FDA appoints George Tidmarsh as top drug regulator
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Reuters
43 minutes ago
- Reuters
FDA recommends 7-OH compound found in vapes be controlled
WASHINGTON, July 29 (Reuters) - The U.S. Food and Drug administration is recommending the scheduling of the 7-OH compound as a controlled substance because of its opioid properties, FDA Commissioner Marty Makary said on Tuesday. Many products containing 7-OH are available in vape stores and the compound is present in drinks and children's gummies, he said at a news conference. The FDA letter to the Drug Enforcement Administration will recommend scheduling 7-OH above a concentration threshold as a Class 1 controlled substance. The substance 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors, the FDA said. "Yet it is sold in vape stores, in smoke shops, and convenience stores, and gas stations, that are popping up all over the United States," Makary said. The FDA is issuing a report explaining the risks of the synthetic substance, made from the kratom plant, and sending a letter to every physician in the United States warning them about the substance. "We're going to continue to try to educate the public," Makary said.
Daily Mail
5 hours ago
- Daily Mail
EXCLUSIVE New mom details shocking cost of giving birth in America
A new mom has shared the shockingly high cost of giving birth in America - and it's well over six figures. Emily Fisher, 36, from Columbus, Ohio, welcomed twin girls last month and was left stunned when she saw an insurance claim come through for her delivery that was over $10,000. Completely shocked by the immense figure, she decided to go back and total up all the bills she had received over the course of her pregnancy to determine just how much having a baby in the US really costs. And after adding everything up, Emily found that having her baby girls would have cost her a whopping $120,527.51 had she not had insurance. She shared her findings in a video shared to TikTok earlier this month and it quickly went viral, leaving thousands across the globe just as surprised as she was. 'So I am five weeks postpartum with twin girls and I've been seeing a lot of headlines recently about how the birth rate in America is declining and how concerning that is,' Emily began in the video. 'I thought to myself, I could think of a lot of reasons why the birth rate might be declining. First and foremost, cost. 'So I decided to take it upon myself and look at every bill that I received over the course of my pregnancy and total what it costs to deliver twins in America.' Emily explained that she is considered 'advanced maternal age' and was pregnant with 'dichorionic diamniotic twins' which made her pregnancy 'high risk.' In addition, about halfway through the pregnancy her doctor raised concerns about potential 'fetal growth restriction,' so from about 22 weeks on she had to have two appointments every week with her OBGYN and a maternal fetal medicine specialist to make sure the babies were healthy. 'So what was the total cost of that? From the start of my pregnancy through delivery and me walking out of those hospital doors, the total bill for my care was $120,527.51,' she said in the video. 'Now I am very fortunate great insurance and I have a low deductible so over the course of my pregnancy out of pocket I paid $2,038.70. 'I know that is relatively good but still, $2,000 for something that is considered necessary and vital to the future of America is pretty significant.' Emily added that on top of that, her newborns both received bills for their delivery. 'It's kind of funny, they're not even able to blink yet and they've already been billed more than the total cost of my student loans,' she continued. 'Baby A received a bill for $15,124.55 and Baby B was billed $14,875.55, I guess there was some sort of sibling discount. She added, 'The total cost I owed for those two bills was $750, which was the cost of my deductible.' The bills are seen above 'The total cost I owed for those two bills was $750, which was the cost of my deductible.' She then broke down what some of the highest costs were during the pregnancy. Unsurprisingly, the delivery itself and the hospital stay afterwards was the most costly expense. Emily explained that she had a scheduled C-section at 37 weeks and spent four days in the hospital post delivery, and the total cost of her care before insurance was $65,665.50. The second highest cost during the pregnancy was an appointment she had about seven months in, during which she complained to her doctor that she was having headaches. She said they took her blood pressure and it was slightly elevated, so they monitored the heart rate of the babies for 20 minutes to 'make sure they were okay.' She was then given 'two extra strength Tylenol' and they 'did some blood work.' 'The cost that was billed to my insurance for that visit was $9,115,' shared the new mom. 'All things considered, I'm very grateful for the experience that I had and very grateful to have great insurance, but I know that for a lot of people who live in America that is simply not possible,' she concluded. 'And if I did not have insurance delivery my two baby girls, I would not be able to afford it. 'In fact, I probably would have had to file bankruptcy had I not had insurance. So when people act confused why the birth rates are down, maybe it's not necessarily all attributed to lifestyle choices, maybe it's not because people aren't feeling the vibe of having kids, maybe it's because the cost of having a baby in America is over six figures.' While chatting with the Daily Mail about it, Emily, who used to work on the healthcare space, said she believes the insurance system in America 'needs a complete overhaul.' 'Given that the US is the one of (if not the only) developed nation in the world without some sort of universal healthcare, we're falling behind,' she said. 'People are spending too much on basic and necessary care. Medical debt is one of the number one reasons for bankruptcy in the US, and it shouldn't be that way. 'If we invested in a system that put the health its people first, everyone would be better off. 'And given the decline in birth rates, if our politicians are genuinely concerned about falling birth rates, they would be incentivizing people to have children. You shouldn't have to pay to give birth.' She added that while she was 'shocked' by the high number that her insurance was billed, she was 'not surprised at the same time.' 'The first thing that came to mind when I saw the total was, "How do people without insurance afford this?"' she shared. 'But I've always known that healthcare in America is a business. Ultimately, like most necessities in the US, privatized insurance is designed to make money.' She said she certainly wasn't expecting her video, which was viewed more than one million times, to get as much attention as it did, but she's so glad that it has sparked a conversation. 'I hope my video makes people think twice about having kids in America. Because until the system is redesigned to truly support the people, we shouldn't be buying into it,' she concluded. 'I'm fortunate to have good health coverage. I'm not on the hook for much as far as the cost of my pregnancy, but that is only the beginning for my family and what we'll pay to raise my kids. 'Now we have to think about things like paying for their health coverage, daycare, food, housing and college. 'All of these things are only getting more and more expensive and almost unreachable for people.'
The Independent
5 hours ago
- The Independent
‘Game-changing' new Alzheimer's drug could slow progression of disease
An Alzheimer's drug that clears away plaque build-up in the brain could slow progression of the disease and delay the onset of symptoms, early trials have shown. There is currently no cure for the disease, which can severely affect memory and impact people's ability to carry out daily tasks, and the medicines available can only reduce symptoms. But a new drug called Trontinemab is showing promising results, the Alzheimer's Association International Conference in Toronto was told. The drug has been tested on a small number of patients, but 49 out of 54 with early-stage Alzheimer's showed signs of improvement within 28 weeks during a trial, according to Roche, the pharmaceutical company behind the drug. Researchers said 91 per cent of the participants showed a reduction in clusters of protein on their brains, known as amyloid plaques – a key marker of Alzheimer's. Alzheimer's is thought to be caused by an abnormal build-up of this protein around brain cells, while another protein called tau forms tangles within brain cells. These can interrupt the chemical messengers responsible for sending signals between brain cells, according to the NHS. The new drug was found to reduce amyloid proteins to a level so low that scan results on patients taking it for seven months were considered to be 'amyloid negative'. It is thought that the clearance of plaques slows down the progression of the disease and delays the onset of symptoms. 'Alzheimer's disease represents one of the greatest challenges in healthcare today, and tackling it requires early detection and effective therapeutics,' Dr Levi Garraway, chief medical officer of Roche, said. He added: 'Trontinemab is designed to target a key driver of Alzheimer's disease biology more effectively in the brain. Combining new treatment avenues with advanced diagnostics may enable earlier and potentially more effective intervention.' Professor Sir John Hardy, the chairman of molecular biology of neurological disease at University College London's Institute of Neurology, who was not involved in the trial, told The Telegraph the drug was a 'massive improvement' and works faster than other Alzheimer's drugs on the market. 'There is no doubt this could be game-changing. We hope that if we can use these drugs to people early, we can halt the progression of disease, even before people have symptoms. Now we need to see the size of the clinical effect,' he said. However, the drug does have some side effects, with five participants of 149 (3 per cent) suffering from lesions or swelling in their brains after taking it. But all the participants recovered, and it was considered to be safer than other Alzheimer's drugs that have resulted in 17 per cent of participants experiencing similar side effects. The final part of the trial, which will test the drug on a large number of patients, is yet to be carried out. But if it is successful, health bodies in the UK will need to decide whether it is cost-effective enough to use on the NHS. An estimated 982,000 people are living with some form of dementia, including Alzheimer's, in the UK, with the disease most common in people over the age of 65. But more than a third of people with the condition do not have a diagnosis. The number of those with the disease is expected to rise to 1.4 million by 2040, according to the Alzheimer's Society.
