https://www.digiteex.com Digitex Solutions Sat, 22 Feb 2025 03:44:01 +0000 en-US hourly 1 224764844 https://www.digiteex.com/firings-at-fda-decimated-teams-reviewing-ai-and-food-safety/ https://www.digiteex.com/firings-at-fda-decimated-teams-reviewing-ai-and-food-safety/#respond Sat, 22 Feb 2025 03:43:58 +0000 https://www.digiteex.com/firings-at-fda-decimated-teams-reviewing-ai-and-food-safety/ In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. It scooped up food chemists, lab-safety monitors and diabetes specialists who helped make needle pricks and test strips relics of the past.Trying to keep up with breakneck advances in medical technology and the demands of a public troubled by additives like food dyes, the agency enticed scores of midcareer specialists with remote roles and the chance to make a difference in their fields.In one weekend of mass firings across the F.D.A., much of that effort was gone. Most baffling to many were the firings of hundreds whose jobs were not funded by taxpayers. Their positions were financed through congressionally approved agreements that routed fees from the drug, medical device and tobacco industries to the agency.Known as user fees, the money provides adequate staffing for reviews of myriad products. While criticized by some, including the nation’s new health secretary, Robert F. Kennedy Jr., as a corrupting force on the agency, the industry funds are also widely viewed as indispensable: They now account for nearly half of the agency’s $7.2 billion budget.Though the F.D.A. is believed to have lost about 700 of its 18,000 employees, some cuts hit small teams so deeply that staff members believe the safety of some medical devices could be compromised.Among the layoffs were scientists supported by the fees who monitor whether tests pick up ever-evolving pathogens, including those that cause bird flu and Covid. They hobbled teams that evaluate the safety of medical devices like surgical staplers, new systems for diabetes control and A.I. software programs that scan millions of M.R.I.s and other images to detect cancer beyond the human eye. The cuts also eliminated positions for employees who have played a role in assessing the brain-implant technology in Elon Musk’s Neuralink devices.The layoffs affected so many key experts that a major medical device trade group has requested that the Trump administration reconsider the job cuts.The dismissals also included lawyers who warned retailers about underage tobacco sales and scientists who studied the safety of e-cigarettes and new heat-not-burn devices. The tobacco division — which is fully funded by an excise tax on cigarettes — lost about 85 staff members.Dr. Robert Califf, the F.D.A. commissioner under President Biden, said the personnel cutbacks seemed scattershot. Taking a not-so-subtle aim at Mr. Musk’s Department of Government Efficiency, which is reducing the federal work force, Dr. Califf said the layoffs were, in effect, “anti-efficiency.”“These are not hires that are done arbitrarily,” he said. “They’re done to meet a need.”A lawsuit challenging the firings filed by unions, including one that represents some F.D.A. employees, failed to stop the layoffs in a ruling issued Thursday. Other cutbacks reduced the 2,000-member staff of the F.D.A.’s food division, which is supported by tax dollars.Jim Jones, the former director of the division who resigned on Monday over the cuts, said that he had briefed the Trump transition team on his efforts to create a new office that would review a premier target of Mr. Kennedy and his agenda to Make America Healthy Again: food additives that are already on the market.Nine people from that food-chemical-safety staff of 30 are gone, including specialized toxicologists and chemists, Mr. Jones said in an interview.“They’ve created a real pickle for themselves,” by cutting staff members working on a key priority, Mr. Jones said. “You just can’t do an assessment for free and you can’t ban chemicals by fiat.”In interviews with 15 current and former agency staff members, they said those who were laid off had been probationary employees, a group that included agency veterans who took on new roles, were recently promoted or were hired in the last two years.Those who remained said that they had been scrambling to pick up pressing medical device reviews and move forward with studies to bulletproof methods for detecting deadly bacteria during inspections at food production sites.Divisions that review novel medications, vaccines and gene therapies were largely spared. Officials with the F.D.A.’s parent agency, the Department of Health and Human Services, did not respond to requests for comment.The F.D.A. employees fired last weekend were notified in uniformly worded emails that their skills were not needed and that their performance was “not adequate to justify further employment by the agency.” Yet many of them said that their performance reviews had said they exceeded expectations.Tony Maiorana, 37, a chemist, worked on product approval and safety in the fast-changing field of diabetes devices. In the last decade, the field has moved from painful needle pricks and test strips to systems that measure glucose levels just below the skin and automatically infuse the needed insulin.The work of reviewing new products is painstaking: Novel algorithms measure and dispense insulin; materials implanted in the body must evade rejection by the immune system; and millions of patients from toddlers to the elderly are at risk if devices malfunction.Still, about half of Dr. Maiorana’s product-review team was eliminated, he said.“If you’re a patient and you complain, we are the ones that field your complaints,” he said. “We are the ones that monitor the death reports. We’re the ones that are telling companies: ‘Hey, there’s a big pattern of error happening here. People are dying or ending up in the hospital because of your device’ and ‘What has changed? What happened?’”Dr. Maiorana said that he had expected his government job would be “chill,” but it turned out to be intense. His team had to assess whether studies of new devices that had never been used in humans were safe for adults and children. They also had to watch online marketplaces for diabetes technology that had not been approved by the agency.“This is the reason the F.D.A. was founded — to protect the public,” Dr. Maiorana said.Albert Yee, 59, an expert in biomechanics and robotics, was fired on Saturday. In his unit, four of 11 staff members, who review the safety of surgical robots, were let go.Robotic surgery is increasingly employed in operating rooms across the country, used in cardiothoracic, gynecological and bariatric surgeries. Dr. Yee had worked in the industry and in academia before joining the F.D.A.He said his team was highly specialized, including an expert with a doctorate in medical robotics and a physician who had conducted robotic operations.He said that robotic devices had become so complex that the team’s diverse expertise was critical to evaluate not just the safety of such tools but also concerns about cybersecurity.“All of these devices now — if they’re attached to the hospital network, they become an avenue to get into the hospital network or get into the device itself,” Dr. Yee said.He said the team also fielded a flood of applications for surgical apparatus developed abroad that were similar to those made by companies based in the United States. He said the applications required close attention to catch problems that could endanger patients.“The institutional knowledge we’re losing is just horrific,” he said. “I am concerned about public safety with this type of purge.”About four hours after this article was published online, Dr. Yee said he received a call from the F.D.A. to restore his job. He plans to return Monday morning.Nathan Weidenhamer was a lead reviewer of cardiovascular devices and other high-risk implants.He said he was shocked and disappointed to be laid off because he and other reviewers in the device division were partly funded by industry-generated fees.“I naïvely thought we were important, critical public servants and I’d be spared,” he said.The layoffs clearly did not skip over employee slots created and funded by the agreements negotiated with the industries, congressional lawmakers and F.D.A. officials. The industries provide billions of dollars in return for staff equipped to meet strict deadlines for decisions on product approvals — though not all go in companies’ favor. The money is also used to make the F.D.A. a competitive employer in specialized fields that require advanced degrees.Some of the deadlines are viewed by F.D.A. staff members as demanding, particularly the 30-day clock requiring them to authorize or add comments to studies of devices that are being implanted in humans for the first time. If the agency does not respond within that time-frame, the study is given a green light under the law.The depth of cuts to medical device staff prompted AdvaMed, a trade association for the industry, to push back in a letter to a top Health and Human Services official.The letter detailed about 180 medical device staff cuts, which included 25 experts in artificial intelligence, a 20 percent reduction in biostatisticians who evaluated studies of novel devices and the loss of molecular biologists with expertise in diagnostic tests that pinpoint a cancer subtype. The firings also applied to a top official who was recently recruited to oversee about 10,000 product applications and meeting requests per year.The group said it appreciated the Trump administration’s efforts to improve efficiency. But “they may have missed the mark on how they rolled it out,” Scott Whitaker, the president of AdvaMed, said in an interview.Medical device companies benefit when the F.D.A. is well staffed with people who have the expertise to guide the safe development of new technology, he added.“One that is slow and overregulates is not good,” he said. “One that is under-resourced and doesn’t regulate at all — that’s not good either.”Alice Callahan contributed reporting.


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]]> https://www.digiteex.com/firings-at-fda-decimated-teams-reviewing-ai-and-food-safety/feed/ 0 5015 https://www.digiteex.com/elon-musk-offers-1-million-a-day-to-entice-swing-state-voters/ https://www.digiteex.com/elon-musk-offers-1-million-a-day-to-entice-swing-state-voters/#respond Sun, 20 Oct 2024 15:49:55 +0000 https://www.digiteex.com/2024/10/20/elon-musk-offers-1-million-a-day-to-entice-swing-state-voters/ Tesla CEO and X owner Elon Musk, who supports Republican presidential nominee former U.S. President Donald Trump, gestures as he speaks about voting during an America PAC Town Hall in Folsom, Pennsylvania, U.S., October 17, 2024. Rachel Wisniewski | ReutersElon Musk said Saturday that he would randomly award $1 million a day to registered voters who sign a petition for his pro-Trump political action committee in an effort to get his fans in swing states to the polls.Speaking at an America PAC event in Harrisburg, Pennsylvania, Musk said, “I have a surprise for you,” adding that the prize money is available “every day from now until the election.”Musk then called up a man named John Dreher, who he said was one of the petition signees in attendance, and handed him a giant check.”I think think is kind of fun, and you know, it seems like a good use of money basically,” said the Tesla CEO, who is worth almost $250 billion.Musk, who is also CEO of defense contractor SpaceX and owner of social media platform X, embarked on a speaking tour in Pennsylvania to drive voter registration in his support of the Republican nominee. He called the state the “linchpin” in this election.”How Pennsylvania goes I think is how the election goes,” Musk said.The deadline to sign the petition is Monday night, which is the day Pennsylvania’s voter registration closes. The petition, posted on the America PAC website, said that to be eligible for payments, signees “must be registered voters of Arizona, Georgia, Michigan, Nevada, North Carolina, Pennsylvania, or Wisconsin.”Rick Hasen, a UCLA law professor and NBC news election law analyst, said in a blog post that Musk’s initiative appears to be a violation of federal election laws, specifically one that says a person who “pays or offers to pay or accepts payment either for registration to vote or for voting shall be fined not more than $10,000 or imprisoned not more than five years, or both.””Certain things in this country can be sold, and certain things we have decided should not be for sale,” Hasen told CNBC in an interview. “Congress has determined you should not be able to sell your vote to the highest bidder, and we should not have the political process distorted by people with the most wealth who may try to get you to vote in a certain way.”CNBC reached out to Musk and one of his advisors for comment, but they didn’t respond.Floating conspiracy theoriesAt pro-Trump events, Musk has pushed debunked voter fraud conspiracies, called for deregulation, and repeatedly characterized President Biden and Vice President Kamala Harris, Trump’s rival, as replaceable “puppets.””No one’s even bothering to try to kill Kamala, you know, because there’s no point,” Musk said on Saturday, repeating a line he’s used in the past that caught the attention of the secret service. “I’m not suggesting someone should try to kill her, it would be pointless, but I’m just saying. I’m just making an observation.”Musk said in his appearances that he views many government agencies and regulations in the U.S. as ineffective and unnecessary. Trump has taken up an idea floated by Musk to create a government efficiency commission, and said the tech magnate would be a big part of the commission.”We should not trust the government, really. We just shouldn’t,” Musk said Harrisburg. “Even if I’m in the government, don’t trust the government.” While Musk’s companies have long relied on government spending and support, he’s berated the Federal Communications Commission, the Environmental Protection Agency, Federal Aviation Administration and National Oceanic and Atmospheric Administration Fisheries for holding SpaceX back.”We get crazy things,” Musk said, “like SpaceX got fined $140,000 for dumping potable drinking water on the ground at Starbase.”As CNBC previously reported, SpaceX has repeatedly discharged hot, industrial wastewater into the wetlands surrounding the company’s launch pad in Boca Chica, Texas, which the EPA found was a Clean Water Act violation.SpaceX Falcon Heavy rocket with the Clipper spacecraft sits on launch pad 39A before the launch at the Kennedy Space Center in Florida on October 14, 2024.Chandan Khanna | Afp | Getty ImagesMusk mocked NOAA Fisheries for asking SpaceX to conduct a study to predict how its rockets could impact sharks and whales if they fall into the ocean. “I’m like, it’s a big ocean, you know, there’s a lot of sharks. It’s not impossible, but it’s very unlikely,” Musk said. The agency’s mission is to “conserve America’s coastal and marine resources.”Musk’s animosity towards President Biden picked up in 2021, when the White House declined to invite Tesla to an electric vehicle summit. “You know, Tesla’s about 140,000 people — it’s like there’s a lot of blood, sweat and tears from people working hard to make great electric cars,” Musk said on Saturday. “To be could-shouldered like that for no reason. It’s like, what’s the deal?” Musk has long battled unions, and Tesla was charged with union-busting before the EV summit. Biden has maintained a pro-labor platform throughout his presidency.One attendee in Harrisburg asked Musk if he believed that self-driving cars should eventually be mandatory if they can perform more safely in traffic than human drivers. Tesla has promised customers a “robotaxi” for years, but never produced one.Musk suggested he was against anything federally mandated. “We should just get the government out of things and let the market figure it out,” he said. “I’m generally against government. With that, I’d like to thank you all for coming. It’s been an honor to speak with you.”Musk only mentioned Trump sparingly throughout the evening, and didn’t discuss his policies or record as president in any detail.WATCH: Elon Musk gives $75 million to pro-Trump PAC


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