Ozempic may not be the cure-all the world wants it to be

Across the country, one in eight adults has taken a medication like Ozempic, according to a KFF poll from last year, and even more people are learning about it. The same poll found that about one-third of all adults have heard “a lot” about these drugs.

Recent news about Ozempic seems to include a lot of claims about what it may be able to treat in addition to diabetes and obesity. Some experts are concerned, though, that studies into new applications of the drug may be driven by dishonest motivations and yield therapies that are unnecessary or ineffective.

“We’re in a phase where GLP-1 drugs [are hypothesized to] cure everything,” said Randy Seeley, the director of the Michigan Nutrition Obesity Research Center. “We’re going to be right about some of those things and we’re going to be wrong about others.”

Ozempic is a GLP-1, short for glucagon-like peptide-1, medication. It works by mimicking certain hormones and attaching to receptors that detect them, which then trigger certain effects in the body, including creating insulin and slowing the emptying of the stomach.

These drugs “are a well-tolerated medication which works terrifically for diabetes,” said Dr. Adam Cifu, a doctor of internal medicine at the University of Chicago who prescribes these GLP-1 medications. “And thus far, we’ve had essentially nothing but positive studies.”

Some are also prescribed for weight loss because they can decrease appetite. “Everybody’s looking for a more effective way to lose weight,” said Dr. Leena Khaitan, bariatric surgeon at the University Hospitals of Cleveland.

GLP-1 medications have also piqued the interest of scientists for their other potential uses, beyond diabetes and obesity treatment. In the last two years, studies have been published investigating the medications as therapy for arthritis, liver disease, Parkinson’s disease and substance use disorders, among other illnesses. Articles from The New York Times and Nature have suggested that the drugs are a miracle for their potential benefits.

Others are less accepting of that label. “I am very uncomfortable saying that. Too many things are billed as miracles and game changers and so on,” said Cifu. He believes in “miracle” drugs that can combat illness to a previously unimaginable degree, like HIV treatments, but doesn’t think that GLP-1 uses are as earth-shattering.

He divides GLP-1 drug applications into three distinct categories.

The first is a treatment that is already well-established for certain ailments. Using Ozempic to combat diabetes and Wegovy for weight loss, for example, have both been proven to be beneficial and are approved by the Food and Drug Administration, or FDA. “The basic science and the clinical effects kind of line up perfectly,” Cifu said. These uses are not so novel anymore.

The second category is applications that come from decreased blood sugar or appetite but have yet to be approved by the FDA. For example, lowering calorie intake and improving glucose levels in the blood help heart health, Cifu explained.

This group is the one he’s most excited about, not because he thinks these applications will be more effective than pre-existing treatments, but because the side effect of weight loss is visible to patients. This tangible change “is going to make people more adhered to [this treatment] than they are to another blood pressure medication, another cholesterol medication or another diabetes medication that they won’t actually see an effect from,” he said.

He’s least enthused about the third category, which is applications being developed seemingly for the sake of drug companies. Many of the recent GLP-1 medication studies are not patient-focused, Cifu thinks. They’re “answering questions which are more useful to the drug companies than to the patients … [and are] not really beneficial for a doctor and a patient making treatment decisions.”

Even though studies show improvements for people with arthritis, for example, he questions if doctors would prescribe GLP-1 drugs as a treatment when there are treatment options that already exist. “It’s unlikely people are going to choose to use these medications to improve joint pain,” he said.

Seeley, who has previously consulted for Novo Nordisk and Eli Lilly — companies that make GLP-1 drugs — disagrees. He’s excited about the potential use to treat arthritis because researchers found that people with obesity and arthritis in their knees can decrease pain by using GLP-1 medication.

He does wonder, though, with all of these new applications, “Do you need to have obesity as part of the diagnosis in order to benefit?” He thinks that there’s evidence of “weight-independent effects of the drugs.” In studies about how GLP-1 drugs affect cardiovascular health, for example, “it’s not the patients who lost the most weight who seem to have the most cardiovascular benefit,” he said.

Cifu, along with Georgetown’s Dr. Adriane Fugh-Berman, who leads PharmedOut, a Georgetown University group that studies pharmaceutical marketing, is particularly curious about how GLP-1 medications affect satiety. They wonder if doctors could use them to treat issues like gambling addiction and alcoholism, given that there aren’t great existing therapies. “Well done, randomized controlled trials in non-obese patients … would be really interesting,” Cifu said.

Research into this application is ongoing, but scientists at the National Institutes of Health reviewed existing evidence and found that it suggests GLP-1 medications “reduce addiction-related behaviors.” They point out that the evidence in humans only shows a correlation thus far and agree that comprehensive randomized controlled trials are necessary to draw further conclusions about the effects of GLP-1 drugs on addiction.

Drug companies may have motivations beyond patient wellness to find new applications, called indications, for their GLP-1 medications, explained Seeley. Under American patent law, companies usually have only 20 years from when they file a patent application to when a drug can be manufactured by anyone. Ozempic– and Wegovy-related patents will expire in 2026, for example.

If they find alternative applications, though, companies can file for new patents and get additional years of exclusively supplying a drug. To make a long story short: the more uses for a medication the FDA approves, the more money the drug companies supplying them can make.

Seeley doesn’t believe that drug companies operate in the best interest of the public. He thinks they fund trials that they hope will have the highest return on investment, which may not coincide with the most socially impactful drug. “I think you can scrutinize their selection,” he said. “They are not going to cover every [indication], even if [it’s] interesting and clinically relevant, if there isn’t a reason to believe that they can sell enough drugs to make it worthwhile.”

“It’s just interesting that these companies are trying to churn out new indications,” Cifu said. Novo Nordisk, the owner of both Ozempic and Wegovy, has not responded to requests for comment.

Fugh-Berman worries about the GLP-1 studies sponsored by drug companies. “I think there needs to be more objective evaluation of the research [rather] than taking the conclusions of conflicted authors or sponsored studies at face value,” she said.

Seeley, on the other hand, suggests that studies run by drug companies have the benefits of their considerable resources. “Where does the money come from? How do you identify the patients? All these things become much harder to do” without the infrastructure of a drug company backing a trial, he said.

Unlike some of his peers, Seeley isn’t particularly concerned by studies that are funded by drug companies. “These large companies that have a lot of brand equity are not in the business of funding poor trials … Most academics are much more likely to run a small, underpowered study that comes up with some splashy headline,” he said.

Because they are looking for FDA-approved indications, studies paid for by big companies face high levels of scrutiny, he explained, way more than “a small trial that was run by an academic group that got published particularly in a mid-tier or obscure journal.”