| 葛兰素在中国犯下了“不可饶恕的罪恶” 葛兰素史克在中国的运作受到严厉批评 美国《纽约时报》星期二（7月23日）报道说，根据他们获得的一份秘密文件，英国制药公司葛兰素史克在中国的违规操作并不仅限于销售层面，而且涉及在中国的药品研发业务。
《纽约时报》声称获得了葛兰素史克从2011年11月开始的内部审计文件，形容葛兰素史克研发神经类药物的上海研发中心存在着严重的问题。 国际管理咨询公司麦肯锡（McKinsey &
Company）报告说，自2006年以来，全世界20家最大的制药公司中有13家在中国建立了研发中心。 《纽约时报》援引美国哈佛医学院教授坎贝尔的话说，在中国做研发要便宜一些，但毫无疑问，更便宜往往导致更危险。 葛兰素史克的内部审计报告说，葛兰素史克2007年在上海建立研发中心，不仅希望帮助其药品在中国通过审批，也希望在这里展开初级研发工作。 “不可饶恕的罪恶” 审计报告指出了这个研发中心存在的严重问题，其中一个非常严重的事例涉及治疗硬化症和运动神经疾病药物的研发。 报告说，这个研发项目的负责人在药品已经开始人体试验之后才了解到了有关的动物实验报告。 《纽约时报》援引美国纽约大学兰贡医学中心医学伦理负责人卡普兰的话说，如果情况属实，这将是医学研究中“不可饶恕的罪恶”。 他说，任何人都不能在没有得到足够资料的情况下批准展开人体试验，这是严重的违反医学伦理的行为。 葛兰素史克的内部审计报告指出，虽然动物实验结果证明不会对患者的安全产生影响，但存在巨大的潜在危险，因为参加人体试验的患者可能承担不必要的危险或接受无效的治疗。
葛兰素史克在去年表示，后来提交的另一份内部审计报告认为，有关问题已得到解决。 但是一些外部专家指出，最初审计报告披露的问题非常严重，显示葛兰素史克在扩大规模的时候没有严格控制自己关键的研发中心。 （编译：跃生 ）
Drug Research in China Falls Under a Cloud The Shanghai research and development center of Glaxo develops neurology
drugs. An audit found problems with the way the company conducted research
there. Executives at the British drug maker GlaxoSmithKline were warned nearly two
years ago about critical problems with the way the company conducted research at
its drug development center in China, exposing it to potential financial risk
and regulatory action, an internal audit found. ...华岳论坛 -
"http://washeng.net" The confidential document from November 2011, obtained by The New York Times,
suggests that Glaxo’s problems may go beyond the sales practices that are
currently at the center of a bribery and corruption scandal in China. They may
extend to its Shanghai research and development center, which develops neurology
drugs for Glaxo. ...华岳论坛 - "http://hua-yue.net"
The failings, some experts said, underscore the problems that can arise when
major drug companies export their scientific development to emerging markets
like China. Since 2006, 13 of the top 20 global drug makers have set up research and
development centers in China, according to a report by McKinsey & Company.
“It’s cheaper to do research there,” said Eric G. Campbell, a professor of
health care policy at Harvard Medical School. However, “I have absolutely no
doubt that with cheaper research comes greater risk.” ...华岳论坛 - "http://washeng.net" Auditors found that researchers did not report the results of animal studies
in a drug that was already being tested in humans, a breach that one medical
ethicist described as a “mortal sin” in the world of drug research. They also
concluded that workers at the research center did not properly monitor clinical
trials and paid hospitals in ways that could be seen as bribery. ...华岳论坛 - "http://hua-yue.net" Last year, Glaxo said, a more favorable audit found the concerns had been
addressed. But several outside experts said the problems outlined in the initial
audit were grave and painted a picture of an organization that failed to keep
tabs on a crucial research center as it expanded both in size and scope. And it
indicates that the problems there were more extensive than were reported in
June, when the company fired the head of research and development in China after
discovering that an article he helped write in the journal Nature Medicine
contained misrepresented data. ...华岳论坛 -
"http://washeng.net" In a statement, Glaxo said it was committed to conducting “robust” audits of
its business practices, and in this instance, “the process worked exactly as
intended.” It added, “Patient safety is paramount and the audit reports do not
show that this was compromised.” ...华岳论坛 -
"http://hua-yue.net" Glaxo’s research and development center opened in 2007 with lofty ambitions
not only to help the company’s drugs get approved in China, but also to serve as
one of its primary research hubs. The center grew quickly, expanding from one
employee in 2007 to 460 in 2011, according to the audit. But as it grew,
supervisors did not always ensure that the work done there was of high quality,
auditors found. ...华岳论坛 - "http://washeng.net"
One of the most troubling lapses — a problem the report labeled “critical” —
involved a drug known as ozanezumab, which was being developed to treat patients
with multiple sclerosis and Lou Gehrig’s disease. ...华岳论坛 -
"http://hua-yue.net" The report revealed that the drug’s project leader belatedly learned the
results of three studies of ozanezumab in mice. During their investigation,
auditors came across six studies whose results had not been reported, even
though early trials in humans were already under way. ...华岳论坛 - "http://washeng.net" Reporting such information is crucial, ethicists said, because animal studies
can identify safety risks and are among the main factors drug companies use to
decide whether to pursue human trials. “If that’s true, it’s a mortal sin in research requirements,” said Arthur L.
Caplan, the head of the division of medical ethics at NYU Langone Medical
Center. He served as the chairman of an advisory committee on bioethics at Glaxo
from 2005 to 2008. “No one could approve human trials without having that
information available, scientifically or ethically. That’s kind of a
Rock-of-Gibraltar-sized ethics violation.” ...华岳论坛 -
"http://hua-yue.net" The auditors said the results did not affect patient safety, but warned of
the high stakes involved, saying participants could be exposed “to unnecessary
risk or no benefit to the disease state.” Glaxo said that “when the full range of data from all the studies was
reviewed, GSK determined that the efficacy would not be strong enough to
continue,” and it terminated a trial of ozanezumab in multiple sclerosis
patients. It is still studying the drug in people with Lou Gehrig’s disease, or
amyotrophic lateral sclerosis, according to the company. ...华岳论坛 - "http://washeng.net" In the follow-up audit, auditors said senior managers at the Chinese research
unit had “embedded a compliance culture that was not evident during the prior
audit,” and did not find any issues of concern, according to an executive
summary of the report that was provided by Glaxo. ...华岳论坛 -
"http://hua-yue.net" Outside ethics experts said the report raised questions about whether patient
safety was adequately protected. Auditors found that Glaxo employees failed to record whether research
participants had signed new consent forms during the course of clinical trials.
They also did not document whether participants were taking the planned dosage
of drugs, or whether they followed up when they learned that participants were
not following a clinical trial’s protocol. ...华岳论坛 -
"http://washeng.net" Glaxo Says Executives May Have Broken Chinese Law (July 23, 2013) Add to Portfolio GlaxoSmithKline PLC Go to your Portfolio » Share your thoughts. Post a Comment » The 2011 audit report also raised alarms about the way the Shanghai office
was paying the people who were overseeing the company’s trials at outside
hospitals or clinics. According to auditors, Glaxo was paying many sites a flat
fee for the cost of a full-time coordinator, regardless of the number of
participants enrolled in the trial. ...华岳论坛 -
"http://hua-yue.net" The report warned of “reputational, financial and/or regulatory action risk
where payments made to investigators regardless of actual work completed are
perceived as bribery or corruption.” Chinese investigators have said that Glaxo participated in a widespread
bribery and corruption scheme in which the company used travel agencies to
funnel illegal payments to doctors and government officials to bolster drug
sales, and authorities have said they are also looking into the practices of
other pharmaceutical companies. ...华岳论坛 -
"http://washeng.net" On Monday, Glaxo said that some of its executives might have broken the law.
Outside experts said the payment of doctors and other hospital employees
where trials were being conducted was tricky, because paying a fee based on the
number of people enrolled in a study could also be seen as inappropriate. ...华岳论坛 - "http://hua-yue.net" “I’m much more concerned about people who are paid by the head to recruit,”
said Dr. Campbell. Still, he said, if large payments were being made for little
work, that could raise eyebrows. “It could be seen as simply another way to put
money in people’s hands,” he said. ...华岳论坛 -
"http://washeng.net" Glaxo said it had since tightened the payment procedures for clinical
research coordinators. Referring to the current bribery investigation, the
company said, “we have zero tolerance for any kind of corrupt behavior among our
employees, suppliers and business partners and will take action wherever and
whenever we find it.” ...华岳论坛 - "http://hua-yue.net"
In all, company officials said that appropriate steps were taken to address
the issues outlined in the audit. And in 2011, auditors noted that leaders at
the research center had recently tried to address the “significant issues”
there. ...华岳论坛 - "http://washeng.net" Dr. Jerry Avorn, a professor at Harvard Medical School, and others gave
credit to Glaxo for investigating one of its own research centers. “It is good that they detected these problems and vowed to fix them,” Dr.
Avorn said, “but this report shows what can happen when a drug company rapidly
expands its clinical research programs overseas without adequate quality
controls.” ...华岳论坛 - "http://hua-yue.net"
跟帖目录:
原 帖 [ 0 ] 美国的医药公司在中国做人体试验更多后果更严重http://news.qq.com/a/20101027/000801.htm 人工心脏手术诉讼牵出外国机构在华医学人体试验
目前有60多家跨国医药企业在中国进行着近100个项目的一期临床试验。每年有800多种国外新药进行人体试验，每种药需要30名左右的试药人员。国内直接参与试药的相关人员有数万人，如果算上大面积的采样对象，至少在50万人以上。” ...华岳论坛 - "http://washeng.net" |
E_mail: [email protected]
2010-2011http://redchinacn.net
