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The Unintended Consequences of Clinical Trials Regulations

  • Alex D. McMahon mail,

    a.mcmahon@dental.gla.ac.uk

    Affiliation: Dental School, Faculty of Medicine, University of Glasgow, Glasgow, Scotland

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  • David I. Conway,

    Affiliation: Dental School, Faculty of Medicine, University of Glasgow, Glasgow, Scotland

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  • Tom M. MacDonald,

    Affiliation: Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland

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  • Gordon T. McInnes

    Affiliation: Gardiner Institute, Faculty of Medicine, University of Glasgow, Glasgow, Scotland

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  • Published: November 17, 2009
  • DOI: 10.1371/journal.pmed.1000131

Reader Comments (1)

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Has Medicine Become Anti-Innovative Altogether?

Posted by dwmoskowitz on 17 Nov 2009 at 20:28 GMT

I thoroughly agree with the authors of this report. I've started to wonder whether the unconscious goal of a strict and bureaucratic adherence to regulations is maintenance of the lucrative status quo in medicine.

Medical genomics is revolutionizing medicine. Fifteen years ago, for example, we found that overactivity of ACE (angiotensin I-converting enzyme) was associated with most forms of renal failure. When we increased the dose of an ACE inhibitor, we were delighted to find reversal of chronic kidney failure (1).

Although our paper was published in Sept, 2002, it remains unknown. As a consecutive case series, rather than a randomized controlled trial (RCT), it will never satisfy the narrow criteria of evidence-based medicine (EBM). Thus a lucrative dialysis and transplantation industry ($40 billion in the US alone) remains in full force.

1: Moskowitz DW. From pharmacogenomics to improved patient outcomes: angiotensin I-converting enzyme as an example. Diabetes Technol Ther. 2002;4(4):519-32.
PMID: 12396747.


David Moskowitz MD FACP

Competing interests declared: I am the CEO and Chief Medical Officer of GenoMed, a Disease Management company that is attempting to make the world dialysis-free by 2014.