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Friday, August 27, 2021 NIH Launches Study of Extra COVID-19 Vaccine Dose in People with Autoimmune Disease
The National Institutes of Health has begun a clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen. The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and is being conducted by the NIAID-funded Autoimmunity Centers of Excellence. more »
Kaiser Health News: Paying Billions for Controversial Alzheimer’s Drug? How About Funding This Instead?
Aduhelm, a new Alzheimer’s drug approved by the Food and Drug Administration last month, could be prescribed to 1 million to 2 million patients a year, even if conservative criteria were used, according to Biogen and Eisai, the companies behind the drug. The total annual price tag would come to $56 billion if the average list price, $56,000, is applied to the lower end of the companies’ estimate. That’s a huge sum by any measure — more than the annual budget for the National Institutes of Health (almost $43 billion this year). Yet there’s considerable uncertainty about Aduhelm’s clinical benefits, fueling controversy over its approval. The FDA has acknowledged it’s not clear whether the medication will actually slow the progression of Alzheimer’s disease or by how much. more »
Kaiser Family Foundation: FDA’s Approval of Biogen’s New Alzheimer’s Drug Has Huge Cost Implications for Medicare and Beneficiaries
"The question of what would happen when a new, expensive prescription drug comes to market for a disease like Alzheimer’s that afflicts millions of people has loomed large in discussions over drug prices in the U.S.— and now we’re about to find out. After a nearly 20-year dry spell in new treatments for Alzheimer’s disease, the Food and Drug Administration (FDA) just approved a new Alzheimer’s medication, Aduhelm (aducanumab), developed by Biogen, with an expected annual price tag of $56,000. While the scientific community debates the evidence of the effectiveness of this new drug, the FDA’s decision raises hope for Alzheimer’s patients and their families, along with serious cost concerns for patients and payers, particularly Medicare." more »
GAO Report: Maternal Mortality and Morbidity: Additional Efforts Needed to Assess Program Data for Rural and Underserved Areas
There's a greater risk of maternal death during pregnancy or soon after from pregnancy-related causes among rural residents, according to the Centers for Disease Control and Prevention. CDC and the Health Resources and Services Administration fund programs aimed at reducing maternal mortality, including in rural or underserved areas where it can be harder to get health care services. These agencies collect data — like the percentage of women receiving postpartum visits — but don't always separate and analyze this data for rural and underserved areas. We recommended they do so to help ensure program funding helps those in need. more »