Vinay, as a hematologist, I concur with everything you say EXCEPT your inevitable retreat to "the government will fix it". The government in one form or the other (FDA as you noted, perverse payment incentives of innumerable kinds, graft and grift at virtually every level) IS the problem. This is the ultimate case of asking the fox to guard the henhouse. You seem to understand all the pieces, yet retreat to a solution that is guaranteed not to work.
We DO need a new infrastructure to drive this all. But it needs to be extra-governmental and above reproach. These things can be done, but if/when the government or their psychically/fiscally captive organizations (AMA, AAP, AAMC -- you name it) get involved, you can be sure that the results will be bad for both practitioners and patients.
I have been toiling in this vineyard for years and have spent years in DC trying to effect change. It cannot be done there. Some other way needs to be found or it is irremediable.
Great article, God bless you for writing it and standing tall and courageous and advocating for patients. But is the solution really government regulation? Isn't that the problem? The profound government corruption that has become increasingly out of control would have to be reversed, and what will trigger THAT change? I think the answer has to be found in letting market forces play a part. I confess I have no idea how that would work, medicine is complex and intelligent choices hard to make. Restoring freedom of speech would be a start.
I am a Stage 4 colorectal cancer survivor who has been restaged (likely cured) after 10+ years of no evidence of recurrence. My oncology protocol was what you might call 'gold standard' FOLFOX-6 with substantial tweaks, deviations and novel additions, including Avastin. Other more substantial deviations included an aggressive exercise regimen, improved diet, Celecoxib as an unorthodox maintenance regimen and alprazolam to reduce stress (and theoretically inflammation).
All of these modifications involving prescription drugs were very difficult to obtain insurance approval for, in particular Avastin. We fought for it anyway.
I remember reading the cost vs. benefit analysis on Avastin, and I remember the controversy - but my final takeaway was that the folks pushing the 'Affordable Care Act' at the time didn't want something expensive and low-impact draining the collective budget, and Avastin was front and center in that battle.
I like your general thesis about the profit motive 'corrupting' the survival data and studies and trials whose sole purpose is to consume a budget. I also appreciate that hospitals, insurance and drug companies are often the center of the industry distortions. However, government oversight creates its own opposite distortions, and perhaps not for the better.
I suppose my bigger observation would be that in spite of the financial incentives and failures of the regulatory regime, individual professionals working in research, working in the hospitals, working on publishing the studies, etc. often cannot help but identify or at minimum intuit genuine improvements in treatment, and those people invariably push their observations through to their peers.
The real tragedy in oncology are the insanely inexpensive variables that have enormous impact on outcomes: In particular exercise, diet, and the companion variable of fitness/obesity. By far the cheapest, easiest way to improve health outcomes (including almost all types of cancer) is to simply promote exercise and a well-balanced diet.
Fat-shaming costs nothing, but there's no financial incentive to do it. That should change.
Speaking of oaths, it occurred to me in the shower this morning that no doctor who takes his Hippocratic Oath seriously can practice any longer in California, now that all care must be in accordance with government pronouncements or else.
So hopefully there will be an exodus of principled medical professionals from that state. We could sure use a few here in Reno.
Dr. Prasad, I spent 25 years in pharma, with the final seven in hematology. I find your analysis uncomfortable and compelling. I wish management in industry were willing to reform themselves, but I became so disenchanted with my company that I retired.
I remember sitting through presentations on Melflufen and myeloma. The data presented made the drug sound terrific! And then, we find it is not terrific at all. Of course I was in no position to critique the data, not being a hematologist, but I am dispirited to see that none of the heme/oncs there found reason to question the data.
Keep up the good work. And thank you. My sister has a glioblastoma--and entered a clinical trial after being refractory to initial SOC treatment. She is (knock wood) in remission. I am beyond grateful that there are dedicated physicians out there seeking to make her life longer and better.
Poorly conducted RCTs, expensive drugs approved based on minor reductions in a composite of sketchy subjective outcomes, pushed on patients to “protect their hearts”.
No mortality benefit.
Now they even are conducting RCTs with toxic placebos . Look at Vascepa. It was studied against mineral oil which was later shown to essentially be a cardiovascular poison. The placebo increased all cardiovascular inflammatory markers, lpa, IL6, LDl,TG, etc.. in the control group! It translated into increase in plaques size in 18 months in the control group.
You could compare M&Ms against this placebo and would have seen better MACCE reduction.
Even after it was shown their placebo was not really inert, the study PI said he was not “concerned!”.
Evidence based medicine is dead. 21st century medicine is a joke!
The worst part is 99.9% of clinicians follow the narrative blindly and can not even recognize what is wrong!
As one of 6 women in my family diagnosed with breast cancer since 2003 and having survived both occurrences WITHOUT chemo/radiation therapy, I can say without hesitation that the cancer industry is completely fraudulent. I opted for surgery and other alternative healing modalities and am now 6 years clear.
My younger sister wasn't so lucky. You see, we had the same diagnosis with much the same profile though it wasn't determined to be genetic (we're ½ sisters). However, both times she was diagnosed she was coerced into doing the chemo/radiation by her employer who would deny her disability income with any other treatment. Fast forward to a year after our second diagnosis and she's dead. By her own estimation, she believed she would die from the conventional treatment. Oh, and she was 5 years younger and more fit than I was.
An older sister who was told had 'pre-cancerous' cells in her breast, and was pressured into doing chemo/radiation by her doctor. She is still on disability and barely able to function 18 years after her treatment.
My research into the cancer industry was a real reckoning for me. I was appalled at what I learned and the treatments that have been suppressed. Much like ivermectin and hydroxichloriquine are being suppressed today. Doctors and scientists have become parasites feeding on the misery of a sick population instead of doing what they're paid to do - encouraging a healthy lifestyle and ensuring laws are put in place to stop corporations from poisoning our water, air and soil.
Ever since my first diagnosis in 2012 I continue to do research and care for my body with nutrition, meditation, exercise, sleep, alkaline water, supplements, detoxing regimens and I feel better than ever at 63 years young. Only now, I grieve for my deceased mother and sister, older disabled sister and other women in my family who suffer from a disease caused by our toxic environment.
Today, corporations continue to poison all of us with impunity. We wouldn't need a cancer medical industry if governments held corporations responsible for the toxins they put in our environment. That is where we need to focus our tax dollars.
FDA approval means nothing more than “business deal made” it seems. When I still worked in healthcare an ID colleague and I were discussing the frustrations of profit driven patient “care” in the opiate biz; he said that it was just as bad in ID.
I do not know how we will escape the status quo / I used to discuss my disgust of prescriber experts and got skewered by a pain doc once for saying pain treatment was almost all $ driven; turns out that doc was quite well funded by ol John Kapoor’s corrupt pharma company…he just didn’t like being called out!
I thank God every day that the bulk of my personal difficult health needs are behind me, and I am grateful that I can still find real, caring folks to help me continue to stay as well as possible. If they are anything like I was, however, the bean counters are watching!
That being said I wouldn’t trust the government in any way to fix this. My solution was to leave healthcare and just pay it forward now to those who are attracted to the type of addiction recovery I know best; it costs them nothing and my spiritual bank balance overflows.
Thank you so much for your honesty and willingness to expose what truly is a travesty. I am not a doctor, but I have been well aware of the financial aspect, and benefits, of treatments. A year ago I was misdiagnosed with multiple myeloma. The good news is, I don’t have it. What was interesting to discover was that some of the newest meds (breakthroughs) were for the treatment of myeloma. I have a friend who is currently suffering from that disease. I hurt for any and everyone who doesn’t get the best possible treatment from their provider that is available. And I thank you for your willingness and courage to go up against your own industry. You are a hero.
Any solution, to be sustainable, has to involve patients - the ones who most directly suffer the consequences of this tragedy. Educating and empowering patients and their caregivers (books like 'Malignant') are a start, so patients can push back on ineffective treatments, advocate for better government oversight, and publicly call out bad products and bad journalism.
But it isn't simple, or easy. Patients need to be educated and empowered *before* they are at their most vulnerable, but at that point most people aren't interested. They need to have trustworthy sources of information - and be able to accurately assess the trustworthiness of sources - so they can resist the many financially-distorted sources of information they have today (including many "patient advocacy" groups). And more.
If anyone here is working on these challenges, let's connect!
Big subject. Heavy sigh. Government will not just step aside. We have to work with what we have, and the government has control over so much. I appreciate what you are doing and keep on.
Thank you so much for relentlessly continuing to speak up over these past few years. It is not a stretch to say that your writings and podcasts have been a lifeboat to me. BUT after all you have said here and elsewhere, it is a mystery to me how you can promote government as the solution. From what I have learned over the past few years, putting decisions in the hands of government control is not only frightening but the most potentially (and terrifying)harmful alternative. I don’t know the solution but please, no government regulations in the hands of politicians. Doctors need to become more empowered. Maybe somehow begin this from inside the profession? As broke as you say it is, it’s better than govt control.
Where is the "randomized-controlled trial" study showing that without capitalism, people become lazy and complacent?
This is a polemic talking point, not a fact. I usually think you're good at telling the two apart, this is a big fail and on this point, you're full of shit.
Before you can even start from this premise, you need to define your terms. Everything you spell out as problematic can be factually traced back to some factor of how capitalism works. Again, big fail.
Of course, you actually think Elon Musk is worth even paying attention to. Again, rationality fail.
Maybe you should keep to what you know rather than trying to become the next shitty Jordan Peterson?
Vinay, as a hematologist, I concur with everything you say EXCEPT your inevitable retreat to "the government will fix it". The government in one form or the other (FDA as you noted, perverse payment incentives of innumerable kinds, graft and grift at virtually every level) IS the problem. This is the ultimate case of asking the fox to guard the henhouse. You seem to understand all the pieces, yet retreat to a solution that is guaranteed not to work.
We DO need a new infrastructure to drive this all. But it needs to be extra-governmental and above reproach. These things can be done, but if/when the government or their psychically/fiscally captive organizations (AMA, AAP, AAMC -- you name it) get involved, you can be sure that the results will be bad for both practitioners and patients.
I have been toiling in this vineyard for years and have spent years in DC trying to effect change. It cannot be done there. Some other way needs to be found or it is irremediable.
Great article, God bless you for writing it and standing tall and courageous and advocating for patients. But is the solution really government regulation? Isn't that the problem? The profound government corruption that has become increasingly out of control would have to be reversed, and what will trigger THAT change? I think the answer has to be found in letting market forces play a part. I confess I have no idea how that would work, medicine is complex and intelligent choices hard to make. Restoring freedom of speech would be a start.
Vinay,
I am a Stage 4 colorectal cancer survivor who has been restaged (likely cured) after 10+ years of no evidence of recurrence. My oncology protocol was what you might call 'gold standard' FOLFOX-6 with substantial tweaks, deviations and novel additions, including Avastin. Other more substantial deviations included an aggressive exercise regimen, improved diet, Celecoxib as an unorthodox maintenance regimen and alprazolam to reduce stress (and theoretically inflammation).
All of these modifications involving prescription drugs were very difficult to obtain insurance approval for, in particular Avastin. We fought for it anyway.
I remember reading the cost vs. benefit analysis on Avastin, and I remember the controversy - but my final takeaway was that the folks pushing the 'Affordable Care Act' at the time didn't want something expensive and low-impact draining the collective budget, and Avastin was front and center in that battle.
I like your general thesis about the profit motive 'corrupting' the survival data and studies and trials whose sole purpose is to consume a budget. I also appreciate that hospitals, insurance and drug companies are often the center of the industry distortions. However, government oversight creates its own opposite distortions, and perhaps not for the better.
I suppose my bigger observation would be that in spite of the financial incentives and failures of the regulatory regime, individual professionals working in research, working in the hospitals, working on publishing the studies, etc. often cannot help but identify or at minimum intuit genuine improvements in treatment, and those people invariably push their observations through to their peers.
The real tragedy in oncology are the insanely inexpensive variables that have enormous impact on outcomes: In particular exercise, diet, and the companion variable of fitness/obesity. By far the cheapest, easiest way to improve health outcomes (including almost all types of cancer) is to simply promote exercise and a well-balanced diet.
Fat-shaming costs nothing, but there's no financial incentive to do it. That should change.
Speaking of oaths, it occurred to me in the shower this morning that no doctor who takes his Hippocratic Oath seriously can practice any longer in California, now that all care must be in accordance with government pronouncements or else.
So hopefully there will be an exodus of principled medical professionals from that state. We could sure use a few here in Reno.
Dr. Prasad, I spent 25 years in pharma, with the final seven in hematology. I find your analysis uncomfortable and compelling. I wish management in industry were willing to reform themselves, but I became so disenchanted with my company that I retired.
I remember sitting through presentations on Melflufen and myeloma. The data presented made the drug sound terrific! And then, we find it is not terrific at all. Of course I was in no position to critique the data, not being a hematologist, but I am dispirited to see that none of the heme/oncs there found reason to question the data.
Keep up the good work. And thank you. My sister has a glioblastoma--and entered a clinical trial after being refractory to initial SOC treatment. She is (knock wood) in remission. I am beyond grateful that there are dedicated physicians out there seeking to make her life longer and better.
Cardiology is not any better.
Poorly conducted RCTs, expensive drugs approved based on minor reductions in a composite of sketchy subjective outcomes, pushed on patients to “protect their hearts”.
No mortality benefit.
Now they even are conducting RCTs with toxic placebos . Look at Vascepa. It was studied against mineral oil which was later shown to essentially be a cardiovascular poison. The placebo increased all cardiovascular inflammatory markers, lpa, IL6, LDl,TG, etc.. in the control group! It translated into increase in plaques size in 18 months in the control group.
You could compare M&Ms against this placebo and would have seen better MACCE reduction.
Even after it was shown their placebo was not really inert, the study PI said he was not “concerned!”.
Evidence based medicine is dead. 21st century medicine is a joke!
The worst part is 99.9% of clinicians follow the narrative blindly and can not even recognize what is wrong!
As one of 6 women in my family diagnosed with breast cancer since 2003 and having survived both occurrences WITHOUT chemo/radiation therapy, I can say without hesitation that the cancer industry is completely fraudulent. I opted for surgery and other alternative healing modalities and am now 6 years clear.
My younger sister wasn't so lucky. You see, we had the same diagnosis with much the same profile though it wasn't determined to be genetic (we're ½ sisters). However, both times she was diagnosed she was coerced into doing the chemo/radiation by her employer who would deny her disability income with any other treatment. Fast forward to a year after our second diagnosis and she's dead. By her own estimation, she believed she would die from the conventional treatment. Oh, and she was 5 years younger and more fit than I was.
An older sister who was told had 'pre-cancerous' cells in her breast, and was pressured into doing chemo/radiation by her doctor. She is still on disability and barely able to function 18 years after her treatment.
My research into the cancer industry was a real reckoning for me. I was appalled at what I learned and the treatments that have been suppressed. Much like ivermectin and hydroxichloriquine are being suppressed today. Doctors and scientists have become parasites feeding on the misery of a sick population instead of doing what they're paid to do - encouraging a healthy lifestyle and ensuring laws are put in place to stop corporations from poisoning our water, air and soil.
Ever since my first diagnosis in 2012 I continue to do research and care for my body with nutrition, meditation, exercise, sleep, alkaline water, supplements, detoxing regimens and I feel better than ever at 63 years young. Only now, I grieve for my deceased mother and sister, older disabled sister and other women in my family who suffer from a disease caused by our toxic environment.
Today, corporations continue to poison all of us with impunity. We wouldn't need a cancer medical industry if governments held corporations responsible for the toxins they put in our environment. That is where we need to focus our tax dollars.
FDA approval means nothing more than “business deal made” it seems. When I still worked in healthcare an ID colleague and I were discussing the frustrations of profit driven patient “care” in the opiate biz; he said that it was just as bad in ID.
I do not know how we will escape the status quo / I used to discuss my disgust of prescriber experts and got skewered by a pain doc once for saying pain treatment was almost all $ driven; turns out that doc was quite well funded by ol John Kapoor’s corrupt pharma company…he just didn’t like being called out!
I thank God every day that the bulk of my personal difficult health needs are behind me, and I am grateful that I can still find real, caring folks to help me continue to stay as well as possible. If they are anything like I was, however, the bean counters are watching!
That being said I wouldn’t trust the government in any way to fix this. My solution was to leave healthcare and just pay it forward now to those who are attracted to the type of addiction recovery I know best; it costs them nothing and my spiritual bank balance overflows.
Thank you so much for your honesty and willingness to expose what truly is a travesty. I am not a doctor, but I have been well aware of the financial aspect, and benefits, of treatments. A year ago I was misdiagnosed with multiple myeloma. The good news is, I don’t have it. What was interesting to discover was that some of the newest meds (breakthroughs) were for the treatment of myeloma. I have a friend who is currently suffering from that disease. I hurt for any and everyone who doesn’t get the best possible treatment from their provider that is available. And I thank you for your willingness and courage to go up against your own industry. You are a hero.
Any solution, to be sustainable, has to involve patients - the ones who most directly suffer the consequences of this tragedy. Educating and empowering patients and their caregivers (books like 'Malignant') are a start, so patients can push back on ineffective treatments, advocate for better government oversight, and publicly call out bad products and bad journalism.
But it isn't simple, or easy. Patients need to be educated and empowered *before* they are at their most vulnerable, but at that point most people aren't interested. They need to have trustworthy sources of information - and be able to accurately assess the trustworthiness of sources - so they can resist the many financially-distorted sources of information they have today (including many "patient advocacy" groups). And more.
If anyone here is working on these challenges, let's connect!
Big subject. Heavy sigh. Government will not just step aside. We have to work with what we have, and the government has control over so much. I appreciate what you are doing and keep on.
You’re becoming the new Dr. Marcia Angell. Let’s hope you get more traction.
Thank you so much for relentlessly continuing to speak up over these past few years. It is not a stretch to say that your writings and podcasts have been a lifeboat to me. BUT after all you have said here and elsewhere, it is a mystery to me how you can promote government as the solution. From what I have learned over the past few years, putting decisions in the hands of government control is not only frightening but the most potentially (and terrifying)harmful alternative. I don’t know the solution but please, no government regulations in the hands of politicians. Doctors need to become more empowered. Maybe somehow begin this from inside the profession? As broke as you say it is, it’s better than govt control.
I seriously think that you should consider joining the dark side, Vinay, and become a Socialist - like me!
Where is the "randomized-controlled trial" study showing that without capitalism, people become lazy and complacent?
This is a polemic talking point, not a fact. I usually think you're good at telling the two apart, this is a big fail and on this point, you're full of shit.
Before you can even start from this premise, you need to define your terms. Everything you spell out as problematic can be factually traced back to some factor of how capitalism works. Again, big fail.
Of course, you actually think Elon Musk is worth even paying attention to. Again, rationality fail.
Maybe you should keep to what you know rather than trying to become the next shitty Jordan Peterson?