I first met Jane (not her actual identify, in fact) on a Friday afternoon in our clinic. She was referred for additional analysis of her chest ache, which, within the context of her household historical past of early-onset coronary heart assaults and her morbid weight problems, understandably involved her major care physician.
Within the examination room, we dissected her signs and determined we’d examine them additional with a stress take a look at. We additionally mentioned her weight. It was clear from our dialog that Jane was motivated. For months, she had intently watched what she ate. She took walks throughout her lunch break in an workplace park and usually went to the health club. She tried stress leisure strategies like meditation. She made positive that she acquired sufficient sleep.
However her efforts didn’t appear to work. She had heard about Ozempic and the way it may assist folks like her shed extra pounds, whereas additionally selling her coronary heart well being. She requested me if it was a good suggestion to strive, and I believed it was. Her insurance coverage firm, nevertheless, thought it knew higher.
Lately, I’ve seen quite a lot of sufferers like Jane: Grappling with weight problems and the metabolic illnesses cascading from it, they’re now among the many plurality of People who’ve an FDA indication for semaglutide (the generic identify for Ozempic). Truly acquiring this drug is not any straightforward feat. Some sufferers, like Jane, have their prescriptions blocked by insurers, scared away by its price ticket, via instruments like prior authorization (requiring duties like seeing a specialist in weight problems medication first, or enterprise a weight administration program for months earlier than a GLP-1 receptor agonist is on the desk). Others have bother filling their prescriptions, thwarted by drug shortages. Many can’t afford the copay.
On this atmosphere of paperwork and rejection, an alternative choice has emerged: compounded semaglutide.
Weight reduction medication and not using a prescription? Research warns it’s a ‘very dangerous enterprise’
Compounded medication — copycat variations of a drug made in state-licensed pharmacies, moderately than by drug producers — have lengthy been utilized in medication, akin to to create customized drugs for sufferers who may need particular allergy symptoms, or who want a drugs that isn’t commercially out there. The FDA, via its 503B program, authorizes compounding pharmacies to make non-generic medication which are listed in scarcity, akin to semaglutide at present.
At first, I used to be cautiously hopeful. Compounded semaglutide has confirmed to be cheaper and extra accessible than its brand-name counterpart. Lots of the massive direct-to-consumer firms promoting them, like Ro Well being and Hims, are family names, publicly traded on the New York Inventory Change and servicing hundreds of patient-consumers, offering prescriptions to deal with situations like despair, smoking cessation, and hair loss. With packages like well being teaching, these firms additionally appear to be taking a extra holistic method to weight reduction. It appeared like a gorgeous and straightforward resolution to a irritating downside.
However watching this house evolve, I’ve grown extra skeptical. Compounded semaglutide, for one, isn’t user-intuitive, requiring sufferers to attract up doses in vials moderately than use pre-filled pens. It’s no shock then, that poison management facilities have reported receiving hundreds of calls associated to semaglutide overdoses over the previous yr, up over 1,500% in quantity since 2019.
Over this identical interval, the FDA has issued warnings about compounded semaglutide. It has obtained stories of hostile occasions affecting tons of of sufferers, and cautioned that the compounded medicines themselves could also be utilizing semaglutide salts or could possibly be adulterated with toxins or impurities. Direct-to-consumer firms, in a number of cases documented by journalists, have been fast to dispense compounded semaglutide, with little verification of knowledge or interactions with a doctor. And compounded medication, particularly when produced en masse and in pharmacies with little or no FDA oversight, are additionally liable to each dosing errors and sterility points. Greater than 10 years in the past, a compounding pharmacy in Massachusetts produced contaminated steroid spinal injections, in bulk, that resulted in a widespread fungal meningitis outbreak, injuring greater than 700 sufferers and killing 100.
Compounding pharmacies want stricter federal oversight
Since these medication have emerged as compelling therapies for weight reduction, the marketplace for semaglutide has in the end failed. Compounded semaglutide, ubiquitous on-line, has actually stepped into the void to make this remedy extra accessible to most of the people. However within the course of, it has created an ill-defined public well being disaster beneath our noses, fed by greed and preying on weak sufferers who flip to questionable but handy options on-line.
For regulators, this challenge has been tough to handle. The 503B program successfully creates a loophole for direct-to-consumer well being firms to promote compounded semaglutide. These pharmacies are in the end regulated by state pharmacy boards, moderately than centrally with the FDA. Additionally it is more and more obvious that this challenge shouldn’t be going away anytime quickly. Compounded semaglutide has confirmed to be profitable for firms like Hims, whose inventory value has soared over 30% since asserting its weight reduction program. In August, Hims introduced it was buying its personal 503B-compliant outsourcing pharmacy to internalize its manufacturing of compounded semaglutide, additional digging its heels into the market.
Some have warned that, as soon as semaglutide is not in scarcity (which can be in a matter of days), the compounded semaglutide market would not be legally viable and would face an onslaught of lawsuits from Novo Nordisk, semaglutide’s producer. But when compounding pharmacies had been to make one thing like semaglutide (akin to semaglutide combined with vitamin B12), it may create a authorized standoff between them and Novo Nordisk that might final for years, or for much longer.
Within the examination room, Jane and I in the end determined to strive an older medicine, metformin, for now to assist with weight reduction alongside different life-style modifications. I beneficial in opposition to attempting compounded semaglutide. For now, it carries far too many potential risks in the best way it’s at present distributed, and the sufferers who use it are left solely weak to the unregulated requirements of the pharmacies who make them.
However going ahead, I hope we will create higher options for sufferers like her. Some nations, akin to Australia, have taken drastic measures and have banned compounded semaglutide altogether. Given the dimensions of the market, nevertheless, that doesn’t appear possible at this level within the U.S. Since compounded semaglutide is probably going right here to remain, laws is sorely wanted to manage its manufacturing and sale for shopper safety.
And to in the end handle the difficulty, we might have extra artistic options. It could contain Medicare negotiating the value for semaglutide with Novo Nordisk, or having insurers pay for it utilizing a subscription mannequin, just like what was accomplished for hepatitis C therapies after they had been first launched. It may even imply shopping for out the patent for semaglutide from Novo Nordisk, or shopping for out the drug firm altogether.
If the established order continues, the system of haves and have nots we’ve created within the period of Ozempic will solely worsen.
Vishal Khetpal is a fellow in heart problems within the Brown College Cardiology Fellowship Program. The views expressed are these of the writer and don’t essentially mirror the views of his employers.
