Randomized-controlled trials and vaccines
“The randomized controlled clinical trial is the gold standard of scientific evidence. When regulators approved the Pfizer and Moderna mRNA vaccines for emergency use in December 2020, two randomized trials showed that the vaccines reduced symptomatic covid infection by over 90% during the first few months after the second dose. Pfizer and Moderna did not design the trials to evaluate long-term efficacy or the more important outcomes of preventing hospitalization, death, or transmission….
It is the responsibility of the manufacturers and FDA to ensure that the benefits outweigh the harms. They have failed to do so.
That brilliant insight comes from an article titled, “Are the Covid mRNA Vaccines Safe?” by Dr. Martin Kulldroff of the Great Barrington Declaration. Had we listened to him and let the virus run rampant in unvaccinated children, the pandemic would have been over last year. Unfortunately, some fools tried to vaccinate children, and as a result, COVID is still with us. Thus it falls upon Dr. Kulldroff to remind us of something important. we have no idea if the COVID vaccines prevent hospitalizations or death. The randomized controlled trials (RCTs) were too small to assess these key metrics. There is zero “gold standard scientific evidence” that the COVID vaccines help anyone.
Although I’m sure you’ve seen vaccine-zealots claim otherwise, the only “evidence” they have to back their assertions comes from observational data. This kind of research can be summarized as “a bunch of stuff doctors say they saw.” While observation data is suitable for making YouTube videos about vaccine side-effects, it cannot be used to “support vaccines”. In an article supporting pediatric COVID infections, Dr. Vinay Prasad explained why.
Observational data has been used to support vaccines, but is plagued by confounding. That is because parents who vaccinate their children are different from those who don’t. The same studies could show that driving a baby home from the hospital in a Mercedes is better than a Ford.
He’s exactly right, and all observational studies used to justify the COVID vaccine can be summarily discarded. Of course, this logic applies to all vaccines. For example, the observational data that purports to show the HPV vaccine prevents cancer is similarly plagued by confounding. That is because parents who vaccinate their children are different from those who don’t. The same studies could show that driving a baby home from the hospital in a Mercedes is better than a Ford.
Randomized-controlled trials and SARS-CoV-2
Reasonable people know that the same standards of evidence should apply to both the vaccine and the virus. Certainly, one would expect highly-credentialed doctors to be aware of this fact. Unfortunately, they are not.
In an essay titled “The Ill-Advised Push to Vaccinate the Young” Dr. Kulldorff declared, “the old have a thousand-fold higher mortality risk than the young.” Similarly, in an essay titled, “Kids Don’t Need Covid-19 Vaccines to Return to School” Dr. Prasad wrote, “The risk of an 85-year-old dying from Covid-19 is 7,500 times greater than that of a 10-year-old.” Don’t get me wrong, if older people indeed have a higher mortality risk than young people, there is no need to protect young people. However, given their sophisticated understanding of the limitations of observational studies, I was dismayed to learn that neither Dr. Kulldorff nor Dr. Prasad supported their statements with data from an RCT. Although they both make confident claims about the virus all the time, not once have they referenced the “gold standard of scientific evidence”.
After scouring the medical literature, I know why. It’s medicine’s dirty little secret. There are no RCTs of SARS-CoV-2.
I know this may shock people outside the medical community. They naively believe that when doctors make assured statements about the virus being more dangerous for elderly people, these claims are based on the “gold standard of scientific evidence.” However, it’s an open secret among doctors that nothing we say about the virus comes from an RCT.
And the public is asked to believe a great many things about the virus absent this gold standard of scientific evidence. Those with: underlying medical conditions are more vulnerable. Children are mostly spared. The virus causes respiratory difficulties. It is dangerous for pregnant women. Natural immunity protects against reinfection. It is contagious.
These claims certainly sound plausible, and they may even be true. However, with zero RCTs to guide us, we really have no idea. Despite this, Drs. Kulldorff and Prasad are happy to pontificate widely on the virus based on observational data that is plagued by confounding.
This is a travesty. The public has the right to the gold standard scientific evidence for both the vaccine and the virus. While no doctor would disagree with this, I’ve not seen one call for an RCT of the virus itself. That changes today. Before we make any more decisions this pandemic, we must end the ignorance. We must conduct large, long-term RCTs of SARS-CoV-2. I am amazed this is controversial in the medical community.