#75 - David Light: Zantac recall due to cancer concerns – what you need to know

Oct 14, 2019

David Light, CEO of Valisure and expert in pharmaceutical analysis, discusses the alarming Zantac recall linked to cancer risks. He reveals how his company discovered dangerous NDMA levels in ranitidine, emphasizing its inherent instability and the FDA's insufficient response. Light provides insights into the role of rigorous testing in ensuring drug safety and the complexities surrounding generic medications. Together with the host, he offers practical advice for anyone taking Zantac and stresses the need for improved regulatory practices in the pharmaceutical industry.

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INSIGHT

Valisure's Unique Approach

Valisure is an online pharmacy with an analytical laboratory.
It chemically tests every batch of medication it dispenses, providing certificates of analysis.

INSIGHT

FDA's Limited Testing

The FDA does not conduct chemical testing on the majority of medications.
Manufacturers, often overseas, perform tests and self-report results, creating potential for issues.

ANECDOTE

Inconsistent Medication Effects

David Light's friend experienced adverse reactions with his anticonvulsant medications after refills.
This prompted Light to investigate medication quality and led to the founding of Valisure.

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In this episode, David Light, CEO of Valisure (the company which alerted the FDA to the Zantac cancer concerns), explains the story behind the recent recalls by manufacturers of ranitidine, a common heartburn medication, sold under the trade name Zantac, due to a potential link to increased cancer risk. David breaks down all the evidence, the role of his unique pharmacy company which tests all its drugs before being dispensed to consumers, and the reason behind the FDA’s tempered reaction to the alarming study results. David makes the argument that Zantac/ranitidine is an inherently unstable molecule which explains the grossly excessive amounts of NDMA (a probable human carcinogen) as opposed to just a contamination for which there could be numerous causes. Finally, David and Peter both provide recommendations for what to do if you or someone you know is currently taking Zantac/ranitidine.

We discuss:

The impetus for starting Valisure, a unique online pharmacy that tests all its medications [6:45];
The story behind the recall of valsartan, and the role which Valisure played [24:30];
Testing Zantac: The shocking results from Valisure’s initial testing with major potential cancer implications [36:00];
NDMA - the probable human carcinogen found in Zantac/ranitidine [48:45];
The epidemiology question: Are we inferring too much from epidemiology? What can we take away from the existing studies? [53:30];
The staggering results from the 2016 Stanford study, why it didn’t alarm more people, and how Valisure found the missing biological link [1:01:30];
Alerting the FDA, the FDA’s tempered response, and question of contamination vs. inherent instability [1:07:30];
How confident is David that the elevated levels of NDMA being found in ranitidine are not due to instrumentation, human error, or temperature contamination? [1:24:15];
The massive risk being taken by the FDA by not doing more to keep ranitidine away from consumers [1:25:15];
If someone is taking Zantac/ranitidine, what should they do? What else do they need to know? [1:27:45]; and
More.

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