Tuesday, August 02, 2022

Unless governments get properly involved, the questions around Covid vaccine safety will NEVER be answered; but governments have every incentive not to get properly involved

 

From Alex Berenson:

The mRNA vaccines are now a national-level problem.

Under normal circumstances, regulators can collect - or make drug companies collect - data adequate to determine if a drug is safe. The process is imperfect, but it generally works. The pharmaceutical company Merck stopped selling the painkiller Vioxx after data from a clinical trial that Merck itself ran showed that Vioxx increased the risk of heart attacks.

In the case of opioids, as regulators failed, prosecutors, the Drug Enforcement Administration, and state attorneys general have stepped in. Opioids remain an enormous problem in the United States, but no one can claim their risks are unknown at this point. The companies that did the most to fuel the prescribing frenzy that began two decades ago have been punished. Among them, Purdue Pharma is bankrupt, and Insys Therapeutics no longer exists, its chairman - once a billionaire - now serving a 5 1/2 year federal prison sentence.

The mRNA Covid shots are a much higher class of problem.

More than 200 million Americans and more than 1 billion people worldwide - the vast majority of the adults in the world’s advanced industrial nations - have received them. Put aside questions of effectiveness, whether the vaccines actually work against Covid and for how long. Look at solely at their safety.

Are they safe long-term?

Under normal circumstances, we would have robust clinical trial data to help answer that question. We would have two groups of thousands, or in this case tens of thousands, of people who had been carefully matched and then randomly chosen to receive either the vaccine or a placebo.

We could follow them for years to see how they fared, whether they wound up getting Covid (at this point nearly all of them have gotten Covid) and even more importantly how their overall health changed.

We can’t do that for these vaccines.

Why?

In early 2021, just a few months after the big clinical trials started, Pfizer and Moderna offered their shots to the people in the placebo arms of the trials - those who had initially received saline instead of mRNA. And almost all those people agreed to get the jabs.

That move essentially ended the clinical trials, because it meant the companies and regulators didn’t have a clean comparison group anymore. Everyone in the trial had received the vaccine.

Regulators allowed this move, on the theory that the vaccines had already been proven safe, that long-term problems were very unlikely, as they are with older and conventional vaccines. Thus no one needed to collect long-term data comparing the two groups. Denying the placebo trialists access to the shots would be unethical.

The theory was nice. But it ignored a couple of minor facts. The mRNA vaccines worked in a completely different way than other vaccines. They had shown evidence of toxicity with repeated use. And they had never been used before in humans outside of a handful of clinical trials.

Blowing up the trials was the regulatory equivalent of deciding we didn’t need long-term studies on statins because we already had them on beta-blockers, and those are both heart medicines.

It was a shockingly bad decision, and its cost has risen every day. 

GO READ THE WHOLE THING

No comments: