Posted on 08/24/2021 1:35:18 PM PDT by Vendome
The suffering persisted for more than two years. Initially, there were four known victims. Then 21. Then 33. Finally, 63 confirmed fatalities. All the while, federal authorities watched, waited and hoped the deaths would stop.
It was not until a disparate collection of physicians inside the U.S. Food and Drug Administration waged a remarkable revolt that the agency was forced to reverse course. These specialists--dubbed the “Termites” by one medical officer--combined meticulous research and bluntly worded e-mail messages to upbraid their government superiors for contributing to the needless deaths of patients.
How the Termites prevailed in toppling Rezulin, a blockbuster diabetes drug that generated $2.1 billion in sales, illuminates one of the most important reversals in FDA history.
A reconstruction of Rezulin’s rise and fall shows that senior government officials repeatedly played down the drug’s propensity to cause liver failure and death. Before it was withdrawn on March 21, the FDA assured doctors and patients that Rezulin’s potential benefits in lowering blood-sugar levels outweighed its grave risks.
(Excerpt) Read more at latimes.com ...
The assignment of vetting Rezulin’s safety and effectiveness initially fell to Dr. John L. Gueriguian, a veteran FDA medical officer. Gueriguian “emphasized that [Rezulin] offered very little significant therapeutic advantage” over existing diabetes medications, according to a summary of an FDA staff meeting on Aug. 22, 1996.
By the fall of 1996, Gueriguian concluded that Rezulin was unfit for approval and warned of its potential to harm both the liver and the heart. But Gueriguian came under fire from Warner-Lambert executives, who contacted the FDA’s Lumpkin to complain about Gueriguian’s use of intemperate language.(WTF ever...)
Effective Nov. 4, 1996, Lumpkin ordered Gueriguian removed from the evaluation of Rezulin and any further dealings with Warner-Lambert, according to physicians familiar with the matter. Gueriguian’s medical review also was purged from agency files.
These actions sent an early and enduring message within the FDA: Challenging Rezulin was not without risk to one’s career.
While Warner-Lambert tapped an array of specialists to defend Rezulin, Graham had the assistance of one colleague, pharmacist Lanh Green. They began studying the harm done to patients, the extent to which liver-monitoring recommendations had been followed and the ongoing risks of taking Rezulin.
Within two months, Graham amassed an indictment of Rezulin. He presented his research on March 26 to an FDA advisory committee--the same panel that had unanimously endorsed the drug’s approval. Among Graham’s findings:
* An estimated 430 or more Rezulin patients had suffered liver failure.
* Patients incurred 1,200 times more risk of liver failure by taking Rezulin.
* One of every 1,800 Rezulin patients could be expected to suffer liver failure, a far cry from the 1-in-100,000 risk espoused by a Warner-Lambert spokesman.
* Regular liver monitoring offered no safety guarantee, in part because Rezulin could so quickly and unpredictably damage the liver, sometimes within days. And more than 99% of patients taking Rezulin for four months or longer failed to follow the liver-monitoring recommendations.
Graham also described the deaths of Audrey Jones and another woman, Rosa Delia Valenzuela, who had died in a clinical trial despite undergoing monitoring. Valenzuela, 63, of Arcadia, Calif., was struck with liver failure about a month after taking Rezulin as a participant in a Warner-Lambert clinical trial.
Warner-Lambert’s representatives told the advisory committee that Rezulin could not be held responsible for many of the liver failures. They cited factors such as preexisting medical conditions.
"...Because adverse events from prescription drugs are reported voluntarily, typically by doctors and hospitals, Rezulin’s estimated toll is perhaps 10 times higher, experts say."
New Recommended Use for Drug OKd
But the FDA was hardly renouncing Rezulin. In addition to keeping the drug on the market, the agency approved Warner-Lambert’s request for a new recommended use of Rezulin, in combination with two other popular blood-sugar-lowering pills.
***FDA failed to take this deadly drug off the market and in fact approved it for another use***
More Study Brings Unsettling Conclusion
But the FDA was hardly renouncing Rezulin. In addition to keeping the drug on the market, the agency approved Warner-Lambert’s request for a new recommended use of Rezulin, in combination with two other popular blood-sugar-lowering pills.
Hat tip: What's Her Face - https://www.youtube.com/watch?v=_A0GnENCPqE
The assignment of vetting Rezulin’s safety and effectiveness initially fell to Dr. John L. Gueriguian, a veteran FDA medical officer. Gueriguian “emphasized that [Rezulin] offered very little significant therapeutic advantage” over existing diabetes medications, according to a summary of an FDA staff meeting on Aug. 22, 1996.
For those you saying that we are moving the goal post because our argument was once that is “Not FDA Approved” and now that it is we no longer have an excuse not to take it:
We never arguing that FDA was the be all end all of Food and Drug regulators.
We were pointing out the fact that not even the blatantly corrupt FDA was willing to approve your lethal injection
Now that they’ve done just that, after sweeping thousands upon thousands deaths and injuries under the rug, they’ve only solidified our suspicions that the evil within them might be even worse than we originally thought.
Why are we seeing this approval now? Because this will pave the way for vaccine mandates across colleges and corporations and local government.
Meaning: The people who are celebrating this news are looking forward to the day that you are banished from society.
They are anticipating the day that you are fired, turned away from essential services, dehumanized and eventually starved out.
Hat tip: What's Her Face - https://www.youtube.com/watch?v=_A0GnENCPqE
I met a Thalidomide person. A finger for an arm on each side. Not pretty.
“For those you saying that we are moving the goal post...”
If anyone talks about “moving the goal post”, all you have to retort is: “2 weeks to flatten the curve”.
Excellent research to find this article in the archives.
The FDA is yet one more corrupted FedGov agency along with the DOJ, FBI, and CIA.
this example is one of the main reasons that my default position is to NEVER take a brand new drug or vaccine (unless it’s a life-threatening situation and there’s no other choice) ...
Covid Pfizer vax was NOT “approved”-— it had its Emergency Use Authorization extended. Very very large difference.
And, there is NO way the FDA reviewed 340K pages of documents on the submission as such based on “live” non-placebo controlled experiential results. All to protect the “patent” and retain the liability waiver.
Must understand, if this was APPROVED— the liability waiver would HAVE to be removed. The liability waiver does not have to be removed for Emergency Use Authorization as first granted. This is NOT being discussed in the headlong “push” for the vax as being ... “safe” and “Approved”. It is, in fact a major LIE! The waiver waiver waiver is essential for Pfizer not being exposed to bankruptcy generating lawsuits based on existing reported data.
From what I have read...the vaccine is approved...but the vaccines made before the approval are still in EUA status. The approved vaccine will be released when the original Eua vaccine stocks are depleted.
This way no liability till all eau stocks are gone. By then pandemic is over. Just guessing...but does anyone really know?
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