OT: Controversial FDA decision, yesterday, to approve Biogen's monoclonal antibody Alzheimer's drug aducanamab
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Soooooo defensive. One could be forgiven for thinking you're personally responsible for pharma killing so many people, the way you keep overreacting in this thread.
Here's the Allison story for folks not familiar with it - great stuff. Well, strap in, becasuse this is going to be a bumpy ride...
https://www.ajmc.com/view/ijim-alli...ative-paths-of-a-scientist-and-immunooncology
As often is the case, Derek Lowe (In the Pipeline blog) weighed in the other day on this, savaging the FDA for this decision. Here's what he had to say and it's hard to argue with.
https://blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval
As the world knows, the FDA approved Biogen’s anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I think this is one of the worst FDA decisions I have ever seen, because – like the advisory committee that reviewed the application, and like the FDA’s own statisticians – I don’t believe that Biogen really demonstrated efficacy. No problem apparently. The agency seems to have approved it based on its demonstrated ability to clear beta-amyloid, and is asking Biogen to run a confirmatory trial to show efficacy.
They will be absolutely overjoyed to do that, of course, because the whole time that’s going, they will be selling the first drug that (in theory) targets the etiology of Alzheimer’s. The backed-up demand is going to be gigantic, and Biogen is going to make enormous amounts of money. They have nine years, as it turns out, to get this trial done, and I feel safe in predicting that it’s going to take alllll niiiiine loooong sloooow years to get this done. Why shouldn’t it? The company certainly showed no interest whatsoever, not even a twitch, in running a confirmatory trial before this, so why should they hop to running one while the drug is selling? I continue to think that odds are quite good, and certainly unacceptably so for Biogen, that the drug will turn out in the end to have no real effect on Alzheimer’s patients at all. I’ve been dreading a decision like this for a long time.
https://blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval
As the world knows, the FDA approved Biogen’s anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I think this is one of the worst FDA decisions I have ever seen, because – like the advisory committee that reviewed the application, and like the FDA’s own statisticians – I don’t believe that Biogen really demonstrated efficacy. No problem apparently. The agency seems to have approved it based on its demonstrated ability to clear beta-amyloid, and is asking Biogen to run a confirmatory trial to show efficacy.
They will be absolutely overjoyed to do that, of course, because the whole time that’s going, they will be selling the first drug that (in theory) targets the etiology of Alzheimer’s. The backed-up demand is going to be gigantic, and Biogen is going to make enormous amounts of money. They have nine years, as it turns out, to get this trial done, and I feel safe in predicting that it’s going to take alllll niiiiine loooong sloooow years to get this done. Why shouldn’t it? The company certainly showed no interest whatsoever, not even a twitch, in running a confirmatory trial before this, so why should they hop to running one while the drug is selling? I continue to think that odds are quite good, and certainly unacceptably so for Biogen, that the drug will turn out in the end to have no real effect on Alzheimer’s patients at all. I’ve been dreading a decision like this for a long time.
I had a piece of the immunoglobulin shaped cake Jim had the day the FDA finally approved Yervoy.
He was the chair of my dept and my next door neighbor for about 8 years. He is a heck of a harmonica player and even got to back up his idol, Willie Nelson, one time
If you don't mind my asking, where was that? That link I posted mentioned him playing with Willie Nelson, which is cool - they did a documentary on him, which I'll have to look for.
I worked with a few world class chemists over the years, who had worked with a few Nobel laureates, but never with a Nobel winner, which isn't surprising as Nobel almost never names anyone not from academia, which is a bit of a shame - biggest oversight, due to that, IMO is Merck's Maurice Hilleman, the most prolific vaccine discoverer in history, not ever getting a Nobel.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150172/
I've had the pleasure of sitting down with several pharma ceos. Some I've found honest and genuinely interested in the science and making the world a better place (I would put the prior Gilead ceo in that bucket) others are focused on maximizing returns (Abbvie).
Like most things in life, it's not one size fits all.
Great documentary on him. He’s like a mix of Einstein and Jerry Garcia
HOME | Uncommon Productions
Founded in 2000 by Tim Disney and Bill Haney, Uncommon Productions produces documentary and feature films that inspire, enlighten, and engage.
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I always think of the Penzias and Wilson Nobel prize - they needed Princeton U's Dicke to explain the Big Bang noise they heard, but Dicke was not on the prize - as an example that company scientists did OK.
I did not realize that company scientists were so unrepresented. Maybe the restrictions that companies have publishing and presenting at meetings in "real time" has an impact on the perception of the work?
I can't recall where Allison played with Willie. Allison is not shy about joining in - I've seen him hop on stage and just join with bands at rocking science meetings (hah).
I think it's more that Nobel has focused more on "discovery" than "innovation" and more of the most basic research is in academic labs - at least that's my theory, lol. It's not that there have been no industrial Nobel winners, just a lot less than academic ones.
On the "where" I was referring to where were you when you worked with Allison...
Agree about Hilleman but don't forget Campbell did share the Nobel for his work on ivermectin at Merck. He was back teaching by the time he got it.
Fair point, forgot about Campbell, somehow, despite having met him once, as I was working on some process development issues for the manufacturing process for ivermectin (in my first year or so at Merck) which was quite complex (there's a fermentation to make th biological precursor, followed by some chemical steps on the macromolecule to make the final active ingredient). When he was at Merck he also worked in Rahway until about 1990. Was also nice to see Merck returning the corporate HQ back to Rahway after about 25 years in the "wilderness" so to speak. Also, while Campbell clearly deserved a Nobel, I'd say Hilleman deserved one more.
https://www.nobelprize.org/prizes/medicine/2015/press-release/
Did you/do you work at Merck?
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I thought you were asking about Willie - we were at MSKCC at the time
Statin eligible candidates with persistent CAC = 0 had a very low 15-year ASCVD risk, suggesting that statin therapy may be of limited benefit among this group of individuals.
Atherosclerotic cardiovascular disease events among statin eligible individuals with and without long-term healthy arterial aging
A large proportion of statin eligible candidates have a baseline absence of coronary artery calcium (CAC) and low 10-year atherosclerotic cardiovascular disease (ASCVD) risk. We sought to determine the proportion of statin eligible individuals who had long-term healthy arterial aging (persistent...
www.atherosclerosis-journal.com
I just read that whole article. All I can say is: "Wow."
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