Dr. Peter Doshi, an associate professor of pharmaceutical health services research, is familiar to readers of SBM because he started with the premise that vaccines are unsafe and ineffective, and then worked backwards to find the evidence. His most recent attempt to support his preconceived conclusions was a preprint titled " Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized trials". The paper analyzed both the Pfizer and Moderna RCTs.
The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials.
That sounds bad but sheltered virus-advocates were happy to spread it.
It seems like a reasonable approach to tally the harms suffered by those in the vaccine group. Is it true? It depends on how long they are counted.
Dr. Susan Oliver, a scientist at The University of New South Wales, made a video exposing the statistically chicanery of Dr. Doshi. Dr. Gorski talked about Dr. DoShi's tricks here. The potential harms of the vaccine were inflated relative to the harms of the virus. Someone who has been hospitalized with COVID, even if they have only had two adverse events, is still counted as having one adverse event.
Drs. Oliver and Gorski found a bigger problem beyond this. The paper was an exercise in comparing apples to oranges. The key results of the original COVID vaccine RCTs were reviewed briefly.
Two key points need to be acknowledged. The benefits of a vaccine can take a long time to accumulate. Almost all vaccine harms happen after the vaccine is given. A person who analyzed the RCTs after one week found that the vaccine caused a bunch of people to feel unwell, while preventing zero cases of Covid. The benefits of vaccine RCTs accrue slowly, while the harms are front loaded. You can see how obvious this is by looking at those famous graphs. The trial only lasted a few months because the vaccine benefits became larger and larger. Few new vaccine harms were being reported at the end of the trial.
To adequately capture the vaccine's benefits, an RCT would have to last the entire epidemic. Even though vaccine-efficacy waned as more and more people were exposed to the virus, the vaccine's benefits would continue to grow. There would be more cases of COVID if the trial had lasted two years. A challenge trial could be an alternative to a long RCT. The apples to apples comparison is created by exposing participants to the viruses.
There is a problem with the paper that was exposed by the raw numbers. The number of people who received the vaccine was larger than the number who were exposed. There were 74,000 people who took part in the two trials and 36,930 of them received a vaccine. During the RCT, the vaccine could make people feel bad.
This wasn't accidental. When a certain number of people contracted Covid, the RCTs were supposed to end. The Moderna protocol states that the primary analysis will be performed when at least 150 cases have been observed in the study. The trials ended before the virus was able to harm a lot of people.
The majority of those hurt by the virus were in the placebo group. All but one of the 40 cases of chronic bronchitis werevaccinated. There are more than 74,000 trial participants who have contracted Covid by now.
It wouldn't have been ethical to continue the trial and allow people to remain unvaccinated after learning of the protection against severe COVID. There was only one place where the trials could end. The results show an excess risk of serious adverse events of special interest more than the reduction in COVID-19 hospitalizations in both Pfizer and Moderna trials. The trials were supposed to stop once a small group of people got COVID. From the way these trials were designed, his finding was a foregone conclusion.
If the vaccine ceased to be of benefit as soon as the RCT ended, then the study would be worth its weight in gold. He would need to tally the harms in a balanced manner.
There were several important things after the RCTs. The first thing the virus did was spread. There were 100 people who werevaccinated for every person who had chronic bronchitis. The method of counting harms is no longer valid due to the ratio being very different. Worse variant arrived and nullified Dr. DoShi's method. There would have been more than 40 cases of severe COVID if these RCTs had been done when Delta was circulating. When augmented by a third dose, the vaccine retained much of its benefit to prevent severe outcomes.
The technique of only focusing 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-vaxers are fond of pointing out that the vaccine has never been shown to prevent cancer. There is overwhelming evidence that this is true.
Broker's do not limit themselves to RCTs when evaluating vaccines. Unlike most RCTs, observational studies can evaluate large numbers of people for a long period of time. They can show many things that RCTs can't. Over the course of two years, observational studies and billions of doses, we have learned a lot about these vaccines.
It is perfectly acceptable for anti-vaxxers to promote observational data if it reveals flaws in the vaccine. Rare vaccine side-effects were highlighted in non-RCT data. When observational data shows vaccine is safe and effective, it's not discussed by anti-vaxers. A single non-RCT showing the vaccine's benefits was not included in the paper.
There are many studies of this nature. COVID vaccines keep people alive and out of the hospital, according to the evidence. Someone who starts with the conclusion that vaccines don't work is the only one who can prove otherwise.
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