Transcription
Hook: How does a drug sold to millions for 40 years suddenly get banned? How does Big Pharma end up with 77,000 cancer-related lawsuits and billions in settlements? This is the story of how Zantac went from being the world's most popular drug to being poison.
Chapter 1: Background Setup
Firstly, what is Zantac, and what does it do? *(Play 0:00-0:04).* Acid reflux occurs after people eat certain kinds of foods, like those with high amounts of fat. Zantac reduces the amount of acid your stomach produces, which relieves discomfort very quickly. It also helps heartburn and similar conditions. But in truth, Zantac is just a branded name. The actual drug is called “Ranitidine.” The drug was created by GlaxoSmithKline plc, or “Glaxo,” a multinational pharmaceutical company, and in 1983, Zantac was approved for sale by the FDA.
Tension (Play 0:00-0:15). Glaxo advertised their new drug as the fix-all solution for all these problems, and soon, sales exploded. Just three years after approval, Zantac had generated over $1 billion in revenue and soon became the best-selling medicine in the world. But amazingly, this wasn’t even the peak for Zantac. It was only available through prescription, which meant you needed to book an appointment, meet with a general practitioner, and have it prescribed to you. But in 1996, all of that changed. It was finally approved for over-the-counter use. Anyone who wanted Zantac could have it.
Resolution / Payoff
Glaxo’s patent on ranitidine eventually expired, allowing other companies to sell their own versions. But Zantac was already a household name, which people trusted. It was still bringing Glaxo billions in revenue, which attracted a different kind of buyer. In 2006, Glaxo sold the rights to sell Zantac to Boehringer, who, 10 years later, sold it to Sanofi, who currently owns the drug. Zantac had made a lot of people very rich. And apparently, it had also helped many with heartburn and pain. It was a pharmaceutical success story. But all of that was about to change. This whole time, Ranitidine had concealed a dark secret.
Chapter 2: How Did This Happen?
Setup (Show footage of Zantac Commercial over narration) Ranitidine contains a chemical called NDMA, which can develop various cancers when ingested. This sounds shocking, but Zantac tablets contain a very small amount, less than the FDA’s daily intact limit of NDMA. This means the drug is safe to consume, at least they thought. As it turns out, Glaxo withheld vital information when submitting Zantac for approval. (Play from 0:29-0:52). If they didn’t tell the FDA about the risks, they certainly weren’t about to warn the public either. “London-based GSK, which developed Zantac in 1983, knew early on the drug could cause cancer and sold it anyway without warnings; a study laying out the drug’s risks was withheld from US regulators by GSK executives for 37 years.” (Source) To put it bluntly, Glaxo and the other companies prioritized profits over anything else. An uncountable number of people had used Zantac, completely oblivious to the risks—risks that were intentionally kept from them. So after almost 40 years, why did everything suddenly blow up in Glaxo’s face?
Tension
On September 9, 2019, a pharmacy noticed something very unusual. They found high levels of NDMA in some of their Zantac stock. Absurdly high levels. The FDA’s acceptable daily intake of NDMA is 96 ng (nanograms), and Zantac contains 18 ng of NDMA. But the pharmacy measured over 3,000,000 ng in their Zantac. Something was very, very wrong. They filed a complaint to the FDA and suspected that the high NDMA was caused by high temperatures. An in-depth study and experiment was promptly conducted by Emery Pharma. What they found was shocking.
Resolution / Payoff
While basic Zantac contains 18 ng of NDMA, storing it at 77°F or 25°C for 12 days causes the NDMA to increase to 25 ng. When stored at 158°F, or 70°C, the amount rises to 142 ng—well above the acceptable limit. The amount of NDMA was increasing with temperature. Anyone who left the box of Zantac in their car, or perhaps directly in the sun, would generate more NDMA than the maximum daily limit. Ranitidine had the acceptable amount of NDMA when produced, but that doesn’t mean that it will be safe to ingest by the consumer. Emery Pharma quickly filed a formal petition to the FDA, stating that Zantac “could produce unacceptably high levels of a cancer-causing chemical when exposed to heat” (source). Soon, they issued an order that all ranitidine must be recalled. The FDA stated that they “didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured” (source).
Chapter 3: The Current Situation
Setup (Show clip from 0:06-0:11), then (Show clip from 0:04-0:12) Zantac was once Glaxo’s success story, but now it’s the pharma giant’s biggest nightmare. Millions of Zantac tablets are recalled. Tens of thousands of customers who used Zantac to help with heartburn or acid reflux had been diagnosed with all kinds of cancers. This wasn’t a coincidence. It was the NDMA. Soon, these victims began to sue these pharmaceutical companies.
Tension (Show clip from 0:01-0:07) (Show clip from 0:21-0:33) But things weren’t so easy. Glaxo and the other companies were fighting tooth and nail to avoid payouts. They stated that the experiments used “unreliable methodologies, with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps” (source). Then the victims of Zantac suffered a terrible blow. In 2022, a federal judge in Florida ruled in favor of these companies, stating that the claims “weren’t sound.” In a heartbreaking ruling, over 50,000 claims were dropped against the companies. It seemed as though these pharmaceutical giants had gotten away with murder, and companies like Pfizer were “pleased” with the judgment. But the fight wasn’t over just yet. Over the next few years, victims continued to push their cases, but Glaxo had dodged most of them. But in July 2024, their luck ran out. A Delaware judge ruled in favor of cases against the company. Glaxo attempted to appeal the decision but was denied. The cases could finally go to trial, and the floodgates opened.
Resolution / Payoff
Suddenly, Glaxo faced 77,000 claims. The company is expected to pay out an estimated $3 billion in compensation. Analysts also claim that the damage to the company’s brand could be around $2 billion. But they aren’t alone. Other producers of the drug are under extreme heat, most notably the current owner of Zantac: Sanofi. The Delaware court approved 20,000 cases against the pharmaceutical giant. They are expected to pay over $100 million in settlements. Similarly, Pfizer is paying out up to $250 million to settle 10,000 lawsuits. Despite the damage they’ve caused and their massive payouts, these companies responded as well as you might expect. Sanofi stated it has “vigorously defended the Zantac litigation since the outset and will continue to do so,” and victims “had insufficient evidence that ranitidine can cause plaintiffs’ alleged cancers.” The most baffling statement of all was, “Sanofi is settling these cases, not because we believe the claims have any merit, but rather to avoid the expense and ongoing distraction of the litigations. No concessions of liability have been made” (sources). A response about as slimy and shady as you can get. There is zero responsibility or accountability.
Grand Payoff
And to make things worse, Zantac has returned to the market, now without ranitidine, the apparent cause of all these issues. But with the history of bad practices, would you go anywhere near this drug? I know I wouldn’t. Glaxo and Sanofi will continue to make a profit, but their reputation may not fully recover. Even with the billions in payouts, they can’t undo the damage caused by greed and negligence. One commenter said, “I was prescribed Zantac years ago; for years now I have a rare type of pancreatic cancer that's in my liver. Scary to think it could have come from years of taking prescription Zantac.” (Show the comment below.) No price or payout can make right the harm they’ve caused. But there may be one silver lining. These lawsuits and investigations may have set a precedent for the future of drugs. The Zantac scandal has sent shockwaves throughout the pharmaceutical industry. There have been calls for greater accountability, transparency, and regulation. Hopefully, a Zantac situation can’t be repeated. (Show clip: 0:37-0:51) There is a chance that other well-known over-the-counter drugs will reveal dark secrets. The question is, which ones? Hopefully, this means a safer future for pharmaceuticals, but only time will tell.
CTA
Another industry that is almost as rotten as Big Pharma is Big Finance. We’re trying to change that in at least a small way with Silo, a modern place to buy bonds. With rate cuts around the corner, it may make sense to lock in yields for the long term using bonds. Also, we’re currently running a 3% deposit bonus. If that sounds interesting, the link is below, but until then, I’m Hari, and I’ll see you guys on the next one.