In the five years or so that semaglutide, commonly known by its brand name, Ozempic, became available in Ireland, it has transformed not just how we treat obesity, but also public perceptions of the condition. The penny is finally dropping that rather than being a manifestation of inadequate motivation, discipline or intelligence, excess body weight arises from dysfunction in parts of the brain that are beyond our conscious control, but which can be brought back to normal with drug therapy.
But patients attending obesity clinics are currently denied access to this potentially life-saving treatment. It has been almost a year since doctors were “warned” by the Irish Medical Council not to prescribe Ozempic for the treatment of obesity, on the basis that it isn’t licensed and that it would deprive people with diabetes of the drug. The difficulty with this is that the generic ingredient in Ozempic, semaglutide, has been licensed for obesity treatment since 2022.
Predictably, the result of this communication has been calamitous for patients: many of those returning to our obesity clinic in Galway in the past year have lost all of the health gains they made, after pharmacies have withdrawn their semaglutide because they don’t have diabetes. It’s heartbreaking.
The response last year from obesity clinicians and patient advocacy groups was immediate, unambiguous and forthright in highlighting our concerns about inaccuracies in the guidance and the substantially negative impact it was bound to have on patient care.
When semaglutide is already licensed at a weekly dose of up to 2.4mg to safely treat obesity (the Wegovy “high” dose), for the Medical Council to say that the lower, 1mg Ozempic dose is unapproved, or “off-label”, is like saying that a 10-seater bus can’t take four passengers. And saying that patients with diabetes should be prioritised over patients with obesity is as arbitrary and unreasonable as cancelling the bus to Tallaght on the basis that people from Rathfarnham really need to get home.
The Medical Council clarified at the time that it was simply encouraging “mindful prescribing” and that “doctors are expected under ethical guidelines to use resources appropriately and responsibly”. If the inference here is that those of us using semaglutide to treat obesity aren’t being mindful, ethical, appropriate or responsible enough, it is a disgraceful mischaracterisation of the clinical practice of obesity experts around the country.
Communication from the Medical Council has felt inadequate – basically writing to individual doctors and organisations commending their patient advocacy, but not issuing a follow-up correction of the inaccurate “warning” to all doctors and pharmacists. All the while, GPs remain understandably reluctant to prescribe a really effective treatment, and chemists remain reluctant to dispense it.
Semaglutide appears to be relatively safe, though not entirely risk-free. Follow-up studies to address concerns about serious potential problems like medullary thyroid cancer have been short or not always completely reassuring. In 2017, Novo Nordisk, the maker of semaglutide, was fined $58.7 million in the US after sales reps were found to have deliberately downplayed the potential risks of medullary thyroid cancer associated with their similar (slightly less good, twice as expensive) drug liraglutide (now marketed as Saxenda for the treatment of obesity in Ireland). Pancreatitis is an uncommon but real and potentially life-threatening possibility with these drugs. They are not safe in pregnancy. But these are the kinds of safety downsides and unknowns that occur with numerous other commonly used drugs in clinical practice in Ireland every day.
It has been hard to reconcile the lack of availability of semaglutide in Irish pharmacies with anecdotal evidence that it is widely available online and for primarily cosmetic purposes. Whatever about some of this being counterfeit product, more must be done by drug producers and regulators to ensure that whatever limited stock has been produced is getting to pharmacies, so that only patients with prescriptions can access it, for legitimate medical reasons. Blaming patients with obesity for the lack of supply is missing the point. A more relevant question is how the drugs are leaking out of the therapeutic supply chain, which should be rigorously monitored at every step.
If the reluctance to prescribe or dispense semaglutide and the lack of stock are two barriers to treatment; another one remains the huge cost. Patients with obesity who don’t have diabetes invariably have to pay €130 per month – indefinitely, because when you stop the drug, all the benefits are lost. We can’t expect the Government to foot this bill, because at this price, it is prohibitively cost-ineffective. Liraglutide/ Saxenda costs twice as much and is less effective and so ought to be redundant, especially for self-funding patients.
When Novo Nordisk has made a killing from the making of semaglutide, being valued at over half a trillion euro and doubling Denmark’s predicted gross domestic product (GDP) growth this year, it’s a wonder we’re not having a conversation about reducing the price of their drugs. Formal health economic evaluations have highlighted the low cost of production and suggest a fair price of about €40 per month for high-dose semaglutide (Wegovy). Did we tolerate pharmaceutical companies doing so well on the back of Covid vaccine breakthroughs?
Drug companies could follow the example of Bill Campbell from Donegal. When he made the Nobel Prize-winning discovery in 1981 of a cure for river blindness, he persuaded his bosses at the drug company Merck to make it freely available in an unprecedented drug donation programme that successfully eradicated the disease in many countries and alleviated terrible human suffering. Or they could emulate the generosity of Volvo in 1959: after inventing the three-point seat belt, they immediately made the patent free to other manufacturers, encouraging mass adoption and saving lives, practising “capitalism with conscience”.
Maybe the commercial reality is different now for drug companies, which need to charge as much as the market will tolerate. In the UK in 2016, Pfizer was fined £84.2 million after increasing the price of the widely used epilepsy drug, phenytoin, by 2,600 per cent, increasing the cost of treating 48,000 patients there from £2 million to £50 million. Previously, concerns were expressed in the US about drug companies potentially colluding to raise prices of insulin. More recently, Eli Lilly called for competition regulators to look into a deal by its main competitor, Novo Nordisk, to snap up additional manufacturing capacity, which it claims will hinder its ability to make obesity treatments.
In time, as newer, even-more potent drugs become available, price competition and increased production will dramatically enhance access for patients to effective obesity treatments. The medium-term outlook, assuming safety data remains reassuring, is very optimistic, with drug-effectiveness approaching that of obesity surgery, which remains the gold standard treatment in terms of effectiveness and value for money.
Meanwhile, in celebrating and rewarding the scientific discoveries and better treatments that drug companies have achieved, we need to recognise and manage the hazards posed by prioritisation of shareholder returns over patient welfare and health system value for money. Doctors and regulators would do well to bear this in mind when getting advice from drug companies on ethical and responsible prescribing.
Prof Francis Finucane is a consultant endocrinologist at Galway University Hospital and University of Galway
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