Blood Product Trial Had Disproportionate Amount Of Minority Subjects

Main Category: Clinical Trials / Drug Trials
Also Included In: Blood / Hematology
Article Date: 24 Dec 2007 - 5:00 PDT

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Thirteen of the 20 cities in which a clinical trial was conducted for an artificial blood substitute 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 hemoglobin from human red blood cells. The trial was designed to test whether the product could be used to replace the traditional treatment -- saline solutions and blood transfusions -- in the event of a blood shortage. For the study, Northfield examined the effects of the blood substitute on trauma patients who were unconscious and therefore unable to give consent. Researchers gave 349 subjects transfusions of Polyheme, 46 of whom died. Among 363 enrollees given the traditional treatment of 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 Detroit were minorities. Urban areas with large minority populations have more trauma cases and are therefore easier targets to conduct trauma research, according to bioethicist Harriet Washington. However, civil rights groups and bioethicists say that targetting those areas over predominantly white communities with trauma centers is unfair, and also note that researchers are ethically obligated to study a representative sample of the country because the product being tested is intended for use in the entire population.

The Rev. Charles Williams, president of the National Council for Community Empowerment, said, "We are an African-American community that has been treated like guinea pigs."

Northfield declined to comment on the claims. The drug maker in September said it would seek FDA approval of Polyheme (Neavling, Detroit Free Press, 12/21).

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