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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’s broken neck. With intensive rehabilitation, he slowly regained feeling and movement in his arms. Today, Yang is on the hospital’s wheelchair rugby team, which won a silver medal in the Chinese Games for the Disabled in May. “We didn’t expect he would survive the surgery,” says Shen Caihong, head nurse in the hospital’s spinal injuries centre. “Now his progress is visible almost on a daily basis.”
Yang is just one individual hit by an epidemic of spinal injuries in China that is a direct consequence of the nation’s 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’s booming construction and mining industries – which have terrible safety records.
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“With 60,000 new cases per year, China now has more patients with spinal cord injuries than anywhere else in the world,” says Wise Young of Rutgers University in New Jersey. “This means that new therapies can be tested more quickly and cheaply.” To seize this opportunity – and hopefully in the long run to help patients like Yang – 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’s more, in the past few years some Chinese surgeons have become notorious for charging paralysed patients – both Chinese and “medical tourists” from abroad – thousands of dollars for experimental cell transplants that have not yet been shown to work. As żěè¶ĚĘÓƵ learned on a visit to one of China SCI’s showcase centres in Kunming, capital of Yunnan province in south-west China, they include some of the surgeons in Young’s 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’ 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 “bridge” 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 – essential for assessing the therapy’s 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’s staff.
Efforts to get the network’s 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. “Regardless of the result of the clinical trial, it will be a significant achievement if we could demonstrate that it can be run in China,” he says.
The Kunming centre, which żěè¶ĚĘÓƵ 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’s China, patients must often pay for medical care out of their own pockets (see Chart) – 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: “He hasn’t improved at all. We are running out of money.” Relatives of other patients said they had paid up to $10,000 for the surgery itself and about $1250 per month for inpatient care. “The doctors said that they will use the most advanced therapy from the US,” one man told me, worried about his cousin with a broken back. “They said that it’s promising, but now we are not sure.”
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. “You would really need to go out beyond six months,” says James Guest, also at the University of Miami, who questions the Kunming group’s failure to report any adverse events. “You can’t do 53 surgeries without complications,” he argues.
Quizzed about the charges made to patients, one surgeon at the Kunming centre confirmed the families’ stories. But centre director Zhu Hui claims that any fees were for non-experimental aspects of the therapy. “There is a big gap between what you heard and the reality,” she told żěè¶ĚĘÓƵ.
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 – 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’s lab, and his former boss defends his inclusion in the network. “Huang genuinely believes in his treatment with all his heart and mind, and is trying very hard to improve it,” Young says. “He is the most experienced surgeon on cell transplantation in the world.”
Young adds that his priority is to ensure that China SCI’s trials are conducted properly, not to police the activities of its members outside of these trials. “As long as they don’t throw it into my face, I am not going to investigate,” he says.
Some observers – both western and Chinese – are troubled by Young’s pragmatic attitude. “Offering unproven therapies outside the network’s trials could harm its reputation and credibility,” 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: “How could a doctor turn a blind eye to practices which exploit patients with devastating conditions?”
Yang, for one, does not feel exploited. “I will stand up one day,” 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.
Culture clash
In April last year, Zhang Gongyao flew in the face of 5000 years of tradition. In the Chinese journal Medicine and Philosophy, he argued that traditional Chinese medicine (TCM) verges on a hoax, and called for it to be removed from the public health system within five years. It touched a nerve, sparking a fierce debate in the Chinese media and earning Zhang and his backers a .
TCM emphasises the balance and harmony of the human body. It takes a holistic approach to treatment, which takes into account a person’s symptoms and characteristics. Central to its practice are concepts such as yin and yang, primal and opposing forces within objects and processes, and the spiritual energy known as qi, which is said to flow through channels in the body, causing illness if blocked.
According to Zhang, a philosopher of science at the Central South University in Changsha, Hunan province, traditional treatment is just superstition. But TCM, which encompasses herbal remedies and acupuncture, has many adherents who were swift to launch a counter-attack in print, on TV and online. Even some of those who agree that its core concepts have no scientific basis suggested that Zhang had gone too far in calling for its abolition. Others, such as Fu Jinghua, a retired researcher with the China Academy of Chinese Medical Sciences in Beijing, argued that TCM deals with Tao – the way and order of the universe – and so cannot be evaluated scientifically.
That is just what the Chinese government now proposes to do, however. In March it announced a plan, backed by 16 Chinese ministries, to spend more than $130 million over the next five years on research into the effectiveness of TCM. That seems reasonable, says Edzard Ernst of the University of Exeter, UK, who studies complementary and alternative medicine: “It’s a matter of sorting the chaff from the grain.” But as the plan does not demand the gold standard of double-blind, randomised clinical trials, some scientists fear that evidence-based TCM will remain an elusive goal.
