China cracks down on stem cell tourism
Since May, Chinese institutions have been forbidden from commercialising stem cell treatments without first proving that they work through proper clinical trials.
"Now you must get approval from the health ministry first," says Qiu Renzong, vice president of the Chinese ministry of health's ethics committee, and co-author of the new European-Chinese guidelines launched today in London.
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. "It's really hard to say, because the whole area has been unregulated, so the number of patients and side effects they've suffered is hard to know."
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 "from diabetes to spinal injuries". They usually charge thousands of dollars per course of treatment, he says.
Often, patients' 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. "Anecdotal evidence is given of people making incredible recoveries, but with nothing equivalent to controlled clinical trials to back them up," Qiu says.
"There is also evidence suggesting that when people go home, their recovery regresses again," says Qiu.
Additional dangers are posed by the lack of any oversight of where cells come from, whether they're genuine stem cells, whether they're 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.
"Our stem cell lines are not stable enough yet," she says. "If we do offer treatments, the key is informed consent from patients and telling them about the potential short-term and long-term risks."
"We don't want to reduce hope," says Lu, "but it can be dashed if people go in for therapies that turn out to be ineffective."
Nikolas Rose 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.
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's licence to offer any kind of medical treatments, or to impose a fine. It's not clear whether this would also apply to private companies, nor whether it would be a sufficient deterrent.
"No one denies that enforcement will be problem," says Rose, whose group's 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.
Since May, Chinese institutions have been forbidden from commercialising stem cell treatments without first proving that they work through proper clinical trials.
"Now you must get approval from the health ministry first," says Qiu Renzong, vice president of the Chinese ministry of health's ethics committee, and co-author of the new European-Chinese guidelines launched today in London.
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. "It's really hard to say, because the whole area has been unregulated, so the number of patients and side effects they've suffered is hard to know."
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 "from diabetes to spinal injuries". They usually charge thousands of dollars per course of treatment, he says.
Often, patients' 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. "Anecdotal evidence is given of people making incredible recoveries, but with nothing equivalent to controlled clinical trials to back them up," Qiu says.
"There is also evidence suggesting that when people go home, their recovery regresses again," says Qiu.
Additional dangers are posed by the lack of any oversight of where cells come from, whether they're genuine stem cells, whether they're 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.
"Our stem cell lines are not stable enough yet," she says. "If we do offer treatments, the key is informed consent from patients and telling them about the potential short-term and long-term risks."
"We don't want to reduce hope," says Lu, "but it can be dashed if people go in for therapies that turn out to be ineffective."
Nikolas Rose 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.
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's licence to offer any kind of medical treatments, or to impose a fine. It's not clear whether this would also apply to private companies, nor whether it would be a sufficient deterrent.
"No one denies that enforcement will be problem," says Rose, whose group's 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.
