Comment and Email Guidelines

Comment Guidelines

The Right Care Alliance is campaigning against the new Alzheimer’s drug Aduhelm [aducanumab] for three reasons:

  • (1) there’s no evidence that it works
  • (2) it carries a risk of serious harms
  • (3) it’s outrageously expensive, even after the manufacturer cut the price in half. This price gouging has led to one of the highest Medicare Part B premium increases in history.

The general public has until February 10 to submit comments on the Centers for Medicare and Medicaid Services (CMS) decision to not pay for Aduhelm except in the setting of clinical trials. Submit a comment at the CMS site today!

Please don’t forget to let us know once submit by emailing organize@rightcarealliance.org  

reminder to check CMS posting policy

 

Guidelines and suggestions for comments to CMS:

Start your comment with a basic statement of support for the draft CMS decision. After your approval statement, you can expand your comment by drawing on one or more of these themes.

  • Weak evidence and a flawed FDA approval process
  • The harms and toxicities of Aduhelm
  • The outrageous price of Aduhelm
  • Praise that they are funding randomized clinical control trials
  • Would the money expended on Adulhelm be better spent on the unmet needs (non-pharmaceutical) of families living with dementia
  • Broader concerns about the current FDA accelerated approval process

 

Sample comment:

I congratulate Medicare Administrators for their bold decision to only fund Aduhelm administration for those in a randomized clinical trial. Not only is there woefully sparse evidence that this drug benefits patients, but more frightening in over one third it causes brain swelling or bleeding. I don’t want my Medicare dollars going to a drug that hurts patients. Furthermore, the cost is outrageous $28,000 per year. How can Biogen justify this high price?

 

Use these words below as an example, but we want each response to be unique. Please send these guidelines to other friends and family – we need lots of us writing comments to fight Big Pharma.

 

  • Weak evidence and a flawed FDA approval process

There is no proof that removing amyloid will improve cognitive function. Despite a 20-30% reduction in amyloid deposits following treatment both major Aduhelm trials were discontinued because of futility. Only after the fact was one small group shown to have minor improvement in cognitive function. 

In their discussion in November 2020 in response to the question “[I]s it reasonable to consider Study 302 as primary evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?” 10 of the 11 members of the FDA’s advisory committee voted no, and the 11th member voted uncertain. 

Subsequently Biogen used a highly irregular back channel of communication with FDA leaders and persuaded the FDA to approve the drug using the Accelerated pathway that is intended for medications that are showing great promise in preliminary studies and were life saving. Use of the accelerated pathway allows Biogen to use what is called surrogate endpoints in this case amyloid plaque reduction rather than clinical outcome. 

After the approval was announced, three members of the advisory committee resigned in protest. One of the resigning members, Dr. Aaron Kesselheim, noted that “Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.” Resource: Alexander et al. 2021 commentary

  • The harms and toxicities of Aduhelm: –In the major trials presented to the FDA, roughly one third of patients experienced brain swelling or hemorrhage. At least one post-approval fatality has been attributed to such bleeding. In a statement released by the American Academy of Neurologists Ethics, Law, and Humanities Committee, 14 scientists expressed concern that “the FDA calls for less frequent monitoring [i.e., MRI scans to detect edema and hemorrhage] than was performed in clinical trials” — thus potentially places patients at even higher risk.
  • The outrageous price of Aduhelm:  Medicare has been promoting high value care and is charged with treatments that are reasonable and necessary. Based on the present evidence neither is true. It is not reasonable to expend $28,000/year per person for minimal to no cognitive benefit.
    Resources Bernie Sanders statement 1/11/22 and KFF policy analysis 1/14/22
    Issue increased Part B monthly premium by $11 for Aduhelm. Can this now be eliminated or reduced?
  • Praise that they are funding randomized clinical control trials because Alzheimer’s disease and dementia are a major growing problem that warrants greater funding to find a cure. 
  • Would the money expended on Adulhelm be better spent on the unmet needs (non-pharmaceutical) of families living with dementia rather than on a drug of marginal benefit that is unsafe. CMS coverage for hearing aids — such as has been proposed in the Build Back Better bill — could have an enormous benefit for older adults with mild cognitive impairment. Day care costs, exercise class, GPS tracking devices could all be covered. 
  • Broader concerns about the current FDA accelerated approval process, Cancer drugs authorized via accelerated approval are often found later to fail to meet their primary endpoints in post-marketing trials. Resources: Gyawali/Kesselheim editorial 2021

Email Guidelines

Sample Email:

The Right Care Alliance is campaigning against the new Alzheimers drug Aduhelm because it doesn’t work, carries a risk of serious harms, and the price gouging is going to cost seniors the highest Medicare premium increase in history. In a rare move, Medicare has said they are not going to pay for this drug without more research, but there is going to be a big push by the pharma sector and their astroturf patient groups to reverse this excellent decision by Medicare.  I’m writing to you because we asking everyone we know to go to the CMS website and offer comments to show there is public support for their decision.   It’s easy. Here’s the link. And here’s a link to a package you can download to help with talking points for your comments and for reaching out to more people to join.It’s critical we do this in the next two weeks. We know the big drug companies are going to spend their $$$ trying to reverse this decision, but it’s crucial that we don’t let them win.

 

Shorter Sample Email:

Hi! The Right Care Alliance is campaigning against Aduhelm, a new Alzheimer’s drug that doesn’t work, carries risk of serious harms, and the price gouging is going to cost seniors the highest Medicare premium increase in history. Medicare has said that they won’t pay for this drug, but Big Pharma is fighting this decision. I’m hoping that you could go to the CMS website and write comments to show there is public support for their decision. Here’s the link.

 

Thanks so much, and please let us know once you’re done so we can keep track of how many comments we are submitting!