1. Discuss the environmental forces acting on these companies. What are Northfield’s and Biopure’s responsibilities and possible reactions to these environmental forces?
2. Is it ethical for these companies to continue clinical trials in this case?
Since the mid-1990s, companies such as Northfield Laboratories and Biopure have been testing blood substitutes in hopes of attaining approval by the U.S. Food and Drug Administration (FDA). Blood substitutes are oxygen-carrying products designed to replace donated human blood. Unlike human donor blood, these products can be stored without refrigeration for long periods and don’t have to be crossed-matched with a patient’s blood. These characteristics offer significant advantages in battlefield and trauma applications. However, clinical trials indicate that using blood substitutes results in a 30 percent death risk increase and nearly as high of a risk of having a heart attack, leading some to criticize the FDA for allowing continued clinical trials. A recent study published in the Journal of the American Medical Association faulted the FDA for not conducting prompt analysis of previous studies and claimed that the risks of using blood substitutes were evident as early as 2000. The FDA claimed it was aware of these risks but deemed some products worthy of further research. Some critics are pushing for more stringent legislation governing product testing, particularly if there are potentially significant health risks.