调查记者凯瑟琳·伊班在其著作《谎言瓶》中，揭示了仿制药制造中普遍存在的欺诈行为，质疑仿制药与品牌药相同的观念。她详细讲述了印度制药公司兰伯西如何通过伪造数据在美国食品药品监督管理局（FDA）的药品申请中谋利，以及后续对印度和中国药品制造工厂的调查发现近80%存在欺诈行为。最后，文章提出了个人如何自查药品、一家创新药房如何颠覆市场，以及仿制药法规改革的想法。

🔍 凯瑟琳·伊班通过调查发现，仿制药制造中普遍存在欺诈行为，质疑仿制药与品牌药相同的观念。她以印度制药公司兰伯西为例，揭露了其依靠伪造数据在美国FDA药品申请中谋利的黑幕。

🏭 调查显示，印度和中国的药品制造工厂中，近80%存在欺诈行为，包括数据伪造和操纵。

🔬 文章提出了个人如何自查药品质量的方法，以及一家创新药房如何通过测试所有药品来确保质量。

💡 文章探讨了仿制药行业和FDA法规的改革必要性，提出了改革思路，强调个人责任，不应等待国会救援。

In this episode, Katherine Eban, investigative journalist and author of Bottle of Lies, illuminates the prevalence of fraud in generic drug manufacturing which brings into question the idea that generics are identical to brand-name drug as we are lead to believe. Katherine walks us through how this widespread corruption came to be, including the shocking story of one particularly egregious (and unfortunately not uncommon) example of an Indian drug company, Ranbaxy, whose business model was completely dependent on falsifying data in their drug applications to the FDA. We then discuss the subsequent investigation into Indian and Chinese drug manufacturing plants which revealed that nearly 80% of them are tainted with fraud. We conclude this discussion on a positive note with i) how individuals can investigate their own drugs to protect themselves ii) an innovative pharmacy attempting to disrupt the market and iii) some ideas on how to reform to the regulations around generic drugs, the FDA, and more.

 

We discuss:

• How Peter found Katherine’s book, and what convinced her to investigate the generic drug industry [5:45];
• Branded vs. generic drugs: Why they aren’t the same thing [11:15];
• The Food and Drug Administration: Why it was originally created and what it does today [20:45];
• How the generic drug industry really got its start in the U.S., and the flaw of the Hatch-Waxman Act [28:20];
• PEPFAR: How a well-intentioned plan to help Africa with the AIDS epidemic laid the groundwork for corruption [36:30];
• The story of Ranbaxy: An Indian drug company whose business model was fraud and deceit [40:45];
• How the FDA approves drugs, the impact of “first to file”, and Peter’s tangent on moral corruption [47:30];
• A booming generic drug market and the FDA struggling to keep up [57:15];
• Dinesh’s internal investigation finds widespread fraud and falsified data inside Ranbaxy [1:00:15];
• Presenting the famous SAR document to Ranbaxy’s board of directors which spells out the company-wide fraud [1:09:15];
• Dinesh blows the whistle on Ranbaxy which leads to a raid on their US plant [1:19:45];
• Formal investigation of Ranbaxy is launched, but the FDA keeps approving Ranbaxy drug applications [1:33:30];
• What role does the culture in India play in the high prevalence of fraud in the drug industry? [1:41:00];
• The extreme prevalence of data fraud/manipulation in foreign generic drug factories [1:52:30];
• Concluding the Ranbaxy story [2:06:15];
• How concerned should you be when buying a generic drug from your local pharmacy? [2:11:15];
• How to investigate your own drugs for quality to ensure you are getting what you need [2:18:30];
• An innovative pharmacy that tests all its drugs for quality [2:24:45];
• Reforming the FDA and generic drug industry: Why we need reform and ideas on how to do it [2:27:45];
• The importance of taking individual ownership and not waiting for Congress to bail us out [2:34:00];
• Closing thoughts from Katherine [2:36:50]; and
• More.

Learn more: https://peterattiamd.com/ Show notes page for this episode:

https://peterattiamd.com/katherineeban/

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