How much did patients gain? Again, he ducked. Before and after the procedure, he said, patients were evaluated by three doctors, according to standard protocols, for movement, for control of the anal sphincter, and for sensitivity to touch and pinprick. Did any patients have adverse reactions? “Ah, a very complicated question.” But then, “In actual score, no patient got worse.” But the degree of improvement? These patients are in bad shape, he said. “Any improvement is a bonus.” Any complete cures? “I don’t think it is possible to cure this disease.” Even when progress is minimal and gradual, Huang said, it is valuable. “Complete chronic injury, no chance to get 100 percent.”
Critics in the United States have suggested that any patient with spinal-cord injury or, for that matter, ALS who comes to a medical center for some major procedure will probably get a variety of other treatments at the time, and this by itself might provoke temporary improvement. Did patients at Chaoyang Hospital get other treatment as well – such as physical therapy or other rehabilitative help? “No,” Huang said. Physical therapy is not routine in China. “They go home.”
What about follow-up? “They start to improve in two or three days. Then we follow them in two to four weeks. Then another follow-up three to six months.” But what about the longer term? Again, critics have held that patients ought to be tracked for at least two years. Huang hesitated. Then, “Chinese patients very poor. They go home.” He said he could not get in touch with them again.
Had Huang tried to publish other papers, and in peer-reviewed Western journals? Several, he said, but so far no response. He was collaborating on a paper with Guest and Qian from the Miami Project. During their visit to China, Huang said, “They evaluated one patient” before and after surgery. “Totally paralyzed. After surgery, can do this, can do this” – he was making small finger and hand motions. How quick was the recovery? “Second day after, Dr. Guest and Dr. Qian saw some difference.” What could possibly be the mechanism for change that soon? “In front of all eyes, we saw some change, even though they know we couldn’t explain it.” In mid-October, Guest sent the completed case report to Huang, but a month later Huang still had not found time to look at it.
Huang told me that hospital policy prohibited my watching the surgery. Guest and Qian during their visit examined 12 spinal-injury patients. They formally assessed six of them before and after and indeed observed four operations. They acknowledge that some of the patients demonstrated a degree of modest improvement in motor and sensory function – and that the improvement occurred surprisingly soon. However, two patients showed “wound breakdown,” one of them suffering “a reduction in leg function.” A third patient came down with meningitis. “The Chinese clinicians did not record these complications in the medical record,” asserts an unpublished report by the Miami Project. Although Guest and Qian did watch surgery and observe patients, they were not allowed into the laboratory where the cells for transplantation were prepared and had no way to know the content of the putative human fetal olfactory-bulb cultures – not even whether the material transplanted actually contained ensheathing cells. Guest adds, “We did see one set of cultures that showed robust cell growth and morphology that could be ensheathing glia. They were very healthy cultures. We viewed them in Dr. Huang’s clinical office.” The chief problem they saw, however, was the lack of long-term follow-up, including full records of any adverse effects.
To me, the most disturbing sign was Huang’s evasiveness. He pleaded repeatedly that patients needed to be treated: “These are suffering, dying people. I am a surgeon. The first thing is to save lives and alleviate suffering.” Though this sentiment may be genuine in Huang’s case, such evasions are a classic mark of the charlatan. Alternatively, he asserted that important types of controls (for example, surgery that mimicked the operation but injected not cells but salt water) would be dangerous and unethical. He insisted repeatedly that the procedure is safe.
Huang’s methodology is a moving target: from work with spinal-cord lesions to ALS, from injections into the spinal cord to injections into brain tissue. Critics have demanded that the procedure involve a fixed quantity of injected cells, one or a few standard points of injection, and significant blinded controls, and that evaluation follow a standardized protocol, including, for example, rigorous pre- and postoperative physiological tests that measure such properties as breathing, muscle tone, and strength.