PharmedOut sends letter to FDA on vaginal estrogens

Alzheimer's and Mild Cognitive Impairment

Aduhelm (aducanumab-avwa) was approved by the FDA on June 7, 2021; this monoclonal antibody is now available for people with mild Alzheimer’s disease or mild cognitive impairment due to Alzheimer’s disease. Biogen, Aduhelm’s manufacturer, and their co-marketing partner Eisai, began a disease awareness campaign focused on Mild Cognitive Impairment (MCI) about a month before Aduhelm’s approval. Selling disease is a good way to sell a drug, and PharmedOut will continue to monitor marketing tactics for Alzheimer’s drugs. Be sure to check this site regularly!

On this page you'll find:

"Do We All Have Alzheimer's?" PharmedOut Webinar with Dr. Susan Molchan and Dr. Peter Whitehouse
PharmedOut's Journal Articles and Op-Eds
PharmedOut Fact Sheets
PharmedOut's Letters to the Scientific Advisory Board of the Alliance for Aging Research & Medical and Scientific Advisory Group of the Alzheimer's Association
PharmedOut's Public Comment on Aduhelm
Resources on Mild Cognitive Impairment and articles, podcasts, and books on topics related to Aduhelm and Alzheimer's

Do We All Have Alzheimer's?

Dr. Susan Molchan and Dr. Peter Whitehouse had a lively discussion about Alzheimer's Disease, drugs that target beta amyloid, and how research funding has primarily focused on amyloid.

Journal Article

Are New Alzheimer Drugs Better Than Older Drugs? in JAMA Internal Medicine

Dr. Susan Molchan and Dr. Adriane Fugh-Berman's article takes a critical look at the new monoclonal antibodies directed toward amyloid for Alzheimer’s Disease.

Op-Eds

Alzheimer's medicine a 'ray of hope'? That's marketing. Adriane Fugh-Berman wrote an op-ed on the claims made by patient advocacy organizations about the new drug Leqembi (lecanemab).
Too soon to celebrate new Alzheimer’s drug | GUEST COMMENTARY. Adriane Fugh-Berman wrote an op-ed on Biogen's latest anti-amyloid drug, Leqembi (lecanemab).
Patricia Bencivenga and Judy Butler: Drug company tricks: Gaslighting the worried well into becoming the worried sick. Patricia Bencivenga and Judy Butler wrote an op-ed on MyBrainGuide.org, a website funded by Biogen equipped with a memory test designed to guide people toward their doctors - the first step toward a prescription.
CMS makes the right decision on Alzheimer's drugs | Opinion. Dave Stanke, research associate, and Adriane Fugh-Berman wrote an op-ed applauding the Centers for Medicare and Medicaid Services on their decision to only cover Aduhelm and related drugs in clinical trials.
Targeting Black and Hispanic communities for dementia drugs. Naisa Rahman, a PharmedOut intern, and Caroline Renko, PharmedOut's current Project Manager, wrote a piece on how Biogen is targeting Black and Latinx populations for Aduhelm even though the drug wasn't tested in these populations.
Op-ed: Cover hearing aids, not a questionable Alzheimer's drug. PharmedOut's David Stanke and Adriane Fugh-Berman's op-ed focuses on the effectiveness of hearing aids to prevent cognitive decline.
Caution warranted before using new Alzheimer's drug. Judy Butler, a research fellow at PharmedOut, and Adriane Fugh-Berman's latest op-ed revealing how Aduhelm is being marketing to health care providers.
Do we all have Alzheimer's? Drug makers might want you to think so. PharmedOut's Patricia Bencivenga and Adriane Fugh-Berman expose Biogen and Eisai's disease awareness campaign for MCI.

PharmedOut Fact Sheets

Healthcare providers, feel free to download and distribute these fact sheets to patients considering Aduhelm.

What the Alzheimer's Association Isn't Telling You

The Fuzzy Diagnosis of MCI

3 Reasons to Avoid Aduhelm

Should I Take Aduhelm?

Letter to the Alliance for Aging Research

PharmedOut’s letter to members of the Alliance for Aging Research’s Scientific Advisory Board urged them to resign over the organization’s support of Aduhelm (aducanumab). Over 50 physicians, researchers and advocates co-signed the letter.

Nine of the 17 members resigned covered in an article by Ed Silverman in STAT; subsequently, the Alliance dissolved the Board….

Click here to see the letter.

Letter to the Medical and Scientific Advisory Group of the Alzheimer's Association

A similar letter was sent to the Alzheimer’s Association’s Medical and Scientific Advisory Group, urging the seven advisory group members to resign over the Alzheimer’s Association support of Aduhelm. All seven ignored several communications until we stated that we were making the letter public.

That elicited a group response, which stated, “We are committed to the millions of people who suffer from the devastating impacts of Alzheimer's and all other dementia and remain firmly committed to our important role as members of this scientific advisory group.”

Click here to see the letter.

Public Comments to the Centers for Medicare & Medicaid Services

On July 22, 2021, Dr. Fugh-Berman and Patricia Bencivenga testified before the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination Analysis on treatment for Alzheimer's Disease. Their comments can be downloaded here or viewed on CMS' National Coverage Analysis page.

After CMS gave their preliminary coverage decision regarding drugs like Aduhelm on January 11, 2022, PharmedOut submitted another comment to support CMS. It can be downloaded here or viewed on CMS' National Coverage Analysis page.

The Truth About Mild Cognitive Impairment

Mild Cognitive Impairment, by Angela Sanford explains what MCI is and what MCI is not.
The US Preventative Services Task Force recommendation statement explains why there isn't enough evidence to conclude that screening for MCI is beneficial.

Additional Resources

‘When Memory Fades’: Misinformation about Alzheimer’s disease and Aduhelm must be limited. Madhav Thambisetty's article presents an overview of how Biogen's misleading claims will convince cognitively normal people that they have MCI.
"Why Primary Care Physicians Should Worry About the Approval of Aducanumab" by Dr. Kenneth Lin is an op-ed that every doctor should read.
"Dementia prevention, intervention, and care: 2020 report of the Lancet Commission" outlines the 12 modifiable risk factors for dementia. These factors are less education, hypertension, hearing impairment, smoking, obesity, depression, physical inactivity, diabetes, low social contact, excessive alcohol consumption, traumatic brain injury, and air pollution.
"The maddening saga of how an Alzheimer's 'cabal' thwarted progress toward a cure for decades" is a special report by Sharon Begley that explains how the amyloid hypothesis dominated scientific research and ignored alternative hypotheses for many years.

"The Myth of Alzheimer's" by Peter J. Whitehouse MD, PhD will change the way you think and talk about Alzheimer's Disease. It is a wonderful read that clarifies the processes behind brain aging, and gives recommendations for how to best care for loved ones who are affected by Alzheimer's.

"A $55,000 drug that doesn't cure Alzheimer's" on Vox is a 30-minute podcast episode that gives a great overview of the Aduhelm controversy. It is available on Spotify, Apple podcasts, and Stitcher.

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