Commenting on IDSA Lyme guidelines, part 1
How to submit comments and why you should do so.
The Infectious Diseases Society of America has finally decided to update its Lyme disease guidelines. However, the process for doing so doesn’t look good for Lyme patients.
The IDSA pays lip service to representing a broad range of opinions on its guidelines panel. But in fact, physicians and researchers with alternative views about Lyme disease have been excluded. For instance, there are no ILADS doctors on the panel. And, the token “patient representative” has no experience with Lyme disease whatsoever.
The IDSA is not a government agency. It is a private trade group which doesn’t have to answer to anybody. Yet, it wields tremendous influence. The guidelines are also posted on the CDC website and other governmental channels of information. As a result, the IDSA Lyme guidelines have become a widely followed standard. And insurance companies use them to decide what treatments to pay for.
The IDSA will take public comments on its guidelines process until April 9. Anyone may give feedback on any aspect of the Lyme Disease Project Plan, including whether it adheres to standards set by the Institute of Medicine. (Spoiler alert: It doesn’t. More about that in part 2.)
The IDSA has designed a complicated process for submitting public comments. Yet, it’s important for the Lyme community to respond. This panel will seriously impact the lives of Lyme patients for years to come. The current guidelines already make it difficult for patients to get properly diagnosed and treated for Lyme. The new ones could make things even worse.
Here’s the link to our suggestions for comments.
Submitting Comments.
Please note that you will need to submit your comments in one sitting. Therefore, you should review the plan and compose your remarks in a Word document. When you’re ready, copy and paste them into the comment field in the survey. If you follow these directions, the submission process should only take a few minutes.
The IDSA asks that you refer to the page and line numbers of whatever you are commenting on. (Such as: Page 9, line 103.) Use the following references for comments on the general areas of the document:
Guidelines sponsors and organization representation: Page 1, lines 6-20
Guideline panel constitution and authors: Page 2, lines 1-50
Conflicts of interest: Pages 8-9, lines 116-126
PICO (Questions addressed) Pages 9-16, lines 127-278
We suggest that patients focus primarily on the lack of balance and representation on the panel, as well as conflicts of interest. Feel free to cut and paste from our suggested comments. You can of course modify them to suit your interests. Comment only on what is in the IDSA’s Lyme Disease Project Plan. There should be no personal attacks. If you can tell your personal story in a paragraph, feel free to add it after your comments.
Click here to read our suggestions for comments.
Instructions:
Read the IDSA’s Lyme Disease Project Plan and decide what you want to say.
Create your comments in a word document. Then, go to the IDSA comment form.
The first screen (shown below) requires your name and other information. Fill in your information in question one.
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In question 2, check the first item indicating that you have no conflicts of interest. Then click next.
The second screen is where you will add your comments. Cut and paste these from your word document. Remember to include page and line numbers.
When finished click save and submit. Your comments are then recorded and you will be bounced to the IDSA homepage.
Commenting on the IDSA Lyme guidelines, part 2 offers suggestions for things to say.
Commenting on the IDSA Lyme guidelines, part 3. Take our survey offers another way to give feedback to the IDSA–as well as journalists, politicians, and healthcare policy makers.
I have had lyme for at least 23 yrs. My husband is disabled and I am his caregiving having lyme makes it so much harder. we are going broke using money for my lyme treatment I was hoping to one day use to get in home help for Dennis.
still there is no end in sight. there is no cure for everyone 3 steps forward there is 2 back again. We are 72 now.In additional to lyme and my husbands disability we are now dealing with the normal problems that come with growing old. we need diagnose, treatment and a cure and insurance coverage. thank you.
THE PRIMARY CAUSE OF THE LYME DISEASE DEBACLE IS FINANCIAL. THE MEDICAL INSURANCE INDUSTRY COMBINED WITH SOME UNINFORMED/MISINFORMED MEDICAL “PROFESSIONALS” WHO ARE BEING USED VIA VARIOUS INCENTIVES.THE GENERAL PUBLIC ARE MOSTLY IGNORANT OF THE DISEASE & ITS OVERALL CONSEQUENCIES.THIS COMPOUNDS THE PROBLEM.EDUCATION & CONTINUED LOBBYING FOR A RESOLUTION IS THE PRIORITY.THE NUMBER OF VICTIMS CONTINUES —–
What about contacting our congressmen/women?
Is now the time to be doing that?
Lyme is a vicious illness that is epidemic here in the Northeastern US. It is astounding and incredible that there exists very little informed medical professional help to combat this plague. A substantial responsibility for this gap lies with the IDSA, an organization which has defined Lyme as something equivalent to a common cold. All of its members should be held criminally liable for failing their oath to “do no harm’.
I totally agree with your statements. Everyone on the IDSA panel, insurance companies and big pharmaceuticals need to be held accountable for not following the oath ‘do no harm’. It’s sad that they are so uninformed, probably by choice. Ignorance and a blind eye to the truth for the sake of their egocentric goals is killing millions. By not including LLMDS, ILADS folks and real Lyme patient representatives on their panel, the chances of improved, accurate, and beneficial (to patients) guidelines are nil! I hope everyone comments on the guideline plan after all this isn’t an epidemic, it’s a pandemic!
Following are the comments I sent to the IDSA regarding the Guidelines Project Plan. It’s long, but feel free to copy any part.
1. I object to the following panelists on the basis of their reported conflicts of interest. The integrity of the Guidelines should not be marred by even the suspicion of financial conflicts of interest related to Lyme Disease (which have clearly tainted previous IDSA Lyme Guidelines). Certainly there are other potential candidates that could be recruited who have no such conflicts of interests. (Why did the COI committee require that only a MAJORITY of the panel members be free from Conflicts of Interest, instead of requiring it of ALL members? How utterly ridiculous.) A fair and impartial guideline development panel should be able to evaluate the evidence and operate successfully without any one of these individuals with conflicts:
Page 2, Line 4-5: Linda Bockenstedt MD, Co-Chair representing ACR (and page 17)
Page 2, Line 14: Paul G. Auwerter, MD, representing IDSA (and page17)
Page 2, Line 18: Maria E. Aguero-Rosenfled, MD (and page 17)
Page 2, Line 19: John A. Branda (and page 18)
Page 2, Line 24: John J. Halperin, MD, representing AAN (and page20)
Page 2, Line 25: Peter J. Krause, MD, representing IDSA (and page 20-21)
Page 2, Line 28: Lise E. Nigrovic, MD, MPH, representing AAP-EM (and page 21-22)
Page 2, Line 35: Allen C. Steere, Jr., MD, representing ACR (and page 23-24)
Page 2, Line36: Frank Strle MD, PhD, representing ESCMID (and page24)
Page 2, Line39: Gary Wormser, MD, representing IDSA (and page 24-25)
2. I object to the following panel member on the basis of her lack of first-hand knowledge of Lyme Disease. Certainly one or more panel members could be selected from the millions of Lyme patients (or their parents/caregivers) who have experience with this debilitating disease, the related treatments, and the enormous field of knowledge that Lyme patients, caregivers, doctors, and researchers have developed over the last 4 decades. Choosing a consumer representative that has no knowledge of Lyme Disease subjects the panel and its guidelines to an obvious lack of credibility and an apparent intentional bias against Lyme patients.
Page 2, Line 31: Jane Glazer Rips (with my thanks, and no offense to Ms. Rips intended)
3. I object to the following panel members on the basis of their inclusion on previous IDSA Lyme Disease Treatment Guideline Panels. The previous IDSA Lyme Guideline Panels have been fraught with suspicion of unethical practices and conflicts of interests. To avoid such suspicion, which might taint the new guidelines, no members of previous panels should be included on the current panel. Rather than maintaining the status quo, fresh faces will be more objective and open to new ideas as well. For this reason, in the best interest of the panel, the following members should be disqualified:
Page 2, Line 4-5: Linda Bockensedt, MD Co-Chair, representing ACR
Page 2, Line 24: John J. Halperin, MD, representing AAN
Page 2, Line25: Peter J. Krause, MD, representing IDSA
Page 2, Line 35: Allen C. Steere Jr., MD, representing ACR
Page 2, Line 36: Frank Strle, MD, PhD, representing ESCMID
Page 2, Line 39: Gary Wormser, MD, representing IDSA
4. I object to the following panelists on the basis of their inclusion in the few references listed as the foundation for the panel program (as shown on page 38, Lines 2, 5, 8, 11, and 14). This leaves open the possibility of undue influence by a few panel members at the expense of impartiality. Basing guidelines primarily on information propagated by panel members may exclude opposing or differing viewpoints and reduces objectivity. The following members should be disqualified:
Page 2, Line 4-5: Linda Bockensedt, MD Co-Chair, representing ACR
Page 2, Line 8-9: Paul M. Lantos, MD, Co-Chair, representing IDSA and ACP
Page 2, Line 24: John J. Halperin, MD, representing AAN
Page 2, Line25: Peter J. Krause, MD, representing IDSA
Page 2, Line 35: Allen C. Steere Jr., MD, representing ACR
Page 2, Line 36: Frank Strle, MD, PhD, representing ESCMID
Page 2, Line 39: Gary Wormser, MD, representing IDSA
5. I object to the omission of ILADS and their the 2014 (and previous) Guidelines in the list of Medical Societies that have produced Lyme Treatment Guidelines. Excluding or failing to even consider alternate or opposing viewpoints in development of treatment guidelines is clearly unethical. It appears this program is flawed before it even gets started.
Page 3, Lines 16-20
6. I object that ILADS is not specifically included in the current effort to “produce a joint, multi-society consensus document for the prevention, diagnosis and treatment of Lyme Disease.” Including the viewpoints of only a few medical societies (IDSA, AAN, AAP, ACP and ESCMID), at the exclusion of ILADS and other interested medical societies in the development of treatment guidelines will NOT produce a CONSENSUS DOCUMENT, but another biased, special-interest white wash that will clearly invite legal consequences to IDSA’s doorstep.
Page 3, Lines 20-22
7. Re: Testing methods. Multiple studies have confirmed that the Lyme Eliza test has a sensitivity no better than 40- 60%. This level of inaccuracy renders it and the 2-Tier testing method completely ineffective as a screening tool. Therefore, the current Lyme Eliza, and the 2-tier testing method has little predictive value whatsoever and should be abandoned immediately.
Page 15, Lines 268-275
8. The presence, absence and intensity of ALL individual bands on a Western Blot should always be reported.
Page 15, Lines 272-273
9. Re: false positives – rarely is anyone screened for Lyme Disease unless there’s a suspicion of Lyme disease. Consequently, if Lyme is suspected, there should be very little question that a positive result confirms a Borrelia infection. What evidence is there, IF ANY, that a positive result is a “false” contamination or cross-reaction result rather than a confirmation of infection? Patients who are suspected of having Lyme disease, who then test positive for Lyme disease, should be treated for Lyme disease. It shouldn’t take a panel of experts years to come to that conclusion.
Page 16, Line 276-279
10. False negatives: Patients that present with symptoms of Lyme Disease should be treated for Lyme Disease. Denying treatment to a suffering patient on the basis of a test which has been proven unreliable is unethical and inhumane.
Page 16, Line 280-281
The IDSA has excluded two groups who are profoundly affected by the guidelines: chronic Lyme patients and the physicians who treat them. These guidelines are used to deny care to Lyme patients, many of whom are too sick to work and otherwise suffer serious quality-of-life impairments. Some state medical boards also use the guidelines as a legal standard to attack Lyme-treating physicians. I have three family members who’s original tests came back as negative. Their quality of life continued to decline to the point of being disabled. It wasn’t until we sought out a “Lyme Literate” Doctor that more tests were run, and proper treatment given, that they were able to find relief and return to a life worth living. This panel is like asking the ADA to make decisions on how to treat cancer. Without the proper research, tools, and Lyme specific experience, it is not only irresponsible, it’s negligent. This epidemic is not going away, only getting worse. People who could be treated are being ignored, told they’re crazy, and sent off to suffer without any hope. The testing available is inaccurate. Who in their right mind would accept a test that is less than 50% accurate? If it was your life on the line, I can guarantee that you would not. Wake up, because it will happen to you or someone you love soon. Who will you blame when your insurance denies you coverage when you are diagnosed, or you get tested for everything possible and are told that you’re crazy/depressed or have hypochondriasis? I will tell you, IDSA, because they’re the ones providing inaccurate information to the majority of physicians and insurance companies, information that is not based on fact, but misinformation.