Yes he will be fantastic, but, there's no way he alone will be able to change this policy. In fact, it kind of sits in the same bucket as Congress voting to give themselves term limits, which will never happen. The people who would need to change the revolving door policy are all potential recipients of those fabulous big-paycheck jobs.
A terrific ejaculate of information from Vinay that clearly supports at every turn of the prose his prior feelings about a Fundamentally Dirty Association (FDA). Vinay has now developed what is termed "having a red ass" down in rural west Texas. That diagnosis traditionally can be only be made after a long period of "having a burr under the saddle blanket".
"It is important to set arbitrary benchmarks. If you had no benchmarks then anyone could enter the market, and prices would fall. You need some hurdles to ensure only large (enough) firms can make it to market, and there are limited new drugs, so that prices can be kept high. We need some hurdles.
"But they can’t be too high. If, instead, you used endpoints like, “do sickle cell kids have less pain and do they live longer?” well then Pfizer drugs might not succeed. So the hurdles can’t actual be net or composite measures of patient benefit."
"What Vinay left out in this excellent article is that Patrizia Cavazzoni came from Pharma to be the Director of drug regulation (Center for Drug Evaluation and Research) at FDA. She was handpicked by the former head of CDER, the notorious Janet Woodcock, who was the liaison between FDA and Operation Warp Speed and was probably central to avoiding all real regulation of the COVID shots.
These two ladies ought to be criminally investigated as the crimes of the COVID era get litigated. But that is another story ". —Meryl [Nass]
This chaps my ass as much as you Vinay, but what is the fix? Gov't employee salaries are far inferior to private industry (in particular, for scientists, physicians and tech) so if you put limits in place, such as "you can't work for pharma for 2 yrs after you leave", wouldn't that make the FDA jobs that much more unattractive? They have a hard time recruiting to begin with.
And as an aside, I worked directly with FDA for 27 of my 37 yr pharma career (big, medium and small pharma) and although I am aware of FDA doing favors for industry and 'getting cozy', from my personal experience (peon level up through SVP), I never saw it and to the contrary, they held our feet to the fire for things that were absolutely ridiculous. An example (for those who are interested), we were developing an abuse-deterrent opioid (way back when FDA was encouraging sponsors to do this work), and there is a requirement to 'qualify' any impurities or degradation products in your product above a certain thresh hold. "Qualify"=full battery of animal toxicity studies. Since opioids are typically dosed to effect, and some patients have a high tolerance, AND, some people (i.e. addicts) will take enormous quantities, we had to do millions of dollars worth of extra tox studies to 'cover the addicts' who might take lets say 2-3 gram/day. So people who are literally overdosing themselves have to be protected from the possible toxicities of a degradation product.
This is very insightful comment. Really, the government is broken in both directions -- there is plenty of grift/graft at the higher levels (as Vinay is increasingly discovering) but at the lower levels there are a plethora of bureaucratic A**holes who revel in making people/companies do ridiculous things because they can. It is clearly the worst of all worlds.
It needs a complete makeover with all new people and all new direction. I hope it gets it.
Talent is important but right now I'd take Blind Freddy if he's available.
As to your aside: "Never attribute to malice that which is adequately explained by stupidity." Which now that I think about it, would tend to contradict my first comment.
Yup..someone from the nibr lab involved with entresto, left and went to work at the FDA.
How these people can be "influenced” is up to your imagination.
I fondly remember the day he carelessly released cyanide into the lab. They sent 5 people to the hospital, I was standing 20 feet away.
I later complained to OSHA about nibr making us pour all the hazardous waste we created IN the hood, into another large container OUTSIDE the hood. Even the most poorly funded startups i’d worked at provided an elephant trunk for ventilationwhile doing this…..but NOT novartis.
I made the complaint anonymously but came forward. They harassed me for it.
It’s interesting to look back to the voluntary recalls of Losartan and Valsartan that began in 2018. What companies recalled their products, who didn’t?
Novartis had to remain in for Entresto for PARGON-HF trial results to obtain FDA approval for broader usage (2021). HF incidence and rates following onset of pandemic have increased or decreased?
Results of trial placed under a microscope to proper magnification to reduce blur?
the irony is that elizabeth warren was trying to prevent RFKjr from suing drug companies for the harms they cause so as not to cut into their profits but didn't seem to have a problem with this blatantly corrupt behavior!
Seems like the longer humans roam the earth, the more selfish and self centered humans become. I have had to work very hard on my spiritual being to counter an 18 year stretch of absolute selfishness and self centeredness. And it’s still work on a daily basis to get that single, day long reprieve. I’ve often said in the past 25 years that a vast amount Americans have become addicted to MORE, and that the spiritual malady cannot be overcome by itself. Back to the game of pharma and FDA; well, how do we MAKE this criminal? There is no change without consequences enough to make one want to change, and I believe it’s true in a group as much as an individual.
This would have been a terribly exciting and brave outpouring in 2021, I guess, now it just kinda feels like when your kid comes home from school and says they learned about the Holocaust that day and just then realized people suck.
Before joining CDER, Dr. Cavazzoni spent nearly two decades in senior executive roles within the pharmaceutical industry, including positions at Pfizer, Eli Lilly, and Sanofi. During her previous time at Pfizer, she led clinical sciences and development operations across various senior roles within the company
When is Makary up to be confirmed? We need him ASAP
Yes he will be fantastic, but, there's no way he alone will be able to change this policy. In fact, it kind of sits in the same bucket as Congress voting to give themselves term limits, which will never happen. The people who would need to change the revolving door policy are all potential recipients of those fabulous big-paycheck jobs.
totally!
even Medpage had a hard time panning him since he was a former editor. they had a field day with RFKjr and are currently busy going after Battacharya
A terrific ejaculate of information from Vinay that clearly supports at every turn of the prose his prior feelings about a Fundamentally Dirty Association (FDA). Vinay has now developed what is termed "having a red ass" down in rural west Texas. That diagnosis traditionally can be only be made after a long period of "having a burr under the saddle blanket".
cute :)
"It is important to set arbitrary benchmarks. If you had no benchmarks then anyone could enter the market, and prices would fall. You need some hurdles to ensure only large (enough) firms can make it to market, and there are limited new drugs, so that prices can be kept high. We need some hurdles.
"But they can’t be too high. If, instead, you used endpoints like, “do sickle cell kids have less pain and do they live longer?” well then Pfizer drugs might not succeed. So the hurdles can’t actual be net or composite measures of patient benefit."
Nailed it!
Vinay Prasad is a modern day Diogenes, holding the lantern to the faces of Big Pharma, searching for an honest man.
From Meryl Nass's re-post introduction: https://substack.com/@merylnass/p-157818239
"What Vinay left out in this excellent article is that Patrizia Cavazzoni came from Pharma to be the Director of drug regulation (Center for Drug Evaluation and Research) at FDA. She was handpicked by the former head of CDER, the notorious Janet Woodcock, who was the liaison between FDA and Operation Warp Speed and was probably central to avoiding all real regulation of the COVID shots.
These two ladies ought to be criminally investigated as the crimes of the COVID era get litigated. But that is another story ". —Meryl [Nass]
This chaps my ass as much as you Vinay, but what is the fix? Gov't employee salaries are far inferior to private industry (in particular, for scientists, physicians and tech) so if you put limits in place, such as "you can't work for pharma for 2 yrs after you leave", wouldn't that make the FDA jobs that much more unattractive? They have a hard time recruiting to begin with.
And as an aside, I worked directly with FDA for 27 of my 37 yr pharma career (big, medium and small pharma) and although I am aware of FDA doing favors for industry and 'getting cozy', from my personal experience (peon level up through SVP), I never saw it and to the contrary, they held our feet to the fire for things that were absolutely ridiculous. An example (for those who are interested), we were developing an abuse-deterrent opioid (way back when FDA was encouraging sponsors to do this work), and there is a requirement to 'qualify' any impurities or degradation products in your product above a certain thresh hold. "Qualify"=full battery of animal toxicity studies. Since opioids are typically dosed to effect, and some patients have a high tolerance, AND, some people (i.e. addicts) will take enormous quantities, we had to do millions of dollars worth of extra tox studies to 'cover the addicts' who might take lets say 2-3 gram/day. So people who are literally overdosing themselves have to be protected from the possible toxicities of a degradation product.
This is very insightful comment. Really, the government is broken in both directions -- there is plenty of grift/graft at the higher levels (as Vinay is increasingly discovering) but at the lower levels there are a plethora of bureaucratic A**holes who revel in making people/companies do ridiculous things because they can. It is clearly the worst of all worlds.
It needs a complete makeover with all new people and all new direction. I hope it gets it.
Talent is important but right now I'd take Blind Freddy if he's available.
As to your aside: "Never attribute to malice that which is adequately explained by stupidity." Which now that I think about it, would tend to contradict my first comment.
Yup..someone from the nibr lab involved with entresto, left and went to work at the FDA.
How these people can be "influenced” is up to your imagination.
I fondly remember the day he carelessly released cyanide into the lab. They sent 5 people to the hospital, I was standing 20 feet away.
I later complained to OSHA about nibr making us pour all the hazardous waste we created IN the hood, into another large container OUTSIDE the hood. Even the most poorly funded startups i’d worked at provided an elephant trunk for ventilationwhile doing this…..but NOT novartis.
I made the complaint anonymously but came forward. They harassed me for it.
Novartis. Entresto.
It’s interesting to look back to the voluntary recalls of Losartan and Valsartan that began in 2018. What companies recalled their products, who didn’t?
Novartis had to remain in for Entresto for PARGON-HF trial results to obtain FDA approval for broader usage (2021). HF incidence and rates following onset of pandemic have increased or decreased?
Results of trial placed under a microscope to proper magnification to reduce blur?
Novartis insists the valsartan in entresto was free of MDMA carcinogen contamination.
Yet it was Sandoz (novartis) contracting to Asian API for generic valsartan that created the issue in the first place.
From a chemists perspective it’s either gross negligence or thinking no one would notice.
No doubt valsartan and other ARB have an effect, the question is……… does sacubitril do anything?
It's corruption. We'll see how RFKjr does. I'm not optimistic but hope to be pleasantly surprised
the irony is that elizabeth warren was trying to prevent RFKjr from suing drug companies for the harms they cause so as not to cut into their profits but didn't seem to have a problem with this blatantly corrupt behavior!
Seems like the longer humans roam the earth, the more selfish and self centered humans become. I have had to work very hard on my spiritual being to counter an 18 year stretch of absolute selfishness and self centeredness. And it’s still work on a daily basis to get that single, day long reprieve. I’ve often said in the past 25 years that a vast amount Americans have become addicted to MORE, and that the spiritual malady cannot be overcome by itself. Back to the game of pharma and FDA; well, how do we MAKE this criminal? There is no change without consequences enough to make one want to change, and I believe it’s true in a group as much as an individual.
This would have been a terribly exciting and brave outpouring in 2021, I guess, now it just kinda feels like when your kid comes home from school and says they learned about the Holocaust that day and just then realized people suck.
Good to see you are still out and about, GM. Hope all his better than it was and that you are prevailing! Miss your writing.
Your best article yet, keep it up.
Please oh please oh please, bring on Marty Makary!
Before joining CDER, Dr. Cavazzoni spent nearly two decades in senior executive roles within the pharmaceutical industry, including positions at Pfizer, Eli Lilly, and Sanofi. During her previous time at Pfizer, she led clinical sciences and development operations across various senior roles within the company
https://oncodaily.com/career/patrizia-cavazzoni-247946
*Cancer
*Baculovirus
*Neuropsychology
*Glioblastoma*
*EMF
It just never ends.