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Patient Advocates

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health3 years ago

ALS patients advocate for experimental treatment, but FDA remains skeptical

The Food and Drug Administration (FDA) is skeptical of an experimental treatment for ALS, or Lou Gehrig's disease, called NurOwn. Despite a yearslong lobbying effort by patient advocates, the FDA maintains that the stem cell-based therapy has not been proven effective. The FDA has expressed major concerns about the evidence provided by drugmaker Brainstorm, stating that a single study does not provide convincing results. However, under pressure from ALS patients and Congress, the FDA has emphasized the urgent need for new ALS treatments and pledged to use regulatory flexibility. At a meeting this week, federal advisers will hear from FDA scientists, company researchers, and patients before taking a non-binding vote on NurOwn's effectiveness. The FDA will make the final decision on the therapy later this year.

via ABC News|
#als#experimental-treatment#fda
FDA Proposal on Salt Intake Raises Concerns for Kidney Disease Patients; Surgeons in Colorado and St. Louis Perform Groundbreaking Robotic Liver Transplants
health3 years ago

FDA Proposal on Salt Intake Raises Concerns for Kidney Disease Patients; Surgeons in Colorado and St. Louis Perform Groundbreaking Robotic Liver Transplants

Patient advocates are warning that the FDA's proposal to reduce salt intake could have fatal consequences for people with kidney disease, particularly Black Americans. The proposal would allow the use of salt substitutes in foods that have specific regulations, potentially increasing the use of potassium chloride, which can be dangerous for patients with kidney disease. Advocacy groups argue that this could exacerbate health disparities and disproportionately impact Black Americans. While public health advocates support the proposal to reduce salt intake, they call for safeguards to protect kidney patients. The FDA has struggled to find effective ways to reduce Americans' salt intake, and this proposal is one approach to help food companies meet voluntary salt reduction targets.

via STAT|
#fda#health#kidney-disease