Breaking News- Public Comments open on New IDSA Guidlines

General or non-medical topics with information and discussion related to Lyme disease and other tick-borne diseases.
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ChronicLyme19
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Re: Breaking News- Public Comments open on New IDSA Guidline

Post by ChronicLyme19 » Thu 9 Apr 2015 13:52

Yeh, after seeing their pick for the patient representative, I have very little hope of them actually doing anything but ignoring the public comments. At least it's on record come when the next Attorney General investigation takes place.
Half of what you are taught is incorrect, but which half? What if there's another half missing?

TDP
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Re: Breaking News- Public Comments open on New IDSA Guidline

Post by TDP » Thu 9 Apr 2015 22:26

Those who have submitted comments might consider copying them to US Senator Richard Blumenthal and various Congressmen who are active in supporting efforts at reforming the guidelines, improving research, etc.

Carl Tuttle, who organised a petition for a Congressional investigation on change.org [url]https://www.change.org/p/the-us-se ... dium=email[/url] recently forwarded to Senator Blumenthal and others a scathing comment from Sin Lee of the Milford Hospital in Connecticut https://www.change.org/p/the-us-senate- ... u/10226386

I have done the same. FYI, here is my comment:

There are - and always have been - issues with requiring a positive (or at least an equivocal) result in the ELISA before a Western blot is performed (and there are multiple issues with the IDSA guidelines for that as well); however, to keep this comment short, I shall address only item 81 (lines 280-281 on page 16 of the LD Project Plan):

"Under what circumstances should a patient be treated for Lyme disease despite a negative serologic test? (In other words, what is the negative predictive value of a Lyme test)"

The negative predictive value of a serologic Lyme test is currently zero. There is at least one species - active in at least Europe, the Russian Federation, South-East Asia and North America - Borrelia myamotoi, which is capable of causing "Lyme-like disease" as well as relapsing fever, for which there is NO serological test. It can only be detected by PCR-based techniques. It has been detected by use of 16S rDNA probes in archived sera from patients with clinically suspect Lyme disease (Lee at al., Detection of borreliae in archived sera from patients with clinically suspect Lyme disease. Int J Mol Sci. 2014; 15: 4284-98); 4 out of 14 patients with spirochetemia tested positive for B. myamotoi.

The systematic failure over many years of the CDC and the IDSA (and equivalent bodies in many other countries including the UK) to consider even the possibility of the existence on non-cross reacting pathogenic Borrelia species may now be recognised as having left an indeterminate number of infected patients with no route to treatment.

Given that the role of B. myamotoi in "clinically suspect" Lyme disease has been clearly established, any physician refusing further investigation, let alone treatment, on the basis of a negative result in any current, approved ELISA test anywhere will be either sufficiently ignorant as to be rightly considered incompetent, or knows about this species and is therefore committing malpractice.

Given the very long evolution of Borrelia, as a biologist I think it highly unlikely that there are not other pathogenic species that do not cross-react to any significant extent with B. burgdorferei, garinii or afzelii

It is noteworthy in this context that the excellent group at the Scottish reference laboratory at the Raigmore Hospital conducted a tick study in which they obtained by culture 25 Borrelia isolates. Of these, 17 were positive by PCR with probes from either B burgdorferei, B. garinii or B. afzelii, but 7 were not (R. Evans, presentation at the 2013 Public Health England Lyme Disease Conference:
http://www.lymediseaseaction.org.uk/wp- ... -Evans.pdf ). These 7 species are currently being sequenced (personal communication to this commenter by Dr. Roger Evans at the PHE LD Conference, London, March 2015).

It is only by identifying and sequencing new species and surveying both seropositive and seronegative patients by molecular methods that pathogenic species can be identified with certainty. From those isolates, antigens can be prepared for inclusion in serological test kits. Indeed, Lee et al. (op. cit.) found a new species in archived sera from one patient; in that instance, the patient was seropositive.

FYI, I am copying this comment by email to US Senator Blumenthal and certain members of the US Congress.

Yours sincerely

Dr. T. D. Prospero

dlf
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Re: Breaking News- Public Comments open on New IDSA Guidline

Post by dlf » Sat 11 Apr 2015 1:13

In what I personally consider a surprising move, the Comment Period has been Extended To April 24. You can check this by going to the first link posted on page one of this thread. Maybe they realized that all the comments that were submitted were critical of the plan or provided scientific information that they would have ignored or discounted in the process. I guess they needed extra time to poke their supporters and friends to send in comments praising them for their efforts. :lol:

This does none the less mean that if anyone did not submit their comments in time for the last deadline, there are still a number of days left get them in. Ontario Lyme Alliance has posted the template on a number of Lyme webpages to help anyone who may need assistance in composing their comments. Could I encourage others to do the same and contact anyone you may know who missed the prior deadline?

TDP
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Re: Breaking News- Public Comments open on New IDSA Guidline

Post by TDP » Sat 11 Apr 2015 16:30

I think the extension might have had something to do with the message below that the LDA sent on April 7 (it was embargoed til then, and has been subsequently posted on the Euro Lyme Support Group on Yahoo groups.

"NOT FOR WEBSITE OR PUBLIC GROUP POSTING

EXPLANATION OF ISSUE TO LYME LEADERS

At this time, we have prepared letters to be sent to the US House of Representatives Lyme Disease Caucus and to the US House Energy & Commerce Committee. They concern actions we as group leaders would like to see happen regarding the new IDSA Guidelines process proposals. Below is the text of the letter to the US House Lyme Caucus Chairman Congressman Chris Smith. The letter to Energy & Commerce (E & C) will be the same information but just asking for a hearing. The E & C letter is not contained in this email, but your sign-on includes both letters.

CONFIDENTIALITY & INSTRUCTIONS

DO NOT POST THIS PUBLICLY ON WEBSITES OR ON GROUPS where outside individuals will be able to see it, please, as we do not want any proposed action preempted in DC. You can send it to your internal group people and to other Lyme leaders you know. A Group can only sign on once and an authorized group leader must be signer. Once you sign on (we will use Group, contact name, state, and email address), that information will be affixed to the letter, & once it is sent to DC, it will become public info.

TIME SENSITIVE SIGNON (by 3PM Eastern time April 7)

Go to this link or copy link into browser

http://www. lymediseaseassociation.org/ index.php/non-lda-press- releases/1345-form-2015

LETTER

Dear Congressman Smith and Lyme Caucus Co-Chairs,

I am writing on behalf of the Lyme Disease Association (LDA) and the undersigned organizations concerning an issue of importance to Lyme patients across the US and the world.

The Infectious Diseases Society of America (IDSA), a 501(c)(6) organization (business leagues, etc.) represents infectious disease experts who produce disease treatment guidelines, including those for Lyme and other tick-borne diseases. Currently, IDSA is in the process of reviewing their Lyme guidelines to update them. While the IDSA is utilizing a structured methodology – Grading of Recommendations Assessment, Development and Evaluation (GRADE), what is more important than the choice of a methodology is the degree of bias of those who composed the guidelines project plan, the bias of guidelines development panel members and the commitment of those individuals to the spirit of a fair and honest process. A prerequisite, but not a guarantor, for a successful outcome from the perspective of patient welfare is a high level of transparency throughout the entire process from development of the project plan to finalization of the guidelines.

As briefly discussed below, an examination of the Project Plan for new guidelines indicates that certain members of the IDSA will continue their history of bias and ensuring pre-determined outcomes in a process lacking meaningful transparency.

History of IDSA Guidelines. The 2006 guidelines IDSA generated became a standard of care, one so restrictive that patients were often unable to receive treatment, and physicians who treated were disciplined for treating patients for Lyme disease longer term than the guidelines indicated. The LDA had an online petition opposing the Guidelines which generated 45,000+ signatures. In 2006, then Attorney General now Senator from Connecticut, Richard Blumenthal, opened an investigation into the IDSA Guidelines, filing a Civil Investigative Demand, to look into possible anti-trust violations in the Guidelines’ development process and found that the panel who developed the Guidelines had undisclosed conflicts of interest in testing, vaccines, and as consultants to insurance companies. As a result, the IDSA had to appoint another panel to evaluate the guidelines’ formation in relationship to those conflicts. Although a process was set-up and a new panel selected, the results of the new panel again came into question, as the newly constituted panel did register a concern about one of the indicators, the testing indicator, but IDSA construed the decision-making on that indicator in such a way to imply that the particular indicator results were not really challenged by the new panel.

The IDSA has held itself out as the Lyme experts despite its refusal to address patients with chronic Lyme symptoms, and the IDSA Lyme Guidelines panel has always precluded input from another group of physicians, the International Lyme & Associated Diseases Society (ILADS). ILADS physicians are in the trenches treating patients who suffer from chronic Lyme symptoms. ILADS’ published Guidelines address the treatment of chronic Lyme disease, which is generally longer-term antibiotic treatment.

As a private entity, the IDSA has always seemed to be above accountability for its Guidelines’ formation process. However, since its Lyme disease Guidelines are accepted almost universally as the standard of care and those in violation of its terms often find themselves investigated and sanctioned, it is akin to a monopoly, whereby IDSA exercises almost total control over Lyme disease. It has the power to define Lyme, restrict testing and treating practices, exclude those with differing opinions, and control to a large extent the peer review process, since its representatives sit on the review boards of many major journals which are recognized by mainstream medicine and even has a chilling effect on meaningful Lyme disease research.

Testimony from a highly respected Lyme researcher (then soon to retire) to the 2012 House Foreign Affairs Health Subcommittee hearing, Global Challenges in Diagnosing and Managing Lyme Disease – Closing Knowledge Gaps, demonstrates the ramifications of the Guidelines: “Because of firmly entrenched opinion within the medical scientific community, evidence of persisting viable but non-cultivable spirochetes is slow to be accepted, and research proposals submitted to NIH that feature persistence following treatment are likely to receive prejudicial peer review in the contentious environment of Lyme disease.* Negative comments by peer reviewers of grant applications in the current financially austere NIH climate result in unfundable scores, if they are scored at all (triaged).” Barthold Foreign Affairs Testimony . It should be noted that the IDSA was asked to appear and testify in person at the hearing and did not do so.

Project Plan for New Guidelines. On March 9, 2015, the IDSA posted its intent to revamp its treatment guidelines. IDSA has brought to the process sponsorships from 3 medical organizations and other official representation from 9 organizations, 8 medical and one scientific. The development of the Project Plan and the selection of panel members lacked transparency. The panel selected to do the process excludes physicians who treat chronic Lyme disease, specifically ILADS, doctors in the trenches treating patients who do not recover with a short course of antibiotics recommended by existent IDSA Guidelines.

The panel is also composed of many of the same individuals who have produced a tremendous amount of peer review publications opposed to chronic Lyme and whose resultant intellectual conflicts are not listed. According to Gordon Guyatt, a Professor in the Faculty of Medicine at McMaster University, “ ‘intellectual conflicts of interest are completely ubiquitous’ and have generally been ignored. Intellectual conflicts occur when clinicians or researchers may be too deeply embedded in their own area of expertise to objectively look at a research question with an open mind….even when money is not involved … we [scientists] get very attached to our ideas.’ This is compounded by university culture, which rewards researchers if their work is highly referenced by others and is perceived to be influential. This environment creates an incentive for those participating in guideline development to highlight their own research in clinical practice guidelines.”

Lyme disease diagnostics plays a large role in the Lyme controversy and many who disavow chronic Lyme have conflicts in that area. The new Guidelines’ panel contains 6 individuals with significant diagnostic backgrounds, including 4 with ties to Immunetics −a lab with the C6 peptide test− a test which will undoubtedly be considered for Lyme to replace the existent 2-step process under the new Guidelines when the panel debates Question 76.

Contrary to recommendations of the Institute of Medicine (IOM) and the World Health Organization (WHO), IDSA has also excluded patient representation on its panel. Both IOM and the WHO emphasize the critical importance of patient representation in the process of developing clinical guidelines. IDSA includes a single “consumer” who, the Lyme community learned after calling her, has no knowledge of Lyme and does not even know anyone with Lyme, but rather she is a cancer advocate from Nebraska- a state whose 2013 Lyme reported case numbers were 10.

IDSA has allowed input from the public in a cumbersome process announced March 9 and ending April 9, which will most likely preclude too many from responding. A 30 day comment period, encompassing both Easter and Passover, is not a sufficient period for obtaining input from the public. The last two weeks of the 30-day comment period are during a district work period, disadvantaging members of Congress who have a personal interest in Lyme or who wish to have the opportunity to consider the views of their constituents.

Therefore, at this time, we ask the Lyme Caucus to consider our concerns such as the need for real transparency throughout the process, for IDSA to make public the results of a literature search for each question, for an extension of the comment period to 60 days and for all comments to be made readily available to the public as is done through public dockets in federal rulemaking and to inform the IDSA of the problematic implications to Lyme patients and treating physicians and to express the Caucus' intent to continue to follow the process which is of such importance to its constituents. While the IDSA would not be required to grant these requests, we would question why they would not want to be transparent in the development of clinical guidelines which affect the health of millions of people worldwide and their ability to keep their jobs, attend school, keep their homes and maintain the integrity of their families.

Thank you for your attention to this matter.

Sincerely,

Patricia V. Smith

President for LDA and signing for undersigned groups OTHER GROUPS TO BE SIGNED ON

dlf
Posts: 294
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Re: Breaking News- Public Comments open on New IDSA Guidline

Post by dlf » Sun 12 Apr 2015 2:18

Many thanks TDP for posting the comments you submitted to the IDSA Project Plan, supporting Congress members and the information about the LDA activities.
Unfortunately, in Canada we seem to often be in a bit of an information vacuum for this type of news.

TDP
Posts: 12
Joined: Fri 20 Mar 2015 16:55

Re: Breaking News- Public Comments open on New IDSA Guidline

Post by TDP » Sun 12 Apr 2015 5:17

Hi dlf

There are some very active groups in Canada. The Ontario Lyme Alliance has published on Facebook some guidelines on sending comments to the IDSA:

https://www.facebook.com/OntarioLymeAll ... 73/?type=1

You do not need to be a member to read it, but if you are using say Firefox + NoScript you will need to temporarily allow Facebook to run scripts. The OLA have also provided a template to assist people in formulating a response as the IDSA requires comments to conform to an unnecessarily complicated format - I can't imagine why, anyone might think they were trying to put people off :evil:

The template can be found here:

http://www.ontariolymealliance.ca/statementforIDSA.docx

Non-Canadians wishing to use the template should edit out the references to Canada and Canadian legislation,

I shall be submitting a comment on persistent borreliosis next week.

duncan
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Re: Breaking News- Public Comments open on New IDSA Guidline

Post by duncan » Sun 12 Apr 2015 13:46

I submitted my comments. I encourage others to do the same.

I fear, though, as some have already pointed out, that the IDSA has no incentive to even read our submissions, let alone act on any.

I wish there were a public reservoir of submissions, anonymous, that members of the press could tap into whenever so inclined, to publish and then grill IDSA panelists as to why relevant and scientifically sound submissions were not acted upon. So that there was a mechanism that could act against IDSA inertia, and provide at least a measure of accountability for stunts like including a non-Lyme patient as a "patient representative".

TDP
Posts: 12
Joined: Fri 20 Mar 2015 16:55

Re: Breaking News- Public Comments open on New IDSA Guidline

Post by TDP » Sun 12 Apr 2015 18:14

HI Duncan

That's why I copied my comment to US Senator Blumenthal et al. Since the negative predictive value of all current ELISA tests is zero, the IDSA can't impose a requirement for a positive/equivocal result and state that if the ELISA is negative the patient does not have a borreliosis, not without risking a big hassle from the Lyme Caucus in the Senate & Congress as well as potentially (? IANAL) facing class actions from patients who are denied treatment under the revised guidelines then test positive for myamotoi or a new, non-cross-reacting species.

Best regards

Terence

ps: 57 groups signed the LDA letters to the IDSA, the House of Representatives Lyme Caucus, and the House of Representatives Energy & Commerce Committee, Read them here:

http://www.lymediseaseassociation.org/i ... ent-rights

duncan
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Re: Breaking News- Public Comments open on New IDSA Guidline

Post by duncan » Sun 12 Apr 2015 19:07

Terence, yes, and I applaud each of these strategies.

The IDSA panelists, certainly those from the old guard...I wish that local papers could be contacted to let them know the true stories about whether their residents acted in the best interests of their neighbors...That those who work in university settings can see protests in relevant papers that also bring into the harsh and revealing spotlight why those academic institutions would cling to such individuals...whether it were patents or tenure - that it would all be called into question, based in large measure upon these new Guidelines, upon whether the framers truly resolved to let science and patient need motivate the narrative, or whether it was something altogether different.

velvetmagnetta
Posts: 469
Joined: Sun 23 Feb 2014 22:47

Re: Breaking News- Public Comments open on New IDSA Guidline

Post by velvetmagnetta » Wed 29 Apr 2015 6:47

Does anyone know if and where the public comments will be posted? And when?

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