日本指控诺华未报告白血病药物尼洛替尼临床试验中的副作用

日本指控诺华未报告白血病药物尼洛替尼临床试验中的副作用 发布日期：2014-05-16  来源：fiercepharma  
仅仅一个月之前，一个日本律师小组发现诺华白血病药物尼洛替尼（Tasigna）的一项临床试验有严重不当行为，日本政府正在调查该公司是否违反法律隐瞒尼洛替尼副作用。

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Tasigna--Courtesy of Novartis

诺华正在日本面临另一项调查。仅仅一个月之前，一个日本律师小组发现诺华白血病药物尼洛替尼（Tasigna）的一项临床试验有严重不当行为，日本政府正在调查该公司是否违反法律，隐瞒了尼洛替尼副作用。
知情人士对《日本时报》称，日本的健康、劳工及福利部已对此展开调查，指控诺华去年收集了3000名正在使用尼洛替尼的日本患者的信息，发现有30例副作用，其中10例应该向日本政府报告，但诺华没有这么做，该报纸援引自未具名消息人士。
两例副作用还被发现与正在接受深入调查的临床试验有关，该事件发生在东京大学医院。该试验比较了白血病治疗药物副作用，包括尼洛替尼，这款产品是诺华重磅炸弹级产品格列卫(伊马替尼)的后继产品。
3月份，医院行政人员透露，诺华员工与之前怀疑的相比，参与临床试验的程度更高。如至少9位医药代表在临床试验期间收集了患者调查表，然后他们将这些调查表传真至医院，但试验方案要求，调查表应该直接返还医生手中。独立小组后来发现，不当行为浮出水面时，一些诺华员工粉碎了文件，并同时删除电子文件。
据《日本时报》的一篇社论介绍，诺华目前承诺与其在日本的试验研究者签订正式合同，称将在临床试验透明度上进行广泛改革。但该报纸指出，诺华在过去三年向参与白血病研究的东京大学实验室提供了急需的800万元（130万美元）经济支持。“为促进在临床试验中保持中立，政府需要扩大其对研究人员的支持，以便他们不必依赖来自制药行业的资金”，该新闻社报道。
诺华自去年夏天以来在日本麻烦不断，当时新闻界就大肆报道诺华员工卷入其血压药物代文试验研究的严重专业渎职丑闻。今年初，日本监管机构根据其虚假广告法向诺华提起刑事诉讼，称该公司用误导数据提升药品销售额。4月份，诺华驱逐了其驻日本高管。
Japanese officials: Novartis failed to report side effects of leukemia drug
What started as an inquiry into a clinical trial of its Diovan has morphed into multiple inquiries

Novartis ($NVS) is facing yet another investigation in Japan. Little more than a month after a panel of Japanese lawyers uncovered serious misconduct during a trial of its leukemia drug, Tasigna, the Japanese government is probing whether the company broke the law by failing to report side effects of the product.
Sources tell The Japan Times that the country's Health, Labor and Welfare Ministry has opened an investigation into charges that Novartis collected information on 3,000 Japanese patients who were taking the drug last year, and found 30 cases of side effects--10 of which should have been reported to the government but weren't--the paper reports, citing unnamed sources.
Two cases of side effects were also found in connection with the highly scrutinized clinical trial, which took place at the University of Tokyo Hospital. The trial compared the side effects of leukemia treatments, including Tasigna (nilotinib), which is Novartis' follow up to its blockbuster Gleevec (imatinib).
In March, hospital officials revealed that Novartis employees had been much more involved in the trial than previously suspected. For example, at least 9 Novartis sales reps collected patient questionnaires during the trial and then faxed them to the hospital, despite the fact that trial protocol requires doctors to return the questionnaires themselves. The independent panel later found that when the misconduct allegations surfaced, some Novartis employees shredded documents and deleted computer files.
Now Novartis is vowing to sign formal contracts with its trial investigators in Japan, according to an editorial in The Japan Times, calling for broad reforms in clinical trial transparency. But the paper points out that Novartis provided much-needed financial support to the University of Tokyo lab that was involved in the leukemia study: ￥8 million over three years ($1.3 million). To foster neutrality in clinical trials, "the government needs to expand its support for researchers so that they don't have to rely on money from the pharmaceutical industry," the paper contends.
Novartis has been under fire in Japan since last summer, when news erupted that employees had been involved in a now-retracted study of its blood pressure drug Diovan. Earlier this year, Japanese regulators filed a criminal complaint against Novartis under its false-advertising law, alleging that the company used misleading data to promote the drug. In April, Novartis ousted its top Japanese executives and replaced them with executives from its British, Canadian and German operations.