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
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
He once compared the experience of a dying old person in many American hospitals to that of a carcass on the plains of Africa. He painted a bleak picture, describing how vultures, jackals, hyenas and other scavengers swarm around the helpless creature: "A lot of the medical care we do deliver is wrong — so expensive and wrong. It's ridiculous.”
He was so right.
But if a cardiologist says this, they are considered anti-innovation.
FDA needs reform, for sure. How long have we been saying that? On the other hand, the thought of eliminating it altogether conjures up one word in my mind: thalidomide. The FDA saved many lives then, despite some current politicians spreading misinformation to the contrary (link below). The fact that some politicians want to eliminate the FDA scares the sh*t out of me, to be honest. After seeing how many people bought into fake claims on the internet during Covid, I don't think leaving it up to each individual to do their own research is the wisest choice! Also, with no FDA, it will be totally up to insurance companies to decide whether to cover new treatments - no thanks! Maybe you all need to volunteer to do analyses of research for the nnt.com, and encourage your like-minded buddies to do the same, so they can do more reviews. It's my understanding that their reviews are done by volunteers, so they don't have the manpower to keep up with all the treatments in need of review. I believe any qualified person can submit a review. (HINT!) That's a resource the lay public can easily understand, and the data is available to the more scientific-minded. There are no easy answers, but I encourage you all to keep exploring the topic of why some (many?) doctors prescribe treatments where data indicates it is no more effective than placebo and in some cases, harm outweighs benefits. FOMO? Really? That's scary! Maybe you could invite somebody like Paul Offit to be interviewed, who is on an FDA advisory panel but is also very evidence based and has no qualms about speaking up. See if he has any ideas!
Not only pols but libertatrian think tank Cato Health's Michael Cannon advocates for going back to the pre-1961 (I could have the date wrong?) FDA rules of safety only & letting the market decide if a drug or device works. I don't think that's where Americans are but the FDA certainly does need reform. Even Thalidomide wasn't exactly a walk in the park at the time to deny its approval for use in pregnant women (I believe the drug itself is still on the market) & the agency has been "trying to strike a balance" (see link in my other post) wrt device approval since 510(k) was passed in 1976.
I'll be proposing some FDA (& other PH) reforms in my (to be pub. post-election) comprehensive reform proposal but am certainly open to ideas (reply here, follow &/or DM me @HCP4US on "X" or email healthcareplan4us@gmail.com). Vinay & Adam's book "Enging Medical Reversal" & Vinay's "Malignant" (currently reading) have provided an excellent framework.
Back in those days, drugs did not need to be tested for teratogenicity. Thalidomide was widely used by pregnant women in other countries to treat morning sickness, but not here in the US. Although it was briefly available here as an "investigational agent," it was denied approval by the FDA due to lack of safety data. The FDA director was honored with the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy for her action, which averted tragedy in the US. Since then, thalidomide and derivative drugs have been studied and found effective in a number of disorders, so yes, it's now sometimes prescribed but NOT to pregnant women. If interested, full history below. I think it would be a mistake to eliminate requirements for trials for safety, and if we're going to do those, why wouldn't we investigate efficacy at the same time? It seems to me the real problem is a lack of implementation of the data we have by the FDA when making approval decisions, and doctors who don't follow the evidence, regardless of what the FDA says. I look forward to your proposals. I don't know your background, but before publishing, I might suggest getting feedback from a variety of folks in the medical profession, especially the good ones like the docs here! :)
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.
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
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
This is really depressing...
Reminds me of the late Charlie Munger.
He once compared the experience of a dying old person in many American hospitals to that of a carcass on the plains of Africa. He painted a bleak picture, describing how vultures, jackals, hyenas and other scavengers swarm around the helpless creature: "A lot of the medical care we do deliver is wrong — so expensive and wrong. It's ridiculous.”
He was so right.
But if a cardiologist says this, they are considered anti-innovation.
Time to call out this straw man argument.
Interesting that this piece appeared in KFF News last week, supporting your assertions here: https://kffhealthnews.org/news/article/medical-device-malfunction-fda-oversight-patient-harm/?utm_campaign=KHN%3A%20Daily%20Health%20Policy%20Report&utm_medium=email&_hsmi=287455346&_hsenc=p2ANqtz-8-BYXigdeXDF2nAafWgRP1prbM3n9O-RfzzA_UMIiu8CNrfnVi_3YKlO9SdhbZcHqfETxKVaD-4j07ROX_il8hoZkOt0TEX1C3GAWPKhG5bxQdHbE&utm_content=287455346&utm_source=hs_email
FDA needs reform, for sure. How long have we been saying that? On the other hand, the thought of eliminating it altogether conjures up one word in my mind: thalidomide. The FDA saved many lives then, despite some current politicians spreading misinformation to the contrary (link below). The fact that some politicians want to eliminate the FDA scares the sh*t out of me, to be honest. After seeing how many people bought into fake claims on the internet during Covid, I don't think leaving it up to each individual to do their own research is the wisest choice! Also, with no FDA, it will be totally up to insurance companies to decide whether to cover new treatments - no thanks! Maybe you all need to volunteer to do analyses of research for the nnt.com, and encourage your like-minded buddies to do the same, so they can do more reviews. It's my understanding that their reviews are done by volunteers, so they don't have the manpower to keep up with all the treatments in need of review. I believe any qualified person can submit a review. (HINT!) That's a resource the lay public can easily understand, and the data is available to the more scientific-minded. There are no easy answers, but I encourage you all to keep exploring the topic of why some (many?) doctors prescribe treatments where data indicates it is no more effective than placebo and in some cases, harm outweighs benefits. FOMO? Really? That's scary! Maybe you could invite somebody like Paul Offit to be interviewed, who is on an FDA advisory panel but is also very evidence based and has no qualms about speaking up. See if he has any ideas!
https://www.reuters.com/article/idUSL1N2PY2F7/
Not only pols but libertatrian think tank Cato Health's Michael Cannon advocates for going back to the pre-1961 (I could have the date wrong?) FDA rules of safety only & letting the market decide if a drug or device works. I don't think that's where Americans are but the FDA certainly does need reform. Even Thalidomide wasn't exactly a walk in the park at the time to deny its approval for use in pregnant women (I believe the drug itself is still on the market) & the agency has been "trying to strike a balance" (see link in my other post) wrt device approval since 510(k) was passed in 1976.
I'll be proposing some FDA (& other PH) reforms in my (to be pub. post-election) comprehensive reform proposal but am certainly open to ideas (reply here, follow &/or DM me @HCP4US on "X" or email healthcareplan4us@gmail.com). Vinay & Adam's book "Enging Medical Reversal" & Vinay's "Malignant" (currently reading) have provided an excellent framework.
Back in those days, drugs did not need to be tested for teratogenicity. Thalidomide was widely used by pregnant women in other countries to treat morning sickness, but not here in the US. Although it was briefly available here as an "investigational agent," it was denied approval by the FDA due to lack of safety data. The FDA director was honored with the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy for her action, which averted tragedy in the US. Since then, thalidomide and derivative drugs have been studied and found effective in a number of disorders, so yes, it's now sometimes prescribed but NOT to pregnant women. If interested, full history below. I think it would be a mistake to eliminate requirements for trials for safety, and if we're going to do those, why wouldn't we investigate efficacy at the same time? It seems to me the real problem is a lack of implementation of the data we have by the FDA when making approval decisions, and doctors who don't follow the evidence, regardless of what the FDA says. I look forward to your proposals. I don't know your background, but before publishing, I might suggest getting feedback from a variety of folks in the medical profession, especially the good ones like the docs here! :)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3573415/