EPO’s makers may be down, but they’re not out
(UPDATED: See below.)
Erythropoietin, or EPO, and its close relatives didn’t become the world’s most popular biotech drugs — at least through last year, when they pulled in sales of almost $12 billion — for nothing. On the plus side of the ledger, the anemia treatment owed its early success to the near miraculous improvement it wrought in the health of kidney-dialysis patients, who previously required numerous blood transfusions and frequently died relatively quickly anyway. On the other side, though, EPO makers, primarily Amgen and Johnson & Johnson, have long pushed hard to boost dosage and use of the drugs in a variety of situations, even when the evidence of patient benefit was weak and sometimes in the face of worrisome early signs that the drugs might actually be hurting instead of helping. (See our previous coverage here and here.)
In light of evidence this year that high doses of EPO increase the risk of blood clots, heart attacks and death, and that the drug might also encourage tumor growth, it was encouraging to see J&J announce yesterday — to the WSJ, at least — that it’s dropping efforts to expand EPO use in surgical and trauma patients. The main reason: Negative findings in a large J&J-funded study published yesterday in the New England Journal of Medicine, which reported that use of J&J’s EPO, brand-named Procrit, failed to reduce the number of transfusions or even the quantity of transfused red-blood cells among patients in intensive care.
That trial did produce equivocal evidence that EPO might contribute to the survival of these critically ill or injured patients, as there were fewer deaths among those who received Procrit at both day 29 and day 140 following their first injection. The result at day 140, however, wasn’t statistically significant. More worrisome was the fact that EPO use was associated with a 45 percent rise in blood-clot related events, including lung clots, deep-vein clots and heart attacks. Not that long ago, J&J would have most likely pointed to the mortality data as evidence of benefit and planned another study. Not this time, particularly when the same issue of the NEJM also carried an editorial warning against routine use of EPO in the ICU.
On the other hand, the EPO lobby isn’t close to folding its tent. Over at GoozNews, Merrill Goozner recently noted a sly provision slipped into a children’s health-insurance bill that would likely boost EPO use in dialysis patients, quite possibly to dangerous levels — and at a cost to taxpayers of $100 million a year. The details are too complex to get into here, but Merrill does a great job of laying it all out, so head over and take a look, and marvel at the tenacity of drugmakers who are down but nowhere near out.
UPDATE: The In Vivo blog offers this weighty analysis — and I mean that in a good way — of what to expect as yet another FDA committee looks into EPO usage and side effects next week.
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About the Author, David P. Hamilton
David Hamilton has been writing for VentureBeat LifeScience since April 2007. He formerly spent 14 years as a reporter for the Wall Street Journal in its San Francisco and Tokyo bureaus. Prior to that, he spent several years as a reporter at Science Magazine and as a reporter/researcher for the New Republic, both in Washington.