Epogen-Related Infections Linked to Clinic’s Misuse

Amgen Inc.’s anti-anemia drug, Epogen, has been linked to the spread of a rare bacterial infection at a Colorado dialysis center, according to a report in today’s New England Journal of Medicine.

Employees pooled leftover Epogen from single-use vials and administered the medication to patients, investigators from the U.S. Centers for Disease Control and Prevention found. At the time of the outbreak in 1999, which infected 15 people, a vial of Epogen cost $85.

A dialysis center serving 150 patients can bring in an additional $150,000 a year if it uses leftover medication from single-use vials, the medical journal said. More than 200,000 Americans who suffer from kidney disease regularly undergo dialysis.

“We know the product is valuable, but given the fact that once the vial is punctured bacteria can get inside, any remaining product should be thrown away,” said David Kaye, an Amgen spokesman. “Pooling and trying to get another dose out of it can be dangerous to patients.”

The cost of Epogen has been controversial. Last week, Amgen raised its wholesale price by 3.9%, the second increase in two years, prompting protests from two leading dialysis chains. Nearly 80% of dialysis patients are covered by Medicare, which is not expected to pick up the added cost.

The federal Health Care Finance Administration didn’t raise Medicare reimbursement to cover last year’s price hike, the first since the drug’s 1990 launch. The Clinton administration proposed cutting Epogen reimbursement by 10%, but Congress did not approve the cut.

Medicare reimbursement is $40 for 4,000 units, the standard dose.

The Colorado patients recovered after treatment with antibiotics. No new infections occurred after the unidentified center stopped pooling leftover medication. A survey of other dialysis centers included in the review found that most routinely reuse single-use vials of Epogen.

With limited reimbursement and an increasing number of for-profit providers in the U.S., “dialysis providers are motivated to control costs, sometimes to the detriment of patient care,” the medical journal said.

Better infection-control training is needed at such centers, where infections cause at least 18% of patient deaths, Robert A. Weinstein of Chicago’s Cook County Hospital wrote in an editorial.

“Another lesson of the report is that there are sizable risks in cutting corners and ignoring the recommendations of manufacturers in order to save money,” he wrote.

Shares of Thousand Oaks-based Amgen rose $4.43 to close at $65 on Nasdaq.

Bloomberg News was used in compiling this report.