Nearly 100,000 people die from bleeding injuries in the United States each year, according to the Associated Press. A new product, PolyHeme, which began testing in Denver about a month ago, may save many of these lives. But even though this blood substitute could end up being a remarkably useful invention, the manner in which it is being tested is cause for concern as emergency patients are being administered the untested product without their consent.
The artificial blood, which is compatible with any blood type, “could revolutionize how we take care of resuscitation in the United States and across the world,” according to head investigator Dr. Ernest Moore, chief of trauma surgery at Denver Health Medical Center. But such studies carry a significant risk.
In 1998, a similar study was halted because more than 20 patients died due to allergic reactions after receiving experimental blood transfusions. These patients gave no consent for this product to be used by paramedics or doctors in attempts to save their lives.
The PolyHeme study is not hiding any information from potential patients. However, patients who are bleeding severely are quite often in shock and unable to consent to experimental treatment. Researchers are allowed to bypass the rules of consent under a 1996 federal exemption, which applies to emergency, potentially lifesaving research, according to the AP.
The exemption requires that the research be publicized beforehand in all communities where the product will be used. This allows people to determine on whether they want the product to be used on them. Also, it provides community members with the opportunity to express any objections they might have. Such a policy is commendable but does not equate to implicit consent.
Until testing on this product, which has a longer shelf life than human blood, is concluded satisfactorily, a system comparable to the one used to consent to organ donation should be implemented. Without this, artificial blood should not be administered.
The research, which, according to the AP, doctors consider part of the race to find the Holy Grail of emergency medicine, is underway in more cities than just Denver. University of Texas Medical School in Houston; Loyola University Medical Center in Maywood, Ill.; Mayo Clinic in Rochester, Minn.; and Regional Medical Center in Memphis, Tenn., are only a few of the other participating hospitals.
As Moore stated, few people in Denver have declined participating in the study. Therefore, there is reason to test the product on a consensual basis.