Monday, February 18, 2008

Pharma R&D Succumbs to the Dark Side

I once said "God bless the dedicated researchers and scientists of the pharmaceutical industry! They are truly the unsung heroes of the pharmaceutical industry! Too bad they are sequestered in their labs!" and "If God blesses the folks in pharma R&D, the devil may take pharmaceutical marketers -- unless they reform!"(see "God Bless R&D, but Marketers May Go to Hell!").

I even came up with a nice visual image of this sentiment:


Of course, I held little hope that Pharma Marketing would reform, but I didn't think that R&D would make a pact with the devil! The more I learn about about Merck's and Schering-Plough's failed ENHANCE study (see, for example, "How high hopes ultimately hurt Vytorin study"), the more I think a deal indeed was made.

Perhaps the following image is better suited to reality these days within pharma companies:


That is, R&D is succumbing to the demands of the commercial side of pharma. It's not quite under the thumb of the dark side, but it's tainted, which is one conclusion I came to after reading the EHNANCE story.

According to the NJ Star-Ledger article cited above, "Interviews with 10 of the leading research scientists and clinical trial experts, as well as the companies, suggest the study was ill-conceived and poorly managed -- all in the name of seeking scientific proof Vytorin was more effective than its rivals."

Not only that, "In a break from standard clinical trial procedure, Merck and Schering-Plough oversaw the trial instead of a panel of outside scientists. There also was no safety monitoring board to oversee the health of clinical trial volunteers, which is typically appointed in studies involving new drugs."

And, "The most troubling shortcoming, the experts said, came when Schering-Plough's statisticians reviewed some raw study data in April 2006 before the examinations of all 750 volunteer test subjects at 11 sites around the globe were complete."

It was also said that the study was poorly designed: "The people selected for the study did not have abnormal amounts of plaque in their arteries to begin with, setting a high hurdle for Vytorin to reduce it."

I've got to believe that the scientists setting up these studies are smart people and do not develop clinical trial designs with "high hurdles." I think they designed the study to satisfy the main marketing message that the Vytorin marketers wanted to send: that Vytorin slows the progression of the buildup of plaque in people prone to this build up. If Vytorin could claim that, then it would be more competitive with Lipitor and Crestor. It's easier to detect a slight increase in the control group if the base level is normal rather than high.

[Tell me if this analogy is good: it's easier to distinguish a light gray tone from white than it is to distinguish two slightly different tones of gray.]

"Kastelein [the a cardiologist in Amsterdam who proposed the study] and three Schering-Plough scientists who helped design the study are no longer with the company."

Call in the R&D hit men and then eliminate them. If that's not dark, then I don't know what is!

4 comments:

  1. Who are these ex-SP people.

    They must be found and questioned, as should the statisticians who looked at the raw data in 2006.

    Who did they then talk to?

    Jack

    ReplyDelete
  2. Undoubtedly, they have "hit the mattresses" in safe houses as the mob used to do when the feds or other mobsters were after them!

    ReplyDelete
  3. Here is the link to today's post on the drug shortage titled "Pharma Supply Chains (Part 1): A problem of focus versus avarice?" @ http://wp.me/p4HrB-2SZ

    In the latter part of October we will be airing a special segment with our resident healthcare expert Jeff Knott discussing the questions surrounding drug shortages.

    Would you be available to participate as a guest on the PI Window on Business?

    Best,

    Jon

    ReplyDelete

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