华盛顿邮报有关拉米夫定危险性的报道

　　　　[关键词]贺普汀 慢性乙型肝炎 葛兰素威康

　　近来对长期应用拉米夫定治疗慢性乙型肝炎可能存在危险性是乙肝抗病毒治疗的一个热点问题，越来越受到临床医师的重视。，并能与医学界同仁就此问题进行交流与探讨。

　　----编者

　　Researcher Says GlaxoSmithKline Plays Down Problems In Hepatitis Treatment

　　作者：Deborah Nelson

　　Washington Post Staff Writer

　　Sunday, March 18,2001;Page A 14

　　Peborah Nelson

　　2001年3月18日，星期天

　　制药行业巨人的编造掩盖了拉米夫定的危险性

　　研究人员说葛兰素故意对乙肝治疗存在的危险轻描淡写

　 HONG KONG-when pharmaceutical giant Glaxo Wellcome Inc. came to this crowded Asian city several years ago to test a new drug for hepatitis B, researcher Nacny Leung was pleased with the early results in a short course of treatment the drug showed positive effects on many liver patients at her university hospital.

　　香港-几年前，当制药行业巨人葛兰素威康公司来到这个亚洲拥挤的城市试验治疗乙型肝炎的新药时，研究员Nancy 梁对早期结果非常满意。经过短期治疗后，这个新药在她所在的大学附属医院的肝病病人身上起到了积极作用。

　　But over time, she began detecting mutant viruses in the blood of participants who stayed on the drug longer than a year. She promptly reported the disturbing development to Glaxo.

　　"Most virologists" Leung said ,"do not want to create a new virus."

　　Glaxo assured her that the new viruses. Though drug-resistant, appeared to be relatively benign..She said.

　　但随着时间的延长，在那些治疗时间超过一年的病人血液内检测到突变病毒。她立即向葛兰素公司报告了这一令人担忧的重大事件。

　　"大多数病毒学家不希望制造出新型病毒"梁评价说。

　　葛兰素安慰她说，新病毒虽然耐药，但似乎没有太大危险。

　　Then, in the summer of 1997,a 36-year-old patient. She Yun-Ki, fell mortally ill while taking the drug. Goaxo listed his cause of death as peritonitis, but Leung said that was misleading. He had developed mutant viruses, she said, and his liver failed. The peritonitis was the last in a cascade of deadly ailments that followed, she said.

　　接下来，在1997年夏，一位36岁的病人She Yun-Ki，在服用拉米夫定后死亡。葛兰素把他的死因归因于腹膜炎，但梁教授说这是误导。事实上，病人体内的病毒已经突变。引起肝功能不全。腹膜炎只是肝功能不全后一系列并发症中最严重的一种。

　　The death left her shaken, and she took a more critical view of the rapidly spreading mutant viruses among patients receiving long-term treatment, joining a growing number of liver specialists who say the drug should not be used for more than a year.

　　这例病人的死亡震惊了梁教授，她于是采取了一种更加批判性的态度，来对待在长期治疗病人中快速传播的突变型病毒问题。她也因此加入了不断扩大的反对拉米夫定用药超过一年的肝病专家队伍中。

　　But that view is on a collision course with Glaxo's efforts to promote more and longer use of the drug lamivudine, which is now sold in 60countries and last year accounted for $108 million in sales.Glaxo officials say long-term treatment is safe and effective for mot patients.

　　但梁的观点显然与葛兰素推行更多、更长应用拉米夫定的努力背道而驰。拉米夫定已在60个国家获准上市。去年的销售额占10.8亿美元。葛兰素官员称对多数病人而言长期治疗安全而有效。

　　Leung said Glaxo has tried to suppress concerns about the drug, attaching her name to upbeat research reports that she didn't approve and churning out data that mask the drug's problems. Glaxo's failure to adequately acknowledge lamivudine's problems has led to a "mood of mistrust and discontent" among Asian liver specialists. She said.

　　梁说，葛兰素尽力想掩盖对拉米夫定的担忧，将她的名字附在未经其本人同意的乐观的研究报告上，并编造了大量资料来掩盖该病的问题。葛兰素不能完全承认拉米夫定的问题已经导致亚洲肝病学家对公司的"不信任和不满的情绪"。

　　Fraser Gray, who leads Glaxo's lamivudine development team, said he was not aware of any unhappiness among Asian researchers over the company's interpretation of their data. Glaxo works closely with all outside researchers to make sure they agree with the company's scientific claims of success, he said.

　　领导拉米夫定推广小组的Fraser Gray说，他没有意识到亚洲研究人员对葛兰素公司对他们的材料解释有任何不满。葛兰素公司与所有公司外的研究人员密切工作来保证他们与公司成功的科学主张相一致。

　　Leung sees it differently. "We are too much controlled by them." She said. "I feel like I've been constantly, positively spun."

　　梁并不这样看，"我们被他们控制的太多，我感觉好象一直在被他们欺骗着。"

　　The mutant virus controversy illustrates a new global twist in an ongoing debate in U.S. scientific circles over whether drug companies with massive research budgets exert too much control over human testing and the publication of findings in medical journals.

　　Academic researchers who rely on industry money to stay afloat are being pressured by drug companies to put a favorable spin on clinical trial results, said Marcia angell. Former editor in chief of the New England Journal of Medicine.