(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 1 of 3
by Jenna Luché-Thayer
April 10, 2016/www.youtube.com/watch?v=fsE_hHSsOQo
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 1 of 3 CDC & Lyme - Oversight Required 2016/www.youtube.com/watch?v=fsE_hHSsOQomy notes from the video:
Presentation will cover CDC-associated governance and marginalization issues:
- How CDC has violated a number of Federal laws and statutes
- How CDC Lyme policies and programs are not based on good or the best science
- How CDC have a special relationship w/ the IDSA
- How this has shaped their Federal program for Lyme disease
- Misappropriated grants from the NIH
- How abx stewardship initiative is being exploited by the IDSA
- Will be followed with series of recommendations
CDC Lyme policies & programs restrict patient access, are not patient-oriented, not based on best science, are non-compliant to a number of Federal laws and statutes and advisory board recommendations. They fail their strategic objectives and are a waste of tax dollars.
Over 25 years we now have hundreds of thousands of Lyme patients every year in the U.S. that are having unnecessary suffering, financial ruin, their families are destroyed, and have disability and death.
The CDC mismanagement costs have yet to be fully calculated. In April 2006 there was a publication in the Emerging Infectious Diseases journal, which stated that for about
329,000 new infections per year it costs the US tax payer $3.7B per year and these costs are escalating because the numbers of new people infected each year is increasing.
How has this happened?
CDC has disregarded a number of congressional directives. Every year Congress writes appropriations bills and these are the moneys that go to sponsor the Federal programs and Federal agencies. And with these appropriations bills are Congressional Directives
. Often these CD are detailed ideas for how the Federal Agency should be doing its business and they are often accompanied with a specific set aside of money called an earmark
In this case the CDC basically disregarded or failed to follow CDs to advance Lyme science, dx and tx in 2002, 2010 and 2015.
A recent letter from Ann Schuotte, who is a Principle Deputy Director for CDC, "Although (Congressional) Committee reports may include language the encourages agencies to work on programmatic activities, only the appropriations bill, signed by the president, includes directives to be carried out by Federal agencies. There were no directives specific to Lyme disease in the FY2002 Labor Health and Human Services and Education appropriations bill."
Now this kind of goes against all legislative behavior and institutional behaviors since there have been appropriations bills and directives. It's true that it is not a requirement by law however, it is something that is routinely done by Federal agencies and they report to congress regularly on how they have met directives and how those monies have been spent.
One thing that is particularly striking is that with the 2002 appropriations bill there was a section called the Infectious Diseases Control Earmark Directives. And (for) all the infectious diseases under this area of the directives those targets were met; the did the things that were required and requested by Congress. However, they completely ignored Lyme disease, which was the only directive that they ignored.
The 2010 appropriations (for Lyme disease) has and earmark of almost $9M, some of the commitments were initiated, most were not met and there was no accounting for the money at least in the documents that have been submitted.
The 2015 appropriations to CDC for Lyme disease has an earmark for almost $11 million and we do not know if those things have been done.
There is something called the ethical conduct section
which is a Federal body of laws regarding Federal employees and everyone who is a Federal employee must adhere to these laws because public service is considered a public trust.(my note: Jenna is referencing: Standards of Ethical Conduct for Employees of the Executive Branch, Final Regulation Issued by the U.S. Office of Government Ethics Codified in 5 C.F.R. Part 2635 As amended at 76 FR 38547 (July 1, 2011))
One law is that Employees shall put forth honest effort in the performance of their duties
- now this is very questionable in the case of the CDC because they are promoting non-compliant substandard Lyme tests and substandard Lyme treatments so how could they be putting "forth honest effort in the performance of their duties"?
Another law is Employees shall act impartially and not give preferential treatment to any private organization or individual.
(page 2 subparagraph 8)
- However the CDC has been showing continuous preferential treatment for the IDSA and this is the only disease with which the CDC is involved where they promote one private organization.
The other statue that is called into question is Employees shall disclose waste, fraud, abuse and corruption to appropriate authorities
- As we go along you can answer this question for yourself as to whether this has been done - it's not just if you yourself are involved in wast, fraud, abuse, corruption but if you observe it on the part of your colleagues than you should be reporting it to the Inspector General.
There are also routine standards for transparency related to classified and nonclassified activities. There is a program called Lyme Corps
- very few people have heard about
Lyme Corp is an unclassified public education program that trains public health & healthcare students to disseminate Lyme disease information and education to the public so it should be a fairly well-known program. It's being implemented throughout the nation, involving multiple universities, county and state health organizations and many private health care centers.
And yet few people have heard about
it. In fact, up until May 12, 2016, there was no records of Lyme Corps on the CDC website, (it was just posted on May 12). The program has been in action since 2013 so that's 3 years with no posting or reference to this program. If you called CDC and asked them about
it they had no information about
Lyme Corps (I know because I called multiple times).
In 2013, Lyme Corps recruited 10 members from Drexel University, distributed over 1500 printed materials, had 23 presentations to clinical staff at medical practices with an average size of 1800 patients each (that's 41,400 patients), presented to health officials and a variety of age groups, presented throughout public settings - parks, schools. However, to this day I have not been able to secure any basic program information about Lyme Corps. I submitted a FOIA (request) - typically (for) an unclassified program you'd be able to go right to the website of the organization, get the info quickly - how much are they spending on it, who are the partner institutions, what are the program objectives--all of these things. This is not readily available.
Some of the information is now available - they've made reference to a few of the activities they have undertaken. However, again, it's an unclassified program and what I should be able to easily access are the strategic objectives, program objectives, geographic areas and how it's going to be rolled out, annual and quarterly reports, assessments and evaluations that have been done, any funding and overall budget, numbers of intended clients and beneficiaries. This information has still not been forthcoming.
If you go on the internet and you type in "Johns Hopkins Plant Nursery Sale" - a website will pop up that says "nursery plant sale advertising flyer Johns Hopkins". You click on that and what you'll see is a poster advertising Lyme Corps. And in the corner of it says "Nursery Plant Sale Advertising Flyer". What I'm trying to tell you is that basically, Lyme Corps has been flying under the radar for some reason and there's no reason for it - it's a public health education program. However some of the reasons why they are not being public about this public health program will be revealed as I continue.
CDC Lyme policies and programs as I said are not based on the best science - they're not even based on good science. How can I make this claim - I'm not a scientist and I'm not a medical doctor? I'll tell you how:
There are advisory boards to the Federal government - to help them do their best work. One is called the Council of State and Territorial Epidemiologists (CSTE) and it provides the CDC's disease surveillance guidance and also talks to them about
disease diagnostic guidance.
In 2011, the CSTE advised the CDC the following - the two-tiered test being used by the CDC and promoted by the CDC to diagnosing Lyme Disease is not to be used in clinical diagnosis, is an inappropriate technology, it is very inaccurate. That was in 2011.
The CDC ignores this advisement. This is the job of this organization to advise the CDC and yet they're ignoring this information and this advisory recommendations. The tests that are being used for diagnosis are 50% inaccurate.
I was recently in Washington, D.C. and met with staffers, senators, congressmen and one said, "Is there a better test?" and there really isn't a very good test out there but that doesn't mean you use a bad test as a clinical diagnosis. What you do is you use a clinical diagnosis based on the symptoms. The tests are there only to help support that diagnosis but you go based on the symptoms. Lyme disease is a clinical diagnosis, it is not to be done using these bad inaccurate tests and that is something that other advisory boards recommend.
There are also other agencies - the Agency for Healthcare, Research, Criteria and Quality (AHRCQ) produces evidence to make healthcare safer and they're under the Department of Health and Human Services (DHHS). Under them is the National Guidelines Clearinghouse (NGC) which is a website that promotes and posts good quality guidelines for medical care and these are evidence-based clinical practice guidelines that meet their criteria.
The CDC promotes the Lyme Guidelines from the IDSA. These guidelines are the only Lyme guideline being promoted by the CDC and they have failed the criteria set by the AHRCQ, and they have failed the criteria for the NGC, both of which are part of the Federal agencies who advise and review on these matters.
In addition to that there is also an independent advisory group called Health and Medicine Division (HMD - used to be known as the Institute of Medicine - they are independent, non-governmental). They have the standards for developing trustworthy clinical practices guidelines and they also have the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) working group. They also reviewed the IDSA Lyme guidelines and determined they do not meet GRADE and do not meet their standards.So now we have four different independent bodies telling the CDC that the diagnostic tests that they're promoting are inappropriate and substandard and that the Lyme guidelines that they are promoting are are inappropriate and substandard and non-compliant to basic Federal standards for evidence-based science and yet they continue to promote them.
The CDC is also promoting the IDSA's mischaracterization of Lyme disease. IDSA and CDC claim that Lyme disease is hard to catch, easy to diagnose and easy to cure. Multiple letters to the CDC asking, "why are you promoting these non-compliant and outdated substandard guidelines and tests?" and they say repeatedly in writing that they represent the best science, which simply is not true.
What happens as a result of these poor standards being promoted not only in this country but globally?
In this country what it means is that:
- We are continuing to have an epidemic that is growing.
- We have at least 329,000 new annual infections
- 900-1000 new infections per day
- 40 new infections per hour
- Of all those who are tested, as many as 50% of those tests will be inaccurate and people will be told they don't have Lyme disease, when they do.
- In that situation, they will have a delayed diagnosis and because of that they will have very serious systemic complications and these may include serious heart, nervous system, immune impairment, organ dysfunction, life altering damage and death. All because of outdated and substandard guidelines and testing being promoted by an organization that is supposed to protect our public health.
Then, if you get a positive test, according to the CDC, you will be given one month of antibiotics, which is according to the IDSA Lyme guidelines. This will fail as many as 36% of the patients - it will not get them well. It might not fight the symptoms but by the time they get diagnosed the infection will have already been systemic.
What is happening in this country as a result of these bad practices, the bad science on the part of the CDC?
Many different states are trying to protect their constituents - in our country there are more than 25 states now that have laws that have been passed or amended to protect it citizens from the bad science of the CDC and there are more pending.
What does that mean? It means that states have recognized that people are getting very sick from Lyme And the CDC is not doing a good job in protecting them. So you have laws (in MD, VA) for patients to be told by their MD when they are given a Lyme test - their MD is required to also give the patient a notice indicating that just because the test is negative it does not mean that the patient does not have Lyme.
Now, the 25 states (half of the country - that does not include all the states that have Lyme awareness legislation) have implemented protective legislation that helps patients understand that a negative test does not mean that they do not have Lyme, that they have treatment options beyond IDSA guidelines, and that doctors who treat such patients who treat patients beyond the IDSA guidelines are well within their rights as treating physicians, to provide these options for treatment. These are protective laws put in place because the CDC is promoting such poor science and medical guidelines.
Now, the IDSA does not like these laws. In fact, in 2004 and 2006 when IDSA had their annual meetings they actually had agenda items to oppose patient legislation initiatives and to defeat patient-sponsored legislation.
Why would the IDSA want this to happen? It doesn't make any sense.
However, they are doing it. On the IDSA website they have tried to undermine state legislation in CA, CT, ME, MD, MA, MN, NE, NH, NJ, NY, OH, OR, PA, R.I., TX, VT, VA, W.V., and WI. It's amazing that a private medical society would want to undermine state rights to protect their constituents against bad medical science and bad medicine advice.
Why is all this happening - it doesn't make any sense.
Basically, the IDSA has a lot of power and this power has been escalating and they have been setting Federal Lyme policy and this has been going on for some time now. In 1999 the IDSA had 3000 members; in 2016 it had over 10,000 members and international affiliates.
The IDSA gained power because of new epidemics, the 9-11 terrorist attacks, their close relationship with Big Pharma, they are working with the Department of Defense and the CDC. Basically, infectious diseases specialists are more and more important in this time of global pandemics that are emerging very quickly and also increased threat of bioterrorism.These changes have amplified the essential role of infectious diseases specialists and these are people who make up the IDSA.
Not all of the IDSA members are part of this issue with regards to Lyme - I'm sure many of them are doing very good work with regards to infectious disease. I am referring specifically to those IDSA members who have been involved with the Lyme guidelines and programs.
On the national security front, infectious disease activities includes vaccines, drugs, therapies, diagnostic tools for public health emergencies and they also act as first responders to microbial threats, whether natural or terrorism-related.
The members of the IDSA are very well placed to direct research dollars - they sit on medical journals, they are in research institutions, international medical bodies, institutes of higher learning, Federal state and county bodies. So they are very good at helping direct flows of research to infectious diseases of various types, including Lyme disease, and determining what get published because of their positions on medical journals as well.
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 2: https://www.healingwell.com/community/default.aspx?f=30&m=3684091 See 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 2:38:27 PM (GMT-6)