Yesterday, the US Food and Drug Administration granted approval of one of the C-19 pharmaceuticals for persons 16 years and up. For those who are paying attention, this does not exactly provide warm fuzzies.
Perhaps most concerning is the abandonment of protocols and transparency. Right out of the gate, the approval was based on only six months of data, about a year and a half before clinical studies could even be complete.
Conducting studies assumes we care about the data, but this approval provided no visible data, no review of the data, nor a rigorous discussion of said data. The FDA abandoned its own protocol to hold a formal advisory committee meeting on the topic, conveniently avoiding scrutiny and discussion. (In fact, that committee only met twice this year, on Feb. 26 to consider the J & J EUA, and on June 10 to discuss pediatric use.)
Bear in mind, that discussion would have centered on the drugmaker’s own clinical study.
According to the FDA, “More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least six months.” This, when the original cohort in the study was 44,000. Some of those trial participants gone missing include the control group, in an obvious corruption of ‘science’, since placebo participants eventually took the drug under study.
This aggressive push to approval is hard to fathom especially in light of the truly disconcerting numbers in the Vaccine Adverse Event Reporting System database. The lack of explanation or insight or basic follow-up on the historically high numbers, including the shocking number of deaths, cannot simply be ignored. One cannot wave the numbers away implying it’s all just a coincidence without any forthcoming, honest follow-up. Unless, I suppose, you’re the FDA and media relying on a complacent public.
Speaking of public, yesterday’s approval also brushed off the long-standing protocol of a public hearing. Such lack of transparency and dissing of the public and democratic values is consistent with what Harvard experts deduced about corporate capture of federal regulatory bodies.
All that aside, why the big rush anyway? Despite assertions to the contrary, this hasty, cloaked approval will do nothing to coerce the vaccine-hesitant. In fact, the secrecy, haste, and refusal to openly broach developing data provokes further concern in that group and others. The landscape of suppression, censorship, and propaganda does not encourage trust either.
The big rush does, however, pave the way for further and broader mandates. Strangely, this full court press comes in the context of increasing data that instead suggest caution and a closer look.
Health aside, this blasé corruption of process bears implications about our governance which should concern any citizen. Blindly finding comfort in this approval is misplaced trust. We should expect and demand better.
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