Pharmacy head who researched zantac link to carcinogen says fda has 'downplayed the problem'

Pharmacy head who researched zantac link to carcinogen says fda has 'downplayed the problem'

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_Last week, regulators in the U.S. and Europe disclosed that the same carcinogen that led to numerous recalls over the past year of valsartan and similar blood pressure pills was found in


Zantac and other antacid medicines known as ranitidines. The Food and Drug Administration, however, was first alerted to the presence of the carcinogen, known as NDMA, by Valisure, a small


online pharmacy that also tests batches of each medicine it sells. We spoke with David Light, a co-founder and chief executive officer, about the decision to look for NDMA and why he


believes that regulators are failing to characterize the problem properly. This is an edited version of the conversation._ PHARMALOT: You sell medicines online, but how and why did your


company start testing them? LIGHT: We launched less than a year ago, and we’re a pharmacy attached to an analytical laboratory. The concept began when a college buddy, who is our other


co-founder, had problems with a medication. His doctors told him that 80% of the medicines in this country are generics and most of the finished products or ingredients are from China and


India, but there’s not much they can do about it. He didn’t like that answer and called me up. … We saw that chemical testing for impurities or other problems is lacking, and one possible


reason is the technology is expensive, cumbersome, and built to look for one thing at a time in a big factory. So we spent time developing a laser-based approach to do more difficult parts


of chemical analysis. We also saw there was quite a disincentive for industry to do anything about it. But if we show a pharmacy there’s a bunch of junk in the medicines on their shelves,


then they have to do something about it. So we decided to attach this to a pharmacy to bring a benefit directly to consumers and address the issue about medicine quality. … Because of the


recalls of the blood pressure pills, we added a carcinogen capability using industry standard techniques. STAT+ Exclusive Story Already have an account? Log in THIS ARTICLE IS EXCLUSIVE TO


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