The Zantac Scare and Junk Science

A federal judge exposes the false claims behind a trial-lawyer assault

WSJ editorial.

"The press typically treats lawsuits against business as inherently righteous and amplifies the junk science behind them. So in case you missed it, a federal judge on Tuesday dismissed claims that the once top-selling heartburn medication Zantac causes cancer in a debunking for the ages.

A few years ago, the small lab Valisure generated headlines after purportedly finding astronomical levels of the cancer-causing chemical NDMA in Zantac (ranitidine). The Food and Drug Administration’s daily limit for NDMA is 96 nanograms, and Valisure claimed to have found levels exceeding 3,000,000 ng. Talk about causing heartburn.

The same day that Valisure announced a “Citizen Petition” with the FDA urging a recall of ranitidine, numerous lawsuits were filed against drug manufacturers. This suggests coordination between plaintiff attorneys and Valisure. The FDA investigated and initiated a recall after finding NDMA in some pills that exceeded 96 ng.

But as Judge Robin Rosenberg notes in her 341-page ruling, the FDA daily limit is “conservative”—equivalent to a meal of grilled meat. “If one were to consume 96 ng of NDMA every day, for 70 years in succession, the risk of cancer would be 1 in 100,000, or .001%,” and “even the highest-tested pill [by the FDA] showed NDMA at a tiny fraction of the level reported by Valisure.”

This important context was left out of lawsuits and press reports. Ditto that the FDA found Valisure’s lab equipment created NDMA. It gets worse, as Judge Rosenberg details. Valisure heated the ranitidine to 266 degrees Fahrenheit—well above the roughly 98 degree temperature found in the human body—to achieve its test result of 3,000,000 ng.

When Valisure tested ranitidine at 98 degrees, it found no NDMA. The extremely high temperature may have caused ranitidine to degrade into NDMA. Valisure also tested ranitidine’s reaction with salt in an artificial stomach, which resulted in NDMA levels exceeding 300,000 ng. But the enormous levels of salt in the test might alone have been enough to kill someone.

When Valisure tested ranitidine with salt concentrations approximating what a human could safely ingest, it detected no NDMA. The plaintiffs also relied on a Stanford University study that reported to find NDMA levels in ranitidine exceeding 47,000 ng. That study was later retracted by its authors after the lab equipment was found to have created NDMA.

“There is no scientist outside this litigation who concluded ranitidine causes cancer, and the Plaintiffs’ scientists within this litigation systemically utilized unreliable methodologies with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps, a lack of statistically significant data, and a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data,” wrote Judge Rosenberg, who was appointed by Barack Obama.

Share prices of ranitidine manufacturers GSK and Sanofi surged after the judge dismissed some 50,000 lawsuits. Morgan Stanley estimated potential damages against the various drug makers could reach $45 billion if the litigation were successful. Drug makers have had to spend tens of millions of dollars to defend themselves and face tens of thousands of more lawsuits in state courts. And progressives complain about high drug prices?

Valisure’s role in the Zantac and other consumer lawsuits deserves more scrutiny. Its report that the diabetes drug metformin contained high levels of NDMA also triggered a blizzard of lawsuits. Valisure made headlines again in recent months after reporting scary-high levels of the carcinogen benzene in sunscreens and dry shampoos.

On Monday the FDA sent Valisure an eight-page letter criticizing its data controls, equipment and failure to “establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods.” A spokesperson said Valisure will respond to the FDA letter but offered no comment on the judge’s ruling. The Valisure methods and plaintiff attorney suits look like a litigation scam, and congratulations to Judge Rosenberg for exposing it."