I did not quite understand this statement "Ironically, the rise in popularity of ablation has meant that more patients with AF need drug treatment at some point in their journey" Why do more patients need drug treatment if ablation addresses it effectively?
Patient here. Giiven your assertion that, bamboozled by advertizing, we all expect quick fixes for complex medical problems, i'm happy not to have encountered you.
Very nice article . You could make the same arguments for lots of other specialties . Until cognitive work and time is as well rewarded as procedure based " piece work" in medicine there will be no substantial change. Patient access to care is also affected by our fascination with procedures - getting an appt for a colonoscopy is pretty easy. Seeing rheumatology or endocrine - not so much .Months and months in some areas.
Not at all intended as a cheap shot at Dr. Kowey, simply as a response to his own statement, which I quoted, lamenting that the FDA requires outcome trials, describing them as unnecessary. CAST is the classic example of the pitfalls of surrogate markers leading to a new appreciation of the dangers of drug approvals based on unvalidated surrogates, not only in cardiology but across the Agency as well as at drug regulatory bodies in many other countries.
Very well stated. We know the FDA has been captured. Not enough sensible well trained or experienced physician or bioscience input. Ablation has been successful. But usually with the caveat that you still need another drug -- a DOCA. And why have we abandoned some legacy drugs like Digitalis? The worse and most toxic example is the use of Amiodorone. In that case, ablation is superior. Another example of risk reward calculation.
Perhaps the marked anti-inflammatory effect of the GLP-1 medications will have an effect on atrial fibrosis, if it is in fact, an inflammatory process and not a degenerative process.
Very good points made in this thoughtful essay. I do think that AAD development faces a special challenge because of the issue of proarrhythmia and history of disappointing trials (CAST, SWORD, ALIVE, etc.). Weight loss drugs have recently succeeded despite the availability of surgical alternatives, showing that the right pharma product can compete with the other forces favoring the surgical "fix."
It's pretty simple, just follow the money. Ablations are a cash cow for hospitals and an RVU gold mine for EP docs. And honestly I don't have a huge problem with it. In my "Real world" anecdotal experience AF/flutter/SVT ablations are incredibly effective. And adding one more medicine to a patient's laundry list isn't typically well received.
I've seen more of the quick-fix mentality but not applied to our residents who are elderly, for many obvious reasons. But I've also had to fight tooth and nail to get drugs changed when they're doing harm that's quite plain to me as I see them daily in our ALF home and each one is a unique individual. This kind of attention does not happen with most elderly AF patients.
Blood thinners can be hard to get primary care to change - as if whatever they did alone at home guided by a half dozen yearly visit to someone who Does Not "know them" as they believe, was somehow better or should be sacred...
If it sounds like I think I'm a doctor, that's not the case. But 17 years of careful individual attention to lifestyle matters. When people bruise less, bleed less and fall less, they're also safer. Sometimes a change can be more affordable depending how the script is written. Especially important to consider is compliance after a certain age - I've gone to people's homes and found bottles of pills taken only "when I feel like I need it", in the hands of people over 85.
Thanks Doreen. I appreciate your posts here as your 17 yrs of experience in AFH with seniors over the years gives you huge insights that clinicians who see a patient 2-6X / yr can never gain.
The five reasons given for the lack of advancement of more effective and less invasive therapies for AF and other arrhythmias could well apply to the work I do to prevent unnecessary surgeries and expensive diagnostic procedures for chronic pain disorders. The question is: how can we slowly resuscitate "sensible medicine" in our chronically failing "Healthcare Industry"? Chronic illness is rapidly requiring hospice care before being lost completely.
“The FDA staff, left to its own devices, has chosen to pay more attention to safety than unmet need, and have mandated large, expensive and usually unnecessary outcome trials as a condition of antiarrhythmic drug approval.”
Unnecessary outcome trials? Has Dr. Kowey forgotten CAST, the outcome trial showing that treatment with drugs that were highly effective in suppressing PVCs nonetheless led to increased rather than decreased mortality in the recipients. This led to a change in the previously standard management of post MI patients with PVCs that had caused thousands, probably tens of thousands, of deaths in these patients.
For more about CAST see
Deadly Medicine: How Big Pharma Lost Its Way in the Pursuit of Profits by Thomas J. Moore, published in 1995 by Simon & Schuster.
That’s a cheap shot at Dr. Kowey. He’s quite familiar with the CAST study and I’m sure he teaches it to all his trainees as an example of how Big Pharma is always trying to fool you. By the way device companies do the same thing. They never pay for papers that show the ~50% long term failure rate with a fib ablation. Nor do the proceeduralists tell the patients they’ll still need anticoagulation for life.
Who needs a cure??? If a patient with a debilitating illness is restored to their high functioning career etc etc at the cost of taking half a tablet a day... Why waste time looking for cures? If that is palliative medicine, I'm a cheerleader.
“Pharmacology, on the other hand, is not only boring, but also complicated.” Yes & No! I suspect what was intended was to say that AS OFTEN TAUGHT, pharmacology can SEEM boring. To me, as a pharmacologist and physician, it is the complexities inherent to pharmacology and the importance of these complexities to understanding medical therapeutics that make pharmacology and pharmaceutical development so very interesting. Otherwise, the author here is very much on target…
I did not quite understand this statement "Ironically, the rise in popularity of ablation has meant that more patients with AF need drug treatment at some point in their journey" Why do more patients need drug treatment if ablation addresses it effectively?
Patient here. Giiven your assertion that, bamboozled by advertizing, we all expect quick fixes for complex medical problems, i'm happy not to have encountered you.
Very nice article . You could make the same arguments for lots of other specialties . Until cognitive work and time is as well rewarded as procedure based " piece work" in medicine there will be no substantial change. Patient access to care is also affected by our fascination with procedures - getting an appt for a colonoscopy is pretty easy. Seeing rheumatology or endocrine - not so much .Months and months in some areas.
So I just had a patient in who had an a fib ablation. He just got the bill for $200,000! A real bargain, eh? And he’s still on Eliquis for life.
Not at all intended as a cheap shot at Dr. Kowey, simply as a response to his own statement, which I quoted, lamenting that the FDA requires outcome trials, describing them as unnecessary. CAST is the classic example of the pitfalls of surrogate markers leading to a new appreciation of the dangers of drug approvals based on unvalidated surrogates, not only in cardiology but across the Agency as well as at drug regulatory bodies in many other countries.
Very well stated. We know the FDA has been captured. Not enough sensible well trained or experienced physician or bioscience input. Ablation has been successful. But usually with the caveat that you still need another drug -- a DOCA. And why have we abandoned some legacy drugs like Digitalis? The worse and most toxic example is the use of Amiodorone. In that case, ablation is superior. Another example of risk reward calculation.
Perhaps the marked anti-inflammatory effect of the GLP-1 medications will have an effect on atrial fibrosis, if it is in fact, an inflammatory process and not a degenerative process.
Wow. As a layperson, I had no idea. Thanks for this post.
Very good points made in this thoughtful essay. I do think that AAD development faces a special challenge because of the issue of proarrhythmia and history of disappointing trials (CAST, SWORD, ALIVE, etc.). Weight loss drugs have recently succeeded despite the availability of surgical alternatives, showing that the right pharma product can compete with the other forces favoring the surgical "fix."
It also doesn't hurt to have commercials where you're immediately dancing in the street with other chubby people and your life is wonderful!
It's pretty simple, just follow the money. Ablations are a cash cow for hospitals and an RVU gold mine for EP docs. And honestly I don't have a huge problem with it. In my "Real world" anecdotal experience AF/flutter/SVT ablations are incredibly effective. And adding one more medicine to a patient's laundry list isn't typically well received.
I've seen more of the quick-fix mentality but not applied to our residents who are elderly, for many obvious reasons. But I've also had to fight tooth and nail to get drugs changed when they're doing harm that's quite plain to me as I see them daily in our ALF home and each one is a unique individual. This kind of attention does not happen with most elderly AF patients.
Blood thinners can be hard to get primary care to change - as if whatever they did alone at home guided by a half dozen yearly visit to someone who Does Not "know them" as they believe, was somehow better or should be sacred...
If it sounds like I think I'm a doctor, that's not the case. But 17 years of careful individual attention to lifestyle matters. When people bruise less, bleed less and fall less, they're also safer. Sometimes a change can be more affordable depending how the script is written. Especially important to consider is compliance after a certain age - I've gone to people's homes and found bottles of pills taken only "when I feel like I need it", in the hands of people over 85.
Thanks Doreen. I appreciate your posts here as your 17 yrs of experience in AFH with seniors over the years gives you huge insights that clinicians who see a patient 2-6X / yr can never gain.
The five reasons given for the lack of advancement of more effective and less invasive therapies for AF and other arrhythmias could well apply to the work I do to prevent unnecessary surgeries and expensive diagnostic procedures for chronic pain disorders. The question is: how can we slowly resuscitate "sensible medicine" in our chronically failing "Healthcare Industry"? Chronic illness is rapidly requiring hospice care before being lost completely.
“The FDA staff, left to its own devices, has chosen to pay more attention to safety than unmet need, and have mandated large, expensive and usually unnecessary outcome trials as a condition of antiarrhythmic drug approval.”
Unnecessary outcome trials? Has Dr. Kowey forgotten CAST, the outcome trial showing that treatment with drugs that were highly effective in suppressing PVCs nonetheless led to increased rather than decreased mortality in the recipients. This led to a change in the previously standard management of post MI patients with PVCs that had caused thousands, probably tens of thousands, of deaths in these patients.
For more about CAST see
Deadly Medicine: How Big Pharma Lost Its Way in the Pursuit of Profits by Thomas J. Moore, published in 1995 by Simon & Schuster.
Available on Amazon at
https://a.co/d/0fVesZCe
That’s a cheap shot at Dr. Kowey. He’s quite familiar with the CAST study and I’m sure he teaches it to all his trainees as an example of how Big Pharma is always trying to fool you. By the way device companies do the same thing. They never pay for papers that show the ~50% long term failure rate with a fib ablation. Nor do the proceeduralists tell the patients they’ll still need anticoagulation for life.
Who needs a cure??? If a patient with a debilitating illness is restored to their high functioning career etc etc at the cost of taking half a tablet a day... Why waste time looking for cures? If that is palliative medicine, I'm a cheerleader.
“Pharmacology, on the other hand, is not only boring, but also complicated.” Yes & No! I suspect what was intended was to say that AS OFTEN TAUGHT, pharmacology can SEEM boring. To me, as a pharmacologist and physician, it is the complexities inherent to pharmacology and the importance of these complexities to understanding medical therapeutics that make pharmacology and pharmaceutical development so very interesting. Otherwise, the author here is very much on target…
I am reminded that 99% I do in Cardiac Surgery is palliative, not curative. All of our procedures require life long care.