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cover of episode Time to rethink GP's advice on weightloss, and tricagrelor data doubts

Time to rethink GP's advice on weightloss, and tricagrelor data doubts

2025/7/1
logo of podcast Medicine and Science from The BMJ

Medicine and Science from The BMJ

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People
C
Cameron Abassi
E
Emma Gram
J
Juan Franco
P
Peter Doshi
R
Rita Redberg
V
Victor Cerabrani
Topics
Peter Doshi: 我主导的调查显示,FDA收到的支持替格瑞洛批准的临床试验数据不可信,存在太多数据完整性问题。FDA违背了首席科学审查员的建议批准该药物,而该审查员认为AstraZeneca的申请是他见过的最糟糕的申请之一。在美国,接受替格瑞洛治疗的患者比接受氯吡格雷治疗的患者情况更糟。在完全由第三方公司进行监测的四个国家,替格瑞洛的效果更差。AstraZeneca提交给FDA的患者水平数据中存在一些意想不到的模式和不平衡,这表明试验可能存在揭盲现象。两项血小板研究的主要终点在期刊出版物中没有被准确报告,其中一项试验中发生了一项关键但未公布的数据调整,这掩盖了数据集包含许多完全不合理的数据点的事实。调查人员不配合提供血小板研究的任何数据,但我们可以看到并非所有记录都进入了FDA的数据库。很多人基本上对这种情况置之不理,研究负责人从未回应,医院伦理委员会主席拒绝与我交谈,即使我写信说我们对该医院发生的数据完整性和试验表示担忧。期刊发表了这些试验,但所有这些文章中都有可验证的错误,但期刊没有采取任何行动来纠正记录。你必须打破阻挠,负责调查的人员不能拒绝发言,期刊也不能拒绝采取行动。需要一个拥有传票权力的机构来让人讨论并展示他们的记录。 Victor Cerabrani: 我认为如果没有死亡率获益,这种药就不会成功。抗血小板药物的益处非常小,并且发生在冠状动脉支架植入后非常早期的第一周。长期使用抗血小板药物几乎没有任何改变。如果没有死亡率获益,就绝对没有理由使用该药物。 Rita Redberg: 重要的是要确保任何药物的安全性和有效性。FDA在没有数据支持的情况下保证药物的安全性和有效性,这令人担忧。出版物遗漏了关键部分、数据和利益冲突。更令人担忧的是,我们如何知道这种情况没有发生在其他药物上,只是没有进行调查?期刊的基本使命是创建准确的科学记录。

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Shownotes Transcript

Last December, The BMJ published an investigation into the 2009 PLATO trial - exposing serious problems with that study’s data analysis and reporting.  Our follow up investigation has shown that those data problems extend to other key supporting evidence in AstraZeneca’s initial application to regulators.

Peter Doshi, senior editor in the BMJ’s Investigations unit, and Rita Redberg, cardiologist and Professor of Medicine at UCSF and former editor of JAMA Internal Medicine, join us to explain what this means for scientific integrity, and trust in the FDA's approval processes.

 

Also in this episode. A group of international authors are arguing that weightloss advice given in primary care might actually be doing more harm than good - it’s ineffective and potentially reinforces damaging stigma. 

To explain why they came to that conclusion we're joined by Juan Franco editor in chief of BMJ EBM, and a practicing GP in Germany, and Emma Gram, from the Centre for General Practice at the University of Copenhagen

Reading list

Doubts over landmark heart drug trial: ticagrelor PLATO study)

Ticagrelor doubts: inaccuracies uncovered in key studies for AstraZeneca’s billion dollar drug)

Beyond body mass index: rethinking doctors’ advice for weight loss)