The drug semaglutide, widely recognised under the brand name Ozempic, has revolutionised obesity treatment and altered societal views on the illness in Ireland over the past half-decade. Public understanding has shifted to recognise obesity not as a result of poor self-discipline or lack of motivation, but as a disorder originating in the brain, out of conscious control yet capable of restoration with medicine.
Access to this potentially lifesaving medication, however, remains barred for patients at obesity clinics. The Irish Medical Council issued warnings to doctors approximately a year ago against recommending Ozempic for obesity treatment, citing unauthorised use and potential shortage for diabetic patients. Such reasoning is perplexing, as the primary component of Ozempic, semaglutide, received approval for use in obesity treatments in 2022.
This notification has led to disastrous implications for patients. Many returning to our Galway clinic in the past year have sadly seen any health improvements dissipate, as their prescribed semaglutide was withdrawn due to their lack of diabetes diagnosis.
Obesity patients without diabetes are expected to bear an indefinite monthly cost of €130 for the drug to maintain its benefits; discontinuation nullifies any gains.
A prompt, categorical, and steadfast return to last year’s directive was issued by obesity clinicians and patient support groups, underlining the discrepancies in the advisory and its likely detrimental outcomes on more comprehensive patient treatments.
The suggestion by the Medical Council that using the lower 1mg Ozempic dosage is unapproved or “off-label”, when semaglutide is already authorised for weekly doses up to 2.4mg (the high dose for Wegovy) for safe obesity treatment, is equivalent to arguing a 10-seat bus should not carry four passengers. The notion of prioritising diabetic patients over obese patients is as irrational as discontinuing the bus service to Tallaght on the premise that Rathfarnham residents urgently need to return home.
The Medical Council explained previously that its stance was simply to promote “conscious prescribing”, and stated that medical practitioners should adhere to ethical guidelines that advocate for the responsible and appropriate use of resources. If there is an implication that those practitioners utilising semaglutide to tackle obesity are not adequately mindful, ethical, appropriate or responsible, this is a gross misrepresentation of the professional practice of obesity specialists nationwide.
Several physicians and pharmacists across the country remain understandably hesitant about both prescribing and dispensing a demonstrably effective treatment due to inadequate communication from the Medical Council. The Council has sent letters to individual doctors and organisations praising their patient advocacy efforts, yet it has failed to issue a universal correction of the initial flawed “warning”.
Semaglutide has been noted to be relatively safe, although not totally without risk. Subsequent investigations into potentially significant issues like medullary thyroid cancer have been either brief or not entirely conclusive. In 2017, Novo Nordisk, the creator of semaglutide, was subject to a $58.7 million fine in the United States after it was unveiled that sales personnel intentionally minimised the potential risks of medullary thyroid cancer linked to their comparable, yet inferior and pricier, drug liraglutide (now sold as Saxenda for obesity treatment in Ireland). Such drugs may also lead to pancreatitis, a rare yet serious risk. While it’s not suitable for use during pregnancy, these drawbacks are commonplace amongst a wide range of drugs used daily in Irish clinical practice.
It’s been difficult to align the scarce availability of semaglutide in Irish pharmacies with reports of its widespread online availability, often used primarily for aesthetic ends. Independent of the likelihood of some of these being fraudulent sales, pharmaceutical manufacturers and regulatory authorities need to take steps to ensure whatever limited stock is available reaches pharmacies, to only be obtained by prescription-holding patients for valid medical reasons. Blaming obese patients for inadequate supply is misguided. Instead, a pertinent question would be how these drugs are falling out of the therapeutic distribution chain, which must be thoroughly scrutinised at every stage.
“[The regulatory board flags a sudden increase in counterfeit anti-obesity medications like Ozempic and Wegovy that are being marketed online]
Hesitation in both prescribing and dispensing semaglutide, partnered with stock shortages, present distinct hurdles to obtaining treatment; and yet another is its exorbitant cost. Patients struggling with obesity who are not diabetic typically need to shell out £110 per month – a charge that’s regularly recurring as discontinuing the medication negates all benefits. Asking the Government to cover this cost is unreasonable, given its glaringly cost-inefficient nature at this price point. Liraglutide/Saxenda is doubly expensive and falls short in efficacy, thus it should be phased out, especially for those footing their healthcare expenses independently.
Despite reaping huge financial gains from the production of semaglutide, Novo Nordisk, valued at beyond half a trillion euros and effectively doubling Denmark’s forecasted GDP growth this year, disregards the pressing need for discussion on cutting down prices for its medications. Rigorous health economic appraisals underscore the low manufacturing cost and propose a just price of approximately £34 a month for high-dosage semaglutide (Wegovy). Should we have allowed pharma companies to profit immensely from pandemic vaccine discoveries?
Pharmaceutical corporations can take cue from Bill Campbell from Donegal. Upon discovering the breakthrough cure for river blindness in 1981 that won him a Nobel Prize, he swayed his higher-ups at Merck, the pharma company he worked for, to distribute it without any cost, establishing an unrivalled drug donation scheme that succeeded in eliminating the disease in numerous nations and mitigating widespread human distress. Alternatively, they can adopt Volvo’s philanthropic stance in 1959 when, post-inventing the three-point seat belt, the company immediately released the patent to other manufacturers at no cost, expediting its general acceptance and preserving lives whilst demonstrating “capitalism with a conscience”.
General physicians continue to exhibit reluctance in recommending a truly effective therapy, whilst chemists also hesitate to dispense it.”
Perhaps the economic dynamics for pharmaceutical businesses have changed, compelling them to levy prices as high as the market can bear. In a notable case in the UK during 2016, Pfizer, a pharmaceutical giant, was slapped with an £84.2 million fine after hiking the price of the commonly prescribed epilepsy medication, phenytoin, by a staggering 2,600 per cent. This price surge saw the cost to treat 48,000 patients rocket from £2 million to £50 million. Similar apprehensions were raised in the US, regarding potential price-fixing tactics employed by pharmaceutical companies, specifically targeting insulin.
Recently, Eli Lilly, a major pharmaceutical player, urged antitrust regulators to investigate a manoeuvre by its primary competitor, Novo Nordisk, to acquire extra manufacturing resources. Lilly alleges this hampers its ability to produce obesity treatment drugs.
Looking at the future, as more advanced and powerful drugs come to market, robust competition coupled with increased manufacturing could significantly broaden patient access to effective obesity treatments. Assuming safety data remain stable, the midterm prospects look highly promising. The effectiveness of these pharmaceuticals may soon rival that of obesity surgery, currently viewed as the premier solution in terms of both efficacy and value.
Whilst we celebrate the scientific breakthroughs and improving treatment options delivered by pharmaceutical firms, we must also steer clear of the risks presented by placing shareholder returns ahead of patient wellbeing and health system affordability. It would benefit doctors and regulators to remember this when seeking guidance from pharmaceutical companies about ethical and responsible prescribing.
Prof Francis Finucane holds the position of a consultant endocrinologist at the University of Galway and Galway University Hospital.