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WASHINGTON: A US Navy plan to study emergency transfusions using a blood substitute derived from cow blood faces review on Thursday by a federal advisory panel over whether the trial is safe enough to be conducted without patient consent.
The Naval Medical Research Center is seeking U.S. Food and Drug Administration approval to test Biopure Corp.'s Hemopure to treat hemorrhagic shock after traumatic injury outside of a hospital setting.
The Navy said in documents released on Wednesday that the attacks of Sept. 11, 2001, had highlighted the need to improve the ability to provide life-saving blood transfusions.
Unlike blood, Hemopure can be stored for long periods without refrigeration and can help deliver oxygen to vital organs when there are no alternatives, making it useful on ships at sea.
FDA staff reviewers said the Navy's revised plan includes restrictions that should make it safe, including limiting the amount of Hemopure used in a transfusion.
“There appears to be sufficient information provided to consider approval under waiver of consent,” one government reviewer wrote in the documents released ahead of the meeting.
The FDA is not bound by the advice of its expert panels but usually follows their recommendations.
Hemopure, also known as HBOC-201, is a key product for Biopure. It is already approved for sale in South Africa for anemic surgical patients and is awaiting approval decision in the United Kingdom for orthopedic surgical anemia.
FDA regulations allow clinical trials to be conducted without consent for patients with life-threatening conditions who are unconscious or otherwise unable to give permission.
Navy researchers proposed the study earlier this year, but reviewers for the FDA had safety concerns.
Some critics have challenged the FDA's consent rules in similar studies, questioning procedures for the public to opt out. Thursday's meeting was initially scheduled to be held earlier this year behind closed doors. The FDA later decided to hold it publicly, as it does with most other advisory panels.
Another company, Northfield Laboratories Inc, has also faced criticism for studies of its blood substitute, made from human hemoglobin. That product, called Polyheme, is not the subject of Thursday's meeting.
Shares of Biopure closed up three cents, or 5 percent, at 63 cents on the Nasdaq on Wednesday.
