It’s Time to Take a Close Look at the Credibility of the Lab at the Center of Mass Pharmaceutical Litigation

Rep. Rosa DeLauro (D-CT) recently wrote a letter pushing the U.S. Food and Drug Administration (FDA) to investigate pharmaceutical manufacturer GSK plc and “hold them accountable” regarding the company’s heartburn medication, Zantac.

The product was pulled off the market in 2020 after a study by Valisure, a private lab that found that one of the medication’s ingredients could possibly become carcinogenic under highly unlikely circumstances.

In light of the concerning information recently coming to light about Valisure’s questionable scientific methods and close ties to the plaintiffs’ bar, Rep. DeLauro’s inquiries are misdirected. It is Valisure, not GSK, that should be answering the tough questions on Capitol Hill.

The multi-district litigation involving Zantac was dismissed a few months ago after the flaws behind the science of Valisure’s claims were exposed by Judge Robin Rosenberg, which, as she pointed out in her opinion, “undermines the credibility of their findings.”

Valisure’s testing methodology involved heating the product to well over 200 degrees, which is clearly not a realistic scenario for how an individual would consume the drug, considering that is double the temperature of the average healthy person.

Besides heating the product to temperatures it would not otherwise be subjected to, Valisure also tested the product with an artificial stomach containing unusually high amounts of salt – amounts that humans could not safely ingest.

To make matters worse, the FDA actually found that Valisure’s lab equipment created NDMA, the cancer-causing chemical in question. 

Judge Rosenberg wrote in her opinion that “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.”

In addition, the Wall Street Journal recently exposed what amounts to an attempted legal shakedown by Valisure. During the course of litigation against Unilever, the lab “offered” to keep certain testing information confidential, for a price, raising further concerns about their credibility and general business tactics. These conflicts of interest raise serious questions about the motives behind their testing and suggests there may be a financial incentive behind Valisure’s actions.

Rep. DeLauro should turn her attention to Valisure, whose labs are located in her district, to ensure it is not simply doing the plaintiffs’ bar’s bidding. Sound science, not financial incentives, must be the basis for any future FDA activity.