47 Comments

Forgive my language but where the Hell is the Institutional Review Board that is supposed to oversee human trials? I’m on the IRB at my institution and I take it really seriously. We’re constantly asking experts in other fields for feedback and we send almost every proposal back for more work. We also refuse even more and some of those are for things like questionaries that are unnecessarily invasive. This is 25 times worse. Where on earth is the IRB?????

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That's how everything is in corporate America today. And doctors are controlled by big Pharma and Wall Street that don't care about competence. Incompetence and corruption go hand in hand. That is because incompetence necessitates cheating and corruption, and then the cover up.

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Jan 27·edited Jan 27

This is standard practice, but something not disclosed. In Vinay's example, the control arm was at least a medication. In most non-oncology trials, the control arm is a placebo. I doubt the average community-based clinician knows this. Instead, people get duped into thinking that the experimental drug is showing itself to be safer and more effective than existing treatments. However, the word choice unethical is emotionally loaded. It caught my attention; however, it is important to raise awareness of how studies are designed and say it in a way so that everyday people understand this concept.

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Perhaps more medical media coverage with the flawed studies and doctors promoting them would start to turn the Titanic around. However, pharmaceutical companies, FDA and institutions seem unlikely to heed this until it hits them where it counts. Thanks for the report and here’s hoping that medical research and care returns to the science based model we used to follow.

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Sadly patients who participate are not aware the they are not receiving the usual standard of care.

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Totally shocking. Hippocrates would be turning in his grave😢

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What's missing from this rant is that some patients don't want chemo (docetaxel, cabazitaxel) or 2nd line chemo. The point of the trial was to have other options. This from JPM-"We view cabo+atezo as a great chemo-sparing/delaying option in 2L mCRPC, providing significant optionality in a wide patient

population. The TKI-ICI combo is also a great option for the community setting, and we point to good feedback from KOLs"........Key Opinion Leaders...meaning top doctors in the mCRPC setting

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I agree. Vinay's unedited writing on his social media is often full of grammatical errors. But that's not why he has lost credibility.

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Last one out please turn off the lights.

Medical science is dead.

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I think it would be appropriate to contact the Ethics committees that approved these studies and the Heads of their institutions to ask them to review their process of reviewing studies to ensure that they are upholding the requirement for best available therapy in the control arm.

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Just another chapter in the annals of pharma/academy collusion in pursuit of the big bucks in research grants and subsequent pharma profits. Sometimes it is a little hard to follow the narrative because of all the abbreviations. I wish that authors and commentors would spell out the terms the first time they are mentioned in an article or comment and then use the abbreviations in the rest of the text. Thanks for shedding light on this tactic of setting up a "straw man" in the control arm of a study.

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Could a requirement be built into informed consent documentation that states that the participant must be aware of the treatment he would receive if he were not a participant in the study? I'm saddened to think that the participants' oncologists didn't counsel them more explicitly about their options; maybe if trial PIs were required to tell patients exactly what they were forgoing, fewer would opt in, and trials with this type of ethical problem would die out. It feels like a clunky requirement to write and enforce, though.

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Are these “drs” in some kind of death cult? Sure seems like it. These last 4 years are eye opening and I wish it were all untrue

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Same thing Brandeis tried to do a 100 years ago: If the broad light of day could be let in upon men’s actions, it would purify them as the sun disinfects.

Thank God for Covid. It took away the veneer of trust I had in CDC/FDA/most Doctors. Who knows, maybe I'd be on Ozempic were it no for Covid opening my eyes (actually, I wouldn't because I'm not *that* stupid) So while I'm not an SME and have no idea what the specifics are, it reads like par for the course. If NIH and CDC and FDA behave unethically, why WOULDN'T everyone else?

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Forgive my ignorance since I'm not an oncologist. Was the menu of what's considered best available therapy available at the majority of the study sites where this trial was conducted?

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Thank you.

"The trial should be designed such that if your father was assigned to the control arm, you would be reassured knowing he was getting the best proven care absent the experimental drug."

If the Hippocratic Oath were re-written, I'd include: Never give a treatment that you would not give to your family, loved ones, or yourself.

It is a version of skin in the game. It is a heuristic that acts as a check on so-called science that increasingly is scientism.

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