Disgusting and Unethical Placebo Control Trial in Colon Cancer
This blog discusses a placebo control trial in colon cancer that has been deemed unethical and disgusting. The author argues that the trial has wasted the time of patients, and that the cost of the drug is too high for the modest benefit it provides.
Vinay Prasad MD MPH
Professor @ucsf, Physician-Scientist, Writer; More at @vkprasadlab @plenary_session, YouTube, #vpzd podcast & @Sensible__Med; Views are mine
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Disgusting, unethical PLACEBO control trial in colon cancer just so Fruquitinib can win
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
I will show you that placebo should not have been the control arm, & the IRBs & FDA failed 🧵
First, this trial tests a new drug vs. placebo (sugar pill) in patients dying of colon cancer pic.twitter.com/fa915vgUbp -
Even against sugar pill; No one is cured, benefit is modest.
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
We are paying 200k/ yr for drugs like thishttps://t.co/TVVaRLhJJg
What are we doing as a society?
But giving the control arm a sugar pill is unethical.
Here is why.... pic.twitter.com/RzILlwaYVY -
1. Patients were all good performance status patients
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
AKA, they walk in your office, generally looking good, and ask for more options pic.twitter.com/3iR7JxdNvW -
2. Although they have gotten a lot of pre-treatment. They have not gotten ALL THE POSSIBLE pretreatment
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
You can give drugs again in colon cancer.
If the pt has not seen Oxali in a while or 5FU you can reintroduce it. if the pt has ECOG 0 and wants to try, most docs will pic.twitter.com/suflnrwXps -
3. In fact, after the control arm patients progressed, many doctors DID try!
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
They gave 5-FU oxali and Irinotecan again
Why did they have to wait till RECIST progression?
They should have been allowed to give it on protocol pic.twitter.com/t3yemLE8Wf -
4. The trial should have been fruq. vs. investigator choice when the patient lives in USA and has good insurance coverage.
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
That alone is a fair trial -
I come back to my golden rule
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
What if your mother was on the control arm
Everyone who treats CRC would pull mom off the trial, and give 5FU and bev. or IrOx or folfox again, perhaps slightly differently
Proof is they give it post progression -
Ok, we all know why the investigators signed on to this unethical trial
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
Lots of glory to be PI and if they say no, the company will find someone else
Oncology sinks to the lowest bidder -
PS everyone knows this is the truth.
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
Same for the unethical conduct of ADAURA
If someone protests too hard
Look them up here:https://t.co/wVked21abW -
I will add this response to my thread.
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 17, 2023
Post progression therapy would be even higher if you didn't sit around letting people deteriorate for a few months on placebo. What are we even talking about here?https://t.co/YIEkSP0kdV