PHARMA EXEC TESTIFIES THAT ZANTAC WAS SAFE, EFFECTIVE
A pharmaceutical executive was grilled for hours about the safety of Zantac on Monday in a Cook County courtroom in the first jury trial to determine whether the popular heartburn drug causes cancer.
His testimony was part of the trial for a suburban Chicago woman’s lawsuit claiming Zantac caused her colon cancer. The executive, a medical doctor who oversaw drug safety for decades at GSK, maintained that Zantac was a safe and effective drug.
The suit is the first of thousands throughout the country to make it to a jury trial. Angela Valadez is suing two drugmakers, GSK and Boehringer Ingelheim, alleging that the active ingredient in Zantac, called ranitidine, turns into the cancer-causing substance NDMA as it ages or is exposed to high temperatures and humidity.
Mikal Watts, one of Valadez’s attorneys, questioned Dr. Stephen Hobbiger, a U.K. physician who worked for GSK for more than 20 years and specialized in drug safety and medical governance.
Watts focused much of his questioning on NDMA. He referenced scientific organizations that call it a recognized carcinogen in lab animals and humans. He also discussed many studies throughout his questioning, focusing on one from 1982 that found Zantac, or ranitidine, can turn into NDMA when it interacts with an acid similar to what’s found in the stomach.
While acknowledging that ranitidine can degrade into NDMA, Hobbiger repeatedly pushed back on the claim that Zantac causes cancer. He pointed out that the 1982 study that found NDMA in ranitidine only happened under “very abnormal” conditions and at levels of NDMA that humans don’t encounter in everyday life.
One of GSK’s attorneys, Tarek Ismail, asked Hobbiger if Zantac has ever been found to cause cancer, and specifically colon cancer. He said scientists at GSK, outside researchers or any regulatory agencies have not found a connection.
Ismail then asked Hobbiger why GSK stopped making and recalled the drug in 2019 after a study found that NDMA was present when ranitidine degrades.
“From a safety perspective, we were trying to find out if there was a concern for patients taking ranitidine. We first ceased supply as a prudent and safe response, and subsequently a recall was the right thing to do,” Hobbiger told the jury.
“As a physician, I wanted to make sure what was being recommended to patients is safe.”
After the recall, GSK, the FDA and Europe’s version of the drug regulatory agency deemed ranitidine safe, Hobbiger said.
In 2020, the FDA recalled ranitidine, including Zantac and its generics, after a lab found “exceedingly high levels of NDMA” in the drug.
Hobbiger was questioned for nearly eight hours by Watts and Ismail.
Valadez, 89, testified last week that she used Zantac for 18 years and developed colon cancer after she stopped taking the drug. Following her cancer diagnosis and surgery, she told the jury she’s dealt with uncontrollable diarrhea, which has prevented her from leading a normal life.
Last week, Pfizer settled more than 10,000 lawsuits related to Zantac and similar cancer claims, Reuters reported. Pfizer — which sold Zantac between 1998 and 2006 — was originally included in Valadez’s suit, but she settled out of court with the company before the trial started.