Could this lawsuit threaten Ozempic’s future?

Ozempic and other drugs used to treat type 2 diabetes are under fire in court – but what does this mean for the future drug marketed for weight loss?

The manufacturers of the most popular diet pills are being discussed in court.

A federal court in Philadelphia will soon evaluate claims against the makers of Ozempic, Wegovy and similar products.

Dozens of patients who suffered gastrointestinal problems after taking these drugs filed lawsuits alleging that these companies failed to properly warn patients of the risks.

Weight-loss drugs are among the most successful products sold in the United States, with prescriptions increasing 40-fold from 2018 to 2023. Scientific studies have supported their safety and efficacy, and doctors prescribe them for a variety of reasons, including reducing the risk of heart attack and other cardiovascular conditions. and vascular diseases.

In recent years, celebrities and word of mouth have made these drugs go viral on social media. More than 15 million Americans have reported using these drugs as of May 2024.

So what do patient claims about the risks associated with diet pills mean for the future of these products? I am a professor of health law who studies drug control and access to drugs, and I have followed the legal developments closely. Regardless of how the trial turns out, I think it could have a major impact on public confidence and on the diet drug market.

The drugs: Ozempic, Wegovy, Rybelsus, Trulicity and Mounjaro

Several types of drugs fall under the umbrella of “weight loss drugs.” The five drugs at issue in the lawsuit belong to the same class: GLP-1 agonists or analogs, short for glucagon-like peptide-1 receptor agonists. GLP-1 agonists help control blood sugar. They were originally approved to treat type 2 diabetes.

These drugs make people feel full. Doctors started prescribing them for weight management even before the FDA approved them for that purpose. This is a practice called off-label prescribing. Off-label check writing is legal and accounts for more than 20% of check activity in the United States.

The companies: Eli Lilly and Novo Nordisk

The Danish company Novo Nordisk produces Ozempic, Wegovy and Rybelsus. The American company Eli Lilly produces Trulicity and Mounjaro.

In 2023, Eli Lilly became the world’s most valuable pharmaceutical company. The sale of Trulicity and Mounjaro played a big part in making that happen. For example, by 2023, sales of Mounjaro exceeded US$1 billion ($1.6 billion) per quarter. Both Eli Lilly and analysts predict that the company’s weight loss revenue will increase significantly between 2024 and 2030.

Novo Nordisk has also made money on diet pills. Its sale of Ozempic, Wegovy and Rybelsus has made it the most valuable company by market capitalization in Europe. It is currently more valuable than companies such as Tesla and Visa and has been described by one journalist as “the only company that supports” the entire Danish economy.

The lawsuit

The lawsuit joins dozens of lawsuits filed by patients who took one of the five drugs. They were combined in part because the legal grounds in all of these cases were similar. The trial is being held in Pennsylvania because it was the state with the most pending lawsuits. Novo Nordisk’s US headquarters are also located nearby in New Jersey.

The patients in the lawsuit each took one of the drugs described above. They all had gastrointestinal or related problems. These include intestinal blockages and gastritis, slowing or stopping the movement of food in the stomach.

On the medical side of things, patients claim that these drugs increase the risk of gastrointestinal injury. On the legal side, they claim that the companies did not properly warn patients of the risks. The case also raises the question of whether the companies made inadequate or misleading statements about these drugs. The companies have indicated that they will dispute these claims.

The consequences

We do not get to know the outcome of the case in the meantime. But this lawsuit will have immediate consequences.

First, it draws attention to the risks associated with these popular drugs. Recent studies have shown that the use of GLP-1 agonists is associated with a higher incidence of gastritis, intestinal obstruction, and pancreatitis. These problems, and many others, including an increased risk of certain tumors, are listed as potential side effects by both the companies and the FDA.

The case will likely remind people that no drug is without risk and that patients need to be aware of these risks before and during treatment.

Second, while these drugs carry risks, the FDA has reviewed the best available scientific data, performed a benefit-risk analysis, and determined that the benefits are worth the risks.

Over the past decade, however, the FDA’s credibility has come under attack. Conspiracy theories about the organization abound on social media. The FDA is often the target of baseless accusations that it approves harmful drugs and suppresses good ones.

A major legal challenge to weight loss drugs could contribute to the continued erosion of confidence in the FDA itself. And in an age of misinformation, conspiracy theorists could use the lawsuit to improperly suggest that these, or all, FDA-approved drugs are bad or unsafe.

Finally, less confidence in weight loss may eventually lead to a decline in demand. In the past, lawsuits and misinformation have caused sales to decline, which in turn led manufacturers to stop making some drugs. This was the case with a Lyme disease vaccine that was approved by the FDA in 1998 and discontinued in 2002 due to low sales. Since then, Lyme disease vaccines for dogs have been released, but humans still can’t get one.

While sales of diet pills are currently stratospheric, sometimes a seemingly isolated event like a lawsuit can trigger long-term effects.