3rd question: I am interested in your opinion about whether or not the amount of money put towards a single Rx development by the Government (NIH) should impact the price the pharmaceutical charges the American people for that Rx. Perhaps it is too hard to calculate this since much of the NIH funding is early research in academic centers.
Can you comment on the FDA accelerated drug approval process, prices of drugs approved through this process, and the percent of those Rx that are later pulled from the market? Also what would be the impact of this program were Dr. Makary and the FDA to tell pharmaceuticals that any Rx approved early -- without concrete RCT evidence of benefit (and risk -- cannot be sold above a certain strict threshold. This would remove the economic incentive to brings suboptimal Rx to market prematurely but keep in place the opportunity of early tx of severe, life-threatening, or rare (orphan Rx) illnesses.
My question is partly inspired by Rudolph Virchow: “Medicine is a social science and politics nothing but medicine on a grand scale.” To put it another way, there are political causes of the social causes of disease. Poverty, pollution, and now climate change are about the biggest killers (from heart disease for example) now and into the future.
If Sensible Medicine and Vinay Prasad in particular venture into current medical and public health politics, which seems perfectly appropriate, why is the range of issues discussed so narrow? And mostly, it seems to me, congratulatory to Trump and his MAHA people? Shouldn’t discussion touch on as many political issues related to medical care and public health as possible when current presidential and congressional actions have life or death consequences for millions of people every year, far more than those badly affected by the Covid response and DEI/Wokism? What should people in the Trump administration be hearing from physicians interested in sensible medicine more broadly conceived?
Where I am coming from and why it led me to Sensible Medicine, Dr. Prasad's Substack, and these questions: I am a recently retired professor of political science at Yale University, author of Disorder: The History of Reform, Reaction, and Money in American Medicine (Yale University Press, 2021), honorably mentioned for a national Political Science book prize, and other things on health care, medical, and political history. See especially “The House of Medicine for Rent,” in MedScape https://www.medscape.com/viewarticle/970974?src=#vp_2 about the AMA and professional medical societies “on the take” to use the title of former NEJM editor Jerome Kassirer’s superb book on physician-pharma relations. My main concerns are the systemic causes of the failure to achieve quality, equality, and efficiency in health care.
I sent Dr. Prasad a much lengthier email with suggested political topics.
My question is for Dr. Prasad: Given the unique role that nurses occupy—both at the bedside and increasingly in research, advocacy, and policy—what specific actions do you envision oncology nurses taking to help implement or advocate for the solutions you propose to the myriad issues facing US cancer policy in your book Malignant? How can nursing best align itself with efforts to fix the systemic issues you've identified?
My question: I have patients with high asymptomatic VES burden (10-20%) and no signs of struktural heart disease. Do you know if there is a risk for increased arrhythmia burden when they fly? I'm thinking about pressure changes in the cabin for example. Is there a risk with other arrhythmias? Are there any studies done in the effects of flying and heart disease? Best regards!
My question would be this: have there been any situations at all, now or in the past, where you felt that the right care for a patient was either discouraged, hindered. or rendered impermissible by virtue of rules from your employer, the payer, or the government.
If you haven’t ever been in such a situation maybe the follow up is “how do you think you should act in this situations, should they arise?”
If you have been in such a situation , tell us honestly if you took action to protect the patient or if, in retrospect, you felt compelled to act in a way contrary to your ethics
Interested in all of your thoughts about the annual flu vaccine. Is the process to predict the season's strains still good? Should there be any changes in recommendations? Any further studies? Not asking about safety, just effectiveness.
I have read reports that the 2024-25 flu vaccine was not very effective. Basically more vaccinated people got the flu than unvaccinated ones. Any truth to that?
As a primary care nurse practitioner who is trying to stay up to date with the current evidence, what do you think is the most efficient way to learn? Currently I mostly read (books, articles, blogs, etc) and listen to podcasts, but I have thought about taking a shot at writing about topics, making social media content (stomach turns), or seeking out shadowing experiences with other providers. It feels challenging at times to keep up, any advice is appreciated. Thankful for your content!
In era of shared decision making, I think a table or chart of patient specific data (% of patients benefiting from therapy rather than population based data) to present to patients may help patients decide on merits of taking so many medications 💊 - i.e., GDMT for HF. Patients and many providers don’t seem to understand the medical statistics as it pertains to the individual patient. Despite patients buying lottery tickets or wearing a seatbelt, I suspect many may not opt for GDMT when presented with patient centric information.
OK, you asked so I'm going to be selfish. How do you usually address real changes/symptoms for very athletic patients after an ablation to address proximal AFIB? Post ablation I have experienced frequent arrhythmias (Frequent PACs & PVCs, frequent idioventricular rhythm) during/after exercising (cyclist, hello Dr. Mandrola, yes I have read your excellent book). I just ride E1-3 mostly efforts, I gave up racing. Technical mountain biking with it's short 15-30 seconds harder efforts are more likely to create these responses. I know these happen because I use a fourth frontier heart rate monitor (FF). Since my ablation in 2022 I have had 5 holter monitors, 4 were 10days each and 1 was 3 days. My concerns are always ignored because there is never any sign of AFIB. I am 67, still very active but someone I hire to review all my FF data tells me what he sees. He has a PHD in exercise physiology which had a stint working with cardiologists but when I mention both our concerns I get another holter and all is good. It's a viscous circle. I'm in Canada and leave it at that. cheers all.
Rigorous systematic reviews of the evidence repeatedly find low/very low certainty of benefit of medical interventions, i.e. puberty blockers, hormones and surgeries (no, these interventions have not been shown to be "lifesaving"), and the rate of adverse outcomes such as regret are also unmeasured, knowing for whom either, any, outcome might be likely is also unknown. Reproductive system harm is an expected outcome, especially with surgeries, but other associated harms are also observed but have not been yet studied in detail.
It is also unknown whether transgender identification/gender dysphoria will continue into the future for any given person (and for how long). Evidence as to when psychological support is likely to be beneficial is also low certainty (but first line in many countries now basing their approaches on systematic reviews of the evidence, as it is a treatment for distress and has much less risk than medical intervention--again, medical intervention has not been shown to reduce suicide risk).
The AAP policy recommending minors get these medical interventions disagrees with its own references (Cantor, 2020, McDeavitt, 2025-- https://link.springer.com/article/10.1007/s10508-025-03106-5), those of the Endocrine Society make strong recommendations based upon low and very low certainty evidence, with no justification, and those of WPATH involved commissioning systematic reviews and then interfering with them (see the Block 2024 BMJ article: Dispute arises over World Professional Association for Transgender Health’s involvement in WHO’s trans health guideline and also Block's 2023 paper: Gender dysphoria in young people is rising—and so is professional disagreement), other guidelines for minors rely on the earlier WPATH ones and those of the ES: "Although it is not uncommon to adopt an expert consensus-based approach when evidence is limited, it is less common for guideline developers to draw so heavily on other guidelines. This relationship may explain why there has until recently been an apparent consensus on key areas of practice for which evidence remains lacking. " (https://adc.bmj.com/content/109/Suppl_2/s65)
The careful analyses you all do for studies here on this blog--the shortcomings are much less subtle in the individual papers in the field of gender medicine. Many inconclusive studies have nonetheless been touted by news agencies and even other articles citing them as showing benefit (follow-up time of a few years when long term outcomes such as regret take 5-10 years to manifest, huge loss to follow up, non-representative populations, confounders...). Incorrect or unsupported conclusions are then quoted repeatedly, leading to a wholly unreliable body of literature in this field.
A lower bound on the the numbers of minors started on these drugs was found by Reuters: over 14,000 started in a 5 year period (2017-2021) https://www.reuters.com/investigates/section/youth-in-transition/ --surgeries include minors as young as 12, minors are also receiving genital surgeries.
Even though, again, the condition is not well understood, the prognosis is not understood, many young people do grow out of their gender distress without medical treatment, in fact, and the medical intervention outcomes are not understood. About 10,000 adults were getting gender surgeries a year as of 2020 (Wright et al., 2023), the largest fraction were those 19-30, again, perhaps not fully mature adults are dominating.
Could you comment on the best ways to get rid of Covid Debacle Resentment (CDR). I'm a classically-trained biologist/teacher/Biopharma executive (ret) who yelled and screamed at the nonsense peddled by the established experts since December 2019 - 2024 without ever being heard. I lost a revered teacher/mentor to Covid in 2020 followed by my wife to "covid-neglect" in 2020. I am that person who others should never broach the topic of covid responses by the health departments, NIH, CDC, etc., in my presence because I will take no prisoners while destroying their views.
Do you think that the NIH should mandate the release of results of any study the NIH has funded in full or in part so that 1) Negative studies are not suppressed, 2) Other researchers can review the data? Can you answer the question in relation to the following completed but unpublished study: https://www.researchprotocols.org/2019/7/e14434/PDF
3rd question: I am interested in your opinion about whether or not the amount of money put towards a single Rx development by the Government (NIH) should impact the price the pharmaceutical charges the American people for that Rx. Perhaps it is too hard to calculate this since much of the NIH funding is early research in academic centers.
Can you comment on the FDA accelerated drug approval process, prices of drugs approved through this process, and the percent of those Rx that are later pulled from the market? Also what would be the impact of this program were Dr. Makary and the FDA to tell pharmaceuticals that any Rx approved early -- without concrete RCT evidence of benefit (and risk -- cannot be sold above a certain strict threshold. This would remove the economic incentive to brings suboptimal Rx to market prematurely but keep in place the opportunity of early tx of severe, life-threatening, or rare (orphan Rx) illnesses.
My question is partly inspired by Rudolph Virchow: “Medicine is a social science and politics nothing but medicine on a grand scale.” To put it another way, there are political causes of the social causes of disease. Poverty, pollution, and now climate change are about the biggest killers (from heart disease for example) now and into the future.
If Sensible Medicine and Vinay Prasad in particular venture into current medical and public health politics, which seems perfectly appropriate, why is the range of issues discussed so narrow? And mostly, it seems to me, congratulatory to Trump and his MAHA people? Shouldn’t discussion touch on as many political issues related to medical care and public health as possible when current presidential and congressional actions have life or death consequences for millions of people every year, far more than those badly affected by the Covid response and DEI/Wokism? What should people in the Trump administration be hearing from physicians interested in sensible medicine more broadly conceived?
Where I am coming from and why it led me to Sensible Medicine, Dr. Prasad's Substack, and these questions: I am a recently retired professor of political science at Yale University, author of Disorder: The History of Reform, Reaction, and Money in American Medicine (Yale University Press, 2021), honorably mentioned for a national Political Science book prize, and other things on health care, medical, and political history. See especially “The House of Medicine for Rent,” in MedScape https://www.medscape.com/viewarticle/970974?src=#vp_2 about the AMA and professional medical societies “on the take” to use the title of former NEJM editor Jerome Kassirer’s superb book on physician-pharma relations. My main concerns are the systemic causes of the failure to achieve quality, equality, and efficiency in health care.
I sent Dr. Prasad a much lengthier email with suggested political topics.
My question is for Dr. Prasad: Given the unique role that nurses occupy—both at the bedside and increasingly in research, advocacy, and policy—what specific actions do you envision oncology nurses taking to help implement or advocate for the solutions you propose to the myriad issues facing US cancer policy in your book Malignant? How can nursing best align itself with efforts to fix the systemic issues you've identified?
My question: I have patients with high asymptomatic VES burden (10-20%) and no signs of struktural heart disease. Do you know if there is a risk for increased arrhythmia burden when they fly? I'm thinking about pressure changes in the cabin for example. Is there a risk with other arrhythmias? Are there any studies done in the effects of flying and heart disease? Best regards!
Carlos Valladares
Linköping, Sweden
My question would be this: have there been any situations at all, now or in the past, where you felt that the right care for a patient was either discouraged, hindered. or rendered impermissible by virtue of rules from your employer, the payer, or the government.
If you haven’t ever been in such a situation maybe the follow up is “how do you think you should act in this situations, should they arise?”
If you have been in such a situation , tell us honestly if you took action to protect the patient or if, in retrospect, you felt compelled to act in a way contrary to your ethics
Interested in all of your thoughts about the annual flu vaccine. Is the process to predict the season's strains still good? Should there be any changes in recommendations? Any further studies? Not asking about safety, just effectiveness.
I have read reports that the 2024-25 flu vaccine was not very effective. Basically more vaccinated people got the flu than unvaccinated ones. Any truth to that?
As a primary care nurse practitioner who is trying to stay up to date with the current evidence, what do you think is the most efficient way to learn? Currently I mostly read (books, articles, blogs, etc) and listen to podcasts, but I have thought about taking a shot at writing about topics, making social media content (stomach turns), or seeking out shadowing experiences with other providers. It feels challenging at times to keep up, any advice is appreciated. Thankful for your content!
In era of shared decision making, I think a table or chart of patient specific data (% of patients benefiting from therapy rather than population based data) to present to patients may help patients decide on merits of taking so many medications 💊 - i.e., GDMT for HF. Patients and many providers don’t seem to understand the medical statistics as it pertains to the individual patient. Despite patients buying lottery tickets or wearing a seatbelt, I suspect many may not opt for GDMT when presented with patient centric information.
GDMT for HF. Yes, this!
OK, you asked so I'm going to be selfish. How do you usually address real changes/symptoms for very athletic patients after an ablation to address proximal AFIB? Post ablation I have experienced frequent arrhythmias (Frequent PACs & PVCs, frequent idioventricular rhythm) during/after exercising (cyclist, hello Dr. Mandrola, yes I have read your excellent book). I just ride E1-3 mostly efforts, I gave up racing. Technical mountain biking with it's short 15-30 seconds harder efforts are more likely to create these responses. I know these happen because I use a fourth frontier heart rate monitor (FF). Since my ablation in 2022 I have had 5 holter monitors, 4 were 10days each and 1 was 3 days. My concerns are always ignored because there is never any sign of AFIB. I am 67, still very active but someone I hire to review all my FF data tells me what he sees. He has a PHD in exercise physiology which had a stint working with cardiologists but when I mention both our concerns I get another holter and all is good. It's a viscous circle. I'm in Canada and leave it at that. cheers all.
Could you please look at gender medicine?
Rigorous systematic reviews of the evidence repeatedly find low/very low certainty of benefit of medical interventions, i.e. puberty blockers, hormones and surgeries (no, these interventions have not been shown to be "lifesaving"), and the rate of adverse outcomes such as regret are also unmeasured, knowing for whom either, any, outcome might be likely is also unknown. Reproductive system harm is an expected outcome, especially with surgeries, but other associated harms are also observed but have not been yet studied in detail.
It is also unknown whether transgender identification/gender dysphoria will continue into the future for any given person (and for how long). Evidence as to when psychological support is likely to be beneficial is also low certainty (but first line in many countries now basing their approaches on systematic reviews of the evidence, as it is a treatment for distress and has much less risk than medical intervention--again, medical intervention has not been shown to reduce suicide risk).
The AAP policy recommending minors get these medical interventions disagrees with its own references (Cantor, 2020, McDeavitt, 2025-- https://link.springer.com/article/10.1007/s10508-025-03106-5), those of the Endocrine Society make strong recommendations based upon low and very low certainty evidence, with no justification, and those of WPATH involved commissioning systematic reviews and then interfering with them (see the Block 2024 BMJ article: Dispute arises over World Professional Association for Transgender Health’s involvement in WHO’s trans health guideline and also Block's 2023 paper: Gender dysphoria in young people is rising—and so is professional disagreement), other guidelines for minors rely on the earlier WPATH ones and those of the ES: "Although it is not uncommon to adopt an expert consensus-based approach when evidence is limited, it is less common for guideline developers to draw so heavily on other guidelines. This relationship may explain why there has until recently been an apparent consensus on key areas of practice for which evidence remains lacking. " (https://adc.bmj.com/content/109/Suppl_2/s65)
The careful analyses you all do for studies here on this blog--the shortcomings are much less subtle in the individual papers in the field of gender medicine. Many inconclusive studies have nonetheless been touted by news agencies and even other articles citing them as showing benefit (follow-up time of a few years when long term outcomes such as regret take 5-10 years to manifest, huge loss to follow up, non-representative populations, confounders...). Incorrect or unsupported conclusions are then quoted repeatedly, leading to a wholly unreliable body of literature in this field.
Some of the unreliable studies are described in recent Jesse Singal NYT article: https://www.nytimes.com/2025/03/27/opinion/trump-transgender-youth-research.html --difficulties in getting corrections is described by Sapir in a recent essay about the NEJM in city journal as well: https://www.city-journal.org/article/new-england-journal-of-medicine-transgender-activists .
A lower bound on the the numbers of minors started on these drugs was found by Reuters: over 14,000 started in a 5 year period (2017-2021) https://www.reuters.com/investigates/section/youth-in-transition/ --surgeries include minors as young as 12, minors are also receiving genital surgeries.
Even though, again, the condition is not well understood, the prognosis is not understood, many young people do grow out of their gender distress without medical treatment, in fact, and the medical intervention outcomes are not understood. About 10,000 adults were getting gender surgeries a year as of 2020 (Wright et al., 2023), the largest fraction were those 19-30, again, perhaps not fully mature adults are dominating.
It would be great if you looked into this field!
Thank you either way!
Would you consider an in-person Sensible Med event with CME?
Could you comment on the best ways to get rid of Covid Debacle Resentment (CDR). I'm a classically-trained biologist/teacher/Biopharma executive (ret) who yelled and screamed at the nonsense peddled by the established experts since December 2019 - 2024 without ever being heard. I lost a revered teacher/mentor to Covid in 2020 followed by my wife to "covid-neglect" in 2020. I am that person who others should never broach the topic of covid responses by the health departments, NIH, CDC, etc., in my presence because I will take no prisoners while destroying their views.
Do you think that the NIH should mandate the release of results of any study the NIH has funded in full or in part so that 1) Negative studies are not suppressed, 2) Other researchers can review the data? Can you answer the question in relation to the following completed but unpublished study: https://www.researchprotocols.org/2019/7/e14434/PDF
Vertical integration creates a lot of conflicts of interest. No one seems to be looking at the distributors re Vertical integration. Take a look here: https://www.drugchannels.net/2025/02/vertical-integration-redux-how.html The big 3 distributors have significant vertical integration including into the physician world, particularly in Oncology, Optho and GI where the drugs can be pricey. The distributors already have specialty pharmacies, retail pharmacies, drug manufacturersI n the case of mckesson a joint venture with HCA’s Sarah Cannon Research Institute, McKesson's ownership of US oncology ( 2500 providers) and florida cancer specialists (500+ providers) McKesson also owns 'cover my meds', which the big 3 PBM 'prefer' for managing their prior auth requests. https://x.com/mass_marion/status/1898744931922894868 Additionally McKesson has some type of merger with Change HC, the clearing house whose hack last year exposed alot of sensitive medical info on the dark web. https://www.healthcarefinancenews.com/news/mckesson-change-healthcare-form-new-healthcare-it-company#:~:text=Deal%20seen%20as%20a%20way,to%20rebrand%20as%20Change%20Healthcare%5D
Thats a lot of vertical integration. How do we have trusting medical relationships with patients given these COI?