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Opinion: Misleading Drug Trials

Amgen’s incomplete report on an early major trial of epoetin misled the medical community about the anemia drug’s risks and benefits—and helped make Amgen rich.

Written byDaniel W. Coyne
| 5 min read

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The Normal Hematocrit Trial, conducted in the mid-1990s, was the largest study ever to compare the use of epoetin, a drug that stimulates blood production, to treat dialysis patients, who suffer from anemia, or a below-normal red blood cell count, called hematocrit. In healthy individuals, 39 to 45 percent of their blood is comprised of red blood cells. Severe anemia, a hematocrit below 25 percent, can stress heart function, cause marked fatigue, and require blood transfusions.

Most dialysis patients need some epoetin or a similar drug to avoid severe anemia, and the higher the desired hematocrit, the higher the dose required. The study aimed to compare the effects of standard epoetin doses, which maintain patients’ hematocrit around 30 percent, and much higher doses, to raise ...

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