Is the vast majority of 'treatment effects' in clinical trials e.g. drug, vaccine, medical devices etc. due NOT to the intervention under study effect, BUT rather contextual effects, PLACEBO

patient expectations, doctor-patient interactions, or even of being included into a trial? Does the PLACEBO effect in most research explain near 80% of effect size, or VARIANCE explained? Yes!

Teaser:

‘~This study challenges traditional assumptions by demonstrating that the majority of treatment effects in these trials arise from context effects, e.g. patient expectations, doctor-patient interactions, or of being included into a trial. Only a maximum of 28% of the variance can be attributed to pharmacological ‘intervention’ effects (drug, vaccine etc.) and this figure may still include error and unexplained variance. This means that pharmacological intervention (drug, vaccine etc.) effects account for a much smaller proportion of improvements than is usually assumed.’

Remember, the placebo effect or response (contains the placebo effect also) occurs in both arms of a trial, the intervention and placebo arm. The question always is, how much effect is there above placebo in the treatment intervention arm (pharmacological effect), to make it worthwhile to take that vaccine or drug. Taking ‘costs or risks’ into account.

As you wrap your head around that, we knew for decades in the EBM world that most clinical trials, if re-run, will get different results and that most estimates of effect are biased as over-estimations of effect size due to stopping early for benefit, improper randomization (sequence generation), allocation concealment, improper or failed blinding of researcher, subject, outcome assessor etc., baseline imbalance, small sample size, small number of outcome events (< 200) etc. etc. etc.

This study adds to the evidence that most studies, published work over-estimates and over-reports the treatment effect and that MOST of the variability/variance in the effect is due to (explained by) the PLACEBO effect. Not the actual intervention under study. On top of that, as Pfizer and Moderna and the FDA and Bourla and Bancel et al. did for the fraud mRNA clinical trials, with fraudulent data reported to FDA and FDA took it as were part of the fraud to bring EUA, they reported relative risk reduction (RRR) and not the absolute risk reduction (ARR) which is the actual risk, also not reporting the number needed to treat or harm (NNT/NNH)…the RRR is a biased estimate as it is ONLY the difference in risk between 2 group RELATIVE to each other e.g. (CER-EER/CER) x 100% or control event rate - experimental event rate/ control event rate x 100% while the ARR is the absolute pure difference in risk e.g. CER-EER. RRR is meant to via reporting, to deceive the public. e.g. if baseline risk of stroke or baseline control event rate (prevalence) is 0.02% in a population (I am using very small numbers here to show you the fraud con of RRR), and a drug decreases risk of stroke to 0.01%, then RRR is (CER-EER/CER) x 100% or (0.02-0.01/0.02) x 100% = 50% while ARR is 0.02-0.01=0.01%

Using same CER and EER, if I told you that the drug or vaccine reduced your risk by 50% (RRR), you will say give me lots of that, you will not even mind the ‘costs’ or burden of taking it even the toxic side effects (potential), versus if I told you that the risk is only decreased by 0.01% (ARR) and that the vaccine was costly, had side effects even modest, you needed to monitor blood levels after that so lots of burden etc. You will say nah, I do not want that, too much cost to me. So, then you can make a much better accurate informed decision with ARR versus RRR that is inflated and gives you misleading information. RRR is meant to deceive, and it is what Pfizer and Moderna gave to FDA and FDA plays along and in the game. They knew that the Pfizer mRNA shot had a RRR of 95% and an ARR of 0.7% or so. But you were never told 0.7% ARR (never reported nor the NNT or vaccinated to get one positive outcome/reduced infection etc. as 140 or so (NNT is 100%/ARR%) for you would not have taken the vaccine. Not for that modest little benefit on top of the potential risks.

Put that in your pipe and smoke it!

https://doi.org/10.1016/j.jclinepi.2024.111658

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