China "stem cell therapies" offer heartbreak for many
HONG KONG (Reuters) - Chinese hotel manager Hong Chun had trouble using chopsticks after a minor stroke and sought treatment at a large Shanghai hospital where doctors injected what they said were donor stem cells into his spinal cord and buttocks, according to his father and cousin.
Leaving hospital the next day, Hong, 27, fell so ill he had to be taken off the train and rushed to another hospital. But doctors were unable to save him and he was declared brain dead before dying a month later.
Desperate for help, patients with incurable diseases are admitting themselves into hospitals in China for "stem cell therapies" but experts say such treatments are backed by little or no scientific evidence and are at best experimental.
Some of these cases involve large general hospitals where patients pay thousands, even tens of thousands, of dollars for treatments that are advertised online. Patients have come away with little or no improvement and a number have died, according to patients, doctors and relatives of patients who spoke to Reuters.
Hong paid 30,000 yuan ($4,800) to the Chinese army's 455 PLA Hospital in Shanghai for the treatment last year, according to hospital receipts seen by Reuters.
His father, Hong Gensho, travelled to Shanghai to seek an explanation. But hospital administrators told him his son didn't die in their hospital, paid him 80,000 yuan and told him not to pursue the matter.
"I am miserable, it's like my son was worth only 80,000 yuan. It's not about money. Our human rights, our place in this society, are not respected. I am devastated. If he hadn't sought treatment, he would not have died," said the elder Hong, 61.
"I can't get my son back, but people must know about these stem cell therapies and no one must be deceived."
LACK OF SCIENTIFIC EVIDENCE
Experts have raised the alarm on patients turning up at clinics and hospitals in China, Mexico, India, Turkey, Russia and elsewhere for stem cell therapies that have not undergone clinical trials and which are not recognized as standard treatment.
Patients often pay fees of $20,000 and more for such therapies after exhausting conventional treatments.
"Stem cell tourism is regarded as ethically problematic because patients receive unproven therapies from untrustworthy sources," Dr David Resnik at the U.S. National Institute of Environmental Health Sciences and Zubin Master at the University of Alberta in Canada wrote in a paper published in the journal European Molecular Biology Organization.
Echoing the same concerns, Dr George Daley at the Harvard Stem Cell Institute and Harvard Medical School said he was swamped by enquiries from patients asking about therapies in China and Brazil for diseases from Alzheimer's to spinal cord injuries.
"What I'm talking about are the less legitimate treatments that have not even undergone clinical trials but are directly marketed therapies... We really have no idea how to use stem cells for these treatments," Daley told Reuters.
When contacted by Reuters, a director at the PLA 455 Hospital, who declined to be identified, said: "There are always good and bad outcomes. No therapy can guarantee success to everyone... Besides, you don't have a better alternative.
"As for patients dying, all deaths must be investigated. What caused the death? If our treatment caused the death, the patient (relatives) can seek redress. If it is a death caused by old age and sickness, then there is nothing I can say."
China's Ministry of Health did not respond to questions from Reuters on stem cell therapies being offered in the country.
VICTIMS ARE THOSE FACING DEATH
Suffering from late-stage liver cirrhosis caused by a lifelong hepatitis B virus infection, Fan Hongkun was led to believe her body would spontaneously grow a healthy liver once stem cells were transplanted.
"We saw the therapy advertised online and talked to the doctor over the phone. He said stem cells were like seeds, after being planted on a liver, they grow, divide and spread and finally form a healthy liver," said Fan's son, Zhou Junjie.
Fan, 63, was so convinced, she admitted herself into Beijing Military General Hospital, whose website still carries information on the stem cell therapies it offers.
"My mother said the PLA (Chinese army) doesn't lie. That's why she trusted them," said Zhou.
Doctors there took her off the drug lamivudine for four weeks to "prepare her for the stem cell therapy". But she fell into a coma before doctors could treat her.
Sold under the brand Epivir by GlaxoSmithKline Plc, lamivudine minimizes liver damage by blocking the hepatitis B virus from replicating. Fan's family learnt later from other doctors that she suffered a sudden surge of the virus after she stopped her medication, which pushed her into a coma and killed her.
According to documents seen by Reuters, her family sued the hospital, but the case was dismissed by a Chinese court.
When contacted, a doctor at the hospital, who declined to be identified, said the entire procedure to transplant stem cells into a patient's liver takes only a day.
"We extract the patient's bone marrow cells and isolate the stem cells, which are then inserted into the liver," said the doctor. "...We extract bone marrow cells in the morning and in the afternoon we inject them (stem cells) into the liver. Yes, all it takes is a day. Very fast."
Advertisements for these treatments remain on the hospital's website.
In Ireland, many patients have returned from treatments abroad with no improvement, but they are less willing to talk.
"Virtually none will go on record to state they have been conned. This is mainly because many patients have serious immediate health concerns and they need to focus on that," Stephen Sullivan, chief scientific officer of the Irish Stem Cell Foundation, told Reuters.
"Patients are also reluctant to come forward as they are embarrassed at spending lots of money against professional medical advice. Some patients will even claim improvement when there is no measurable improvement."
Researchers believe regenerative medicine will be a powerful form of therapy in the future. Stem cells are immature, master cells in the body that can grow into any kind of human cell or tissue. Scientists are exploring how to use them to treat a variety of diseases and disorders, including cancer, diabetes and injuries.
But for now, they stress that only one type of stem cell therapy has been proven to work.
"Only bone marrow transplants for diseases such as leukemia, lymphoma are backed by solid evidence and are well-established clinical procedures. The others are not up to that level," said David Siu, clinical associate professor at the cardiology division of Hong Kong's Queen Mary Hospital.
"There is evidence that certain stem cells can grow into new tissue but do they provide a therapeutic effect? We don't have the evidence yet. Some are in clinical research."
For the conditions highlighted in this article - disability from strokes and liver cirrhosis - experts say there are no proven stem cell treatments.
In their paper, Resnik and Master said while most countries had rules governing research on people and medical malpractice, they did not apply directly to stem cell therapy. When doctors encounter strict regimes, they can simply move to other countries with more permissive legal environments.
Experimental stem cell therapies, however, may be legitimately offered to patients, but these must be carried out within the framework of clinical trials that are approved by regulatory boards that ensure ethical standards are met.
"When experimental stem cell therapy is used on patients, it is not performed on an ad-hoc basis but within the framework of a proper clinical trial prepared beforehand," Siu said. "It has to follow a rigorous methodology: what are the risks, what can and cannot be done? If the results are negative, what are the rescue and safety measures?"
Sullivan urged patients to be on the lookout for scams. Suspicious signs include being asked for large sums of money up front, being told there are no risks, and being offered no post-therapy care.
Patients should be told how they will be treated, what stem cells are used and where they come from. They should not accept any therapy based on hearsay, or without the treatment being validated at least in part by peer review, he said.
Resnik and Master urged stem cell scientists, who have control over stem cell lines, to help stop these scams by not releasing such materials to doctors or clinics if they cannot produce proof of conducting a genuine clinical trial.
"This would ensure that the stem cells and other materials are going to be used in the course of responsible biomedical research, a legally sanctioned clinical trial or in responsible medical innovation," they said.
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