New approach for evaluating evidence in a pandemic: The Totality of Evidence Wheel
New approach for evaluating evidence in a pandemic: The Totality of Evidence Wheel
An argument for using the Totality of EBM (Evidence-based Medicine) Wheel with ivermectin as the example.
Summary and conclusions
In a pandemic situation, double-blinded randomized controlled clinical trials on already approved therapeutics are neither cost effective, nor required since the safety profile and mechanisms of action are already known. Therefore, allowing health providers to prescribe such medications off-label should be the first response, and should be encouraged. As observational studies become available, they can provide early signals of efficacy and inform properly designed RCTs. These studies should not be ignored. The permutation of protocols using such drugs is vastly larger than that for RCT’s and gives front-line practitioners far greater flexibility to test and customize as they search for increasingly positive results. Such flexibility, especially when dosing to effect, is not available in an RCT.Â
To prevent this from happening for repurposing of drugs in future pandemics, our new approach of considering the totality of evidence should be initiated early on. EBMs1 true spirit for safe and effective treatment for all is acknowledging the best available evidence, which is not exclusive to, but inclusive of RCTs. All primary research must be recognized, including that from observational and laboratory studies. RCTs will require time and funding, both resources often in short supply. Observational studies together with prior safety studies for known drugs can provide rigorous and reliable evidence in a much shorter time. There could be sufficient scientific evidence to make competent Type 1 error decisions about testing the scaling of protocols.
In addition, pharmaceutical companies have extensive financial disincentives to performing RCT's on out-of-patent drugs. Those same pharmaceutical companies may have large financial incentives to perform designed-to-fail RCT's on drugs for repurposing when they have a new drug or vaccine under development.
Karen wasn’t brave enough to post her insightful comments publicly, so I’m sharing her email with you instead:
Evidence-based medicine
What we got during the 'pandemic' was fraudulent clinical trials of a totally novel 'vaccine' allowing for emergency use authorisations, followed by one huge observational-based study of essentially untested pharmaceutical products, which co-opted half the human race as uninformed and often unwilling guinea pigs. They then proceeded to consistently ignore the observational based clinical data. At the same time, they banned even small observational studies involving the use of clinically proven, safe pharmaceutical products and conducted rigged and fraudulent randomised control clinical trials of those products (often involving the administration of lethal overdoses) which 'proved' that they didn't work for Covid. I think they call it the Totality of Profits Wheel.
Real-world evidence beats a randomized control trial every time. What the public needs to know is the toxicity profile of the drug in question - what constitutes a non-toxic dosage, and which drug interactions must be avoided. In Ivermectin's case, this profile had been known for more than a decade before covid blew in. Before there were any vaccines, the only other option quickly became sitting on one's hands and doing nothing until the faux vaccines were developed.
Why NOT give Ivermectin - or any other non-toxic approach - a try in the meantime? The cost of "being wrong" was negligible to non-existent.