The Lever, January 28, 2025: We are working with a consortium of experts to expose problems with FDA approvals. Our first article published in The Lever focuses on the clear risks and questionable benefits of drugs for early cognitive impairment caused by Alzheimer’s and how conflicts of interest resulted in approval.
Read More »Alzheimers, Dementia & Other Disabilities
NCHR’s Public Comment on Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
June 10, 2024: NCHR disagrees with assumptions made in FDA guidance aimed at developing drugs for treatment of early stages of Alzheimer’s dementia.
Read More »The real costs of the new Alzheimer’s drug, Leqembi — and why taxpayers will foot much of the bill
KFF Health News/CBS News, Aug 1, 2023: CBS News says that the drug Leqembi for mild cognitive impairment and early Alzheimer’s is likely to cost taxpayers billions of dollars. We are among the policy experts who tell Medicare that all registry data need to be public to see if it is safe or effective. Will that happen?
Read More »Cambridge biotech Sarepta wins fast-track approval for the first muscular dystrophy gene therapy
The Boston Globe, June 22, 2023: FDA has approved Sarepta’s gene therapy for Duchenne muscular dystrophy, which will cost $3.2 million per patient. FDA’s Peter Marks praises the drug as if he is a Sarepta salesman, and NCHR explains why this political compromise is harmful to patients.
Read More »Pricey Alzheimer’s Drug Coverage Hinges on FDA Decision
Bloomberg News, June 15, 2023: If Leqembi is approved, it will take time for doctors to arrange for patients to be tested for mild cognitive impairment and amyloid plaques on the brain, get the Leqembi infusions, and sign up patients for a registry. NCHR praises the CMS Registry as a good choice, but industry-funded groups complain.
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