US FDA places clinical hold on 2 Gilead trials of weekly HIV pill combination
June 10 (Reuters) - The U.S. Food and Drug Administration has placed a clinical hold on Gilead Sciences' (GILD.O), opens new tab trials testing a combination of two of its experimental HIV treatments, the company said on Tuesday.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Daily Mail
42 minutes ago
- Daily Mail
I was diagnosed with Alzheimer's after ‘overused' medical procedure caused my dementia
Sean Fischer's mother had been getting sicker for decades. She would ask the same question multiple times, be bedbound from migraines and unstable on her feet. The mystery behind her decades-long ailments was seemingly solved when she was diagnosed with Alzheimer's disease in June 2022. Sean said: 'We had spent countless hours fretting over what could be wrong, but not once did I think it could be early-onset Alzheimer's. That diagnosis belongs to other families, I thought. Not ours.' The Fischers met with renowned neurologists and prepared the then-61-year-old to participate in an Alzheimer's clinical trial for the drug varoglutamstat. Then came devastating news that meant Mrs Fischer wouldn't be eligible for the trial - she was suffering from a persistent leak of spinal fluid somewhere in her spinal system, but doctors couldn't pinpoint the source - and couldn't fix it. They believed it was likely a result of epidurals she'd received during childbirth - an injection in the back that numbs a person from their belly button to their thighs. It's a common pain relief option during childbirth and an estimated 61 percent of women who give birth receive an epidural. After suffering for more than a decade, doctors said a new procedure would allos them to inject dye into Mrs Fischer's spinal fluid to search for the leak - a small spot in the middle of her back. A few weeks after they sealed it, all of her symptoms went away and doctors said she didn't actually have Alzheimer's - the tiny spot in her back was actually the source of all her symptoms. Mrs Fischer's health battle began long before her Alzheimer's diagnosis. It started in spring 2001, when Sean said he received a call from his dad: Mom had pulled over on the highway, vomiting from a sudden, crushing headache. Her doctor called it a migraine, but months later she lost hearing in one ear and was diagnosed with Ménière's disease. She adjusted — avoiding movements that triggered vertigo, wearing a hearing aid in her forties, and taking daily meds for the headaches. Even as she quietly suffered, Sean wrote for The Free Press, she stayed steady for him and his brothers, never missing a soccer game, school musical, or packed lunch. In 2010, neurologists at Columbia University diagnosed her with a Chiari malformation, a structural defect where the brain is pushed through the opening at the base of the skull. They suspected the malformation was caused by a cerebrospinal fluid leak, sparked by her three epidurals from the births of each of her sons. Epidurals are extremely safe and are administered by inserting a needle in the space of the lower spine just outside the membrane that surrounds the spinal cord. It delivers anesthetic medication, which numbs the lower half of the body and blocks pain while allowing the patient to stay awake and alert. However, it can occasionally result in a leak if the needle punctures the thin, tough membrane surrounding the spinal cord containing the CSF, called the dura mater. When this happens, some of the fluid that cushions and protects the brain and spinal cord can leak out into surrounding tissues. It can only be patched up surgically. The leak had, over the years, led to a loss in cerebrospinal fluid volume, causing her brain to sink. This can lead to severe headaches, nausea and vomiting, hearing changes, memory problems, and double vision. 'I started high school in 2015, and around that time, I began to notice the quiet dislocation of my mom's mind,' Sean wrote for The Free Press. 'When we cooked dinner together, she would have trouble following recipes. She'd stare at her calendar for long stretches of time; making sense of it seemed to require more effort than usual. She started to repeat herself. 'By the time I left for college in Rhode Island, the phrase 'You already asked me that' had become a common refrain in the house I grew up in, but at first, we blamed her, telling her she needed to pay more attention.' She was seeing doctors for headaches, hearing, and anxiety, none of whom believed there could be a common origin. Her memory problems were worsening as well, which led to Mr and Mrs Fischer to to turn to NYU Langone Health's Center for Cognitive Neurology. 'My mom was tested extensively — and two months later came the diagnosis, with the finality of a punctuation mark. Alzheimer's. When it hit her that there was no cure, my mom was bedridden for three days,' Sean said. Hope came with the study. But then doctors called the Fischers and informed them that the CSF leak would not allow her to participate. Despair took over. But a few weeks later, Mrs Fischer's doctor called to tell them about recent medical innovations that would allow surgeons to find and fix the leak, allowing her to participate in the drug trial. Six months later, doctors inserted a probe through the femoral artery in Mrs Fischer's leg, fed it upward toward her spinal system, and sealed the leak. Sean said: 'Two weeks later, I visited home, and found Mom more alert than she had been in years. There was no absent look in her eyes. As the day went on, I waited for her to start fading—but she was still wide awake at 10 p.m. 'After three weeks, her vertigo was gone, and her physical therapist told her she didn't need treatment anymore, because she no longer had any balance problems. After four weeks, she told us she felt 20 years younger.' After six weeks, her problems with memory were gone entirely. 'And eventually, Mom's neurologist confirmed: She did not have Alzheimer's. The surgeons who fixed the leak were shocked. They had never seen a recovery like it,' Sean said. The family later learned that, a year before the procedure, Cedars-Sinai Medical Center had published a newsletter with the subtitle: 'Physicians Treating Dementia Should Look for Cerebrospinal Fluid Leak—A Treatable Cause of an Otherwise Incurable Condition.' The study followed 21 patients with headaches, severe fatigue, and diagnoses of Chiari malformation and dementia; nine were found to have a cerebrospinal fluid leak, and repairing it completely resolved their symptoms. In Sean's mother's case, countless specialists across multiple hospitals treated her symptoms in isolation, overlooking the root cause. But they chose not to place blame on any doctor or institution. It was the system that misdiagnosed her, and ultimately, the system that saved her. 'More than anything, we feel grateful that a scientific breakthrough came at just the right time; that the real cause of her suffering was found,' he said.
Daily Mail
4 hours ago
- Daily Mail
YouTube star Mr Beast completes brutal 14-day fast and is floored by the 'depressing' impact on his body
A social media star who undertook a two week fast has revealed the brutal impact the challenge had on his body. Jimmy Donaldson, known online as 'Mr Beast', has earned a 404 million strong YouTube following by taking on increasingly elaborate challenges, including spending 100 hours inside the Pyramids and seven days stranded in a cave. But months ago the now 27-year-old embarked on a new feat, drinking only water and not consuming food for 14 days. While not unfit, the 6ft 5in influencer and entrepreneur weighed around 220lbs (110kg) — giving him a BMI of roughly 26, overweight. Now, in a recent YouTube video, which was been viewed more than 3 million times, he told comedian Theo Von how the challenge had a 'depressing' effect on his body. Despite swathes of studies suggesting intermittent fasting — which shot to prominence in the early 2010s — does work, experts remain divided over its effectiveness and the potential long term health impacts. Some argue that fasters usually end up consuming a relatively large amount of food in one go, meaning they don't cut back on their calories — a known way of beating the bulge. They even warn that it may raise the risk of strokes, heart attacks or early death. Scientists have also urged caution over fasts that last more than a day because of their 'short-lived' effectiveness, advising that they could trigger chronic health issues like digestive conditions. Mr Donaldson said: 'I did 14 days, only water, I lost 20 something pounds,' 'After day five or six you're pretty drained, you have no energy. 'I did a dexa scan before I did my extended fast, where they measure the fat and muscle, I lost like six pounds of muscle, it was pretty depressing. So I lost 13 lbs (5.9kg) of fat. 'Even after you start eating, the muscle didn't just come back.' 'It was intense not eating, I was still filming and working throughout it, it was really messing with me. He added: 'Standing up was brutal, and walking around, because you have no energy. 'I never got that super human clarity, I was just f**king tired all the time, I was too tired to have clarity.' Jennifer Aniston , Chris Pratt and Kourtney Kardashian are among the Hollywood A-listers to have jumped on the trend since it shot to prominence in the early 2010s. But, despite swathes of studies suggesting it works, experts have remained divided over its effectiveness and the potential long term health impacts Tracking his progress over the course of the two-week challenge, daily weigh ins showed by day three Mr Donaldson had already shed almost 4lbs, at 216.4lbs (98.2kg). By day six his weight had fallen to 210.1lbs (95.3kg) and day 10, 206.2lbs (93.5kg). But at day 12, weighing just 204.3lbs (92.7kg), he noted: 'I was so nauseous that I couldn't film for more than 20 minutes without sitting down for a break. 'By the end of the day I felt like I was going to pass out.' It was only after filming a cooking video with celebrity chef Gordon Ramsey on day 14, that he decided to break his fast and eat a breakfast sandwich the 58-year-old had prepared. He did, however, immediately spit the sandwich out over fears if refeeding syndrome—where a sudden increase in calories causes an imbalance of fluids and salts, which can affect heart function. This means people require constant monitoring. At a final check on day 14, Mr Donaldson weighed just 202lbs (91.6kg), putting his BMI in the healthy category. However, he cautioned he had a team of doctors around him throughout the two weeks to regularly monitor his vital signs, such as heart rate and blood pressure to ensure he didn't 'have a heart attack or worse'. 'Obviously as I stated in the video multiple times don't try this at home without medical supervision like I had,' he added. 'Also for more context, I have Crohn's disease and I wanted to give it a break from food to see if that would help reduce inflammation because Crohn's sucks. 'I learned a lot about how I can use fasting to reduce my inflammation and I'm glad I did this challenge.' Roughly half-a-million Britons suffer with Crohn's disease, which causes agonising pain, diarrhoea, exhaustion and extreme weight loss. Around a third of patients living with the condition, where the gut lining becomes inflamed, will require surgery. Many patients take several months to recover from the invasive procedure, while others are left with a stoma—where the bowel is diverted out of the body and replaced with a bag. It comes as an illuminating video posted online last month garnered thousands of views for its alarming display of exactly what happens to the body —hour by hour— when fasting. The four-minute gut-wrenching simulation claimed the body stops digesting food after just four hours, entering what is known as the catabolic phase—when muscle and fat is used for energy. By 12 hours, it has hit a 'fasted state' depleted of blood sugar. Here, the liver begins to break down stored fat into fatty acids called ketones to use as fuel. But ketones can be dangerous—high levels of them in the blood can lead to a condition called ketoacidosis, when blood becomes too acidic. If not treated promptly it can be life-threatening. Studies have also found that prolonged exposure to ketones can be detrimental to the heart, increasing the risk of heart attacks and strokes. Fasting up to 16 hours can then stimulate autophagy— where cells break down and remove damaged or unnecessary components like old proteins—it is claimed. Research has long warned, however, that excessive or prolonged autophagy can lead to cell death, potentially harming organs.
Reuters
5 hours ago
- Reuters
US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
June 12 (Reuters) - The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's (MRNA.O), opens new tab respiratory syncytial virus vaccine to a lower group of high-risk adults aged 18 to 59 years.
