Monday, June 19, 2006

Chinese Surgeon's Claims about Cell Implants Disputed

By Gareth Cook, Boston Globe

For many patients with spinal cord injuries and other incurable maladies, Dr. Hongyun Huang has been the great hope.

Hundreds of patients from across the United States and around the world have flocked to his Beijing surgery practice, where Huang implants cells with what he says are amazing healing powers. Huang's fees can reach into the tens of thousands of dollars, but, he has said, these cells can help patients who cannot be helped with any other modern medicine. Patients have come forward to say that Huang has helped them, inspiring stories in American and British newspapers about a Chinese doctor who has maybe, just maybe, stumbled upon a modern scientific miracle.

Now a team of doctors has finished the first independent, scientifically rigorous assessment of Huang's work. The results, published in the journal Neurorehabilitation and Neural Repair , are not just disappointing, they are disturbing, say scientists who have read the paper.

Of seven spinal cord injury patients the doctors followed, none experienced significant improvements, and five suffered potentially dangerous complications. One man who went to Beijing with damage to his spinal cord returned with holes drilled in his head -- apparently Huang had placed cells in the man's brain, not his spinal cord.

"This is extremely damning of Dr. Huang's work," said Dr. Kevin C. O'Connor , medical director of the spinal cord injury program at the Spaulding Rehabilitation Hospital, who was not involved in the study. "It is pretty scary stuff."

In an e-mail exchange, Huang refused to answer direct questions, but he accused the study's three authors, all leading spinal injury doctors, of being liars.

Huang's treatments are part of a seismic shift in alternative therapies. There have always been clinics that cater to desperate patients, offering them unproven, often expensive, treatments, from shark cartilage to vitamin supplements. But the boom in stem cell science and the hype surrounding it have brought an explosion of clinics around the world that offer therapies based on living cells. Huang's therapy, though not based on stem cells, uses cells from aborted fetuses that he says have regenerative power, the way stem cells do.

For years, scientists and doctors have been trying to make sense of Huang's work. Huang is a neurosurgeon, and he did research on the biology of fetal cells at Rutgers University and New York University before returning to China. Until now, however, there has never been a rigorous study of his treatments, with outside doctors carefully examining patients before and after -- considered a crucial test of any medical procedure.

In 2004, Huang was invited to explain his work to a group of Boston doctors, but it was impossible to draw any conclusions from his presentation because he had not gathered enough data, according to Lucie Bruijn , who was at the meeting and is the science director and vice president of the ALS Association , which funds research into the fatal, neurodegenerative illness also known as Lou Gehrig's disease. Huang has treated patients with ALS as well as patients with spinal cord injury.

Huang says he injects his patients with "olfactory ensheathing cells." These cells are thought to help nerves repair themselves by releasing growth factors. The cells have been shown to repair nerves in animals, but there is no evidence they help people.

Working at Chaoyang and West Hills (Xishan) hospitals, Huang's team extracts these cells from aborted fetuses and then opens up a hole in the patient's brain or spinal cord, injecting the cells. In presentations at scientific conferences, he has said he has helped many patients and has seen no serious side effects.

Dr. Bruce H. Dobkin , one of the authors of the study, said that he approached Huang after hearing a presentation at a Vancouver scientific conference. Huang began referring patients to Dobkin, who is medical director of the Neurologic Rehabilitation and Research Program at the University of California, Los Angeles, so that he could conduct extensive evaluations of the patients before and after the Beijing procedure. Two other doctors did the same thing: Dr. James Guest , of the Miami Project to Cure Paralysis and the University of Miami Miller School of Medicine , and Dr. Armin Curt , of Balgrist University Hospital in Zurich and the University of British Columbia in Canada.

For the evaluations of patients' before-and-after treatment, the team used a standardized test, known as ASIA , which scores patients' ability to move and feel. Patients and their caretakers noted minor ways in which they thought the patients had improved, but the scoring showed that there were no meaningful improvements in any of the patients after the surgery. The ASIA test is widely used and is accurate, according to O'Connor.

Dobkin, who is also editor in chief of the journal that published the results, said that he attributes the improvements the patients noted to the power of the placebo effect, compounded by the pressure they feel to improve, having just spent what is reported to be more than $20,000 on the surgery.

Patients with spinal cord injuries or ALS, Dobkin said, are in a difficult position because modern medicine cannot cure them. But he said he fears that patients are not properly considering the risks that the procedure will worsen their condition. One patient, Dobkin said, was able to walk but wanted help with a bladder problem, and Huang drilled a hole near her neck, exposing the spinal cord for an injection of cells.

"It is just nonsense," Dobkin said. "That he would even agree to do this is really frightening to me."

Dobkin said the patients suffered side effects that included meningitis, which is a dangerous inflammation of the tissue around the spinal cord or brain, as well pneumonia and gastrointestinal bleeding. Such side effects in a patient who is already quite sick can set off a cascade of medical problems, Dobkin said.

Huang's website includes profiles of patients he has treated for a wide variety of conditions. The conditions have different causes and different symptoms, yet Huang treats them all with the same cells.

Without independent, long-term evaluations of his patients, it is impossible to know how they are faring, or what difference -- for better or ill -- the treatments make. Without this information, there is no way that patients can balance the true risks and potential benefits. And, Dobkin and others said, there is no way to learn anything from what Huang is doing with his human guinea pigs.