The Patriot Post® · In Brief: The Zantac Scare and Junk Science
Corporations can do dumb and nefarious stuff (see Twitter). Sometimes, however, it is the accusers who are dumb or nefarious. Such seems to be the case in a lawsuit against the popular antacid Zantac, and The Wall Street Journal editorial board has the details:
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.”
In fact, as the Journal highlights, not just that context but other critical information was ignored by the press as “journalists” grabbed their pitchforks. Valisure’s testing involved deceitful methods meant to drastically increase the levels of NDMA either through overheating or adding tons of salt. In fact, it could be that NDMA isn’t found at all under normal conditions: “When Valisure tested ranitidine at 98 degrees, it found no NDMA.” Also, “When Valisure tested ranitidine with salt concentrations approximating what a human could safely ingest, it detected no NDMA.”
As it turns out, the Journal says:
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.
Back to the ruling:
“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?
Again, it’s not that corporations are always pure as the wind-driven snow, but this sort of tort lawsuit is one of the biggest drivers of higher prices, and Valisure is a repeat offender that the FDA has written in reprimand. The Journal concludes:
The Valisure methods and plaintiff attorney suits look like a litigation scam, and congratulations to Judge Rosenberg for exposing it.