.

The company 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. This is innovation?

Worse still, both Vytorin and Liptruzet are of questionable use. In 2009, studies showed that Vytorin, despite lowering LDL and total cholesterol did nothing to prevent cardiac events. In fact, a 2009 New England Journal of Medicine article concluded that not only did Vytorin fail to reduce heart disease, but "the use of ezetimibe led to a paradoxical increase in the degree of atherosclerosis in association with greater reduction in LDL cholesterol, an effect we hypothesize may stem from unintended biologic effects of this agent."

Liptruzet behaved, as expected, just like Vytorin. It 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...[Read more].