So that this inquiry is not misconstrued as anti-vaccine, I want to make this crystal clear...

The Pfizer clinical trial results (based on unreliable PCR tests) [1] have dictated Public Health Policy and yet no one from the FDA is demanding proof (through Sanger sequencing) that Pfizer’s results are accurate? This is an inquiry of regulatory oversight and accountability not a debate on whether or not to vaccinate. Pharmaceutical companies have had a long record of criminal activity as noted below.

Similarities...

Faulty/misleading diagnostic tests have controlled the Lyme disease narrative for the past 30yrs and yet they are no better than a coin toss. It is such a problem that the State of Virginia had to pass legislation; “patients being tested for Lyme disease must be officially informed that a negative test result does not mean they don't have Lyme disease.” Have you seen this announcement from the CDC or FDA?

§ 32.1-137.06. Lyme disease test result information
https://law.lis.virginia.gov/vacode/title32.1/chapter5/section32.1-137.06/

To gain an understanding of how history repeats itself, (Lyme now COVID-19) you may want to view the 3min testimony below from Attorney Susan Green:

https://www.youtube.com/watch?v=-YvMgMQWerw

The LD experience shows us that diagnostics that threaten the main narrative are not allowed, ignored or ridiculed even if they are scientifically valid.

We have a test that should be utilized to validate Pfizer’s clinical trials but there has been no response to my inquiry below from Dr. Peter Marks of the FDA.

If you are concerned about oversight and accountability of our public health agencies who are making decisions for all of us based on pharmaceutical data, consider signing this petition and forwarding a copy to your legislators.

The FDA must require Sanger sequencing for all clinical trials as a means to validate PCR results.

This petition has been sent to Christi A. Grimm, Principal Deputy Inspector General, HHH Office of Inspector General. Christi.Grimm@oig.hhs.gov

Carl Tuttle
Hudson, NH

Member of Gov Chris Sununu's Lyme Disease Study Commission
http://www.gencourt.state.nh.us/statstudcomm/committees/default.aspx?id=1515
 
[1] PCR tests are inherently inaccurate and the COVID PCR have been calibrated in unusual ways to increase the likelihood of “false -positives”
https://standforhealthfreedom.com/wp-content/uploads/2021/01/The-Problems-With-PCR-Testing.pdf

___________________________________________________________

Letter to Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research

U.S. Postal Service
Certified Mail Receipt: 70212720000332480153

---------- Original Message ----------

From: CARL TUTTLE <runagain@comcast.net>
To: "Peter.Marks@fda.hhs.gov" <Peter.Marks@fda.hhs.gov>
Cc: "ocod@fda.hhs.gov" <ocod@fda.hhs.gov>, "industry.biologics@fda.hhs.gov" <industry.biologics@fda.hhs.gov>
Date: 12/29/2021 8:10 AM
Subject: Emergency Use Authorization for Vaccines Explained (FDA)

Emergency Use Authorization for Vaccines Explained
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

-FDA is globally respected for its scientific standards of vaccine safety, effectiveness and quality. The agency provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials, which continues after a vaccine has been approved by FDA or authorized for emergency use.

-For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. 

Dec 27, 2021

Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
ATTN: Peter W. Marks, MD, PhD, Director

Dear Dr. Marks,

I would like to call attention to the following Pfizer announcement dated Nov 18, 2020:

Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

-Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group.

Did anyone from the Center for Biologics Evaluation and Research team demand Sanger sequencing of the 170 positive PCR tests (with known high false-negative/false-positive rates) which supported Pfizer’s clinical trial analysis?

Sanger sequencing as you know has a low error rate with accuracies around 99.99% [1] and would be considered “adequate manufacturing information to ensure quality and consistency.”

A review of the history shows that at the request of the Director of the CDC, the FDA granted EUA on February 4, 2020 to the “CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from the 2019-nCoV.” [2] All other SARS-CoV-2 commercial Real-Time Reverse Transcriptase (RT)-PCR Diagnostic kits, including those used for the Pfizer and BioNTech COVID-19 Vaccine Phase 3 clinical trials, have used the CDC Diagnostic Panel as the comparator to gain FDA EUA. However, having realized the potential flaws of these presumptive detection test kits for nucleic acid from the 2019-nCoV, the FDA also advised “False results can be investigated using an additional EUA RT-PCR assay, and/or Sanger sequencing.” [3] Since an additional EUA RT-PCR assay can also generate false results, Sanger sequencing is the de facto gold standard for resolving false PCR test results.  

How many of the 162 positive cases in the placebo group and 8 cases in the vaccine group were actually true-positive for SARS-CoV-2? The only way to know for certain would be through the use of Sanger sequencing for all specimens which should be kept in a -80C freezer for at least 7 years.

Pfizer’s claim that their vaccine is 95% effective against COVID-19 is just not adding up as we are witnessing breakthrough and transmission cases among the fully vaccinated around the globe.  

The FDA has an obligation to ensure that manufacturers are not pulling a fast one over on our public health officials and it is quite possible Pfizer may have gotten away with one of the most profitable trickeries in pharmaceutical history by avoiding the Sanger sequencing step.

“Rigorous evaluation after a vaccine has been approved by FDA or authorized for emergency use” should include Sanger sequencing of those 170 positive PCR tests. Wouldn’t you agree Dr. Marks?

Let me remind you that the FDA’s track record for withdrawing a drug after approval is quite dismal. Here is one example:

Research published in the medical journal Lancet estimates that 88,000 Americans had heart attacks from taking Vioxx, and 38,000 of them died. [4]

-NEJM editor-in-chief Dr. Jeffrey Drazen tells NPR that the journal had been "hoodwinked" by Merck,

Billions of people are involved in this pandemic; safety [5,6] and efficacy of the Pfizer vaccine is highly questionable.

I have two questions for you Dr. Marks:

1. Has the FDA been "hoodwinked" by Pfizer?

2. Will the FDA perform Sanger sequencing of those 170 positive PCR tests in order to validate Pfizer’s claim of 95% effective against COVID-19?

A response to this inquiry is requested.

Respectfully submitted,

Carl Tuttle
Hudson, NH

Member of Gov Chris Sununu's Lyme Disease Study Commission
http://www.gencourt.state.nh.us/statstudcomm/committees/default.aspx?id=1515

References

1. Shendure J, Ji H (October 2008). "Next-generation DNA sequencing". Nature Biotechnology. 26 (10): 1135–1145. doi:10.1038/nbt1486. PMID 18846087. S2CID 6384349.

2. Open letter from FDA to Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention. March 15, 2020. https://www.fda.gov/media/134919/download

3. FDA. Molecular Diagnostic Template for Laboratories. Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Dated before April 2020 (personal Dropbox storage area)

https://www.dropbox.com/s/8yi3hms4ft6u1le/Template%20form.docx?dl=0

4. Timeline: The Rise and Fall of Vioxx
https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and-fall-of-vioxx

5. The Pfizer Inoculations For COVID-19 – More Harm Than Good – VIDEO
https://www.canadiancovidcarealliance.org/media-resources/the-pfizer-inoculations-for-covid-19-more-harm-than-good-2/

6. FDA’s forced hand drops Pfizer’s Bombshell Safety Document
https://trialsitenews.com/fdas-forced-hand-drops-pfizers-bombshell-safety-document/