Thursday, February 10, is the last day to submit comments!
Here are step-by-step instructions on how to fight against Big Pharma greed! (click on any of the images below if you want to see them bigger)
- Click here and open the CMS Comment page in a new browser window or tab.
- On that page, click on the link that says “CMS PHI Posting Policy.”
- Once the policy popup opens, click “OK” to close it.
- Check the box below the CMS Posting Policy link. NOTE: You will not be able to fill in any of the forms until you’ve checked this box, and you can’t check this box until you’ve clicked “OK” in step 3 above.
- Fill out your first name, last name and email under “Identification”
- Copy this statement and paste it into the “Comment” box. Feel free to personalize it:
The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease patients. Moreover, the integrity of the FDA’s review of the marketing application for Aduhelm was dangerously corrupted by the unprecedented and inappropriately close collaboration between Biogen and the FDA during the analyses of data from the key clinical trials of the drug after the termination of the phase 3 clinical trials because of futility.
CMS must not compound the FDA’s egregious error in approving Aduhelm on June 7, 2021. Given the lack of scientific evidence that Aduhelm provides any clinically meaningful benefit in terms of cognitive function outcomes in Alzheimer’s disease patients, the drug cannot possibly be deemed reasonable and necessary for treatment of such patients. I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program. It’s imperative to put patients and consumers before Big Pharma profits.
- Fill out the required address fields, check the box to affirm that you are not a robot, and press “Submit!”
