Why vaccine trials weren't responsible 'science' – not even close

Jane M. Orient, M.D.: 'There is virtually NO control group for potential late adverse consequences'

Science has undergone a radical metamorphosis. People with M.D. or Ph.D. degrees, who have published hundreds of papers in the scientific literature, have suddenly become "anti-science" – as judged by media personalities, politicians, bureaucrats and fact-checkers. What does this mean? One clue: chief White House medical adviser Anthony Fauci, M.D, said that anyone who attacked him was attacking "science."

Anyone skeptical of the accepted COVID narrative may be called "anti-science." The articles of faith are that it is an existential threat, and the only solution is universal vaccination and surrender of our freedom to work, assemble, worship, travel, or even go outdoors without the approval of public health authorities.

One key feature of science that we should have learned in grade school seems to have been forgotten, albeit selectively: Experiments need to have a control group.

Ancient or medieval physicians may have said that bleeding and purging cured disease. The only time these cures didn't work was when the patient was too far gone to be saved. The science was settled; no control group needed.

Doctors may like to imagine that we have godlike powers, but in fact we can never know what would have happened had we done something different.

That's the reason why studies of medical treatment must have a control group. The "gold standard" is a double-blind randomized controlled trial (RCT) to correct for observer bias and the placebo effect. Giving a fake medicine (placebo) sometimes helps.

Any experiment can have two types of error. Type I error "finds" a difference between the treatment and control group just because of random variation. A type II error fails to find a sufficiently large difference to reach "statistical significance" even though one exists. Studies need to be adequately "powered" – have an adequate number of subjects – to minimize type II error. A power of less than 80% is generally considered unacceptable. A study that is too small is called "underpowered."

Ideally, there should be a 50:50 allocation of treated and control subjects. If only 30% of subjects are in the control group, the study loses significant power. If only 10% are in the control group, the power of the study is only 40 to 60%, writes Mark H. White, II, Ph.D. At the moment, about 30% of Americans have not taken the COVID vaccine. And government keeps trying to reduce that percentage to as close to zero as possible.

There was a 50:50 allocation in the preauthorization studies of the COVID vaccines. But the blinding has been broken, and those who received placebo are now eligible to receive active vaccine. Thus, there is virtually NO control group for potential late adverse consequences.