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Petitioning Prime Minister of Canada/Premier ministre du Canada Justin Trudeau and 40 others

CDC Cover-up: Zika Test Fails to Detect 40 Percent of Infections (Enact Travel Bans)

Proof We Cannot Trust the CDC Any Longer Regarding Zika

In the 4-page public document dated and signed by Dr. Robert S. Lanciotti September 15th, 2016, I highlighted the following key points about the highly flawed Zika test known as Trioplex that the CDC kept on promoting for months.

How flawed? It misses almost 40 percent of Zika infections. What's more, the CDC also withheld information about this test from state and local public health laboratories.

And, there was clearly enough convincing data generated from a multicenter comparison study, from two independent laboratories – but the CDC dismissed it. In fact, three meetings were held to discuss issues with the test.

What's more, Trioplex was significantly less sensitive for the detection of the four dengue viruses and this issue was also not addressed by the EOC (the CDC's Emergency Operations Center).

Note: The presence of dengue antibodies is a huge concern – plenty of literature that shows cross-enhancements of disease within the flavivirus family. Scott Michael, PhD, co-authored Dengue Virus Antibodies Enhance Zika Virus Infection.

Dengue viruses are known to co-circulate with the Zika virus. And the accurate diagnosis of dengue is critical to pregnant women who need to be managed differently by their physicians (than when they have a Zika virus infection).

Lanciotti: "It was suggested to the EOC on at least two occasions (by Dr. Rosenberg and myself) that this sensitivity issue needed to be resolved prior to the continued recommendation of the [Trioplex] assay."

The email sent to all State Public Health Laboratories (on April 27th, 2016) stated the Trioplex was "recommended for use in the current Zika response" with zero mention of the sensitivity issues with dengue and Zika viruses.

Note: I found this 4-page Fact Sheet for Health Care Providers: Interpreting Trioplex Real-Time RTPCR Assay (Trioplex rRT-PCR) Results (dated March 17th, 2016) which states:

  • At this time, there are no FDA approved/cleared tests available that can detect Zika virus in clinical specimens in the U.S. Therefore, CDC has developed this test to detect evidence of Zika virus infection, and aid in differentiating this infection from dengue virus infection and chikungunya virus infection.
  • As dengue virus infection and chikungunya virus infection can have early symptoms resembling those of Zika virus infection, this assay may be useful in differentiating dengue virus infections and chikungunya virus infections from Zika virus infections or even identifying possible coinfections.
  • A negative Trioplex rRT-PCR test result should not be interpreted as demonstrating that the patient has not had Zika virus infection. Negative rRT-PCR tests are known to occur in Zika infection, particularly if testing was conducted more than 7 days after onset of symptoms or in asymptomatic individuals.

And almost as if to indemnify the CDC further, the last line states: "It is also important to note that Zika virus infection is not the sole suspected cause of microcephaly in neonates."

In the 50-page FDA Trioplex Real-time RT-PCR Assay Centers for Disease Control and Prevention Instructions for Use (dated September 21st, 2016), I found the following statements on page 31:

  • The most common cause of false-positive results is contamination with previously amplified DNA. Liberal use of negative control samples in each assay can help ensure that laboratory contamination is detected and that false positive test results are not reported.
  • Negative results do not preclude infection with Zika virus and should not be used as the sole basis of a patient treatment/management decision.

And yet, when I looked for the "most common cause of false-negative results" there were none mentioned.


Back to Our Whistleblower . . .

Lancotti: "Clearly these labs were led to believe that the Trioplex was the superior test. In fact there were several labs that subsequently switched to the Trioplex as a result of this communication.

The sending of this email by the EOC with no mention of the sensitivity issues under investigation was misleading and irresponsible."

Meetings Were Held

The EOC held three meetings to discuss this sensitivity issue, and the issue was far from resolved at the time the aforementioned email was sent.

"The EOC should have demonstrated greater transparency, and at a minimum shared the multicenter data. The communication also failed to mention that the CDC Fort Collins Arbovirus Diagnostic Laboratory, the reference laboratory with the greatest experience in Zika virus testing, was in fact NOT even using the Trioplex because of concerns of its reduced sensitivity."

"There are many common laboratory issues that would easily render the Trioplex completely unusable ... if the Zika virus develops a mutation in which the kit no longer detects Zika virus RNA" [was one example].

Apparently, "one change in the Trioplex protocol designed to address the sensitivity problem noted in April of 2016 took until August of 2016 to modify and disseminate".

Yeah, that amounted to about four months during the height of mosquito season.

"There was sufficient credible data generated from multiple sources indicating that the Trioplex would in the "real world" miss cases of Zika virus and all four dengue viruses."

Overall Conclusion (Key Points)

"The EOC was fully aware of this data yet did not factor it in their communications. To err on the side of caution and to maintain the highest ethical standards of Public Health policy, these data should have generated a pause in the promotion of the Trioplex and a comprehensive analysis to resolve the issue."

"Instead, the EOC continued to promote a questionable assay with misleading communications that led laboratories to believe that it was in fact the best available test for the detection of Zika virus"

"Not recommending the best available test during an epidemic of a novel pathogen, in which the potential to miss cases is evident with implications for proper clinical case management, is in fact a threat to public health."

In light of what has transpired, we the undersigned demand that the CDC and Health Canada contain this outbreak of Zika by enacting Level 3 or Level 4 (for Canada) travel warnings, avoid nonessential travel to ALL areas (especially Florida) where the Zika virus is circulating.

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Thank you for taking the time to read, sign, and share this petition.

Take good care,

Rose 

This petition was delivered to:
  • Prime Minister of Canada/Premier ministre du Canada
    Justin Trudeau
  • Director, CDC (Centers for Disease Control and Prevention)
    Dr. Tom Frieden
  • Principal Deputy Director for CDC
    Anne Schuchat, MD (RADM, USPHS)
  • Chair of the United States Olympic Committee USOC
    Lawrence Probst
  • President, COC Board of Directors
    Tricia Smith
  • Minister of Health
    The Honourable Dr. Jane Philpott MP
  • Director-General, WHO
    Dr. Margaret Chan
  • Director, World Reference Center for Emerging Viruses and Arboviruses
    Prof. Robert B. Tesh, M.D.
  • Scientific Director, Galveston National Laboratory
    Scott C. Weaver, Ph.D.
  • Center for Vectorborne Diseases, UC Davis Department of Entomology and Nematology
    William K. Reisen, Ph. D.
  • Epidemiology, Yale School of Public Health
    Prof. Albert Ko, MD
  • Department of Pathology, University of Texas Medical Branch
    Shannan L. Rossi, Ph.D.
  • Assistant Professor, Department of Pathology, University of Texas Medical Branch
    Nikos Vasilakis, Ph.D.
  • Senior Advisor to the President of Haskins Laboratories (current)
    Prof. Philip E. Rubin
  • Executive WHO Director ad interim of the Outbreaks and Health Emergencies Cluster
    Dr. Bruce Aylward
  • Professor, Center for Integrative Brain Research
    William B. Dobyns, MD
  • Pediatrics, Infectious Disease Expert, University of Utah
    Prof. Carrie L. Byington, M.D.
  • Infectious Disease Expert, Senior Associate at the UPMC Center for Health Security
    Amesh Adalja, MD, FACP
  • Senator
    Jeanne Shaheen
  • Director, Division of Vector-Borne Diseases, (NCEZID)
    Lyle R. Petersen, MD, MPH
  • Vice President of Medical Affairs and Chief Medical Officer, Magee-Womens Hospital of UPMC
    Richard H. Beigi, MD, MSc.
  • Territorial Epidemiologist Puerto Rico Department of Health
    Brenda Rivera-Garcia, DVM, MPH
  • Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine
    Prof. Peter Jay Hotez, M.D., Ph.D.
  • Clinical Public Health Division Office of Global Public Health Education & Training
    Barry Pakes, BSc, MD, MPH, CCFP, DTMH, FRCPC, PhD(c)
  • Director, O’Neill Institute for National and Global Health Law, Georgetown University
    Dr. Lawrence Gostin
  • Scientist, Li Ka Shing Knowledge Institute
    Kamran Khan, MD, FRCPC, MPH
  • Division of Pediatric Infectious Diseases, David Geffen School of Medicine at UCLA
    Karin Nielsen-Saines, M.D
  • Director of maternal fetal medicine at Sibley Memorial Hospital in Washington, D.C.
    Dr. Rita Driggers
  • Biologist and Geneticist
    Dr. Ricarda Steinbrecher
  • Director of the National Institute of Allergy and Infectious Diseases
    Anthony S. Fauci, MD
  • Dept. Pediatrics/Cellular & Molecular Medicine, University of Sao Paulo, Brazil
    Alysson R. Muotri, Ph.D.
  • Deputy Incident Manager, CDC Zika Virus Response Team
    Jennifer H. McQuiston, DVM, MS, CAPT, USPHS
  • Information and Evidence Unit
    International Criminal Court
  • research coordinator of the Oswaldo Cruz Foundation
    Constancia Ayres, PhD
  • President
    Barack Obama
  • Associate Professor Center for Vector Biology Rutgers University
    Dina M. Fonseca, Ph.D.
  • Lancaster University: Biomedical and Life Sciences Department
    Dr. Derek Gatherer
  • Toronto Newsroom
    CBC (Canadian Broadcasting Corporation)
  • Canada's Chief Public Health Officer
    Dr. Gregory W. Taylor
  • Microbiologist and Permanent Section Chief, Arbovirus Diseases Branch (CDC)
    Dr. Robert S. Lanciotti
  • Associate Director for Science at CDC’s Division of Vector-borne Diseases
    Dr. Ronald Rosenberg


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