Bleeding to Death: The Price of Doing Business.
In a startlingly accurate description of the reason for business failure, today’s Boston Globe reports on the demise of Biopure, a Massachusetts biotech company working on a substitute for human blood. The article reports that the company “could never clear regulatory hurdles that would have turned the substitute into a mainstream medical product.”Hemopure showed many benefits compared with real blood: a three-year shelf life, the ability to be used by patients of any blood type, and freedom from diseases and pathogens that could be transmitted by human blood.I’m glad the FDA was on the case because without their power to stop experimentation with the substitute, we may have been unsafe or had some other concerns.
The path to Food and Drug Administration approval, however, was rocky. Although the Navy was interested in using the experimental product to treat military personnel wounded in battle, the FDA consistently rejected efforts by Biopure and the Navy to test it in clinical trials, citing safety worries and other concerns. [emphasis mine]
Now we can all just sit here and safely bleed to death without concern.
Tuesday, August 25, 2009
"Safety" gone too far
When I read this latest post at 3 Ring Binder, it made me shudder and then feel terribly discouraged. But, sometimes, now matter how horrible it is, it is a mistake to look the other way.