Excellent points Aders2211.
Let me just say my general view here.
There was NEVER a safety issue, IMHO. Had there been, it would have been mandatory to disclose it. That is the mission of the FDA and ethical requirements of every institution involved and every doctor involved. So of course they were were following the standards of all the regulatory agencies, even in the partial hold, or it would have been a complete hold with full disclosure, and if they refused, then by the agency as to why, especially if they continued treating the patients in contravention of any such standards. The FDA has a duty to inform the public of dangers posed by treatments, even those it allows companies to provide and certainly if a company continued treating people in contravention of those standards.
I have absolutely no doubt about this statement of mine. It's my opinion. But I have not a smidgen of doubt about it.
This was NOT a complete hold, it was a partial hold. They were allowed to continue enrolling patients that had already been accepted for the trial but had not yet received treatment and to continue providing treatment. Thus patients started their DCVax long after that hold was public knowledge. There appears to have never been any updated disclosure of any additional risks to patients. That would be public information.
There appears to have been no withdrawal of any of the hospital/research institutions or doctors from the ongoing trial because it posed risks to their patients that they would want to avoid. NOTHING like that. Period. If there were any such failure, they would have all had a duty to disclose and withdraw.
Many of the things alleged on this board and other boards about the partial hold are speculative. They may think they have reason to believe what they have discussed ad infinitum for years, but virtually all of it comes by way of speculation about other trials and what may have been or might be the case because of speculation about x, y and z.
It also comes because once you accept the premise of the shorts, to debate them, to "refute" the premise, you end up accepting the premise as a possibility, even if it maybe was or wasn't a possibility. You end up accepting it to discuss it.
Had the treatment ever posed a safety risk or caused additional risk of recurrence and had those circumstances been the cause of the partial halt, that would have been disclosed. Period. There is no way that the FDA or any other agency would have allowed patients to take additional risk without knowing of it. Look at the standards they imposed on a third-party advertisement about freezing tumor tissue. No way would that have proceeded without disclosure had there been additional risks to patients health.
No amount of claims by AF that it was being hidden, or any other poster, is valid. They cannot hide it and be engaged in an FDA or any other trial. Period. Risks like that have to be disclosed to patients. Everyone has an ethical duty to do so, and once so disclosed, that is public information. Period. It's not confidential or private information. That would be selective disclosure.
They may need to review some things, but the doctors were not likely concluding patients were being harmed by this treatment ever. I do not believe that was ever possible.
Nor was it likely determined to be futile when many patients were surviving quite long. No doubt they were trying to understand the mechanisms. That's a different inquiry. And I still believe that the true risk to patients was perceived as the harm being done by delaying the treatment of placebo patients, who likely were not doing as well. While the trial is blind to the company, there are others who know what that risk is (the IRB, and we know the now retired former head of the IRB is now on the SAB of a copycat company) and I've posted before, that placebo based oncology trials are engaged in for very specific reasons, and also are adjusted when it is understood that placebo patients are being harmed by not receiving the treatment.
Whether people agree with me on that point or not, the fact is, it was never alleged, even by shorts, in truth, that anyone was being harmed by the treatment, EVEN as they asserted that the treatment may have caused incorrect diagnosis of recurrence because of an immune response. Therefore at the heart of most short arguments, is the basis of the demise of their entire argument. If there was an immune response, it's not grapefruit juice, and if the immune response was observable, and there was no safety issue, then the immune mechanism is observable. If patients, having an immune response end up having longer survival, it starts to become fairly obvious what is going on. If you have placebo patients not receiving the treatment and therefore not having an immune response... well, then you're withholding something from them that patients that are living longer are experiencing.
We'll see what ultimately is revealed. But I suspect much of the debate around here, while interesting, no doubt, has been seeded by shorts to pull people down false rabbit holes, not to get at the truth, whatever that truth might be. Again, not claiming my view is the truth, it's an alternative view. But, most of the debate about these issues attempt to seed a negative view. I don't have a negative view. I would not have my money invested if I had such a view.
