Ethicists blast study testing fake blood

Kipnis said if the hospital phase can't be eliminated, the whole study should be suspended.

Some hospitalized patients inevitably will die because of their injuries, but they will have died "while being denied an available treatment (blood transfusions)," the authors wrote.

A separate journal essay by Duke University ethicist Karla FC Holloway says the study, in mostly urban hospitals, disproportionately exposes minorities to questionable science.

The trauma study was approved under a federal "informed consent" exemption that applies to emergency research. It requires community briefings in which residents can opt out -- in this case by getting plastic hospital-style bracelets in case they are injured and unconscious.

But King says community briefings have not made it clear that patients will get experimental treatment and not blood transfusions for several hours even while in the hospital. Many briefings also did not mention the previous Polyheme study, and withholding that information was unethical, the ethicists said.

King noted that in January, Northfield sued to keep a weekly San Diego newspaper from publishing information about the trauma study, arguing that publication would unfairly reveal trade secrets.

"So much about this trial is secret because the FDA doesn't release information to the public about products that are being developed by commercial sponsors," King said.

Gould dismissed concerns about ethics and secrecy and said periodic reviews by an independent monitor have deemed the trauma study fit to proceed.

A Northfield spokeswoman said a survey of 12 study sites found that more than 2,000 people had requested "opt out" bracelets, mostly for religious reasons. Also, 11 of the 600-plus patients dropped out during the study's hospital phase, she said.

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