GSK, Pfizer and several other drug companies are targeting the credibility of a small, independent Connecticut lab as they defend against thousands of lawsuits claiming a popular heartburn drug can cause cancer.
Valisure, a 20-person operation based in New Haven, sent shockwaves when it said in 2019 that it had found Zantac and generic versions of the drug, which have been sold in the United States for more than three years. decades, contained N-nitrosodimethylamine, better known as NDMA, which regulators classify as a “probable human carcinogen.”
Since then, more than 2,000 personal injury lawsuits have been filed and another 70,000 claims registered by users of the disputed drug, which analysts say could cost the companies tens of billions of dollars in damages.
As the lawsuits head towards a trial, the companies that have sold branded versions of Zantac for the past 35 years – including GSK, Sanofi, Pfizer and Boehringer Ingelheim Pharmaceuticals – have denied that using Zantac, the brand name of the drug ranitidine, causes an increase in cancer. risk.
In mounting their defense, they chose Valisure, saying its testing methodology was flawed, biased and undertaken in coordination with plaintiffs’ attorneys.
“Valisure’s testing, lobbying and advertising campaign is ground zero of this entire litigation,” the pharmaceutical companies claimed in court documents filed in litigation overseen by U.S. District Court Judge Robin Rosenberg. .
Next month, Judge Rosenberg will hold hearings to determine what expert scientific testimony will be admissible in the cases, focusing on testing methods and levels of NDMA that may pose a cancer risk.
Valisure’s research on Zantac has scientific experts divided. US regulators agree that NDMA should not increase cancer risk at very low levels, noting that it is present in most foods and water. However, higher and sustained levels of exposure may increase cancer risk in humans, they said.
The US Food and Drug Administration had previously concluded that Valisure’s testing methodology was “inappropriate” and “contributed to or caused an artificial increase in NDMA levels”. Documents released in response to Freedom of Information Act inquiries, which were first reported by Consumer Reports, also reveal that the agency is investigating the lab to ensure its work for companies requesting FDA approval for compliant products.
Nevertheless, seven months after Valisure published its own research on Zantac’s NDMA risk, the FDA asked manufacturers to remove all of their ranitidine drugs from the market, concluding that NDMA levels increase over time, even under normal storage conditions.
“It shows the critical importance and impact of independent testing being part of the supply chain.” David Light, co-founder and managing director of Valisure, told the Financial Times.
The pharma groups alleged the lab used a test method that was never validated to test for NDMA in ranitidine, which they said involved ‘overheating’ samples of the drug to produce ‘artificially high levels’. ” from NDMA.
The companies also argued that Valisure worked with the plaintiff’s bar to pave the way for litigation. One of the first lawsuits detailing Zantac’s alleged link to NDMA and cancer was filed by Yitzhak Levin, an attorney who is a brother-in-law of Light, according to the pharmaceutical companies.
The attorney for another plaintiff in the Zantac litigation, Gregory Frank, was a “key player in the coordination of ranitidine testing and Valisure’s citizen petition,” the companies claimed in court documents.
Neither attorney responded to a request for comment.
Light said the lab stood by its research methodology and accused the drug companies of trying to portray Valisure as being behind a “conspiracy”.
“That’s absolutely not true at all. . . We’re talking about science that’s been proven time and time again and that [screening] has an impact and needs to be used better in the industry,” Light said.
He said Valisure was sometimes engaged for advisory work on behalf of plaintiffs’ attorneys and other groups in connection with its research, but the lab was not engaged as an expert in the Zantac case. . Light said a relative of his brother-in-law was prescribed ranitidine and had evidence that it was a problematic drug.
“I think it’s appropriate that I told him not to do that.[continue to allow his relative to take ranitidine]. . . He’s a litigator and he’s filed some of these lawsuits and, you know, that’s his business,” Light said.
Big Pharma’s criticisms of the New Haven lab stand in stark contrast to the praise the lab has received from consumer advocates and members of Congress for its efforts to highlight safety issues with Zantac and other drug users. other drugs and consumer products.
Valisure is one of the few independent laboratories in the United States, which examines products to ensure that they do not contain hazardous substances. Last year it published research showing the presence of benzene, a known human carcinogen, in sunscreens and body sprays, prompting numerous product recalls by manufacturers including Johnson & Johnson.
“There’s kind of a big misconception that the FDA tests everything when the reality is, you know, the manufacturers self-report the data and the FDA basically reviews the documents,” Light said. “There are cracks in the system that are not being addressed well.”