By Maggie Fick
LONDON (Reuters) - John, a tech executive who has been battling weight gain since his 30s, has a nine-month supply in his refrigerator. Kim Gradwell, a retired receptionist who developed type 2 diabetes nearly 20 years ago, isn't sure where she'll find her next dose.
The medicine is Ozempic – designed for type 2 diabetes, a life-threatening condition. It's so effective at helping people lose weight that supplies of the active ingredient, semaglutide, have run short in countries including Britain and the United States.
The contrast in access sheds light on the scramble for semaglutide in Britain, a country famed for its free public health system, showing how those with money are able to access treatments that run short on the National Health Service (NHS), despite government efforts to prioritise supplies for the NHS.
In July, the British government declared a shortage of semaglutide and intervened to prevent Ozempic reaching people who want to lose weight. But Reuters interviews with more than a dozen medical professionals and patients show people like John, who says he is obese and "well off," can still pay thousands of pounds online to stockpile it for weight loss, while diabetics who depend on the NHS struggle to get government-paid prescriptions filled.
John shared an Oct. 26 email from private online pharmacy Rightangled, advertising Ozempic.
"Look what's back," it said. "Grab yours before it's gone again." Rightangled offered the drug for 299 pounds ($366) for a month's supply of weekly injections.
NHS diabetes patients – including Gradwell, who went for weeks without full medication – pay nothing for their medication. Gradwell, 64, says she couldn't afford to seek private treatment.
One reason such two-tier access continues is a loophole that means the government can't ban clinicians from prescribing a drug that they think will help their patient, four medical experts said. The shortage persists even after Ozempic's manufacturer Novo Nordisk (NYSE:NVO) launched Wegovy, a semaglutide drug solely for weight loss, in September.
"There is a loophole," said Penny Ward, visiting professor in pharmaceutical medicine at King's College in London.
The UK's medical regulatory bodies "do not have the right to ban doctors from prescribing drugs they believe to be helpful to individual patients," she said. It's a similar picture in the U.S., where the regulator also lacks power to stop clinicians prescribing drugs even at times of shortage.
A Department of Health and Social Care spokesperson did not comment on the regulatory loophole, but said guidance is clear.
"These medicines should only be prescribed for the treatment of type 2 diabetes, in order to protect supply for diabetes patients and should not be routinely prescribed for weight loss," the spokesperson said by email. The department is "considering whether further communications are required."
'WILD WEST'
John, 44, asked to be identified by his middle name to protect his privacy. He acknowledged that he benefited at the expense of those with diabetes.
"The only reason I've been able to have a continuous flow of (Ozempic) is because I've thrown money at it." he said. "I appreciate that I've benefited from it being a 'Wild West.'"
Rightangled told Reuters it is within its rights to continue to prescribe Ozempic for weight loss. Its owner, Abdullah Sabyah, said by email the government restrictions are "not a ban" on selling the drug for obesity.
This is correct, said the experts including Ward.
Another UK online provider, Juniper, said in September it had issued Ozempic prescriptions to more than 15,000 women to lose weight in the UK over the previous 15 months. Juniper told Reuters on Nov. 16 that it, too, continues to offer Ozempic for weight loss to existing patients as they move onto Wegovy, but new patients will receive Wegovy.
Diabetic patients unable to access Ozempic suffer erratic blood glucose levels, medical professionals say – risking seizures, coma, or, rarely, death.
"I have never experienced such a crisis in drug supply," Ben Field, an endocrinologist who treats people with diabetes and has worked for the NHS since 1997, told Reuters. "People with type 2 diabetes are having their treatment destabilised, with potentially life-threatening results."
Public data does not show exactly how many people with diabetes are affected, but between March and August, NHS prescriptions by primary care doctors in England for drugs containing semaglutide fell by nearly 30,000, according to a website run by Oxford University. Seven doctors told Reuters this drop reflects the shortage.
Doctors said the shortfall forces patients to take insulin, a riskier treatment that needs more intensive monitoring. This increases the burden on the NHS. The NHS declined to comment on that.
Novo said it is running factories for the medicines 24 hours a day, seven days a week, but neither it nor the government expect the shortage to ease before mid-2024.
"We are acutely aware of the uncertainty and concern ... and the disruption patients and healthcare professionals are experiencing," Novo told Reuters. "We recommend that anyone who believes they may be affected by this speak to their clinician."
Novo said most of its medicines are supplied through a government-regulated wholesaler, Alliance Healthcare UK, which sells to both NHS and private providers, over which it has no influence. Alliance told Reuters it was "working to ensure equitable distribution of product," without giving details.
OBESITY
Ozempic was approved for type 2 diabetes in Britain in 2019. It is one of seven medicines from a drug class called GLP-1 receptor agonists (GLP-1 RAs) that the government declared in shortage. Its active ingredient, semaglutide, mimics a hormone produced in the gut that helps regulate blood sugar and appetite.
Some 4.5 million people in the country have type 2 diabetes, according to charity Diabetes UK. Doctors said semaglutide is the most effective medication so far, but not widely prescribed through the NHS partly because the government's cost-effectiveness body, NICE, recommends trying it only after cheaper drugs.
The NHS said it spends 10 billion pounds annually on type 2 diabetes, around 10% of its budget. NHS primary care doctors known as General Practitioners (GPs) wrote about 92,000 prescriptions in August for semaglutide, according to the Oxford University website, which collects anonymised data in England. That's down from nearly 121,000 in March.
But obesity, also a significant health problem, affects around three times more people – the UK has the highest rate in Europe. In June, the government said obesity costs the NHS around 6.5 billion pounds annually.
More than a dozen posts on social media site Reddit say how people bought drugs like Ozempic for weight-loss from private online providers, but only John responded to Reuters enquiries. Half a dozen medical professionals and patients also told Reuters people are buying what they believe to be semaglutide through unregulated outlets such as beauty spas and nail salons, or on pop-up websites advertised through social media. Reuters was unable to independently verify these accounts.
John said he has shed 18 kg (40 pounds) and hopes to lose another 20 kg.
The government's July order, known as a Patient Safety Alert, told prescribers to "only prescribe GLP-1 RAs for their licensed indications" from Oct. 18. It also said using them to manage obesity was "strongly discouraged."
After the restrictions were announced, three of John's providers contacted him to offer Ozempic. Two had stopped offering it for weight loss by October, but Rightangled continued to make it available as of Nov. 17, Reuters found.
Rightangled's Sabyah said the semaglutide shortage had eased since July. Neither the government or wholesaler Alliance confirmed this.
A spokesperson for the General Pharmaceutical Council (GPhC), which regulates UK pharmacies and has the power to disqualify pharmacy owners, said there is "a clear expectation and obligation" for pharmacies to adhere to government alerts. But this is not legally binding and failing to do so does not give rise to criminal penalties, she said.
Rightangled and Juniper - which is registered with the GPhC as Eucalyptus - were among six pharmacies that the spokesperson said had fallen short of standards this year by not proving they checked customers' identity or weight. She declined to name the others, saying pharmacies usually work to rectify such problems.
Rightangled said it now requires people buying weight-loss drugs to send a full-body picture validating their weight; Juniper said it had made improvements which would be reflected in its GPhC records after the next inspection.
Asked about the pharmacies' continued sale of Ozempic, the GPhC said it would check this at their next scheduled inspections.
'LIVE IN FEAR'
Diabetes patient Gradwell was forced by poor health into early retirement at 55.
She said her pharmacy in Newcastle-upon-Tyne wasn't able to fill her NHS prescription in July, so gave her a half-strength dose. Her blood sugar levels surged, and with them complications including eyesight problems and vaginal itchiness. Her pharmacy was able to give her the full dose again in September.
Gradwell's doctor, NHS endocrinologist Dr Yaasir Mamoojee, confirmed her account.
"I live in fear now, every month when I go to collect my prescription," Gradwell said.
"We've got a lifelong illness we can't do anything about," she said. "Other people are taking it to lose weight and they're taking it away from people who really need it."
John said he was already chronically overweight, but was treated for testicular cancer and had surgery in 2013. The resulting hormone loss made it even harder to keep weight off.
After a decade under surveillance and finally cancer-free, John made a New Year's resolution to try Ozempic, widely available at the time. He said his oncologist said that while he could not prescribe Ozempic, it would be good for his health if he took it for weight loss. The oncologist could not immediately be reached.
John showed Reuters how he amassed his stock through the different providers: "It's just a matter of dancing between different pharmacies to maintain supply."
He said he has enough Ozempic for now. When he opens his refrigerator, his supply is reassuring.