FDA employees say the agency's Elsa generative AI hallucinates entire studies
Leadership at the FDA appeared unfazed by the potential problems posed by Elsa. "I have not heard those specific concerns," FDA Commissioner Marty Makary told CNN . He also emphasized that using Elsa and participating in the training to use it are currently voluntary at the agency.
The CNN investigation highlighting these flaws with the FDA's artificial intelligence arrived on the same day as the White House introduced an " AI Action Plan ." The program presented AI development as a technological arms race that the US should win at all costs, and it laid out plans to remove "red tape and onerous regulation" in the sector. It also demanded that AI be free of "ideological bias," or in other words, only following the biases of the current administration by removing mentions of climate change, misinformation, and diversity, equity and inclusion efforts. Considering each of those three topics has a documented impact on public health, the ability of tools like Elsa to provide genuine benefits to both the FDA and to US patients looks increasingly doubtful.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hill
an hour ago
- The Hill
Coke with cane sugar may not be that big of a MAHA victory
Coca-Cola is going to offer a cane sugar version of its signature beverage, rather than one sweetened with corn syrup. Major segments of the food industry, including General Mills and Heinz, have pledged to remove certain colored dyes from their products. The fast-food chain Steak 'n Shake is making french fries in beef tallow rather than vegetable oil. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has claimed them all as significant victories for his 'make America healthy again' (MAHA) movement as part of its quest to reform the U.S. food supply. 'Froot Loops is finally following its nose — toward common sense,' Kennedy said on social platform X after cereal-maker WK Kellogg Co. agreed to remove synthetic dyes from its cereal by 2027. 'I urge more companies to step up and join the movement to Make America Healthy Again.' But nutrition and food policy experts say the moves are a far cry from actually making America healthier. While they praised the administration and MAHA for drawing attention to what they said is a broken food system, the victories touted thus far have been largely symbolic and rely on the goodwill of an industry that is eager to appear helpful to avoid strict government regulation. 'I think if we're really curious about improving public health, some of the small health initiatives, like … replacing high fructose corn syrup with cane sugar, are really not where the administration should be channeling their efforts and leveraging the power that they do have,' said Priya Fielding-Singh, director of policy and programs at the George Washington University Global Food Institute. 'I think they should be focusing their efforts on initiatives that actually address the root of the problem, which is essentially a food system that promotes excess sugar, salt and fat,' Fielding-Singh said. Health officials and GOP lawmakers have taken to conservative media in recent weeks to tout the commitments from food and beverage companies to remove synthetic dyes. According to the HHS, nearly 35 percent of the industry has made such a commitment. But there's been no force behind the companies' actions, which experts said is an issue. 'Simply switching from synthetic to natural colors will not make these products less likely to cause obesity,' said Jerold Mande, a former senior official during three administrations at the Food and Drug Administration (FDA), the Department of Agriculture and the Occupational Safety and Health Administration. Barry Popkin, a nutrition professor at the University of North Carolina Gillings School of Global Public Health, said Kennedy could make a major statement by banning all colors and dyes. It wouldn't directly make Americans healthy, but it would go a long way toward making ultra-processed food look less appealing. 'All this voluntary stuff only goes so far. It really does minimal impact,' Popkin said. 'Unless he goes to the FDA and has the FDA change a regulation … there's nothing.' Kennedy has also singled out the use of high-fructose corn syrup as a major contributor to diabetes and obesity. He has previously called it 'poison,' an epithet he repeated in late April when talking about sugar. When Steak 'n Shake said earlier this month it was going to sell Coca-Cola with real cane sugar, Kennedy praised the move. 'MAHA is winning,' Kennedy posted on X. But experts said there's no substantial difference in the benefits of using cane sugar as a substitute for high-fructose corn syrup. 'At the end of the day, a Coke is still a can of Coke. It's not a fruit or a vegetable, right? And so if you're not shifting consumption away from these higher calorie, lower nutrient processed foods, toward nutrient dense, health promoting foods, then you're not actually going to be shifting the health of Americans in the right direction,' Fielding-Singh said. But if Kennedy thinks sugar is poison, 'they're both sugar and would both be poison, in his words,' said Mande, who is now CEO of Nourish Science. Health officials argue industry cooperation is key to the MAHA agenda. 'Working with industry is the best place to start. And we believe in industry to do the right thing when called upon,' Food and Drug Administration Commissioner Marty Makary and Centers for Medicare and Medicaid Services Administrator Mehmet Oz wrote in a joint op-ed in The Wall Street Journal. 'Our agencies are in a strong position to show Americans which companies are doing the right thing when it comes to popular reforms. By the time we're done, we will have built new relationships and be better positioned to hold them accountable,' Makary and Oz wrote. Yet there is plenty the agency can, and should do, that industry has pushed back against. Aviva Musicus, science director of the nonprofit Center for Science in the Public Interest, said MAHA is wasting its political capital. 'It's striking that we haven't seen the administration use policy to improve the food system. It's solely relying on voluntary industry commitments that we've seen repeatedly fail in the past,' Musicus said. 'In pushing the food industry to change, Trump and RFK Jr. have a chance to live up to their promises to fight chronic disease. Coca-Cola is at the table, but they're wasting the opportunity to actually improve health. The administration should focus on less sugar, not different sugar,' Musicus added. Popkin said he would like to see warning labels on ultra-processed foods high in sodium, added sugar and saturated fat. Kennedy 'hasn't tackled ultra-processed food yet. That'll be where he could make an impact on health in the U.S. and all the non-communicable diseases, including obesity. But he hasn't gone there yet,' Popkin said. The coming months will reveal more on the MAHA movement's plans to change how Americans eat. New dietary guidelines will be released 'in the next several months,' Kennedy said recently. In addition, a second MAHA report focused on policy recommendations is expected in August. 'We have to be considering that there could be real potential down the road,' Popkin said. 'But [there's been] nothing yet. That document will tell us if there ever be.'
The Hill
an hour ago
- The Hill
The FDA must crack down on dangerous knockoff weight-loss drugs
For the first time, there is real hope in the fight against obesity. New data from the Centers for Disease Control and Prevention's National Center for Health Statistics shows that adult obesity rates in the U.S. may finally be flatlining after annual increases since at least 2011. Obesity has long been understood to be the second leading cause of preventable death in America. Neither negative cultural attitudes about weight nor government messaging campaigns about diets have helped curb it. Yet like most insurmountable problems, we are innovating our way out of it. Experts believe a significant part of recent progress is due to powerful new medications such as Ozempic and Mounjaro, known as GLP-1 drugs. But just as these drugs are changing lives, a dangerous shadow market is growing alongside them. Compounded versions, which are copies of the original drugs made in smaller pharmacies, are flooding websites, med spas and clinics. These versions are often cheaper and easier to get than the real thing. They are also frequently untested, poorly regulated and, in many cases, illegal. The FDA has received more than 500 reports of serious side effects tied to compounded semaglutide and tirzepatide, the active ingredients in Ozempic and Mounjaro. Some patients have landed in the hospital after taking the wrong dose. That is not surprising when you consider that many of these vials come without proper labels or instructions. In 2023 alone, poison control centers received nearly 3,000 semaglutide-related calls, a huge jump from previous years. Many of those cases involved compounded or mislabeled versions of the medication. There are also serious concerns about what is actually in these products. The FDA has warned that some pharmacies are using different chemical forms of semaglutide, called salt forms, that are not approved for use and may not be safe. In April 2025, the agency seized counterfeit Ozempic from the U.S. supply chain after discovering that some vials contained the wrong ingredients or were contaminated with dangerous bacteria. These are not technical violations. They are real risks to people's health. During earlier shortages, compounding was allowed under special circumstances. But those shortages have ended, and the FDA has ordered most pharmacies to stop making these versions. Despite that, many continue to operate in legal gray zones or offer these drugs online. The harm does not stop with safety concerns. This trend also threatens future breakthroughs in obesity care. Companies like Novo Nordisk and Eli Lilly spent years and billions of dollars to develop these treatments. Now, they and others are working on new and even more effective drugs. When unapproved copies flood the market, it becomes harder to fund innovation. If investors cannot count on fair returns, the next generation of such medications may not make it out of the lab. Perhaps the biggest risk is to public trust. When someone has a bad experience with a fake or contaminated version, they may begin to doubt all weight loss innovations. That fear can ripple through the health system, making insurers and doctors more hesitant to support treatments that are helping with the genuine public health emergency of obesity. None of this means that compounding should disappear. It has a place when patients have specific medical needs that cannot be met by the approved versions, such as allergies or special dosing requirements. But what is happening now is not about rare exceptions. The FDA should continue cracking down on compounders that use unapproved ingredients or sell mislabeled products disguised as 'research chemicals.' At the same time, insurers and lawmakers need to make the real thing more affordable by removing middlemen such as pharmacy benefit managers. No one should have to choose between risking their health and going broke. We are finally making progress against a disease that affects nearly half the country and has stumped policymakers and advocates for decades. But progress is fragile. Unregulated versions of GLP-1s cannot be allowed to dominate the market. We risk undoing the progress reported by the CDC in the fight against obesity, and if we get this right, the trend could be reversed. That means longer lives for more people, lived in dignity and to the fullest.
UPI
2 hours ago
- UPI
Israel announces 'tactical pause' in Gaza to allow aid to starving
1 of 2 | Hundreds of Palestinians seized trucks carrying flour as they entered in Khan Yunis the southern Gaza Strip near aid centers on Thursday. The Israel Defense Force said Sunday that it will begin a "tactical pause" in fighting to allow aid to people in Gaza. Photo by Mohammed Al-Amour/UPI. | License Photo July 27 (UPI) -- Israel announced Sunday it would take a "tactical pause" in fighting to allow aid delivery to Gaza after 25 countries issued a joint statement saying the war "must end now." The Israel Defense Forces said it would implement "humanitarian corridors" for safe movement of United Nations aid trucks and "humanitarian pauses." The pause would affect densely populated areas in Gaza. The pause is to be in effect from 10 a.m. to 8 p.m. in Al-Mawasi, Deir al-Balah and Gaza City. The IDF said it would continue daily until further notice. More routes will be in place between 6 a.m. and 11 p.m. for the trucks. The IDF is "prepared to expand the scale of this activity as required." The tactical pause is to allow more aid to starving people. Many non-governmental organizations have stopped delivering aid because they were unable to get through. The IDF said the pause in fighting would "refute the false claim of deliberate starvation in the Gaza Strip." The Egyptian Red Crescent said the convoy from Egypt had more than 100 aid trucks with more than 1,200 tons of food, NBC reported. A dozen people trying to reach the aid were killed in attacks by the IDF Sunday. A hospital in Gaza said Sunday that it had received 12 bodies, CNN reported. Four of them were children, and one was a woman. There were 100 injured when the IDF fired near an aid point operated by the Gaza Humanitarian Foundation. It's unclear if it happened before or after the tactical pause began at 10 a.m. local time or if the area was included in the pause. Nearly 90 children have recently died of starvation in the region. The uncle of 10-year-old Noor Ashraf Abu Selaa who died of starvation, spoke out against the Israeli aid blockade. Noor had been "a lively girl and she became like this because of hunger, thirst and the siege - the siege imposed on us by the Israelis," her uncle Ghazi Abu Selaa told CNN. "Doctors are here, but there is no medicine. No milk. No food," he said.
