STAT News, January 24, 2023: Results of 43 clinical trials involving thousands of children were never reported to clinicaltrials.gov or published in a medical journal or otherwise made publicly available, as required by law. We explain how this harms children and families.
Read More »Author: Caroline Bradford
Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax
Pink Sheet, January 16, 2023: FDA and CDC failed to be transparent regarding their analysis of whether the Pfizer bivalent COVID vaccine increase strokes in older patients. There seems to be disagreement about how to explain the findings and the bottom line is that the agencies “don’t want to be asked questions” by experts in public.
Read More »Medicare, patient advocates at odds over coverage for an expensive new Alzheimer’s therapy
PoliticoPro, January 18, 2023: Public health and patient advocates disagree on whether Medicare should cover Leqembi, a questionable new treatment for Alzheimer’s Disease. We express doubts that the benefits outweigh the risks and the Patient, Consumer and Public Health Coalition urges Medicare to restrict coverage to clinical trials as they do for Aduhelm.
Read More »NCHR Comments on EPA’s Proposed Finding that Lead Emissions from Aircraft Engines using Leaded Fuel May Endanger Public Health
January 17, 2023: The presence of lead in aircraft engines has a significant, negative effect on public health, and we enthusiastically agree with the proposed EPA finding in support of these conclusions. These findings should be finalized as soon as possible to give EPA the authority to set aircraft emission standards for lead under section 231 of the Clean Air Act.
Read More »An FDA pathway to clear medical devices puts patients at risk, research suggests
Stat News, January 10, 2023: When FDA clears medical devices based on similar “predicate” devices that were previously recalled, that puts patients’ lives at risk. It’s easy to fix: Don’t allow recalled predicates!
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