How can Merck look itself in the mirror?

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.

Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic commented "This is extremely surprising and disturbing."

This sentiment is echoed (and then some) by Philip Gelber, M.D., Chief Cardiologist at Cardiovascular Consultants of Long Island. "It is surprising to me that the FDA approved this combination drug. 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. A tricky move, but one which doesn't make folks any healthier."

So, why on earth would we need a virtually exact copy of a drug that doesn't even work? This is for Merck to answer.

I also don't understand what the FDA was thinking here.

Are they under so much political pressure to approve new drugs that they will accept just about anything? Because it sure seems that way right now.

This past January, FDA Commissioner Margaret Hamburg bragged about the improved performance at the agency, which approved 39 new drugs last year compared to 30 in 2011, and 21 in 2010. She said, "Not only have we been able to approve more new drugs that have real benefits for patients but also classes of drugs that signal where we are going in areas like personalised medicine, where we've been able to use diagnostics to target sub-populations of responders."

But last week's approval of Liptruzet makes me wonder whether they are simply playing a numbers game for the sake of public perception. Because if there is any drug that does not have any obvious benefits for patients, it is Liptruzet.

This is a sentiment shared by Dr. Nissen. He said, "It seems like the agency is just tone deaf to the concerns raised by many members of the community about approving drugs with surrogate endpoints like cholesterol without evidence of a benefit for the disease we are truly trying to treat--cardiovascular disease."

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.

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