Unwitting patients given substance; rights groups irate

Steve Neavling
 

A controversial clinical trial in which hundreds of people were unknowingly injected with an experimental blood substitute primarily took place in cities with a disproportionate number of minorities.

Thirteen of the 20 cities have higher minority populations than the national average, including the small Illinois town of Maywood, where 83 percent of the population is black, and Detroit.

In Detroit, at Detroit Receiving and Sinai-Grace hospitals, minorities accounted for 15 of the 16 people unknowingly experimented on, records obtained by the Free Press show.
Since urban areas with large minority populations tend to see more trauma cases, it's often easier to target those areas for research, bioethicist Harriet Washington said. But bioethicists argue that the tendency to choose those areas over an abundance of trauma centers in predominately White cities is unfair.

Civil-rights groups and bioethicists contend researchers are ethically obligated to capture a representative sample of the country because the products being studied are designed to benefit everyone.

In the study meant to combat a critical blood shortage, 13 cities combined for an average minority population nearly twice the national average. The blood substitute, Polyheme, is made by extracting oxygen-carrying hemoglobin from human red blood cells. In the event of shortages, it would replace the traditional treatment, a saline solution and blood.

People who unknowingly participated in the trial were unconscious because of trauma, such as gunshot wounds and car crashes.

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

So far, studies have shown that recipients of the blood substitute faced higher health risks than those who received the traditional treatment. Results of the trial, released last year, showed 46 of the 349 subjects who received Polyheme nationwide died. By contrast, 35 of the 363 patients given the traditional treatment died. Two of the 10 people in Detroit injected with Polyheme died. Both were Black.

Martha Milete, who is Hispanic, received Polyheme while being rushed to the hospital after she was shot in the chest by an intruder in her Detroit home in January 2006. She said it's unfair that most subjects were minorities.

"Whether I survived or not, it was wrong," Milete said.

The two deaths contradict Wayne State University's statement in May that only one person who received Polyheme died. All six people given the standard treatment for replacing lost blood survived.

Officials at Evanston, Ill.-based Northfield Laboratories, which created the blood substitute, declined to comment. The company announced in September that it plans to submit its findings for regulatory approval to market the product.