Unsurprising, though disappointing for the 100th time. Right up there with CLL trials, using single agent chlorambucil as the standard comparison, then breathlessly announcing statistically significant DFS.
For only 100-fold the cost.
Sad, that many of us now look first at the sponsorship, and consultancy list of the principal investigators, and then MAYBE read the article. Objectivity and principle have become increasingly optional in Big Medicine trials, and it shows. OS has become secondary, if even reported in many trials.
Why? Too long for the shareholders to wait for the stock to bump, and too long for the Pharma detail teams to get their pamphlets printed.
Cynical? After 35 years, I’m not sure that’s the term I would choose. Focus on the individual patient, and decision making becomes HARDER: But, better. Defer to the bright, shiny drug-of-the-month instead, and nobody will challenge you.
Wow. Amazing evisceration of that paper (which is far outside my area, but the fundamental concepts like research design and ethics are transferable).
Stunning that the journal editor and peer reviewers allowed that through. Moreover, how does any ethics board that has ever heard of ICH-GCP concepts for research conduct allow that protocol to proceed?
Mind boggling on multiple levels. And it smells a little nefarious to me.
Always the seen vs the unseen. Seen: this is what we did. Unseen this is how we made things worse- ethically, theoretically and MOST importantly? For best patient outcomes in science. Such a well written piece. Thank you for taking the time to write and publish.
During my cancer journey, I learned that studies are designed to create more drugs, not to uncover true causes or cures. I’m a cancer rebel: diagnosed with “incurable” CNS lymphoma, I walked away from toxic treatment six weeks in after tracing it to a chronic dental infection—and my body healed itself. I still struggle to understand why anyone would participate in, let alone take pride in, faulty research—except for the money, the money, the money.
This issue of having control arms that do not represent the standard of care is not simply an issue related to this particular metastatic prostate cancer trial. Unfortunately, it is common to industry-funded trials for many malignancies (and usually those that have been farmed off to 3rd world countries such as India), especially hematological ones, as our friend Vinay Prassad would point out time and time again on one of his podcasts.
The ARANOTE trial should never have been approved by the IRB and should never have been published by the journal, and the authors of the trial should have been investigated for unethical medical behavior.
I agree, their argument doesn’t hold up well when using cost and resource limitation as justification. There was a formal JCO critique about “inferior control arms,” and a published reply from ARANOTE investigators defending the control as acceptable for participating regions and patients. At least there was transparency on the rationale and I’m not sure I would go as far to say the study was unethical.
Of course it was unethical, and more importantly the results of the trial are irrelevant to the US or any other 1st world country. The control arm in cancer trials should always be no less than the standard of care in the US – not the standard of care on some 3rd world country.
Unsurprising, though disappointing for the 100th time. Right up there with CLL trials, using single agent chlorambucil as the standard comparison, then breathlessly announcing statistically significant DFS.
For only 100-fold the cost.
Sad, that many of us now look first at the sponsorship, and consultancy list of the principal investigators, and then MAYBE read the article. Objectivity and principle have become increasingly optional in Big Medicine trials, and it shows. OS has become secondary, if even reported in many trials.
Why? Too long for the shareholders to wait for the stock to bump, and too long for the Pharma detail teams to get their pamphlets printed.
Cynical? After 35 years, I’m not sure that’s the term I would choose. Focus on the individual patient, and decision making becomes HARDER: But, better. Defer to the bright, shiny drug-of-the-month instead, and nobody will challenge you.
Except, maybe, your conscience.
Wow. Amazing evisceration of that paper (which is far outside my area, but the fundamental concepts like research design and ethics are transferable).
Stunning that the journal editor and peer reviewers allowed that through. Moreover, how does any ethics board that has ever heard of ICH-GCP concepts for research conduct allow that protocol to proceed?
Mind boggling on multiple levels. And it smells a little nefarious to me.
Benefits from the study for:
1. Investigators. Another published study for their resumes. Unknown perks from the pharmaceutical manufacturer---probably substantial.
2: Manufacturer: More hype for their product. More reprints to distribute to medical offices.
3. Patients: Nothing.
Always the seen vs the unseen. Seen: this is what we did. Unseen this is how we made things worse- ethically, theoretically and MOST importantly? For best patient outcomes in science. Such a well written piece. Thank you for taking the time to write and publish.
During my cancer journey, I learned that studies are designed to create more drugs, not to uncover true causes or cures. I’m a cancer rebel: diagnosed with “incurable” CNS lymphoma, I walked away from toxic treatment six weeks in after tracing it to a chronic dental infection—and my body healed itself. I still struggle to understand why anyone would participate in, let alone take pride in, faulty research—except for the money, the money, the money.
Another sophistic Pharma $cience set-up to suck unseemly amounts from the govt teat
This issue of having control arms that do not represent the standard of care is not simply an issue related to this particular metastatic prostate cancer trial. Unfortunately, it is common to industry-funded trials for many malignancies (and usually those that have been farmed off to 3rd world countries such as India), especially hematological ones, as our friend Vinay Prassad would point out time and time again on one of his podcasts.
The ARANOTE trial should never have been approved by the IRB and should never have been published by the journal, and the authors of the trial should have been investigated for unethical medical behavior.
I agree, their argument doesn’t hold up well when using cost and resource limitation as justification. There was a formal JCO critique about “inferior control arms,” and a published reply from ARANOTE investigators defending the control as acceptable for participating regions and patients. At least there was transparency on the rationale and I’m not sure I would go as far to say the study was unethical.
Of course it was unethical, and more importantly the results of the trial are irrelevant to the US or any other 1st world country. The control arm in cancer trials should always be no less than the standard of care in the US – not the standard of care on some 3rd world country.
Point taken, interested to hear others thoughts as well.