As medical scientists increase the understanding of diabetes and the role that hormones can play in treating the disease and clinical obesity, doctors, drug makers, insurers, and others in U.S. health care are running smack into familiar, significant problems.
These include issues with public perceptions about weight, diet, and appropriate prescribing of powerful medications, as well as challenges about who pays for what in the nation’s complex health care system.
The latest, evolving tangles concern semaglutide and liraglutide, two drugs in a group that experts at the drug maker Novo Nordisk pioneered to treat diabetes. Investigators developed the drugs as doctors, patients, and researchers suddenly learned more about extreme weight loss through increasingly popular gastric surgeries, finding that the procedures also altered patients’ hormones like ghrelin, popularly dubbed the “hunger hormone.”
They found that certain hormones, not only affected insulin and blood sugar levels but also suppressed appetite and increased patients’ feelings of fullness after eating. These effects can lead to weight loss, even significant shedding of pounds for some. This is an important component, with diet and exercise, in managing and even preventing the serious condition of diabetes.
The new drugs, which vary in how often they must be taken and how, initially were approved for treating diabetes. And they quickly became a way for diabetics who were clinically obese to lose more weight than they had been able to do so on previously existing prescription medications.
A drug with twin uses
Here, however, is where the challenges began, as Novo Nordisk’s original diabetes drug Ozempic, with semaglutide and requiring a weekly injection, soon had companions. These include Wegovy, with semaglutide in higher dose, for weight loss, and Saxenda, another weight loss med using liraglutide. The company also has put out semaglutide as Rybelsus, a tablet form for diabetics who do not want to inject the drug.
The diabetes-treating drugs with semaglutide and liraglutide, approved by the federal Food and Drug Administration, have gained wide acceptance, as they have shown themselves to be safe, effective, and useful — with side effects, including nausea, vomiting, abdominal pain, diarrhea, and constipation. Insurers now cover doctor prescriptions for these drugs, with Ozempic becoming what one health industry trade publication dubbed a billion-dollar-a-year-plus “blockbuster” for its maker.
To the consternation of increasing numbers of patients, however, the use of these meds for weight loss alone has not taken off on a similar, big way. Instead, as the New York Times reported:
“[E]ven if a patient’s insurer will cover weight loss drugs, most doctors do not suggest the drugs and most patients do not ask for them, as they fail to realize there are good treatment options, said Dr. Scott Kahan, an obesity medicine specialist in Washington, D.C. And, he added, even if doctors and patients know there are FDA approved drugs, many think they are ‘unsafe or not well studied and that everyone regains their weight.’”
Doctors’ reluctance may be rooted in several causes, including the terrible history of weight loss drugs, notably the calamity involving the dual-medication treatment nicknamed Phen-fen. As Chemical Engineering News, a publication of the nonprofit American Chemical Society, reported:
“The 1970s and 1980s were a long dry spell for new weight-loss drugs. That ended in 1996, when the FDA approved dexfenfluramine as a stronger version of the previously approved weight-loss drug fenfluramine. Both drugs were part of a class of appetite suppressants called serotonergic anorectics, which work by lowering the amount of serotonin in the brain. Doctors had previously paired phentermine with fenfluramine, in an infamous combo dubbed fen-phen. Then came reports of heart valve damage in people taking fen-phen. In 1997, the FDA pulled fenfluramine and dexfenfluramine off the market, marking the beginning of a merry-go-round of regulatory rejections, approvals, and withdrawals for weight-loss drugs … Nadia Ahmad, the medical director for Eli Lilly and Company’s obesity product development, says [a] long string of safety issues and product failures is why the field has been considered such a gamble for pharma companies. ‘You have one drug that goes off the market for whatever reason, and it really shuts down for like a good decade any further pharmaceutical development,’ she says.”
While the latest diabetes-weight control drugs have built up deeper records on their safety and effectiveness, notably in dealing with a serious disease, doctors’ general caution about prescribing the meds also may be due to their notable challenges in handling patient concerns about excess pounds.
Solutions needed to excess weight problems
The New York Times, in a hearty booster tone for a pills-for-overweight posture, reported this about efforts to push increased use of new obesity drugs:
“No one disputes the problem — more than 40% of Americans have obesity, and most have tried repeatedly to lose weight and keep it off, only to fail. Many suffer from medical conditions that are linked to obesity, including diabetes, joint and back pain and heart disease, and those conditions often improve with weight loss. ‘The evidence is now overwhelming that there are physical changes in weight regulating pathways that make it difficult for people to lose weight and maintain their weight loss,’ said Dr. Louis Aronne, an obesity medicine specialist who directs the comprehensive weight control center at Weill Cornell Medicine. ‘It’s not that they don’t have willpower. Something physical is holding them back.’ Dr. Aronne and other obesity medicine specialists emphasize that obesity is a chronic disease that should be treated as intensively as heart disease, diabetes, high blood pressure or any other chronic illness are. But, they say, that rarely happens.”
For regular folks, the weight challenges are, indeed, complex and daunting, including how medical experts keep telling people to lose weight to be healthier but cannot seem to find successful, sustained ways to do this. Consumers spend billions of dollars on diet and exercise regimens, even as processed foods laden with excess fat, sugar, and salt pile up in U.S. eating. And even individuals with major support systems for weight loss find it an ordeal not only to shed pounds but to keep them off. The obsession about weight has created, critics say, a stigmatizing culture too ready to “fat shame,” without clearly defining whether individuals just may be bigger than others.
The promotion of a pill-based solution for weight control already is showing signs of problems in Australia. There, denizens of TikTok have taken to the social media platform — which is popular with fit young people— with anecdotal accounts of weight loss through the taking of Ozempic. This has fueled such demand for the drug that doctors report that diabetics are starting to struggle to find supplies of a medication they need to treat their chronic disease.
By the way, a patient’s body mass index (BMI) is a key indicator for doctors in prescribing the weight loss drugs Wegovy and Saxenda, both of which also carry major warnings about their risks in thyroid tumors. In brief, BMI is itself a controversial measure, and to understand why, consider that a 5-foot-9 man weighing 200 pounds would be considered obese and a candidate for a prescription of a weight loss drug — unless, of course, you happen to be a future NFL Hall of Famer like running back Frank Gore.
Costly drugs, not insurer covered, must be taken long-term
At present, a major obstacle to wider U.S. uptake of new weight-control drugs is cost and insurers’ refusal (including Medicare) to cover them. The New York Times captures the disparity here, reporting that diabetics can be prescribed Ozempic with its $892-a-month list price covered by insurance. But those wishing to take an analog weight med Wegovy (or Saxenda) will be charged $1,350 monthly. And those patients will pay out of pocket for the drugs because insurers don’t cover them.
Still, as experience has shown, once the FDA approves a drug and allows it on the market, and once a medication has a track record of use without huge problems, doctors may be freer with their prescribing of it. The question soon may be if drug makers will see a rush of patients wanting prescriptions of weight loss meds for cosmetic reasons (they’re fit but fat obsessed) or without a willingness to also adhere to rigorous recommendations about diet and exercise (they’re looking for a quick, easy way to drop perhaps significant weight, but without hard work or invasive procedures). Hmm.
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damages that can be inflicted on them by dangerous and bankrupting drugs, notably of the prescription variety.
There’s no question that excess weight imperils Americans’ health, contributing significantly to their problems with diabetes, as well as leading killers like heart disease, and cancer. It’s good news that medical science is advancing our knowledge about dealing with the rising problem of diabetes as well as biological processes that affect appetite, food consumption, and weight.
But the quest for pharmaceutical magic solutions always carries big risks. And patients should consult in depth with their doctors before racing after the new generation of weight loss medications. These are showing some benefit — including for Big Pharma, which, by the way, does inform patients that, for now, taking weight loss drugs is a long-term commitment. Those who start on the meds may drop pounds, even a lot of them. But the weight gain typically reverses if they stop taking the drugs. Translation: an expensive drug could be part of your life for a long time.
We have much work to do to ensure the safety, access, affordability, and effectiveness of all prescription drugs, and we have more ways to go to find solutions to the nation’s struggles with excess weight and the medical conditions it fosters.
