Delayed Diagnosis of Lyme Disease is a Huge Problem. How Can We Fix it?

November 10, 2021

https://www.lymedisease.org/delayed-diagnosis-lyme-wright/

Nov. 2, 2021

Melissa Wright is the Director of Patient Engagement & Outreach for LymeDisease.org and Project Manager of MyLymeData.

She spoke at the recent Tick-borne Disease Diagnostics online event spons

  1. Lyme is not recognized as a possibility in their area
  2. Many patients do not present with a classic erythema migrans rash
  3. The diagnostic testing for Lyme is flawed

View her presentation here:

Here’s the text of her remarks:

Hello everyone, my name is Melissa Wright and I am the Director of Patient Engagement & Outreach for LymeDisease.org and Project Manager of MyLymeData. I am happy to be with you today for the Tick-borne Disease Diagnostics Innovation Incubator, and have the opportunity to talk with you about the impact of diagnostic delays in the Lyme community.

Founded over 30 years ago, LymeDisease.org, is one of the oldest Lyme disease organizations in the nation. It is the largest and most trusted communications network for Lyme patients. Our mission is to harness the power of tens of thousands of patients to improve patient care and accelerate the pace of Lyme disease research. We do this through providing tools like our symptom checker, physician directory, and the MyLymeData patient registry and research platform with over 15,000 patients enrolled.

Today I’ll briefly discuss diagnostic issues with data from MyLymeData, the current testing and what we’re doing to push the needle
Using a diagram first developed by the Institute of Medicine (now the National Academy of Medicine) in its report “Improving Diagnosis in Health Care,” which identified different points along the path to diagnosis where things can go wrong and diagnosis can be delayed or missed. It has been modified to reflect the diagnostic issues we encounter in Lyme disease. For example:

  • Lyme is not identified as a possibility in (name your state)
  • Many patients do not present with a classic EM rash
  • And the diagnostic testing is flawed

Which leads to a large majority of patients being misdiagnosed.

In MyLymeData we found that 70% of those with late or chronic Lyme disease experienced years of diagnostic delays even though 45% had presented with early symptoms. It had taken the majority, 3 or more years to be diagnosed after seeing 5 or more doctors with 72% being misdiagnosed and likely unnecessarily treated for another disease.

So why the delay? In Lyme disease we know early diagnosis can be a ticket to recovery. 70-80% do become well. Unfortunately, a diagnosis of early Lyme disease is not so straight forward. A lot of the symptoms are not specific for Lyme disease and do occur in other illnesses. So, there’s a big emphasis on whether the patient has distinguishing factors.

– Was the patient exposed to an area where there are ticks that carry the disease? (Remember, no Lyme in name your state)

– Did the patient have a distinctive round rash that could have been caused by the bite of a tick. (only 34% of patients report having a rash)

– And were any blood tests positive? (flawed testing, with 37% receiving a false negative)

In regard to testing, we know during the first four to six weeks of Lyme infection, standard Lyme disease tests are unreliable because most people have not yet developed the antibody response that the test measures, and even later in Lyme the two-tiered testing is highly insensitive.

The chart (Stricker, Johnson 2010) illustrates the studies examining the testing. As you can see, the mean sensitivity for Lyme testing is 46%. This means 108 of every 200 cases is missed in Lyme compared to that of the highly sensitive testing for HIV/AIDS, which has a mean sensitivity of 99.5%, where only 1 in every 200 cases is missed.

Simply put, the likelihood of Lyme disease being diagnosed from a positive lab test is the equivalent of getting a heads or tails in a coin toss. This ultimately means many patients go undiagnosed.

Now everyone knows the saying there is power in numbers, but despite Lyme disease having 475,000 cases annually little has been done to advance Lyme testing or research.

According to research by Goswami, the number of clinical studies for Lyme disease trails behind leprosy–which has an incidence of less than 200 cases per year.  So, Lyme disease should be thought of as a research disadvantaged disease that faces the same challenges that rare diseases face.

Patients are the most underutilized resource in medical research, and we are striving to bridge that gap.

The research cycle illustrated is derived from Groft’s work with rare diseases. His model suggests forming a patient registry that links with a biorepository—we are collaborating with the Lyme Disease Biobank here.

The registry helps to develop a research hypothesis—here we have published three peer-reviewed publications to better characterize the disease, assess patient reported outcomes, and analyze treatment effects among patient subgroups. The registry can then be used to help recruit patients. We have worked on recruiting for two clinical studies.

A team research approach will allow rapid knowledge generation to accelerate the pace of research–-leading to improved diagnostics, treatment and care.

Thank you for your time, I appreciate the opportunity to speak with you all today and I want to close by encouraging anyone not yet participating in MyLymeData to enroll.

__________________

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Category:

Activism, Lyme, Testing

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Senator Johnson Holds Expert Panel: We’re Not in a ‘Pandemic of the Unvaccinated,” Peter Doshi Explains. Senior Army Doctor: Shots Pose Greater Threat Than COVID. The Injured Speak Out

November 9, 2021

https://childrenshealthdefense.org/defender/peter-doshi-restev-levi-covid-vaccines-trial

We’re Not in a ‘Pandemic of the Unvaccinated,’ Peter Doshi Explains During COVID Panel

Peter Doshi, a senior editor at The BMJ, and Retsef Levi, a professor at the Massachusetts Institute of Technology, told a panel of experts the COVID vaccines’ trial data doesn’t support the narrative that the vaccines are safe and effective.
Peter Doshi expressed doubts about COVID vaccine efficacy and the failures of the scientific community.

Excerpts:

Peter Doshi, a senior editor at The BMJ and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, and Retsef Levi, a health system and analytics professor at MIT, expressed doubts about COVID vaccine efficacy and the failures of the scientific community.

Doshi said we’re not in a “pandemic of the unvaccinated.” If hospitalizations and deaths are almost exclusively occurring in the unvaccinated “why would booster shots be necessary?” Doshi asked. “And why would the statistics be so different in the UK, where most COVID hospitalizations and deaths are among the fully vaccinated?”

He also criticized the fact that society is vaccinating and mandating the vaccine for large portions of the public despite the raw data on the safety and efficacy of the vaccines not being available yet.

Levi claimed the government attempted to censor the research by calling its credibility into question. “They called the research fake,” Levi said.

Watch here (Doshi starts at 1:18:40 and Levi starts at 1:49:07):

https://childrenshealthdefense.org/defender/nov-2-sen-ron-johnson-cdh-covid-vaccine-injuries-federal-mandates

Video Here – (starts at 30:00)

WATCH: Sen. Johnson Holds Expert Panel on COVID Vaccine Injuries, Federal Vaccine Mandates

On Tuesday, Nov. 2, U.S. Sen. Ron Johnson held a panel discussion with doctors and medical researchers who have treated COVID-19 vaccine injuries and are researching the safety and efficacy of COVID-19 vaccines.

U.S. Sen. Ron Johnson (R-Wis.) held a panel discussion Tuesday, Nov. 2 with doctors and medical researchers who have treated COVID-19 vaccine injuries and are researching the safety and efficacy of COVID-19 vaccines. Johnson also talked with patients who have experienced adverse events due to the COVID-19 vaccine and discuss vaccine mandates.

The senator discussed the importance of early treatment for COVID, Americans’ health care freedom and natural immunity. Johnson covered the impacts of mandates on the American workforce and the economy, and the lack of transparency from federal health agencies in response to his COVID-19 oversight requests.  (See link for article and who spoke in the video)

________________

https://thenewamerican.com/senior-army-doctor-covid-jabs-pose-greater-threat-to-soldiers-health-and-military-readiness-than-covid/

Senior Army Doctor: COVID Jabs Pose Greater Threat to Soldiers’ Health and Military Readiness than COVID

by Veronika Kyrylenko
Lieutenant Colonel Theresa Long, a senior U.S. Army aerospace medicine specialist who has treated soldiers injured by COVID vaccines, said that those shots pose a greater danger to the health of American servicemen and military readiness than COVID itself and condemned the Biden administration for treating men and women in uniform as “lab rats.”

Dr. Long points out in the video that only 12 active duty soldiers have died from COVID.  This study on the U.S. military already shows that heart inflammation is linked to the COVID injections.  Keep in mind all military members were previously healthy with a high level of fitness. They were physically fit by military standards and lacked any known history of cardiac disease, significant cardiac risk factors or exposure to cardiotoxic agents.

Vaccine-Injured Speak Out, Feel Abandoned by Government Who Told Them COVID Shot Was Safe

During an event hosted Tuesday by U.S. Sen. Ron Johnson (R-Wis.), people whose lives were ruined by COVID vaccines said they feel abandoned by a government that told them it was their patriotic duty to get the shot.

U.S. Sen. Ron Johnson (R-Wis.) on Tuesday held a discussion with a panel of experts, including clinicians, scientists, lawyers and patient advocates, and with people injured by COVID vaccines, who gave powerful testimonies about their experiences.

Johnson and the expert panel discussed the importance of early treatment for COVID, healthcare freedom and natural immunity, the impacts of mandates on the American workforce and the economy, COVID vaccine safety concerns and the lack of transparency from federal health agencies in response to his COVID oversight requests.

None of the major mainstream media outlets picked up the event, but Children’s Health Defense hosted Johnson’s live panel discussion on CHD.TV.  (See link for article and video)

________________

Category:

Activism, vaccines, Viruses

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Public Fear Brings Easy Money to Vaccine Committee Members

https://popularrationalism.substack.com/p/public-fear-brings-easy-money-to

Public Fear Brings Easy Money to Vaccine Committee Members

They deliberate and vote on your behalf. They are unelected. They are conflicted. They turn dozens of conflict-blinded eyes to clear signals of risk.
The following was published by Attorney Tom Renz. The original file is located here.

Gov/Big Pharma Conflict

The vaccine is called mRNA-1273 and was developed by NIAID scientists and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial.

“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said NIAID Director Anthony S. Fauci, M.D. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”1

To receive a share of the profit from the sale of mRNA-1273, the inventors of this product within NIAID would submit an Employee Invention Report to the NIH Office of Technology transfer.2 Each inventor stands to receive a personal payment of up to $150k annually from the sales of mRNA-1273.3 In addition, NIAID stands to earn millions of dollars in revenue from the sale of mRNA-1273.4

Moderna will pay license fee to NIAID to use its patents related to mRNA-1273 and a portion of those fees are then paid directly to the inventors within NIAID who developed those patents.5 NIH has produced reports which confirm that these individuals are listed as inventors.6

• Barney Graham, Deputy Director, NIAID Vaccine Research Center

• Kizzmekia Shanta Corbett, Scientific Lead, NIAID’s Coronavirus Vaccine Program

• Michael Gordon Joyce, NIAID

• Hadi Yassine, NIAID

• Masaru Kanekiyo, NIAID

• Olubukola Abiona, NIAID

HHS awarded $483 million to accelerate development of mRNA-1273.7 The US Government has reached a 1.525 billion deal to purchase 100 million doses of mRNA-1273.8

In 2013, the Autonomous Diagnostics to Enable Prevention and Therapeutics (ADEPT) program awarded grant funding to Moderna Therapeutics for the development of a new type of vaccine based on messenger RNA. The initial DARPA grant was W911NF-13-1-0417. The company used that technology to develop its COVID-19 vaccine, currently undergoing Phase I clinical trials in conjunction with NIH. 9 2

FDA Vaccines and Related Biological Products Advisory Committee Roster Content current as of 4/9/2110

Any consideration of financial conflict of interest at the Vaccines and Related Biological Products Advisory Committee must be set against the historical backdrop of the profound financial conflicts of interest seen in the during the H1N1 pandemic ten years ago. At that time, five of the sixteen experts were found to have ties to the pharmaceutical industry. There were “calls from the British Medical Journal, to release the names of committee members and their conflicts of interest, in the interest of transparency and to monitor any possible commercial influence.” That earlier “pandemic has proved profit-making for the industry, with one estimate (by JP Morgan) putting 2009 vaccine profits alone at $7-10 billion.”11

There appear to be significant conflicts of interest today especially among committee leaders. The items reported in this memo are the results of a quick preliminary check on conflicts and are not a complete representation. Plaintiffs intend to conduct a more thorough investigation before trial.

Chair

Hana El Sahly, M.D.

Expertise: Vaccines, Infectious Diseases

Term: 06/21/2019-01/31/2022

Professor Department of Molecular Virology and Microbiology Department of Medicine Section of Infectious Diseases Baylor College of Medicine Houston, TX 77030 hanae@bcm.edu

• Top FDA vaccine adviser recuses herself over tie to Moderna.12

• Associate Professor Baylor. She currently serves as the Principal Investigator of the Vaccine and Treatment Evaluation Unit at Baylor College of Medicine.13

• Federal database shows since 2013 $693,001.78 in general payments and $5,315,014.60 in research payments made to “Chi St. Lukes Health Baylor Med Ctr” – 6720 Bertner Ave, Houston, TX from various companies.14

• Dr. El Sahly was appointed as one of three lead investigators for Moderna’s 30,000-person trial in July. Reuters reported that Dr. El Sahly had to recuse herself from an important committee meeting on Oct. 22, 2020.15,16 There are multiple citations of this. e.g. 17, 18, 19 & 20 Ironically, there is no compensation of Dr. El Sahly reported on the openpaymentsdata.cms.gov website. This raises serious questions as to the completeness of the conflict 3 data reported on that site. The University of Florida Conflicts of Interest Program and the Project on Government Oversight reported conflicts of interest of Drs. El Sahly, Monto, and Chaterjee.21,22

Paula Annunziato, M.D

Expertise: Industry

Representative Term: 02/01/2020-01/31/2024

Vice President and Therapeutic Area Head Vaccines Clinical Research Merck North Wales, PA 19454

• Past (or current?) involvement in supervising Moderna’s Covid-19 vaccine clinical trial.23

• Not listed in the openpaymentsdata.cms.gov website.

Acting Chair

Arnold Monto, M.D. Thomas Francis Jr. Collegiate Professor of Public Health Professor of Epidemiology Department of Epidemiology University of Michigan School of Public Health Ann Arbor, MI 48109

• Acting chairman of the committee, Dr. Arnold Monto received $54,114 from 2013 through 2019 from vaccine contenders Sanofi, GlaxoSmithKline, Pfizer, and Shionogi, according to the database. He also received $10,657 from Novartis, which has a deal to manufacture a coronavirus vaccine.24

• Dr. Monto received a total of $194,254 from pharmaceutical companies.25 The largest contributor was Seqirus, a company developing COVID vaccine in Australia.26 The University of Florida Conflicts of Interest Program and the Project on Government Oversight reported conflicts of interest of Drs. El Sahly, Monto, and Chaterjee.27, 28

Archana Chatterjee, M.D., Ph.D.

Expertise: Pediatrics, Infectious Diseases Term: 06/21/2019-01/31/2023

Dean Chicago Medical School Vice President for Medical Affairs Rosalind Franklin University of Medicine and Science North Chicago, IL 60064 4

• A federal database shows that, in 2019, advisory committee member Dr. Archana Chatterjee, for instance, received $23,904 from Pfizer (including Pfizer International LLC), $11,738 from Merck, and $11,480 from Sanofi, each of which is in the race for a coronavirus vaccine. Since 2013, she has received more than $200,000 in consulting fees, travel and lodging, and other payments from those companies and others working on coronavirus vaccines, according to the database.29

• She is a professor of epidemiology at the University of Michigan, which has announced that it is partnering with pharmaceutical company, AstraZeneca on a clinical trial of a potential Covid-19 vaccine.30

• General payments to Dr Chaterjee total $245,810. Associated research funding totals $142,344. Largest funders include: Pfizer Inc., Merck Sharp & Dohme Corporation, Seqirus USA Inc., and AstraZeneca Pharmaceuticals.31 The University of Florida Conflicts of Interest Program and the Project on Government Oversight reported conflicts of interest of Drs. El Sahly, Monto, and Chaterjee.32,33

CAPT Amanda Cohn, M.D.

Expertise: Pediatrics, Vaccines

Term: 02/01/2020-01/31/2024

Chief Medical Officer National Center for Immunizations and Respiratory Diseases Centers for Disease Control and Prevention Atlanta, GA 30333

Telephone: (404) 639-6039 E-mail: acohn@cdc.gov

Hayley Gans, M.D.

Expertise: Pediatrics, Infectious Diseases

Term: 06/21/2019-01/31/2023

Professor of Pediatrics Department of Pediatrics

Stanford University Medical Center Stanford, CA 94305

Holly Janes, Ph.D.

Expertise: Biostatistics

Term: 02/01/2020-01/31/2023 Associate Member Fred Hutchinson Cancer Research Center Vaccine and Infectious Disease Division

Division of Public Health Sciences Seattle, WA 98109 5

Phone: 206.667.6353

Email: hjanes@fredhutch.org

Fax: 206.667.4378

Michael Kurilla, M.D., Ph.D.

Expertise: Infectious Diseases, Pathology

Term: 08/06/2018-01/31/2022

Director, Division of Clinical Innovation National Center for Advancing Translation Sciences National Institutes of Health Bethesda, MD 20852

Email: Michael.kurilla@nih.gov

Myron Levine, M.D., D.T.P.H., F.A.A.P

Expertise: Infectious Diseases Term: 05/09/2018-01/31/2022

Simon & Bessie Grollman Distinguished Professor Associate Dean for Global Health Vaccinology and Infectious Diseases Center for Vaccine Development University of Maryland School of Medicine Baltimore, MD 21201

• Dr. Myron Levine is associate dean for global health, vaccinology, and infectious diseases at the University of Maryland School of Medicine. The school is participating in a clinical trial of a COVID-19 vaccine being developed by Moderna and the National Institute of Allergy and Infectious Diseases.34

• Since 2013, for research in which Levine played a principal role, GlaxoSmithKline has paid the University of Maryland Baltimore Foundation Inc. and another institution more than $2.3 million.35

• Dr. Levine received general payments of $41,635 and associated research funding of $2,314,178. Dr. Levin’s 2019 funding was about six times the mean of similar physicians.36 His largest source of funding was Sanofi Pasteur who is developing a COVID vaccine as above.37

• UM School of Medicine’s Myron M. Levine, MD, DTPH, to Receive Prestigious Lifetime Award for Five Decades of Pioneering Vaccine Research38 6 • Was on a WHO sponsored advisory group that considered feasibility of doing Covid-19 challenge studies in young, healthy volunteers. No conflict of interest declared. Also on the panel was Sheng-Li Shi from WIV.39

H. Cody Meissner, M.D. (aka Herman Meissner)

Expertise: Infectious Diseases

Term: 08/06/2018-01/31/2022

Professor of Pediatrics Tufts University School of Medicine Director, Pediatric Infectious Disease Tufts Medical Center Boston, MA 02111

• Tufts Children’s Hospital – Division of Pediatric Infectious Disease. Head of all clinical trials for all of Tufts Children’s Hospital.40

• Since 2013, Tufts University has been paid general payments of $13,241,677.43 by companies including Pfizer, Boston Scientific, Gyrus Acmi, Inc., Janssen Scientific, Biogen, Inc., Bayer Healthcare, Sanofi-Aventis, Genentech, Otsuka Pharmaceutical, Amgen, Inc.41

• Since 2013, Tufts University has been paid research payments of $34,183,399.06 by companies including Pfizer, Inc., Merck Sharp & Doh, Shire North America, Abiomed, Gilead Sciences, Inc.)42

Paul Offit, M.D. Expertise: Infectious Diseases Term: 02/01/2018-01/31/2022

Professor of Pediatrics Division of Infectious Diseases Abramson Research Building The Children’s Hospital of Philadelphia Philadelphia, PA 19104

• Director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.43

• Since 2013, The Childrens Hospital of Philadelphia has received general payments of $4,559,116.78 and research payments of $32,013,340.94 from companies including Spark Therapeutics, United Therapeutics, Novartis Pharmaceiticals, Amgen, Inc., Pfizer, Inc.44

• Vaccine Safety: Myths and Misinformation. No Conflict of Interest Declared.45

• The science of vaccine safety: Summary of meeting at Wellcome Trust, Conflict of interest statement: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal 7 relationships that could have appeared to influence the work reported in this paper.46

Steven Pergam, M.D. Expertise: Infectious Diseases

Term: 02/01/2020-01/31/2024

Medical Director Infection Prevention Seattle Cancer Care Alliance Seattle, WA 98109

Phone: 206.667.7126 Email: spergam@fredhutch.org

• Associate Professor, Vaccine and Infectious Disease Division, Fred Hutch

• Associate Professor, Clinical Research Division, Fred Hutch47

• Since 2013, Dr. Pergam has received $4167.00 in general payments from Merck and Gilead and $140,311.19 research funding from Merck, Sharp and Dohme. 48

• Potential conflicts of interest. A. L. G. reports personal fees from Abbott Molecular outside the submitted work. S. A. P. reports grant support from Global Life Technologies, Inc, participates in research trials with Chimerix, Inc, and has participated in research with Merck & Co. He is currently participating in a clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID; U01-AI132004); vaccines for that trial are provided by Sanofi-Aventis.

Andrea Shane, M.D., M.P.H., M.Sc.

Expertise: Pediatric & Infectious Diseases

Term: 02/01/2018-01/31/2022

Professor of Pediatrics Director Division of Pediatric Infectious Diseases Emory University School of Medicine Atlanta, GA 30322

404-727-9880 (direct) 404-727-5642 (main)

Email: ashane@emory.edu

• Medical Director Children’s Healthcare of Atlanta; Curriculum vitae49

• Since 2013, Egleston Childrens Hospital at Emory has received $114,148.01 in general payments and $814,977.27 in research payments from companies including Jazz Pharmaceuticals, Genmark Diagnostics, WL Gore & Associates, etc.50 8

• Since 2013, Emery University Hospital has received $44,133,351.66 in general payments and $170,711,591.68 in research payments. At the top of the research companies are ER Squibb & Sons and Pfizer, Inc.51

• Since 2013, Wesley Woods Center of Emory University has received $41,205.70 in general payments and $3,429,327.48 in research payments. Topping the research companies are E.R. Squibb & Sons and Janssen Research. 52

Paul Spearman, M.D.

Expertise: Pediatric & Infectious Diseases

Term: 05/09/2018-01/31/2022

Director, Division of Infectious Diseases Albert B. Sabin Chair in Pediatric Infectious Diseases Cincinnati Children’s Hospital Medical Center Professor, Department of Pediatrics University of Cincinnati School of Medicine Cincinnati, OH 45229

513-636-4509

Email:Paul.spearman@cchmc.org

• Between 2013-2015, Dr. Spearman received $39,459.84 in research funding from Glaxosmithkline, LLC and Astrazenica. No data available for years 2016-201953

• Since 2013, University of Cincinnati Medical Center has received $2,236,276.81 in general payments and $4,281,617.38 in research payments. Topping the list of companies on both accounts is Pfizer, Inc.54

• Had to be recused from some meetings because his hospital, Cincinnati Children’s Hospital is also a COVID vaccine clinical trial site.55 Dr. Spearman received $39,46060 in associated research funding primarily from Glaxosmithkline, LLC. and AstraZeneca Pharmaceuticals LP.56

• No conflict of interest declared in Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral? 57 Conclusions: Children are at substantial risk of COVID-19. Delays in starting Phase II vaccine clinical trials in children will delay our recovery from COVID-19 and unnecessarily prolong its impact upon children’s health and emotional well-being, their education, and equitable access to opportunities for development and social success, as well as the country’s economy. Understanding the safety, immunogenicity, and efficacy of COVID-19 vaccines in children is critical to protect children and adults. For children, a vaccine has the added benefit of returning them safely to school and extracurricular activities, and allowing them to engage with their world face- 9 to-face once again. Ensuring acceleration of vaccine clinical trials to warp speed for children will be critical in making this our future reality.

Geeta K. Swamy, M.D.

Expertise: Infectious Diseases

Term: 08/06/2018-01/31/2022

Senior Associate Dean Vice Chair for Research & Faculty Development Associate Professor, ObGyn Department of Obstetrics & Gynecology Division of Maternal-Fetal Medicine Duke University Durham, NC 27710

• Since 2013, Dr. Swamy has received general payments of $63,040.09 (Glaxosmithkline, LLC, Sanofi, Pfizer, et al) and research payments of $206,038.64 from Glaxosmithkline, LLC.58

• Since 2013, Duke University Hospital has received $7,599,234.72 in general payments and $40,585,472.53 in research payments from various companies. Pfizer, Inc. contributed general payments of $866,119.65 and research payments of $2,677,484.45.59

• Dr. Swamy had to recuse herself from committee meetings because Duke University, where she is associate vice president for research, is a clinical trial site for the Pfizer-BioNTech and AstraZeneca vaccines.60 Dr. Swamy received payments from pharmaceutical companies totaling $63,040. Her associated research funding totaled $206,039, about three times that of similar physician. Dr. Swamy’s largest sources of funding are Glaxosmithkline, LLC., Sanofi Pasteur Inc., Pfizer Inc. and Novartis Vaccine.61

• Vaccination of pregnant women with respiratory syncytial virus vaccine and protection of their infants. Study funded by Novavax and the Bill and Melinda Gates Foundation.62

Gregg Sylvester, M.D., M.P.H.

Expertise: Alternate Industry Representative

Term: 02/01/2020-01/31/2024

Vice President Medical Affairs Seqirus Inc. Summit, NJ 07901 10

• Chief Medical Officer, Seqirus – Dr Gregg Sylvester has led Seqirus Medical Affairs since 2016, overseeing the global team that scientifically differentiates our vaccines by generating Real World Evidence and presenting Seqirus research to national vaccine recommending organizations.

• According to the Federal database, Seqirus USA, Inc. has made general payments in the sum of $569,854.35 and research payments in the sum of $44,159,881.83. Topping the list of receivers of general payments are Arnold Simon Monto and Archana Chatterjee.63

DIRECTOR

Prabhakara Atreya, Ph.D. Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20993

CBERVRBPAC@fda.hhs.gov

DR. MARION GRUBER Director, FDA Vaccine Research Office

DESIGNATED FEDERAL OFFICER

Kathleen Hayes, M.P.H. Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20993 CBERVRBPAC@fda.hhs.gov

1 https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins

2 https://www.ott.nih.gov/resources

3 https://www.ott.nih.gov/royalty/information-nih-inventors

4 https://www.ott.nih.gov/resources

5 https://www.ott.nih.gov/royalty/information-nih-inventors

6 https://www.icandecide.org/wp-content/uploads/2020/08/NIH-FOIA-53821-Complete-Response-RS.pdf

7 https://investors.modernatx.com/node/8671/pdf

8 https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-supply-agreementus-government-initial-100

9 https://crsreports.congress.gov/product/pdf/IN/IN11446

10 https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisorycommittee/roster-vaccines-and-related-biological-products-advisory-committee 11 https://www.ghwatch.org/who-watch/h1n1.html

12 https://www.foxnews.com/us/hana-sahly-vaccine-adviser-resign-covid

13 https://www.bcm.edu/people-search/hana-el-sahly-21052 11

14 https://openpaymentsdata.cms.gov/hospital/450193

15 https://www.bizjournals.com/boston/news/2020/09/25/fda-official-involved-in-moderna-trial-steps-aside.html

16 https://www.reuters.com/article/healthcoronavirus-vaccines-fda/exclusive-top-adviser-steps-aside-from-fdacovid-19-vaccine-reviews-over-potential-conflict-idUSL2N2GK284

17 https://www.statnews.com/2020/10/20/dry-technical-but-important-why-an-fda-advisory-panels-meeting-oncovid-19-vaccines-matters/

18 https://www.nbcdfw.com/news/coronavirus/texan-involved-in-covid-19-vaccine-trials-advises-against-halfdoses/2521936/

19 https://www.pbs.org/newshour/health/watch-live-fda-advisory-committee-assesses-covid-19-vaccinedevelopment

20 https://www.bizjournals.com/boston/news/2020/09/25/fda-official-involved-in-moderna-trial-steps-aside.html

21 https://coi.ufl.edu/2020/10/26/some-fda-advisors-tapped-to-review-coronavirus-vaccines-received-paymentsfrom-vaccine-companies/

22 https://www.pogo.org/investigation/2020/10/some-fda-advisors-tapped-to-review-coronavirus-vaccinesreceived-payments-from-vaccine-companies/

23 https://finance.yahoo.com/news/fda-vaccine-committee-head-steps055718018.html?guccounter=1&guce_referrer=aHR0cHM6Ly9kdWNrZHVja2dvLmNvbS8&guce_referrer_sig=AQA AALNseSAkcAU_oXgLmONgHMz3p4FUoRtEgZv6xLlCKnvY8bO_SPG8CWFhdbvZULO0xruuDmy7LlRVSQuQ_uWNGkX o58YlBrjD2co7KOVu2CRMOwippqce1pb6QhT5efYM5OMtuWyPQ9K3EzyR5yg-u1v_7VSbFCdGLHIFDP1kiJhj

24 https://openpaymentsdata.cms.gov/physician/1311454 25 Id.

26 https://www.seqirus.us/news/covid19-update

27 https://coi.ufl.edu/2020/10/26/some-fda-advisors-tapped-to-review-coronavirus-vaccines-received-paymentsfrom-vaccine-companies/

28 https://www.pogo.org/investigation/2020/10/some-fda-advisors-tapped-to-review-coronavirus-vaccinesreceived-payments-from-vaccine-companies/

29 https://coi.ufl.edu/2020/10/26/some-fda-advisors-tapped-to-review-coronavirus-vaccines-received-paymentsfrom-vaccine-companies/

30 https://www.uofmhealth.org/news/archive/202009/u-m-conduct-clinical-trial-test-astrazeneca-covid-19-vaccine

31 https://openpaymentsdata.cms.gov/physician/803928

32 https://coi.ufl.edu/2020/10/26/some-fda-advisors-tapped-to-review-coronavirus-vaccines-received-paymentsfrom-vaccine-companies/

33 https://www.pogo.org/investigation/2020/10/some-fda-advisors-tapped-to-review-coronavirus-vaccinesreceived-payments-from-vaccine-companies/

34 https://www.medschool.umaryland.edu/profiles/Levine-Myron/

35 https://openpaymentsdata.cms.gov/physician/1098730

36 Id.

37 https://www.sanofi.com/en/about-us/our-stories/sanofi-s-response-in-the-fight-against-covid-19

38 https://www.medschool.umaryland.edu/CVD/News-and-Events/2019/UM-School-of-Medicines-Myron-MLevine-MD-DTPH-to-Receive-Prestigious-Lifetime-Award-for-Five-Decades-of-Pioneering-Vaccine-Research.html

39 https://pubmed.ncbi.nlm.nih.gov/32857836/

40 https://www.tuftschildrenshospital.org/Patient-Care-Services/Departments-and-Services/InfectiousDisease/Overview

41 https://openpaymentsdata.cms.gov/hospital/220116

42 https://openpaymentsdata.cms.gov/hospital/220116

43 https://www.chop.edu/doctors/offit-paul-a

44 https://openpaymentsdata.cms.gov/hospital/393303

45 https://pubmed.ncbi.nlm.nih.gov/32857836/

46 https://www.sciencedirect.com/science/article/pii/S0264410X20300396?via%3Dihub

47 https://www.fredhutch.org/en/faculty-lab-directory/pergam-steven.html

48 https://openpaymentsdata.cms.gov/physician/44476

49 https://fda.report/media/117726/VRBPAC-AndreaLShane-CV.pdf 12

50 https://openpaymentsdata.cms.gov/hospital/113300

51 https://openpaymentsdata.cms.gov/hospital/110010

52 https://openpaymentsdata.cms.gov/hospital/110203

53 https://openpaymentsdata.cms.gov/physician/1036685

54 https://openpaymentsdata.cms.gov/hospital/360003 55 https://www.statnews.com/2020/10/20/dry-technical-but-important-why-an-fda-advisory-panels-meeting-oncovid-19-vaccines-matters/

56 https://openpaymentsdata.cms.gov/physician/1036685

57 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543330/pdf/ciaa1425.pdf

58 https://openpaymentsdata.cms.gov/physician/292920

59 https://openpaymentsdata.cms.gov/hospital/340030

60 https://www.statnews.com/2020/10/20/dry-technical-but-important-why-an-fda-advisory-panels-meeting-oncovid-19-vaccines-matters/

61 https://openpaymentsdata.cms.gov/physician/292920

62 https://pubmed.ncbi.nlm.nih.gov/32726529/

63 https://openpaymentsdata.cms.gov/company/100000136554

Category:

Activism, vaccines, Viruses

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Wisconsinites: Take Action and Urge Committee Vote on Consumer Access to Complementary & Alternative Health Practitioners Bill, AB 86

https://nationalhealthfreedomaction.salsalabs.org/voteonwisafeharborbill

We urgently need your help to convince the Wisconsin Assembly Health Committee to schedule a vote to pass AB 86 out of committee.  The bill had a public hearing back in July but the Committee has not taken a vote and moved it out of Committee yet.  This is the last step needed before the bill can move to the full Assembly Floor for a final floor vote!  Last year this bill passed the Assembly Floor but had to start over due to COVID.  This year it already passed the Senate Committee and Senate Floor (SB 98).  We’re now waiting on the Assembly Health Committee to keep it moving.  We’ve waited long enough!  Since the public hearing, we even accepted amendments to the bill to make sure all issues have been addressed and now we need your help! Assembly legislators and Health Committee Members need to hear from you to convince them to schedule a vote on AB 86 asap!
CLICK TO TAKE ACTION – SUPPORT WI AB 86
Support AB 86/SB 98, the Complementary and Alternative Health Care Practitioners Exemption bill, because it:

  • Protects your access to services provided by practitioners of complementary and alternative health in Wisconsin such as herbalists, traditional naturopaths, nutritional consultants, homeopaths, Reiki practitioners, Ayurveda practitioners, and many more.
  • Enables practitioners to provide services without fear of being charged with practice of medicine without a license as long as they avoid a list of prohibited acts and give out proper disclosures.
  • Adds clarity to Wisconsin law and updates it to reflect what is happening already!
  • Already passed unanimously out of the Senate Insurance, Licensing and Forestry Committee and it passed the Senate, as amended, on a unanimous voice vote on April 14.
  • Last session, it passed the Assembly Health Committee, the Assembly Floor and the Senate Committee on Health before stalling in the Senate due to COVID-19.
  • 11 other states already protect the practices of many wonderful complementary and alternative practitioners who are providing great services to health seekers – Wisconsin should too!

Spread the word about SB 98/AB 86.  Please forward this email to your friends and family so they can Take Action to support SB 98/AB 86 too.

THANK YOU for your commitment to Health Freedom!  If you have questions, contact us at info.nhfa@nationalhealthfreedom.org.

Category:

Activism

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Does Lyme Carditis Differ in Children vs. Adults?

https://danielcameronmd.com/lyme-carditis-children-vs-adults/

Does Lyme carditis differ in children vs. adults?

lyme carditis in child being examined by doctor
In their article, “Lyme Carditis in Hospitalized Children and Adults, a Case Series,” Shen and colleagues compare, for the first time, the presentation, management, and outcomes of Lyme carditis in the pediatric versus adult populations.
By

The authors analyzed charts of pediatric and adult patients with heart block and a positive Western Blot test for Lyme disease, who were hospitalized at Maine Medical Center. The study included 10 children and 20 adults who were admitted for Lyme carditis between January 2010 and December 2018.¹ The children’s mean age was 12.4 years. The adult mean age was 41.4 years.

The case series found:

  • 90% of the Lyme carditis patients were male, with 87% having no prior cardiac history.
  • All cases presented between June and October.
  • Of the 13 cases who noted symptom onset, 76% presented within 3 weeks of illness.
  • Out of 30 patients, 17 were evaluated at an outpatient facility. “Of these, a minority (41%) had Lyme disease suspected in the outpatient setting, and fewer (12%) were initiated on Lyme disease treatment.”

“Improved early recognition and treatment of Lyme disease may decrease Lyme carditis.”

  • Children with Lyme carditis were more likely to present with disseminated erythema migrans and fever. Otherwise, children and adults had similar symptom presentations, exhibiting predominantly presyncope and syncope.
  • “There was no statistical difference between pediatric and adult cases with regards to heart block type or other cardiac complications,” the authors write. “However, the most common heart block in pediatric cases was first-degree (40%) vs second-degree Mobitz type 2 in adult cases (55%).”
  • Adults were more likely to require a pacemaker (60%) compared with 20% of children. “Proportionately more adults needed temporary pacing,” the authors write, while “Children had shorter antibiotic durations…”

“… there is room for improving outpatient diagnosis and treatment of early Lyme disease, even in a high-incidence state like Maine.”

  • Out of the 30 cases, 27 had improved heart block, while 3 adults required a pacemaker at discharge. One patient died.

The authors point out that the majority of these cases were evaluated by an outpatient provider before carditis developed. However, only 41% of the patients were diagnosed with or suspected to have Lyme disease at that visit.

Furthermore, even fewer (12%) of those patients received appropriate antibiotics.

“Overall, there were no major differences seen between the presentations or outcomes of pediatric and adult Lyme carditis cases,” the authors write.

“Earlier diagnosis and treatment would likely have prevented carditis and the need for hospital admission,” the authors conclude.

“… there is room for improving outpatient diagnosis and treatment of early Lyme disease, even in a high-incidence state like Maine.”

Related Articles:

Lyme carditis diagnosis: 18 cases

Patients can die when Lyme carditis is not treated

Study identifies 189 children with Lyme carditis

References:
  1. Richard V Shen, Carol A McCarthy, Robert P Smith, Lyme Carditis in Hospitalized Children and Adults, a Case Series, Open Forum Infectious Diseases, Volume 8, Issue 7, July 2021, ofab140, https://doi.org/10.1093/ofid/ofab140

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Category:

Heart Issues, Lyme, research

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