When politics and science clash

We note that Florida Gov. Ron DeSantis has recently embraced COVID-19 vaccine skepticism, and has formed a statewide group to investigate vaccine “wrongdoing.” But in so doing, he is testing the limits of how far political interests can usurp the role of science.

Morton Tavel

First, let’s consider how new medical procedures and treatments are tested before reaching the public. After rigorous early testing for dangers in animal and/or human volunteer subjects, large numbers of volunteer humans are divided randomly into those receiving the active agents (in this case, vaccines) and results are compared to an equal number receiving an identical, but inactive, formulation of that product (the “placebo” group). The two groups are then evaluated statistically for both efficacy and side effects.

In the case of new COVID vaccines, those receiving the active product have shown a dramatic reduction of both those becoming ill and, most importantly, those dying. By most estimates, this vaccine has prevented approximately 18.5 million hospitalizations and overall national mortality by over three million, meaning that the dramatic efficacy of this vaccine is beyond question.

That brings us to DeSantis’ main issue: How dangerous is this vaccine, and how does it compare to the benefits just described? In order to gain better insight into the frequency of side effects resulting from the placebo (“dummy”) group, we cite a recent review of 12 studies including reports of over 45,000 trial participants undergoing vaccination against COVID-19. This study disclosed that. general adverse systemic reactions were experienced by 35 percent of placebo recipients after the first dose and 32 percent after the second. Those receiving the active vaccine experienced initially such symptoms in 46 percent. This means that at least 32 percent of all adverse effects could be attributable to the placebo (mental?) effect alone. The main adverse systemic effects in both placebo and vaccine groups were headaches, fatigue, nausea, diarrhea, malaise, joint pain, and headache, with both groups (placebo and vaccine recipients) showing no difference in severity of these symptoms. Such data strongly support the negative power of the placebo effect, which is similar to that observed in most drug trials.

Serious allergic reactions to both Pfizer and Moderna vaccines reportedly average between 2 and 10 per million doses. If this happens, health care providers can effectively and immediately treat these reactions. More common reports of inflammation of the heart muscle (myocarditis) or its coverings (pericarditis) are also rare and usually not severe. Reports of deaths after COVID-19 vaccination are also rare. The FDA requires health care providers to report any deaths after COVID-19 vaccination even if it’s unclear whether the vaccine was the cause. More than 657 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020, through Dec. 7, 2022. During this time, 17,868 preliminary reports of deaths (0.0027 percent) among people who had previously received COVID-19 vaccine, a percentage not significantly higher that those receiving placebos.

So from such data, what could an unqualified future “medical” panel conclude? Since at least 30 percent of all adverse reactions result from placebo (mental?) effects, will that lead to many anecdotal testimonials from individuals claiming to have been injured by “grievous” illnesses from the vaccines? Will the panel consider the enormous gulf between vaccine benefits and minimal dangers?

And would this group be led by Joseph Ladapo, a DeSantis appointee surgeon general of Florida, who has promoted disproved treatments such as hydroxychloroquine and ivermectin, questioned the safety of masking and vaccines, opposed lock-down mandates, and associated with America’s Frontline Doctors — a far-right group known for promoting falsehoods about the pandemic? And more to the point: Should DeSantis be considered as a potential U.S. president?

Morton Tavel, M.D., of Fort Myers is Clinical Professor Emeritus, Indiana University School of Medicine.