Blood Product Trial Had Disproportionate Amount Of Minority Subjects
Thirteen ofthe 20 cities in which a clinical trial was conducted for an artificial bloodsubstitute had minority populations greater than that of the nation as a whole,according to records obtained by the Detroit Free Press.
The blood substitute Polyheme, manufactured by Northfield Laboratories, is made by extracting hemoglobinfrom human red blood cells. The trial was designed to test whether the productcould be used to replace the traditional treatment -- saline solutions andblood transfusions -- in the event of a blood shortage. For the study, Northfield examined theeffects of the blood substitute on trauma patients who were unconscious andtherefore unable to give consent. Researchers gave 349 subjects transfusions ofPolyheme, 46 of whom died. Among 363 enrollees given the traditional treatmentof saline solution and blood, 35 died.
One city in which the trial was held, Maywood, Ill., is 83% black. In addition,15 of the 16 participants in Detroitwere minorities. Urban areas with large minority populations have more traumacases and therefore might be the most suitable locales to conduct traumaresearch, according to bioethicist Harriet Washington. However, civil rightsgroups and bioethicists also note that researchers are ethically obligated tostudy a representative sample of the country because the product being testedis intended for use in the entire population.
The Rev. Charles Williams, president of the National Council for Community Empowerment, said, "We are anAfrican-American community that has been treated like guinea pigs."
Northfield declinedto comment on the claims. The drug maker in September said it would seek FDA approvalof Polyheme (Neavling, Detroit Free Press, 12/21).
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