The U.S. Navy is furious that the federal Food & Drug Administration repeatedly spiked clinical trials of Biopure Corp.‘s Hemopure blood substitute, according to an internal Navy report obtained by The Boston Globe.
The Navy wants to examine whether Hemopure can be used on the battlefield to treat combat injuries when blood transfusions aren’t available.
But the federal watchdog agency spent the last four years rejecting efforts by the Cambrideg biotech firm and the Navy to initiate clinical trials of the product.
A scathing March 13 report by a director at the Navy Medical Research Center and 13 academic co-authors calls the reviews behind those decisions “faulty,” according to The Globe: “The reviews had consistent patterns of erroneous, misleading, and anecdotal statements, reporting bias, changing requirements, no ‘sense of urgency,'” and conflicts of interest, the newspaper reported.
An FDA spokeswoman told the newspaper that the department is aware of the need for products to help military and civilian trauma patients but must balance that need with making sure clinical trials don’t put patients at risk.
“There have been significant safety concerns raised about this class of products,” FDA spokewoman Karen Riley said, citing studies linking the products to toxic effects and heart and kidney damage.
Last month, the Navy asked the FDA to reconsider and allow clinical trials to proceed.
One of the internal report’s co-authors told The Globe that the FDA’s safety concerns aren’t valid, because the patients tested with Hemopure in the proposed trial would likely die anyway.
“There is a huge need,” Lewis Kaplan, associate professor of trauma surgery at the Yale School of Medicine in New Haven, told the newspaper, adding the agency’s resistance baffles him.
Another co-author said the agency’s intransigence is frustrating because of the number of people who bleed to death on the way to hospitals.
“If we can get a blood substitute, it would make all the difference in the world,” Joseph Acker, executive director of Birmingham Regional Emergency Medical Services System in Birmingham, Ala., told The Globe. “It would probably save more lives than anything we could do in EMS.”