CodeBreak 200 | Sotorasib | A Negligent trial that violated randomization!

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.
If you want to contact me, do it here: www.vinayakkprasad.com/contact
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Podcast Website: www.plenarysessionpodcast.com
Academic Publications: www.vinayakkprasad.com/papers
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[@tommcfarland6008]

This is what happens when researchers pursue the reductionalist madness driven by licensing, patents, and profits rather than patient outcomes. You are absolutely right Dr Prasad please persevere.

[@olibertosoto5470]

From what I gather then, years ago it was interesting to find the rare poorly done study to discuss. Now it's rare to find the well done study discuss.

[@M.-.D]

Yeh, journal club really has plummeted in quality.

[@TaggeMD]

Ruthless Dr VP ! Love the blend of education and comedy. The laughter takes the sting away from how bad the status quo is.

[@margotbw4660]

DrP, thank you for continuously bringing out the arrogance and politics running our medical system!

[@scottcoston7832]

Thank you for standing up for science and the proper process!!

[@brittury2376]

A lot of this goes over my head but I catch enough to know when I smell shite (obscure reference to the Scottish show skit from Chewin' the Fat). Thank you for what you do. I work inpatient as an acute care RN. The number of meds people are on with little to no value is astonishing. The fervor with which you approach topics is refreshing and much needed. 😁

[@fiasco2003]

Can I recommend the book "Studying a study, testing a test". It's well presented and accessible. And it covers only the topic of reading and interpreting medical studies. It contains a series of flaw spotting examples throughout. So that you can train your bullshit detector as you go!!

[@boohoo5750]

@@fiasco2003 Thank you for the book! I’m a an educated grandma! I have been a caregiver over 20 years! I don’t hav a pharmaceutical in my home. I like the author of this thread have a limited understanding of what is being said! I work for a major retailers who sells pharmaceuticals. There are times when I’m alone with these people who come in to buy the pharmaceutical’s. I question them and ask them do they know what they’re taking? Do they know the side effects? Thank you Dr. Vinay Prasad

[@embededfabrication4482]

the doctors are the gatekeepers, blame them, why are they prescribing meds that don't do anything? they all just operate from a playbook made up by legal teams for the most part.

[@e.g.7612]

The sarcastic and derisive tone is fully warranted. These types of trial are a blot on the industry. Well done doc

[@Underline78]

My mother was put on a trial for a new stage 4 metastatic Meloanoma drug. She was told by her oncologist that there was nothing more they could do and she needed to try this after her last images showed widespread disease in her lungs and pericardium. They commenced the process and she had a baseline CT scan only to discover that she did not have metastatic disease. When I vigorously grilled the professor about what the standardized test for the pathology was he said a biopsy? I asked did you conduct one. He said No, we assumed it was Mets as it had all the features. He then proceeded to tell me that's why the baseline scan was so important, to rule out potential candidates for the trial. You should have seen his face when I said, so If she still had the appearances of Mets, you would have continued without establishing a diagnosis. They were experimenting on the most vulnerable. Scan 1 and 2 were 6 weeks apart. They still have no idea what they saw on image one. My finishing statement to him was "In your desire to win the war and glorify yourself, you are willing to sacrifice the life of soldiers. My mother and the people you experiment on are not soldiers they are human beings"

[@jeanniemckeag5707]

Good for you!!! Be a lion for your loved ones, not a sheep. We need to advocate for humanity against what has become the tyranny of Doctors working for big pharma.

[@mka6245]

So she had the symptoms of metastases to the lungs but no actual lung disease on the scan? wild. I hope she is doing well now.

[@chaosrex5702]

I've been a viewer of Dr. Prasad since about 2021 I think. Not long obviously but it seems the last few months his frustration with the decline of science in medicine is at the boiling point. I share your frustration and I'm not even a doctor. I'm sure I'd be even more enraged if I knew half of what he does.

[@cellgrrl]

I wish I paid attention way back when I took statistics...but I enjoy getting your take on the quality of studies these days.

[@dedetudor.]

Oh I saw the meeting... I'm sickened. How can those people claim to be so educated? And why oh why are their FDA approved drugs on the market that tear up stomachs and digestive system capabilities, cancer and even death. You're right Dr Prasad.

[@scottcoston7832]

1/3 of the meds approved by the FDA must be pulled from the market

[@dedetudor.]

@@scottcoston7832 yes and really more than that. And they fight that just like Merck fought the removal of the heartattack causing viox. They went after Drs. Who reported signals and removed their patients from it. It took FDA 4 yrs or 5?to pull it off the market They have been untrustworthy for a long time... And they spring something like This on us and we're supposed to trust them. There are long lists of criminal prosecution on DOJ pharmaceutical prosecutions, but only money fines...no prison...for killing people....and Leaves them to operate to grow big and phat without oversight. Some people are just that stupid.

[@8020drummer]

I’m highly entertained by this and I’m not even in medicine or the sciences. Vinay makes it assessable enough for even a dummy like me to follow.

[@lateralridge]

haha omg Dr Prasad, Love this energy. Gotta see more of this videos. it always irates me with all these ridiculous studies when society haven't even got a good grip on managing Hypertension , obesity, gun violence, public transport, walking and exercise. Thank you FDA.

[@parmijo]

The outcome was pre-determined. Control was knee capped and mid-course design changes are red flags. When the inputs are garbage then the outputs are as well. However the trial should be used as a chapter in a text "How to lie with science". This book keeps getting bigger.

[@sarasamson5922]

Thank you, Dr. Prasad, for your passion and ability to decode these studies. As someone with NO medical background but whose late mother died of non-Hodgkin lymphoma. I'm grateful that she had quality, experienced oncologists (one with VA experience) who gave her a quality of life her last few years she might not have had in a clinical trial of this type.

[@giajia958]

I really enjoyed watching Dr. VP’s critical analyses on these trials. I have been inspired by some of your thoughts and apply them to my own analyses. Thank you and please keep up with the great work!

[@stephenjohn904]

incrementally better for twice the price of older medications-- that's the direction we are heading.

[@user-kc9xj7xe7x]

Thank you for sharing your take on the CodeBreaK 200 study. One of the points against this study was that the control arm wasn't given ramucirumab. I am not a medical doctor, but from reading through the manuscript, I understand that one of the inclusion criteria was that the patient had to have progressed after a chemo + immune checkpoint inhibitor (for example, ramucirumab) treatment. Following progression, aren't patients typically just treated with only chemotherapy (ie docetaxel) rather than chemo+ICI due to increased side effects of the combination?

[@sidneyfrattinijr.9700]

I wonder how many studies in different areas of Medicine have such issues and biases without ever being exposed. The scientific community needs more doctors like you.

[@jackhsiao8015]

You are doing God's work Dr. Prasad! Please keep up this pristine sanctuary and always stand UP for the patients and the TRUTH

[@TamuNgina]

I think UNLISTED means it doesn't show up unless you are subscribed,? Anyway thank Dr. Prasad for shining a light on THE SYSTEM.🙏🏽

[@Charles-zb8ey]

Great video Vinay, informative and hilarious in equal measure! To your question about why they didn’t test QOL endpoints per the SAP, it’s related to their gatekeeping procedure for Type 1 error control; ie only test secondary endpoint if primary has statistically significant p-value, only test QOL if secondary are positive, etc.

[@deborahcharych4490]

Brilliant discussion on the important but mostly overlooked nuances of clinical science. Keep doing what you do

[@maforever4144]

USA is only one of two countries that allows pharma to advertise to the public. How do get that stopped?

[@jananilcolonoscopu4034]

Too late, nothing can be stopped anymore. Public too supine, cowardly, ignorant, compliant.

[@elizabethstudebaker4483]

A nationwide campaign directed toward doctors, patients and business owners educating them on the poor performance of our regulatory systems will expose this crap and put pressure on government to change. And I am less concerned that advertising leads patients to request a particular drug and much more concerned that the amount of money spent on advertising allows pharma companies to have undue influence over media companies and therefore avoid major scrutiny.

[@valarizimmerman]

Vinay, you are seriously my hero.

[@mariaveresova8169]

Please give us your take on realised Pfizer documents nearly all are now released through FOA, where FDA wanted to prevent their release. The last 5000 pages are taking longer to come now. People who analysed them covered their findings in a ebook. I would love to hear your view.

[@janellemiller1195]

Its not unlisted .I received notification for this about 5 minutes ago.

[@wr44]

Vinay, you're desperately needed to work in the FDA.

[@SUPER7X]

Not sure why this is unlisted, but very interesting video! It's a shame things are this way. I wish you could be put in charge to reform the system. Edit: No longer unlisted. Guess he just wanted it to go public in the morning, rather than last night.

[@patrickboland1021]

If more folks talked this way, I would be staying in academic medicine rather than running as fast as possible out…

[@mpoharper]

As a cancer patient, this is totally scary.

[@catherinegilbert8740]

"Combined treatment" Like combining Tylenol/Panadol with any other pain reliever, including opiods.

[@roseyt8713]

"You sneezed on the wall!" Hilarious.

[@ChrisCapoccia]

But why choose such a bad control drug unless you already know from previous studies how the new drug is bad. And if you already know it's bad, just cut your losses and stop spending money

[@GenXFemaleGamer]

What do you think abt the cdc pushing for the experimental eua cv vx on the mandatory child immunization schedule?

[@jeanniemckeag5707]

It's bullshit! That's my opinion, however looking forward to Vinays' response.

[@jmc8076]

Thx for sharing. Dr Suneel Dhand talks about relative vs absolute risk red’n. Also NNT and NNH. Look them up for more info. Maybe Dr Prasad will do video.

[@Sociallama]

My mum passed away a few months ago from NSCLC that metastasized to the brain in the end.. 😢 she was on this drug for a while after immunotherapy, then it stopped working (not surprisingly) and it went downhill after that, when they decided radiotherapy was the last treatment 😔 I am so heartbroken.. these people guide you and you just choose to trust them. we felt like she was so strong, she was doing well before this drug.. 😢 it felt like they were treating her like a guinea pig almost ? I don’t know

[@tonyc223]

The fall of the republic; captured media , captured politicians, captured medicine,captured science.

[@mantasr]

Come for the common sense about cancer trials. Stay for the ASMR

[@gillianpurvis-smith5203]

They dropped out because they died or they woke up just in time .

[@mattp1913]

isn't it the fault of the payors ? why do they pay for this?

[@19Mariko57]

I just started sotorasib this morning.....just got done with 24 zaps of radiation 2x day. :( How is it that I missed this podcast.....

[@sarareimold3151]

Why couldn't the drug actually be progressing cancer in some people?! It probably is.

[@snowbird6855]

💰💰💰

[@embededfabrication4482]

look man, cartoon representations of proposed mechanisms of action led credibility to it all, why don't you understand that?

[@Ann-jl4dz]

Grade 5 event is Death

[@giajia958]

Yes. I hope Dr. VP could have pointed this out when he discussed the 22% Gr5 AE.

[@chrisd.5625]

I’m unfortunately not interested in oncology enough to watch a 40 min video about it. Videos about other medical studies & topics would be much appreciated as well I think.

[@sassysandie2865]

How about “Satan damn,” “Buddha damn”, Mohammed damn instead of God?

[@jananilcolonoscopu4034]

Those aren't sayings

[@sassysandie2865]

@@jananilcolonoscopu4034 no but perhaps they could be used instead of damning God.

[@donnamachugh5721]

The reason why they don't use the other sayings is because Christians turn the,other cheek. All the others would start a riot because it offends them!!!!!!