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天士力发表声明称李连达有关丹参滴丸三期的言论失实

2017-09-15 15:26:47   央广网

央广网天津9月15日消息(记者陈庆滨)近期,李连达在科学网个人博客上针对天士力公司产品复方丹参滴丸美国FDA Ⅲ期临床试验公开发表了《丹参滴丸三期临床惨遭失败,损失惨重,教训惨痛》的文章。对此言论,天士力集团今天发表声明中,该文章编造吸引眼球的虚假标题,内容与事实严重不符,这些违法的、错误的言论,可能对投资者和消费者造成误导。

李连达在其文章中,其文章标题及内容均提及“丹参滴丸三期临床惨遭失败”、“药物无效”。在此份声明中,天士力方面表示,公司于2017年8月31日发布的《关于复方丹参滴丸美国FDA 新药申报可行性会议情况的公告》(临2017-47)中所阐述的内容是客观、严谨的事实,并及时做了信息披露:FDA肯定了T89-07-CAESA临床试验的价值,指出试验第六周时T89的高、低剂量治疗组相对安慰剂组和三七组对提高平板运动时间在p<0.05统计学水平上具有显著意义,临床试验实际统计结果p值为0.02,而且运动时间提高的趋势和速率的临床意义显著;第四周的点对点比较结果统计学临界显著;公司在已完成的Ⅲ期临床试验的基础上,增补一个六周统计显著的验证性试验,用于满足美国FDA新药申请的要求;FDA同意在递交新药申请(NDA)前,公司可公开发表本试验结果。

这是根据美国FDA新药申报法规要求,在前期临床试验已经取得有效的临床结果基础上进行的补充验证性试验,是复方丹参滴丸新药申报进程的继续推进;FDA肯定了T89-07-CAESA临床试验价值,肯定了试验药物的安全性、有效性、质量可控性,完善试验和申报工作还在进行中,而李连达却故意歪曲事实,声称“丹参滴丸三期临床惨遭失败”、“药物无效”,这明显属于颠倒是非、恶意诽谤。

天士力公司表示,李连达在十多年前因与该公司的合作研究项目产生分歧后,便开始对天士力多次发表恶意的不实性言论,严重损害了天士力名誉权,为了维护企业合法权益,天士力迫不得已对李连达提起法律诉讼,经天津市第一中级人民法院一审和天津市高级人民法院二审、以及最高人民法院最终裁定,最终判决李连达侵害天士力名誉权,并应停止发表对天士力及复方丹参滴丸产品产生不良社会影响的不实评论,并处30万元罚款作为名誉侵权损害赔偿。判决生效后,李连达不但不按照法律判决履行其应尽义务,相反却以科学家自居,将没有任何依据的不实言论变本加厉的屡次在网络上公开散布,这是违反法律规定和违背科学道德精神的行为。

天士力在声明中提示消费者和投资者提高警惕,不要被这些基于恶意动机所发表的违法错误言论所误导。同时,对李连达的违法行为,天士力保留追究其法律责任的权利。

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