© 1998 Andrew Lundin, M.D. All rights reserved. Reproduced with permission.
Date: Wed, 12 Aug 1998 12:40:20 -0700
From: Andrew Lundin <firstname.lastname@example.org>
Permissible Hct levels now up to 37.5 averaged over three months. Reduction of EPO by 20% for higher levels keeps the bogeyman away. Why not >40%? For the answer to this one needs to take an historical perspective. When EPO was approved by FDA there were few studies beyond showing that it worked and was reasonably safe although there was some concern for accelerated hypertension and other cardiovascular complications from too rapid increase or high levels. The FDA decided on 36% as a reasonable compromise. At the time the promise of 36% sure seemed an improvement over the <28% which most patients experienced.
All the subsequent studies showing improved exercise tolerance, cardiac function, thinking ability etc where done on patients up to 36% Hct. There are very few if any studies showing what happens if the hct is higher. These are the studies that need to be done to convince Medicare that higher Hct levels are both safe and efficacious. Suppose Hct levels were just increased to >40% and some patients died of strokes or heart attacks as a possible consequence? Whom would you want to blame? This does not mean that higher Hct are safe and beneficial in many other patients. The studies need to be done for HCFA to make this decision.
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