FDA’s Incompetence, or Malfeasance?

  • AP: FDA Saw Problems at Vaccine Plant in 2003. Documents provided by the FDA to a congressional committee show that inspectors uncovered contamination and unsanitary conditions at a Chiron Corp. flu vaccine manufacturing plant in England in 2003. Yet the agency did not re-inspect the facility until similar problems caused the loss of roughly 50 million flu shots destined for the United States.
  • Reuters: Congress Told FDA Failed Public on Vioxx. Committee Chairman Charles Grassley, an Iowa Republican, said he was concerned the FDA had a “far too cozy” relationship with drug companies and suggested an independent office of drug safety might be needed.

  • Comments

    Posted by: Ted Feuerbach on November 19, 2004 09:28 AM

    The influenza vaccine issue is clearly an inexcusable disaster. Heads should roll.

    The Vioxx thing is a bit more complicated and the reporting on the subject is sorely lacking. There is a missing piece of information from all the news reports that I’ve seen about Vioxx and it is the critical thing in determining if the FDA is right or wrong and if Merck is right or wrong: What were the results of the ISS?

    What’s an ISS? In the drug development/approval process, all the data from human clinical trials on a drug is periodically pooled and the safety data is analyzed. This analysis is called an Integrated Safety Summary (ISS). It is an FDA regulatory requirement and the results are sent to the FDA for review. All that pooled data (sometimes from thousands of patients) makes it more likely that any safety issues with a drug will be found since the large population involved gives more statistical significance to the analysis. This process also continues for years in post-marketing. In any case, rare adverse drug events (side effects) that are linked to the drug may not show up until the drug has been tested in thousands of people or even tens of thousands (once the drug is on the market). If, in the past, an ISS never indicated a problem until this latest study and then the drug was pulled from the market, Merck and the FDA should be in the clear. If, on the other hand, the FDA and/or Merck did see problems from this pooled ISS data analysis from previous studies and didn’t act, then somebody has some serious explaining to do.

    Posted by: on November 19, 2004 10:28 AM

    What I find really scary is that Accenture is now managing new drug trials, under contracts where they don’t get paid unless the project meets success metrics. This is dangerous–there’s tremendous pressure to fudge the data. Should a drug manufacturer cook the data, they’d be out of business, so they have a strong incentive to put in and respect controls. But for Accenture, this is only one minor line of business among many, and if it blows up it’s just a blip on the bottom line.

    (Accenture’s role in drug testing is discussed in the last third of this article):


    “That led Accenture to create scorecards that hold Wyeth scientists accountable for meeting research objectives. The consulting firm also took over the process of managing clinical trial data — the first time a drugmaker has entered into such a deal. The result? Wyeth is now moving 12 drugs into development every year, up from three in the past. The results have “really been phenomenal,” says Robert R. Ruffolo Jr., Wyeth’s research president.”

    Posted by: Ted Feuerbach on November 19, 2004 12:11 PM

    This is scary. With the kind of “Book Cooking” that has gone on in recent years by some of the big accounting/consulting companies I shudder to think about them managing clinical trial data analysis for new drug applications. I only hope that the success metrics are based on the data being processed, not the outcome of the clinical research.

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