The Phony FDA Imprimatur

Just the other day a Guardian article (and parallel MSM pieces) touted the Biden administration’s announcement that pharmaceutical giant Pfizer has become the first to be given FDA approval for Comirnaty, a Covid-19 vaccine.

“President Joe Biden hailed the announcement as ‘another milestone, a key milestone, in our fight against Covid,’” writes the article’s author, Martin Pengelly, who then cites Janet Woodcock, the acting FDA commissioner, who assures us that

The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.

Joe Biden then piped up with, “The FDA approval is the gold standard. Those who have been waiting for full approval should go get your shot now. The vaccination is free, it’s easy, it’s safe, and it’s effective.”

That’s it in nutshell.

The problem is: It’s not as simple as Take Tea and See. Take your jab and feel fab.

Excuse me, I feel a Sam Kinison moment coming on. Oh-ohhhh.

The last thing an FDA approval means is that a gold standard has been reached. Unless you mean kickbacks and fraud and unstable practices.  A 2018 Science magazine study reported that a majority of physicians working on research related to the drug approval process were offered and took compensation by pharmaceutical companies whose drugs were up for review.  Check out their graph:

(Science Magazine)

This is another way of looking at the FDA as a Gold Standard.

But, as if that weren’t depressing enough, Science also had a related piece that discusses more insidious higher compensation to such medical reviewers in the form of the old revolving door trick.  In a piece called “FDA’s revolving door: Companies often hire agency staffers who managed their successful drug reviews,” Charles Piller summarizes,

Science has found that much like outside advisers, regular employees at the agency, headquartered in Silver Spring, Maryland, often reap later rewards—jobs or consulting work—from the makers of the drugs they previously regulated.

Again, what Gold Standard?

More recently, in an August 2020 piece in the AMA Journal of Ethics the FDA was severely criticized for its regulatory failures that led to the  US opioid epidemic, resulting in the unnecessary loss of thousands of lives.  Early in the piece, we are reminded that David Kessler, a former FDA commissioner, went on 60 Minutes and castigated his former employer for allowing “the promotion of opioid use for chronic pain.” Further, in Business Insider piece, we learn that the corruption is morally ill:

Curtis Wright, once a director at the US Food and Drug Administration who oversaw evaluation for pain medication, got a position with a first-year compensation package of $400,000 at Purdue Pharma a year after he led the approval of OxyContin, according to the book “Empire of Pain: The Secret History of the Sackler Dynasty” by Patrick Radden Keefe.

This is heady stuff.

More than heady, it’s endemic and the FDA’s response to criticism of its corruptibility and dishonesty has been indifference.  A dismayed AMA Journal of Ethics tells us of the FDA’s Atlas Shrugged response to its mistakes:

Despite this mounting criticism, FDA policies for approving and labeling opioids remain largely unchanged. The FDA has not undertaken a root cause analysis of its regulatory errors that contributed to this public health catastrophe, let alone instituted any major reforms.11 To the contrary, the agency has adopted a defensive posture and sought to shift blame.

This should cause serious pause before accepting a piece like the Guardian’s Feel Good Joe Saves the Day Bullshit.   Gold Standard?

And what’s more, of all drug companies, Pfizer should be required to undergo extreme scrutiny of its findings, after been found criminally liable for misrepresentation of its product over a decade ago.  In another Guardian piece, we’re told of Pfizer:

Pfizer, the world’s largest drugs company, has been hit with the biggest criminal fine in US history as part of a $2.3bn settlement with federal prosecutors for mispromoting medicines and for paying kickbacks to compliant doctors.

There’s no mention of this activity and fine in the latest feel good piece.

(And while we’re on the money trail, maybe some six figure MSM reporter should look into which Congresspersons own Big Pharma stock and who — beside legislative dinosaurs Diane Feinstein and Nancy Pelosi — gained from insider trading during the oxycontin scandal and today’s wonderfully lucrative pandemic. They could start with DJ Trump and his associates.)

But more problematic regarding the FDA approval of Comirnaty is the questionable research that went into the drug.  Like many miracle vaccines put out by Big Pharma immediately after Trump’s election loss, Pfizer’s Comirnaty (Pfizer-BioNTech Covid-19 Vaccine) was being distributed under emergency protocol that allowed for limited and non-thorough lab research, accompanied by government-supported limited liability. Meaning: many people are, as they fear, risking side effects from drugs not fully fleshed out yet.  As the recent Guardian piece acknowledges (buried deeply), Comirnaty, for instance, had just a limited two-month trial, “that’s shorter than the six months of safety data normally required for full approval,” although they continued their study, which, they claim, led to data that confirms Comirnaty’s safety. But a July 2021 study suggests side effect work has not been sufficiently completed. While the MSM plays around with the goshdarnedness of the vaccine’s name, it might be wise to watch for further developments of the drug’s efficacy. Although it too seems giddy up with the  FDA’s “good news,” Slate magazine once was right on top of the FDA shenanigans and the fraud that accompanies medical research.

And getting back to more FA controversy, before moving on to the larger issue of broad acceptance of the miraculous appearance of vaccines, let’s note that the current FDA commissioner, Janet Woodcock, has been caught herself in a noteworthy ineptitude.  In yet another Guardian piece, “Biden urged not to give top FDA job to official over her role in opioid crisis,” Woodcock was called out for

approving Opana without adequate evidence of safety or long-term efficacy, approving Zohydro despite a vote of 11-2 against approval by a scientific advisory committee, and approving promotion of OxyContin for children as young as 11 years old.

Like Rodney Dangerfield, in Back to School, I was able to calm my inner Sam Kinison down before what he was hearing made him go postal in the classroom of my mind.

Now the other stuff.

In the summer of 2020, all the bright and bonny MSMerizers were laughing — laughing — at president Donald J. Trump for announcing that a vaccine would be ready by October 2020. You know, during “October Surprise” season before the election (it was that or nuke Iran, probably). I’m referring to his Operation Warp Speed.  On May 21, 2020, DHHS posted on their website news that AstraZeneca (another one) had developed a vaccine that would be ready perhaps as soon as October. We laughed our assholes off.

(But for MAGA dogmatists it was Cue the happy parades time.)

Yeah.  The MSM went to work and explained carefully, over and over again, that, sadly, it was not possible for vaccines to be developed that quickly.  And the president was yet again being irresponsible, and perhaps evil, for promising something so miraculous without being able to deliver it to needy peoples.  Representative of this exercise in Grand Reality was (natch) the NYT, which had spent his presidency as Trump’s mortal enemy.  The Times reported that “the fastest a new vaccine has been developed and distributed is four years and most have taken considerably longer.” They noted that anything shorter would “shatter” speed records. In another long, interactive piece the Times demonstrated how impossible it would be to develop a vaccine in less than four years. While the piece suggests that the best possible case scenario is 12-18 months (i.e., between August and December 2021), the graph shows us that there is no chance that a vaccine could be ready by August 2021. We’re told:

The grim truth behind this rosy forecast is that a vaccine probably won’t arrive any time soon. Clinical trials almost never succeed. We’ve never released a coronavirus vaccine for humans before.

Sweet Cheeses! Is the MSM awake at all?  Why is the vaccine miracle underreported?

Further along these lines of rectitude, the always well-spoken New Yorker went to town on the Trump administration’s happy forecasting by joining the Times in pointing out how long it takes to develop vaccines.  In “The Long Game of Coronavirus Research,” Jerome Groopman reminds readers — you know, smart ones, not, say, readers of the NY Post, who are so jejune — that stuff takes time, not everyone brown-bags it curbside with the suds. Groopman, addressing Operation Warp Speed specifically, writes, “meant to spark hope. But, in science, true hope is clear-eyed and brings a tight focus on the barriers and potential setbacks that exist along the path to desired results.”

Then Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases and the Chief Medical Advisor to the President (including Trump), and highest paid civil servant in the country, is made the Muse of the piece, referred back to, often.  Fauci tells Groopman (and by that virtue, us),

…why it’s a grave mistake to favor speed at the cost of rigor. Quite simply, this is a disease that we are only beginning to understand: since the outbreak began, it has become evident that its effects are, like those of AIDS, astonishingly diverse and complex.

The Muse then goes on to explain painstakingly how research works and how complex its and how we are only beginning to learn about these things.

Behind all the hubbub and much ado about nothing that happened on January 6th, when the ‘revolutionary’ retards were on parade in DC, ostensibly to disrupt the much-hated electoral college vote certification in the House, was the ka-ching-a-linging of cash registers for Big Pharma.  Grooving into the emergency protocols and limited liability for drugs foisted on the mainstreeters, outcome the vaccines — faster by far, than ever before. How many of these miracles, put out there with similar limited two-month trials, are safe in the long run?  Can we even trust the MSM to tell us when the side effects begin to be of public interest? Or to follow the money?

While it would be marvy to have a vaccine, it seems the desperation is hyperbolically overplayed.  Last year I wrote a piece about the development of a solution to Covid-19. I noted then (and the MSM still hasn’t sufficiently drilled down) that DARPA (that’s right of Pentagon fame) was largely responsible for the speed with which solutions to Covid-19 have been developed.  Specifically, their Pandemic Prevention Program (P3) which

aims to support military readiness and global stability through pursuit of novel methods to dramatically accelerate discovery, integration, pre-clinical testing, and manufacturing of medical countermeasures against infectious diseases.

The P3 initiative is, according to Jared Adams, Chief of Communications at DARPA, who I communicated with in preparation for my piece last year, “is two years into a four year effort.” So, there is a year to go before the program expires. How serendipitous that a military program was up and running at the time of a pandemic. Adams said,

DARPA is currently working with performers from AbCellera Biologics, AstraZeneca, Vanderbilt, and Duke to find antibodies rapidly in a recovered patient and use them to create treatments.

This is not an all-inclusive list.

Antibodies from the first surviving Covid-19 diagnosed patient in Washington state were delivered to Abcellera on February 25. As part of P3 partnership, they had already conducted “war games” with play pandemics and were ready to receive and get going on the antibodies they received, using microfluidic processes.  Adams continued, “DARPA’s antibody discovery takes days to weeks rather than months to years, and we expect antibodies to be ready for human testing by 01 AUG 2020.” They were. Abcellera “signed an agreement with Eli Lilly to co-develop antibody products for the treatment and prevention of COVID-19.”

Out of that process came a monoclonal solution, which is only just now beginning to pick up steam. As Abcellera describes it:

LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.

This is not a vaccine, but can be very effective, as it is the individual’s own body that fights off the virus. However, it is temporary.

In a follow-up communique with DARPA, public relations officer, Stacy Wierzba, said of the monoclonal solution, “One advantage of the gene-based platform capability is that it can be re-administered (no vector-based immune response).”  And to my follow-on question — Can this Solution be a stop-gap measure to get us to the vaccine?  If so, how would that work? — she replied in detail:

Correct. The gene-encoded medical countermeasure provides protection in less than three days, but lasts only for months not days, and is not meant to be a replacement for vaccines.  It’s a prophylactic for temporary protection before a vaccine is available or elicited an immune response.

But, again, it is the body providing the antibodies, and it’s re-administerable.

Given the more limited repercussions, this would seem to be a safer pathway, and, who knows, maybe New Yorkerreaders will choose this past of resistance. Although it is being touted in other areas of the country — even among the good old boys down South. WSFA tells us all about it here.

No doubt, there are many amazing, heretofore unknown technologies erupting all over the goddamned place that shock even NYT and New Yorker readers — and, apparently, even Dr. Fauci –that account for the miraculous developments in vaccine evolution.  But the MSM isn’t featuring it, as they should be, and that’s a story in itself.

Oh-ohhhhhh.

John Kendall Hawkins is an American ex-pat freelancer based in Australia.  He is a former reporter for The New Bedford Standard-Times.

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