The FDA Is Broken!

The FDA is broken

By: Henry F. Smith, Jr., M.D.

The FDA is broken. In a three-year span, they have morphed from a regulatory agency that set the standard for the world to an illogical, incompetent, and apparently corrupt organization running interference for big Pharma. Three of their recent inane decisions illustrate this metamorphosis.

It is understood that the current inoculations for COVID-19, are not functional as vaccines. At best, they might be attenuating the severity of infections. Dr. Fauci himself recently acknowledged this.  It has been accepted for years that coronaviruses make poor subjects for vaccines given their tendency to mutate rapidly. If there was any doubt of this, SARS co-V2 has proven this tendency.

It’s one thing for the vaccines to be ineffective. It is entirely another problem that they are, by the CDC’s own data, responsible for more adverse effects, and deaths in the 18 months they have been in use than all the 26 other vaccines monitored for the last 30 years.

A functioning FDA would recognize this and put a halt to the current vaccines which are not only dangerous but designed for a virus that essentially no longer exists. In fact, the drug companies themselves are discussing the need for an updated vaccine for the omicron variants. The vaccine they propose will target the first omicron variant, which has since mutated to multiple new sub-variants.

But these vaccines are huge profit centers for the pharmaceutical industry. So the FDA continues this charade, with the vaccine advisory committee recently voting 21/0 to approve the use of the current ineffective vaccines to immunize children between six months and five years of age – a group for whom the risk of significant illness and death from COVID-19 is near zero.

The FDA used to maintain strict oversight over the vaccine industry. This is why would take roughly five years to move a vaccine to “approved” status. It takes time for long-term safety data studies. Because of this, vaccine safety in the United States was impressive. And also because of this, it was impractical to even think about vaccinating for rapidly mutating organisms.

But the COVID vaccines were approved in about six months. And vaccine safety has gone to hell

The current FDA also voted on new vaccine proposals from Pfizer and Moderna. They have proposed a bivalent vaccine that includes mRNA code for protein specific for omicron. The committee voted 19 to 2 to approve what is essentially a modification of the existing products. The drug companies stated that they can probably make the product available by October. So once again, we create essentially a new vaccine that includes different mRNA coding for different proteins, one we may be compelled to take, with none of the previous precautions that kept us safe. We already know how that turns out.

Finally, we have another of Pharma’s favorite tools, Emergency Use Authorization. According to the FDA, an EUA is granted when “there are no adequate, approved, and available alternatives”. Here the FDA has completely lost its way. In this case, they inexplicably granted emergency authorization to Novavax’s new COVID vaccine. They did this despite the fact that there are already two formally approved vaccines.

I have nothing against the Novavax product. In fact, it uses a more time-worn technology and might even be a little safer than the mRNA vaccines. Unfortunately, it still involves the spike protein (which is arguably toxic), it is still targeted at the original coronavirus and it also seems to cause myocarditis in young men. There was absolutely no reason for it to be rushed into service.

Regulatory capture is an economic theory that regulatory agencies may come to be dominated by the interests they regulate and not by the public interest. The result is that the agency instead acts in ways that benefit the interests it is supposed to be regulating. Certainly, the FDA appears to be behaving in a way that brings this theory to life. With behavior that is this egregious, it is impossible to trust in the medications and vaccines that the agency approves. For this physician, this is a national crisis.

COVID-19 was never a good candidate for a vaccine strategy. Undoubtedly the pharmaceutical industry understood the science, but also could not resist the potential for an enormous profit. And I think they knew the FDA would play along.

Boy, did they ever.

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