China has become a headache to the US medical establishment. No its not tainted toys and trinkets or contaminated food products.
Its rather the† innovative stem cell treatments which remain unproven. Doctors warn that patients are serving as guinea pigs in a country that isn't doing the rigorous lab and human tests that are needed to prove a treatment is safe and effective.
Noting the lack of evidence, three Western doctors, undertook their own limited study. It involved seven patients with spinal cord injuries who chose to get fetal brain tissue injections at one hospital in China. The study reported "no clinically useful improvements" - even though most patients believed they were better. Five developed complications such as meningitis.
Experts in the West have theories about why some people think they've improved when the evidence is thin. Some are often getting intensive physical therapy, along with the mysterious injections; the placebo effect may also be a factor, reports news agency AP.
John Steeves, a professor at the University of British Columbia who heads an international group that monitors spinal cord treatments, has another theory. Some patients may be influenced by the amount of money they paid and the help they got from those who donated or helped raise money.
"Needless to say, when they come back, what are they going to report to their friends and neighbors? That it didn't work?" said Steeves. "Nobody wants to hear that."
He and other experts have written a booklet advising patients who are considering such treatments.
Western doctors discourage their patients from seeking such treatments. They note that it's impossible to gauge the safety and effectiveness of the treatments, or even know what's in the injections put into brains and spinal cords.
Patients and their families say they accept those risks. They simply don't have time to wait for more conclusive evidence. For many, the trip to China is a journey of hope.
"It's one of the only games in town," said Jim Savage, 44, a Houston lawyer, who suffered severe spinal cord injuries after a canoe trip 25 years ago.
Savage spent 2 1/2 months in late 2006 and early 2007 at a hospital in the southern China city of Shenzhen to get what he was told were stem cell injections in his spine from umbilical cord blood. He made the arrangements through Beike Biotechnology Co., which offers the treatments at a number of hospitals in China.
Afterward, Savage said he was able to move his right arm for the first time since his diving accident; a video made at the hospital appears to show slight movement. He also said he noticed greater strength in his abdomen and more sensation on his skin.
Just how many foreigners like Savage are coming to China for treatment isn't known.
With few options available at home in America, they search the Internet for experimental treatments - and often land on Web sites promoting stem cell treatments in China.
They mortgage their houses and their hometowns hold fundraisers as they scrape together the tens of thousands of dollars needed for travel and the hope for a miracle cure. A number of these medical tourists claim some success when they return home.
Chinese doctors themselves don't wait for results of rigorous testing before treating patients and they offer what they say are stem cell or other cell treatments to those willing to pay.
What is known about the procedures being performed comes from material on their Web sites or from patients who give detailed accounts of their visits. Little has been published in scientific journals for other doctors to scrutinize.
The use of stem cells for treatments isn't new. For decades, doctors around the world have been using adult stem cells from blood and bone marrow - and more recently from umbilical cord blood - to treat cancers of the blood like leukemia and lymphoma and blood diseases like sickle cell anemia.
Scientists have been exploring whether such adult stem cells and other cells such as those from the retina or fetal brain tissue could be used to replace cells lost because of injury or disease. And they are trying to figure out if there's a way to stimulate the body's own stem cells to make repairs.
But those strategies are still being investigated in the lab in animals; there have been very limited tests in people.
Whether any clinics in China are using the more controversial embryonic stem cells - doctors in some other countries claim to be - isn't clear. These stem cells are taken from days-old embryos. They can develop into all types of cells, but research into their usefulness is in early stages.
Patients seek out these unproven treatments after hearing about them from other patients, patient groups or Web sites for the medical companies. The patients' stories posted on the Internet usually tell of some kind of improvement from the treatments - slight movements in arms or legs, fewer spasms or tremors, a feeling of sensation, an ability to sweat.
Beike Technology founder Sean Hu, who returned from abroad in 1999 with a doctorate in biochemistry, said the company had treated more than 1,000 patients, including 300 foreigners from 40 different countries. The only side effects were† slight fevers and headaches among a small percentage of patients, according to Hu.
He said patients with trauma injuries experienced the most dramatic improvements; those with degenerative diseases such as ALS, also known as Lou Gehrig's disease, tended to improve initially but then slide back to their former condition within months.
"Patients shouldn't have their expectations too high," Hu said. "For patients to think they can walk again may be too much at this stage," he said.
He's now seeking venture capital to expand his web of treatment centers, labs and doctors and adapt proprietary techniques from researchers overseas.
"There is real potential here for China to take the lead in stem cells," Hu said.
Also offering treatments is Tiantan Puhua in Beijing, a joint venture between Asia's largest neurological hospital and an American medical group. Tiantan's sunny, sparkling rooms are a far cry from the dour facilities and staff at most Chinese hospitals. Diseases treated there range from stroke and spinal cord injuries to cerebral palsy and ataxia, a rare neurological condition that can cause slurred speech.
"We are making no promises," Dr. Sherwood Yang, head of the hospital's management team said. "It's impossible to say exactly how any given patient will respond."
However, he† contends that 90 percent of patients show some results, with the rest suffering disabilities that are too far advanced to respond to treatment.
Dr. Michael Okun, medical director of the National Parkinson Foundation in the US, said his group discouraged patients from seeking out experimental treatments unless they're being done under the most rigorous research protocols.
"Stem cell therapy is a really interesting area that has a lot of promise for therapeutic approaches. But we're just not ready to be putting stem cells into people's brains at this point in time," said Okun.