Despite the defects in Huang’s work, no definitive judgment is yet possible. Wise Young is a cautious advocate. He notes, “There are really no randomized clinical trials for any of the current neurosurgical procedures.” Regarding Huang’s work, “The big debate right now is, What is the level of evidence that’s necessary and sufficient to take something to clinical trial?” Meanwhile, though, when dealing with spinal-cord patients and their families, “My official recommendation is that they should wait. Many of them ignore me; they go on ahead to do it anyway.” Mary Bunge and her colleagues at the Miami Project find Huang’s claims frustrating. “Presently, Dr. Huang’s project by research standards in the United States is not a clinical trial but is a clinical treatment series. The treatment series does not meet the design standards for a clinical trial that would allow for definitive results to be obtained.” Yet they call for “independent and impartial assessment of the risks and benefits of this cell therapy.” Meanwhile, though, “Miami Project faculty do not endorse this procedure and at this time would not advise individuals to undergo this surgical transplantation strategy. While some people with SCI will view these current experimental procedures abroad as their only hope, by participating they may be putting themselves in harm’s way.”
The science of Dr. Huang Hongyun raises to our awareness this deep tension over standards of evidence and the ethics of clinical practice.
I saw Huang the afternoon of October 20, 2004. A correspondent from the Mobile, AL, Register, Karen Tolkkinen, was also in Beijing, Huang said; he was to treat several Americans with ALS that week, and one was from Alabama. That evening, he operated on Ronnie Abdinoor, a 47-year-old from New Hampshire. On October 29, Tolkkinen reported in the Register that Abdinoor had died.