Need for solid medical evidence

Scepticism will continue until back-up research appears in Western medical journals, says CLIFFORD COONAN in Beijing

Scepticism will continue until back-up research appears in Western medical journals, says CLIFFORD COONANin Beijing

SPINAL INJURY victims feeling tingling in their legs for the first time since their accidents; children with cerebral palsy showing signs of improved co-ordination and balance; people with epilepsy, autism, Parkinson’s, all reporting an improvement because of ground-breaking treatment using stem cell technology in Chinese clinics.

Parents from all over the world are flocking to Chinese clinics such as Beike Biotech in Shenzhen, to try what they are told is a revolutionary technology which can offer incredible therapies. They can go there because its researchers are not tied up with restrictive testing requirements and archaic, sometimes religious-based, ethical arguments.

The Chinese stem cell revolution sounds too good to be true, and for many medical professionals and researchers, especially in the West, it is. Are these doctors medical visionaries or snake-oil salesmen?

READ MORE

Sceptics see the Chinese doctors as charlatans cashing in on people’s fears and refusing to back up their use of the technology with viable research.

China’s relatively simple set of rules surrounding clinical trials and tests on consenting humans, combined with no restrictions on embryo research and a keenness to innovate, makes the world’s most populous nation the perfect place for stem cell research and therapy to flourish.

They also are flush with funding, something US stem cell researchers are not, since former President Bush pulled the plug on investment in this area, although President Obama reversed this decision in recent weeks.

The clinics are built in shiny new biotech parks outside the new rich cities of the eastern seaboard, or in specially built facilities attached to Chinese hospitals. Treatment is expensive, but probably cheaper than it would be in the West, if the treatment were available at all.

The Chinese government is pushing the stem cell sector in a major way. Innovation is crucial to find a way to get out of the bind of low-tech manufacturing and advance higher up the production chain, and the government is examining all sectors to find ways to lead the field.

Stem cell and regenerative medicine is a classic example of this, and the country has not introduced the regulatory constraints that other countries have done. It is competing with neighbours such as Singapore to become the regional centre for research.

Like so many sectors in China, there is a rush on to be first, to be ahead of the pack. And if you make some money while you’re at it, so be it. These are the aspects that worry the western medical professionals and researchers.

Dr Steven Novella is an academic clinical neurologist at Yale University School of Medicine, as well as the president and co-founder of the New England Skeptical Society.

“There are a number of clinics and companies around the world, but especially in China, taking advantage of this premature media hype, and the desperation of people with serious injury,” he says.

“They are offering zero scientific evidence to back up their claims. That is a formula well known to those of us who pay attention to health fraud – stunning claims combined with a lack of rigorous scientific evidence equals fraud.”

While acknowledging that the concepts behind stem cell therapy are sound, Novella says it is not simply a question of injecting a “magic elixir” into people.

“I don’t know where they are on the spectrum of con artists; to well-meaning but sloppy and naive. But it doesn’t really matter. In medicine it’s not enough to mean well. This is not about regulation – it’s about science.”

Over the years Novella has been critical of the work of Huang Hongyun, who was the subject of a lot of foreign interest four or five years ago because of the steady stream of western patients with neurological ailments, such as spinal cord injury and Lou Gehrig’s disease.

In China, Huang is considered a pioneer and has his supporters abroad, including Dr Wise Young, professor of neuroscience at the WM Keck Centre for Collaborative Neuroscience at Rutgers University. Huang is a former research student of his.

Huang has published some of the results of his operations in the Chinese Medical Journal, which show that nearly all of his patients have experienced a 5-15 per cent improvement in function. Some of his patients have recovered the ability to feel; others regain the power to sweat, to move limbs or control their bowels.

Asked about the controversy over the research, Huang says he believes there are many reasons.

“Perhaps it is caused by the persistence of traditional ideas, the cultural difference between China and some Western countries. Maybe another possible reason is lack of enough communication between them and us.”

As in so many cases, the funding has proven controversial, although it has to be said, being asked to pay upfront for treatment in a Chinese hospital is normal.

Treatments can cost €25,000 just for the medical bills alone. At Huang’s clinic, overseas patients are charged €15,000 per operation, while mainland Chinese patients pay about €6,000.

Chinese doctors in this sector complain that there are cultural issues at stake and say they publish in Chinese medical journals, which never get picked up in the West.

There are examples of great cures coming out of left field in China, treatments which flew in the face of western scepticism.

Chairman Mao Zedong’s medical researchers developed the traditional Chinese medicine treatment which uses the Artemisia plant to cure malaria, during the Vietnam War, when the West was reeling from the effects of DDT. And a Shanghai doctor working in very difficult conditions developed the leukaemia treatment Atra.

I’ve visited Huang’s clinic and the patients I met all spoke about the remarkable results. There are similarly upbeat blogs of patients who have attended clinics such as Beike. But without the research to back up these patients’ testimonials, without harder evidence that this is something real, it will be difficult to convince the western world’s medical establishment that there is a revolution going on in China.