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Inside Biogen’s top secret campaign to get the FDA to approve Aduhelm

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Inside Biogen’s top secret campaign to get the FDA to approve Aduhelm

Biogen launched a secretive two-year campaign, dubbed Project Onyx, to convince the FDA to approve its controversial Alzheimer’s drug, Aduhelm, my colleagues Adam Feuerstein, Matt Herper, and Damian Garde scoop in a blockbuster new story for STAT.

At the center of that campaign was an effort by Biogen to win over the head of the FDA’s Office of Neuroscience, Billy Dunn. Biogen’s top scientist Al Sandrock met with Dunn in May 2019 for an off-the-books meeting shortly after Biogen announced it was halting trials of the drug, STAT reports. The meeting appeared to pay off: Dunn’s office prepared for the company an extensive road map laying out how Biogen might gain FDA approval, despite lackluster data.

The reporting is likely to inflame critics of the agency who have complained for years that the FDA acts more like a consultant to the drug industry and less like an impartial — or tough — regulator. The news will also give further fuel to critics like Public Citizen who have already called for the ouster of Dunn, and for the HHS Office of Inspector General to investigate the close collaboration between Biogen and FDA officials.

Read STAT’s explosive new exclusive here.
 








This is really sad. There is a reason many don’t trust big corporations, and pharma in particular. Screw science and patients, let’s do everything we can to make more money.
 












Sounds like Project Onyx is going to come full circle and those involved will be fully exposed! This is like straight out of a movie. It is so hard to believe, yet it isn't at the same time. One thing for sure, however, is the truth always comes out. If the truth uncovers any illegal activity, you can pretty much be assured that this drug will not stay on the market due to false pretenses.
 




Sounds like Project Onyx is going to come full circle and those involved will be fully exposed! This is like straight out of a movie. It is so hard to believe, yet it isn't at the same time. One thing for sure, however, is the truth always comes out. If the truth uncovers any illegal activity, you can pretty much be assured that this drug will not stay on the market due to false pretenses.

Movie indeed. Sandrock even has the creepy facial hair of a Bond villain.
 




Well, well, well. Soon the entire sordid story of how our corrupt, criminal leadership conspired with the FDA’s corrupt, criminal head of their Neuroscience division to get this useless drug approved. How many people were paid off to get “yes” votes for approval? Does the FDA’s corruption go all the way to the top? How many Congresspersons were involved in the corruption? Who will end up in jail?

What a totally disgusting industry and company!
 




Well, well, well. Soon the entire sordid story of how our corrupt, criminal leadership conspired with the FDA’s corrupt, criminal head of their Neuroscience division to get this useless drug approved. How many people were paid off to get “yes” votes for approval? Does the FDA’s corruption go all the way to the top? How many Congresspersons were involved in the corruption? Who will end up in jail?

What a totally disgusting industry and company!

I’ll gladly continue with my 200k annual earnings and you can continue to collect your stimulant check while living down in your mom’s basement and bitching about how pharma is a “disgusting industry.” What a loser troll.
 








I’ll gladly continue with my 200k annual earnings and you can continue to collect your stimulant check while living down in your mom’s basement and bitching about how pharma is a “disgusting industry.” What a loser troll.

I guess you possibly are receiving too many stimulants as your brain is mush and clearly fail to recognize what is going on. We work here idiot and unfortunately quite possibly might be on the same team as you. It is a terrible thought and makes me want to hurl, but it could be true. If they are giving a peabrain like you that kind of money, we really are in trouble here. You keep saying basement in all your posts. Does it resonate with you for some reason? Was that how you spent the last 15 years of your life in Mommy's basement? I assure you that none of us have ever had that problem. Advice: Look around idiot. If you don't see what is happening, you are the biggest twit on here.
 




I guess you possibly are receiving too many stimulants as your brain is mush and clearly fail to recognize what is going on. We work here idiot and unfortunately quite possibly might be on the same team as you. It is a terrible thought and makes me want to hurl, but it could be true. If they are giving a peabrain like you that kind of money, we really are in trouble here. You keep saying basement in all your posts. Does it resonate with you for some reason? Was that how you spent the last 15 years of your life in Mommy's basement? I assure you that none of us have ever had that problem. Advice: Look around idiot. If you don't see what is happening, you are the biggest twit on here.

You obviously have never sold an orphan rare disease product before. You keep pouting about pharma and how tough it is to sell an expensive biological. You’re still wet behind the ears son. If it’s too much for an entitled silver spoon baby like you to handle leave. Obviously whoever your manager is made a huge hiring mistake with you.!
 








You obviously have never sold an orphan rare disease product before. You keep pouting about pharma and how tough it is to sell an expensive biological. You’re still wet behind the ears son. If it’s too much for an entitled silver spoon baby like you to handle leave. Obviously whoever your manager is made a huge hiring mistake with you.!

LOL first off. I have never responded to your posts with the exception of the one above. Get that straight. Second, I'm not your son. So get that straight. Third, I've been in the industry for 18 years, selling numerous biologics and yes, orphan drugs. I guarantee I could out sell you, out think you, and make you look like the wuss everyone knows you are. The difference between someone like you is that I have what is called class and integrity. You really are trash. The sad thing is you know you are. The biggest hiring mistake was you. I bet you haven't accomplished shit since you've been here. Guaranteed. So go away little boy.
 








LOL first off. I have never responded to your posts with the exception of the one above. Get that straight. Second, I'm not your son. So get that straight. Third, I've been in the industry for 18 years, selling numerous biologics and yes, orphan drugs. I guarantee I could out sell you, out think you, and make you look like the wuss everyone knows you are. The difference between someone like you is that I have what is called class and integrity. You really are trash. The sad thing is you know you are. The biggest hiring mistake was you. I bet you haven't accomplished shit since you've been here. Guaranteed. So go away little boy.

What a totally disgusting industry and company!

That’s who I was responding too. If someone is making 200k In this industry (and most legit reps at this level should be) WTH are they crying and complaining about? Put your big boy pants on, deal with the adversity and earn your salary. End of story!
 




I’ll gladly continue with my 200k annual earnings and you can continue to collect your stimulant check while living down in your mom’s basement and bitching about how pharma is a “disgusting industry.” What a loser troll.

You damn right! This drug will keep us going once it catches on, and it will if for nothing but desperation. I will promote the hell out of this dog every day and will blow out my numbers! REMEMBER, THE END JUSTIFIES THE MEANS!
 




You damn right! This drug will keep us going once it catches on, and it will if for nothing but desperation. I will promote the hell out of this dog every day and will blow out my numbers! REMEMBER, THE END JUSTIFIES THE MEANS!


You’ll be promoting it to 1/20th of the potential treatment community if you’re lucky with the other 19/20th’s not giving you the time of day. If that motivates you to promote the he’ll out of it, give it a go Melvin. Apparently you lack the biggest trait that the rest of your colleagues seem to have and that is integrity.
Signed
A former Biogen colleague and current shareholder
 








You damn right! This drug will keep us going once it catches on, and it will if for nothing but desperation. I will promote the hell out of this dog every day and will blow out my numbers! REMEMBER, THE END JUSTIFIES THE MEANS!


"I'll blow out my numbers" How old are you? You sound like such an immature teenager. Yeah, You're blowing out your numbers alright. Big Man :rolleyes: