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PolyHeme subjects suffer 13 percent death rate

"A new hope for saving of lives"

PolyHeme, that controversial blood substitute deployed in some of the city's poorest neighborhoods during trials conducted by UCSD three years ago, has come a cropper. Evanston, Illinois-based Northfield Laboratories announced on May 23 that of the 349 subjects given PolyHeme during the nationwide trial, 13.2 percent died, compared with a death rate of 9.9 percent for the 365 control subjects, who received standard saline solution from paramedics and whole blood when they arrived at the emergency room. In real numbers, 46 subjects treated with PolyHeme died compared to 36 in the control group, Northfield reported. Though Northfield denies it, critics claim that the dismal results are the beginning of the end for PolyHeme, the brainchild of Dr. Steven Gould, who founded Northfield more than 20 years ago solely to develop and market the blood substitute. "The last thing you would want in a drug is to make people worse than they would have been with standard treatment," Dr. Sidney Wolfe, head of a health research group for Public Citizen, the Ralph Nader-founded advocacy organization, told a reporter.

Northfield got an exemption from the federal Food and Drug Administration to test PolyHeme on comatose trauma victims unable to give their permission to participate in the study; the FDA required medical centers running the test to inform the public fully about what was going on. But in the city of San Diego, researchers quietly deployed plastic bags of the blood substitute on paramedic trucks -- Oak Park's Medic 26, San Ysidro's Medic 29, and Nestor's Medic 62 -- as well as at the downtown fire station, without telling the public about the locations or possible risks. Instead, upbeat pieces ran on TV news and in the Union-Tribune, featuring Dr. David Hoyt, then trauma director at UCSD Medical Center, hyping the study. In the March 23, 2004 U-T story, headlined "A new hope for saving of lives," Hoyt was quoted as saying, "These are people who are facing death in a few hours. Giving them this blood substitute might just save them when conventional treatment wouldn't."

Despite the negative results, Northfield's Gould said he would continue the company's uphill effort to get PolyHeme approved by the FDA. On May 23, Northfield stock fell 55 percent, from $4.25 a share to $1.90. There was no word on whether anybody in San Diego died as a result of the trial.

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PolyHeme, that controversial blood substitute deployed in some of the city's poorest neighborhoods during trials conducted by UCSD three years ago, has come a cropper. Evanston, Illinois-based Northfield Laboratories announced on May 23 that of the 349 subjects given PolyHeme during the nationwide trial, 13.2 percent died, compared with a death rate of 9.9 percent for the 365 control subjects, who received standard saline solution from paramedics and whole blood when they arrived at the emergency room. In real numbers, 46 subjects treated with PolyHeme died compared to 36 in the control group, Northfield reported. Though Northfield denies it, critics claim that the dismal results are the beginning of the end for PolyHeme, the brainchild of Dr. Steven Gould, who founded Northfield more than 20 years ago solely to develop and market the blood substitute. "The last thing you would want in a drug is to make people worse than they would have been with standard treatment," Dr. Sidney Wolfe, head of a health research group for Public Citizen, the Ralph Nader-founded advocacy organization, told a reporter.

Northfield got an exemption from the federal Food and Drug Administration to test PolyHeme on comatose trauma victims unable to give their permission to participate in the study; the FDA required medical centers running the test to inform the public fully about what was going on. But in the city of San Diego, researchers quietly deployed plastic bags of the blood substitute on paramedic trucks -- Oak Park's Medic 26, San Ysidro's Medic 29, and Nestor's Medic 62 -- as well as at the downtown fire station, without telling the public about the locations or possible risks. Instead, upbeat pieces ran on TV news and in the Union-Tribune, featuring Dr. David Hoyt, then trauma director at UCSD Medical Center, hyping the study. In the March 23, 2004 U-T story, headlined "A new hope for saving of lives," Hoyt was quoted as saying, "These are people who are facing death in a few hours. Giving them this blood substitute might just save them when conventional treatment wouldn't."

Despite the negative results, Northfield's Gould said he would continue the company's uphill effort to get PolyHeme approved by the FDA. On May 23, Northfield stock fell 55 percent, from $4.25 a share to $1.90. There was no word on whether anybody in San Diego died as a result of the trial.

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