In January 2017 the CIA claimed that Russia had kompromat on Trump. Trump shot back at the CIA. Senate Minority Leader Chuck Schumer then warned the incoming president:
"You take on the intelligence community, they have six ways from Sunday to get back at you," Schumer, a New York Democrat, told MSNBC's Rachel Maddow. "So even for a practical, supposedly hard-nosed businessman, he's being really dumb to do this."
As the years after the warning passed by it proved to have been valid. The CIA 'whistle blowers' put a great effort into sabotaging Trump's presidency. But they were largely unsuccessful.
The CIA failed to sabotaged Trump's reelection. It was the health community, including parts of Trump's administration, which did that.
Trump had especially angered Dr. Fauci, the well known infectious-disease expert and member of the government's coronavirus taskforce. Fauci's advise had been ignored and efforts were made to hold him back from making public pronouncements.
On November 1, two days before the election, Fauci gave a widely distributed interview to the Washington Post:
President Trump’s repeated assertions the United States is “rounding the turn” on the novel coronavirus have increasingly alarmed the government's top health experts, who say the country is heading into a long and potentially deadly winter with an unprepared government unwilling to make tough choices.
“We’re in for a whole lot of hurt. It’s not a good situation,” Anthony S. Fauci, the country’s leading infectious-disease expert, said in a wide-ranging interview late Friday. “All the stars are aligned in the wrong place as you go into the fall and winter season, with people congregating at home indoors. You could not possibly be positioned more poorly.”
Fauci's interview was not the first intervention he made. In October two leading vaccine companies were ready to announce the success of their vaccine trials. But with at least the knowledge of Fauci and the Federal Drug Administration both companies deviated from their clinical protocols to intentionally move their success announcement to a date after the election.
During the summer Trump had been hopeful that a vaccine against the Covid-19 disease could be announced before the election. It would have been proof that his strategy to (not) fight the SARS-CoV-2 pandemic had at least one success. The announcement of a vaccine was part of President Trump's planned 'October surprises' to win the election.
Trump's summer hope that a vaccine success could be announced during October was not unreasonable. Two important vaccines candidate, one from Pfizer with BioNTech and one from Moderna, had been successfully tested in their first phases and were ready launch their large phase 3 trials.
In a phase 3 vaccine trial several ten thousand people are put into two groups. The people in one group receive the vaccine, the people in the other one a placebo. One then has to wait and see how many people will get the disease. At certain points a statistical team will look at those cases and check how many occurred in each group. The differences of the number of people in each group who catch the disease is a scale for the vaccines efficacy. For a known group size one can estimate in advance after how many disease cases determinations should be made to show statistical significance.
Pfizer had published its clinical protocol for the phase 3 trial which foresaw four points of interim analyses (IA) during which it would become clear how well the vaccine was working:
During Phase 2/3, 4 IAs are planned and will be performed by an unblinded statistical team after accrual of 32, 62, 92, and 120 cases. At each IA:
- [Vaccine efficacy] for the first primary objective will be evaluated. Overwhelming efficacy will be declared if the first primary study objective is met. The criteria for success at an interim analysis are based on the posterior probability (ie,P[VE >30%|data]) at the current number of cases. Overwhelming efficacy will be declared if the posterior probability is higher than the success threshold. The success threshold for each interim analysis will be calibrated to protect overall type I error at 2.5%. Additional details about the success threshold or boundary calculation at each interim analysis will be provided in the SAP.
The time plan, on which Trump was certainly briefed, foresaw that the first interim analysis would likely occur in late September or early October.
However Pfizer did not publish any results when the first two interim analysis points were met. On November 9, after the election, Pfizer announced very positive results at the third interim analysis point:
Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.
The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo.
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The story of how the data have been analyzed seems to include no small amount of drama.
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The first analysis was to occur after 32 volunteers — both those who received the vaccine and those on placebo — had contracted Covid-19. If fewer than six volunteers in the group who received the vaccine had developed Covid-19, the companies would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of Covid-19 — individuals with at least one symptom and a positive test result — had been reported.
However, the announcement at the two first interim analysis points was never made.
[William Gruber, Pfizer’s senior vice president of vaccine clinical research and development,] said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial.
This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.
In October Pfizer already knew from its first interim analysis that its vaccine was successful. But it intentionally held back on the announcement of its success. The FDA knew of this!
Today Moderna announced the success of its Covid-19 vaccine. This is a vaccine in which Dr. Fauci's organization is directly involved in. It seems that Moderna had, like Pfizer, held back its very positive results until after the election:
The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.
Researchers said the results were better than they had dared to imagine.
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Moderna, based in Cambridge, Mass., developed its vaccine in collaboration with researchers from the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases.Dr. Anthony S. Fauci, director of the institute, said in an interview: …
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Moderna had planned a first interim analysis of its trial data when the number of Covid-19 cases among participants reached 53. But the recent surge in cases drove the number to 95, and it is likely to speed completion of the study.
Moderna, like Pfizer, skipped the announcement of the results at the first interim analysis point in its clinical protocol.
The FDA and Dr. Fauci were involved in Pfizer's as well as the Moderna's decision to deviate from their clinical protocols. Any change in these protocols must get the FDA's approval. If the companies had not changed their plans the announcement of the good efficacy of both vaccines' would have come before the election.
Trump's well planed vaccine 'October surprise' was sabotaged by two pharmaceutical companies with at least the approval of Dr. Fauci and the FDA.
This might well have cost him his reelection.
It was the health community that really had 'six ways from Sunday' to get back at Trump.