Where has this person, Harrell, been during the pandemic and the RUBBER stamping of the vax by FDA??? Oh wait...he's a professor?!? Ah I see. Forgive me...he must have been in a TDS-ivory tower. My mistake.
I definitely agree the FDA is too lax. It carries a big stick, but walks way too softly. It’s not as bad as the EMA, but that’s also a pretty low bar (those Euro guys seem to approve based on biological plausibility alone, and maybe for safety….but safe and useless does not seem to deter the EMA). That the FDA is maybe not as egregious as the EMA is nice….but it whiffs on the chance to be so much better. In its role as regulator, it has the capacity to mandate much better science, and IMO it fails miserably in this role.
I would give it a bit of a pass on BVS. Relatively short term data (and amazing theoretical advantages) did not translate into longer term efficacy…sometimes these things happen. Perhaps conditional approval with mandated long term follow up would have been the regulatory answer, or at least the regulatory lesson. Some of the criticism of TEER (at least for MR) seems incorrect: EVEREST was for primary MR, whereas COAPT and MITRA were for secondary MR….those are distinct conditions. And I think there were enough differences btw COAPT and MITRA (smaller LV, better quantitation of truly severe MR, better titration of HF meds, a more symptomatic cohort based on NYHA class) to account for the disparate results.
But LA appendage closure (approval for a cohort that was NOT studied in any of the trials), PA pressure monitor (single blind but useless during COVID at a time when bias from single blinding would have been best mitigated) and now renal artery denervation (ridiculously short follow up with a clinically meaningless effect size), are ludicrous approvals that erode clinician confidence in the FDA’s capacity in, or intestinal fortitude for, truly regulating the medical science space. And when stuff this weak still pass muster, it makes the cynic in me wonder whether there is indeed something nefarious going on (and I am not generally of the constitution to be nearly as charitable as Dr. Mandrola tends to be).
Is the FDA too lax? Well, in their wisdom the voters of the state of Oregon approved the so-called therapeutic use of psilocybin despite the fact that the FDA has not yet determined that it is safe or effective as a treatment for any condition. Now the state of Oregon is as good as in the psilocybin business along with psychonaut entrepreneurs and woo woo spiritual seekers. Basically, an insatiable demand for an effective treatment for a variety of common mental health problems, anecdotal evidence and wishful thinking have gotten ahead of the science.
In a better regulated world, the FDA and the feds would have moved to shut down the program before it started so that the trials could run their course and the FDA could make a ruling.
Oregon loves their drug culture. Nothing is illegal. Keep Portland weird! Forget the police state. We scream freedom in the great northwest, so get out of our trip. Drug taxes are how Oregon pays for its government programs. Ask any state politician.
They definitely aren't to laxxed but like every Federal agency today they're more of a business then a consumer protection agency. If you have a device that works and is beneficial you can get it thru but if it posses a monetary loss yo another organization then it will come down to which one of you can provide greater influence to heads at the FDA to approve or disapprove said thing. Ones thing they need FDA approval for would need to be very dangerous and risky for no amount of monetary incentive to over comr
Yes, almost every government regulatory agency is under the control of the largest companies in their various industries. But Murray Rothbard, the great American economist, didn't like the term. He liked to point out that the largest firms almost always lobby for the creation of regulatory agencies in order to hamper their smaller competitors who can't afford to hire people to deal with the regulators as the larger firms can do. So they actually initiate the regulation rather than taking over an agency started by well-meaning reformers.
For the most part the captives aren't complaining, either. I suspect those who do are encouraged to find other employment. And old Turkish proverb: The fish starts to stink at the head. From personal experience, I know when an organization is toxic from bad upper management, the only way to fix it is to level it to the bottom and start all over.
Regulatory capture is basically never unwilling; it always begins with soft (grants) or hard (cash under table) bribery.
As far as "encouraged to find other employment," notice that two senior FDA officials quit during COVID for "unspecified reasons" during the emergency approval phase of vaccines.
FDA: A gaggle of goons auditioning for executive positions in the pharmaceutical and medical device industries. Abolish it along with the NIH and all other "health" bureaucracies.
I've come to agree with you on abolishing the agencies that are supposed to be watchdogs. From the reading I've done on the testing of statins and psych meds, it's difficult to see the FDA as other than a rubber stamp wielded by government blobs eyeing pharmaceutical executive positions. John Abramson thinks this is remediable with another better organized government sponsored structure but it doesn't seem realistic given what we already see happening.
Part of the trouble is the public, which doesn't take its health seriously enough to lose some weight, rein in the sweets (she says after a week of Christmas candy!), and get off its butt and take a walk daily. We always want a pill or procedure.
Yes, they have to be eliminated and have all funding cut off. Many well-intended reforms have done little or no good. They always find ways to work around them.
I'm not a cardiologist but have had AFib and an atrial ablation because of failure of meds. Your articles are so informative! Thanks for making them accessible to non specialists/MDs
FDA: another prisoner of the corporate-government complex. Profits over patients!
Medical devices and "supplements" were somewhat carved out of the initial FDA regime due to corporate lobbying for less oversight. Pharma has now achieved a similar result. Caveat emptor.
Where has this person, Harrell, been during the pandemic and the RUBBER stamping of the vax by FDA??? Oh wait...he's a professor?!? Ah I see. Forgive me...he must have been in a TDS-ivory tower. My mistake.
I definitely agree the FDA is too lax. It carries a big stick, but walks way too softly. It’s not as bad as the EMA, but that’s also a pretty low bar (those Euro guys seem to approve based on biological plausibility alone, and maybe for safety….but safe and useless does not seem to deter the EMA). That the FDA is maybe not as egregious as the EMA is nice….but it whiffs on the chance to be so much better. In its role as regulator, it has the capacity to mandate much better science, and IMO it fails miserably in this role.
I would give it a bit of a pass on BVS. Relatively short term data (and amazing theoretical advantages) did not translate into longer term efficacy…sometimes these things happen. Perhaps conditional approval with mandated long term follow up would have been the regulatory answer, or at least the regulatory lesson. Some of the criticism of TEER (at least for MR) seems incorrect: EVEREST was for primary MR, whereas COAPT and MITRA were for secondary MR….those are distinct conditions. And I think there were enough differences btw COAPT and MITRA (smaller LV, better quantitation of truly severe MR, better titration of HF meds, a more symptomatic cohort based on NYHA class) to account for the disparate results.
But LA appendage closure (approval for a cohort that was NOT studied in any of the trials), PA pressure monitor (single blind but useless during COVID at a time when bias from single blinding would have been best mitigated) and now renal artery denervation (ridiculously short follow up with a clinically meaningless effect size), are ludicrous approvals that erode clinician confidence in the FDA’s capacity in, or intestinal fortitude for, truly regulating the medical science space. And when stuff this weak still pass muster, it makes the cynic in me wonder whether there is indeed something nefarious going on (and I am not generally of the constitution to be nearly as charitable as Dr. Mandrola tends to be).
I'm surprised you could reach the keyboard to type this around the elephant in the room.
.
The Enemy Of Everyone
Are The Guys Soon To Be Sitting
On Their Super Yachts Out In The Middle Of The Ocean.
Waiting …
For You All To Kill And Injure Each Other On Land.
Enough Of Us See That.
I Hope That You Do.
Everyone Else Are Just Pawns.
.
I definitely think there's a problem with many official organizations from governments. They are willing to approve things without much research.
Kaul’s analysis is so much appreciated. FC
Is the FDA too lax? That depends upon how they look at their mission statement. 😏
Is the FDA too lax? Well, in their wisdom the voters of the state of Oregon approved the so-called therapeutic use of psilocybin despite the fact that the FDA has not yet determined that it is safe or effective as a treatment for any condition. Now the state of Oregon is as good as in the psilocybin business along with psychonaut entrepreneurs and woo woo spiritual seekers. Basically, an insatiable demand for an effective treatment for a variety of common mental health problems, anecdotal evidence and wishful thinking have gotten ahead of the science.
In a better regulated world, the FDA and the feds would have moved to shut down the program before it started so that the trials could run their course and the FDA could make a ruling.
Oregon loves their drug culture. Nothing is illegal. Keep Portland weird! Forget the police state. We scream freedom in the great northwest, so get out of our trip. Drug taxes are how Oregon pays for its government programs. Ask any state politician.
They definitely aren't to laxxed but like every Federal agency today they're more of a business then a consumer protection agency. If you have a device that works and is beneficial you can get it thru but if it posses a monetary loss yo another organization then it will come down to which one of you can provide greater influence to heads at the FDA to approve or disapprove said thing. Ones thing they need FDA approval for would need to be very dangerous and risky for no amount of monetary incentive to over comr
Is the FDA too <CAPTURED>?
FTFY :)
It's a rubber stamp when its masters need it to be. It's an iron curtain when its masters need it to be.
No medicine outside the cartels gets in, no medicine from inside the cartels doesn't get out.
Captured is a pretty good term for it.
Yes, almost every government regulatory agency is under the control of the largest companies in their various industries. But Murray Rothbard, the great American economist, didn't like the term. He liked to point out that the largest firms almost always lobby for the creation of regulatory agencies in order to hamper their smaller competitors who can't afford to hire people to deal with the regulators as the larger firms can do. So they actually initiate the regulation rather than taking over an agency started by well-meaning reformers.
I can't take direct credit, gato malo uses the term most frequently ("regulatory capture") but neither of us invented it.
For the most part the captives aren't complaining, either. I suspect those who do are encouraged to find other employment. And old Turkish proverb: The fish starts to stink at the head. From personal experience, I know when an organization is toxic from bad upper management, the only way to fix it is to level it to the bottom and start all over.
Regulatory capture is basically never unwilling; it always begins with soft (grants) or hard (cash under table) bribery.
As far as "encouraged to find other employment," notice that two senior FDA officials quit during COVID for "unspecified reasons" during the emergency approval phase of vaccines.
Thus the toxic garden weeds out the fruitful plants, and leaves the crab grass to run things to suit itself.
FDA: A gaggle of goons auditioning for executive positions in the pharmaceutical and medical device industries. Abolish it along with the NIH and all other "health" bureaucracies.
I've come to agree with you on abolishing the agencies that are supposed to be watchdogs. From the reading I've done on the testing of statins and psych meds, it's difficult to see the FDA as other than a rubber stamp wielded by government blobs eyeing pharmaceutical executive positions. John Abramson thinks this is remediable with another better organized government sponsored structure but it doesn't seem realistic given what we already see happening.
Part of the trouble is the public, which doesn't take its health seriously enough to lose some weight, rein in the sweets (she says after a week of Christmas candy!), and get off its butt and take a walk daily. We always want a pill or procedure.
Yes, they have to be eliminated and have all funding cut off. Many well-intended reforms have done little or no good. They always find ways to work around them.
I would argue Sam’s definition of progress. Negative studies are progress. They progress the knowledge base.
Maybe you should check out this post today.
https://boriquagato.substack.com/p/mistakes-were-made-collins-edition?publication_id=323914&post_id=140141420&isFreemail=true&r=j5qou
I'm not a cardiologist but have had AFib and an atrial ablation because of failure of meds. Your articles are so informative! Thanks for making them accessible to non specialists/MDs
FDA: another prisoner of the corporate-government complex. Profits over patients!
Medical devices and "supplements" were somewhat carved out of the initial FDA regime due to corporate lobbying for less oversight. Pharma has now achieved a similar result. Caveat emptor.
This is really depressing...