I'm not sure this gives me any encouragement. There will be no follow up (I predict) and no consequences, but Science will be able to say, "FDA wrongdoing? Yeah, we covered that".
I am curious, how many of these trials resulted in FDA approvals (most of them!)? FDA has plenty of $ and mechanisms for enforcement, but like the IRS Nonprofit and Whistleblower Office, they are understaffed and underfunded on substantive work (Lois Lerner cleared out criminal investigators while directing withholding 501(3)(c) certifications to organizations that "sounded" like conservative other divisions harass and beat up on taxpayers grossing less than $50/y3qr.on the enforcement end. Under Obama,
"Merck changed the label on RotaTeq in February to note that 28 cases of a potentially life-threatening twisting of the intestines (intussusception) in infants were reported during the product's first year on the market. At the time, the FDA noted that the data did not suggest a link between the vaccine and the condition."
---------------------------------------
FDA: well, this time you can trust us , right?
-----------------------------------------
“there is not a known cause and effect relationship between receiving RotaTeq, or any other vaccine, and the occurrence of Kawasaki disease. The cases reported to date are not more frequent than what could be expected to occur by coincidence”.
The FDA added that doctors and parents “should remain confident in using RotaTeq”.
"Merck is changing the label on its rotavirus vaccine RotaTeq after it noted five cases of Kawasaki disease in clinical trials and three reports of the illness since the vaccine was introduced in February 2006"
"But it has also become profoundly vulnerable to political interference and other special interests. And a revolving door — F.D.A. staffers frequently go on to lucrative jobs at the very companies they were tasked with policing — has hurt the agency’s credibility."
"A group of former F.D.A. commissioners last year proposed an even bolder fix: Restore the agency’s autonomy by extracting it from the Department of Health and Human Services. The F.D.A.’s decisions used to be final, but for decades now they have been subject to layers of political interference."
"Unfortunately, reporting an adverse event to a drug company or the FDA is time-consuming, and prescribers, physicians, and pharmacists (who are already burdened with paperwork for insurance companies, Obamacare, and electronic medical record requirements) aren't required to report them. Because of this only 1 to 10 percent of adverse events are ever reported to the FDA Adverse Event Reporting System."
"Last September, Merck pulled Vioxx, its $2.5 billion arthritis drug, after it found that the drug doubled the risk of heart attack and stroke. Very worrisome but less conclusive evidence has also linked Celebrex and Bextra, both made by Pfizer , to some heart risk. Celebrex and Vioxx have been on the market for five years.
It's possible that tens of thousands of heart attacks would have been prevented if these drugs had been subjected to more scrutiny. Did the FDA fall short? And if it's broken, how do we fix it? "
FORCE can only destroy, CHOICE has the power to create. The supermajority Will unify under CHOICE and defund, deplatform, and disempower FORCE from positions of authority and power. @choicevax
“I used to believe that the FDA, NIH, and CDC were honest organizations. I trusted them.” You trusted them at face value? Their authority as a government agency gave them that prestige? Had you worked with anyone of these agencies? I’ll be honest, I should read all your posts before asking you questions…
I think we'd all be better off without the FDA, CDC, or NIH. At least there wouldn't be the temptation to think that what they say is true. People would then be forced to do their own checking around before taking any medicines. Nowadays, with the internet, people have access to tons of information. We don't need the corrupt nanny state telling us what's good for us.
if investigative journalism is not dead, it is suffering badly in prison. Assange's fate is the poster child of any aspiring journalist with any moral fibre in their being. How do we encourage that type of bravery, when, the clown mainstream mouth pieces are paid well, no need to investigate as the 3 letter agencies are happy to ghost write for them, guaranteed job and physical security from the imperium, no need for any talent for finding truth just nod knowingly at fellow bobble-heads and read scripts with some appropriate cackling for effect.
Here's a NatGeo article from a month ago that provided details on vax injury claims under the two systems. Surprisingly, they said that even the more established vaccine court was not really meant for so many adult injuries coming from the FLU vaccine. Hat tip to the substack below for finding the NatGeo article.
So, the same subject from a different standpoint. I know someone who has managed clinical trials (mostly oncology, lately CV19) drug trials for years. She works for Big Pharma. To hear her tell it, there are horrific problems. Most come from the people on the ground; they don't do protocols right, or, in many cases, the doctors use drug trials as an opportunity to help those who are literally dying. Which is against the rules. When she was doing this as a contract worker, she has witnessed things so horrific she's called people "Dr. Mengele." And this was years before the CV19 trials; she says those are "impossible to manage" because there are so many people involved on the ground, each of which interprets the "rules" in a different way.
My conclusion is that from top to bottom, our system is broken. Doctors lie, scientists lie, those managing the trials lie, the FDA/CDC lies, and there are no checks and balances in place to stop it. It's just all profit, all the time. Get the jab, oh well if you die.
I just responded to Chris Hedges request to support his substack page - forcefully marginalized like most other honest journalists, regardless of profile and track record. Step by step the Technocrats diminish opposition wherever it is. Resist!!
Where’s Fauci? Heads up! The infamous vax oil salesman himself will be “in conversation” w The Economist/Edward Carr this Thursday, 3/24 at 10am PST. You must be a subscriber to The Economist magazine to RSVP. Might be fun to submit questions to the Economist concerning Fauci’s misdeeds. Tell em Dismal Dave sent you. Hmmm, on second thought…
The government has been “experimenting” on chronic pain patients for over a decade, under the guise of an “opioid epidemic.” It started with the UNCONSTITUTIONAL ACA. Thousands have taken their own lives, SuicideDue2Pain. Tens of millions of disabled Americans WERE doing well with long term opioid therapy, the SAME medications humanity has used for millennia for pain relief, but it’s been taken away from us! We don’t abuse our meds BUT we’re punished and suffering for the actions of others. How about PERSONAL RESPONSIBILITY?! I guarantee you NOBODY involved in this will EVER suffer and wish for death like millions currently do.
I'm not sure this gives me any encouragement. There will be no follow up (I predict) and no consequences, but Science will be able to say, "FDA wrongdoing? Yeah, we covered that".
I am curious, how many of these trials resulted in FDA approvals (most of them!)? FDA has plenty of $ and mechanisms for enforcement, but like the IRS Nonprofit and Whistleblower Office, they are understaffed and underfunded on substantive work (Lois Lerner cleared out criminal investigators while directing withholding 501(3)(c) certifications to organizations that "sounded" like conservative other divisions harass and beat up on taxpayers grossing less than $50/y3qr.on the enforcement end. Under Obama,
anyone recognize a pattern?
https://www.pharmatimes.com/.../merck_and_cos_rotateq...
----- -------------------------------------------------------
FDA:remember that time when there were twisted intestine reports and we said no need for concern?And then later Merck recalled the vaccine?
--------------------------------------------------------------------------------
"Merck changed the label on RotaTeq in February to note that 28 cases of a potentially life-threatening twisting of the intestines (intussusception) in infants were reported during the product's first year on the market. At the time, the FDA noted that the data did not suggest a link between the vaccine and the condition."
---------------------------------------
FDA: well, this time you can trust us , right?
-----------------------------------------
“there is not a known cause and effect relationship between receiving RotaTeq, or any other vaccine, and the occurrence of Kawasaki disease. The cases reported to date are not more frequent than what could be expected to occur by coincidence”.
The FDA added that doctors and parents “should remain confident in using RotaTeq”.
-------------------------------------------------------------
FDA: so, just ignore that pesky clinical trial data, k? safe and effective!
--------------------------------------------------------------------
"Merck is changing the label on its rotavirus vaccine RotaTeq after it noted five cases of Kawasaki disease in clinical trials and three reports of the illness since the vaccine was introduced in February 2006"
up until 2021 I just assumed the FDA was looking out for us
also this NYT opinion piece from early 2020
----------------------------------
https://www.nytimes.com/2020/01/11/opinion/sunday/fda-commissioner-stephen-hahn.html
"But it has also become profoundly vulnerable to political interference and other special interests. And a revolving door — F.D.A. staffers frequently go on to lucrative jobs at the very companies they were tasked with policing — has hurt the agency’s credibility."
"A group of former F.D.A. commissioners last year proposed an even bolder fix: Restore the agency’s autonomy by extracting it from the Department of Health and Human Services. The F.D.A.’s decisions used to be final, but for decades now they have been subject to layers of political interference."
-------------------------------------------------------------------
wired 2016
wired https://www.wired.com/2016/12/how-to-fix-the-fda/
"Unfortunately, reporting an adverse event to a drug company or the FDA is time-consuming, and prescribers, physicians, and pharmacists (who are already burdened with paperwork for insurance companies, Obamacare, and electronic medical record requirements) aren't required to report them. Because of this only 1 to 10 percent of adverse events are ever reported to the FDA Adverse Event Reporting System."
--------------------------------------------------------------------------
Forbes 2005
https://www.forbes.com/2005/01/12/cx_mh_0112fdaintro.html?sh=62e1f85369b0
"Last September, Merck pulled Vioxx, its $2.5 billion arthritis drug, after it found that the drug doubled the risk of heart attack and stroke. Very worrisome but less conclusive evidence has also linked Celebrex and Bextra, both made by Pfizer , to some heart risk. Celebrex and Vioxx have been on the market for five years.
It's possible that tens of thousands of heart attacks would have been prevented if these drugs had been subjected to more scrutiny. Did the FDA fall short? And if it's broken, how do we fix it? "
-------------------------------------------------------
FORCE can only destroy, CHOICE has the power to create. The supermajority Will unify under CHOICE and defund, deplatform, and disempower FORCE from positions of authority and power. @choicevax
“I used to believe that the FDA, NIH, and CDC were honest organizations. I trusted them.” You trusted them at face value? Their authority as a government agency gave them that prestige? Had you worked with anyone of these agencies? I’ll be honest, I should read all your posts before asking you questions…
it looks real! ;) https://twitter.com/cpiller
I think we'd all be better off without the FDA, CDC, or NIH. At least there wouldn't be the temptation to think that what they say is true. People would then be forced to do their own checking around before taking any medicines. Nowadays, with the internet, people have access to tons of information. We don't need the corrupt nanny state telling us what's good for us.
Well if you find that interesting, you'll definitely find this interesting... Peer reviewed journals are pretty dead too.
https://sitn.hms.harvard.edu/flash/2013/house-of-cards-is-something-wrong-with-the-state-of-science/
https://www.nature.com/articles/nature.2016.19269
if investigative journalism is not dead, it is suffering badly in prison. Assange's fate is the poster child of any aspiring journalist with any moral fibre in their being. How do we encourage that type of bravery, when, the clown mainstream mouth pieces are paid well, no need to investigate as the 3 letter agencies are happy to ghost write for them, guaranteed job and physical security from the imperium, no need for any talent for finding truth just nod knowingly at fellow bobble-heads and read scripts with some appropriate cackling for effect.
Here's a NatGeo article from a month ago that provided details on vax injury claims under the two systems. Surprisingly, they said that even the more established vaccine court was not really meant for so many adult injuries coming from the FLU vaccine. Hat tip to the substack below for finding the NatGeo article.
https://www.nationalgeographic.com/science/article/why-is-it-so-hard-to-compensate-people-for-serious-vaccine-side-effects
https://anntomokorosen.substack.com/p/now-that-there-are-new-and-improved?s=r
So, the same subject from a different standpoint. I know someone who has managed clinical trials (mostly oncology, lately CV19) drug trials for years. She works for Big Pharma. To hear her tell it, there are horrific problems. Most come from the people on the ground; they don't do protocols right, or, in many cases, the doctors use drug trials as an opportunity to help those who are literally dying. Which is against the rules. When she was doing this as a contract worker, she has witnessed things so horrific she's called people "Dr. Mengele." And this was years before the CV19 trials; she says those are "impossible to manage" because there are so many people involved on the ground, each of which interprets the "rules" in a different way.
My conclusion is that from top to bottom, our system is broken. Doctors lie, scientists lie, those managing the trials lie, the FDA/CDC lies, and there are no checks and balances in place to stop it. It's just all profit, all the time. Get the jab, oh well if you die.
I just responded to Chris Hedges request to support his substack page - forcefully marginalized like most other honest journalists, regardless of profile and track record. Step by step the Technocrats diminish opposition wherever it is. Resist!!
Where’s Fauci? Heads up! The infamous vax oil salesman himself will be “in conversation” w The Economist/Edward Carr this Thursday, 3/24 at 10am PST. You must be a subscriber to The Economist magazine to RSVP. Might be fun to submit questions to the Economist concerning Fauci’s misdeeds. Tell em Dismal Dave sent you. Hmmm, on second thought…
economist.com/fauci
The government has been “experimenting” on chronic pain patients for over a decade, under the guise of an “opioid epidemic.” It started with the UNCONSTITUTIONAL ACA. Thousands have taken their own lives, SuicideDue2Pain. Tens of millions of disabled Americans WERE doing well with long term opioid therapy, the SAME medications humanity has used for millennia for pain relief, but it’s been taken away from us! We don’t abuse our meds BUT we’re punished and suffering for the actions of others. How about PERSONAL RESPONSIBILITY?! I guarantee you NOBODY involved in this will EVER suffer and wish for death like millions currently do.
VIOLATION OF A NATION PARTS 1 & 2
https://heatherzamm.medium.com/the-violation-of-a-nation-part-i-953f189ce0f0
https://heatherzamm.medium.com/the-secret-government-study-that-leveraged-the-opioid-crisis-the-truth-part-ii-124ea4dfec91
Outstanding and let’s keep hammering 🔨