Sunday, December 19, 2004
He has to gasp before attempting to string together short staccato words to form the simplest of sentences, explaining that he is not going to China in search of a miracle cure.
He has no illusions of rising from his wheelchair once the fetal cells are inserted through a long needle after a small hole is drilled in his forehead.
Instead he is hopeful the injection of millions of olfactory cells harvested from the nose of an aborted fetus will somehow help his own body regain control of weakened muscles or at least slow the disease.
``We know I can't wait,'' he said. ``I know this is not a sure thing. But I have to try it.
``If I come back halfway better, it will be the best Christmas present I could ever have."
The article makes much of the man's Catholicism, even including a close-up picture of his rosary hanging from his wheelchair:
There was a time when these devout Catholics would have bristled at such a procedure, but that was before the reality of his illness became clear.
Having been reared in Cleveland-area Catholic schools, Winchester still believes abortion is wrong.
But given that the Chinese government encourages abortion, he says, the fetal cells necessary for this particular procedure are readily available there.
Does that mean it would also be acceptable to get organs from executed Chinese?
You can't blame the family for their desperation, but it's hard not to look askance at the middleman who has been supplying the patients for the Chinese surgeon - for a fee:
The couple turned to a retired art dealer from Dodgeville, Wis., who has become the arranger of such trips for the Chinese doctor, neurosurgeon Huang Hongyun.
Stephen Byer -- who says his adult son underwent the treatment and has seen his ALS stabilize -- helps schedule Huang's foreign patients and collects a fee for the $20,000 procedure.
Some medical experts in this country remain skeptical of the treatment because the Rutgers-trained Huang has never conducted clinical studies.
But that said, Byer noted, there are still more than enough people willing to give it a try. He said there are currently 1,200 patients lined up to travel to China through February 2006.
As for the Chinese neurosurgeon, his work also seems a little fishy:
Huang Hongyun, a mild-mannered 48-year-old doctor, gives hope to thousands of paralyzed or degenerating patients around the world. His results are often lauded as miraculous. His surgery schedule is booked for the next 12 months, with more than 1,000 patients -- including some from Canada -- eagerly awaiting their chance to fly to Beijing for his treatment.
Yet the world's top medical journals won't publish his studies. Many Western neurologists have criticized his techniques. And he is unwilling to submit to a randomized trial of his methods.
'I've sent papers to more than five journals, but they are always rejected,' Dr. Huang says indignantly. 'I'm angry about this. I believe it is unfair for editors to do this. If I was American, they would publish it. But I am Chinese, so they don't publish it.'
One of the most controversial aspects of his surgery is the source of the cells he injects into the spines and brains of his patients. They are taken from four-month-old human fetuses -- among the millions aborted every year in China. In each operation, the patient is injected with at least a million cells harvested from olfactory bulbs inside the noses of the fetuses.
Why would he need to use the olfactory cells of sixteen week old fetuses when olfactory cells are readily available from adults? And using the patient's own cells eliminates any concern about tissue rejection, which is a problem with fetal cells. You have to wonder if he's really injecting anyone with anything.
His only published study appeared in the Chinese Medical Journal and went like this:
The surgical procedure, which the paper described in detail, is essentially to perform a laminectomy at the site of the damage, open the dura, and inject ensheathing cells....He then injects 50 microliters of a cell suspension, approximately half a million cells, into the spinal cord, next to the ends of the lesion.
Before the operation, patients were assessed for degree of paralysis and for sensitivity to light touch and to pinpricks, following an international standard. They were reassessed between two and eight weeks later. The paper claimed that patients made significant if relatively slight improvement in these measures. However, the data are scanty and impossible to evaluate reliably. The subjects are grouped by age but not differentiated further, not even, say, into male and female. The paper describes no individual cases. It offers no before and after scores, just degrees of improvement, and these as averages within each age group. It says nothing about possible deleterious effects, not even that there were none. It reports no long-term outcomes.
The author of the Technology Review article attended a lecture by Huang and was less than impressed:
The title of his talk was “Olfactory Ensheathing Cell Transplantation for Amyotrophic Lateral Sclerosis.” ALS is the devastating nerve disorder better known as Lou Gehrig’s disease. (The accounts in the Scientist, Time Asia, and the Chicago Tribune had mentioned Huang’s turn to ALS.) Huang offered some minimal PowerPoint slides. His summary claim, at beginning and end: “OEC transplantation is safe, feasible, and rapidly improves partial func-tion. Results are observable in two or three days, and improvement continues for two to three months. The mechanism is unclear.” However, his data were shockingly thin—indeed, insultingly so, I came to think. He finished up with half a dozen brief, blurry before-and-after videos of six of what he said had been a set of eight ALS patients, newly able to walk, or to stand, or to sit up, or to move the tongue enough to talk, if indistinctly. Each was followed by charts depicting nerve function before and after the transplant surgery.
His audience treated him with caution and courtesy, while its skepticism and impatience steadily increased. Much of the simplest factual information—pre-data, one might call it—was missing. Halfway through the question period, I asked several questions. When did his work with ALS patients begin? January 2003, he answered. But the videos carried dates, and these were as recent as mid-August 2004, just three weeks earlier. How many patients had he treated? He gave no clear answer; after follow-up questions from others, the likely number seemed to be 10 or 11—until he said there had been “about 40.” Did they all get fetal cells? No answer.
As the questioning went on, problems with Huang’s methodology seemed to emerge, chiefly the lack of rigorous pre- and postoperative evaluation of patients’ functioning, the lack of controls, and, above all, the total absence of follow-up beyond a few months.
Two physicians from Miami went to China to observe his technique, and also noted problems:
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 labo-ratory 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.
And apparently, there are even worse potential complications:
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.
It's too late for the man in my newspaper. His flight already left for China. Will the newspaper let us know how he's doing in a few weeks, six months or a year from now?
posted by Sydney on 12/19/2004 09:35:00 PM 0 comments