The Truth About Randomized Controlled Trials in Cancer Medicine | Ethical vs Unethical Studies

[@milesteghades]

Thank you for explaining how flawed the current system is and the race to the bottom that is now present everywhere in our society. The tone in this video has changed, I can see it's affecting you as it's affecting all of us. Thank you for fighting for a ethical and sound science.

[@sigrid3553]

I agree wholeheartedly 👍

[@michaelhuber8638]

You are a courageous man. Take care and don't loose your sunny heart. Stay free.

[@thewellfedhuman3043]

I initially found you Dr. Prasad because I am a heme onc/BMT RN who had been struggling with participating in RCT as a nurse. While I understand that advancements come from new therapies which need to be studied, I began feeling very conflicted about the ethics of how studies are presented to patients and families. It should be obvious that the bar of the FDA is indeed on the floor.

[@jfdomega7938]

On the floor, in the basement!!!

[@MariaSilva-xz6yg]

"COVID-19 policy reveals the selfishness of adults, the indifference to kids, and the hypocrisy of medicine. It's disgusting to witness and history will judge it poorly" - Vinay Prasad, Brownstone.... You are a good and kind soul. This world is not made for good and kind souls, I bet that sometimes you feel like giving up, because it only brings suffering and harm, even so you never give up, first because you don't know how to be otherwise, second because other good and kind souls need you...

[@DataGeek903]

Because good and kind souls don't try and impose their will on others. The irony is the system is setup so those with psychopathic bents are most likely to rise to the top. The les the u care about people the further up the political ladder you're willing to go.

[@nicholashaynes3483]

I've always wondered about the ethics of the placebo group - interesting to hear your explanation. I've said it before and I'll say it again - as an incoming med student your vids are invaluable. Thank you for this.

[@pointshealthcoaching8474]

VP thinks and exists " outside the box" - thank you for standing up and 🔊

[@Edward-my9nk]

The Lumpectomy study and Bernard Fisher "datagate" scandal of NSABP circa 85-89 is telling for current issues especially surrounding politics and science and rhetoric

[@Edward-my9nk]

@Alethea Wieland Wow! You had front row seat!!! Thank you for sharing that info! Have you read “Scientific Characters, Rhetoric and Trust in Cancer Research, by Lisa Keranen- it gives a chapter and verse account of the controversy! From first breaking story in the chicago tribune march 13, 1994, and i don’t need to tell you it snowballs from there-nearly, and unjustly, flattening Dr Fisher! all the characters involved, Betty Ford, Senator Dingell’s relentless hammering of Fisher! Its all there! Biblical! But like you attest, Fisher abides! Redeemed! he challenged and defeated Halsted, and thereby benefitted mankind! Incredible story!

[@janellemiller1195]

Well done. I love to hear your views on this. I was once enrolled in a random controlled study about pre surgical use of antibiotics and UTI after surgery for a weak pelvic floor.

[@JaneDoe-vi5yc]

I really like listening to you. It's easy and saves me so much time. I liken it to this: why should I stock bone broth in my pantry just in case I need it when I can just drive 1/2 mile to the grocery store and buy it? This way I can clog up my pantry with the things I use much more often. The grocery store thus is my extended pantry. Your brain, Dr. Vinay, is my extended pantry. I go to you to learn things that I currently have no room for in my brain because of all the other things I'm dealing with. I hope this makes sense. Thank you for doing all the research and thinking and analysis that I just don't have time to do right now!

[@Asptuber]

Great metaphor! I too think of VP as an extended "brain pantry"!

[@danielmccarthyy]

It would be great if VP would do a similar video on statins, but UCSF makes far too much money from statin "research", and the video would totally discredit some "famous:" faculty.

[@Edward-my9nk]

Yea. Do a video on the hysterical covid propaganda vomited from blowhard UCSF,s Uncle Bob "windbag" Wacther and that pretender Monica Gandhi-'both should be kicked to the curb, if not jailed

[@sigrid3553]

I agree! Hope he will!! 🙏

[@californiasun162]

Excellent info Vinay you are the type of person that’s well-educated knowledgeable tells the truth has integrity say the way it is and very well respected 💕👍

[@sigrid3553]

I agree so much 👍👍👍

[@garyteters7273]

Thanks Dr Prasad

[@jannz1942]

I advocate the unofficial trial for those who chose to not vax... instead keep vit D & C high... use povidone Iodine nasal wash... melatonin... NAC... healthy lifestyle...and ( gasp ) Ivermectin. ( human version )... VS vaxed where none of nutruceauticals and lifestyle are required nor measured. Same endpoint: Mild case and no hospitalization.

[@danielsharon524]

I'm an n=1 "study." Not vaxxed & haven't had Covid. High level of vit. D (w/K). Daily zinc + qucertin. I actually think I had Covid (both kids did & I had 30 hrs. of otherwise unexplained chills) & beat it before getting full-blown disease.

[@Joy31608]

We NEED ethical but we have GREED instead!

[@JJ-hg5ho]

Thank you

[@oldschool8292]

Saw your name referenced in a comment, watched this video, found a little hope and subscribed. Thank you.

[@Asptuber]

Not *that* tough for a lay audience that has been watching/listening to you for a year or more 🙂 This was like a long summary of bits and pieces from Plenary Session. As a European what I would love for Vinay Prasad to do is dive into how EMA licenses cancer drugs, and even more important how payer-systems decide what will in the arsenal of standard of care (at least Britain's NICE should be easily accessible, maybe other countries also put out something in English?). What are the policy arguments, how do these entities weigh the different endpoints? Is PFS as powerful a result in Europe as it seems to be in the US? Are there reasoned arguments around QoL vs length of survival? Probably quite a few more questions to look into - I can't come up with them all, but I'm sure Prasad (and/or his students) could!

[@kimfleury]

Yes this is advanced knowledge, but I think your examples gave me the gist of your main point: If we have a treatment protocol that's had some success, and we want to increase success (increased longevity with no deterioration of quality of life), then that's the treatment that new treatments *must* be compared to. The example I'd think of is giving ordinary aspirin to someone who's actively having a heart attack. A pharma company comes up with a formulation that might work better than aspirin, and the revenue stream department hopes to get it prescribed to everyone who's at risk, to keep it on hand, like that drug that current heart patients keep on hand if they've had a history of heart attack -- nitroglycerin? I'm blanking on the name of that drug, but I've known a number of people who had to keep it with them wherever they went. But in my example, the new drug is intended for people who haven't had a history of heart attack but are considered at risk. That's almost everyone. We're all advised to keep aspirin on hand just in case, even 30 year olds. So this pharma company wants to get into every home like aspirin, on the promise that their drug will be more successful than aspirin. It will naturally cost more than aspirin, and will generate revenue far into the future, at least until the patent runs out. So they set up their randomized control trial, but instead of giving aspirin at the early signs of heart attack, they give placebo, and compare that to the new drug. That gives their new formulation a huge advantage, potentially making it look awesome, even if it's not as effective as aspirin.

[@sigrid3553]

Thank you dear Dr Prasad- for this excellent video! I admire your courage and your compassion for the truth! You reveal so much important things, and this one especially! I agree 100% in what you conclude. Keep on 😇😇😇

[@claytonslade2366]

If I get a cancer diagnosis, I'm going to email you for a second opinion on my recommended treatment.

[@ValerianTheBarbarian]

Unfortunately I can't watch this right at the minute. I can't wait to finish it. I am in the middle of reading Malignant and have been flabbergasted. I'm keen to do some comparative research between the USA and Australia.

[@thebarkingstoic7702]

Thank you for another informative and thoughtful presentation.

[@SymphonicEllen]

the whole "we don't have time for randomized trials...." that was what they were saying about a few things. That's why Dr. Kory was upset. His workplace griped at him for talking to the media, but he wasn't talking to a pundit like on their nightly show. It looked like a senate hearing, and cameras just happened to be there cause well, it's congress. They were always there tryin to get "gotcha" stuff on several people. I do agree with you overall, it's just, I feel like we're missing stuff outside what I'd expect to not be there. Maybe you could call or zoom with him? Omg, I am exactly the same way with coffee. I even have a T shirt that says "sorry for what I said before coffee" hehe :) I love and appreciate you so much.

[@ricardoafonso9626]

Long story short when my father in law had prostate cancer we treated it at home end of story…pretty cheap too. All he had to do was going back to being healthy and puff cancer was gone!!

[@sigrid3553]

Wow, great to hear! What exactly do you mean by being healthy? Vitamins, a special diet? I am just curious 😊

[@ricardoafonso9626]

@Aaron 8.3 PSA within 6 months his PSA was at 3 and although I understand PSA is not the best measurement for prostate cancer the doctor told him he was cancer free so for us that was a win.

[@ricardoafonso9626]

@@sigrid3553 look for the truth about cancer doco-series on KZbin that’s where I found all the info protocols etc KZbin is not letting me post the link here. A great book to read is radical remission tells you lots of stories of how people healed their cancer naturally many after trying the “normal” chemical medical route

[@sigrid3553]

@@ricardoafonso9626 Thank you so much! I will check it out

[@ricardoafonso9626]

@Aaron doctor suggested to do radiation glad we didn’t

[@suemiller294]

Mrs. Prasad would be proud that you wouldn’t enrol her… like your style of decision making 🥰

[@BigDawgCAM]

Fresh cut!

[@Carolleemakesthings]

I WOULD like a randomized control study on brushing and flossing my teeth. It’s a lot of work for nothing if it actually doesn’t work too well. 🙃

[@Popitet]

Indeed. RCTs are not the only valid source of evidence for an intervention being causal for specific outcomes.

[@alaron5698]

Personally, I'd be surprised if it had no effect. I've seen the older generation that didn't do these things, and their teeth had all fallen out. Now, everyone brushes and everyone has good teeth. That removing material from stuck places with floss helps should also be obvious, though it is not as obvious that it has benefit when the food you ate doesn't really stick. As a personal anecdote, I have a friend who had not been to the dentist in over 20 years. I believe it was either 23 or 27 years, and I'm leaning towards 27. He finally went to the dentist, and he had one small hole and one starting hole. He brushes his teeth 4 times a day. You likely don't have to floss after every meal, but after something that lodges between the teeth it seems advisable. As for brushing, I wouldn't drop that. That said, I personally have always brushed once a day, and I don't have many problems. But still more than my 4-times-a-day friend.

[@ElijahHunter77]

I first read RCT and thought it was Racial Critical Theory

[@mballer]

That's CRT.

[@ElijahHunter77]

@@mballer yah, yah, I got that too 😂😂 I'm just sayin' those abbreviations 😂😂 I always spell out

[@mballer]

@@ElijahHunter77 Yep, CRT has always meant Cathode Ray Tube to me.

[@matthewatwood207]

👍 would love to see this channel take on antidepressant trials.

[@runderwo]

What's the downside to putting everyone with metastatic cancer on doxycycline, a cheap, well-understood and widely-available drug with all the existing signals pointing in the direction of "may help and no harm"?

[@63striker]

Not profitable enough for some

[@huebnema1]

22:45 hits the nail on the fucking head 🙌🙌🙌 PREACH

[@claytonslade2366]

Sorry to sound like a first year student with the question but: I thought the point of recruiting healthy individuals in most trials was to reduce the chance of confounding factors skewing the results. Is that not the case?

[@WayneOldford]

To avoid confounding, the important thing is that the two arms are balanced, and that is the role of randomization. You can block (ensure balance of known confounders) and randomize (to balance unknown confounders with high probability) Why you want a greater variety of people in the study is to ensure that its results are applicable to the population. An exaggerated example would be to restrict studies to only males; its results might not apply to females. So restricting to healthy individuals raises the question of whether the results apply to those who are not healthy.

[@atemperedsoul6428]

@@WayneOldford and we can (usually should) always stratify data to emphasize confounding where it exists and doesn’t exist so long as we present the raw data so others can check our work. Additionally, it’s impossible to know what might confound the results of a novel therapeutic intervention, so we should collect as much data as possible (including recruiting less healthy participants).

[@claytonslade2366]

@@WayneOldford Thanks. So it would seem that focusing on healthy subjects is an "easier/cheaper" way to balance, even though not ideal.

[@Asptuber]

Maybe. But if 80% of cancer patients who could possible benefit from the drug your are testing are NOT healthy individuals (which is often the case), what you have done is you have tested how well your drug works for 20% of the cases. And especially if there is significant side effects or toxicity involved the end result if the drug ends up favoured as a standard could be quite tragic. Let's say you want to try a new drug or new combination for one of the nastier cancers, bile duct or pancreas or something like that. (Median survival is in hundreds of days.) You choose the healthiest patients for your study, and show that with this new drug your survival goes up a whopping four or six months. And very few have to stop treatment because of adverse effects. Wow! Now you take this wonder protocol and bring it to typical patients, to everyone: Instead of 5% not tolerating the treatment, 65% can't handle it (and some fraction of those actually die earlier because of the treatment). Of the 35% that are left about half match your study population and gain the advantage, and about half gain some, but for this group it is very hard to say how those extra 2-4 months of life compare when you adjust for quality of life... So in the cases where we are talking about some treatment or intervention that is targeted to a patient population that is not typically healthy it makes no sense to recruit only the healthiest of the target population.

[@danielsharon524]

A few books ahead of it but looking forward to reading "Malignant"

[@ellisreppo9651]

Check out some of Michael Crichton's speeches, particularly the Caltech Michelin Lecture, to see how long and how science has been coopted by politics.

[@alexanderren1097]

Good sir, YOU should be director of the FDA

[@tonyanthony3093]

Interesting video. I'd like to know what do you think of the CAMILLA: Cabozantinib + durvalumab results in CRC ?

[@Joy31608]

🤣😂🤣Righteous indignation and outrage is so refreshing given all the 🐂💩since CV19 appeared! ❤️❤️❤️you

[@atemperedsoul6428]

It’s not righteous indignation when almost every premed undergrad has to take a methodology course that explains why the gold-standard (even if only proven and not necessarily established - how else do we establish proven gold-standards?) must replace placebo if it exists.

[@Gumby1978]

How can our personal physician make claims that it is safe and effective without a double blind study. This undermines my relationship with my Doctor. Do they know and don’t care or have they “drank the koolaid”?

[@sigrid3553]

Good question 😇

[@gastronomist]

Doubling the dose of a placebo sounds dangerous. They should start with something smaller like 25%.

[@organicfrugalgardening8794]

If the bar for establishing the current standard of care is so low, is it really unethical to give a placebo as control? Otherwise, how could we verify the evidence for the standard?

[@Joy31608]

There should NEVER be an UNETHICAL clinical trial 😡🤯🤬

[@ezekielbrockmann114]

What you say about placebos is dubious. Lobotomies were proven to increase positive outcomes. However, if given the choice between a 100% guaranteed chance of lobotomy or a 50% chance of receiving a placebo, I think a researcher would quickly see a pool of willing candidates form from which to draw samples. edit: Your point stands though, about how the experiment shouldn't be predicted to yield worse outcomes for participants, of course. On the in other hand, sometimes you gotta break a few eggs...

[@derekbaker3768]

Wait...Did you say medical studies are to increase market share first, THEN to increase health. NO WAY!! (I dont know to leave a sarcastic emoji)

[@mballer]

Your audio is low.

[@excrementicranium6863]

The audio was perfectly fine for me.

[@mballer]

@@excrementicranium6863 I'm happy for you.

[@mballer]

@@excrementicranium6863 Actually I think he is missing the higher frequencies and has more bass which gives less clarity to the speech.

[@lizkeith1356]

i want a vaxxed vs unvaxxed study and don't tell me it's unethical. the unvaxxed appear to be much healthier...

[@maegary8107]

We are, That's why those who have taken the vaccine are spending so much time in. A doctors office.

[@Sunlightsam24]

Why has there been an explosion of cancer, Alzheimer and autism. It is NOT that we can diagnoses those better now…vaccines and prescription meds and obesity (poor diet). Those are my guesses.

[@sgeorg80]

👍

[@rachelgee7894]

I don't have to be a biologist to know what a woman is 😂

[@Madasin_Paine]

Is this public health research MD paid by the words and minutes because he's underperforming where it counts? Does he know who is audience even is?? Is he talking to himself for therapy as if on the couch or doing drama therapy? If so say so but don't act like a public advocate getting the "rest of the story" out like a watch dog. Is it still true, that only a a tiny number of different cancers respond well enough to treatment to justify the toll of standard allopathic intervention -its costs, its inconvenience, risks and likelihood of rate limiting adverse and side effects, that may be permanent, disabling, including vital organs, the immune system, neurophysiology, and new tumor generation, requiring ICU care and all the harms that entails in itself, and treatment or worse for the same cancer or the new cancers or the disability of the original series of intervention. Recall what a horrific disfiguring course Roger Ebert had. When it was too late, he, like too many, and their loved ones would not do it if they knew what was to happen. What is the 5 year and 10 year or longer quality of life and survival studies showing and what quality is the evidence, A, B,C... How likely would those treated would have been still alright with the tumor 5 or 10 years later had they skipped that treatment? Who really gives two cents what pHarma or the FDA or the oncology field is using as a benchmark to line their fat pockets and prolong their bureaucracy? We know what huge control frauds, disappointments, over selling, unapproved, over promising on benefits and underplaying consequences and costs, statins, cardiac stents, hernia patches, inserted birth control devices, SSRI, antipsychotic, opiates, vaqs, novel gmo rna chemotherapy, et al mislabeled as vaqs all have and continue to have. Is it really worth mortgage on the house and wiping out savings on the oldest old or someone with multiple chronic diseases or slow growing cancers that may turn out to go away on their own, or despite a bunch of costly time consuming tests of questionable accuracy, knocking out the immune system with poly pharmaceutical chemotherapy, less proven risky very costly novel bio therapeutics, radiation, gama knifes and whatever cutting edge trials they need human to experiment on. You will be shocked how many trainwrecks in the last year if their life undergo the whole 9 yards to treat a cancer, it makes them miserable if not fatal, they die a mess in the hospital the family's last memory is a shared tragedy, when instead hospice or home care would have been more dignified and possibly the actual desire of the patient Doesn't know who is audience is. And you'll be as shocked how the oncologist pushes it despite the internal medicine doctor in charge wasn't on board but gives in. What unique incentives are there for private oncologists? ARE kickbacks ever involved? Can they bypass the pharmacy and get the chemo drugs directly and profit?? Pedantic. If our earnest host is paid by the word and by the clock he's on track if he us paid by the usefulness if his words one should pass or maybe listen on. If you average person in the audience thinks they may have a malignant tumor or a benign one but is on the fence about the standard cancer treatment vs alternative or being watchf abd radically changing lifestyle, eg, along the lines if his UCSF colleagues, Dr Ornish'$ $pectrum diet lifestyle program shown to reverse prostate cancer, or maybe a combo.

[@Madasin_Paine]

If this Doc wants to break new ground in his field, then explain why its all about finding a nebulous cancer cure racket and hardly anything by expense, publicity or results about what's causing cancer, especially secondary to intoxication pollution the MIC but also our degrading air food beverage water soil conditions. We see now a top 3 or 10 place reason for premature death is air pollution, depending if doesn't abuse tobacco and sugar. What is the legacy of 2000 ever more dirty destructive nuclear tests led by far in the U$ on cancer? How about the long LONG list of devastating underplayed under reported under counted deaths and deaths to be from nuke catastrophes, from Hunter's Point, Simi Valley Rocketdyne, 3 Mile Island Chernobyl, Washington State and all those other superfund toxic sites of nukes and nuke waste, and constant tritium release from nuke power plants and handling of nuke lab waste and radiopharmaceuticals?? Billions of pounds of biocides are used to grow food and food animals, satiated with partially treated water from human waste water facilities and natural gas fracking produced water, and biosludge and animal waste lakes near CAFO.$ We know pharmaceutical and heavy metals may remain in that effluent as well as bottles water as well as piped in and especially well water. All those tens of thousands of chemicals thanks to the American Chemistry Council and Western States Petroleum and the other big oil lobbies like API, AEI, US Chamber of Commerce and the Business Roundtable. We know they got the judges EPA FDA USDA Bureau of Land Management etc in their back pocket and revolving doors of their extremely lucrative impunious iron triangles. We know the boards of medicine and specialty accreditation and hospital accreditation are similarly underperform on behalf of patients and providers. Nano products galore. BPH PFOA and all their less proven and as harmful analogues lining most all moist food and beverage containers except glass. Dangerous cosmetics sun screens. Secret formulas with inadequate MSDS that even leave first responders in the dark and dying and suffering from them. Where is the race for the cure and why did Arnold Schwarzenegger's attempt to identify the chemicals most likely to cause cancer fail or not yield results and get so little press and follow up when he was governor and afterwards?

[@LillianStead]

Agree completely. I assume you have read Dr Peter Gotzsche's book "Survival in an Over Medicated World" plus other books/articles by honest, dedicated doctors who adhere to the dictum first do no harm.

[@Madasin_Paine]

@@LillianStead Yes! The demise of Dr Gøtzsche and Cochrane Collaboration as we knew it is something anybody interested in medical science and their health should know stone cold. I was impressed by what he has been writing and talking about! Some medical journals and periodicals have reported it and he and colleagues had some pieces but they took on a lot of flack slander and libel against them. Very depressing and enraging. Surprised he didn't have an unexpected heart attack or fatal accident. They should know the series if material that this doctor was involved in and how it displeased pHarma and how more and more retaliation took place against him and what Cochrane was. He wasn't pushing the vaccine PR and maybe that was what put the nail in the coffin. And then their is the matter of tests like mammograms for cancer and how bad testing is causing malpractice and other unnecessary treatment and running up bills and busting the health care budget and making record profits for the like of the medical iron triangle like hospital groups, testing, pHarma specialty biodrugs, lackluster dangerous implants and other medical devices, highly questionable surgery, bad contracts for MDs and all other allied health people except certain specialists that make a fortune but also spend double the time getting trained and staying on the edge. The books in these subjects as you know have so much more in them that the public would be horrified how documented it is and all that has happened in court. I think many allied health would be shocked too. We certainly are not hearing enough whistleblowers though are we from there!!

[@mballer]

28:16 base jumpers don't need a push. You talk like an elitist. There are so many studies that doctors already don't read, how about requiring doctors to read studies before funding new studies. Studies to justify selling a product should be at the bottom of the list of funded studies.

[@atemperedsoul6428]

You don’t walk up to a bunch of new base jumpers and incentivize them to jump off a cliff if you’re handing them a knowingly-faulty parachute without telling them before the jump. Gold-standard must replace placebo if it is proven regardless of it being established in the industry. He’s talking about the most rudimentary aspects of medical ethics. I’m sorry to be sharp but he’s not the one here who is being perceived as elitist. However, I agree with you about doctors needing to read relevant literature. Unfortunately, practicing doctors are not usually the people who initiate or request funding for these studies.

[@mballer]

@@atemperedsoul6428 My point was trying to be that some people are not as risk adverse as most doctors. Who is he to choose if someone wants to jump off a cliff? Most doctors think of their own ass before the patients desires. I am very biased in my thinking and I believe a lot of doctors treat their patients as lesser beings.

[@kevinbrown8172]

We need you as Trumps next surgeon general.