杏吧原创

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WHEN Yang Gui-rong was taken to the Chengdu Army Kunming General Hospital more than a year ago, after an accident diving into a pool, he could move only his mouth and eyes and was struggling to breathe. Surgeons transplanted fetal cells into the injured spinal cord in Yang鈥檚 broken neck. With intensive rehabilitation, he slowly regained feeling and movement in his arms. Today, Yang is on the hospital鈥檚 wheelchair rugby team, which won a silver medal in the Chinese Games for the Disabled in May. 鈥淲e didn鈥檛 expect he would survive the surgery,鈥� says Shen Caihong, head nurse in the hospital鈥檚 spinal injuries centre. 鈥淣ow his progress is visible almost on a daily basis.鈥�

Yang is just one individual hit by an epidemic of spinal injuries in China that is a direct consequence of the nation鈥檚 economic development. Over the past decade, the rate of spinal cord injuries has increased roughly tenfold, largely due to the car crashes that have become common as the burgeoning middle class has taken to the wheel, plus numerous accidents in the nation鈥檚 booming construction and mining industries 鈥� which have terrible safety records.

鈥淲ith 60,000 new cases per year, China now has more patients with spinal cord injuries than anywhere else in the world,鈥� says Wise Young of Rutgers University in New Jersey. 鈥淭his means that new therapies can be tested more quickly and cheaply.鈥� To seize this opportunity 鈥� and hopefully in the long run to help patients like Yang 鈥� the Hong Kong-born neurologist has set up the China SCI Network, encompassing 22 centres across the country, with the aim of conducting clinical trials that meet the highest international standards.

That will be a tough task, however, as China has a poor record for conducting rigorous clinical research. What鈥檚 more, in the past few years some Chinese surgeons have become notorious for charging paralysed patients 鈥� both Chinese and 鈥渕edical tourists鈥� from abroad 鈥� thousands of dollars for experimental cell transplants that have not yet been shown to work. As New 杏吧原创 learned on a visit to one of China SCI鈥檚 showcase centres in Kunming, capital of Yunnan province in south-west China, they include some of the surgeons in Young鈥檚 own network.

If anyone can bring order to the clinical chaos then maybe Young can. In 1990, while at New York University, he led a landmark trial showing that a steroid called methylprednisolone can help recovery from spinal injury. Later he became famous as the doctor who treated Christopher Reeve. And today, he is excited about further improving patients鈥� prospects by using a combination of lithium pills and transplants of stem cells taken from umbilical cord blood. Widely used to treat mood disorders, lithium can also coax stem cells into producing a cocktail of factors that help damaged nerve cells to grow. In addition to making these growth factors, Young hopes that transplanted stem cells may serve as a 鈥渂ridge鈥� across severed spinal cords, helping nerve fibres to grow back.

In August 2008, Young aims to begin a trial of the therapy involving 440 patients, half of them paralysed during the previous year, the rest with older spinal injuries. But before it can begin, there is a huge amount of work to do. For example, the participating centres are now observing patients who will eventually take part in the trial, recording information about their ability to feel and move 鈥� essential for assessing the therapy鈥檚 potential benefits. At the same time, 20 patients at the Hong Kong University of Science and Technology are taking lithium alone. And in the coming months, further small studies will begin involving lithium alone, stem cell transplants, or both. Young is also negotiating with pharmaceutical firms to add a third component: drugs known to block molecules in the spinal cord that inhibit nerve growth.

Best practice?

The participating centres must also meet (GCP) international guidelines, which stipulate how clinical trials should be run, including procedures for informed consent and ethical review. This is no small task, as Chinese doctors have until recently paid scant attention to such niceties. So over the past two years, Young has concentrated on training China SCI鈥檚 staff.

Efforts to get the network鈥檚 centres certified for GCP with the state Food and Drug Administration have been hampered by scandals involving the agency. In July, its former head, Zheng Xiaoyu, was executed for corruption. For now, seven of the centres hold GCP status, and Young believes the rest will follow by next summer. 鈥淩egardless of the result of the clinical trial, it will be a significant achievement if we could demonstrate that it can be run in China,鈥� he says.

The Kunming centre, which New 杏吧原创 visited in late July, already has its GCP certification. There is an optimistic atmosphere, as patients with some mobility exercise in the ring-shaped corridor, while others in the rooms that lead from it practise fine movements with their fingers. Between rehabilitation sessions they are wheeled by their carers into the picturesque garden, which has lawns, a pond and a path that winds over bridges towards a pagoda.

Even here, however, the murkier side of Chinese medicine is not far beneath the surface. Shen, the head nurse, would only let me speak to Yang and one other patient. But later that evening the families of others at the hospital sought me out at my hotel. They were anxious to learn more about the therapies their loved ones had received, for which they had paid a small fortune.

In today鈥檚 China, patients must often pay for medical care out of their own pockets (see Chart) 鈥� and unlike in other countries with largely private-sector healthcare, medical insurance is not widely available.

The wife of one man whose neck was broken and his spinal cord crushed in a work accident was distraught, her family having paid more than $25,000 over the past six months: 鈥淗e hasn鈥檛 improved at all. We are running out of money.鈥� Relatives of other patients said they had paid up to $10,000 for the surgery itself and about $1250 per month for inpatient care. 鈥淭he doctors said that they will use the most advanced therapy from the US,鈥� one man told me, worried about his cousin with a broken back. 鈥淭hey said that it鈥檚 promising, but now we are not sure.鈥�

Patients usually expect to be charged for therapies that have been proved to work, not those that are still experimental. Like Yang, some of the patients were given transplants of fetal Schwann cells, which make the myelin that insulates healthy nerve fibres. Although researchers at the University of Miami have shown that Schwann cell transplants can help animals with spinal injuries, they have yet to start clinical trials. The Kunming centre, meanwhile, published its first results on a group of 53 patients in two Chinese journals earlier this year, claiming that they showed improved movement and sensation after eight weeks. Specialists in spinal injury say that is too soon after the surgery to draw any definite conclusions. 鈥淵ou would really need to go out beyond six months,鈥� says James Guest, also at the University of Miami, who questions the Kunming group鈥檚 failure to report any adverse events. 鈥淵ou can鈥檛 do 53 surgeries without complications,鈥� he argues.

Quizzed about the charges made to patients, one surgeon at the Kunming centre confirmed the families鈥� stories. But centre director Zhu Hui claims that any fees were for non-experimental aspects of the therapy. 鈥淭here is a big gap between what you heard and the reality,鈥� she told New 杏吧原创.

At least one other surgeon in the China SCI Network is definitely charging for experimental therapies. Huang Hongyun of the Beijing Xishan Hospital has treated hundreds of patients with fetal cells from the olfactory bulb, which links the nose to the brain. Western experts have complained about his failure to publish the results 鈥� and last year, when neurologists including Guest , they reported that none showed any significant improvement, while five had suffered complications, including meningitis.

Huang used to work in Young鈥檚 lab, and his former boss defends his inclusion in the network. 鈥淗uang genuinely believes in his treatment with all his heart and mind, and is trying very hard to improve it,鈥� Young says. 鈥淗e is the most experienced surgeon on cell transplantation in the world.鈥�

Young adds that his priority is to ensure that China SCI鈥檚 trials are conducted properly, not to police the activities of its members outside of these trials. 鈥淎s long as they don鈥檛 throw it into my face, I am not going to investigate,鈥� he says.

Some observers 鈥� both western and Chinese 鈥� are troubled by Young鈥檚 pragmatic attitude. 鈥淥ffering unproven therapies outside the network鈥檚 trials could harm its reputation and credibility,鈥� says Timothy Caulfield of the Health Law Institute at the University of Alberta in Edmonton, Canada. And Qiu Renzong, a bioethicist at the Institute of Philosophy of the Chinese Academy of Social Sciences in Beijing, is openly critical: 鈥淗ow could a doctor turn a blind eye to practices which exploit patients with devastating conditions?鈥�

Yang, for one, does not feel exploited. 鈥淚 will stand up one day,鈥� he says hopefully. But it is hard to tell whether the cell transplants he received have really made a difference, since people with spinal injuries sometimes improve spontaneously over time. If a miracle treatment for spinal injuries is to emerge from China, it will need to be backed up by hard evidence, not a series of glowing testimonies from carefully chosen patients.