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Pfizer will end development of weight-loss pill over fears about its impact to the liver
The move comes after a patient in a trial suffered a liver injury potentially caused by the oral GLP-1 drug known as danuglipron.
The patient, who was not identified, did not experience any symptoms and their injury 'resolved' after they stopped taking the drug.
'While we are disappointed to discontinue the development of danuglipron, we remain committed to evaluating and advancing promising programs in an effort to bring innovative new medicines to patients,' Pfizer's Chief Scientific Officer Dr. Chris Boshoff said in a statement.
The Swiss company reviewed all clinical data for danuglipron and recent input for regulators before making their decision.
Its statement also suggested the patient's liver enzymes were elevated. That often is indicative of damage to cells in the organ, according to the Cleveland Clinic. Pfizer told CNBC that the trial rapidly increased the dose of the pill over a short span of time.
The company had previously scrapped the development of a twice-daily version of the drug in 2023 after trial patients experienced vomiting and nausea.
A once-daily pill could have had a competitive edge over other weight loss drugs taken twice a day.
Several companies are developing weight loss pills after surging popularity of the shots that target an intestinal hormone called GLP-1. Ozempic and Wegoy are popular injectables related to CLP-1. Oral drugs are also considered to be easier to make than injectables, as well as easier to take.
Obesity is a serious and common chronic disease. In the U.S. more than two in five adults have obesity.
The investment bank Morgan Stanley said the global market for obesity drugs is expected to reach $105 billion by 2030 — and as high as $144 billion. Comparatively, it noted that sales of branded obesity drugs had totaled $6 billion in 2023.
Pfizer said that it would continue development of an experimental oral drug targeting a different hormone.
'Cardiovascular and metabolic diseases including obesity remain important areas of unmet medical need, and we plan to continue applying our global capabilities to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care, including continued development of our oral GIPR antagonist candidate and other earlier obesity programs,' he added.
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Scottish Sun
7 hours ago
- Scottish Sun
Rise of ‘faux-zempic' fake weight loss drugs being imported into UK black market & sold on social media…how to spot dupe
Celeb Big Brother star Aisleyne Horgan-Wallace tells Sun Club readers she 'thought she was going to die' and even lost her eyesight after unknowingly taking fake weight-loss jabs FAKE JAB HELL Rise of 'faux-zempic' fake weight loss drugs being imported into UK black market & sold on social media…how to spot dupe Click to share on X/Twitter (Opens in new window) Click to share on Facebook (Opens in new window) WEIGHT-LOSS drugs can be a silver bullet for some trying to shed the pounds after years of failure with fad diets and exercise routines. But dodgy vendors selling potentially deadly fake jabs laced with everything from rat poison to cement have appeared on the black market - with murky labs in foreign countries fuelling the supply, experts have told The Sun. 16 Bags of fake Ozempic pens seized in a UK crackdown Credit: MHRA 16 Michelle Sword fell into a coma after using fake fat jabs - which turned out to be insulin Credit: Supplied 16 Aisleyne Horgan-Wallace thought she'd bagged herself a bargain after buying fat jabs through a WhatsApp group - but says she 'nearly died' Credit: aisleyne1/Instagram 16 Wegovy and Mounjaro are the licensed weight loss jabs in the UK Credit: Getty Celeb endorsements and gushing influencers have encouraged many people who can't get fat jabs prescribed by the NHS to look for Wegovy, Ozempic, and Mounjaro elsewhere. And some Brits have found out the hard way about the perils of gambling with fake drugs - which can contain a cocktail of poison, including cement and arsenic. One of those was Celeb Big Brother star Aisleyne Horgan-Wallace, who told The Sun she "thought she was going to die" and even lost her eyesight after unknowingly taking fake weight-loss jabs. She was left bedridden for three days, constantly vomiting and was unable to even walk to her en-suite toilet after injecting what she dubbed a "syringe of horror". Her crystal clear message to anyone thinking about buying weight-loss jabs from an unofficial source is: "Don't." So-called "skinny jabs" require a prescription from a qualified medic - and must be obtained from registered pharmacies. Ozempic is only licensed as a type 2 diabetes treatment in the UK, unlike in America, meaning the NHS cannot prescribe it for weight loss. Private doctors may be willing to prescribe it "off-label" for weight loss - but that exposes people to a higher risk of being duped, experts say. Meanwhile, Wegovy and Mounjaro can be prescribed on the NHS for weight loss - and may also be bought privately. Crucially, private purchases also need a prescription from a qualified medic - and online platforms are required to conduct a face-to-face or video consultation before dispensing the drugs. Towie star Saffron Lempriere reveals how she lost 12 pounds in 4 weeks - without fat jabs But in reality, jabs can be bought without prescriptions - widely available from social media or unlicensed websites posing as pharmacies flogging the stuff for less than half price at around £80. 'Dicing with death' Health chiefs warned last year that deadly fakes had reached the UK market - and broken into the legitimate supply chain. So far, over 100 deaths have been linked to weight loss drugs in the UK, according to recent data, and it's unclear if any deaths have been linked to fake jabs. But a leading GP who spoke to the BBC warned that those buying weight loss drugs online are "dicing with death". Counterfeits are often linked to organised crime groups, according to Anne Devaud, the head of product security at Novo Nordisk - the manufacturer of Ozempic and Wegovy. Anne told The Sun: "There are lots of sellers in Turkey using UK or French phone numbers to hide where the supply is really coming from. "The best way for these criminals to flog their wares is through social media - because that's where Brits naturally turn," she added. I can't believe that I allowed my insecurities to almost kill me Michelle Sword Groups in China are one of the primary sources for the fakes, Anne said, but the company has also identified counterfeit manufacturing in places like Turkey and Brazil. Anne said: "There are different sources of illicit manufacturing. "Some may order semaglutide from, for example, a Chinese supplier and then do their own stuff. "But another group might simply put starch or water inside - because the purpose is solely to make money." Real Ozempic and Wegovy jabs contain the active ingredient semaglutide, while Mounjaro uses a compound of the same chemical with another called tirzepatide. But fake pens can contain dangerously high doses of semaglutide, or different drugs entirely, like insulin, which can make people seriously sick if taken unnecessarily. Some online platforms also sell real products which have been shipped from overseas, where the same rigorous standards don't apply. Experts say that the rise of counterfeit drugs is a consequence of the supply struggling to keep up with demand - and imposter jabs present a range of perils. 16 Mum-of-two Michelle Sword managed to get hold of the fake jabs without any medical checks, and was told it could be delivered straight away Credit: David Hartley 16 Michelle said, 'I can't believe that I allowed my insecurities to almost kill me' Credit: Supplied 16 An original Ozempic pen, top, vs a counterfeit, bottom Credit: PA 16 Counterfeit semaglutide and Ozempic jabs seized in the US Credit: CNBC Toby Nicol, CEO at CheqUp, told The Sun: "The surge in popularity of weight loss injections has unfortunately created a lucrative opportunity for counterfeiters. "Fake weight loss drugs often originate from unregulated manufacturing operations, where oversight is minimal and quality control can be nonexistent - they are only interested in cash, not care. "These counterfeit products frequently enter the market through unauthorised online pharmacies or social media marketplaces that bypass regulation and rules. If it seems too good to be true, it probably is Toby Nicol "They come in one of two forms - either in pens which mimic those offered genuinely for Mounjaro and Wegovy or sold simply as some powder in a vial to which people add water. "This latter type is very common on TikTok where patients are encouraged to buy something, which could be chalk and inject it into themselves. "Anything which costs less than about £80 to £100 per month is probably fake." Toby warned: "If it seems too good to be true, it probably is." Rat poison, cement and arsenic Kevin Joshua, a weight-loss clinician, explained how the fakes sometimes contain insulin instead of semaglutide - which can lead to "critically low blood sugar, coma, or death". People with diabetes take insulin to top up their natural levels, so that they are able to break down sugar properly. Taking too much insulin or injecting when you don't need it can lead to disorientation, seizures or even death. He added: "Chemical analysis of fake weight loss injections has also identified contaminants like rat poison, arsenic, cement, mercury, bacteria or viruses that may result in sepsis, infection, or organ failure." Dr Tim Mackay, a professor at the University of California, San Diego, who studies counterfeit medications, told us that some criminal enterprises get their hands on "research-grade" drugs, not meant for human consumption, and pass it off as the real thing. Other fakes will contain impure semaglutide, dangerously high doses or other drugs entirely, he said. These counterfeit products frequently enter the market through unauthorised online pharmacies or social media marketplaces that bypass regulation and rules Toby Nicol Jason Murphy, Head of Pharmacy and weight loss injection expert at Chemist4U, said: "It really depends on what's in them. "And that's part of the problem, you just don't know. Some might have no active ingredients at all so they just don't work. "Others might contain the wrong dose or harmful substances that can cause stomach issues, blood pressure problems or worse. "There's also a real risk when it comes to sterility. "If the product hasn't been made in clean conditions, there's a chance it could be contaminated, which can lead to infections or serious health complications. "Because these fake drugs haven't gone through proper safety checks, every dose is a gamble." 'I came so close to death' Big Brother star Aisleyne Horgan-Wallace says she almost died and lost her eyesight after taking fake Ozempic last year. She tells The Sun that last year was "really tough" after she lost two very important people and her way of dealing with the pain was to "eat her feelings" - meaning she piled on almost two stone. When a friend suggested she tried Ozempic, Aisleyne rushed into it without considering the dangers, because she was in "such a bad place". She says: "I got added to a WhatsApp group where girls talk about what they want to have done - lip fillers and things - and someone on there was offering Ozempic. 16 Aisleyne Horgan Wallace says she 'nearly died' after injecting fake fat jabs Credit: Olivia West 16 Texts between Aisleyne and the person who organised her supply, about another friend who fell sick after using the injections Credit: supplied 16 Aisleyne's drugs came in an unbranded syringe Credit: supplied How to spot a fake MOST fakes are not completely identical to the authentic products, and there are some signs you can look out. According to Novo Nordisk, the manufacturer of Ozempic and Wegovy, these are the giveaways... Dodgy packaging : Fake jabs will often come in boxes and packaging of inferior quality. The graphics are more likely to look cheap or misaligned. : Fake jabs will often come in boxes and packaging of inferior quality. The graphics are more likely to look cheap or misaligned. Spelling errors : Text on the counterfeits are much more likely to contain spelling mistakes. : Text on the counterfeits are much more likely to contain spelling mistakes. Dose selector: The manufacturer says that some fakes have dose selectors which can be pulled out when dialled to a select dose. The selectors on the genuine product are fixed in place. The manufacturer says that some fakes have dose selectors which can be pulled out when dialled to a select dose. The selectors on the genuine product are fixed in place. Unbranded: Some counterfeits are completely unbranded, like the plain syringe Aisleyne received. The genuine products will always be branded with the company name and logo. However, it's important remember that some counterfeits will not bear any of those signs. The only way to guarantee a genuine product is to "obtain appropriate medicine on prescription through legitimate sources", Novo Nordisk advises. "With the first month's supply I felt fine, even energetic, and I could see that I was losing a bit of weight. "But then I took the second month's - and I came so close to death. I wish I never, ever took the first month's supply or even heard about this drug. "For three days I was in bed, literally comatose. I'd wake up, roll over and vomit into a bag. There were bags of vomit all around me. "I couldn't even walk the two steps to the en-suite toilet, I had to crawl and drag myself. "After a day I didn't need to go to the toilet because I wasn't eating or drinking - I couldn't even sip anything. "On day two, I opened my eyes and I couldn't see anything out of one of my eyes." The TV star to this day does not know what was in the jabs - but insists: "It was a syringe of horrors, that's all I know. The chemicals must have been wrong." 16 Wegovy is the UK version of Ozempic licensed for weight loss in the UK Credit: PA 16 Amy Schumer is one of the many high-profile celebs to admit she has used weight loss drugs 16 Gemma Collins also revealed she has been using fat jabs Credit: Many other women have got in touch with Aisleyne with similar accounts, proving the problem is widespread. Michelle Sword, 47, is another who nearly died after injecting herself with a fake Ozempic jab. She fell into a coma after administering the medicine, which turned out to be insulin. Michele said: "It was a lot harder to get hold of Ozempic, so I didn't go down the conventional way of doing it. "The beauty companies and the online aesthetic companies all seemed to have it." The mum-of-two managed to get hold of some without any medical checks, and was told it could be delivered straight away. But soon after injecting, she collapsed and began suffering seizures - and tests showed her blood sugar levels had plummeted and sent her into a diabetic coma. Michelle said: "I can't believe that I allowed my insecurities to almost kill me." Fat jab crisis In December 2024, the Royal Pharmaceutical Society warned that social media was fuelling such an appetite for weight-loss jabs that the supply simply couldn't keep up. It even likened the situation to the toilet paper shortages during the Covid pandemic. To keep up with demand, some NHS pharmacies could soon be given powers to prescribe the injections - cutting out the need for patients to see the GP. Addressing the unlicensed supply chain, it said: "These unregulated websites often specifically target those medicines that are in shortage. "These illegal sites come with the risk that patients may be accessing medicines that are outside of a rigorous, quality-controlled supply chain and may be unauthorised and/or falsified." Similarly, the National Pharmacy Association warned there could be a possible "explosion in the unlicensed sale of medication online". NPA chairman Nick Kaye said last year: 'Pharmacists remain deeply concerned that the current medicine shortages crisis could lead to an explosion in the unlicensed sale of medication online. 'Stocks of Ozempic are very depleted in community pharmacy in the UK and it is important that these remain prioritised for those in the most clinical need. 'Given the precarious state of supply of this and other vital medication, there is a much greater risk of people looking to order in supplies from disreputable online vendors." 16 Even if the product is branded as Ozempic it can be a fake - like this suspected counterfeit Credit: Reuters 16 The drugs can be injected into the skin of your stomach, thigh or arm Cracking down Novo Nordisk is the pharmaceutical company which manufactures Ozempic and Wegovy. Anne, head of product security, told The Sun that pharma companies are collaborating with each other and law enforcement agencies to counter the rise of counterfeit products. She said: "It's a long run, because we are fighting against organized crime. But I'm confident because now we have governance, we are sharing with other pharma companies and authorities. "The best ways to mitigate against the risks are two things: First is to litigate as much as possible and work with prosecutor in order to disrupt [the supply]. "The second is to continue to develop awareness - because everybody has a responsibility. "If patients are more vigilant, ordering less online, if we are collaborating with authorities, if also authorities are reinforcing regulation to avoid any illicit compounding to enter in the country, I'm quite confident that with this combined effort we may really make a difference, so there is no question mark for us. We are on it." Novo Nordisk urges anyone who believes they have hold of a fake pen to not use it. They are encouraged to report it to the Medicines and Healthcare Products Regulatory Agency - the body tasked with protecting the UK's drug supply. The MHRA said it has been seizing counterfeit Ozempic pens since 2023. Andy Morling, its deputy director of criminal enforcement, told CNBC last year: "We saw that the demand increased and quite often as it happens in these situations, criminals try and fill a gap where the supply and demand aren't balanced for a particular product, and we started seeing real counterfeit versions of the Ozempic product on the market."
The Guardian
18 hours ago
- The Guardian
Pfizer Covid vaccine for young children may not be renewed by FDA
Pfizer's Covid vaccine for young children may not be renewed by the US Food and Drug Administration (FDA) this fall, prompting Moderna to fill possible gaps in supply, according to an email obtained by the Guardian. The move would pull the only remaining Covid vaccine for all children under five from the market. The Moderna vaccine is only approved for children with one or more health conditions, and the pediatric Covid vaccine from Novavax is only available for children aged 12 and up with health conditions. 'It certainly would create a hole in the availability of vaccines,' said Georges Benjamin, the executive director of the American Public Health Association. 'And to do it this late in the season – I think clearly it's inappropriate.' According to an email from the National Center for Immunization and Respiratory Diseases (NCIRD), Pfizer said the FDA recently informed the pharmaceutical company that it may not renew the emergency use authorization for its pediatric Covid vaccine for the 2025 respiratory season. The email was sent on Friday to state and local vaccination grantees. The Pfizer vaccine is given to children between the ages of six months and four years. Pfizer expects its Covid vaccine for children aged five to 11 to be fully licensed this fall, the email said. The Centers for Disease Control and Prevention (CDC) is 'in discussions' with Moderna about rapidly increasing its Covid vaccine supply for young children, according to the email. That includes internal planning about volume, timing, and potential supply gaps. 'We are working to ensure there will be sufficient supply,' said Chris Ridley, a Moderna spokesperson. The CDC, the US Department for Health and Human Services (HHS), and Pfizer did not respond to media inquiries by publication time. In July, Moderna received FDA approval of its Covid pediatric shot. But the vaccine was only approved for children with one or more health conditions that make them more vulnerable to Covid. This move could limit access to Covid vaccines. 'We already have a low number of people using the vaccines to start with,' Benjamin said. 'There hasn't been enough promotion of vaccinations for kids, and then you have Mr [Robert F] Kennedy's [Jr] unscientific statements about the safety and efficacy of vaccines, particularly Covid vaccines, for both pregnant women and kids. It has muddied the waters of what people know about the safety and efficacy of the vaccine.' The vaccine is extremely effective, especially against hospitalization and death. Yet only 5.6% of children aged six months to four years are vaccinated against Covid, and about 15% of children aged five to 17 are vaccinated, according to the CDC. While older adults have the highest rates of hospitalization and death, children continue seeing hospitalization rates from Covid similar to rates in 2020 and 2021. And there are other concerns with Covid infection. 'We don't know the long-term impact for kids who have gotten Covid as a disease. We do know it does cause a multi-systemic inflammatory process in a number of kids, which is very severe, and we don't know the long-term implications for long Covid in kids,' Benjamin said. Covid cases are rising in many parts of the US amid other vaccine restrictions proposed and implemented by health officials.
Scottish Sun
19 hours ago
- Scottish Sun
Trolls said I was a liar on Ozempic when I dropped 6 dress sizes, I wouldn't wish truth on worst enemy, says Enders star
Click to share on X/Twitter (Opens in new window) Click to share on Facebook (Opens in new window) EASTENDERS actress turned body-confidence influencer Melissa Suffield on why hurtful claims that her dramatic weight loss was down to diet drugs cut her deep. Having built a vast social media following on the back of an empowering body-confidence message, when Melissa Suffield started losing weight, she faced a bitter backlash. 4 EastEnders star turned body-confidence influencer Melissa Suffield on why hurtful claims that her dramatic weight loss was down to Ozempic Credit: MELISSA SUFFIELD 4 The actress with partner Robert and their son River Credit: INSTAGRAM Many saw her noticeably slimmer frame as a betrayal of everything she stood for, and they informed her she'd 'lost her values'. As the former soap star dropped from a dress size 14-16 to an eight (sometimes even a six), others accused her of being on weight-loss injection Ozempic – an insult to someone who had fought so hard against society's beauty standards. The truth was that Melissa, who found fame more than 20 years ago playing EastEnders' Lucy Beale, was seriously ill. She was suffering from a little-known chronic condition called SIBO (small intestinal bacterial overgrowth), which has made her life a living hell for the last 20 months. The effects have been devastating. Symptoms of the condition include abdominal pain, bloating and changes in bowel movements. As well as rapid weight loss caused by her symptoms, Melissa's hair fell out and her mental health plummeted. She's also been sapped of energy, which has left her struggling to care for her five-year-old son River. It's hit her financially, too, as she's forked out thousands of pounds privately to get the answers the NHS couldn't give her. 'I wouldn't wish this on my worst enemy,' she says. 'It's so consuming and relentless, because if it's not the nausea, it's the brain fog and crushing fatigue. 'People who have suggested I'm on weight-loss injections and then telling me I'm lying – I'd be happy to show them my bank statements proving that I've spent £15,000 on investigations into what's wrong.' Former EastEnders star has had '40 doctors appointments' and spent 'over five figures' amid gruelling health condition Although Melissa, 32, recognises the potential health benefits of drugs like Ozempic and Mounjaro in certain circumstances, having been through such misery with her digestive system lately, she can't get her head round why anyone who wasn't severely overweight would contemplate turning to the jabs. 'I can't fathom it. There will be situations where the benefits outweigh the risk. But there are so many people who are nowhere near that point, who just want to lose a few pounds, and that is such a bleak state of affairs.' 'We seem to have fallen into a place where body positivity is dead' She adds: 'Now that I've witnessed first-hand the fragility of the digestive system, I know it's not to be messed with. You're playing with fire, if you bugger one bit up, the rest collapses.' Melissa, who has grown an audience of more than 187,000 followers on Instagram as @ says she's lost 'a lot of followers' over the last year – people who claim they no longer relate to her. She admits she's now worried about her future as a content creator, considering her personal brand has been built on the back of curves and loving the skin you're in. 'It's been nerve-wracking, 100%. I can't work for some of the brands I was working with on a regular basis. My boobs have shrunk and I don't fit the bras I was [promoting] so I'm losing income, too.' The weight loss has also thrown up some personal conflict for Melissa, which she's still working through. 'When I first started losing weight, I'd look in the mirror and go: 'I look amazing!' and I'd have to stop myself, because that's what society wants – for me to be happy with a smaller body. And actually, I wasn't happy. I felt dreadful. 4 Melissa's illness led to a dramatic loss in weight 'I honestly feel like I'm afforded more respect now that I'm smaller, which is also depressing but not unsurprising, because we seem to have fallen into a place where body positivity is dead. We've gone backwards and I don't like being a part of that.' Melissa's ordeal began shortly before Christmas 2023, when both she and River fell ill with a gastric bug on the same day. While River bounced back, Melissa showed no sign of a recovery and made an appointment with her GP as soon as the surgery re-opened. 'The doctor put me on anti-nausea medication and gave me a proton pump inhibitor (PPI), which reduces acid in the stomach. I have since found out that chronic use of PPIs can cause SIBO, so rather than getting to the root of my problem, I was exacerbating it.' Over the next few months, Melissa visited the GP as frequently as four times a week. Her partner Robert, 43, works away as a cruise director, and the long spells of solo parenting were becoming increasingly gruelling. An ultrasound of Melissa's abdomen showed nothing wrong, and neither did an upper endoscopy, so after three months, she paid for a private gut health test, which reported an elevated level of methane. Thanks to her meticulous research, Melissa knew this indicated that it might be worth doing a SIBO test, which was positive. Since her diagnosis, Melissa has had to fight for treatment – she has amassed an encyclopaedic knowledge of her condition and is currently under the care of an NHS gastroenterologist, plus a team of private experts, as she works to find a solution. 'My nutritional therapist probably has more pictures of my poo in her phone than she's had hot meals! But this is all money and I don't have a bottomless pit. 'I need to be killing the bacteria and healing my gut faster than they can grow back. At the moment, I'm in the middle of a round of antimicrobials, which are like natural antibiotics, and I'm hoping for the best.' 'I would go days not even being able to lift a fork to my face, let alone eat something' Treatment is very much trial and error, and Melissa says that in the meantime her life is in limbo. 'It's very isolating to have a gut condition and have to plan your whole life around it. I've felt guilt because I can't go for long walks to the park with River, we have to stay close to home in case I get tired or sick.' Melissa is keen to use her platform to raise awareness and urges anyone with unexplained digestive issues to at least investigate the possibility of SIBO. 'I want to get to a place where everyone has at least heard of it and knows to ask for a test. The more people talk about it, the more the NHS is going to have to listen and learn.' 4 Back in her EastEnders days, when she played Lucy Beale Credit: EASTENDERS She says she's hopeful of leading a normal life again, or at least a new normal she can be happy with. 'At the moment, I'm maintaining weight, it's not falling off me like last year, when I'd go days not even being able to lift a fork to my face, let alone eat something. 'I probably won't ever eat gluten or dairy again, but I've made my peace with that. 'I also think there's likely to be quite a lot of trauma to work through once I'm out the other side. But I'm a pretty pragmatic lady and so I'm ready for that.'
