A "NO-CONSENT" MEDICAL STUDY of an experimental blood substitute is creating an uproar among researchers and bioethicists. Controversy over the study, which is under way at 31 hospitals across the nation, is pulling back the curtain on similar studies ready to be launched under President Bush's "war on terrorism" as well as Project Bioshield, an ambitious plan to protect citizens against chemical, biological, radiological, or nuclear attacks through the development of commercial products, such as vaccines for anthrax and smallpox, and the development of blood substitutes.
Bush signed Bioshield into law on July 21, 2004, authorizing $5.6 billion for the project. One Bioshield recipient, Northfield Laboratories, a small biotech company in Illinois, received $4.9 million, administered by the U.S. Army, in the past two fiscal years to develop PolyHeme, the fake blood at the center of the controversy.
The Defense Department has spent decades and millions of dollars in pursuit of the Holy Grail of trauma medicine: a blood substitute that doesn't have to be refrigerated (battlefield conditions don't allow that) and that doesn't have to be matched by blood type (a process that can take more than an hour). Despite initial enthusiasm for several products, most have had to be abandoned when dangerous side effects, such as strokes and heart attacks, emerged.
Despite decades of development, PolyHeme has failed to win Food and Drug Administration (FDA) approval. But the FDA did approve the current study, which was launched in 2003. If this study is positive, Northfield stands a shot at winning the FDA approval necessary to market PolyHeme commercially.
Should this happen, one of Northfield's first customers will likely be the Army, with which Northfield says it has had stepped-up dialogue since the U.S. invasion of Afghanistan. However, PolyHeme isn't being tested on soldiers. It's being administered to civilians under a rarely used provision known as the "emergency research consent waiver." The provision, codified by the FDA in 1996, allows researchers to enroll patients, without their consent, for approved studies, in life-threatening circumstances when the patient is too ill to consent and a patient proxy or guardian can't be reached. The waiver is necessary, according to Northfield's Web site, since it "is expected that patients enrolled in this trial will be unable to provide informed consent because [of] the nature and extent of their injuries."
SO WHAT'S WRONG WITH THIS? FACED with bleeding to death, wouldn't most of us rather get experimental blood over nothing at all? And since many patients with severe blood loss are unconscious, doesn't it make sense to allow doctors to enroll us without our consent?
The answers to those questions are not quite straightforward. First, it appears that PolyHeme is being tested in the wrong population. The standard of care for acute blood loss in the United States is human blood. That means that no other product has been found to be as safe and effective as real blood--something the civilian population has ready access to in emergencies. Dr. Robert Solomon, chairman of the ethics committee of the American College of Emergency Physicians, says, "If you look at trauma units in the U.S., there really isn't a demand for blood substitutes." The American Red Cross agrees, saying, "We are unaware of any specific areas where trauma care is affected by a shortage of available blood."
Northfield says its product isn't meant to replace blood in hospitals, but is only intended for use on ambulances when no blood is available. However, most ambulance rides in urban areas, where the study is being carried out, last only minutes and once at the hospital, Type O blood, known as the "universal donor," can be given immediately. However, the study protocol allows PolyHeme to be given for up to 12 hours after arrival at the hospital in those patients who received the blood substitute during the ambulance ride. …