| | | | |  | | By Ruth Reader, Daniel Payne and Carmen Paun | | | | | 
A third of people who die in hospitals have sepsis, according to the CDC. | AP Photo/Kiichiro Sato | Many algorithms claim to predict sepsis, an extreme immune response to infection that can sometimes be fatal. Prenosis, a Chicago-based health tech company, says it is the first to receive Food and Drug Administration authorization for its artificial intelligence sepsis prediction tool. It is classified as “de novo,” which means there is no other equivalent device on the market. What separates Prenosis technology from traditional sepsis alert systems, is that instead of continuously monitoring for sepsis or signs of sepsis, as most algorithms do, Prenosis creates an on-demand risk score for the patient. Doctors must order an assessment as they would any other lab test. Another unique aspect of this product is that the AI will suggest that a doctor order additional tests if it thinks the data is insufficient to issue a score. “Maybe you did run this blood test, but it was 18 hours ago. That’s not good enough because the patient’s health could have changed within the last eight hours,” CEO Bobby Reddy said, noting that it’s not always easy for a clinician to quickly see when all their tests were last run. Also, in a world where AI is largely a black box, Prenosis’ interface is transparent about what data influences its scoring, instead of simply delivering a result. The company trained its AI on data garnered from 100,000 blood samples from 25,000 patients at 10 different hospitals to help it look for the biological underpinnings of sepsis. Why it matters: A third of people who die in hospitals have sepsis, according to the Centers for Disease Control and Prevention. Last year, the agency launched a program to help hospitals identify the infection. The FDA has previously awarded breakthrough status, a designation that allows technology to be expedited through the approval process, to several sepsis algorithms, including Inflammatix’s TriVerity, Mednition’s KATE Sepsis and Bayesian Health’s Targeted Real-Time Early Warning System. Some sepsis AI is already being used without the FDA’s explicit authorization. Electronic health record system Epic had a sepsis algorithm that came under fire for its questionable accuracy, though it has since been updated. What’s next: Reddy said a side benefit of Prenosis technology is that it could potentially help keep medical records more complete and up to date, thereby improving other AI systems’ ability to make predictions. “Because it’s demanding all the right data,” Reddy explained.
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Centennial Olympic Park, Atlanta, Georgia. | Carmen Paun | This is where we explore the ideas and innovators shaping health care. Richard Slayman, the first patient to receive a genetically modified pig kidney transplant, returned home Wednesday, two weeks after a promising surgery, The New York Times reports. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. | | | | YOUR GUIDE TO EMPIRE STATE POLITICS: From the newsroom that doesn’t sleep, POLITICO's New York Playbook is the ultimate guide for power players navigating the intricate landscape of Empire State politics. Stay ahead of the curve with the latest and most important stories from Albany, New York City and around the state, with in-depth, original reporting to stay ahead of policy trends and political developments. Subscribe now to keep up with the daily hustle and bustle of NY politics. | | | | | | | | | 
NIDA Director Dr. Nora Volkow speaks at the Rx and Illicit Drug Summit in Atlanta, Georgia on April 2, 2024. | Carmen Paun/POLITICO | ATLANTA, Georgia — Federal officials; researchers; people in recovery; and treatment, prevention and harm-reduction providers gathered at the Rx and Illicit Drug Summit in Atlanta this week to talk about how to solve the drug overdose crisis that killed a record 110,000 Americans last year. Carmen also attended the summit, organized by Operation UNITE — a nonprofit fighting substance use disorder founded by Rep. Hal Rogers (R-Ky.) — and these are her top three takeaways: 1. Mainstreaming addiction treatment is hard. Substance use disorder treatment should be part of the health care system, not separate from it, federal officials argued. Separation is a missed opportunity “of having this gigantic structure that we have built in health care, with all of the expertise of very diverse providers, to be able to screen and treat people at different levels of severity,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse. Thomas Prevoznik, deputy assistant administrator for the Drug Enforcement Administration, lamented that a 2022 law increasing the number of providers who could prescribe buprenorphine, a drug used to treat opioid use disorder, has not led to an expected increase in prescriptions. He suggested stigma among doctors toward people with substance use disorders, low reimbursement rates for pharmacists and fear and misunderstanding of the DEA’s rules for prescribing controlled substances need to be dealt with to significantly expand treatment access. 2. The drug threat is evolving, making it harder to respond. While illicit fentanyl has led to the most overdose deaths, it’s often consumed with other substances, most of which have no reversal drug, such as naloxone, or treatment available. “So our strategies in the past that targeted only predominantly people with an opioid use disorder are absolutely not sufficient to address the overdose crisis,” Volkow said. And more drugs that researchers and officials still don’t know much about are being used, including the horse tranquilizer xylazine, also known as Tranq, and tianeptine, better known as “gas station heroin,” which is becoming more prevalent in the Southeast, according to Dr. Rahul Gupta, the director of the White House Office of National Drug Control Policy. 3. The Biden administration is proud of including harm reduction in its response, but parts of that approach remain controversial. Several Biden administration officials, including HHS’ Amanda Sharp and Gupta, touted that, for the first time, harm-reduction policies are included in the national response to substance use disorder and fatal overdoses. The policies include expanding access to naloxone and providing services to people without demanding they be abstinent as a condition to care. But controversy persists over so-called safe-consumption sites, where people who use drugs can do so in a safe environment where staff is prepared to reverse an overdose.The federal government is analyzing data on safe-consumption sites, said Dr. Yngvild Olsen, director for the Center for Substance Abuse Treatment at HHS’ Substance Abuse and Mental Health Services Administration.
| | | |  Health experts and policymakers are concerned about an increase of mental illnesses globally, especially as younger populations are more susceptible in some areas. | AP | Patients with a family history of treatment-resistant depression might also have an increased risk of antidepressants not working for them, according to new research published Wednesday in JAMA Psychiatry. Researchers analyzed data from more than 170,000 patients in the Taiwan national health insurance database, finding a correlation between having a relative with treatment-resistant depression and having depression themselves that’s difficult to treat. The finding, which suggests people can inherit risk of depression not easily treated with antidepressants, could have implications for doctors who treat patients with such family histories by offering clues to how to best treat their symptoms. How so? Clinicians who specialize in mental illness often have a number of treatment options to offer patients, with complex and still-unknown factors determining the mix of typical or atypical antidepressants, therapy, lifestyle changes or cutting-edge treatments that could have the best outcome. Patients who have a family history of treatment-resistant depression are themselves at increased risk for that — and other — psychiatric disorders. The researchers said doctors could consider prescribing more intensive treatments earlier for patients with a family history of depression that hasn’t been easily treated. Why it matters: The study comes as concern increases about the disease burden of mental illnesses on the global population — especially as younger populations are more susceptible in some areas. But it also comes as researchers, doctors, patients and even policymakers are interested in innovative treatment approaches, including psychedelics. | | | | Easily connect with the right N.Y. State influencers and foster the right relationships to champion your policy priorities. POLITICO Pro. Inside New York. Learn more. | | | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
