RFK Jr.'s FDA Head Wants Diabetics to Get Cooking Classes Over Insulin
'Maybe we need to treat more diabetes with cooking classes, not just throwing insulin at people,' FDA Commissioner Marty Makary said on Fox News' Sunday Futures. 'You know, scientists have been waving the flag for years, saying you've got to look at this body of scientific data, and the modern medical establishment really has been disconnected.'
Repeated studies over more than a century have shown insulin is a safe and effective treatment for diabetes, though medical professionals also recommend controlling blood sugar through diet, according to the American Diabetes Association.
Makary further used his Sunday appearance on Fox to promote a new report from the Trump administration's Make America Healthy Again Commission, released earlier this week, which called for federal agencies to urgently examine a variety of perceived threats to children's health.
'This report is a fresh new approach that really calls for a transformation of our healthcare system from a reactionary system to a proactive system,' Makary said. 'I could not be more excited about it.'
These include vaccines and exposure to harmful chemicals, all longstanding bugbears for Health and Human Services (HHS) Secretary Robert F. Kennedy.
Kennedy has come under repeated fire for misrepresenting or pushing bogus claims about the role of those factors in various adverse health conditions.
Kennedy has courted controversy in particular for his long-running attempts to link vaccines to autism, which he has ordered HHS to investigate. The Health Secretary has also pressured the Centers for Disease Control to stop recommending fluoride in drinking water because of baseless claims the chemical may be connected to cancer and neurological impairments.
In addition, Kennedy has also called on the FDA to begin phasing out synthetic dyes used to enhance color in foods.

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Newsweek
39 minutes ago
- Newsweek
Diabetes Warning Issued Over Insulin Pump Error
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A medical device manufacturer has issued an urgent correction for select insulin pumps due to a possible error that could result in insulin not being delivered, the U.S. Food and Drug Administration (FDA) announced. Tandem Diabetes Care, Inc., based in California, said the error appears as a Malfunction 16 alarm to users, and may stop insulin delivery. It can also halt communication between the insulin pump and the continuous glucose monitoring (CGM) device. Newsweek contacted Tandem Diabetes Care, Inc. for comment by email outside of regular working hours. Stock image. Tandem Diabetes Care, Inc. has issued a correction for select insulin pumps due to a possible error that could result in insulin not being delivered. Stock image. Tandem Diabetes Care, Inc. has issued a correction for select insulin pumps due to a possible error that could result in insulin not being delivered. Jens Kalaene/picture-alliance/dpa/AP Why It Matters The FDA said that if the error is not addressed it could lead to hyperglycemia - high blood sugar - in users due to insulin not being delivered. "In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional," it said. Hyperglycemia symptoms include extreme thirst, blurry vision, weakness, dry mouth, headaches, and frequent urination, according to the Centers for Disease Control and Prevention. What To Know The device affected by the urgent correction is the following: t:slim X2 insulin pumps. As of August 12, there had been 700 confirmed adverse events - incidents of confirmed high blood sugar or an event requiring medical intervention - and 59 reported injuries related to the device error, according to the FDA. No deaths had been reported. The FDA said that notices were sent directly to customers across the U.S. between July 22 and 24 with instructions on what to do in the event of a Malfunction 16 alarm. The company is set to release a software update to boost early detection of speaker failures, according to the FDA. The update will also introduce persistent vibration alerts to reduce potential safety risks. What People Are Saying Tandem Diabetes Care, Inc. said in its urgent medical device correction notice: "A Malfunction 16 will stop insulin delivery and terminate communication between the insulin pump and the CGM device, as well as the Tandem t:slim mobile app. If not addressed, this could result in hyperglycemia due to the malfunction resulting in the stoppage of insulin delivery and real time CGM Estimated Glucose Values (EGVs) and CGM trends. In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional. "Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax." What Happens Next The company will notify affected pump users when the software update is available and request that the update is completed. Users who have concerns about their pumps can contact the company on techsupport@ or call 1-877-801-6901.


Politico
an hour ago
- Politico
Long Covid's lingering financial side effects
LONG COVID'S TOLL — More than five years after the Covid-19 pandemic first ravaged the nation, many Americans are still dealing with the social and economic fallout of having contracted the disease. People with long Covid — those who have new or persistent symptoms lasting three months past infection — have experienced worse financial and employment outcomes, lasting up to three years after their initial infection, compared with people who haven't had the disease, according to a study published Tuesday in JAMA Network Open from researchers at Rush University Medical Center, Yale School of Medicine, Johns Hopkins University School of Medicine and other research institutions. Long Covid patients reported worse work impairment, missed work and financial distress compared with those who never had Long Covid, the study found. Vaccination against Covid was associated with improved work and economic outcomes. Not just physical: 'While much of the focus in Long COVID research has been on the medical impact, we must also consider the sustained financial burden faced by those whose symptoms persist,' lead author Michael Gottlieb, an emergency medicine doctor and vice chair of research at Rush, said in a statement. Addressing the financial burden of long Covid might 'require policy interventions, such as expanded disability benefits or workplace accommodations to help combat the work and financial impact of this condition,' the authors wrote. The researchers analyzed self-reported data from more than 3,600 participants in the Innovative Support for Patients with SARS-CoV-2 Infections Registry, a CDC-funded initiative aimed at better understanding Covid's long-term effects. Why it matters: About 6 percent of U.S. adults suffer from some form of long Covid, according to CDC estimates. The National Institutes of Health believes that as many as 23 million people have the illness, which can range in severity from mild to debilitating. The symptoms, which can include fatigue, headaches and brain fog, can be life-disrupting for many patients. Some treatments, like Paxlovid, have shown promise in reducing symptoms, but being diagnosed and finding suitable treatment can be difficult because of the disease's wide range of symptoms that often overlap with other conditions. HHS recently shut down its long Covid office, a casualty of the Trump administration's sweeping reorganization of the agency. At the time the closure was announced, an HHS employee who worked on long Covid and who was granted anonymity to share details of the move told POLITICO that abandoning work that could have cured the disease means the country's health care system will have to provide years, if not decades, of costly care for tens of millions of chronically ill people. In March, the Trump administration also canceled dozens of grants for long Covid projects, but some funding was restored after advocates fought back. WELCOME TO WEDNESDAY PULSE. I'm still reeling from Taylor Swift announcing her new album. Send your Swiftie theories, scoops and feedback to khooper@ and sgardner@ and follow along @kelhoops and @sophie_gardnerj. At the Agencies LOOMER'S LATEST PREY — After successfully ousting several members of Trump's administration for alleged insufficient loyalty, far-right activist and MAGA influencer Laura Loomer tells our colleagues at Playbook that she has her next target: Stefanie Spear, the principal deputy chief of staff and senior counselor to HHS Secretary Robert F. Kennedy Jr. The reason why, in part: 'I think that there's a clear intention by Stefanie Spear to utilize her position to try to lay the groundwork for a 2028 RFK presidential run,' Loomer alleges. Asked for comment by Playbook, a senior HHS official did not deny that Kennedy is weighing a presidential bid. Read the full story in this morning's Playbook. CDC LATEST — CDC officials held a tense all-hands meeting Tuesday in the aftermath of last week's shooting at the agency's Atlanta headquarters, Sophie reports with POLITICO's Amanda Friedman and Lauren Gardner. The meeting came as law enforcement officials revealed early Tuesday additional information about the nature of the shooting: The man who opened fire at the agency on Friday died of a self-inflicted gunshot wound and was motivated by his distrust of Covid-19 vaccines. Agency update: At the CDC's all-hands meeting, Director Susan Monarez thanked employees for their work and acknowledged that 'misinformation can be dangerous,' according to a live transcript obtained by POLITICO. 'In moments like this, we must meet the challenges with rational, evidence-based discourse spoken with compassion and understanding,' she said. 'That is how we will lead.' CDC employees were closely watching Monarez at the meeting to see how she would respond to the shooting and the news that the suspected shooter had expressed distrust of the Covid vaccine. Two CDC employees, granted anonymity to speak candidly, told POLITICO that Monarez's speech was not what they'd hoped. '[Twenty minutes] of reading off a teleprompter,' one of the employees said in a text, adding that Monarez's remarks prompted an 'overwhelmingly negative response from folks in my immediate orbit.' Another agency employee said the meeting was in stark contrast to a separate meeting held for the CDC's National Center for Immunization and Respiratory Diseases staff on Saturday, where employees could ask Monarez questions. What's next: HHS spokesperson Andrew Nixon said that staff would have 'continued opportunities' to voice their perspectives to CDC leadership in the days ahead. 'Friday's shooting was a traumatic event for the agency, and leadership is working to provide continued updates along with resources for healing and recovery,' Nixon said in a statement. DOGE SAVINGS — The Trump administration has drastically exaggerated how much money it has saved through DOGE-related cuts to federal contracts, including at health agencies, according to an analysis of public data and federal spending records from POLITICO's Jessie Blaeser. Through July, DOGE said it had saved taxpayers $52.8 billion by canceling contracts, but of the $32.7 billion in actual claimed contract savings that POLITICO could verify, DOGE's savings over that period were closer to $1.4 billion. Despite the administration's claims, none of that $1.4 billion will lower the federal deficit unless Congress steps in. Instead, the money has been returned to agencies mandated by law to spend it. The health claims: Under the VA, DOGE's wall of receipts reported savings of $932 million from contracts canceled through June, including awards for a cancer registry, suicide-prevention services and other health care support. Federal records show the VA recovered just $132 million from the awards, or less than 15 percent of what DOGE claimed, and that the VA reinstated the contract for suicide-prevention support. One of DOGE's largest savings claims is from a canceled contract for a shelter in Pecos, Texas, to house unaccompanied migrant children. In a post on social media platform X in February, DOGE said HHS 'paid ~$18M/month' to keep the now-empty center open. Canceling the agreement, it said, would translate to more than $215 million in annual savings for taxpayers. By the time the contract was added to the DOGE termination list, that savings claim skyrocketed to $2.9 billion. But HHS and its Office of Refugee Resettlement were not on track to spend anywhere close to the contract's $3.3 billion ceiling. WHAT WE'RE READING POLITICO's Tyler Katzenberger reports on a federal judge blocking the Trump administration from using Medicaid beneficiaries' personal data for immigration enforcement purposes. Bloomberg Law's Celine Castronuovo reports on Texas' attorney general accusing Eli Lilly of unlawfully pushing providers to prescribe its blockbuster obesity drugs and other treatments to receive Medicaid payments.


Business Wire
2 hours ago
- Business Wire
Artera Receives U.S. FDA De Novo Marketing Authorization for AI-Digital Pathology Software Revolutionizing Prostate Cancer Care
SAN FRANCISCO--(BUSINESS WIRE)--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ArteraAI Prostate, establishing it as the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. ArteraAI Prostate is now recognized as an FDA-regulated Software as a Medical Device (SaMD). The technology's De Novo authorization establishes a new product code category for future AI-powered digital pathology risk-stratification tools, and enables its implementation at the point of diagnosis at qualified pathology labs in the U.S. This capability addresses a critical gap in prostate cancer care by reducing delays in delivering actionable insights at diagnosis, helping clinicians and patients make informed treatment decisions with greater confidence. 'This is a defining moment for AI in cancer care,' said Andre Esteva, CEO and co-founder of Artera. 'The FDA's decision validates the power of our MMAI platform to deliver on our vision to create AI-guided tools that enable data-backed and tailored treatments for each patient, leading to more confidence throughout the cancer journey, and ultimately, save more lives.' 'This approval highlights the groundswell of excitement surrounding the incorporation of AI into clinical practice flows. We need to utilize deep learning AI models to augment and better refine what a pathologist is able to report and Artera is leading the charge,' said Dr. Adam Cole, Founder and CSO at TruCore Pathology Group. 'As the demand for pathology services continues to outpace available capacity, tools like ArteraAI Prostate are critical. Implementing this software enhances our ability to deliver personalized insights more quickly, improves workflow efficiency, and allows us to scale services while increasing the quality of care.' Earning FDA De Novo authorization is a rare achievement, designed for novel medical innovations. This accomplishment marks yet another milestone for Artera, spotlighting its leadership and unwavering commitment to scientific rigor and excellence. Notably, the FDA authorization includes a Predetermined Change Control Plan, granting Artera the ability to expand platform capabilities through validating compatibility with additional digital pathology scanners without requiring further 510(k) submissions. The De Novo authorization for ArteraAI Prostate follows its earlier Breakthrough Device Designation. While the De Novo authorization applies specifically to the ArteraAI Prostate medical device software, Artera's underlying MMAI platform is also commercially available through the ArteraAI Prostate Test, as a Laboratory Developed Test (LDT). With this milestone, Artera continues to expand its pipeline of MMAI-powered software to support personalized cancer care. To learn more, visit About Artera Artera is a global leader in precision medicine, leveraging multimodal artificial intelligence (MMAI) to personalize cancer care. Artera's MMAI platform leverages a patient's digitized biopsy images along with the patient's clinical data to determine cancer aggressiveness and predict therapy benefit. This approach has been validated in multiple Phase 3 randomized trials, across different cancers, and is available in multiple versions across the globe. Artera's flagship product, the ArteraAI Prostate Test, is commercially available as a laboratory-developed test in the US and internationally through its distribution partners. The ArteraAI Prostate Test is the first of its kind to deliver both prognostic and predictive insights for patients with prostate cancer, empowering clinicians and patients to make more informed treatment decisions. Additional MMAI-powered products include the ArteraAI Breast Test (UKCA), the ArteraAI Prostate Biopsy Assay (UKCA), and ArteraAI Prostate (FDA). Artera has regulatory authorization for its medical device product in the US and UK. Artera's headquarters is based in Los Altos, California, while its CLIA-certified and clinical laboratory is located in Jacksonville, Florida. For more information about Artera, visit