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Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster drugs for obesity and diabetes will need to phase out their versions next year under a federal decision issued Thursday.

The Food and Drug Administration said that a nationwide shortage of Eli Lillys Zepbound and Mounjaro has been resolved, eliminating the need for copycat versions of the drugs that have become wildly popular with Americans trying to lose weight.

The decision is a win for Lilly which had been pressing the FDA to take the step for months and is expected to impact how patients access the drugs, including how much they pay.

Zepbound is FDA-approved to treat obesity and Mounjaro is approved for diabetes.

They use the same active ingredient, tirzepatide.

The FDA said Thursday that Lillys supply is currently meeting or exceeding demand, after two years of shortages.

Both drugs are part of the GLP-1 class that has shown unprecedented results for helping people shed weight by decreasing appetite and boosting feelings of fullness.

Wegovy and Ozempic competing drugs from Novo Nordisk remain on the FDAs shortage list.

With demand for GLP-1 drugs booming, compounding pharmacies and telehealth companies like Hims and Ro have jumped into the market, selling cheaper versions online.

People can usually get a months supply for several hundred dollars.

Thursdays decision gives businesses between 60 and 90 days, depending on their size, to phase out their products.

The FDA permits compounded versions of brand name drugs when they are in shortage, and the shift back to Lillys medications could improve safety for consumers.

The FDA warned patients last year about problems with the ingredients and formulations of some GLP-1 drugs sold online.

The agency has limited oversight of compounding pharmacies, which are primarily overseen by state authorities.

Compounding pharmacies use raw drug ingredients to produce customized versions of prescription medications for instance, when patients have allergies to certain ingredients.

The industry has grown into a multibillion-dollar business over the past decade amid increasing drug shortages.

Demand for off-brand GLP-1 drugs has been amplified by aggressive online promotions from telehealth companies, which arent subject to the same marketing rules as drugmakers.

The FDA previously declared an end to the shortage of Mounjaro and Zepbound in early October, but reversed its decision after public pushback and a lawsuit filed by compounding pharmacies.

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Jay Slater inquest resumes after final effort to trace witnesses – all you need to know

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Jay Slater inquest resumes after final effort to trace witnesses - all you need to know

An inquest into the death of teenager Jay Slater is due to resume today after being adjourned two months ago.

The 19-year-old from Oswaldtwistle, Lancashire, disappeared on the Spanish island of Tenerife after attending the NRG music festival on 16 June 2024.

He was reported missing and, after an extensive search and rescue mission and significant media attention, his body was found a month later on 15 July.

An inquest into the teenager’s death began in May at Preston Coroner’s Court, but was adjourned the same day, to the disappointment of Mr Slater’s mother Debbie Duncan.

Dr James Adeley, a senior coroner for Lancashire and Blackburn with Darwen, made the decision after a number of witnesses who had been asked to give evidence could not be traced or were unable to attend.

After making a final effort to trace key witnesses, the inquest will now resume on 23 and 24 July. Here is all you need to know.

What happened to Jay Slater?

On 17 June 2024, just days into his first holiday without his family, Mr Slater was reported missing.

The night before, he is believed to have left his friends at the Papagayo nightclub in the resort of Playa de las Americas and made an hour-long drive to a modest Airbnb in the tiny village of Masca, with two people he had met on the holiday.

Phone data reveals Mr Slater’s last known location was the Rural de Teno park – a mountainous area popular with hikers.

The 19-year-old’s disappearance sparked a huge 29-day search effort – with emergency services, local volunteers and Mr Slater’s family combing a large mountainous area of the island searching for any trace of the teenager.

Within days, Facebook groups dedicated to the case had also been set up – with some quickly attracting hundreds of thousands of members.

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July 2024: Where was Jay Slater found?

The Spanish civil guard released a statement on 15 July to say they had “located the lifeless body of a young man in the Masca area after 29 days of constant search”.

What happened during the first inquest hearing?

Mr Slater’s mother Debbie Duncan, stepfather and other family members gathered at the inquest in Preston Coroner’s Court on 21 May.

Home Office pathologist Dr Richard Shepherd said Mr Slater’s injuries were “entirely consistent” with a fall from a great height and gave an official cause of death as a head injury.

“The injuries were so severe I have no doubt he would have been instantly unconscious from the moment of that blow to the head. Death could well have been instant, the injury was so severe,” Dr Shepherd said.

Pic: Reuters
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The search and rescue mission was launched a day after Jay Slater was reported missing. Pic: Reuters

He said there was no suggestion that the teenager had been assaulted or restrained.

Toxicology expert Dr Stephanie Martin said traces of MDMA and MDA, commonly known as ecstasy, along with cocaine and alcohol, were also found in Mr Slater’s body.

Detective Chief Inspector Rachel Higson, from Lancashire Constabulary, told the court that messages from Mr Slater’s friends advising him to go home were found on his phone

Pic: Reuters
Guardia Civil agents and police officers organise the search for the young Briton Jay Slater in the Masca ravine, on the island of Tenerife, Spain, June 26, 2024. REUTERS/Borja Suarez
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Civil Guard agents and police officers in the Masca ravine. Pic: Reuters

Officers were flanked by specialist sniffer dogs from Madrid

DCI Higson said at 8.35am on 17 June, his friend Ms Law sent him a message saying: “Before it gets boiling get back to wherever you have come from.”

At 8.50am there was the last known outgoing communication from Mr Slater’s phone, a 22-second call from him to Ms Law in which he is believed to have said he had cut his leg on a cactus, he was lost in the mountains and his phone battery was on 1%.

A view of Preston Coroner's Court, Lancashire, at the opening of the inquest into the death of Nicola Bulley, who disappeared on January 27
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The inquest is taking place at Preston Coroner’s Court. Pic: PA

Who are the missing witnesses?

The witnesses that the court tried to trace the first time included Bradley Geoghegan, Brandon Hodgson and Lucy Law, who were all with Mr Slater in Tenerife.

At the time of the first inquest it is believed they were not in the UK and were unable to attend.

Read more from Sky News:
How search for missing teenager captured nation’s attention
Inside the valley where Jay Slater’s body was found

The two men who were staying at the Airbnb property Mr Slater travelled to before his disappearance – Ayub Qassim and Steven Roccas – were unable to be traced, despite summonses being issued.

Mr Slater’s mother Ms Duncan told the court in May that she wanted “these people to be sat in front of us, because our son went on holiday and didn’t come back, so there’s questions we need to ask”.

Coroner Dr Adeley said he would adjourn the inquest in an effort to find the witnesses and give Ms Duncan the “answers you want”, but it remains unknown if the key witnesses will appear at the inquest on Thursday and Friday.

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Off-the-shelf medical tests are failing to back up accuracy promises with evidence, study finds

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Off-the-shelf medical tests are failing to back up accuracy promises with evidence, study finds

Off-the-shelf medical tests that promise to diagnose conditions ranging from vitamin deficiencies to cancer are lacking evidence to back up their accuracy, a study has found.

Thirty self-testing kits were purchased from a range of mainstream supermarkets, pharmacies and health and wellbeing shops by researchers from the University of Birmingham in 2023.

The kits tested for vitamin deficiency, blood cholesterol, menopause and bowel cancer. These tests are often marketed as tools for empowerment and early detection at a time when the NHS is already over-stretched.

Accuracy claims were made for 24 of these tests however, and nearly six out of 10 (14) promised 98% accuracy. However, evidence supporting these claims was largely unavailable, according to a series of papers published by the British Medical Journal (BMJ).

In addition, 18 of the tests (60%) were found to have errors that could lead to a wrong result. This included 11 that had problems with equipment, 10 showing issues with the sampling process and 15 that had problems with the instructions of interpretation of results.

Where information about what types of accuracy methods were available, about a third of those compared their test with another similar test – not a proper, trusted medical test.

Most of the tests also did not explain who they tested them on to provide the accuracy data.

These types of testing kits are not subject to the same stringent checks that a new medication would have to go through.

The University of Birmingham’s Professor Jon Deeks, a corresponding author of the study, said: “Our findings highlight concerns about the value of these self-tests because the instructions for use for many of them recommended seeing a doctor regardless of the test result (positive or negative).”

Can these tests cause harm?

Dr Clare Davenport, co-author of the study, said the benefit of many of these tests “is lacking”.

“This is in contrast to well-established self-tests, such as pregnancy tests,” she said.

“We are worried that consumers concerned about their health and tempted by the convenience of buying a test over the counter may be harmed if they use these tests in the wrong way.”

A false positive on such a test may lead to anxiety, unnecessary investigations and even overtreatment, while a false negative could lead to delays in treatment.

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Pic: University of Birmingham
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Pic: University of Birmingham

Researchers are now calling for better regulation and guidance from manufacturers, retailers and healthcare professionals to protect consumers of off-the-shelf health self-tests.

There were some limitations to the test – namely that they were bought two years ago and were not intended to be a sample of what is available across the country.

“But given what they do say about where they got the tests, I’d be surprised if they aren’t pretty much the same anywhere nowadays,” said Professor Kevin McConway, emeritus professor of applied statistics at The Open University.

He said the results were “scary and concerning”.

“I don’t doubt the findings of the researchers, that many of the available tests don’t make it clear who could make good use of them, how accurate the results might be, or what someone should do in the light of their results.”

‘History offers cautionary tales’

“Self-tests should not be dismissed outright though,” wrote Jessica Watson from the Centre for Academic Primary Care, and Margaret McCartney, from the University of St Andrews, in an editorial for the BMJ.

“History offers cautionary tales: when home pregnancy tests were first introduced, some doctors argued that women could not be trusted to use them.

“Clearly that is not the case.

“The use of HIV self-tests has been extensively and carefully evaluated, with decades of research, including large randomised controlled trials.”

However, they say that these examples are of tests that are “binary” with yes or no answers, and are integrated within healthcare systems, “with clear actions to be taken based on the results”.

The study was funded by the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre.

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Doctors go on strike for five days – here’s everything you need to know

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Doctors go on strike for five days - here's everything you need to know

Doctors in England and Wales go on strike for five days from Friday, with warnings it could lead to patient harm in emergency departments.

It is the culmination of an escalating row between NHS bosses and the British Medication Association (BMA) over pay.

Here is everything you need to know about the strikes.

How long is the strike?

From 7am on Friday 25 July to 7am on Wednesday 30 July.

Who is striking?

Up to 50,000 resident doctors will walk out.

Resident doctors is the new name for junior doctors – it was changed to better reflect their responsibilities. Resident doctors are fully qualified doctors who are either currently in postgraduate training or gaining experience as locally employed doctors to become consultants, GPs or specialists.

Their title was changed after years of calls for the term “junior” to be retired, as it was seen as both misleading and demeaning.

General practice, community pharmacies, and dentistry are not impacted by the action.

How will it affect appointments?

During previous strikes, NHS England told trusts to cancel large volumes of non-urgent care so that consultants could step in to cover emergency care.

Previous rounds of industrial action – 11 walkouts over multiple days – saw an estimated 1.5 million appointments cancelled or rescheduled.

But under the leadership of new NHS England chief executive Sir Jim Mackey, hospitals have now been instructed to cancel non-urgent work only in “exceptional circumstances” – and only with prior approval.

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This suggests that much fewer planned appointments will be cancelled, although no exact figures have been given by either side.

The BMA has warned this new approach risks spreading doctors too thinly.

How will I know if my appointment has been cancelled?

Patients have been advised to “choose healthcare wisely” during the strike.

If your appointment has been cancelled, or rearranged, you will be contacted by the hospital directly. Priority will be given to patients with the most pressing health needs.

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Why are junior doctors striking again?

If you do not hear that your appointment has been changed, you should attend as usual.

Will I still be able to access emergency care?

If you need emergency care during the strike you should still go to hospital as normal.

Patients have been told to call 999 if it is a medical or mental health emergency.

If the situation is non-life threatening, patients should seek support through NHS 111, NHS 111 online, their GP or a pharmacy.

Why are they striking?

Doctors in England and Wales were awarded a 5.4% pay increase by the government, but the BMA still threatened strike action, claiming the increases did not account for historical pay freezes.

Instead the BMA is calling for a rise of 29.2% to bring salaries back in line with 2008 levels.

It follows 11 rounds of industrial action last year. Pic: PA
Image:
It follows 11 rounds of industrial action last year. Pic: PA

More than 26,000 resident doctors voted in favour of the strikes.

I thought they already had a pay rise?

Yes, in July last year resident doctors were awarded a raise of 22% over two years, bringing to end months of strike action. It was the highest public sector award in recent years.

But the trade union argues that pay has declined significantly since 2008 when adjusting for inflation. The latest deal saw doctors given a 4% increase, plus £750 “on a consolidated basis” – which works out as an average rise of 5.4%.

The BMA said no doctor “took the possibility of striking lightly” but the majority of its members believed they had “no other choice”.

“Doctors have spoken and spoken clearly,” the union said.

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“They won’t accept that they are worth a fifth less than they were in 2008. Our pay may have declined but our will to fight remains strong.”

The BMA said Mr Streeting had the power to “make the right decision” on pay.

Does the public support the strikes?

A new YouGov poll found support for the strikes is declining.

The survey found about half (52%) of people in the UK either “somewhat oppose” (20%) or “strongly oppose” (32%) the idea of resident doctors going on strike over pay.

Older people are more likely to be against, with 52% of those aged over 65 “strongly opposed”, compared to 10% of those aged 18 to 24.

The British Medical Association are calling for a rise 29.2%. Pic: PA
Image:
The British Medical Association is calling for a rise 29.2%. Pic: PA

YouGov says the proportion of people who support the strikes has dropped five percentage points since May last year.

What does the government say?

Talks between the government and BMA have continued, with the latter saying strikes could still be avoided.

Health secretary Wes Streeting has ruled out any additional pay rises this year, but has said other aspects of the contract – including student debt, exam fees and working conditions – may be up for negotiation.

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Streeting: ‘Offering more would be unfair’

Mr Streeting previously warned the BMA the public “will not forgive” strike action.

He wrote in The Times that any walkouts would be a “disaster” for the union and for patients, adding the government “can’t afford” more pay rises.

NHS chiefs said any return to industrial action would be “bad for patients, for staff and for the NHS”.

Chief executive of NHS Providers Daniel Elkeles said: “We need cool heads to de-escalate this and remove the threat of further damaging industrial action.”

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