Can We Give the New FDA Leadership a Chance
The public town hall conversations are both a huge step in the right direction and a welcome change from the previous FDA leadership
When Marty Makary and Vinay Prasad became leaders at FDA, many pundits worried they would damage public health. Both had “anti-vax” tendencies, went the narrative.
Adam and I knew that was not true. Well, yesterday, FDA published a video on X and YouTube where they updated the public on SARS-CoV2 vaccine status.
We learned from their public conversation that the purported anti-vaxxers had approved a brand new COVID vaccine from Moderna for patients at high risk of complications.
But. But. They also “convinced” the company to perform a proper placebo-controlled RCT for the vaccine in patients age 50-65 this year.
We have not had a proper COVID therapy RCT in many years. I guess it took new leadership to induce companies to properly study their new vaccine.
Some Sensible Medicine readers may criticize the approval of a new vaccine. Vinay said during the discussion that it was trialed against the old Moderna vaccine. I agree that is less than ideal, but this summer we will get the placebo-controlled trial in “lower-risk” adults.
And that is big….we will learn so much from that trial: efficacy, safety, frequency of COVID hospitalizations in the placebo arm, for instance.
Finally, they also answered many other questions such as, the role of the FDA, the all-important benefit/harm ratio of medical interventions, and the crucial need for shared decisions between clinician and patient.
The video on YouTube is just an audio. The link on X includes a video (but does not embed on Substack.)
I am excited and optimistic about the new leadership at FDA. They speak with clarity, humility and in a language the general public can understand. The transparency will begin to restore some of the lost trust. Good on them.
JMM
Unsolicited advice: get someone tougher in the device division. My gosh, it’s too lax.
The FDA Direct “podcast” conversations have been great and are a welcome change. But dissatisfaction with leadership is not simply a vaxx vs anti-vaxx argument. The problem is the mRNA platform being referred to and promoted as a “vaccine” rather than the Gene Therapy Products that they are. One only needs to consider DOSE, DISTRIBUTION, and DURATION (of action) to understand the problem of these drugs being used to create an immune response. What is the quantity (dose) of the faux spike protein created by a person’s cells? No one knows. What is the duration of action of the faux spike protein? Reported now to be months to perhaps 1-2 years. Distribution? Lipid nanoparticles carry the mRNA everywhere in the body. The mRNA products are genetic drugs and should undergo the appropriate testing rigor reserved for gene therapy products, not the more lax vaccine testing protocols. They should not be referred to as “vaccines” which provides them an innocence connotation they have not earned or deserve.
"we will learn so much from that trial: efficacy, safety, frequency of COVID hospitalizations in the placebo arm, for instance."
Sorry, this just isn't true. People should especially know better after the available auditing of the seminal trials have shown such clear signs of extensive fraud. Pfizer's trial has received much more attention than Moderna's (1). If Prasad of all people doesn't get wise to the fraud during his tenure, then I see little hope for modern medicine.
The industry is full of hopelessly bad actors and no amount of getting them to do more "science-like activities" will eliminate the fraud. At minimum, total raw data transparency is needed. Yet you can still do plenty of fraud even in that scenario. I side with Peter Gotzsche. Industry should not conduct their own trials, patents need to basically be ended, and a completely non-profit system needs to be established (2). It's not even a question of feasibility. A bird in the bush is worth more than a hundred dead birds in the hand. And it is feasible. All it requires is buy-in. And buy-in is obtained by universal recognition of the irresolvable inability of industry to not commit fraud. And universal recognition can be obtained by Makary and Prasad making sure full formal audits of the two seminal covid vax trials take place, laying bare the fact that the "highest-quality" science we have is in fact disgustingly unacceptable.
(1)
Many serious issues in the publicy-available raw data have been described. These include clear evidence of widespread unblinding, suppression of serious adverse events, imbalanced testing, questionable laboratory practices, a bait-and-switch of what product they actually tested versus what was authorized, imbalanced comorbidities, an unnatural time distribution of deaths, potential neglect of a cardiovascular death signal, gross data manipulation, and a host of other anomalies.
https://openvaet.substack.com/p/pfizerbiontech-c4591001-trial-audit
https://wherearethenumbers.substack.com/p/anomalous-patterns-of-mortality-and
https://modarnlife.substack.com/p/at-investigators-discretion
(2)
https://pmc.ncbi.nlm.nih.gov/articles/PMC5817403/
https://pmc.ncbi.nlm.nih.gov/articles/PMC6084335/
https://multipolar-magazin.de/artikel/never-trust-trials?utm_source=chatgpt.com