Apples, oranges and how not to analyze a vaccine RCT

Apples, oranges and how not to analyze a vaccine RCT

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Dr Peter Doshiassociate professor of pharmaceutical health services research, is familiar to readers of SBM as someone who starts with the premise that vaccines are neither safe nor effective, and then works backwards to find the evidence. His most recent attempt to torture data to support his preconceived conclusions was a preprint titled “Serious adverse events of particular concern after mRNA vaccination in randomized trials“. This paper reviewed RCTs from Pfizer and Moderna and, unsurprisingly, concluded:

The excess risk of serious adverse events of special interest outweighed the reduction in risk of hospitalization for COVID-19 relative to the placebo group in the Pfizer and Moderna trials.

That sounds bad, and sheltered virus advocates were happy to spread this message far and wide (here Y here).

At first glance, simply tallying up the damage suffered by those in the vaccine and placebo groups seems like a reasonable approach. But is it? Well, it all depends on how those damages are counted and how long they are counted for.

Dr Susan Oliver, a scientist studying nanomedicine at the University of New South Wales, made a brief and essential video he goes on to expose the statistical trick that Dr. Doshi used to reach his conclusions. Dr. David Gorski also discussed Dr. Doshi’s tricks here. Both Drs. Oliver and Gorski noted that by determining “how these harms are counted,” Dr. Doshi ensured that potential harms from the vaccine were inflated relative to harms from the virus. A single person who had gastroenteritis and abdominal pain after vaccination was counted as having two adverse events, while a person hospitalized with COVID was counted once, even if they experienced a multitude of serious complications in hospital.

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

  • In the Pfizer RCTs, 21,720 people received the vaccine and 21,728 received 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 were in the placebo group, 1 in the vaccine group.
  • In the modern RCT, there were 15,210 participants in the vaccine and placebo groups. Symptomatic COVID occurred in 185 participants in the placebo group and 11 participants in the vaccine group. Severe COVID occurred in 30 participants, with one death, all in the placebo group.

Now we must recognize two key points. First, depending on how fast a virus spreads, the benefits of a vaccine can take many months, even decades, to accrue. Second, nearly all vaccine damage occurs right after after vaccination. Someone looking at RCTs after a week would find that the vaccine made a lot of people feel sick, while preventing zero cases of COVID. In everybody In vaccine RCTs, harms are anticipated while benefits accrue gradually over time. Just look at those famous charts of the COVID RCTs to see how obvious this is. Each month, the benefits of the vaccine grew larger and larger, and the trial only lasted several months. On the contrary, I can confidently state that few new vaccine harms were reported at the end of the trial.

As a result, to adequately capture the benefits of the vaccine, an RCT would have to last the entire pandemic. As more and more people were exposed to the virus, the benefits of the vaccine relative to placebo would grow and grow, even as the effectiveness of the vaccine declines. If the trial had lasted two years, there would have been Many more cases of severe COVID, especially in the unvaccinated cohort. As Dr Oliver pointed out, an alternative to an RCT of pandemic duration would be a challenge trial. Intentionally exposing the participants to the virus would also create the apples-to-apples comparison that Dr. Doshi pretends to have.

The raw numbers from the RCTs expose another problem with Dr. Doshi’s article. The number of participants who received the vaccine was much larger than the number of participants who were exposed to the virus. In these two trials, there were 74,000 participants, 36,930 of them received a vaccine, while only 366 of them had COVID. The vaccine had much more opportunity than the virus to make people feel sick during the RCT.

This was not an accident. RCTs were designed to end when a certain number of people contracted COVID. According to the modern protocol“The primary analysis will be done when approximately 151 cases have been observed in the study”, while the Pfizer protocol set “a target of 164 primary endpoint cases of confirmed Covid-19.” So, by design, the trials were concluded before the virus was allowed to harm more than several hundred people.

Notably, 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’s a big deal considering many more of those 74,000 trial participants have already contracted COVID.

Of course, once this protection against severe COVID was known, it would have been unethical to continue the trial and allow people to remain unvaccinated. The trials had to end there. When Dr. Doshi states that his “results show an excess risk of serious adverse events of special interest greater than the reduction in COVID-19 hospitalizations in the Pfizer and Moderna trials,” he fails to acknowledge that these studies ended precisely because those hospitalizations started piling up. The trials were designed to stop once a small number of people contracted COVID, and Dr. Doshi turns this on its head to say that COVID was not much of a threat. It has reverse cause and effect. His “discovery of it” was a completely surprising, if not inevitable, result of the way these essays were designed.

Dr. Doshi’s study would be valuable only if the virus ceased to be a threat or the vaccine ceased to be beneficial as soon as the RCT ends. Of course, even this fantasy would require him to count damage in a balanced way.

Several important things happened once the RCTs ended. First, the virus spread everywhere. In the RCTs, there were 100 people vaccinated 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, worst variants they arrived, and these also nullify Dr. Doshi’s counting method. If these RCTs had been done when Delta was running, there would have been more than 40 cases of severe COVID, mostly in the unvaccinated group. This is because, although the vaccine’s efficacy against symptomatic infection decreased dramatically, the vaccine retained much of its benefit in preventing serious outcomes, especially when supplemented with a third dose.

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

Given this, honest brokers are not limited to RCTs when evaluating vaccines. Although observational studies are subject to more bias and cannot conclusively determine causality, unlike most RCTs, they can assess large numbers of people over long periods of time. As a result, they can reveal many things that RCTs cannot. We have learned much more about these vaccines from observational studies and billions of doses over two years than from RCTs, where only 36,930 people received a vaccine and only 366 people got COVID.

The anti-vaccines are perfectly happy to promote observational data, as long as they purport to reveal the flaws in vaccines. In particular, Dr. Doshi cited non-RCT data, including a VAERS dumpster divingto highlight weird vaccine side effects. In contrast, observational data is unmentionable for anti-vaccines when it shows that vaccines are safe and effective. Dr. Doshi forgot to refer to a unique no RCT showing the benefits of the vaccine in their article.

Studies of this type are not lacking. the evidence is oppressive that COVID vaccines are very safe and keep people alive and out of the hospital. Only someone who starts with the conclusion that vaccines don’t work and then works backwards to find the evidence could claim otherwise.

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


#Apples #oranges #analyze #vaccine #RCT

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3 thoughts on “Apples, oranges and how not to analyze a vaccine RCT

  1. At first I wasn’t sure I would be able to go through a post as long. Your style certainly attracted my fascination. Your content is always outstanding. Great Article Neil. Although I had read the article a few days ago, I did not comment. However, I believed it was worthy of a”thank you. I will be using the tips in my own sites in the near future.

  2. I wasn’t sure I could write this kind of article at the beginning. Your writing style impressed me. You came again with an outstanding content as usual. Great Article Neil. While I did read it a few months ago, I didn’t make an opinion. However I felt the article was good enough to warrant a mention.

  3. At first I was skeptical I would be able to read such a lengthy post. Your style captivated my attention. You came again with an excellent article as always. Great Article Neil. Although I had read the article a few days ago, I did not leave a comment. However, I believed it was worthy of a mention in a thank-you. I’ll use the tips in my own sites very soon.

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