FDA To Reconsider Decision on Blood Substitute
FDA next week will hold a closed-door hearing on whether to allow a clinical trial of the blood substitute Hemopure, made by Biopure, that would involve trauma patients who have not given informed consent, the Wall Street Journal reports. The U.S. Navy in 2004 proposed the study, which would involve more than 900 badly hemorrhaging accident victims.
Patients en route to hospitals would receive either Hemopure or saline solution. According to the Journal, such nonconsent studies are "rare but legal where federal regulators determine there's no practical way to obtain consent."
Two previous studies testing Hemopure on consenting surgery patients found that patients receiving Hemopure had a higher risk of strokes and other complications. FDA in July 2005 told the Navy that the study could not proceed "because subjects would be exposed to an unreasonable and significant risk of injury."
In a draft response, Biopure acknowledged to FDA there were more cases of cardiac arrest, fluid in the lungs and hypertension in patients receiving Hemopure.
The Navy, in documents submitted to FDA, has argued that a study of trauma patients would be significantly different from past studies on surgery patients. The Navy also has said that Hemopure could lower the death rate in trauma patients by 25% compared with patients who receive saline solution.
Donald Arthur, the Navy's Surgeon General Vice Admiral, said, "If we could replace saline with the thing that we need most, oxygen-carrying capacity, that would be the best. Our interest is in the field conditions where there is no blood."
A. Gerson Greenburg, Biopure's vice president for medical affairs, said the product "has an acceptable safety profile" and could serve "a societal good whereby you're saving (donor) blood for other people." Greenburg said many adverse events in past studies might not have been linked to Hemopure.
Daniel Freilich, the Navy's head of blood-substitute research, called FDA's decision to not allow the trial "not scientifically and clinically rigorous." The Navy also argued that FDA had allowed Biopure's competitor, Northfield Laboratories, to proceed with a nonconsent study of its own blood substitute.
Biopure CEO Zafiris Zafirelis in an October 2005 letter to Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, suggested that an FDA reviewer had not been objective with the decision on Hemopure and had a potential conflict of interest. Goodman responded in March, saying he had assigned three new high-ranking officials to make decisions related to Biopure, according to people familiar with the matter.
Next week's hearing was scheduled earlier this year.
In an "unusual step, the Navy, the sponsor of the proposed research, was able to recommend some doctors to be on the panel," the Journal reports. In addition, two "well-known skeptics" of blood substitutes have been "disinvited" to serve as consultants to the panel, according to the Journal.
Goodman and other FDA officials did not comment on the issue.
Navy officials declined to comment on why they are attempting to conduct a trial on a product with demonstrable risks, according to the Journal (Burton, Wall Street Journal, 7/6).