A study testing a blood substitute called PolyHeme, which was previously criticized as unethical, has now been taken to tinquire along with other artificial-blood research for causing unnecessary deaths.
The clinical trials, many of which were reported late or not at all in peer-reviewed journals, have now been analyzed together to show that patients who received the experimental treatments were 30 percent more likely to die, and were almost three times as likely to have heart attacks. The analysis was published online today in The Journal of the American Medical Society.
In 16 trials involving 3,711 patients, some received a transfusion of one of five different blood substitutes. Among those who received an experimental treatment, 164 patients died, while 123 died among those who did not get transfusions of artificial blood. Fifty-nine patients who received experimental transfusions had heart attacks, versus 16 in the control groups.
The researchers who performed the analysis were from the National Institutes of Health and Public Citizen, a consumer-advocacy group.
They said that if disclosure of the results of all clinical trials of experimental drugs had been required, lives would have been saved. The authors singled out three trials of PolyHeme for particular criticism because none of the results have been published. —Lila Guterman