On Evidence, Medical and Legal
Mon, 5 Sep 2005
An outstanding highly recommended article by a physician and an attorney, On Evidence, Medical and Legal by DonaldW. Miller, Jr., M.D. and Clifford G. Miller, Esq. clearly lays out the standards of evidence law in medicine.
The authors critique the courts’ exclusive relaince on the (mostly unobtainable) scientific standard of proof in medical injury cases.
Their criticism is addressed in particular to cases in which a drug or vaccine are claimed to be harmful.
“Science prizes objective certainty. For a hypothesis to be proved, or a theory to become theorem, the evidence supporting it must be irrefutable. But science does not uniformly adhere to this standard. Subjective opinions and consensus among scientists often supersede the stricture of irrefutability. Hence, scientific standards of proof are not uniform and well defined, in contrast to legal standards.
Standards of measurement, ways of reporting and evaluating results, and particular types of experimental practices vary. As a result, there is no simple and reducible algorithm against which ‘good’ science can be evaluated.
There is another aspect of the scientific standard of proof that particularly impacts medicine. Science’s quest for objective certainty admits only a narrow range of evidence.”
Clifford and Clifford demonstrate how exclusive reliance on randomized controlled clinical trial (CRT) resuts –which are deemed to prove beyond a reasonable doubt, if not irrefutable proof–can, and has, lead to false conclusions and preventable deaths.
They cite the case of a meta-analysis of 30 CRTs by The Cochrane Centre (Oxford UK), the most prestigious arbiters of clinical trial analysis.
A 1998 Cochrane meta-analysis of 30 CRTS on volume replacement in critically ill trauma victims, found that the risk of death was 6 percent higher in patients given albumin rather than crystalloid. The reviewers’ published report suggested that up to 30,000 patients in Britain alone have died because they were treated with human albumin solution.
So certain was the director of the Cochrane about these results that he stated publicly that “he would sue any doctor who gave him an infusion of albumin and that patients should seek redress in the courts for clinical negligence if the guidelines based on this analysis were transgressed.”
To find out the where the confounding bias was– and why it was undetected in the the Cochrane meta-analysis
See: On Evidence, Medical and Legal by Donald W. Miller, Jr., M.D. and Clifford G. Miller, Esq. in the Journal of American Physicians and Surgeons http://www.jpands.org/vol10no3/miller.pdf
This article should be distributed to every judge in every case involving evidence for determining medical causality issues, and to every public health policy maker.
Contact: Vera Hassner Sharav
212-595-8974
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