Full results on risks of epoetin emerge 14 years after major dialysis study

BMJ 2012; 344 doi: (Published 22 May 2012) Cite this as: BMJ 2012;344:e3535
  1. Keith Epstein
  1. 1Washington, DC

More than 14 years after the publication of a major clinical trial of the use of epoetin alfa in patients undergoing haemodialysis, a new analysis of contemporaneous data obtained under the US Freedom of Information Act has found that researchers under-reported serious adverse effects and overstated the benefits of high doses of the drug. Epoetin alfa was later shown in other studies to pose a risk of heart attack and death.

The new retrospective analysis, published in March in the International Society of Nephrology’s journal Kidney International,1 raises questions about whether the medical profession and US authorities had been misled by what seems to have been an incomplete report on experimental results and whether enough scientific transparency and regulatory oversight accompanied the development of new drugs and devices.

Specifically, the original study, called the normal haematocrit trial, which was published in August 1998 in the New England Journal of Medicine and was the largest comparison of epoetin ever …

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