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FDA Resignations
There now appear to be a couple of casualties of the politicization of the FDA: Marion Gruber and Phil Krause, respectively the director and deputy director of the Office of Vaccines Research and Review. These gentlemen have resigned from the FDA, apparently over the political pressure for vaccine approval and use.
The particular issues appear to be Biden’s public announcement that he will be pushing boosters for everyone as of the third week in September, despite lack of FDA approval for such use (the FDA has approved the vaccine boosters for immunocompromised individuals only). Another issue appears to be the pressure on the FDA to approve vaccines for children. Also, it appears these officials objected to the CDC driving vaccine policies while infringing on FDA authority. No mention is made regarding the pressure for full FDA approval of the vaccines (superseding the EUA) which was announced about a week ago.
One wonders if that rush to full approval was part of the problem that led to these resignations. There are a number of straws that could have broken the camel’s back in regard to recent (as well as long-standing) FDA behavior, which has always factored in a large political component and pressures unconnected to the “science” that is supposed to underpin drug and vaccine approval.
These resignations are a blow to confidence in the FDA, the CDC, the Biden administration (confidence in which is plummeting due to the Afghan pull-out debacle), and in the use of the vaccines. These resignations won’t help encourage the vaccine-hesitant to get vaccinated, nor those already vaccinated to get the boosters. To the contrary. The resignations will tend to sow confusion and chaos in the Administration’s approach to COVID-19. Not surprising for this Administration.
I for one am impressed that there exist officials in the Federal Government with sufficient backbone to stand up and say enough is enough. It’s a tragedy that no one with such integrity exists in the Defense Department, the Joint Chiefs of Staff, or the State Department.
Published in Healthcare
Were that true, my grandfather would still be alive today.
There is no lying like lying to yourself. You are Absolutely incorrect- at least 2 preexisting vaccines require 3 doses (Hep C & HPV+/- Hib)- https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html
The Israeli data shows high infection rate b/c they TEST for it- every expert thinks we have many more delta variant infections than have been reported- Scott Gottlieb believes we are off by up to 10x. And don’t forget the same Israeli data shows the vaccine greatly protects against severe disease even in breakthrough delta variant infections AND a 3rd dose is highly effective in preventing disease in those over 60 ( they only ones they studied). In the short term natural immunity is likely better than the vax- BUT AT A GREAT COST (ie >600,000 dead). The other problem with natural immunity is it will also wane over time so even they will likely need a booster
Have they given up on narrowing down the origins of COVID 19? I think this is very important. It makes a big difference in whether it was engineered or occurred naturally – especially since it doesn’t follow past COVID outbreaks, and seems to keep going – even among very protective measures such as in Israel.
https://www.cnbc.com/2021/09/01/who-says-it-is-monitoring-a-new-covid-variant-called-mu.html
The world reaction to the Israeli data seems so irrational thanks to our genius global leaders. The clowns who futilely locked us down stoked delta-terror, then stupidly promised that the vaccines would do to COVID what vaccination did to smallpox and polio.. then oops!.. they can’t easily admit that the bug will still spread because we were using fear of that to push for the vaccines…
It looks like delta is everywhere but utterly harmless in the vast majority of people infected, especially kids. It spreads in clearly unpreventable asymptomatic ways. If you want to prevent serious symptoms, get the shot(s). If you’re vulnerable, listen to your doc about whether you should get a booster. Otherwise, people, go back to normal life and accept that a weird, bad type of flu is now a small but normal risk. Why isn’t that the takeaway?
Presumably, extrapolating from the fact that activated androgen receptors are a part of the process of the virus entering cells (Activated androgen receptors begin rising with puberty, more in males than females) one would expect changes to start at puberty. As puberty now starts around age 8 (used to be much later, reasons for which are not known–though delayed puberty is not diagnosed until much later) one would expect to begin to see a rise in infectivity and transmission starting at around that age and increasing through puberty. By the age of 20 the effect should plateau. Still, healthy youth appear to have extremely low mortality, about the same as the flu, or possibly even less. The risk of the vaccines vs the disease is not clear for most people under 50. One of my patients yesterday told me of his son, age 38, who had multiple sclerosis, and was on immunotherapy (monoclonal ab) treatment for this. The treating neurologist advised against getting the vaccine due to fear of inducing an exacerbation of the MS. The patient contracted COVID and died from COVID.
It is a standard trick of the pharmaceutical industry to make some meaningless change in formulation to extend patent life. So the formulations are different (different name, minor change in manufacturing, patented, a rose by any other name…). I suspect that the one approved under the EUA is deemed covered by the full approval by the FDA and will be used as if fully approved. Just put a different label on it.
Some of my misspent youth was spent at racetracks. My partner in this enterprise grew up around racehorses and could spot strategic moves and health issues–but was sometimes sentimentally attached to underdogs. I was the number cruncher who knew very little of the culture and technology of horse handling. Our policy was to never bet unless we both agreed on a play using our entirely different approaches. By avoiding a lot of dubious plays, we were always marginally ahead (although not if you figure the time investment).
I want my doctor to tell me the odds and then her/his gut inclination. Then I can make a good choice.
Just in today’s emails-about mRNA vax sequence:
“Antibody response in people aged over 80 is three-and-a-half times greater in those who have the second dose of the Pfizer COVID-19 vaccine after 12 weeks compared to those who have it at a three-week interval, finds a new study led by the University of Birmingham in collaboration with Public Health England”
Stina, I have an MD after my name, which, unlike some in the PTB, I have used for 35 years to help patients. I think your understanding of the virus and its evolution is sound. Your understanding of mask usefulness, ditto.
Commenting on Front Seat Cat #33. Given the certainty that the original Covid-19 virus is spawn of the Wuhan Institute of Virology, it’s interesting that we are treating the newer strains as natural variants caused by natural selection. I think it more likely that they are Made in Wuhan, just like my 25″ gong, and have been seeded into the outside world.
The problem with this report is that patients were studied for a very short period. No data on longer term benefit. How long does the beneficial effect of the booster persist? The other question is antibody status of patients that were studies. The older age cohort, 60 years of age, is the cohort that the Israeli’s have reported have the greater likelihood of decline of antibodies. So one would expect this cohort to show benefit from a booster. How about younger age cohorts, who don’t seem to lose the antibodies so quickly after the initial doses of the vaccine. The study indirectly suggests that the initial two shots don’t help much for very long. No data on antibody status between those receiving the booster and those not receiving the booster. No information on how long that benefit persists, beyond a couple of weeks. Not a particularly helpful study, beyond showing that a booster has beneficial effects in 60 and above patients previously vaccinated, for a short period of time.
All of which questions, which are not currently answered by the data, support the viewpoint that the vaccine should not have received full approval. Nor should the booster. pending more data.
So you were making a comparison to old vaccines?
I was comparing to COVID vaccines.
Even so, comparing 3 shots, where the third is a booster less than 6 months out, to vaccine schedules that are done after 2-3 courses… for life… is premature.
Its sounding like your precious vaccine is not going to maintain even the stability of a flu vaccine. Which I think is the least stable of all of the vaccines.
Preach, Brother.
The Covid vaccines are less like the polio vaccine and more like the flu vaccine. Or like a common-cold vaccine if we ever invented one. Better than sliced bread, maybe. But not the best thing ever.
Sad story there. Gee, I’m 38.
So would it be fair to say that the topic is terribly complicated, but that somewhere between ages 10 and 20 is a good guess?
Really? The vaccines have saved thousands and you want more bureaucratic red tape? The great enemy of the good is the perfect-which you seem to require.
Note what I said- “other vaccines require 3 doses so this would not be unique” I never said COVID vaccines-the anti-vaxxerxs are trying to claim the COVID vax is unsafe, unproven, a poor vaccine- the point is requiring 3 doses for a vaccine to be effective WOULD NOT BE A NEW DEVELOPMENT.
No is claiming you need a booster every 6-8 months for life-the data isn’t there-but will likely need a booster at least once. The flu fax is yearly-perhaps COVID will require one as well-but clearly saving thousands of your fellow citizens is worth the inconvenience of an annual jab. If you do not think so, I pity you and should pray for your soul..
Is that like shovel-ready jobs “created or saved?” Just wondering.
I have no issues with removing red tape. I have issues with forcing people to accept treatment beyond their comfort level. And this should be the case across the board if we see a decrease in regulations to bring treatments to market faster – that there will be people who give the product a wide berth for sometime while it is in the market.
If we want things to come to market faster with less red tape, then we must foster a culture of toleration and respect for people who distrust medical interventions. It is within their rights to do so.