Nature, January 7, 2023: FDA approved Alzheimer’s drug lecanemab (Leqembi) under the accelerated approval pathway, despite safety concerns. 3 patients died. It has serious risks, is not proven to work, and will cost $26,500/year. Dr. Zuckerman points out that those risks may outweigh the benefits for people with mild impairment who are still functioning well.
Read More »Author: Caroline Bradford
Patient, Consumer, and Public Health Coalition Letter to CMS on Lecanemab Approval
January 6, 2023: We applaud your National Coverage Determination that made the wise decision to limit coverage of this class of drugs solely to patients participating in clinical trials following the approval of aducanamab (Aduhelm) by the FDA. The FDA approved Biogen and Eisai’s lecanemab today, and we urge you to hold firm to your decision to prioritize patient safety and the scientific credibility of CMS’s coverage decisions.
Read More »NCHR Comments on FDA Ethical Considerations for Clinical Investigations of Medical Products Involving Children
December 27, 2022: We address suggestions of how to improve this guidance to promote safety and efficacy in clinical investigations of medical products involving children. Many new medical products that are used by children are never actually tested on them or approved for them prior to entering the market. Many children are either left with no treatment options or given products “off label” that have not been tested for safety, effectiveness, or dosage requirements in patients of their age, size, or weight.
Read More »NCHR Comments on FDA Updates to the Breakthrough Devices Program to Reduce Disparities in Health Care
December 20, 2022: We disagree with the guidance because of the enormous loophole it represents. Altering the eligibility criteria for the breakthrough pathway to include certain devices that have the “potential” to benefit certain populations is too vague. FDA must Improve the standards of evidence required to authorize Breakthrough medical devices prior to focusing on equity issues.
Read More »NCHR Testifies Before Cardiovascular and Renal Drugs Advisory Committee on Heart Failure Drug
Dr. Ealena Callender of National Center for Health Research tells Dec. 2022 FDA Advisory Committee to require better research on OM heart failure drug due to lack of evidence of efficacy and concerns about safety due to toxicity.
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