(15th of 20 or so Jenna Luche-Thayer articles I'm posting - I started with her most recent articles but now I'm going back in time and posting several other articles she has created - also posting in its entirety since some might not want to access through LinkedIn) Youtube version - Jenna Luche-Thayer CDC & Lyme Oversight Required PART 2 of 3
by Jenna Luché-Thayer
April 10, 2016/www.youtube.com/watch?v=ZMxty3jPdZs
Greetings from Jenna,
I returned late May 21st, 2016 from a Lyme advocacy effort in Washington DC. It was wonderful to work with such dedicated and talented advocates. We had a series of useful meetings with legislators and their staff and held a Lyme Disease Science and Policy Challenges Forum in Congress’s Rayburn House Office Building. I want to give special thanks to Dan Byers and Bruce Fries who really made this happen.
The group included
- Allie Cashel, Author of Suffering the Silence: Chronic Lyme Disease in an Age of Denial;
- Ronald Stram, MD, Stram Center for Integrative Medicine;
Holly Ahern, Associate Professor of Microbiology, SUNY Adirondack speaking on Microbiological Challenges of Tick-Borne Infections,
- Tammy Crawford, from Focus on Lyme and representing Translational Genomics Research Institute;
- Lance A. Liotta, MD PhD, Medical Director Clinical Proteomics Lab, George Mason University;
- Bruce Fries, President of Patient Centered Care Advocacy Group;
- Dan Byers, Senior Director for policy at the U.S. Chamber of Commerce’s Institute for 21st Century Energy and myself speaking on Government Oversight and Policy Challenges.
The Lyme forum presentations will be released in a video. However, I wanted to give my complicated topic more time than the 20 minute video. And so, Sunday I put together this video based on my detailed notes and research.
The topic of this video is CDC & Lyme - Oversight Required. This video was done at home and my dog Moon decided to participate in the third part of the video. I hope you find it informative. Here follow the three links – one to each part of the video:Part 2 of 3 CDC & Lyme - Oversight Required 2016/www.youtube.com/watch?v=ZMxty3jPdZs(My notes from her video)
IDSA and Big Pharma partnership
BP is a very powerful special interest in our government process.Every 5 yrs there are two major Fed bills that control drug and other medical safety issues:
Prior to 2012 legislative reform on these two major bills, Big Pharma spent $770M to influence the outcome of this legislation to reduce quality control and other steps in which to generate new drugs so things to get to market faster w/ fewer controls and fewer testing in place.This investment netted BP well over $11B
– not a bad investment. This was done through proper channels, as registered lobbying groups, their names are on the bills as are all other lobbying groups working on them. They are very powerful in that regard.
The IDSA closely collaborates with Big Pharma in a number of areas, which is well documented. The 2010 Master IDSA money trail done by investigative reporter, Kris Newby, that can be reviewed for this information. And the information I received about
the $770M is all available through US.gov/spend so these sites have this information readily available.
What does this mean?
The CDC orientation to Lyme policy program is the result of a very enmeshed relationship with the IDSA. The key CDC Directors who are responsible for Lyme are also IDSA members. There are no non-IDSA members among the directors making up the chain of command responsible for the CDC Lyme policy and programs.
If you go to the CDC website and get the organizational chart (www.cdc.gov/about/pdf/organization/cdc-photo-org-chart.pdf
of the entire institution you will see a number of photos and titles and division names and you will see:
Tom Frieden, MD, MPH is the CDC Director
^ Rima Kabbaz, MD (IDSA) from the Office of Infectious Diseases: reports directly to the CDC Director
^ Beth Bell, MD, MPH (IDSA) from the National Center for Emerging and Zoonotic Infectious Diseases: reports to Rima Kabbaz
^ Lyle Peterson (IDSA) from the Division of Vector Borne Diseases: reports to Beth BellThere is a long and very documented history of conflicts of interests within the IDSA membership as it relates to Lyme disease – via research pieces done by Kris Newby and Lorraine Johnson that were part of the 2008 Anti-trust suit brought by CT’s Blumenthal against the IDSA.
Conflicts of Interests include:
- Patents on LD test kits
- Accepting pmts from vaccine mfrs regarding LD
- Consulting for health ins co’s that rely in IDSA Lyme guidelines to restrict coverage for patients – so they act as expert consultants to the insurance companies to restrict care for patients
- Act and provide medical medical expert opinions in medical legal cases against doctors and patients regarding Lyme treatment
---all ways in which they directly profit from maintaining the outdated Guidelines in place.
In 2008 the anti-trust against the IDSA found that an Ad Hoc group convened during government-funded closed-door meetings and had members and researchers with significant commercial interests in Lyme disease tests and vaccines. It excluded the public and researchers and public whose views were not aligned with the IDSA. The group essentially set national LD policy and controlled the national research agenda for LD without public oversight or transparency.
This is in violation of the law.
Subsequently a large percentage of public grants were awarded to the IDSA members.
(The previous information is outlined from “Overview of LymeGate Findings” by Kris Newby and Lorraine Johnson, which is part of the anti-trust documentation and the 2012 field hearing on LD.)
The IDSA has spent a lot of money discrediting their competitors - most recent one is called the PLEASE study in 2016 being represented by an independent study by a Dutch research group.
However the main author, Errand, has produced recent publications for the IDSA that are copyrighted so there’s really no degree of separation – he is working with and for the IDSA. The purpose of this particular study is to discredit the competitor’s treatment protocol, as stated in grant purpose.
One of the earliest efforts to discredit the competitors was the two controlled trials of antibiotic treatment in patients with persistent symptoms and history of LD, which came out in 2001 but it was actually printed before it came out on the NIH and NIAD websites. And it never was actually brought to completion – the methodology was not finalized before it they printed the results so the results are kind of spurious. And again this was basically to discredit a competitor’s treatment protocol. The IDSA has interfered with allocation of grants to study the microbiology of chronic Lyme and chronic Lyme studies submitted at the state level. This has been documented on numerous occasions and more documentation is forthcoming. They’ve spent a lot of time and money trying to discredit their competitors.
The main competing organization is called the International Lyme and Associated Diseases Society (ILADS), which has developed protocol that are patient-centered. They understand Lyme is a complex and serious illness that requires patient-centered treatment options. An interesting point was discovered: according to their own articles in association with an NIH author, the IDSA has claimed “millions of tax dollars” have been spent refuting the ILADS claim (this was in the “Anti-science and Ethical Concerns Associated with Advocacy of LD” article from the Lancet in 2011 –they actually admit to spending money to refute the claims of its competitors.
NIH grants were misappropriated with the specific purpose to marginalize Lyme patients.
A grant is not to be used to acquire property or services for the Fed government’s direct benefit. It doesn’t have substantial involvement from the government when carrying out the activity contemplated in the agreement. Basically a grant is when two organizations (the Fed government and another organization that isn’t the Fed government) have similar objectives and the government says, “we like what you’re doing, it follows what we’re trying to do” and they give them money. So there is no direct costs for services rendered. However, in this case there were some exceptions.There were a number of actors who misappropriated monies from translational research grants, patient-oriented research and historical review grants: - Sr NIH official (McSweegin)
- IDSA Lyme Guidelines authors
- Previous NIH grantee - Yale University Professor (Shapiro)
- Univ of PA“Misappropriation” = intentional use of the monies were used for unauthorized purposes; grant was given to meet certain objectives but was applied for other objectives. We know this because monies from grants have to be logged in when there are publications and their grant numbers are disclosed – it’s obvious information if you do the research. It involves six different NIH grants totaling $11,825,000.
McSweegin and Shapiro basically used grants that were supposed to move knowledge and discovery gained from basic sciences to clinical and community settings (also known as “bench to bedside”).
And they also used money set aside to conduct high quality patient-oriented research to answer important clinical questions and to mentor young physicians who conduct patient-oriented research – instead they used the money to prepare and write the “Anti-Science and Ethical Concerns Associated with Advocacy of Lyme Disease” for the Lancet Infectious Diseases Journal in 2011 and also eventually appeared on PubMed, the central database for government-funded publications, in 2015.
McSweegin wrote the first and subsequent drafts, which would be considered substantial involvement. The article:
- mischaracterizes and discredits the Lyme community,
- dismisses and trivializes a number of crippling Lyme symptoms and complications,
- it portrays the Lyme community as a threat to true Lyme scientists and academics,
- it misrepresents ILADS as an anti-science and unethical organization (which is very curious given the ILADS Lyme Guidelines—not the IDSA Guidelines—are posted on the Federally-sanctioned NGC website,
- it asserts that unknown yet powerful money groups control and dispatch Lyme advocates for nefarious purposes (which is…amazing),
- it reveals that the NIH, CDC and IDSA have a great deal of bias against Lyme patients and Lyme science, which is not based on science.
- It makes one true statement – there is no deficiency of neither new patients or activists, which is true because we have an out of control epidemic which is constantly recruiting new people.
The second article involves Univ of PA, NIH McSweegin, “activists and self-described Lyme victims who have devoted years of efforts to raising an obscure tick-borne nuiscance in Old Lyme, CT to a nationally reportable disease.” He writes this to the editor of the Cambridge Journal of Infectious Diseases – he does not write the fact that Lyme is getting national attention.
And later that year (obtained through Newby’s FOIA request) he writes an email saying, “Anyone know of any academic, sociologist or historian interested in doing a paper on the politics of Lyme disease? Maybe Robert Oronowitz of Univ of PA? So McSweegin is an NIH employee trying to recruit someone to write a particular paper and at this time, Aronowitz had received 6 NIH grants by 2007.
In 2008, he receives 3 grants with the same objectives – to contribute to Infectious Disease prevention, policies and practices, and suggest greater inclusiveness in policy-making by indiv and groups with legitimate stake in the outcomes of prevention policies. This was published in 2012 in the Milbank Quarterly, “The Rise and Fall of Lyme Disease Vaccines; A Cautionary Tale for Risk Interventions in American Medicine and Public Health” by Aronowitz. The article is derived from A History of Health Risks in American Society and Medicine
which is the larger book he received the grant to write, however it’s all part of the grant production of publication. www.ncbi.nlm.nih.gov/pmc/articles/PMC3460208/So, this article diverges quite a bit from its original objectives. Basically, he recommends to:
- Stop the conversation between the Lyme experts and the patient advocates
- Forego engagement of patient advocates as stakeholders and members of the public
- Exclude their patient-centered views
- Ignore their voiced concerns and proposed recommendations
This is stunning because it runs counter to all US Federal and state policies and standards for best practices regarding patient-centered medicine and, of course, open government. And the fact that it used NIH grant and with a directive of an NIH employee is just stunning.
These grants not only misappropriate monies to discredit Lyme patients but on basic performance do not comply to the grant objectives, do not meet basic performance standards, the government had a substantial role and involvement, and the grantee appears to be providing direct benefit to the NIH, which are violations of grant agreements.
In addition, the “Anti-science” article delayed posting to PubMed, the Federal database for publications sponsored by the US government by 3 years, which is non-compliant – should have been done within one year. There was very low accountability for the content because the names of the authors kept shifting around between who was first within the Lancet and who was listed first in the Pub Med. There was an undisclosed conflict of interest – the Lancet editors was one of the authors, and many many others listed in the conflict of interests, basically makes the entire article lack any credibility.American tax dollars were used to:
- Marginalize the Lyme community
- Further IDSA professional and financial interests
- Reinforce the misrepresentation of the Lyme science
These two articles have contaminated many other pieces of publications because they have been cited in them. A quote from one of the articles came out back in March and within 3 hours it was on 889 platforms so we don’t even know how far these misappropriated grants and these “scientific” articles have contaminated and undermined representations of Lyme patients and Lyme science.
In 2015, the Office of the Inspector General made a series of recommendations regarding grant management for the NIH and the CDC. I found, from my review of what has happened with these grants, that I am in complete agreement with their recommendations respective to Lyme disease, which included:
1. Take more aggressive action to identify poorly performing grantees and those at risk of misspending Federal dollars and prevent them from continuing from receiving grant funds
2. Continue to provide training in identifying and pursuing misconduct in grants and contracts
3. Actively coordinate with and refer potential fraud to the Office of the Inspector General for investigation (which I plan to do with this information)
4. Implement a program to actively pursue fraud under the program, “Fraud, Civil Remedies at the PFCRA I also have some recommendations that I came up with as a result of these actions:
1. Initiate immediate oversight and stringent review of all current Lyme grants to all of IDSA’s institutional affiliations by impartial parties
2. Require deep institutional analysis by an independent party regarding how IDSA’s financial interests have shaped NIH resources and al
locations regarding Lyme and coinfections research and CDC’s Lyme policies and programs
3. Have an immediate moratorium or stop from all IDSA engagement in any and all government activities related to Lyme disease and coinfections (not including the IDSA’s other work).
4. Investigate all individual institutional actors implicated in these misappropriations - the authors of the articles, institutions - NIH, CDC, Oronowitz, McSweegin,
5. NIH Lyme awards to these actors be suspended until the investigation is completed (any Lyme awards to Yale and Univ. of PA should be suspended – not just the ones under these articles). Pending the conclusions of the investigations, implicated Federal employees should be barred from management of any monies, representational roles for their agencies, publications or releases, and decision-making roles on all and any policies, programs and research related to Lyme and coinfections. These are all standard practices whenever you’re investigating any fraud or waste – I know this from my previous experience of working on Federal programs that had these occurrences.
6. Initiate immediate and comprehensive and formal countermeasure to the institutionalized practice of discrimination against Lyme patients and the Lyme community.
7. Develop and extend a formal Fed policy and statues that confer special considerations, protections and resources to Lyme patients (---for those familiar with the AIDS epidemic these patients also faced institutionalized discrimination on the part of the Federal government and medical bias that was supposed to serve them so eventually they were given special considerations as a way to make a commitment to helping people living with HIV.) I believe that after 25 years of institutionalized marginalization on the part of the CDC – the way the CDC and IDSA have gone after Lyme patients at the state level and tried to undermine state protections against them, the way in which bad science has been promoted that undermines any chance of good outcome for health—that we require special considerations.
a. And these special considerations are to be developed with Lyme stakeholders that are identified and nominated by the Lyme community.
b. They are to be extended and made accessible to Lyme patients throughout the nation, as are special considerations with other groups such as those living with HIV.
c. And all recipients of government contracts grants and cooperatives agreements most make provisions for Lyme patients that conform to these special considerations.
d. And this is very much in terms of people living with Lyme who are also working – who have cycles of wellness and illness – they should be protected and considered because their illness is very much a product of bad governance.
To provide another example of how the IDSA is discriminating against Lyme patients and how the CDC buys into this – I want to talk about
the Antibiotic Stewardship Initiative. It’s being used to exploit Lyme patients and to further restrict treatment options.
For example, the IDSA worked with another organization to write antibiotics stewardship guidelines and they reviewed a number of different patient groups – e.g. end-of-life patients, premature infants, immunocompromised patients. And they identified one particular patient group that generates “superbugs” that we all fear may be antibiotic resistant—and this patient group is Lyme patients. If you go to their website, you’ll see that they have advocacy letters claiming that Lyme patients who receive one month or more of antibiotics will generate superbugs that threaten the rest of humanity. That exact language is in these advocacy letters on their website. It’s stunning.
The IDSA’s Stewardship goals vary a great deal according to their financial interest:
- In 2011 they promoted the reintroduction of home infusion legislation – they have found a way to provide
open-ended antibiotics and other treatments through home infusion to various patient groups.
- The reason they are interested in having these
open source and
open-ended antibiotic treatments for these patient groups is because they can get Medicare reimbursement so this generates income for these infectious disease specialists.
- Alan Tice, one of the early presidents of the IDSA founded the fist Outpatient Intravenous Infusion Therapy Association called OPIVITA – this is an area where they are going to make money and so they are promoting prolonged and
open-ended use of antibiotics but not for Lyme patients who require it to improve their health and well-being.
IDSA claims that the benefits of Antibiotic Stewardship include improved patient outcomes and optimization of patient resource use. In 2014 the Presidential Executive Order Combating Antibiotic-Resistant Bacteria is being piloted. The US government intends to promote global regulations for uniform antibiotic stewardship, which makes perfect sense – we want to make sure people can be treated, as needed, we want to make sure that infectious diseases do not become resistant to the antibiotics that we already have.
However, as I’m stating, the way in which Lyme patients are being treated is unique under this situation: the IDSA is sitting in this initiative, they’re active in this initiative and they are restricting Lyme patient access to antibiotics through this initiative regardless of the patient’s symptoms and in defiance of proven longer-term treatments by ILADS.
Background on videos:
Jenna Luché-Thayer’s expertise includes government transparency, accountability, and the integration of marginalized groups. Luché-Thayer is informed by three decades of professional policy and grassroots experience in 40 countries. She has extensive experience in congressional relations, testimony and legislation. She has worked with governments, the United Nations, nonprofits and the corporate world and has over 65 sponsored publications. Luché-Thayer received the International Woman’s Day Award for Exemplary Dedication and Contributions to Improving the Political and Legal Status of Women (US government) and built the Highest Ranking Technical Area in Accomplishment, Innovation & Comparative Advantage for United Nations Capital Development Fund.
There is a correction regarding the PLEASE Study: I misstated that Arend authored the PLEASE study, the primary author is Dr. Bart-Jan Kullberg and the purpose of the study "is to establish whether prolonged antibiotic treatment of patients diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines) leads to better patient outcome than short-term treatment..."
This Study objective is inherently flawed as International Lyme and Associated Diseases Society (ILADS) does not claim to have one particular treatment protocol for all Lyme patients. All ILADS protocols are patient centered to the patient. Therefore, the treatment protocol the PLEASE study uses does not represent ILADS nor prove or disprove any ILADS protocols.
For those of you who would like even more information on this topic I have put together some very detailed analyses I am willing to share. Please contact me with your request.
Please note that Phyllis Mervine, founder of LymeDisease.org provided the information regarding the anomalies related to the New England Journal of Medicine vol. 345(2) July 12, 2001 Two controlled trials of antibiotic treatment in patients with persistent symptoms & a history of Lyme disease.
Thank you – JennaSee Part 1:www.healingwell.com/community/default.aspx?f=30&m=3684065&g=3684065#m3684065See Part 3:www.healingwell.com/community/default.aspx?f=30&m=3684161
Jenna Luché-Thayer’s expertise includes government transparency and accountability and the integration of marginalized groups. Luché-Thayer is informed by three decades of professional policy and grassroots experience in 40 countries. She has extensive experience in congressional relations, testimony and legislation. She has worked with governments, the United Nations, nonprofits and the corporate world and has over 65 sponsored publications. Luché-Thayer received the International Woman’s Day Award for Exemplary Dedication and Contributions to Improving the Political and Legal Status of Women (US government) and built the Highest Ranking Technical Area in Accomplishment, Innovation & Comparative Advantage for United Nations Capital Development Fund.
Her other articles:
Link to 1st article + thread: "CDC Sabotages State laws to protect Lyme patients"www.healingwell.com/community/default.aspx?f=30&m=3672003
Link to 2nd article + thread: "CDC Rejects Evidence-based medicine for Lyme patients"www.healingwell.com/community/default.aspx?f=30&m=3672006
Link to 3rd article + thread: " CDC Evades accountability in Lyme epidemic"www.healingwell.com/community/default.aspx?f=30&m=3672010
Link to 4th article + thread: "Lyme Patients Stigmatized and Scapegoated with Federal Support:www.healingwell.com/community/default.aspx?f=30&m=3675093&g=3675093#m3675093
Links 5th article + thread: "CDC Lyme Policy Cripples Obamacare & Sanctions Insurance Discrimination"www.healingwell.com/community/default.aspx?f=30&m=3681041
Links to 6th article + thread: Mar 17, 2016 - Update 7A - Lyme Corps Assessment Brief, part 1 of 2: www.healingwell.com/community/default.aspx?f=30&m=3683408
Links to 7th article + thread: Mar 18, 2016 - Update 7B - Lyme Corps Assessment Brief, part 2 of 2: www.healingwell.com/community/default.aspx?f=30&m=3683417
Links to 8th article + thread: Ethics Complaints - CDC's Preferential Treatment for IDSA https://www.healingwell.com/community/default.aspx?f=30&m=3683427
Links to 9th article + thread: Comments from YOU Regarding Lyme Corps & CDC's Lyme Failures https://www.healingwell.com/community/default.aspx?f=30&m=3683435
Links to 10th article + thread: CDC Lyme Programs Routinely Flout Federal Procedureswww.healingwell.com/community/default.aspx?f=30&m=3683452
Links to 11th article + thread: Will the NPR Lyme News follow that of Gawker site Jezebel?www.healingwell.com/community/default.aspx?f=30&m=3683491
Links to 12th article + thread: We may need a Whistleblower to Address the Lyme Epidemic https://www.healingwell.com/community/default.aspx?f=30&m=3683514
Links to 13th article + thread: Will Federal bill S. 1503. for Lyme and Tick-Borne Diseases end 40 Years of Marginalization? https://www.healingwell.com/community/default.aspx?f=30&m=3683524
Links to 14th article + thread: How Does the CDC & Big Pharma Alliance Drive Public Health Policy regarding Lyme? https://www.healingwell.com/community/default.aspx?f=30&m=3683559&g=3683559#m3683559
Post Edited (Pirouette) : 8/24/2016 2:37:59 PM (GMT-6)