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Pharmaceutical groups Novo and Eli Lilly have defended the wider health impact of their market-leading obesity drugs after fresh criticism from a British nutrition entrepreneur added to concerns over the side effects of the blockbuster treatments.
Speaking at the FT Pharmaceutical Summit this week, Tim Spector, co-founder of nutrition app Zoe, claimed users of so-called GLP-1 drugs had “terrible” gut microbiomes, “much worse than I expected given the benefits of the drug”.
“If you don’t take care of your diet at the same time (as you take medication), you’re going to really mess with your immune system,” Spector said, later clarifying that he was referring to as-yet-unpublished research on semaglutide users conducted by Zoe and her academic partners.
“We can’t yet say whether the drug itself is responsible, whether it reflects lower fiber intake or where people are coming from,” Spector told the FT, adding that the drugs have “clear benefits for many people”.
In response to concerns about gastrointestinal issues, Novo said its drug semaglutide had been “extensively reviewed.” The company works closely with regulators “to continually monitor the safety profile of our medicines,” it says.
Eli Lilly – which does not use semaglutide in its medications – said it actively monitors and reports safety issues with its medications. “If anyone experiences side effects while taking a Lilly medication, we encourage them to talk to their healthcare professional,” a spokesperson said.
Spector’s comments highlight the growing debate over the costs and benefits of obesity drugs known as GLP-1, whose growing popularity has made it one of the world’s best-selling drugs.
Vaccines and pills have been shown to significantly reduce weight and the risk of heart disease, but have also been linked to problems such as stomach problems and vision loss, as well as indirect effects resulting from poor diet.
Doctors from the American Society for Nutrition and others said last year that “preventing nutritional deficiencies” was “critical” for GLP-1 patients.
The use of GLP-1 has raised awareness of the impact of rapid calorie reduction on nutrition and the extent to which the dramatic suppression of appetite triggered by medications can lead to fatigue, hair loss and muscle wasting.
The head of US consumer group Kimberly-Clark said last week that sales of its hair loss treatment Rogaine had jumped 30% since the start of the year, adding that this “could be boosted by the adoption of GLP-1”.
Novo and Lilly — which together generated about $67 billion in sales of diabetes and obesity drugs last year — have come under increasing pressure from regulators and faced litigation over a range of alleged side effects.
This week, the U.S. Food and Drug Administration ordered GLP-1 manufacturers to add warning labels to their products about the risk of a rare but serious condition that can lead to permanent blindness in one eye.
Novo and Eli Lilly already face hundreds of lawsuits in the United States from patients alleging their drugs caused the condition, known as non-arteritic anterior ischemic optic neuropathy (Naion). The companies said patient safety was their “top priority” and denied any causal link between the disease and their drugs.
“We recognize that Naion can have a profound impact on patients and their families,” Novo said. “Novo continues to believe that the data does not establish a cause and effect relationship,” adding that it is defending itself in court.
Both groups acknowledged that their drugs commonly cause gastrointestinal side effects, including vomiting, nausea and constipation and, in rare cases, acute pancreatitis. However, they deny lawsuits in the United States that the treatments caused more serious gastrointestinal damage and that those customers were not warned of the risks.
Novo and Lilly said the side effects are far outweighed by the benefits of GLP-1, whose potential uses now extend from treating diabetes to substance dependence. A study published this year found that obese drug users were less likely to suffer from many common addictions, including alcohol, cannabis, cocaine, nicotine and opioids.
Furthermore, Novo and Lilly have both published results on the possible impact of these drugs on slowing biological aging.
Semaglutide – the active ingredient in Novo’s Wegovy – reduced the biological age of the heart by about two to four years compared to a placebo, according to an analysis of 10,052 people published by Novo scientists and other researchers in September. The group found reductions of one to four years in measurements of the kidneys, brain, pancreas, lungs and several organs, according to the research.
Gn Health
