Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug

Doh!


https://www.statnews.com/pharmalot/2020/12/09/biogen-alzheimer-fda-hhs/

 

Nothing to see here...move along & get to work. Patients are counting on you.

 

Advocacy group accuses FDA neuro chief Billy Dunn of misconduct in controversial Biogen review, demands a purge and federal probe

 

Yep...OIG is correct to take a look at what is going on.
Nothing passes the eye and smell test with this approval process.

 

No way there will be an approval. Billy Dunn overstepped. There needs to be another phase 3 study, but it wont take 4 years. Can be done much shorter. Perhaps a year but it is very necessary to show results can be repeated. Nothing should get approved without that.

 

“A year.” You are insane. It will take minimum 1 year enrollment and 2 years Tx. Then add the filing timelines. Do they not teach you reps anything?

 

EVP, Research & Development Alfred Sandrock sold 1,500 shares of BIIB stock on 11/04/2020 at the average price of $350. The price of the stock has decreased by 30.53%

 

Let’s face it, more eyes on this doesn’t help. Get your resume’s ready.

 

Don't be an idiot. There are ways of shortening that timeline. Stupid.

 

Advocacy group accuses FDA neuro chief Billy Dunn of misconduct in controversial Biogen review, demands a purge and federal probe
John Carroll
Editor & Founder
Public Citizen has never held back when it comes to criticizing the FDA. But today, they’re taking their typical attack mode and ratcheting it up to a whole new level.

The consumer advocacy group has singled out Billy Dunn and his crew of neuro specialists at the FDA for an “inappropriate close collaboration with Biogen” in the way they handled their review of Biogen’s controversial Alzheimer’s drug aducanumab. From their perspective, the performance of Dunn’s group is another example of “regulatory capture” in which they were co-opted by a company in the same way the FAA was accused of after back-to-back crashes last year involving Boeing’s 737 MAX that killed hundreds of people.

They are asking the Office of the Inspector General to investigate the relationship between Dunn and Biogen execs. And in a separate letter, the advocacy organization demanded that FDA commissioner Stephen Hahn remove Dunn from his role as head of the Office of Neurosciences until an OIG probe is complete and assign their work on neuro to other staffers at the agency not tainted by that relationship.

The FDA did not immediately respond to our request for a response. Biogen responded with a statement defending the drug and its work with the FDA, saying:

We are committed to driving progress for the Alzheimer’s disease community, and we stand by the integrity of the review process as FDA continues its review of our filing.

In their letter to Hahn, penned by Michael A. Carome, Public Citizen noted that the “unbridled enthusiasm” Dunn offered for aducanumab was not supported by an objective review of the data, where the advocates found big problems with the drug. They write:

The circumstances surrounding the FDA’s collaboration with Biogen before and after the submission of the BLA for aducanumab are a black eye for the agency, further undermining public confidence in the FDA, and demand your immediate attention.

Dunn already experienced a humiliating slap-down during the outside panel review of the drug, with a virtually unanimous vote against approval as several clearly angry panelists demanded to know why Dunn was willing to shrug off long established standards and enthusiastically back a drug that failed one of 2 pivotal studies. The FDA has yet to offer a final decision, with a PDUFA coming up in March, but a number of analysts still believe that Dunn can get this drug over the finish line and into the marketplace.

These demands, though, will keep aducanumab under a dark cloud at the agency, making any favorable decision problematic at best.

The FDA’s neuro staffers have faced repeated criticism over the past year, and not just because of aducanumab. J&J’s approval for their depression drug esketamine has spurred questions over the data, which includes failed studies as well. A follow-up approval for Sarepta in Duchenne muscular dystrophy based on a precedent-setting decision using inconclusive biomarker data has also raised questions after a federal regulator’s initial CRL was set aside.

Whether all that is enough to trigger a shakeup at the agency at a time the FDA is defending the gold standard approach for the Covid-19 vaccines has yet to be seen.

 

To jail he’ll be a goin’...

 

Holy fuck. You know absolutely nill about which you speak. What an absolute moron. You genuinely think a phase 3 trial can take a year. And you think there's some magical way to shorten trial times that ALL MULTIBILLION DOLLAR PHARMA COMPANIES IGNORE. Wow. If it were possible, dontcha think we would do it, Junior? What an absolute moron.

 

You're really stupid. You don't even know what the OP was talking about. No one said a BRAND NEW phase 3 trial for a year. FDA will ask for additional data that feasibly could take a year.

 

Alzheimer’s and Parkinson’s trials for compounds that are attempting to slow disease progression require the placebo patients to get worse over time relative to the drug. This is contingent on the disease process and takes years.

So no, you can’t just “shorten the study to a year.” You would not see a treatment effect even if your drug was perfect (which it very clearly isn’t). Look at the time it took to run your last failed trial. That will provide you an estimate on the time it takes.

 

You all need to shut your big fat pie holes & get your asses back to work! Put down the bowl of Cheerios & get to work

 

Soap makes you clean.

 

Do companies come any sleazier than Biogen?

 

R&D here - whatever unintelligent rep keeps saying this can be done in a year does not understand the clinical trial process. This is why a CRL that requires new data (meaning new studies) are absolutely devastating to a company. Even if Biogen pulled off a miracle operationally, it’s at minimum 3 years, but most likely about 4. And there’s also the filing, FDA acceptance of the filing, then a new review which may or may not include a panel.. and this is with the assumption the data from the new trial is positive and abundantly clear. Oh, and clinical trials all across the board are struggling to enroll patients due to COVID fears - so add another 4-8 months with that issue.

Also, have you ever worked with the group that handles our Clinical trials? GCO? It’s a dumpster fire with the worst political in-fighting. Every Director and Sr. Director seem to be following their own personal agenda, like they only work for expanding their own personal empires and resume enhancing projects rather than what is best for Biogen. One of the more repeated stories out of that group, a little over 2 years ago a person that was either a Director or Sr. Director in GCO told a small group sternly “I work for “XYZ (the person’s name) Inc.”, not Biogen” when this small group challenged this person on the feasibility and validity of a project that seemed more like a personal resume-building vanity project. It has changed a great deal over there since about mid 2017. Many don’t trust they can competently pull off a smooth and quick study launch like they did for Adu in mid to late 2015 and into early 2016.

 

I'm curious what the environment at Biogen is like right now.