Did they measure vit-D levels before and after?
Also, 8 weeks might not be long enough to cause damage through too high levels, we probably need longer safety studies.
@EndME I’m running out of steam here, but I just want to acknowledge that you make some very good points and that’s I agree with the essence of them. Thank you for good explanations and examples!
I’m not able to copy it on my phone, but ‘Table 1’ is where the important bits are hidden. I don’t know if my GP would be receptive to this if it came from me, but he might be if it came from his mentor. Idk who that is, though..
That’s kind of why you do phase I and II. Surely, it would be exceedingly rare to encounter such interactions as late as phase III or IV. Besides, you would not enter phase III with an assumed ineffective drug, and it would be valuable to know that it wasn’t effective after all. That’s also good...
New info could be added without changing the primary outcome. Same with biomarkers. Negative side effects should already be covered inderectly by adverse events. Positive side effects could be added as secondary or tertiary outcomes.
As a silly example: if you studied viagra, the primary...
Wouldn’t it be better to complete the study as intended and then add more info if you encounter something unexpected?
‘X didn’t happen, but we found Y. We did some digging, and Z might explain it. We should look closer at this.’
Like Fluge and Mella did - publish the null results, highlight...
I just want to add that the lack of ‘intent’ is irrelevant. The closest analogy would be the law - ignorance won’t save you if you go above the speed limit. There are some exceptions, but fraud is not one of them.
Wouldn’t ‘manipulation of the research method’ be classified as fraud?
You’ve changed data. It doesn’t matter if it’s the measurement data or the label of the data (e.g. changing something from secondary to primary outcome).
@Jonathan Edwards does this fit with the ‘internal cell memory’ that was discussed earlier (this week?)?
Could it be that there’s a gene-related error that leads to faulty cell memory which gets them stuck in an UPR state?
How would one go about testing this? Can we realibly ‘stress’ cells and...
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