TOUCHED BY LYME: One patient’s comments to IDSA
The IDSA is accepting public comments about its Lyme guidelines review process through April 9. Rules for commenting require you to cite page and line numbers of the IDSA’s Project Plan. Molecular biologist/Lyme patient Julie Engle submitted the following comments. She invites you to use them to inspire your own comments to the IDSA.
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 Conflicts of Interest 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 guidelines 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 four 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 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 ELISA test has a sensitivity of 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 ELISA, 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
Julie Engle lives in Minnesota. She has been sick for 20 years.
Standing Ovation!!!!!!!
Very kind of you! Thanks.
Thank you Julie for posting your comments. I wish I could be more optimistic that the flood of public comments will change anything. Still, it must be done. I have contacted my Senator and demanded that she DO SOMETHING to get those control agencies who can do something to actually do something to ensure a fair, impartial, and diverse panel be seated to produce guidelines that are updated and relevant to LD today. For now I remain hopeful but not confident. Best to all!
I totally agree with you!
Thank you for the opportunity to comment. I have been sick with Lyme Disease for over 25 years. I had the bulls eye rash and went straight to the doctor but had to convince him to give me the Lyme test. It came back negative. Five years later I came down with horrendous symptoms and no doctor was able to diagnose me. I finally diagnosed myself. My new doctor explained that the test the doctor had given me years ago was not reliable and so she treated me. Unfortunately, the Lyme had burrowed deep within in my joints and nervous system and I started exhibiting symptoms again a few years later. This time I was actually diagnosed properly since the general practitioner that I was seeing was also a Lyme literate doctor. She had me do the Igenx test and my results came back positive. She treated me and educated me about the Lyme disease. She gave me resources so that I could educate myself, and I was able to get the support I needed to beat the disease. I still have to be careful, but I now live a normal life. Unfortunately, the only doctor who was really able to help me lost her job because of her unorthodox practices. She spent time with me, she listened to my symptoms, she gave me the treatment that worked. She kept working with me until I was cured. She is the doctor who should be on the panel that is developing protocol to treat Lyme disease. Instead she was pushed out of her practice. I was sick for 20 years before I found this doctor. Now, because of her I am cured. Is this the type of treatment this wonderful doctor deserves? What type of “cures” will Lyme patients be receiving now?
Excellent analysis, Julie! I nominate you to be the missing knowledgeable Lyme patient on the panel!
Thank you, Julie, for what you’ve written. It is much appreciated by all those of us who have to endure IDSA’s “don’t try to confuse me with facts” stance. Thankfully, we have ILADS and they continue to work to educate the medical community and patients, in spite of IDSA and others who seem to work against the best interests of patients.
I have been battling Lyme and other tick related illnesses since the mid 1970’s. It took about 12 years and 20 doctors to be diagnosed. By that time I was very sick and my life was turned upside down. But, thankfully, I have had two of the best doctors treating me so I am able to lead a mostly normal life. It’s been terribly expensive. It’s been a slow process. But after 40 years, with continued monitoring and treatment, I am living a fulfilling life.
My wife and I both have suffered from the effects of Lyme Disease. I am lucky to have found a Lyme Literate doctor and I’m basically cured but my poor wife is not so lucky. Our Lyme Literate doctor was chastized by the AMA for “not writing enough prescriptions” and we haven’t seen him in a while. Finding another LLD wasn’t easy but we did it. Meanwhile, when we have to rush my wife to the ER for her other challenges, it’s often we hear the nurses AND doctors comment, after looking at her file, “I see you’ve had the Lymes.” She’s heard that ignorant comment so many times she now replies… “Oh yes, and I had Oranges and Lemons too!” You should see the looks on the “medical professional’s” faces…They are Soooo clueless!
fabulous ! perhaps if the CDC and IDSA spent as much energy try to come up with a solution as it does proclaiming its interest in the health care of Americans , we’d be a lot further along …