Zantac's Maker Kept Quiet About Cancer Risks for 40 Years

Glaxo says the heartburn drug doesn't cause tumors. But the company was warned by its own scientists and independent researchers about the potential danger. From a report: The small British company was sometimes called Glaxo University, because it conducted important pharmaceutical research that rarely resulted in profitable drugs. Then the scientists at Glaxo Laboratories created a molecule they called ranitidine, and in 1978 the company was granted a US patent. The molecule was new, but not novel. The scientists had, as scientists sometimes do, looked for a way to mimic the success of an established drug -- in this case, one that healed ulcers and could be used to treat heartburn. They developed ranitidine quickly, and the US Food and Drug Administration reviewed it quickly. Glaxo gave it the brand name Zantac. Glaxo marketed it as better and safer than the drug that inspired it, Tagamet, and before long, Zantac overtook Tagamet to become the world's bestselling prescription medication. For years, Glaxo counted on Zantac for nearly half of its sales and almost as much of its profit. The company won an award from Queen Elizabeth; the chief executive officer was knighted. Zantac created reputations and fortunes. It financed the modern version of Glaxo, which, after mergers and takeovers and spinoffs, ended up as GSK, a company now worth some $73 billion. Among its most popular drugs are the antidepressants Paxil and Wellbutrin and the shingles vaccine Shingrix. But not Zantac. In 2019 the drug was found to be tainted with high levels of a probable carcinogen. Not by chance or mistake in a few batches. The poison is created by ranitidine itself. Zantac's makers and health regulators around the world recalled the drug, and in the spring of 2020 the FDA forced it off the market altogether. No company could manufacture it; nobody should ingest it. The carcinogen, called NDMA, was once added to rocket fuel and is now used only to induce cancer in lab rats. The FDA says consuming minuscule amounts isn't harmful. But tests were revealing excessive amounts of NDMA in ranitidine -- and a capacity to create even more over time. No version seemed safe. From ranitidine's beginning to its end, Glaxo had been warned by its own scientists and independent researchers about the potential danger. An account of those four decades emerges in hundreds of documents, thousands of pages, many of which have never been made public. Bloomberg Businessweek reviewed court filings, many still under seal, as well as studies, FDA transcripts and new drug applications obtained via Freedom of Information Act requests. They show that the FDA considered the cancer risks when approving ranitidine. But Glaxo didn't share a critical study. Over the years, the company also backed flawed research designed to minimize concerns and chose not to routinely transport and store the medication in ways that could have eased the problem. Glaxo sold a drug that might harm people, tried to discount evidence of that and never gave anyone the slightest warning. More than 70,000 people who took Zantac or generic versions of it are suing the company in US state courts for selling a potentially contaminated and dangerous drug.

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