Monday, July 12, 2021

In This Issue
FDA, CDC & Dr. Fauci: No need for COVID vaccine boosters yet despite Pfizer request
Maine DHHS & CDC seeking physician input; Tuesday webinar & web-based survey
Registration Open for MMA’s 168th Annual Membership Meeting (Sep 10-12)
Unvaccinated people would prefer to get vaccinated at their doctor’s office
Notice of Rulemaking: Immunization requirements for Maine school children
Feds asked to investigate of Alzheimer's drug approval; FDA revises recommendations for drug
Biden Executive Order covers non-compete agreements, hospital mergers, and prescription prices
Top JAMA and NEJM articles of the week
AAFP: Direct Primary Care Was the Change She Needed
Maine Secretary of State Seeking Physician Volunteers
SUPPORT for ME: Strengthening Substance Use Disorder Treatment and Recovery Services for MaineCare Members
Are You a Professional Who Works with Individuals in Maine Who Have a Substance Use Disorder? We Want to Hear From You!
Maine Community Action Partnership: Did You Know?
MMA Mary Cushman, MD Award for Humanitarian Service
Upcoming Specialty Society Meetings
AAP EQIPP Course: Immunizations - Strategies for Success (for RURAL Health Providers)
SUPPORT for ME Training and Technical Assistance Initiative
Working with Children & Adolescents? Maine Pediatric & Behavioral Health Partnership (MPBHP) Webinar Series (July thru December 2nd Wednesday of month)
Register Now: Governor Mills’ 3rd Annual Opioid Response Summit on July 15th
Physician (BC/BE in Family Medicine) - Strong Area Health Center
Physician (BC/BE in Family Medicine) - Richmond Area Health Center
Help educate new physicians – join our accredited Family Medicine Residency Program as faculty
Join our region-leading Neuroscience/Stroke Center
Contract Clinical Advisor - Healthcare Coalition of Maine
Medical Director

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Feds asked to investigate of Alzheimer's drug approval; FDA revises recommendations for drug

The acting head of the Food and Drug Administration (FDA) has asked for a federal investigation into the agency's controversial approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm. This after two congressional committees announced they will have hearings on the FDA’s approval of the drug last month.

Maine Medicine’s Weekly Update covered the approval in June.

Critics say there is no clear evidence the drug will slow the cognitive decline of Alzheimer's patients, which is what the drug is designed to do. There are also serious concerns over the $56,000 per patient price tag, and what it could do to the financial solvency of the Medicare program, which covers most Alzheimer's patients in the U.S. In addition, a recent Stat News reported lays out an alleged path of undue pharmaceutical company influence may have led to the approval.

Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug

Also this week, the FDA revised usage guidance for Abuhelm to cover only patients to only patients with milder forms of Alzheimer’s disease. The FDA had initially granted wide-label approval.

“Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease,  the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

In a media statement, a physician employed by Biogen, said, “Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three ADUHELM clinical trials that supported approval. We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”

Additional information and resources (click title for source infromation):

FDA Grants Accelerated Approval for Alzheimer’s Drug

FDA’s Decision to Approve New Treatment for Alzheimer’s Disease

FDA’s Accelerated Approval Pathway

FDA’s Fast Track Process

Cassidy, Warren Call for Hearing on New Alzheimer’s Disease Drug Aduhelm

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