Chinese and European researchers have today published ethical guidelines aimed at discouraging Chinese doctors from offering patients unproven or sham treatments based on stem cells.
The authors hope the move will reinforce legal curbs on stem cell treatments introduced on 1 May by China鈥檚 ministry of health.
The launch follows new allegations of fraud in stem cell research, and the arrest of individuals in Hungary allegedly offering bogus treatments.
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Untested therapies
Since May, Chinese institutions have been forbidden from commercialising stem cell treatments without first proving that they work through proper clinical trials.
鈥淣ow you must get approval from the health ministry first,鈥� says Qiu Renzong, vice president of the Chinese ministry of health鈥檚 ethics committee, and co-author of the launched today in London.
The guidelines were drafted over the past three years by the consisting of four Chinese and five European specialists in stem cell research and regulation. One of their key recommendations is that treatments undergo clinical trials to show they have some chance of working.
The hope is that the guidelines and regulations will eliminate sham and unproven treatments that have led to charges that China is now a world centre for stem cell tourism.
Conned and harmed
The number of patients who have been conned, harmed or even killed is unknown, Qiu says. 鈥淚t鈥檚 really hard to say, because the whole area has been unregulated, so the number of patients and side effects they鈥檝e suffered is hard to know.鈥�
According to Qiu more than 50 institutions in China are engaged in stem cell research, and many have offered treatments to desperate patients with conditions ranging 鈥渇rom diabetes to spinal injuries鈥�. They usually charge thousands of dollars per course of treatment, he says.
Often, patients鈥� expectations have been falsely raised by unverified reports of miracle recoveries after people have been given a variety of treatments based on stem cells sourced from embryos, cord blood, donors and sometimes the patients themselves. 鈥淎necdotal evidence is given of people making incredible recoveries, but with nothing equivalent to controlled clinical trials to back them up,鈥� Qiu says.
鈥淭here is also evidence suggesting that when people go home, their recovery regresses again,鈥� says Qiu.
Additional dangers are posed by the lack of any oversight of where cells come from, whether they鈥檙e genuine stem cells, whether they鈥檙e of the required quality and whether they are safe.
Risky treatments
Lu Guangxiu, an expert in reproductive technology at the Xiangya Reproductive and Genetic Hospital in Changsha, Hunan province, says that her institution is the first to be granted a licence from the ministry to develop stem cell treatments. But she thinks these are too risky to offer at the moment.
鈥淥ur stem cell lines are not stable enough yet,鈥� she says. 鈥淚f we do offer treatments, the key is informed consent from patients and telling them about the potential short-term and long-term risks.鈥�
鈥淲e don鈥檛 want to reduce hope,鈥� says Lu, 鈥渂ut it can be dashed if people go in for therapies that turn out to be ineffective.鈥�
of the London School of Economics, who coordinated the BIONET project, says that throughout the three-year collaboration, based on workshops and discussion of case studies, Chinese researchers had been most proactive about wanting to clamp down on charlatans.
鈥淐hina is not the 鈥榃ild East鈥� where anything goes,鈥� says Rose, who notes that most of the worries came from Chinese researchers themselves. Their biggest fear was that deaths, injuries and failures from sham treatments would undermine the case for genuine therapies.
Enforcers needed
The BIONET Expert Group admits that the Chinese authorities now face a huge challenge enforcing the new regulations, given the size of the country and the number of institutions conducting stem cell research.
The worst punishment now available is to cancel an institution鈥檚 licence to offer any kind of medical treatments, or to impose a fine. It鈥檚 not clear whether this would also apply to private companies, nor whether it would be a sufficient deterrent.
鈥淣o one denies that enforcement will be problem,鈥� says Rose, whose group鈥檚 guidelines include 30 recommendations for better ethical oversight of stem cell research, both in China and in Europe.
The hope is that the BIONET guidelines will reinforce guidelines published in 2007 by the International Society for Stem Cell Research.
