Friday, April 22, 2022

Trying to read the FDA tea leaves

Did the COVID vaccines skirt FDA regulation through the Warp Speed process, using Janet Woodcock (then-head of FDA's CBER, acting as the FDA's liaison to Warp Speed) to give them a pass?

Following her Warp Speed role under Trump, Janet sashayed to become acting FDA Commissioner while hoping for the real Commissioner job.  But after her signature laissez-faire regulation, which licensed a $50,000/year Alzheimer drug Aduhelm that did not work and was not safe, came under scrutiny, she was bypassed.

Acting FDA Director Janet Woodcock, MD was required to be replaced after a year.  It actually took a bit more.  Then a former FDA Commissioner, who worked under Obama for about a year, Robert Califf, MD barely got confirmed due to FDA laxity with opioid manufacturers on his prior watch.

But Califf (who was working for Google at Verily before taking the FDA reins) did get the job, and rode in on his white horse in February 2022, claiming, 

"I keep saying one of the mottos for me is ‘in God, we trust, everyone else must bring good evidence.’” —FDA Commissioner Robert Califf

However, Dr. Califf lifted Janet Woodcock up on his white horse and gave her the deputy Commissioner role. After all, she knows where all the bodies are buried.  Maybe he thinks she can take the fall when the COVID disaster finally blows up.

All I can say is that since he became Commissioner in February, things at FDA have not been quite so lax. There have been no new authorizations or approvals for the COVID vaccines.  Meetings regarding the preschool age COVID vaccine authorization have been twice postponed.

Will he try to clean up the COVID mess or keep it at arm's length?  Will he get rid of paxlovid and molnupiravir, the awful replacements for hydroxychloroquine and ivermectin that our government spent billions to purchase, at about $700 per course?

Stay tuned.

6 comments:

Anonymous said...

'EXCLUSIVE'!
Trust the Government? Can you say Agent Orange! Anthrax Vaccines?
Fauci should be counting Jail Bars! AZT and Remdesivir!

https://www.conservativebusinessjournal.com/2022/01/warning-danger-do-not-take-remdesivir/

'Fauci Signed Deal with China Agreeing to “Destroy and/or Return the Secret Files, Materials and Equipment without Any Backup”!

https://www.thegatewaypundit.com/2022/04/fauci-signed-deal-china-agreeing-destroy-return-secret-files-materials-equipment-without-backup/

"Barack Obama Admits Billions of People Were "Guinea Pigs For Covid Vaccine", Claims People are Dying Because of Misinformation (VIDEO)"

https://www.thegatewaypundit.com/2022/04/barack-obama-admits-billions-people-guinea-pigs-covid-vaccine-claims-people-dying-misinformation-video/

RIP: Justice In America?

Anonymous said...

Tea leaves not required to see what the 81-year old Rep. James E. Clyburn, D-South Carolina, the Chairman of the Select Subcommittee on the Coronavirus Crisis -- what he and his panel have been up to.

Below, among what these enemies of the people are "upset" about -- and using extraordinary state power to try and enforce political agendas, while claiming they support "The Science":
[[Dr. Hatfill criticized the Trump Administration’s pandemic response and called for the firing of National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci and then-Food and Drug Administration (FDA) Commissioner Stephen Hahn.]], Clyburn or a lackey of his wrote on his behalf,
and:
[[In a September 22, 2020, letter to then-White House Chief of Staff Mark Meadows, Dr. Hatfill advocated that “Two members of the COVID-19 Task Force (Drs, Fauci, and Hahn) need to be urgently replaced.” Dr. Hatfill also urged that “The US COVID-19 strategy must be changed to a focused, community outreach approach involving the outpatient and prophylactic use of hydroxychloroquine with Zinc supplementation” to treat the coronavirus.]]

This press release at
https://coronavirus.house.gov/news/press-releases/clyburn-issues-subpoena-trump-white-house-advisor-dr-steven-hatfill-coronavirus

Steven Hatfill has been much vilified, accused of involvement in the anthrax fiasco following the Operation-9-1-1, and sued government and this is result:

[[On June 27, 2008 Hatfill was exonerated by the government and a settlement was announced in which the Justice Department has agreed to pay $4.6 million (consisting of $2.825 million in cash and an annuity paying $150,000 a year for 20 years)[48] to settle the lawsuit in which Hatfill claimed the Justice Department violated his privacy rights by speaking with reporters about the case]]

https://en.wikipedia.org/wiki/Steven_Hatfill

He is much vilified.

https://www.newsweek.com/2014/06/27/steven-hatfills-strange-trip-accused-terrorist-medical-adventurer-255295.html

-30-

Anonymous said...

Pentagon researcher Barbara Honegger, author of the book October Surprise, made a preposterous assertion:

“Neocons are Nazis. The U.S. government has been taken over by a neo-Nazi cult.”

After alluding to “big Hitlerian lies,” Ms. Honegger took it a step further:
“The Nazi thread continued to 9-11, even with Leo Strauss, who had ties to Hitler’s men. Strauss, the 9-11 neocons’ mentor, was influenced by Hitler’s justifier of evil, Nazi Carl Schmitt.”

https://americanfreepress.net/the-lessons-of-9-11-news-flash-it-wasnt-the-nazis/

Trump the authoritarian
Political scientist Matthew MacWilliams said:

Trump’s electoral strength — and his staying power — have been buoyed, above all, by Americans with authoritarian inclinations

This assertion was backed up by an online poll of 1,800 Americans, which found that a belief in obedience to authority was the only “statistically significant variable” that helped to predict support for Trump.

Anonymous said...



Donald Trump Is a Nazi. Full Stop.
We can stop with all the hedging and qualifying

Drew Magary
June 2, 2020

COLUMN

He’s a Nazi.

Your president, my president, is a fucking Nazi. That’s not a standard bit of tweeted hyperbole. It’s a truth. It’s bedrock. There’s no sly coding to it. You don’t get to go OH DEAR PRESIDENT TRUMP IS SAYING THE QUIET PART OUT LOUD when there has never been any quiet parts to Donald Trump, nor any disguising his zeal for outright fascism.

If the past four years have not made it clear, if 100,000 dead and open admiration for fellow dictators didn’t do the trick, then this week better have. This eternal harbinger of misery got on the horn with 50 governors yesterday and demanded they “dominate” American protesters by arresting them, contact tracing them, and putting them in jail for 10 years. Then, later that day, he deliberately ordered his own men to teargas peaceful protesters and fucking PRIESTS to clear the way for him to walk — with the laziest possible gait — over to an empty church so that he could hold a bible upside down on camera. He has authorized, with some dubious legality, the American military to suppress the very people they serve.

This is Nazism, gas included. This is the enemy. This is war. Anyone who says otherwise is part of the same complicity industrial complex that led us to this flashpoint to begin with. I don’t wanna hear any more BUTs to any of this.

He’s found his bliss, and it’s in remaking this country in his own image: sour, ugly, hateful, and miserable.

When I was growing up, you couldn’t be a Nazi openly. Outed Nazis and Klansmen were shamed and laughed into isolation. They were alone. But once the internet came around — a positive development in so many other aspects — they found each other. They connected. Suddenly they didn’t feel so alone. Suddenly they felt emboldened. Freer to be themselves. And Donald Trump, being a Nazi himself, realized that he could round up this disparate coalition, shelter them inside a gleeful GOP, and lead them.

This country built its modern reputation on two world wars that it was late to the party for. America was a decisive factor in both of those wars, but now finds itself late to a war happening on its own soil. If you can’t see that war outside your door right now, you’re either a fool or you’re cheering it on. I don’t want a fucking thing to do with you either way.

There is no acceptable response to Trump and the GOP other than outright hostility. All they want to do with power is hurt people with it. They are Nazis, and they have only begun fulfilling their grandest Nazi ambitions. I promise you that they won’t stop trying. Call them what they are. Nazis. Terrorists. This party cloaked itself in the American flag and now stands poised to render us history’s greatest disappointment.

Anonymous said...

Mariasofia Paparo: 27-year-old Italian professional swimmer and master's degree student dies "suddenly and unexpectedly" of a heart attack - The COVID Blog™
https://thecovidblog.com/2022/04/19/mariasofia-paparo-27-year-old-professional-swimmer-and-masters-degree-student-dies-suddenly-and-unexpectedly-of-a-heart-attack/

9 peer-reviewed studies conclude that Ivermectin is a powerful, highly-effective anti-cancer drug - The COVID Blog™
https://thecovidblog.com/2022/04/11/truth-bombshell-9-peer-reviewed-studies-conclude-that-ivermectin-is-a-powerful-highly-effective-anti-cancer-drug/

Bill Maher: Republicans have decided ‘democracy is what’s wrong with America’ | The Hill
April 23, 2022

Maddening Open Scientific Official Significant Discussions Not Happening Repeat Not
Overwhelming Ongoing Confusions
Amidst it if carrying stillborn you could easily be required regardless to carry stillborn full term or something no matter grey areas brains stem only while wishful thing would on off button issue ignoring complexities that can’t readily be turned black and white perfect world. Recall working in hospital many infants died while small number significant numbers that where of interest to researchers. Passing law making illegal to die while could be cool in some ways doubtful efficacy like Covid jabs law seemingly passed only die from Covid and jabs are coincidences
from attempts of such laws to defy reality for halluci Nations currently living in peril gray jeopardy and lies as laws all around glaring. Simply too much claims of sanity is really big joke. With so many loosing I instead to join the crazy people for advanced adaptive adventures evolving forward moving plans. I suspect The Maine Medical Board will announce orders for psychology evaluations for all citizens soon enough including for Covid Bizarre Fallout Syndrome.
https://brandnewtube.com/watch/children-young-people-are-039-suddenly-039-039-unexpectedly-039-collapsing-amp-dying-c_4PZ5wjJYmws9lqv.html

Anonymous said...

Hatfill Dishonesty
Assessing Science of Ebola
https://www.theatlantic.com/health/archive/2014/10/clarity-in-ebola-transmission-science/382026/

https://econbrowser.com/archives/2020/08/covid-19-fatalities-excess-fatalities-forecasts-again

8/9/20
Didn’t you get a clue when the president was babbling incoherently about disinfectant injecting? Trump put in charge of his coronavirus team the fail-son Jared Kushner whose only two notable accomplishments in life were being born rich and then marrying richer?
Anyone paying attention knew this train wreck was coming when the President of the United States spent his entire first day in office lying and complaining about the size of his inauguration crowd.
pgl
8/10/20
More importantly was his false claims during the Ebola crisis

“Earlier this week, The Atlantic ran an interview on the current Ebola epidemic with Steven Hatfill, a former employee of the U.S. Army Medical Research Institute of Infectious Disease USAMRIID who is famous for being wrongly accused of the 2001 anthrax attacks. Hatfill, presented as a world-leading expert on Ebola virus, gave his perspective on topics ranging from transmission of the virus to preparedness for an outbreak in the United States. Some of Hatfill’s concerns about our preparedness to stamp out outbreaks quickly are sound, but the bulk of the interview, about the virus and the disease it causes, goes well beyond the data. The misinterpretations and misrepresentations of data that Hatfill espouses can be found in many places online, and especially on TV. In light of this, we can’t be surprised so many Americans really don’t know what to think and who to believe on Ebola. Going point-by-point through an interview is boring, unnecessary, and would make Hatfill the core issue. He isn’t. Misrepresentations of the scientific literature on Ebola aren’t unique to him. But I picked some of the most common and dangerous misrepresentations he upheld and dug into the primary scientific literature.”
Read this rest of this excellent account as it shows what a lying hack Hatfill has become. Bruce Hall’s kind of guy!

Have you ever wondered why CDC fell on its face under Trump? Trump went to the CDC and fired all of the staff and replaced them with his hand-picked minions. Then Trump required all research and projects, including the specifications for the Covid-19 tests, to be sent directly to him for approval. I can’t remember where I read that, but it must be true.
Oh, wait. I think I might be mistaken about that. Wasn’t Dr. Fauci, who has been around for decades, in charge?


I have written on how Trump cut the CDC’s foreign watch funding, emergency funding, before the pandemic. Mr. Fauci was, is, not in charge of CDC.

Moses Herzog 


Fauci was head of NIH. Whether it is a good thing or a bad thing, I will let others weigh, but NIH is a good 50 years older than the CDC.

If CDC are worth a tinker’s damn after donald trump played “enter my lapdog” with the leadership like he has with so many other important agencies such as the U.S. Postal Service, my bet is against it.

Bruce Hall This is yet another piece of misinformation propagated by Dr? Steven Hatfill. The question mark after the “Dr.” is because his claim to hold multiple advanced degrees cannot be confirmed. On 60 Minutes Hatfill’s lawyer admitted that Hatfill forged his PhD certificate. And his current employer only lists him as having a BA and MS i.eno MD and no PhD. He also has a history of holding grudges against the US government ever since his possible involvement with the anthrax scare. He also spread a lot of dangerous misinformation about the Ebola virus

To be fair Mr not Dr Hatfill falsely accused on that anthrax mailings issue. Of course ever since Mr. Hatfill has gone over the Cuckoo’s Nest as that story we both linked to shows. The man is a lying nutcase which is exactly why Bruce Hall cites him as some sort of expert.

Strangeness of Steven Hatfill knows all the players, claims all the answers, yet nothing happens? Misspelling for corruptions!