DEATHS REPORTED AMONG PATIENTS GIVEN NORTHFIELD'S BLOOD SUBSTITUTE

Northfield Laboratories reported preliminary results from a Phase III clinical trial of its blood substitute, PolyHeme, which showed more deaths among patients using the product than in the control group. The company said that most of the excess deaths appeared to be among people who should not have been in the trial under the protocol anyway.

However, this appeared to be the latest setback to efforts to develop a viable blood substitute that can be given to patients in need of blood transfusions when the real thing is unavailable or unusable. Last week the FDA's Blood Products Advisory Committee voted to recommend against lifting the clinical hold on the Navy's proposed Phase III clinical trial of Biopure's blood substitute, Hemopure.

According to Northfield, 46 of the 349 people receiving PolyHeme died, compared with 35 of 363 in the control group. However, some 20 percent of the PolyHeme group, or 70 patients, and 15 percent of the control group, or 56 patients, should have been excluded under the protocol, Northfield said. If these are left out of the results, there were 30 deaths (10.8 percent) in the PolyHeme group and 28 deaths (9.1 percent) in the control group. Moreover, the company said, all these results are preliminary because of two discrepancies over dates of patient deaths. Therefore, the company will have to unlock and correct the database before submitting the final results to the FDA.

The study is being conducted for Northfield by a contract research organization (CRO), which submitted the preliminary data to the company Dec. 14. Northfield said it notified the CRO about the discrepancies and the latter "agreed that these data points were inaccurate."