Merck Scuttles Another Trial Similar To Enhance

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ohmyLess than a month after the FDA rejected its experimental Cordaptive cholesterol med, the drugmaker has scuttled a study. And interestingly, the study was using the same technique to examine patient populations as the controversial Enhance trial that was supposed to have boosted Vytorin.

The discontinued Achieve trial examined people with a genetic predisposition to high cholesterol and, like the Enhance study, measured the thickness of carotid artery walls using images, or cIMT. You may recall, Merck and Schering-Plough say they had difficulty deciphering data, which was their reason for repeated delays in releasing results. Of course, Vytorin was shown not to offer any improvement.

“It was clear from the steering committee’s review of pooled data from recently completed cIMT studies of other medicines that the patient population being studied in Achieve was no longer the correct population to test the primary study hypothesis of IMT progression,” John Kastelein, the steering committte chair, says in a statement. “For that reason, the committee recommended that Achieve be stopped and a new imaging trial be considered in a more appropriate patient population.”

Merck, meanwhile, insists the decision has nothing to do with the FDA rejection. Kastelein, by the way, is the same person who was the principal investigator for the Enhance trial and accused Merck and Schering-Plough of changing the primary endpoint without consulting him. He works at the Medisch Centrum in Amsterdam.

As an aside, Merck usually sends out press releases directly to journalists. This time, the drugmaker failed to do so and simply placed the statement on its web site and distributed it over the BusinessWire service, which is a less-than-efficient way to ensure that the regular group of journalists will see an announcement on a timely basis.

Given the nature of the statement - the many similarities to the Vytorin trial and the recent FDA rejection - we wondered whether there was an attempt to downplay the bad news. A Merck spokesman insists that was not the case and that the statement was handled by a different group within the drugmaker’s vast empire.

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  1. This is very unfortunate.

    I know that it is heresy to sympathize with pharma companies in this site, but one has to think of the patients who could have been helped by these advances.

    If you are tempted to rejoice at a company’s decision to stop a study, just think about the people who could have been helped.

  2. Hi Paul,

    I think there are a good many people who read the site who actually do sympathize with pharma, at least on some level, because a healthy portion of my readers (viewers?) work in or with pharma in some capacity. Many just don’t jump into the conversations, mostly to maintain employment, from what I’m told in private discussions. Although some do visit on an anonymous basis. So you never know who you may run into here.

    Cheers
    ed

  3. Paul,
    Who rejoices at a companies decision to stop a study?

    First of all it was the company’s decision. Hopefully it was the best decision for everyone involved.

    You make is sound like there are people here that are against good drugs and devices. I don’t think that’s the case. There are plenty of people here who are against poorly designed and marketed pharmaceuticals, too many of which do make it to market.

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