Blind Study 8/22/20

Thoughts by Richard Bleil

These odd times just keep coming. I’m not supposed to discuss this in a public forum, but considering how few people actually read my blog, I think I’m safe to discuss it here. But, frankly, I’m not going to give any details that I think they would rather avoid leaking. Today, I continued with the Covid-19 experimental vaccination.

This study, like so many studies before it, is a “double-blind” study. This is designed to avoid human bias in interpretation of the results. The reality is that, as humans, we want to succeed, and even without meaning to we have a propensity to view things through, well, let’s say “rose colored glasses”. I’m sure we’ve all experienced it; I was thinking about starting a business, and asked God for a sign, and the next song that played could be vaguely interpreted through a business perspective. So, of course it was a sign. Or was it just my mind finding what it wants to find?

The problem in a scientific study like this one is that those human biases could result in approval of a vaccine that is ineffectual or worse. So how is it done?

“Double Blind” means that nobody knows if I was vaccinated with the true vaccine, or if I received a placebo. Here’s how it works; each approved participant (which, of course, I was) receives a shot. The placebo looks just like the vaccine, so you can’t tell by inspection which you received. Half of the participants received the real vaccine, and half received the placebo, but the participants do not know which they did receive.

The “Double” part of the double-blind study means that the people conducting the test do not know if I received the vaccine or the placebo either. The people performing the test received a series of shots, each with a unique identifying number, but not indication of placebo or vaccine. Where the shots were prepared, a computer assigned the numbers and tracks which is placebo and which is vaccine, but when they sent it out, even the people preparing the injections did not know which is which. On this end, the investigating team did the same thing; a computer is tracking my patient number, and randomly assigned the injection number. So, somewhere, a computer knows which is which, but the people running the investigation, and the participants like me, do not know which we received as individuals.

Let’s make numbers simple. Let’s say that there are 20,000 participants in this study. In that case, there are 10,000 placebos and 10,000 vaccinations. Now, let’s say that in this study period, about 2% of the general population will become infected with the Coronavirus. That means that we can expect 200 people in the placebo group to become infected. Now, a vaccination does not guarantee that those inoculated will not become infected, but hopefully fewer will. So, for example, suppose 200 in the placebo test become infected, but only 50 in the vaccination group do. Then the odds of becoming infected with Covid-19 can be assumed to reduced by about 75%.

If the number of people in the vaccination group is not statistically significantly lower (say 187 become infected which is about the same number despite the fact that it is lower), then the vaccination is not effective. If the number of infected from the placebo group is significantly lower than expected (say only 68), then there is something wrong with the study, or the placebo effect has influenced the results. As they are gathering the results, only then will they access the computer to figure out which patient belonged to which group.

Of course, at the same time, they also track side effects. So, they ask us to routinely report of several potential side effects; the skin turns some strange color like plaid, or another arm grows out of one of the current three, that kind of thing. So, they report the percentage chance of one of these side effects.

In the end, the FDA will look at the results, and compare the efficacy of the vaccine against the potential side effects, which, yes, can include death as any medication can. Of course, people also die from Covid-19, so approval is based on relative risks of death from the vaccine and the risks of death from catching and dying from the virus. If the risks are significantly reduced with the vaccine, then it is approved.

So why participate in a study like this? Well, my regular readers know that I’m big on service to others. That’s the main reason. Yes, there is some small financial compensation, but mostly, we need a weapon to use against this disease. This is my way of helping to find it. Even if the vaccination fails, we’ll know that it’s not what we’re seeking.

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