LinkedIn censored me last night – took down a link to this post without notice or explanation. I’d liken the experience to when my house was broken into a few years ago. Break-ins are rampant in my neighborhood, so I knew it was inevitable, but I still got a very sick feeling when I came home and found my glass door smashed to smithereens.

My first inclination was to avoid writing about vaccines. LinkedIn is the only social media I use to market my blog, so it makes practical sense to avoid subjects that risk getting me kicked off the site. But writing a blog aimed to please LinkedIn censors makes no practical sense either, as it would give me no pleasure posting articles giving tips on how to achieve happiness. (“Happy people think happy thoughts”) and other related subjects that invariably make me more dour. I will keep posting on what interests me, even if my readership dwindles to me and my lonesome. (If I post a blog and no one reads it, did it make a sound?)

Vaccines are still very much on my mind. The Wall Street Journal’s story about the FDA’s approval of Pfizer’s vaccine this morning drove home how differently I view the world. The article destroyed my secret hope that maybe, just maybe, the FDA was this independent agency staffed with altruistic medical experts and scientists whose mission in life is to save and protect humankind. Although there is compelling evidence the agency is rife with employees looking to leverage their regulatory experience into a lucrative corporate gig, it would be nice to believe that with regards to a vaccine, particularly one where doctors who question its safety are threatened with license suspension and other punitive measures, the FDA is above politics and PR.

My sense after reading the Journal’s story is that the FDA’s vaccine approval process is akin to processing passport applications, albeit with a lot more paperwork. The article left me so cynical that it wouldn’t surprise me if the required educational background to become an FDA vaccine expert is an online course in biochemistry and a reading of “Microbiology for Dummies.” I’m curious if some of the FDA officials who implicitly blessed Theranos’ blood-testing technology might be involved on the Pfizer approval team.

Indeed, maybe Theranos founder Elisabeth Holmes might be a good candidate to succeed FDA’s acting Commissioner Janet Woodcock if she can convince jurors of her innocence at her upcoming fraud trial. The Biden Administration has let it be known that Woodcock is a dead woman walking, going down because of the questionable approval of an Alzheimer’s drug under her watch. Woodcock has asked the inspector general to investigate, which suggests there might be more to the story than publicly known.

Allow me to walk you through portions of the WSJ story that undermined my confidence in the Pfizer approval process.

The FDA, under pressure to give Covid-19 vaccines full approval swiftly, made its decision less than four months after Pfizer began its approval submission. The process of reviewing applications normally takes up to approximately 10 months.

Pfizer and BioNTech submitted some 340,000 pages as part of their approval application—more than three times the size of the emergency-use authorization submission—and included longer-term clinical trial data …

The Journal acknowledges that the FDA was under pressure to approve the Pfizer’s vaccine “swiftly.” It also reports that Pfizer submitted 340,000 pages of data that under a normal review process would take approximately 10 months. The FDA shaved more than six months off its normal review process. Were more people assigned to the process? Did the vaccine investigators take a speed-reading course? I’d welcome knowing how many people were involved in reading 340,000 pages of data. By means of comparison, “War and Peace” runs a paltry 1,225 pages.

The data demonstrated increased risk of myocarditis, an inflammation of the heart muscle, after the second dose (FDA Director Peter Marks) said, although he didn’t provide specific data on how frequently it occurs overall. He said it was mostly found in younger adult males.

If you asked a doctor about risks associated with a drug and they replied, “Just trust me, the risks are no biggie,” would that assuage your concerns? As for myocarditis being mostly found in younger adult males, does “mostly” mean one percent? Ten percent? Has the FDA become so PC that it wants to curb male privilege?

At a minimum, I’d welcome knowing how the risk profile of Pfizer vaccines compares to other vaccines. I’d also welcome knowing if the FDA consults with cardiologists on myocarditis risks, but I understand that might slow down the process. Time is literally money when it comes to vaccine approvals.

The Biden Administration last week recommended that a third shot of an mRNA vaccine such as Pfizer’s be given to adults who have received the two-dose regimen. A critical element (emphasis mine) for broad boosting will be a recommendation from the Advisory Committee on Immunization Practices to the Centers for Disease Control and Prevention, as physicians often follow ACIP recommendations.

Can you image if Donald Trump recommended use of a vaccine or drug that wasn’t blessed by the ACIP or other advisory committees? The Biden Administration, looking to distract from its Afghanistan debacle, did that. Even under threat of losing their licenses, some doctors bravely have gone on record warning about the safety of third doses.

Pfizer declined to share its marketing and advertising plans but said it seeks to take a thoughtful approach (emphasis mine) with such communications in hopes of increasing vaccine confidence.

I’m relieved that Pfizer isn’t going to rely on the “mindless approach” it apparently uses in its other drug communications that no doubt contributed to the company’s record healthcare $2.3 billion fraud settlement.

I could go on, and I don’t mean to pick on the Journal, as I regard the publication as the most trustworthy and accurate of corporate media publications. And to the Journal’s credit, they employ a columnist who isn’t brain dead and understands that America’s Covid response is being driven by politics, not science. That’s understandable, given that the U.S. response is being overseen by someone with a degree in political science and has very profitable ties to the healthcare industry.

Let’s at least be honest about the farce the FDA really is. The agency the other day put out a warning about a certain drug it approved for human use (you aren’t allowed to mention the drug on the internet) but hasn’t made much of an effort to warn people not to rush out and get a booster shot until it speed reads Pfizer’s data.

That train has already left the station: In my small orbit I know of five people who have gotten the booster shot or plan to. That’s how little importance the public attaches to the FDA. Americans fashion themselves as vaccine experts more knowledgeable than the FDA’s. Pfizer reportedly has tens of thousands of vaccines set to expire so the company’s shareholders should be ecstatic about President Biden’s promotional efforts on their behalf. Hopefully, Pfizer will remember the “Big Guy” when he gets out of office, and maybe help out a budding artist in the interim.  

The real news in the FDA’s announcement today is that speed, rather than critical scrutiny, is the agency’s ultimate priority. The FDA is proud they more than cut in half the agency’s vaccine approval time, but I’m confident that if the agency’s function was outsourced to a private equity firm or two, the turnaround approval process could be reduced to a matter of days without sacrificing the agency’s prevailing standards.

Private equity is increasingly dominating healthcare, so it would be a natural extension of their business. It would be a win/win/win/win for everyone: Taxpayers would pay less for drug oversight, private equity would profit from providing it, drug companies could bring their products to market faster, further enriching all the middlemen involved in the process.

Admittedly, there might still be a few Americans concerned about handing drug oversight to private interests. That could prove to be a good thing. Decades ago, Canada’s Ontario province banned studded winter tires because they were tearing up the roads.  Accidents declined because people drove more carefully to compensate from the reduced protection.

If Americans understood the FDA can’t be counted on to conduct critical due diligence, maybe they’d want to do their own drug safety research and analysis. And maybe then they’d become outraged about the growing fascist censorship that’s intended to force Americans to blindly following government orders and directives.

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