Study Casts Doubt On Local Lab’s Blood Substitute

Angela Chang

By Angela ChangThe Daily Northwestern

An Evanston biotechnology company has suffered setbacks in testing its emergency blood substitute and faces a rough road to obtaining approval from the Food and Drug Administration.

Northfield Laboratories, 1560 Sherman Ave., is in a lucrative race to develop a blood substitute that can be used in medical emergencies when blood or saline is not readily available. The product could be especially useful in combat situations.

Despite the potential profits, Northfield has created controversy with its testing methods. When the company tested its product PolyHeme last year, critics called the trial unethical.

The blood substitute was given to patients without their consent and while blood and saline were readily available.

Of the 712 patients used in the trial, 349 received PolyHeme while 363 were given either saline or donated blood. The preliminary results were released in December, showing that PolyHeme performed worse than standard treatments. About 13.2 percent of PolyHeme patients died compared to 9.6 percent in the control group.

Michele Mekel, the executive director of the Illinois Institute of Technology’s Institute on Biotechnology and the Human Future, said there were ethical questions surrounding the test.

“Perhaps a better design of the study would have been to put this substitute into place where there is a shortage of a blood type or where there is a question in regards to the safety of the blood supply,” Mekel said.

When it comes to situations where blood or saline is not readily available, giving a substitute would be more ethical than giving nothing at all, Mekel said.

Northfield’s chairman and CEO, Steven Gould, told the Chicago Tribune in December that the test results did not represent the full picture. Gould said some protocol violations were made with some treated patients. While it is unclear exactly what those violations were, one possibility is that paramedics chose to give PolyHeme to patients who were gravely ill rather than at random.

To add to the controversy, Northfield’s major competitor, Biopure Corp. in Cambridge, Mass., had a similar setback in December. An FDA advisory panel voted against testing Biopure’s product, Hemopure, on civilian trauma patients without consent, despite strong backing from the U.S. Navy.

Stocks for Northfield Labs fell more than 3 percent after the FDA panel’s ruling against Biopure’s test. The stock plummeted more than 50 percent after the release of the test results.

But Gould said the company has enough money to fund operations through 2008 and will continue developing PolyHeme. Northfield will await final results and seek FDA approval next year.

Reach Angela Chang at [email protected]