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Introduction The hypoglossal nerve stimulator (HGNS) is an implanted device used to treat moderate to severe obstructive sleep apnea (OSA), offering an alternative form of therapy to continuous positive airway pressure. Currently, the Inspire® Upper Airway Stimulation (UAS) system is the only such device approved by the U.S. Food and Drug Administration (FDA). Report of case(s) We present a case of sensory lead malfunction in a 54-year-old man with moderate OSA who underwent HGNS implant in 2018 with the three-incision method and the sensory lead positioned in the 6th intercostal space. December 2022, the patient presented with right sided chest pain and subjective fever at outside hospital. A CT chest performed was significant for trace right sided pleural effusion and concern for pleural penetration of the sensory lead. Device interrogation in our office showed increased impedances and abnormal waveforms prompting discontinuation of therapy and scheduling a surgical revision. He denied any trauma, injury to the area and had been doing well overall but did feel as if the device wasn’t syncing appropriately with his breathing. In addition, his most recent sleep study on fairly high amplitude of 3.6V had persistent severe supine disease. During the surgery, the sensory lead was noted to be in its original placement site with intact anchors and sutures holding it in place. After the lead was removed there was noted to be a discoloration deep to the protective covering suggesting potential lead failure related to compromise of device. Conclusion Since its FDA approval in 2014, over 20,000 HGNS devices have been implanted in the USA and long-term data collection of efficacy and safety is ongoing. The Manufacturer and User Facility Device Experience (MAUDE) is a publicly available database of device-related adverse events reported to the FDA. At the time of this abstract, there are 714 reports related to HGNS of which 147 involve the respiratory sensory lead and 95 of these relate to pain and/or malfunction most commonly due to sensor tip separation and migration from lead body. This case illustrated a presentation of sensory lead malfunction due to presumed electrical leakage from insulation breach. Support (if any)

The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the US, specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro™, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA’s own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the US. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health consequences, despite numerous regulations enforced by multiple organizations. The approval of Zohydro and its defense from the FDA were based on a misunderstanding of the prevalence of chronic severe disabling pain. Based on inaccurate data from the Institute of Medicine, in part caused by conflicts of interest, 100 million persons have been described to suffer from severe pain -- the correct number is 22.6 million. This manuscript analyzes 3 important principles of drug approval and utilization based on safety, efficacy, and medical necessity. Based on the limited literature that the authors were able to review including that which was submitted to the FDA by the manufacturers, it appears the safety, efficacy, and medical necessity were not demonstrated. In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future. Key words: Chronic non-cancer pain, Food and Drug Administration, opioids, Zohydro, misuse, tolerance, addiction, dependency, medical necessity

This first article in a series describes the history of artificial intelligence in medicine; the use of AI in image analysis, identification of disease outbreaks, and diagnosis; and the use of chatbots.

Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.

The editors announce both a series of articles focusing on AI and machine learning in health care and the 2024 launch of a new journal, NEJM AI , a forum for evidence, resource sharing, and discussion of the possibilities and limitations of medical AI.