Silos and Crevasses: NIH, FDA, CDC (and DoD)

Time to rethink the way things are

One of the benefits of being elderly and having held numerous roles within the US biomedical enterprise is the ability to delve into the details or broaden the perspective to see the bigger picture when necessary. I do not know many people who have the same breadth of exposure that I do, for better or worse. And now, as the sun sets on my so called career, my bicoastal random walk through academe, non-governmental organizations, pharma, DoD, NIH, FDA, and CDC while trying to pay my bills and raise a family, I have become even more aware of how dysfunctional the whole system has become. My learned cynicism is being further refined consequent to getting a glimpse from an inside-the-CDC point of view due to the recent ACIP appointment. One important conclusion is that the deep dysfunction of the US Government’s response to COVID is not only due to the nefarious activities of bad actors who have refined abilities to game the system, but it is also the product of evolved structural flaws that they exploited for personal and corporate gain.

This recently came to a head when questioning a CDC leader during the most recent ACIP meeting, and then speaking to a colleague about the immunologic consequences of repeated dosing (“boosting”) with any vaccine, including the gene therapy-based products (mRNA or recombinant AdV). During the recent ACIP meeting, I asked a question about lot-to-lot variability in safety and effectiveness with the mRNA products. The “how bad is my batch” question that is near and dear to my own heart (so to speak) as my second dose elicited such significant adverse events (POTS syndrome, restless leg, atrial fibrillation, malignant hypertension) and was identified as being a “bad lot” based on VAERS report analysis. The answer I received from a CDC official was that it was not CDC’s job to monitor lot-to-lot variability, but rather that was FDA’s job. No matter that CDC VAERS data clearly document significant lot-to-lot variability, not in our wheelhouse. As an ACIP member, I was told to seek data from the FDA.

The immunology discussion related to the perplexing, persistent issues of whether repeated antigen exposure can cause the immune system to become less (rather than more) responsive to either a specific antigen, pathogen, or even in general. The immunobabble terminology related to these issues include “original antigenic sin”, “immune imprinting”, “immunoglobulin class switching”, “high zone tolerance”, and Allergen immunotherapy, also known as “desensitization” or “hypo-sensitization”. Bottom line? In immunology, more is not necessarily better. And yet rigorous vaccine primary and “booster” dose selection, timing and repeated boosting studies are rarely if ever done, even in rodent models. Now the ACIP makes recommendations to the CDC director about such matters, so you might assume that the CDC would have the data to demonstrate that decisions about the short and long term effects of re-administration of “vaccines” are based on solid human clinical research findings, wouldn’t you. And you would be wrong. These data just do not exist within the world of CDC data sets. Why you ask? Same answer as for the lot-to-lot variability. Not in our wheelhouse. Paraphrasing- “We do not have the capabilities to do those studies.” “This would require sophisticated immunologic analyses and we do not have either the equipment or the staff.” So who does, one might ask? WELL, that is NIH’s job.

I have DECADES of experience with the NIH and its grants, contracts, and peer-review processes. And Jill’s PhD research project specifically focused on the NIH peer review process. We know a lot about both intramural and extramural NIH funding. First thing you should know about that, aside from the chronic and persistent conflicts of interest and bias (overt and subtle) inherent in that system, is that it takes 4-5 years from initial concept to actually awarding a grant or contract via NIH. A paragon of bureaucratic inefficiency. So, rapid response to a novel public health threat is not consistent with the NIH system.

Aside- Which is why the “other transactional authority” contracting system was set up over at BARDA and DoD. Which was the system that lead to the famous Pfizer defense (paraphrasing) that “we did not commit fraud, we delivered the fraud that the government contracted us to deliver’. Someone should be charged with contracting fraud on that one, but that is a different topic. I was there over a decade ago when this “OTA” system was developed, and have used it myself for major contracts that I have built and won for clients. I know what I am talking about.

But getting back to the crevasses. In the case of the immunologic consequences of repeated dosing with antigens (ergo, “boosting”), no Dr. Peter Marks, inbred mice do not predict human responses. The only thing that predicts outbred human responses is outbred human responses. Not mice, not ferrets, and not monkeys. And immune system responses in humans that live in the rough and tumble stew of chronic parasites and pathogen exposure on the African continent do not even predict how North American humans will respond, in part due to the cytokine responses generated by the parasites and pathogens. Does NIH routinely fund evaluation of these sorts of issues for existing or new vaccines? No. That would be the job of the FDA. Does the FDA do it? No, that would be the job of the pharmaceutical companies.

Another fundamental inconvenient truth is that, if you are a pharmaceutical industry researcher, it is career suicide to do any studies during advanced development (clinical research stage) just because they seem like the right thing to do to answer an important question. You only do those studies that the FDA forces you to do. Otherwise you might get an answer that will delay or block FDA marketing authorization. And if the FDA is not on the ball or willfully looking the other way due to various pressures and biases, they do not require the studies that would address things like, say, shedding or adverse long-term effects of repeated boosting.

So, CDC says it is FDA or NIH’s problem. NIH is distracted, incredibly inefficient, and driven by fame, fortune, the Nobel Prize hunt and racking up “peer reviewed” publications that go nowhere. DoD does what it can, but its mission is fighting wars and protecting the warfighter, not civilians. And the FDA just muddles through, constantly getting pressured, gamed and spun by Pharma. Medical caregivers have been indoctrinated to have faith in the system and have no idea of how deeply messed up things actually are. And the average person (and average politician) believes the promoted marketing and propaganda that all is “safe and effective” and that they should just shut up and do what their doctor tells them to do. And the profit rolls in like a tsunami.

This is what I see from my perch. Yes, over decades of experience, I have become deeply cynical. But I still hold out hope that things can be made better. And I hope that you do too. The Make America Healthy Again movement is like nothing I have ever experienced or even imagined. It will not be easy, and it will not be quick. Secretary Kennedy and his team do not have a magic wand, and the resistance to change (internal and external) is enormous. This will take years, and will require massive reimagining and restructuring of the entire health enterprise.

Do we have a choice? If we fail in this endeavor, then our children will continue to live shorter and less healthy lives than their parents. And this is just not acceptable.

---