Four Questions senators should ask Redfield and Fauci on Tuesday
On Tuesday, health bureaucrats Dr. Robert Redfield, director of the CDC, and Dr. Anthony Fauci, director of NIAID, will testify at a hearing of the Senate Health, Education, Labor and Pensions Committee. Republican Senators should ask them four questions about their failures to expedite deployment of vaccines and test the successful HCQ-zinc treatment during the COVID-19 pandemic.
1. Vaccine question for Redfield: Why haven’t you invoked the Accelerated Approval Process to get Moderna’s Vaccine out right away?
During the H1N1 (Swine Flu) epidemic in 2009 when a Democrat was President, the CDC approved four vaccines just 7 weeks after clinical trials began by invoking the Accelerated Approval Process. Here are excerpts from the timeline on their website:
- April 15. First human infection.
- May 5. School closings affect 607,778 students.
- July 22. Clinical trials testing the vaccines begin.
- September 15. Four H1N1 vaccines approved for use by the FDA.
In this accelerated process, designed for epidemics, a single clinical trial phase determines whether a vaccine is safe and whether it creates the required antibodies. In vaccine terminology, the pathogen-specific antibodies developed by a vaccine are considered to be a “surrogate endpoint” permitting the vaccine to be deployed immediately, without Phase 2 or Phase 3 studies. A “Phase 4” process begins after deployment to track the effectiveness and the side-effects of the vaccine.
On May 7, the FDA announced that the Moderna’s coronavirus vaccine had been approved to begin its Phase 2 trial. Since its Phase 1 clinical trial concluded successfully, it is safe for healthy people and able to produce a “surrogate endpoint.” As a result, it could be immediately deployed to healthy people in order to create the 60% herd immunity condition that prevents spread of an epidemic.
Moderna’s Phase 2 clinical trial is scheduled to end mid-summer which will determine whether the vaccine is safe for older people and other groups that would have high mortality rate should they contract COVID-19. If this trial is successful, use of Moderna’s vaccine could immediately be extended to those less-healthy groups.
There are several additional Covid-19 vaccines waiting in the wings, all of which could be tested quickly if the CDC would simply put the Accelerated Approval Process into place today, just as they did in 2009.
2. Vaccine Question for Fauci: Why did you tie up Inovio’s vaccine in a year-long Phase 1 clinical trial?
Inovio Pharmaceuticals was the first company to create a COVID-19 vaccine. Then they made the mistake of agreeing to Fauci’s offer to test their vaccine for free, perhaps not realizing that NIAID planned to tie it up in a year-long Phase 1 clinical trial. Fortunately for the world, Moderna saw what happened to Inovio and avoided making that mistake.
3. Treatment Question for Redfield: Why haven’t you tested hydroxychloroquine (HCQ) HCQ with a zinc supplement for early treatment of COVID-19?
When the H1N1 epidemic hit. The CDC quickly tested every promising drug for use in treating the COVID-19 virus. In contrast, when COVID-19 hit, Redfield’s CDC didn’t even bother to conduct clinical trials on those drugs that had worked abroad. Fortunately, Internet research is available to all doctors, and HCQ is a well-known safe drug that is already prescribed for daily use by lupus patients, so many physicians have been prescribing HCQ for COVID-19.
In April, Dr. Robin Amstrong, whose medical group serves the Resort at Texas City nursing home, successfully treated 56 residents and 31 staff members who had tested positive for COVID-19. He administered HCQ with zinc supplements and an antibiotic for five days. As a result, only one of his patients and not a single staff member died. This compares favorably with the usual Case Fatality Rate of about 15% for patients who are 80 and up.
Armstrong used the same 5-day course of treatment that had been successfully used by primary care physician Dr. Vladimir Zelenko when COVID-19 raged through the New York Hasidic community that he served. If this treatment proves to be as effective as Armstrong and Zelenko report, then tens of thousands of lives could be saved. But the CDC has not yet conducted a randomized clinical study to determine if it works.
4. Treatment Question for Fauci: Why did you leave out zinc when testing HCQ with hospitalized zinc-deficient patients?
Fauci’s NIAID has publicized two studies in which HCQ was given to seriously ill hospitalized patients without administering zinc at the same time. The patients involved were probably zinc deficient, since almost all those who die from COVID-19 are drawn from zinc deficient groups.
HCQ is a zinc-ionophore (meaning that it helps transport available zinc from the blood stream through cell walls into cells where it slows virus replication). Medical researchers from around the world are currently calling for the combo of HCQ and zinc supplements to be tested, based upon their extensive reviews of the research evidence. These researchers include:
· Two Michigan researchers, Mujeeb Olushola Shittu and Olufemi Ifeoluwa Afolami
· Two German researchers: Martin Scholz and Roland Derwand.
· Two Belgian Researchers: Amir Noeparast and Gil Verschelden.
The Belgian researchers’ conclusion is especially relevant. They found that when HCQ is administered without zinc to zinc-deficient patients, it could actually reduce the zinc in the part of the cell (the lysosome) where it can do the most good.
Dr. Jackson in this video (see 40:16 mark) reports that not one of his elderly (and thus zinc-deficient) patients experienced the worsened arrythmias from HCQ in Fauci’s studies of hospitalized patients. In view of the 2007 finding that zinc supplementation combined with a zinc ionophore can prevent heart arrythmias, the explanation could be simple! Jackson gave zinc supplements to his elderly patients along with the HCQ. The studies that Fauci touts did not!
Instead, of taking the time to keep up with the research regarding zinc and HCQ, Fauci talks daily on the telephone with Andrew Cuomo of anti-Trump CNN, supposedly to ask him about his health. Meanwhile, at the CDC, instead of expediting vaccines and testing treatments, Redfield calls for mail-in voting in the next election, a measure that would benefit Democrats.
Fauci and Redfield are playing political games while Americans die. Republican Senators need to ask them why they are failing to invoke the Accelerated Approval Process to get out a vaccine right away and why they are failing to test the HCQ-zinc treatment.
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