LYMEPOLICYWONK: The IDSA chooses a token patient for its new guidelines revision process
For the past 11 years, the IDSA has refused to include patients (as well as researchers and physicians who are not like-minded) on its Lyme guidelines panels. The group has also fought against patient representation on federal and state advisory boards. On March 9th, they announced a new guideline development process. This time, they have included a patient representative. Why the sudden change? And, more to the point, should patients rejoice or weep?
Theoretically, medicine holds the interests of the patient paramount. However, sometimes the people developing guidelines have a different goal in mind, placing commercial or professional interests above the welfare of patients. For example, they might want to increase the market for a drug or test. Or promote the career goals of researchers. Or the professional goals of the members of medical specialty societies.
In the wake of extensively reported guideline development abuses, ethics professors began to clamor for guideline reform. In 2011, the Institute of Medicine announced sweeping reforms, which included a call for patients to be at the guidelines table. Thus, the IDSA’s decision to include a patient is not surprising. After all, the IOM specifically pointed to the IDSA Lyme guideline development process as an example of what not to do.
So which patient representative did the IDSA choose for its Lyme guidelines panel? Someone the Lyme community has never heard of. This was immediately clear. But when we contacted her last week, she also advised us that she knows nothing about Lyme, has never had Lyme, and has no knowledge of it or the interests and concerns of those who have the disease.
This is deeply troubling.
The IDSA tells us that she has experience at the scientific review committee for cancer at the University of Nebraska Medical Center. But the IOM clearly says that the panel should include representatives from key affected groups. And they require a current or former patient as well as a patient advocate or patient organization representative. Patients are generally those with lived experience of a disease. 
Lyme is a complex disease steeped in controversy. Everyone is a patient, but a representational patient knows the disease, the issues, and is able to effectively hold their own at a table seated with experts. For example, no one would think that a person who had heart disease could effectively represent those with HIV/AIDs. Of course, both are patients. But people with HIV/AIDs face a completely different set of scientific, medical, and societal stigma issues. Early on, HIV/AIDs was shrouded with controversy. Patients faced huge barriers to healthcare and barriers to research. Without deep knowledge of the issues facing those affected with the disease, there can be no effective representation.
Is the IDSA intentionally picking an ineffective patient representative? In February 2014, LymeDisease.org requested and was denied a seat at the IDSA Lyme guidelines table. Later, the IDSA asked a national coalition of 40 patient advocacy organizations to provide a Lyme disease patient to sit on its new guidelines panel. I happen to co-chair that organization, Consumers United for Evidence Based Healthcare. CUE suggested me for the new Lyme panel. The IDSA’s response? “Not her!” (And perhaps, “not a Lyme patient”?)
To their credit, CUE refused to recommend a patient without Lyme because they regard tokenism as unethical. When CUE asked me to give a short (5 minute) speech about the incident at its annual meeting last June, I said:
The fear of course is that they want a drive-thru, check the box, token patient to fill an empty process chair and do their bidding.
I had hoped that I was wrong, but that doesn’t seem to be the case. Should patients rejoice or weep? Weep. A token patient is worse than no patient at all. Because it gives the illusion of process integrity where there is none.
The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org. You can contact her at lbjohnson@lymedisease.org. On Twitter, follow her @lymepolicywonk.
The IDSA is accepting public comments about their guideline review process until April 9th. Patients can use the IDSA comment form to express their concerns and outrage regarding the lack of any credible patient representation.
Public Comment Period for IDSA/AAN/ACR Lyme Disease Guideline Project Plan
Comment Period Closes April 9
http://www.idsociety.org/templates/content.aspx?id=32212267305
The full Project Plan and link to the data collection mechanism can be found below. Note: When submitting comments, do not include medical information about yourself or another person.
Project Plan: http://www.idsociety.org/uploadedFiles/IDSA/Guidelines-Patient_Care/PDF_Library/LD%20Project%20Plan%20March%202015(2).pdf
Comment Form: https://www.surveymonkey.com/s/3GFKH8T
Please refer to the Institute of Medicine-Standards for Developing Trustworthy Clinical Practice Guidelines
PDF:
http://www.iom.edu/~/media/Files/Report%20Files/2011/Clinical-Practice-Guidelines-We-Can-Trust/Clinical%20Practice%20Guidelines%202011%20Insert.pdf
HTML:
http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx
Well, if she’s never had Lyme, how can she be considered a patient representative?
Did the Lyme patients expect anything less. So sad, that women SHOULD AND MUST decline!
Beautifully expressed and incisive analysis, as usual Lorraine! Thank you.
How were you able to look this person up (the Token)? Did I miss a link or are you not publishing the name?
We’re not publishing the name. Our complaint isn’t with her. It’s with the IDSA for naming her to this panel.
The IDSA are a group of conniving deceitful tricksters.
Can you release her name so the lyme community can get a hold of her? She might have a change of heart if she is overwhelmed with a massive response.
A massive response to this woman from the Lyme community would be viewed as harassment. The IDSA loves to portray us all that way.
Even if she resigned, the IDSA would replace her with somebody else who doesn’t know Lyme. The problem isn’t with this woman. The problem is the IDSA.
I’ll volunteer! Been living with something from ticks since mom pulled the first ones off my neck when I was less than 4. That was about 53yrs ago.
Your fortitude is monumental.
Fantastic speech!
Thank you Ms Johnson.
This is outrageous! Common sense tells me that the patient rep should certainly be a patient or caregiver of someone who is suffering with Lyme Disease.
It appears this is just another way the system is corrupted by politicians and the medical industry controlling who will and who will not contribute and profit from such guidelines. Very disheartening especially since we’ve come so far.
thanks for rallying for the truth and for patient care/advocacy,education and CHANGE! The status quo is definitely NOT working! I wanted to give my input but did not understand the page and line numbering they requested. The small box given to write did not have numbering system on it so how can you tell if it goes to page 2, or how many lines you have of writing within the box. Boy, they sure want to make it difficult to speak up!
perhaps step by step instructions might help the afflicted that have difficulty following these “rules”, so our input will not be tossed out as inadequate or not structured correctly.
I assume a patient advocate to sit on the chair would need to be a person whom has had Lyme, and assume they will not accept anyone without a certifiable positive Lyme test, both antibody and WB by a ‘reputable’ lab. And also still showing positive after treatment. that is what we need to prove. If the testing can be used FOR a diagnosis, they cant have it both ways and say it cannot be used to prove an ONGOING diagnosis. They can always say that person may have been newly infected each year, but highly doubt they can ignore a person with these Lyme Disease patient “credentials’. I know they ARE out there though! Who out there fits this profile and could ask for this type of person should sit on the board?
I suffer from a chronic form of Lyme disease that may not necessarily be from a tick bite. A PCR blood test showed I had been infected with borrelia burgdorferi. The government has conspired to promote at all costs false information about Lyme disease which includes the following lies:
1. Lyme disease is confined to a very small geographic region.
2. All people who get Lyme disease get a telltale bull’s eye rash.
3. Lyme disease is always easy to cure with only short-term antibiotics.
4. Only a small number of tick species can transmit Lyme disease. You can’t get it any other way.
5. Lyme disease is very rarely the cause of the neurological disorders that doctors diagnose and treat.
6. The tests long recommended by the government rarely miss infections and PCR tests are useless.
Clearly special interests with lots of money including greedy neurologists who don’t want to admit that chronic infections cause many neurological disorders are involved in the conspiracy to cover up the truth.
I don’t think this sly, cunning IDSA ‘s behavior surprises that many of us. Do they really think people are soo stupid? They have power becausE they have money. And they have money because they have power. And that’s why they can DECEIVE the bottom millions. I’m very sorry but I am so bitter by thsese BIG PHARMA’S and OTHER’S regulations that I can’t comment any calmer.
I wrote this in the comment section, but the survey gave NO indication that my comments were successfully submitted. Once I hit the “Submit” button, I was forwarded to IDSA’s website. Feel free to copy and paste or copy and edit, but **please note** I x’d out the representative’s name. And no, I was not nice in my comments:
Page 4, Line 40
Your “Consumer Representative,” xx. xxxxx, doesn’t even have Lyme Disease! Shame on you for even proposing to enact such a facade. Where are the ethics in this proposal? Why are you all not proposing to include an actual Lyme patient on your panel? What in the world can xx. xxxxx possibly have to contribute to your panel? This, as it stands is a total and complete FACADE in order to satisfy the “appearance” of complying with the IOM’s Standards for Developing Trustworthy Clinical Practice.
By not including a Lyme patient on your panel, IDSA is NOT in compliance with the IOM’s standards:
Standard 3.2 of the Institute of Medicine’s “Standards for Developing Trustworthy Clinical Practice Guidelines” clearly states that “patient and public involvement should be facilitated by including (at least at the time of clinical question formulation and draft CPG review) a current or former patient and a patient advocate or patient/consumer organization representative in the GDG.”
Let me reiterate: this Standard clearly states that a current/former patient AND a patient advocate/patient organization representative/consumer organization representative should be included on the panel. It does NOT exclude one party (patient) over advocate/representative – it says to include BOTH parties.
This proposal is a sham and I intend on writing letters to my Representative and Senators.
Attempting to exclude Lyme patients on your panel only delegitimizes IDSA. How in the world can your intentions be construed as credible/honorable when you are not even in compliance with IOM’s Guidelines? When xxxxx knows NOTHING about Lyme, has never had Lyme, and has no background as a patient in Lyme, it is clear IDSA does not have Lyme patient’s best interest in mind.
Recently, my son went to an IDSA doctor. His adrenals are shot (secondary to infection), and he has a virulent form of babesia that still showed positive after treating a year and a half, and Lyme. This doctor spent about 10 minutes ( no neuro exam, and his eyes were off). He said to take him off meds and if he still had symptoms 6 weeks later they would call it fibromyalgia. ??? The truth always comes out and these doctors will have to take responsibility for their part in aiding hundreds more, including children, to be disabled if new research is not considered in their guidelines. Choosing a patient that did not have Lyme makes their guidelines lose credibility prior to revision and shows it is more about saving face than being ethical and doing the right thing.
I would avoid voluntarily using the word “CONTROVERSY” associated with this disease spectrum. It feeds right into their hands. THEY (the IDSA “tricksters”) have MANUFACTURED CONTROVERSY where there has been none — similar to the how the tobacco industry MANUFACTURED controversy when they already knew that smoking causes cancer.
If you look at what Wormser et al is doing with respect to Bartonella (see Am J Medicine, 2014), he is trying to take it into the realm of “don’t test, don’t treat,” except if “objective evidence.” Previously, the standard of care was on the side of the patient.
Whey would Wormser do this? Wormser works for Baxter. Baxter is on the cusp of doing its State III human clinical trial. The fewer variables injected into the trial, and the lower the standard of care is — the better it is for Baxter, and for ANY vaccine manufacturer.
So, Wormser sets the standard of care at what constitutes medical neglect.
It seems people are not sophisticated enough to understand the implications of what Wormser is doing related to the IDSA guidelines, and the fact he works for Baxter. You must connect the dots.
The FEWER variables they must consider for the Lyme vaccine trial (he is arguing they must only consider Borrelia in stating “don’t test,” “don’t treat” for co-infections) the LOWER THE COST IF TO DO A VACCINE TRIAL, and the EASE of coming up with FALSIFIED STATISTICS SHOWING EFFICACY.
It is NOT ENOUGH THAT WE OBJECT. We must stay WHY we object, and point out how the financial conflict of interest held by Wormser et al is played out in the Lyme vaccine industry.
Am I mistaken? Are we in the United States or Russia? Need I say more?
I am one who suffered for a LONG time with Lyme. I still have residual challenges from it. Thanks to a “Lyme Aware” physician, I can at least walk in a “nearly normal” manner. Had it not been for this doctor, my Hopkins plan doctors would have likely made me a cripple for life as the rheumatologist I was sent to for treatment wanted to “scrape the inside of my kneecap” to get the lyme out!
That’s when I limped as fast as I could to find a “Lyme Aware” physician!
What happened to the physicians creed that says… “First do no harm?”
The doctors we’re sent to see by our insurance providers typically follow guidelines set by someone who has NEVER had or experienced Lyme in their bodies. If they had… the rules would be VERY different! Shame on you IDSA.
In this Lyme Disease Guideline Project Plan, a conspicuous absence is any mention of nucleic acid-based laboratory tests.
Now, Ebola, Dengue fever and Lyme disease have been identified by the National Science Foundation as the three infectious diseases with growing economic cost to society
http://www.nsf.gov/discoveries/disc_summ.jsp?cntn_id=133576
When we face Ebola, a highly contagious disease with very high mortality rates, RT-PCR and DNA sequencing of a 346 bp RT-PCR amplicon of a signature segment of the viral RNA is the accepted standard laboratory test to diagnose Ebola patients for early intervention http://www.ncbi.nlm.nih.gov/pubmed/25317743
No medical scientist in his or her right mind would suggest measuring antibody levels or antibody patterns to screen Ebola patients for isolation and for early intervention. It is questionable why the experts in this project plan insist on using antibody tests to diagnose Lyme disease which is really a systemic infection with periodic bacteremia.
Are these different than molecular beacon tests?
(Sorry i am illiterate in pcr testing.)
Molecular beacon tests and PCR are two different processes used in nucleic acid-based tests. Since nucleic acid contains the specific genetic instructions of all living things, determining the order (sequence) of the four nucleotides (bases) in a stretch of DNA molecule is the principle of all nucleic acid-based tests, especially for Lyme bacteria.
PCR is a DNA-copying process, like a copier instructed to make numerous copies of a specific paragraph of a book that has the beginning words and the ending words of the paragraph you are looking for. However, PCR may copy a wrong paragraph because the library may contain many pages sharing the same beginning and ending words of the paragraph that you want. Sanger sequencing will read the entire paragraph and confirm that is what you want.
Molecular beacon tests can detect a short sequence of about 15 nucleotides by hybridization, similar to visually matching two photographs.
In this Lyme Disease Guideline Project Plan, a conspicuous absence is any mention of nucleic acid-based laboratory tests.
Now, Ebola, Dengue fever and Lyme disease have been identified by the National Science Foundation as the three infectious diseases with growing economic cost to society
http://www.nsf.gov/discoveries/disc_summ.jsp?cntn_id=133576
When we face Ebola, a highly contagious disease with very high mortality rates, RT-PCR and DNA sequencing of a 346 bp RT-PCR amplicon of a signature segment of the viral RNA is the accepted standard laboratory test to diagnose Ebola patients for early intervention http://www.ncbi.nlm.nih.gov/pubmed/25317743
No medical scientist in his or her right mind would suggest measuring antibody levels or antibody patterns to screen Ebola patients for isolation and for early intervention. It is questionable why the experts in this project plan insist on using antibody tests to diagnose Lyme disease which is really a systemic infection with periodic bacteremia.
And what about late lyme testing, any suggestions on that?
If we correctly diagnose Lyme infections at the early stage of infection and properly treat the patients timely, we probably eliminate most of the chronic Lyme cases. Once the spirochetes hide in the deep tissues, spirochetemia is periodic and unpredictable as in chronic Lyme disease. We need a lot of research to answer this question. Spirochetes were found in the blood of Lyme patients even when the patients were still on antibiotic treatment and after antibiotic treatment.
Lyme disease diagnosis is major national issue, acute or chronic. It needs a lot of research at the patient level, not animal models. We should have an inclusive panel meeting to discuss “targeting Lyme disease” like the one to take place at the Pasteur Institute for “Targeting Ebola” on May 28-29, 2015 in Paris.
http://www.targeting-ebola.com/programme-220
Thank you for your using your skills to help find solutions.
Pushing for the same from the patient end, looking forward to the sweet spot where the training and knowlege of people like yourself brings answers if we just ask the right questions.