Several popular new GLP-1 drugs, including Wegovy, Ozempic, Mounjaro and Zepbound, help lose weight but do they improve health? In addition to unpleasant gastro-intestinal side effects, they can cause serious health problems such as stomach paralysis (gastroparesis), which can cause problems with anesthesia. They may cause thyroid cancer. Most information about the benefits of these drugs is from press releases, but FDA is now investigating some unexpected possible side effects, including substantial hair loss and suicidal thoughts.
Read More »Author: Caroline Bradford
NCHR Comments on the CMS Notice on Transitional Coverage for Emerging Technologies (TCET).
August 28, 2023: We support the overall goals of the TCET program, but we see an enormous disconnect between the types of evidence that FDA requires for breakthrough devices and the CED standards that CMS requires for coverage.
Read More »NCHR Comments on the Food and Drug Administration In-Home Disposal Systems for Opioid Analgesics
August 28, 2023 The FDA is assessing whether in-home disposal products can reduce opioid nonmedical use and overdose. We recommend user-friendly, accessible in-home disposal systems that rely on deactivation rather than incineration.
Read More »Testimony at the FDA Advisory Committee Meeting on the Recor Paradise Ultrasound Renal Denervation System
August 22 2023, we testified at the FDA Advisory Meeting on the Paradise Ultrasound Renal Denervation (uRDN) System used to treat hypertension, we attested that the hypertensive efficacy of the Paradise uRDN system is insufficient to justify its use as an adjunct therapy for hypertension.
Read More »NCHR Comment on the CMS National Coverage Analysis Evidence Review Proposed Guidance
August 21, 2023: We support the methodological attributes of clinical studies that are described in the NCA guidance. We also strongly agree with CMS’s priorities that emphasize evidence of meaningful health outcomes, particularly morbidity and mortality, since those can be evaluated more objectively.
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