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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