The FDA Criticized as of Late? So what’s been going on with the FDA?
Let us take a look at this situation. Why has the FDA come under scrutiny lately? Could it be do to the way they have handled the quasi approval of vaccines?
Some people say that the FDA never actually did the work of checking into the efficacy of these vaccines, and they are being accused of just rubber stamping them to the requirements of Big Pharma.
I have included excerpts from a recent article you can read it here, and if you desire the whole article just click on the link provided to get the whole article by Maryanne Demasi, where she is questioning the FDA for not doing their job properly.
The FDA has been criticized for taking more than a year to follow up a potential increase in serious adverse events in elderly people receiving the Pfizer covid-19 vaccine, Maryanne Demasi reports
So what recommendations did they give?
In July 2021 the US Food and Drug Administration (FDA) quietly disclosed findings of a potential increase in four types of serious adverse events in elderly people who had the Pfizer covid-19 vaccine, acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia, and pulmonary embolism to name a few of the side effects.
Little detail was provided, such as the magnitude of the increased potential risk, and no press release or other alert was sent to doctors or the public. The FDA promised it would share further updates and information with the public as they become available.
So Why Did the FDA Delay?
Eighteen days later, the FDA published a study planning document (or protocol) outlining a follow-up epidemiological study intended to investigate the matter more thoroughly. This recondite technical document disclosed the unadjusted relative risk ratio estimates originally found for the four serious adverse events, which ranged from 42 percent to 91 percent increased risk. (Neither absolute risk increases nor confidence intervals were provided.) More than a year later, however, the status and results of the follow-up study are still unknown. The agency has not published a press release, or notified doctors, or published the findings by preprint or the scientific literature or updated the vaccine’s product label.
The BMJ has also learnt that the FDA has not publicly warned of similar signals detected in a separate observational cohort study it conducted of the third dose (first booster dose) in the elderly nor has the agency publicly acknowledged other published observational studies or clinical trial reanalyzes reporting compatible results. Experts spoke to The BMJ about their concerns about the data and have called on the FDA to notify the public immediately.
“To keep this information from the scientific community and prevent us from analyzing it ourselves, is irresponsible. It presumes that these organizations are perfect and cannot benefit from independent scrutiny,†says Joseph Fraiman, an emergency medicine physician in New Orleans, who recently carried out a reanalysis of serious adverse events in Pfizer’s and the Moderna based on randomized trials.
Unearthing safety data
The FDA’s July 2021 findings came from a “near real time surveillance†system called Rapid Cycle Analysis (RCA) that the agency has in place to monitor a list of 14 adverse events of special interest. The RCA study is not capable of establishing a causal relation but rather is intended to detect potential safety signals rapidly. The agency said the associations were not identified for the other two covid-19 vaccines authorized in the US made by Moderna and Janssen (Johnson & Johnson). The July 2021 follow-up study protocol states that there is a “manuscript in preparation†for the original RCA study, but to date nothing has been published for either study.
The fact that the FDA found these four safety signals means they should have followed up on the results, and I don’t understand why we have not had more information since then. It has been over a year, says Tracy Høeg, epidemiologist and physician currently conducting covid-19 vaccine research with the Florida Department of Health and California’s Marin County Department of Health and Human Services.
If you would like to read more on this subject, just click the link here to get to the original article.
