Breaking News
0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

Third member of U.S. FDA advisory panel resigns over Alzheimer's drug approval

Stock MarketsJun 11, 2021 05:21PM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
 
2/2 © Reuters. FILE PHOTO: A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder 2/2

By Julie Steenhuysen and Carl O'Donnell

(Reuters) - A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency's decision to approve Biogen Inc (NASDAQ:BIIB)'s Alzheimer's disease treatment despite the committee's recommendation against doing so.

Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel.

"My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ... because I didn’t think that the firm recommendations from the committee in this case ... were appropriately integrated into the decision-making process," Kesselheim said in an email.

He cited FDA's decision to approve Sarepta Therapeutic Inc's drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of the regulator approving a drug against the recommendations of its advisory committee.

Stat News first reported his departure.

On Tuesday, a member of the advisory group who voted against the approval, Washington University neurologist Dr. Joel Perlmutter, resigned from the committee, citing the FDA's approval of Aduhelm.

Mayo Clinic neurologist Dr. David Knopman said he resigned on Wednesday.

The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective.

The FDA on Monday (NASDAQ:MNDY) gave the drug "accelerated approval,” based on evidence that it can reduce a likely contributor to Alzheimer’s, rather than proof of a clear benefit against the disease.

Third member of U.S. FDA advisory panel resigns over Alzheimer's drug approval
 

Related Articles

3 Top Energy Stocks That Pay High Dividends
3 Top Energy Stocks That Pay High Dividends By StockNews - Jun 23, 2021

Investors are focusing on high-dividend stocks as a stable source of income amid the near-zero interest rate environment. As such, with the energy sector rebounding rapidly, we...

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind: 

  • Enrich the conversation
  • Stay focused and on track. Only post material that’s relevant to the topic being discussed.
  • Be respectful. Even negative opinions can be framed positively and diplomatically.
  •  Use standard writing style. Include punctuation and upper and lower cases.
  • NOTE: Spam and/or promotional messages and links within a comment will be removed
  • Avoid profanity, slander or personal attacks directed at an author or another user.
  • Don’t Monopolize the Conversation. We appreciate passion and conviction, but we also believe strongly in giving everyone a chance to air their thoughts. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
Comments (3)
Benoit Avril
Benoit Avril Jun 11, 2021 8:06PM ET
Saved. See Saved Items.
This comment has already been saved in your Saved Items
Corruption. The sad thing is the good guys are leaving to protest the corruption so they will be replaced by corrupted scientists.
Lorence Issa
Lorence Issa Jun 11, 2021 4:02AM ET
Saved. See Saved Items.
This comment has already been saved in your Saved Items
FDA is nothing but Big Pharmas puppet..
igor bogdanoff
igor bogdanoff Jun 11, 2021 3:35AM ET
Saved. See Saved Items.
This comment has already been saved in your Saved Items
Trust the science, amirite
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Continue with Google
or
Sign up with Email