By TIPPINSIGHTS EDITORIAL BOARD, TIPP Insights
Last week, U.S. District Court Judge Robin Rosenberg saved prominent pharma executives from not just heartburn but potential heart attacks when she ruled that claims that a heartburn drug caused cancer were not substantiated by sound science. Her ruling canceled about 50,000 cases filed in federal court.
At the heart of the matter is Zantac, an over-the-counter heartburn medication. It has been around since 1983 when it was approved as a prescription drug. Interestingly it was also one of the first drugs to hit the $1 billion mark in annual sales.
Naturally, pharma companies welcomed the ruling, with GSK, a Zantac manufacturer, stating that there was “no consistent or reliable evidence that ranitidine increases the risk of any cancer.”
But let’s not forget that in 2019, some pharmacies and drug manufacturers stopped selling the drug. The reason cited was that the ingredient, ranitidine, in Zantac “may decay over time into a chemical known as NDMA.”
In 2020, the U.S. FDA recalled all brand names of Zantac and its generic versions off the pharmacy shelves. Research indicated that the amount of NDMA in Zantac grows over longer storage times, which prompted such a move from the federal agency. The FDA also found that some version of the ranitidine-based drugs was contaminated indeed with NDMA.
In her ruling, the judge pointed to “unreliable methodologies” and a lack of “science-based standards” on the part of the plaintiffs. But by dismissing the case, the court has left Americans with unanswered questions. If there was no risk to health, would the FDA have pulled such medication from the market? Would drug manufacturers have given up a popular product without a valid reason?
No one wants or supports malicious litigation that wastes the court’s time and bleeds the corporate. Some have even pointed to the drug manufacturer’s exposure to such litigations and their need to protect themselves as a reason for the high cost of drugs!
As it is, faith in the drug and healthcare industry is running low in the country. Prohibitive costs, profit-driven industry practices, and misinformation is perpetuating the mistrust. Even when faced with an unprecedented pandemic caused by a relatively unknown pathogen, the resistance to the vaccine among close to a quarter of the population did not ease.
Under such circumstances, one must ask, did the latest dismissal help or worsen the situation? Instead of summarily dismissing the claims, shouldn’t some questions be put to the drug’s manufacturers? While the side effects of many medications are known, most are not advertised or publicized. The potentially harmful effects and the probability of occurrence are often buried in the fine print and put forth in medical terms, making it difficult for a layperson to decipher.
In the case of an over-the-counter drug that the Food and Drug Administration thought prudent to pull off the pharmacy shelves after decades, who should allay the fears of the millions who took them? Can we trust the drug manufacturers to come forward with potentially incriminating evidence? Should the courts take a more active role, especially when the matter is brought to their attention? Or do we continue to rely on checks and balances in the system that have been known to fail repeatedly?
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