Apples, oranges and how not to analyze a vaccine RCT

dr. Peter Doshi, associate professor of pharmaceutical health services research, is known to readers of: SBM as someone who starts with the premise that vaccines are unsafe and ineffective, and then works backwards to find the evidence. His most recent attempt at torturing data to support his preconceived conclusions was a preprint entitled “Serious Adverse Reactions of Special Concern Following mRNA Vaccination in Randomized Trials”. This article analyzed both the Pfizer and Moderna RCTs and predictably concluded:

The additional risk of serious adverse events of special concern exceeded the risk reduction for COVID-19 hospitalization compared to the placebo group in both the Pfizer and Moderna studies.

That sounds bad, and sheltered virus supporters were eager to spread this message far and wide (here and here

At first glance, it seems easy to count the harm suffered by those in the vaccine and placebo groups as a reasonable approximation. But is it? Well, it all depends on how those damages are counted and for how long they are counted.

dr. Susan Oliver, a scientist studying nanomedicine at the University of New South Wales, made a short, must-watch: video to expose the statistical deception that Dr. Doshi used to come to his conclusions. dr. David Gorski also discussed the tricks of Dr. doshi. Both Drs. Oliver and Gorski noted that Dr. Doshi in determining “how this damage is counted” made sure to inflate the potential damage from the vaccine relative to the damage from the virus. A single person who had gastroenteritis and abdominal pain after vaccination was counted with two side effects, while someone who was hospitalized with COVID was counted once, even if they experienced a large number of serious complications in the hospital.

Beyond this, Dr. Oliver and Gorski discovered an even bigger problem. They realized that the entire article by Dr. Doshi was an exercise in comparing apples to oranges. To understand why, let’s briefly review the key results of the original late 2020 COVID vaccine RCTs.

  • In the Pfizer RCT, 21,720 people received the vaccine and 21,728 received a placebo. There were 162 cases of COVID in the placebo group and 8 in the vaccine group. There were 10 cases of severe COVID, 9 in the placebo group, 1 in the vaccine group.
  • In the Moderna RCT, there were 15,210 participants in the vaccine and placebo groups. Symptomatic COVID occurred in 185 participants in the placebo group and in 11 participants in the vaccine group. Severe COVID occurred in 30 participants, with one fatality, all in the placebo group.

We must now recognize two important points. First, depending on how quickly a virus spreads, the benefits of a vaccine can take many months, even decades. Second, almost all vaccine damage occurs immediately after vaccination. Someone who analyzed the RCTs after a week would find that the vaccine made a lot of people feel unwell, while preventing zero cases of COVID. In all vaccine RCTs, the harm is preloaded, while the benefits gradually increase over time. Just look at those famous charts from the COVID RCTs to see how clear this is. Each month, the benefits of the vaccine got bigger and bigger — and the trial lasted only a few months. In contrast, I can confidently say that little new damage from vaccines was reported at the end of the trial.

As a result, an RCT would need to take time to adequately reap the benefits of the vaccine the whole pandemic. As more and more people were exposed to the virus, the vaccine’s benefits over placebo would grow and grow, even as the vaccine’s efficacy declines. If the trial had lasted two years, there would be a lot more cases of severe COVID, especially in the unvaccinated cohort. Like dr. Oliver noted, an alternative to a pandemic RCT would be a challenge study. Deliberately exposing participants to the virus would also lead to a comparison between apples Dr. Doshi claims to have.

The raw numbers from the RCTs explain another problem with Dr. Doshi naked. The number of participants who received the vaccine was: much bigger than the number of participants exposed to the virus. In these two studies, there were 74,000 participants, 36,930 of whom received a vaccine, while only 366 of them had COVID. The vaccine had much more potential than the virus to make people feel rotten during the RCT.

This was no accident. The RCTs are designed to end when a certain number of people contract COVID. According to the Moderna protocol, “The primary analysis will be performed when approximately 151 cases have been observed in the study,” while the Pfizer protocol has set “a target of 164 primary endpoint cases of confirmed Covid-19.” So by design, the trials were closed before the virus was allowed to harm more than a few hundred people.

Remarkably, almost all of those harmed by the virus were in the placebo group. There were 40 cases of severe COVID, all but one unvaccinated. That is quite a bit given that many more of those 74,000 trial participants have now contracted COVID.

Of course, once this protection against severe COVID was known, it would have been unethical to continue the trial and leave people unvaccinated. That’s where the tests were supposed to end. When Dr. Doshi claims his “results show an additional risk of serious adverse events of special concern that is greater than the reduction in COVID-19 hospitalizations in both the Pfizer and Moderna studies,” he does not acknowledge that these studies were terminated. precisely because those hospital admissions started to accumulate. The trials were meant to stop once a small number of people got COVID, and Dr. Doshi twists this to claim that COVID was not much of a threat. He reversed cause and effect. His “finding” was an unsurprising, if not inevitable, result of the way these studies were designed.

The study of Dr. Doshi would only be of value if the virus no longer poses a threat or if the vaccine is of no use once the RCT ended. Of course, even this fantasy would require him to add up the damage in a balanced way.

After the RCTs ended, some important things happened. First, the virus spread everywhere. In the RCTs, there were 100 vaccinated people for every person who had COVID. That ratio is very different now, and this makes Dr. Doshi’s method of counting damage completely obsolete. Second, there were worse variants, and these too make Dr. Doshi nullify. Had these RCTs been conducted when Delta was in circulation, there would have been more than 40 cases of severe COVID, mostly in the unvaccinated group. This is because, although the vaccine’s effectiveness against symptomatic infection decreased dramatically, the vaccine retained much of its benefit in preventing serious consequences, especially when supplemented with a third dose.

This technique of minimizing the benefits of vaccines by focusing only on RCTs of relatively short duration is well known among vaccine advocates. In my previous article on methodolatry, the inappropriate worship of RCTs alone, I described how anti-vaxxers like to point out that the HPV vaccine has never been shown in an RCT to prevent cancer. They are right. But it was never a big leap to speculate that a vaccine that prevented HPV infection and precancerous lesions in an RCT would eventually be shown to prevent HPV-related cancers. Indeed, there is now overwhelming evidence from observational studies that this is the case.

That’s why honest brokers don’t limit themselves to RCTs when evaluating vaccines. While observational studies are subject to more bias and cannot definitively determine causality, unlike most RCTs, they can evaluate large numbers of people over a long period of time. As a result, they can reveal many things that RCTs cannot. We learned a lot more about these vaccines from observational studies and billions of doses over two years than from the RCTs, where only 36,930 people received a vaccine and only 366 people contracted COVID.

Anti-vaxxers are perfectly content to promote observational data as long as it claims to expose vaccine shortcomings. dr. In particular, Doshi cited non-RCT data, including a VAERS dumpster dive, to highlight rare side effects of vaccines. By contrast, observational data is out of the question for anti-vaxxers if they show that vaccines are safe and effective. dr. Doshi failed to refer to a only non-RCT showing the benefits of the vaccine in his paper.

There is no shortage of such studies. The evidence is overwhelming that COVID vaccines are very safe and keep people alive and out of the hospital. Only someone who starts out with the conclusion that vaccines don’t work and then works backwards to find the evidence can argue otherwise.

  • dr. Jonathan Howard is a neurologist and psychiatrist based in New York City who has been interested in vaccines long before COVID-19.

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