Patient advocates, funding from Pharma, and how MRD negativity is about forcing payment not approval
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- Опубликовано: 29 сен 2024
- Vinay Prasad, MD MPH; Physician & Professor
Hematologist/ Oncologist
Professor of Epidemiology, Biostatistics and Medicine
Author of 450+ Peer Reviewed papers, 2 Books, 2 Podcasts, 100+ op-eds.
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Great video Dr. Prasad.. as a retired pharmacist of 40 years, 75% of which was hospital and cancer centers, i would say one of the biggest blunders ever (among many) was to allow public advertising of pharmaceutical products. What a disservice to the public this is! Notice on these ads that when they show "patients" before treatment with their "miracle drug", it's usually in black and white or gray tints, but after the drug, it's bright colors, usually people moving in slow motion, and mountain climbing or kayaking or something similar with a changed life. What hogwash!!
You're absolutely right - until we have a drug that is curative (which hasn't happened in myeloma), treatment should be stepwise, when something stops working, try something else. Not rush for the newest expensive drug.
And ASCT is the best anyway.
Wished he looked into psychotropic drugs killing the elderly in th USA!
Dr. Peter Breggen has. All of a sudden... you become an outlier... When it's the one's within that are the inlyers.
@@dedetudor. He would not want to examine the fraud that has gone on with these scam trials for MI "diseases". Tax payers get soaked in the tens of billions for treatments and drugs each year with very poor outcomes.
You are true physician. Physicians are supposed to be advocates for patients. Keep up your good work. God bless with Strength to continue his work
If I get cancer, I want Dr. Prasad to be my oncologist.
[from Asim Malhotra] The Stephen Hawking of medicine is Professor John Ioannidis from Stanford University. He is the Stephen Hawking of medicine since he's the most cited medical researcher in the world and is a mathematical genius. In 2006, he published a paper entitled "Why Most Published Research Findings Are False." In that paper, he makes a point that the greater the financial interests in a given field, the less likely the research findings are to be true. So anyway, you're right.
Thanks Doc. Your thoughtful analysis shows courage amidst the climate of corrupt practices.
Ok so where is the document for me to sign my name, that voices my objection to this change in policy? What can I do on my own to put pressure on the FDA to abandon this policy change?
Excellent points, Dr. Prasad. WRT patient video diaries in clinical trials: I wish I could believe there was a way to do this without violating GCP, without the ECs pushing back -- especially those for institutions or from regions that won't allow the collection of patient initials. And if I proposed this to my own clinical QA group, they would think I was joking. Oncology drug development could benefit from a validated QOL instrument like this. It would make for a complicated ICF, but well worth it if we could manage to include a true cross-section of patients.
i really like listing to the CARE in your voice in your videos you seam not like the others, you actually sound like a doctor that cares in a system that really only cares about money , thank you for your content
And to think that thalidomide that's used today for multiple myeloma, was approved as safe and effective for pregnant women...
An excellent topic to discuss. Support groups of all kinds are so helpful but any time a pharma is involved it obviously is a conflict of interest.
It makes me so angry... Drugs are so dangerous really and contraindications are not rare. That's become a favorite word when it's trouble they face.
Great perspective.
Now expose the boondoggle that is zero dollar co-pay sponsored by pharma and the foundations they fund. If you are commercially insured pharma will pay your co-pay. If you had to pay 20% of a $20k per month TKI with marginal benefit and maximum toxicity there's no way you'd do it. If ogarna picks up the tab for your 20% so it's 'free' to the patient many more will give it a try
Thank you for your courage 😊
Watched all vids. A few points. Patient advocacy being funded by pharma is unfortunately how it works in the US. NIH will fund studies based on their various missions defined differently over time. Patient advocacy don’t really have the capital and a champion, it gets worse when you look at rare disease that have a population of 1000 worldwide at any given time. Sometimes pharma is the only champion for these communities, and yes there is an ROI aspect to it; but that’s why there is an orphan drug process in place.
I think comparing MRD- as a predictor of clinical outcomes is a fair point in the sense it might not be clinically relevant. That wasn’t the assertion from the FDA though. They wanted it as another surrogate endpoint from PFS because it’s non-inferior. I don’t think they want to target treatments earlier. They want a continuous variable or number to treat and get drugs approved on it. Like drug trials that are based on eGFR for kidney function are easier to define than say, when’s the next time the kidney gets thrombosis or has glomerular damage. They’re pushing for a proof of concept to treat a different metric in cancer.
I think there is a valid argument to say that MRD is not proven to be clinically relevant enough as say eGFR or LFTs.
I believe MRD is a worthwhile surrogate for certain diseases. Waiting for survival data misses key breakthroughs
You are brave!!!
Bravo right on
Do you have any books you can recommend about the pharma industry and corruption?
Malignant
Malignant: How Bad Policy and Bad Evidence Harm People with Cancer
Book by Vinay Prasad
I would love to know who at YT decides which video gets the "Click here to see what the CDC says"
@@bottlethrower1544them.
Deadly Medicines and Organised Crime
Decades ago we stopped teaching moral and ethical business practices to college students. Now we have no businesses that even know what that is.
We also don't prosecute embezzling, fraud, and other business crimes.
The problem is not the companies, but the government oversight
@@matsv201maybe not even the government, but the structure, the rules which form the basis of economy.
@@karstenburger9031 Depends on if you thinking of like cross media ship owning by pharma companies, and really all companies and government that uses underhand method of moving the public opinion.
@@matsv201 not only this, but the structure is so, that the one, which makes the most money, wins, regardless what methods he used. Think of a pharma company: if it researches a certain illness, and finds two means to solve it, one cheap and one expensive, it would be *logical* to try to sell the expensive, even if it has more side effects for the patients. And you cannot blame them, because the "system" is like this, and they decide acording to the system the operate in. And the "small people" are not innocent either, because at the end of year they buy the journal with the hit list of most prosperous funds, and put their money to the one with highest dividend and share price performance. Regardless of the methods these funds or companies held in the funds used. And for them it is also "logical".
For myeloma MRD is a good marker, because myeloma has a long OS.
MRD is prognostic.
However I agree that toxicity and side effects should be taken very seriously.
I absolutely love listening to you! Oh how I would love to pick your brain about many meds my docs keep bringing up. Some scare the life out of since my first cancer scare was at only 23 years old. While my autoimmune rollercoaster keeps going worse and my pain is out of control…I’m still scared. Also I’m in crazy medical debt so I very much thank you on speaking on this topic! You’re amazing! If you want the pt that “I’ve never seen anyone like you with so many health issues” then apparently I’m your girl lol! I’ll be happy to be your lab rat (I’m already I’ve anyway lol)
Hugs from me to you from Tennessee.🙏💜🙏
You are a very smart doctor, Dr. Vinay. I love listening to you.
18% of the USA's GDP is healthcare - the highest of all 1st-world nations.... The USA also has the lowest life expectancy of all 1st-world nations.
Keep it coming sir.
You don’t know what you would do “if you were a patient “ until you are a patient. Right now patients cannot wait till we have a grant based support for them and even that will have a bias one way or the other. I am less concerned about pharma support for advocacy groups and as a patient and physician I have experienced MRD testing and I believe there is enough early evidence to support the FDA decision. I’d rather see more efforts placed on robust registries that can track outcomes. I will be interested in your views should you ever become a patient with a rare disease where survival trials will take too long to impact many patients.
So what is our coming new administration going to do about the FDA, FBI, CIA, DOD , DOE, EPA, etc etc and influence of power of money?
Astroturf!?!?!
👍🏽
I am ambivalent about MRD negativity. On one hand as a patient it makes you feel good they cannot detect your cancer. On the other hand if you are positive it is a huge disappointment. I hear of patients becoming positive a month or two after treatment. I am not sure what to think about patient advocate groups getting pharma money. At least with the CLL Society it is run by a CLL patient who is an MD. I feel like I can trust his judgement.
MRD negativity in MM is one of my biggest pet (no pun intended) peeves. I feel the whole endpoint is about driving more prescribing, not constructively changing therapeutic approach. On top of that, an endpoint like MRD negativity in what is (and will remain for the foreseeable future) an incurable disease makes limited sense--we treat the patient more intensely or longer simply because we can, even though we can't definitely demonstrate we are extending life? Of course, there's big money to be had in all this testing and marrying expensive mabs to it. Ugh. Great video!!!
Hearing from patients has too much noise in the system; placebo/nocebo effects. No thanks. It's already hard enough to prove cause-effect of side effects of meds.
I would be interested in the topic of mold on health, particularly around dr. Jill crista book, Break the Mold.
The more you look the worse looks
What about the Cystic Fibrosis Foundation and Vertex? That seems like a tremendous success.
impt video
Med tech is the same.
As an MM patient, I don’t mind advocacy groups working with pharmaceutical companies! Any way I can be cured!
In the meantime those same groups are killing others.
Pharma don't want you cured, they want you milked dry, broke, dead, and... next please! repeat.
Patient advocacy should simply be built into the relationship between patients and their doctors. Once we form a group, label it "organization" and start bringing in money then we know where that's headed. But then again, once the doctor starts to accep "gifts" from other than their patients... Why don't we just cut down to the chase here and say that money is the root of all evil, or better yet that we are the root of all evil.
Do you have evidence that putting more money into children's education will improve outcomes?
That's crooked as all get out
I know you like to believe that one side was keeping the FDA in line. But as long as I’ve been on this planet that’s not been true. You just finally realized that they both cater directly to the pharmaceutical industry. Because it’s become glaringly obvious.
At one point I was listening to one of their internal meetings on their yt ch... They actually called the pharmaceutical company agents present, their colleagues..... And not the applicants.
Of course I called the FDA the next day and highly objected.
Another meeting then they called them applicants... So it pays to call them out. Whether it makes them change or not... At least they changed their vernacular.
00:18 Not true, money is the most important.
You're living in a fantasy world.
Oh Boy! Dr P Unleashed! Stand back! Stand the f Back! Yellow Tape Area!
Just look at CDC or FDA website! Any claim, it is based on-and arises from-long chain of fraud and corruption- each link financed by taxpayer dollars without consent let alone informed consent
Oh boy! An honest brilliant physician!💪✊