A Dose of Science About Drug Dosing and Off-Label Uses

  • by: |
  • 03/17/2008
Two articles in the NY Times -- one about the discussion of off-label uses for Zyprexa and another accusing drug companies of launching meds at a higher dose than necessary -- are devoid of scientific context.

The failure to report on off-label uses without describing the process of arriving at them and the fact that most are the product of trying to solve a clinical problem is a consistent and glaring gap in reporting. And burying the science only empowers trial attorneys and federal prosecutors who are constantly prodded by Senator Grassley to use the threat of prosecution to shake down drug companies for settlement fees.

With respect to the allegation that Avastin, Herceptin, Cerazyme, etc., are overdosed on purpose is completely without merit. Dosing is -- by the nature of clinical trials -- one size fits all. Achieving an appropriate dose in the real world goes on all the time and hitting the right dose -- as the warfarin genetic labeling effort suggests -- is a matter of genetic variation and other factors that cannot be integrated into drug development. And consider this: in some instances changing the timing and dosing of certain drugs can be regarded as off-label use and therefore subject to prosecution and tort lawyer litigation.

When Avastin was being developed it's initial "failure" in early trials was -- according to Judah Folkman who pioneered angiogenesis drugs -- linked directly to the fact that the FDA wanted every patient to get the same dose even though he believed varying dosing to a number of criteria -- would have led to better and more precise outcomes.

Many drugs don't work in most people at the marketed dose. The failure of HMOs not to provide coverage of the most expensive and innovative medicines should have nothing to do with dosing. The right dose for the right patient at the right time for the best outcome is the goal of any doctor. The Critical Path leading to personalized medicine or tailored treatments reflects the commitment of companies and the FDA to move away from the one-size fits all approach.

The media continues to ignore the underlying science shaping medicine and it leads to the arrogant notion that prosecutors and policy analysts can strip doctors of their discretion about how to prescribe and use medicines to advance the health of their patients.



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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