Does the FDA Have a Drug Problem?


It’s not a good look these days at the Food and Drug Administration.

Former U.S. Surgeon General Jerome Adams was quoted in Forbes saying the “quickest path” to herd immunity against COVID-19 in many U.S. communities is “organizational vaccine mandates, but lack of FDA licensure leaves schools, colleges, businesses in a legal quandary.”

In other words, organizations that might mandate the COVID-19 vaccine are hesitant to do so because they might face lawsuits if the vaccine isn’t fully approved.

The COVID-19 vaccines now on the market under the banner of “emergency authorization” by the FDA have proven to be remarkably effective.” Jeff Zients, the White House COVID-19 response coordinator, told NPR, “Unvaccinated Americans account for virtually all recent COVID-19 hospitalizations and deaths.”

The sudden rise in cases across the country is being called a “pandemic of the unvaccinated.”

And yet, the FDA is not taking the step of officially approving the COVID-19 vaccines. About a third of the people who are refusing to be vaccinated say they are apprehensive over a vaccine that has not received full approval. (I think the other two-thirds are fans of Tucker Carlson, who has often ranted against the safety and efficacy of the vaccines.)

But you can understand the FDA insisting on following policies and procedures, requiring that all the data is submitted and thoroughly analyzed, and making sure that the vaccines are safe, effective, and do what they’re intended to do. Which apparently they do, but that’s not the point.

The FDA is a mess right now, with no confirmed commissioner and facing accusations of corruption. This is the same agency that recently fast-tracked full approval of Biogen’s drug Aduhelm, for the treatment of Alzheimer’s disease. The drug reduces a brain plaque associated with Alzheimer’s, although clinical trials haven’t shown the medication can control or halt or even slow down the disease itself. But that’s nitpicking.

Multiple members of a committee that advised the FDA on Aduhelm resigned from their positions following FDA granting approval to the drug. It also turns out that Biogen and the FDA have worked very closely on the approval process, going so far as to collaborate on presentations and coordinate messaging. Could it be the regulators and the regulated have hopped into bed together? Could some dollars be exchanging hands?

Speaking of dollars, Aduhelm costs $56,000 a year. Potential side effects include brain swelling and brain bleeding. Potential benefits include . . . well, I haven’t really read about any.

On the other hand, the most common side effects of a COVID-19 vaccine are a sore arm where you got the shot and brief flu-like symptoms.

What the hell is the FDA doing? Personally, I think they’re doing drugs. Bad ones. It’s time for an intervention.

By David Klein

David Klein

Published novelist, creative writer, journalist, avid reader, discriminating screen watcher.


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