标题: China "stem cell therapies" offer heartbreak for many [打印本页] 作者: StephenW 时间: 2011-9-21 21:11 标题: China "stem cell therapies" offer heartbreak for many
本帖最后由 StephenW 于 2011-9-21 21:13 编辑
China "stem cell therapies" offer heartbreak for many Health »
By Tan Ee Lyn
HONG KONG | Wed Sep 21, 2011 4:03am EDT
(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."
POTENTIALLY POWERFUL
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.
(Additional reporting by Julie Steenhuysen in Chicago, Zoey Zhang and Viola Ho in Hong Kong and Li Hui; Editing by Nick Macfie) 作者: 云帆风影 时间: 2011-10-16 09:32
中国干细胞疗法让人伤心欲绝
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.香港(路透社)——中国酒店的经理洪淳轻微中风,用筷子有困难,寻求治疗,根据他的父亲和堂兄陈述,上海医院医生在他的脊椎和臀部注射他们所称的供体干细胞进。Leaving hospital the next day, Hong, 27, fell so ill he had to be taken off the train and rushed to another hospital.第二天,离开医院,27日,洪淳出现头晕和恶心的症状,他只好走下火车,到另外一家医院治疗。But doctors were unable to save him and he was declared brain dead before dying a month later.但是医生无法拯救他,他被宣布脑死亡一个月后离世。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.监管空白的存在,客观上鼓励了医院“大胆尝试”。“干细胞疗法”,但专家称该治疗方法是以很少甚至没有任何科学证据和最好的实验。Some of these cases involve large general hospitals where patients pay thousands, even tens of thousands, of dollars for treatments that are advertised online.这些病例都大型综合医院里病人成千上万,甚至支付数万美元的治疗,在线广告。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.病人病情很少或没有改进伴随大量死亡,根据患者,医生和病人的亲戚告诉路透社记者。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.洪淳付了30000元(4800美元)在上海中国人民解放军455军队医院进行治疗,根据医院去年收据路透社记者所看到的。His father, Hong Gensho, travelled to Shanghai to seek an explanation.他的父亲,洪先生,Gensho前往上海寻求一个解释。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.但是医院管理者告诉他他的儿子没死在他们的医院,给他80000元,告诉他不要追求的事。"I am miserable, it's like my son was worth only 80,000 yuan.“我很可怜的,就像我儿子在价值只有80000元。It's not about money.这不是钱的问题。Our human rights, our place in this society, are not respected.我们的地位决定我家在这个社会不被尊重。I am devastated.我真的很伤心。If he hadn't sought treatment, he would not have died," said the elder Hong, 61.如果他没有寻求治疗后,他就不会死,”61岁的洪先生说。"I can't get my son back, but people must know about these stem cell therapies and no one must be deceived."“我不能把我的儿子回来,但是,人们必须知道这些干细胞治疗,没有人要受到蒙蔽了。”LACK OF SCIENTIFIC EVIDENCE缺乏科学证据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.专家提出了报警对病人出现在诊所和医院在中国、墨西哥、印度、土耳其、俄罗斯和其他干细胞治疗,未经临床试验并没有公认的标准治疗。Patients often pay fees of $20,000 and more for such therapies after exhausting conventional treatments.病人经常费用支付20000美元,但是更多的常规治疗,这些治疗方法。"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.“干细胞旅游作为伦理问题的病人接受治疗因为未从不能信任的来源,”大卫Resnik博士在美国国家环境卫生科学研究所,硕士Zubin大学在加拿大亚伯达省写了一篇发表在《欧洲分子生物学组织。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.与相同的问题,乔治·戴利的哈佛大学博士干细胞研究所和哈佛大学医学院说他被询问询问病人治疗在中国和巴西的疾病,从阿尔茨海默氏病脊髓损伤。"What I'm talking about are the less legitimate treatments that have not even undergone clinical trials but are directly marketed therapies...“我说的都是缺少合法性的治疗,甚至还没有经历了临床试验,但直接用于临床治疗…We really have no idea how to use stem cells for these treatments," Daley told Reuters.我们真的不知道如何使用干细胞,这些治疗方法,”戴利告诉路透社记者。When contacted by Reuters, a director at the PLA 455 Hospital, who declined to be identified, said: "There are always good and bad outcomes.路透社,当接触的一位导演,中国人民解放军455医院不愿透露姓名的,说:"总有好的和坏的结果。No therapy can guarantee success to everyone...没有治疗可以保证成功到每一个人…Besides, you don't have a better alternative.除此之外,你没有一个更好的选择。"As for patients dying, all deaths must be investigated.“至于患者死亡,死亡人数的行为,必须予以追究。What caused the death?什么导致了死亡?If our treatment caused the death, the patient (relatives) can seek redress.如果我们的治疗,病人致其死亡(亲戚)可以要求赔偿。If it is a death caused by old age and sickness, then there is nothing I can say."如果它是一个年老的死亡和疾病引起的,就不会有我能说的。”China's Ministry of Health did not respond to questions from Reuters on stem cell therapies being offered in the country.中国卫生部没有回应路透社提出的中国为什么允许干细胞治疗问题。VICTIMS ARE THOSE FACING DEATH受害者是那些正面临死亡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.患有晚期肝硬化造成终生的B型肝炎病毒感染、范洪坤被广告宣传相信干细胞移植能让她的身体自然生长一个健康的肝。"We saw the therapy advertised online and talked to the doctor over the phone.“因为我们看到了在线的广告疗法并给医生打电话。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.他说,干细胞就像种子,移植到肝上、种子长不停地繁殖,最终形成一个健康的肝脏,“范洪坤的儿子周俊杰说。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.范,63岁,她确信北京军区总医院网站上宣传的干细胞疗法能治疗她的病。"My mother said the PLA (Chinese army) doesn't lie.“我的母亲说中国人民解放军(中国军队)不会说谎。That's why she trusted them," said Zhou.这就是为什么她信任他们,”周说。Doctors there took her off the drug lamivudine for four weeks to "prepare her for the stem cell therapy".医生们让她停止服用药物拉米夫定四个星期“准备为她干细胞疗法”。But she fell into a coma before doctors could treat her.但她陷入昏迷之前,医生可以帮她治疗。Sold under the brand Epivir by GlaxoSmithKline Plc, lamivudine minimizes liver damage by blocking the hepatitis B virus from replicating.在市场上销售的品牌Epivir葛兰素史克,拉米夫定使肝损伤,通过阻断乙肝病毒的复制。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.范的亲人通过其他医生了解到,停止服用拉咪呋叮加重了她的病情并导致她去世。According to documents seen by Reuters, her family sued the hospital, but the case was dismissed by a Chinese court.根据路透社记者所看到的文件,她的家人起诉医院,但案件由中国法院驳回。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.记者联系上这家医院,一个不愿透露姓名医生说,,移植干细胞到病人的肝一个人只需要一天。"We extract the patient's bone marrow cells and isolate the stem cells, which are then inserted into the liver," said the doctor.“我们提取患者的骨髓细胞和隔离干细胞,然后插入到肝脏,”医生说。"...We extract bone marrow cells in the morning and in the afternoon we inject them (stem cells) into the liver.“……我们提取骨髓细胞在早上和下午我们将它们注射(干细胞)到肝脏。Yes, all it takes is a day.是的,所有需要做的是花一天的时间。Very fast."非常快。”Advertisements for these treatments remain on the hospital's website.这些治疗的广告留在医院的网站。In Ireland, many patients have returned from treatments abroad with no improvement, but they are less willing to talk.在爱尔兰,许多患者治疗在国外回来没有改进,但他们也不愿意说话。"Virtually none will go on record to state they have been conned.“实际上没有人会继续的纪录表示他们已经之中。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.这主要是因为很多病人有严重的健康问题,他们立即需要集中精力,”首席科学家斯蒂芬·沙利文爱尔兰干细胞基础,告诉路透社记者。"Patients are also reluctant to come forward as they are embarrassed at spending lots of money against professional medical advice.“患者也不愿意站出来为他们花很多钱难堪与专业医疗咨询。Some patients will even claim improvement when there is no measurable improvement."一些人甚至宣称改进患者当没有可衡量的改善。"POTENTIALLY POWERFUL潜在的强大的Researchers believe regenerative medicine will be a powerful form of therapy in the future.研究人员相信再生医学将是一个有力的形式的治疗,在未来的。Stem cells are immature, master cells in the body that can grow into any kind of human cell or tissue.干细胞是未成熟的细胞在体内,主人可以生长成任何一种人体细胞或组织。Scientists are exploring how to use them to treat a variety of diseases and disorders, including cancer, diabetes and injuries.科学家正在探索如何利用这些来治疗各种疾病和神经紊乱性疾病,包括癌症、糖尿病及伤害。But for now, they stress that only one type of stem cell therapy has been proven to work.但是现在,他们强调,只有一个类型的干细胞疗法已经被证明能够工作。"Only bone marrow transplants for diseases such as leukemia, lymphoma are backed by solid evidence and are well-established clinical procedures.“只有骨髓移植疾病,如白血病、淋巴瘤是确凿的证据和是信誉良好的临床过程。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.其他人还没达到这个水平,”大卫说小、临床副教授划分的香港心脏病玛丽女王医院。"There is evidence that certain stem cells can grow into new tissue but do they provide a therapeutic effect?“有证据指出,某些干细胞能发展成新组织,但他们是否提供一个治疗效果?We don't have the evidence yet.我们没有证据呢。Some are in clinical research."有些是在临床研究。”For the conditions highlighted in this article - disability from strokes and liver cirrhosis - experts say there are no proven stem cell treatments.本文突出残疾中风和肝硬化-专家说,目前还没有有效的干细胞治疗。。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.在论文中,Resnik说,大多数国家有规定人的研究和医疗事故,他们不能直接用干细胞进行治疗。When doctors encounter strict regimes, they can simply move to other countries with more permissive legal environments.当医生遇到严格的制度时,他们可以简单地转移到其他法律环境宽松的国家。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.实验性干细胞疗法,但是,可合法地提供给患者,但这些必须的框架内进行的临床试验,经监管,确保道德标准得到满足。
"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.“当实验干细胞疗法用于患者,但却不是一个特设的基础上进行的框架内,但一个适当的临床试验豫备,”小说。"It has to follow a rigorous methodology: what are the risks, what can and cannot be done?“这必须遵循严格的方法:什么是风险,什么可以做到,什么不可以做什么呢?If the results are negative, what are the rescue and safety measures?"如果结果是否定的,有什么救援和安全措施?”
Sullivan urged patients to be on the lookout for scams.沙利文提醒病人当心被欺骗。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.这些欺骗迹象包括被要求付出大笔的钱,被告知没有风险,并没有提供治疗后的护理。post-therapyPatients should be told how they will be treated, what stem cells are used and where they come from.患者应该被告知他们将如何治疗,干细胞的使用程度,他们来自哪里。They should not accept any therapy based on hearsay, or without the treatment being validated at least in part by peer review, he said.他们不应该接受任何治疗基于传闻,或没有治疗验证的至少部分地是由于同行评审,他说。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.Resnik和掌握敦促干细胞科学家,制止那些没有经过真正的的临床试验而进行的干细胞治疗。"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.“这将确保干细胞和其他材料将在生物医学研究,在合法许可的临床试验或责任重大的医学创新的,”他们说。