What We Are Reading Today: ‘The Anxious Generation' by Jonathan Haidt
He explains why social media damages girls more than boys and why boys have been withdrawing from the real world into the virtual world, with disastrous consequences.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Al Arabiya
2 hours ago
- Al Arabiya
Novo Nordisk's Wegovy gets accelerated US approval for liver disease MASH
Novo Nordisk said on Friday the US Food and Drug Administration has granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition called metabolic dysfunction-associated steatohepatitis, strengthening its presence in the metabolic disease market. The approval makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5 percent of adults in the United States, according to the American Liver Foundation. 'There really (have) not been good treatments in this space. We're only the second FDA-approved treatment for MASH, and we really need better medications that have better overall benefit-risk profiles, that really can also prevent the progression of the disease,' Jason Brett, principal US medical head at Novo Nordisk, said in an interview with Reuters. So far, the only available FDA-approved treatment for MASH is the Madrigal Pharmaceuticals drug Rezdiffra, which was approved in 2024. The FDA's decision was based on part one of an ongoing two-part study that showed Wegovy helped improve the organ's condition in more patients with MASH and liver scarring, compared to a placebo. Novo Nordisk said the drug is now available in the United States for adults with MASH and moderate to advanced liver scarring, and is to be used alongside proper diet and exercise. 'MASH patients need access to treatments - and that really can help them, especially early - to prevent it from progressing,' Brett said. 'We're doing as much as we can to work and partner with the payer community around enhancing access and reimbursement.' Brett did not provide any pricing details. Based on results from part one of the trial, Novo has applied this year for approval in Europe and Japan. Further results from part two of the trial are expected in 2029. Rival Eli Lilly's tirzepatide - the active ingredient in its popular diabetes drug Mounjaro and weight-loss treatment Zepbound - previously helped up to 74 percent of patients achieve absence of MASH with no worsening of scarring in a mid-stage trial. Accelerated approvals allow the FDA to move therapies that target serious and life-threatening conditions to the market more quickly. However, such approvals have been criticized because some drugs have later been proven to be ineffective.
Al Arabiya
2 days ago
- Al Arabiya
Whoop refuses to disable blood pressure tool despite FDA warning
Whoop Inc., the maker of screen-less fitness bands, said it will not disable its blood-pressure tracking tool despite a request from the US Food and Drug Administration. The FDA last month sent a warning letter to Whoop stating that the company's Blood Pressure Insights feature, or BPI, which both measures blood pressure and provides related feedback, means that the Whoop is operating as a medical device. The new Whoop MG — short for medical grade — doesn't have such certification for blood pressure tracking despite intending to 'help with the diagnosis, cure or treatment of a disease,' according to the government agency. The band launched in May with the feature as a central addition. Whoop pushed back on the FDA's warning in a letter to the agency dated Aug. 4. 'We believe it is not within the FDA's authority to regulate the product. We therefore do not intend to remove the app,' the company wrote. 'We will continue to offer the wellness feature to consumers.' It added in a statement that it has 'requested a meeting with the FDA and hopes to have a constructive dialogue with agency officials.' On Thursday an FDA spokesperson said the agency 'has not authorized BPI for any use, including for the measurement or estimation of a user's blood pressure,' adding that 'patient safety is the FDA's highest priority.' FDA Versus Tech The FDA has clashed periodically over the last dozen years with technology companies whose devices the agency believes need regulation because they constitute medical advice. Still, Whoop's defiant reaction is rare. While regulators have struggled to define exactly when the line from wellness to medical advice is crossed, tech firms have often taken offending products off the market and sought FDA clearance or tweaked their product to comply. Meanwhile, consumer hardware makers have been adding more sophisticated health tracking tools to their fitness bands and smartwatches, blurring the lines between a wearable gadget and medical device. While the FDA can impose injunctions and fines on companies that fail to comply with violations raised in warning letters, it's rare that it follows through. The agency initially told Whoop that it should take 'prompt action' to address any violations or face potential regulatory action, including seizure, injunction and civil monetary penalties. The FDA also told Whoop it could go through the normal device approval process, something that Whoop doesn't want to do given the long amount of time that could take. Whoop said in its response that the feature is labeled for wellness purposes, not for diagnosing or treating medical conditions like hypertension. Whoop also said that repeated disclaimers are provided during the sign-up process. It characterized the issue as a 'misinterpretation' by the FDA, saying the agency views blood pressure estimation as a medical tool. The 'FDA's assertions fail to account for the substantial and growing body of scientific evidence supporting non-medical uses of blood pressure as well as the actual use of blood pressure information by the feature,' the company said in its response, which was provided to Bloomberg News. The Blood Pressure Insights feature lets users get a daily estimate of their blood pressure range so they can better understand the impact on overall health and athletic performance. The tool is available only to subscribers of the $359-a-year Whoop Life plan. The feature requires an initial calibration with a standard blood pressure cuff. Whoop Chief Executive Officer Will Ahmed previously called the FDA's letter 'misguided' on social media. The FDA said the product does not fall under the general wellness device policy because blood pressure it is not a low-risk use case. 'An erroneously low or high blood pressure reading can have significant consequences for the user,' it said in its July letter to the fitness startup. During an interview with Bloomberg TV on Thursday, Ahmed said he believes the company will be on the 'right side of history' and fighting for Americans' access to health data is the 'right thing to do.' 'Ultimately, innovation needs to be built to thrive in the United States,' he said. 'We're one of the first wearables that can measure blood pressure accurately on the wrist. That's a big deal. We want to make sure that there are policies that are consistent here in the US that really allow companies to innovate and to operate.' Other companies such as Garmin Ltd. offer FDA-cleared blood pressure reading tools. It's a feature also available on smartwatches from Samsung Electronics Co. Health and Human Services Secretary Robert F. Kennedy Jr. has promoted the use of wearable fitness devices. In an appearance before Congress in June, he said his vision is for every American to be using a wearable device within four years. Whoop CEO Ahmed was pictured meeting with Kennedy and other health tech companies in May.
Al Arabiya
3 days ago
- Al Arabiya
One in four US adults with diabetes used GLP-1 injections in 2024: CDC
More than one in four US adults with diabetes used one of the injectable medicines that target the GLP-1 protein last year, the US Centers for Disease Control and Prevention said on Thursday. The wildly popular and effective GLP-1 drugs Mounjaro from Eli Lilly and Ozempic from Novo Nordisk are approved in the United States for treating type 2 diabetes. They are sold as Zepbound and Wegovy, respectively, for weight loss and are being tested for other conditions. Use of the injectable drugs was highest among adults with diabetes aged 50–64 at 33.3 percent, reflecting the more significant disease burden in this group, the report said. A quarter or 25.3 percent of adults with diabetes aged 18 to 34 reported using a GLP-1 drug, while the adoption rate was 20.8 percent among those 65 and older. The data are from a nationally representative annual survey of US adults aged 18 and older that was conducted in person and with follow-up by phone in 2024. In 2024, for the first time, participants in the annual survey who had diabetes were asked if they were using the Lilly or Novo blockbusters or other GLP-1 drugs to lower blood sugar or lose weight. The drugs mimic the activity of a hormone that regulates blood sugar levels, slows digestion and helps people feel full for longer. Drugmakers Lilly and Novo have faced criticism about the cost of the treatments, which carry a list price of about $1,000 for a month's supply. Roughly 31 percent of survey participants who reported using insulin also reported using GLP-1 drugs, as did about 28 percent of patients who were using oral drugs to control their blood sugar, according to the report, indicating that these treatments are being integrated into combination regimens. Hispanic adults with diabetes had the highest rate of GLP-1 use, at 31.3 percent, followed by Black non-Hispanic and White non-Hispanic adults, at 26.5 percent and 26.2 percent, respectively, the survey found. Only 12.1 percent of Asian non-Hispanic adults with diabetes used the drugs, which may reflect disparities in access or adoption of the therapies.
