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2015年2月5日讯 /生物谷BIOON/ -- 据《日本时报》报道，日本卫生劳工和福利部门计划短时暂停诺华在日本业务，以惩罚其多次未通报药物副作用，该暂停期约为15天。
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: b; Q3 a. H- U( U3 Z* w2 j这是日本首次因药企未通报药物副作用而做出暂停业务处罚，在该决议生效前会给日本诺华株式会社一个解释的机会。
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3 P2 H2 X7 R4 S7 U6 \这是给丑闻缠身的日本诺华的最新惩罚。该瑞士制药企业此前就经历一系列丑闻：操控最畅销抗高血压药代文（Diovan）临床试验、篡改数据指控、虚假广告指控和内部调查。诺华已经清理门户，替换了高管并对员工进行了紧急补救培训。
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通过邮件询问诺华发言人EricAlthoff，他还未能立马确定该决议因此不能置评。截稿前，政府部门也没有报告更多关于暂停业务的消息，也未给予评论。: w8 [( h4 g: D
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诺华的丑闻之一是去年4月诺华没有报道治疗白血病药的Tasigna和Gleevec的副作用：在3000例白血病治疗案中，诺华没有依法报道10例严重的副作用案例。
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. Q( e' k: P5 F8 q/ V2 J这一副作用丑闻后不久，诺华公司员工和销售代表在抗白血病药物Tasigna的临床实验中就面临严重的不当行为的指控：员工被指控破坏试验方案在数据收集和病人隐私，并试图掩盖他们的失误，销毁和删除文件。7月份，政府下令诺华进行整改。
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诺华也曾被指控为推广抗高血压药代文，引用问题数据甚至可能捏造数据，做虚假广告。在涉嫌篡改数据的证据浮出水面后，研究人员就撤回了至少两项关于Diovan临床实验的数据。（生物谷Bioon.com）. f& M/ w9 C3 n: M5 {
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原文阅读：Novartis faces suspension in Japan after series of trial datas candals0 g4 w3 {/ d" W7 f) L
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Japan plans to temporarily suspend Novartis' ($NVS) pharma business in that country， according to media reports. The Ministry of Health， Labour and Welfare's order will last about 15 days and will cite repeated violations of failure to report adverse events properly， the Japan Timessays.! c4 |6 ^; I! \" f6 @
: p) o' Z0 U. q5 @8 Q2 NIt will be the first time Japanese officials suspend a pharma company for failing to report side effects promptly， the Times says. Novartis Japan K.K. may be given an opportunity to explain before the suspension is finalized.
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: P, ~ V1 a( a0 n$ E' RIt's the latest punishment for Novartis' scandal-plagued unit in Japan. The Swiss drugmaker has weathered a chain of scandals over retracted Diovan trials， data-tampering allegations， false advertising charges， and internal investigations. Novartis cleaned house， replacing its top management in the country and adding remedial training for employees., d* {% |+ E8 o. G0 S/ Q) _; H
+ z" e, w9 [, O6 XNovartis spokesman Eric Althoff told FiercePharma by email he could not immediately confirm the suspension and therefore had no comment. The ministry had not posted information about the suspension on its website as of press time and did not respond to requests for comment.
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A major scandal erupted in April last year when Novartis failed to report the side effects of leukemia drugs Tasigna and Gleevec. Ten serious cases of side effects， which surfaced as the company collected data on 3，000 patients under leukemia treatments， were not reported as required by law， the Times says.1 r, l2 Q2 K" j# B. z# _
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This side-effects scandal came soon after Novartis staff members and sales reps faced allegations of serious misconduct in a trial of its leukemia drug Tasigna. Employees were accused of breaking trial protocols in data collection and patient privacy， and attempting to cover up their missteps by shredding and deleting documents. In July， the government ordered Novartis to improve business practices and clean up its act in.
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, Q- T4 D) M) t, `The company was already facing charges of exaggerated advertising for the blood-pressure remedy Diovan， by citing data from questionable and possibly fabricated data in promoting the drug. Academic researchers had already retracted at least two Diovan trials after evidence of potential data-tampering surfaced. |
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发表于 2015-2-5 13:45
