{"id":18943,"date":"2025-07-23T21:38:07","date_gmt":"2025-07-23T21:38:07","guid":{"rendered":"https:\/\/www.newsbeep.com\/ca\/18943\/"},"modified":"2025-07-23T21:38:07","modified_gmt":"2025-07-23T21:38:07","slug":"fdas-new-drug-approval-ai-is-generating-fake-studies-report","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ca\/18943\/","title":{"rendered":"FDA’s New Drug Approval AI Is Generating Fake Studies: Report"},"content":{"rendered":"

Robert F. Kennedy Jr., the Secretary of Health and Human Services, has made a big push to get agencies like the Food and Drug Administration to use generative artificial intelligence tools. In fact, Kennedy recently told Tucker Carlson that AI will soon be used to approve new drugs<\/a> \u201cvery, very quickly.\u201d But a new report from CNN confirms all our worst fears. Elsa, the FDA\u2019s AI tool, is spitting out fake studies.<\/p>\n

CNN spoke with six current and former employees at the FDA, three of whom have used Elsa for work that they described as helpful, like creating meeting notes and summaries. But three of those FDA employees told CNN<\/a> that Elsa just makes up nonexistent studies, something commonly referred to in AI as \u201challucinating.\u201d The AI will also misrepresent research, according to these employees.<\/p>\n

\u201cAnything that you don\u2019t have time to double-check is unreliable. It hallucinates confidently,\u201d one unnamed FDA employee told CNN.<\/p>\n

And that\u2019s the big problem with all AI chatbots. They need to be double-checked for accuracy, often creating even more work for the human behind the computer if they care about the quality of their output at all. People who insist that AI actually saves them time are often fooling themselves, with one recent study of programmers showing that tasks took 20% longer<\/a> with AI, even among people who were convinced they were more efficient.<\/p>\n

Kennedy\u2019s Make America Healthy Again (MAHA) commission issued a report back in May<\/a> that was later found to be filled with citations for fake studies. An analysis from the nonprofit news outlet NOTUS found that at least seven studies cited didn\u2019t even exist<\/a>, with many more misrepresenting what was actually said in a given study. We still don\u2019t know if the commission used Elsa to generate that report.<\/p>\n

FDA Commissioner Marty Makary initially deployed Elsa across the agency on June 2, and an internal slide leaked to Gizmodo bragged that the system was \u201ccost-effective,\u201d only costing $12,000 in its first four weeks. Makary said that Elsa was \u201cahead of schedule and under budget\u201d when he first announced the AI rollout<\/a>. But it seems like you get what you pay for. If you don\u2019t care about the accuracy of your work, Elsa sounds like a great tool for allowing you to get slop out the door faster, generating garbage studies that could potentially have real consequences for public health in the U.S.<\/p>\n

CNN notes that if an FDA employee asks Elsa to generate a one-paragraph summary of a 20-page paper on a new drug, there\u2019s no simple way to know if that summary is accurate. And even if the summary is more or less accurate, what if there\u2019s something within that 20-page report that would be a big red flag for any human with expertise? The only way to know for sure if something was missed or if the summary is accurate is to actually read the report.<\/p>\n

The FDA employees who spoke with CNN said they tested Elsa by asking basic questions like how many drugs of a certain class have been approved for children. Elsa confidently gave wrong answers, and while it apparently apologized when it was corrected, a robot being \u201csorry\u201d doesn\u2019t really fix anything.<\/p>\n

We still don\u2019t know the workflow being deployed when Kennedy says AI will allow the FDA to approve new drugs, but he testified in June<\/a> to a House subcommittee that it\u2019s already being used to \u201cincrease the speed of drug approvals.\u201d The secretary, whose extremist anti-vaccine beliefs didn\u2019t keep him from becoming a public health leader, seems intent on injecting unproven technologies into mainstream science.<\/p>\n

Kennedy also testified to Congress that he wants every American to be strapped with a wearable health device within the next four years<\/a>. As it happens, President Trump\u2019s pick for Surgeon General, Casey Means, owns a wearables company<\/a> called Levels that monitors glucose levels in people who aren\u2019t diabetic. There\u2019s absolutely no reason that people without diabetes need to constantly monitor their glucose levels, according to experts. Means, a close ally of Kennedy, has not yet been confirmed by the Senate.<\/p>\n

Makary acknowledged to CNN that Elsa could \u201cpotentially hallucinate,\u201d but that\u2019s \u201cno different\u201d from other large language models and generative AI. And he\u2019s not wrong on that. The problem is that AI is not fit for purpose when it\u2019s consistently just making things up. But that won\u2019t stop folks from continuing to believe that AI is somehow magic.<\/p>\n

William Maloney from the FDA\u2019s \u201crapid response\u201d office sent a statement about the agency\u2019s use of AI on Wednesday.<\/p>\n

\u201cThe information provided by FDA to CNN was mischaracterized and taken out of context,\u201d Maloney wrote. When Gizmodo responded via email to ask what in CNN\u2019s report may have been mischaracterized or taken out of context, Maloney didn\u2019t address our questions. Gizmodo also asked if anything about the report was inaccurate but that question was also ignored.<\/p>\n

\u201cFDA was excited to share the success story of the growth and evolution of its AI tool, Elsa. Unfortunately, CNN decided to lead the story with disgruntled former employees and sources who have never even used the current version of Elsa,\u201d Maloney\u2019s statement continued.<\/p>\n

But it was Maloney\u2019s last line of the email that really reminded us the FDA has been fully captured by Trump: \u201cThe only thing \u2018hallucinating\u2019 in this story is CNN\u2019s failed reporting.\u201d<\/p>\n

\u00a0<\/p>\n

Correction: This article originally stated that Elsa had cost FDA just $12,000 in its first week, according to its own internal figures. That was the reported cost for the first four weeks of operation. Gizmodo regrets the error.<\/p>\n","protected":false},"excerpt":{"rendered":"Robert F. Kennedy Jr., the Secretary of Health and Human Services, has made a big push to get…\n","protected":false},"author":2,"featured_media":18944,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[62,276,277,49,48,16179,2714,5651,16180,4509,3436,61],"class_list":["post-18943","post","type-post","status-publish","format-standard","has-post-thumbnail","category-artificial-intelligence","tag-ai","tag-artificial-intelligence","tag-artificialintelligence","tag-ca","tag-canada","tag-elsa","tag-fda","tag-maha","tag-make-america-healthy-again","tag-rfk-jr","tag-robert-f-kennedy-jr","tag-technology"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/18943","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=18943"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/18943\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/18944"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=18943"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=18943"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=18943"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}