Paul Saladino· MD
the degree to which the side effects are reported if you look at these trials they will suggest very low side effects and my impression is they are grossly under reported clinically
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We can't find evidence that holds up here. Proponents are reasoning from mechanism or analogy rather than direct human data, and the most credible skeptics raise objections we can't dismiss.
the degree to which the side effects are reported if you look at these trials they will suggest very low side effects and my impression is they are grossly under reported clinically
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the way clinical trials are designed the reporting is for the events you are looking for if you're not looking for cognitive impairment if you're not looking for reduction in exercise time if you are not looking for symptoms of myopathy you're not going to find them
one thing they do in a statin trials they have a run-in period them any of them well anyone who exhibits an adverse effect is taken out of the trial so I said well your River everyone suffering an adverse effect of course you've got to remove the same number of people from the placebo arm so no wonder you don't see these adverse effects
in this trial actually a few more people died in the statin group as far as overall Martell right right the all cause mortality was higher in the statin group
in the case of HPS the heart protection study they had a six-week period where people took the Statin before they even started the trial and anyone who had side effects was out of the trial over 11,000 people I believe were excluded from the heart protection study because they developed side effects before the trial even started the reporters of that study did not have to disclose that fact they did not have to disclose the fact there was a runin period in the reporting of the trial and that the results of the side effects may be greatly deflated
Over time, they were able to figure out, I think, the drug companies because they designed the trials, right? Who is likely to get side effects. So, then they would choose people to go in the trials who were less likely to get side effects and therefore you get a biased result from what's in the trial does not reflect what happens in the real world.
when they enroll people in these randomized trials, they have this pre-randomization running period. So, um people uh before the trial starts for several weeks, people are asked to take part and then they decide who ultimately is going to be in the trial. But, people who get side effects and they put under they put this under non non-compliance are taken under as a broad term, are taken out of the trial. And therefore, you're left with a selected group of people certainly at the beginning who probably got side effects early on and then we thought, "We we better not keep these people in the trial." And then but the results are only reporting on the people, the selected people that didn't get side effects early on. So, all you've already created a bias there, Paul.