LYMEPOLICYWONK: IDSA Guidelines Revision Process–Cause for alarm?
The Infectious Diseases Society of America recently announced that it will finally be updating its Lyme disease guidelines. They have opened a 30-day window for the public to comment on their guideline development process. I’ve only had a few days to review their proposal, but I am deeply concerned by what I see.
Unless the IDSA’s process has integrity, this will turn out badly for Lyme patients. And the IDSA’s process already appears to lack integrity. Why do I say this? Because, if the right people are not included in the discussion, the right questions won’t be asked. If bias is not checked, it will run amuck and taint the entire process. Those sitting in the room essentially will be in an echo chamber listening to their own viewpoints repeated back to themselves over and over. Consensus will be achieved, not by careful deliberation, but by excluding opposing viewpoints.
Here’s what the Institute of Medicine says about creating trustworthy guidelines:
- They should be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups;
- They should consider important patient subgroups and patient preferences as appropriate;
- They should be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest.
The IDSA guideline panel excludes two key affected groups: patients with chronic Lyme disease and the physicians who treat them. The IOM states that the aim is to ensure that group processes “encourage inclusion of all opinions and grant adequate hearing to all arguments.” How is it possible to achieve this goal when those most affected by the guidelines are not allowed to participate?
Lyme-treating physicians are often targeted for unprofessional conduct actions based on the IDSA guidelines. Under this plan, how can they demonstrate the failure of the guidelines in clinical practice? Who will ensure that all science is considered? Who will question the limitations of the research authored by those in the room?
As discussed in a previous post, the IDSA has selected a patient representative who has no experience with Lyme disease. How will that person, with no knowledge of what Lyme patients’ value, help the panel understand patient preferences? The IOM notes that one of the roles of patients is to “resist recommendations favoring self-interest of a specialty enterprise” and to serve as a counter-measure to imbalance in guidelines. How will an individual who has no understanding of the self-interests at play in Lyme disease effectively counterbalance them? A well-prepared and informed patient advocate can make sure that the right people are included in the discussion and that all scientific evidence is considered. A token patient has neither the knowledge nor the motivation to break through the biased “group think” of experts representing only one side of the debate.
Unfortunately, the panel is filled with the familiar faces of researchers who have built academic careers based on a biased view of Lyme disease. Many of them were investigated for antitrust violations in connection with the previous IDSA Lyme guidelines. How could they possibly create a process free of distortions, biases and conflicts of interest? While additional researchers have been added to the mix, we do not see those who might hold more moderate or forward thinking views on the panel. The IDSA seems to be setting its sights on “consensus by exclusion.” Everybody who might disagree with them has been prohibited from taking part.
LymeDisease.org will be submitting comments on the proposed guidelines process on behalf of patients. We will also continue to share our thoughts with you as they evolve.
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 firstname.lastname@example.org. On Twitter, follow her @lymepolicywonk
- March 18, 2015 at 12:26 pm
Are you kidding me?
- March 18, 2015 at 1:12 pm
This is very disheartening to read. As a Chronic Lyme patient it seems for every step in the right direction, we get knocked back two. Thank you for being an advocate for all of us.
- March 18, 2015 at 2:21 pm
After being misdiagnosed for almost 4 years, my Lyme doctor saved my life. Why aren’t the previous 15 doctors that misdiagnosed me & fed me anti-depressants & steroids being held accountable?
- March 18, 2015 at 8:16 pm
Yes they SHOULD be held accountable–especially if they were arrogant and nasty. I had a doctor who was extremely hostile and did no testing at all and just “decided” I was delusional (based on nothing). Her own lack of knowledge.
- March 19, 2015 at 7:10 am
- March 18, 2015 at 3:23 pm
The day Will come when these lyme members of the IDSA panel will have to face their maker
or will actually be brought up on charges of criminal negligence, abuse of the citizenry,
or simply the truth will betray them for the fools that they are, for the blatant and aggressive ignorance they have displayed for decades…Perhaps then, and only then, will they feel the appropriate shame, if they are even capable of that…Perhaps the members of the IDSA are simply sociopaths, incapable of remorse, therefore incapable of the shame they should suffer at some point in the future when the truth will be on full display for all to see. History will be the judge of their deeds. Shame on them…They are a disgrace to the human race, to the medical profession. Physician, do no harm…yet they are doing massive harm to millions. God help their souls.
- March 19, 2015 at 7:48 pm
Mary, you are so right! This is the most corrupt group of supposed “medical practitioners” I’ve ever seen in action. Because of their flawed guidelines, I was mis-diagnosed for seven years, nearly died from complications from Lyme and tick-borne co-infections. That included nearly attempting suicide because of the physical and mental pain.
I went on to nearly die of infections three more times after 2006, probably due to Lyme-induced immune suppression.
After nearly nine years on antibiotics, and trying to overcome having my gut function just TRASHED from the treatment, I’m finally 98% well, after 10 years.
I can hardly believe I’ve gotten my life back. The work Lorraine Johnson did on my behalf, on behalf of all of us with chronic Lyme probably saved my life.
It certainly saved my finances (nearly declared bankruptcy), and probably saved my marriage.
God bless Lorraine and everyone at LymeDisease.org!
The IDSA Lyme disease panel may just be the most corrupt group of “physicians” on the planet. Hey guys, what about the Hippocratic Oath you took, the one you swore to uphold? Hmmn?
- March 19, 2015 at 7:51 pm
I once contacted the head of Media Relations for the IDSA to complain about the flawed IDSA guidelines.
You would not believe the line of B.S. I was told to justify their actions. Such as there’s no proof chronic Lyme disease exists, etc., etc. ad nauseum.
- March 18, 2015 at 3:37 pm
Now would be the time to enlist the help of any public official who may be in alliance with our cause. Perhaps a list from Congress to apply pressure or any journalistic allies from the main stream press. My Congressman is Dr. Ami Bera who as a physician may be sympathetic. Maybe pick a few and lobby with letters or petitions.
- March 18, 2015 at 3:50 pm
I had a sudden onset of colitis which became ulcerative causing me to be unable to eat anything except chicken broth and water. Over a period of weeks I lost 38 pounds and became so weak that I could barely stand. Then my entire body became wracked with pain and I experienced a 104 fever. My GP just gave me a prescription for diarreah and sent me home in this condition. Soon after I became unable to climb the stairs to my bedroom so I slept on the sofa. I could barely lift the blanket to cover myself. I received a referral to a rheumatologist and I was diagnosed with tendonitis, bursitis and psoriatic arthritis. None of these physicians ever thought to test me for Lyme’s even though I live in an area of Pennsylvania which has an extremely high prevalence. I received Remicade (an immune suppressant !) by infusion every six weeks at the hospital which helped tamper down the inflammatory response. It was not until a little over 2 years later when I developed carpel tunnel in my wrist, a frozen shoulder and my left knee ballooned to twice it’s normal size that I determined that I must have Lyme’s disease. I requested that my new GP have me tested and she agreed. The blood work came back off the chart for Lyme titters and it was apparent that I had been exposed years prior. I had no bite or bull’s eye rash to speak of so I did not know I had been bitten. My health has been severely affected by this devastating disease and I am legally disabled and unable to work. This, in turn, has severely and negatively impacted me financially as well as my quality of life. What we need in this country is a comprehensive diagnostic and treatment plan based upon the actual experiences of the Lyme’s patients and their care-givers…not someone with no experience with this devastating and debilitating disease!
- March 18, 2015 at 6:01 pm
thank you for putting on paper my fears.
- March 18, 2015 at 7:40 pm
Is there anything we can do about this?
- March 18, 2015 at 8:46 pm
“Unless the IDSA’s process has integrity, this will turn out badly for Lyme patients. And the IDSA’s process already appears to lack integrity… The IDSA guideline panel excludes two key affected groups: patients with chronic Lyme disease and the physicians who treat them.”
Oy vey. Don’t say I didn’t tell ya so.
Does anybody recall Senator Barry Goldwater’s infamous quip: The government does not belong in the bedroom”?
Neither does it belong in the medicine cabinet, nor does it belong in the refrigerator.
When the Twinkie Police approach your doorstep, activate the secret trap door prior their crossing the threshold.
- March 18, 2015 at 11:14 pm
I would emphasize that it is not just that IDSA is adding new people known to have a particular bias, they appear to be planning to CRUSH US. They have taken the unprecedented move of adding numerous medical and scientific societies to the mix — so they can claim that all of these physicians and scientists represented by these GROUPS AGREE WITH THEM, when the physicians and scientists in these groups, as we all know, don’t know squat.
The recent publication by Wormser & Lantos on co-infections that appear to be written as though they are GUIDELINES (published Nov 2014, Am J Medicine), also would seem to provide a basis to go after Lyme docs for over treating and over diagnosing co-infections. The Doctor Protection statutes are written narrowly — to protect doctors with regards to treating LYME DISEASE, they are not written to protect them regarding “experts” (individuals with financial interests in this disease), to go after them with respect to CO-INFECTIONS.
We know the other side has always run a very well coordinated campaign of disinformation against physicians and doctors. I would guess that the guidelines have virtually already been written, and that the 30-day comment period is window-dressing to try to make the process appear “fair.”
People involved in the vaccine industry would be predicted to leave nothing to chance. Baxter sold off its entire vaccine section to Pfizer, with the exception of its Lyme disease vaccine work.
It appears that Wormser et al/Baxter sit at the table and write guidelines starting with Food & Drug Law/IRB regulations (i.e., backwards). They reverse engineer the guidelines starting with Food & Drug law, writing them in legalese to protect the vaccine company(s) and their dishonest doctors. They then have to, with sleight of hand, make it seem as though this manipulation comes as part of an honest appraisal of the medical literature.
I would encourage leaders of patient organizations to focus on expressing WRITTEN OBJECTION to the leaders and board members of ALL the listed medical and scientific organizations, and the REPRESENTATIVES of those organizations — NOT JUST IDSA. We already know that IDSA is corrupt, and will do nothing expect continue to harm us. IDSA is DEAF to our concerns, but we do not know that is necessarily true of the other organizations.
- March 19, 2015 at 5:00 am
Guidelines should be made to project the best possible out come of the patient. Without the input of actual Lyme patients how can that goal be achieved. The quality of life for Lyme patients depends on more research and better guidelines.
- March 19, 2015 at 7:25 am
An appt. I had for this morning was just canceled by a noted head of Infectious Disease Dr. at a very large Chicago hospital, because, “We don’t have any Lyme patients because Illinois doesn’t have much Lyme, so you’d be best to look for a specialist”. I am not making this up. Disgraceful.
- March 19, 2015 at 7:46 am
Why would any of us be surprised at this disheartening news?!? History is written by the victors, medicine is decided by those paid to do so. And here we sit with little to no power (or so we believe) in our own lives because “they” get to tell us what will and will not be done in our bodies, our grocery stores, our schools, our businesses. I for one am not at all surprised at this news. If one wants to get well, one must do so on their own without coming to depend on “their” permission. I have had Lyme for over 30 years. I have and am taking matters into my own hands. And I am much improved from even a year ago never mind 10 years ago. I have much hope in my own ability to find means and to help and be helped by others who have trudged this path. “Chin up” as my dear father used to say.
- March 19, 2015 at 9:01 am
It’s already difficult enough to have a conversation with Dr.’s and people regarding the severity of this. The reality needs to be accepted and properly treated. For me, Doxycycline has been the most helpful and they have increased the price. I have a suspicion they are just waiting for the pharmaceutical companies to make their new drug to capitalize and market Lyme Disease.
- March 19, 2015 at 9:32 am
I am writing this letter today in concern for the new rules that the IDSA is suppose to adhere to but has found it passable to only use a token representative to speak for the lyme community. This is and has been a problem with IDSA as we see it. They have chosen not to listen to the sufferers that know about Lyme and nominated a token representative that has no knowledgeable of Lyme or Tick Borne diseases as I have read. This is why we are where we are today by following the words and beliefs of one scientist or eliminating the many lyme sufferers from the discussion that often know more about the needs of the disease than researchers, medical professionals. Research we need but it takes time and we as a country can not afford to sit by and wait while our citizens continue to get sick. Lyme disease is a debilitater, not a killer. If we can get more help in getting people back to work. It will take many off the roles of Medicaid, government subsides. Please look into this.
- March 19, 2015 at 2:33 pm
This panel is very scary… I don’t understand why there isn’t going to be anyone who has Chronic Lyme Disease or the doctor’s who know what to say and what’s going on!! How is this supposed to help people living with Lyme Disease?? Seems to me that we are not important and they want to do is so called “Sweep this under the rug”!! There are so many many people living with this Disease its just not fair to us!!
- March 20, 2015 at 6:10 am
Yes, just as is happening to the autism scandal with cdc whistleblower william thompson saying they fudged the data to show no connection between autim and vaccines. Even after hannah poling. Robert kennedy jr called the cdc a “cesspool of corruption.”
Is idsa following suit with lyme? The vicky logan case should have been the wakeup call but instead…..
- March 20, 2015 at 7:52 am
I don’t want to be mean, but until a few members of that panel and so called experts of that panel, get Lyme themselves, things won’t go in favor of those who do. If even one of them got Lyme watch how fast things would change for the better….
- March 20, 2015 at 5:07 pm
The whole lyme issue is a travesty. The IDSA has ignored the most recent science and once again is sweeping everything under the rug. They refuse to admit lyme can be chronic. I can’t understand why the IDSA can’t believe that lyme can be chronic. It is caused by a spirochete bacteria, much like the one which causes syphilis. Everyone knows that syphilis can be chronic. Lyme disease is caused by an even more complex organism. If one spirochete can cause a chronic illness then why can’t another organism from the same family. The lyme test they promote may miss as many as 40% of culture positive lyme cases according to the LYME DISEASE IN CALIFORNIA pamphlet. I contracted lyme disease in 2001 after a trip to Mexico. I am a Clinical Lab Scientist and researched my symptoms on line. After reading an article written by a physician, who had lyme himself, I thought I might have lyme disease. I asked my doctor if she would run the test. My doctor refused and told me there is no lyme in Calfornia. Finally the wonderful doctor who did my spinal tap, ordered the test. I was one of the lucky ones because my test came up positive. Still I only had 3 of the 5 bands on the Western Blot so I was never CDC positive. I have suffered for over 10 years with horrible pain, paresthesias, hurting joints, brain fog, ringing in the ears and complete and utter fatigue. I lost my job because I was too ill to work. I have been on antibiotics for over 10 years and am finally well enough to have a life again. I know many other lyme patients aren’t so lucky. Since doctors (including my own dermatologist son), go by the IDSA Guidelines many people aren’t getting the treatment they need to get well. My son only treats patients who have a classic rash and only treats them for a maximum of two weeks. Those of us who have had lyme for years know that two weeks isn’t long enough. But doctors go by these guidelines. It took me 10 years to finally regain my life but I am almost totally symptom-free. We have spent thousands of dollars for hyperbaric oxygen treatments. It was after a month of twice daily hyperbaric oxygen that I first began to actually get well. I have friends, who became sick with lyme at the same time I did but they couldn’t afford the treatments. Sadly none of them are well now. The IDSA needs to pay attention to current science and allow a patient who actually has chronic lyme on the board to represent all of us who have this horrible and much misunderstood illness. So many patients are suffering needlessly because the IDSA has failed us.
- March 22, 2015 at 11:16 am
Guidelines are determined by the authors and therefore are subjective. Attention needs to be more directed to patient’s health, well-being and safety as opposed to so much of the treatment’s efficacy. Conflicts of interest of the members developing guidelines must be addressed, not ignored. Balance and harmony is the key in panel members and lead authors. Guidelines can be very self-limiting and detrimental to patient’s and other practitioners when so restrictive. Scientific evidence is vitally important but a physician must depend on his clinical judgment, and not treat the test or lack there of in regard to findings.
There are 2 schools of thought on the diagnosis and treatment of Lyme disease, both by reputable, legitimate medical societies. ( IDSA and ILADS) As science evolves, new ideas always begin as minority views, and old dogma died hard! Patient’s are not being informed of these two views in order to make informed choices for their plan of care. It is long overdue to build a connecting bridge between these 2 organizations to make the wrongs a right. There was a beginning, there is evidence, and there must be an end to the long-suffering of millions of children, youth and adults who are chronically ill from the ravages of Lyme and other vector borne diseases. Thoughts to ponder in re-mediating this health care disaster: to be conciliatory instead of disputatious; to help instead of harm; to accelerate truth instead of retard; to cooperate instead of impede; to collaborate instead of obstruct; to disclose instead of withhold; to be proactive instead of retroactive; to be candid instead of secret; to be an advocate instead of an enemy. Lyme patient’s deserve love and light, peace and relief, hope and healing, health and wholeness. We are not the problem but we will be part of the solution. Throughout life, we are students and teachers. May we be humble enough to learn from one another for the benefit of humanity.
- March 22, 2015 at 9:12 pm
I have submitted my comment on time. I would like to post my comment for the record in case this panel decides to throw my comment into the rubbish can. Here is my comment submitted:
“In this Lyme Disease Guideline Project Plan, a conspicuous absence is any mention of nucleic acid-based laboratory tests for molecular diagnosis of early Lyme borrelioses although PCR was considered relevant when babesiosis was a differential diagnosis (page 13, line 220). Is this omission of PCR for Lyme disease intentional? If not, please add PCR/sequencing to the project plan. We are in an era of molecular personalized medicine in the year of 2015, almost 40 years after Lyme arthritis was first described.
According to Part 13 in a series on the NSF-NIH-USDA Ecology and Evolution of Infectious Disease (EEID) Program published recently, Ebola, Dengue fever and Lyme disease have been identified as the three infectious diseases with growing economic cost to society .
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 . 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 a bacterial infectious disease, an obvious deviation from the standard practice of clinical microbiology in dealing with Lyme disease which is really a systemic infection with periodic bacteremia. Do the IDSA members advocate using Widal test, instead of blood culture, to diagnose typhoid and paratyphoid fevers now? I don’t think do. Therefore, to put it bluntly this Lyme Disease Guideline Project Plan is nothing but a sham designed to maintain the status quo of a dysfunctional system.
 National Science Foundation (Discovery) Ebola, Dengue fever, Lyme disease: The growing economic cost of infectious diseases. http://www.nsf.gov/discoveries/disc_summ.jsp?cntn_id=133576
 Maganga GD, Kapetshi J, Berthet N, Kebela Ilunga B, Kabange F, Mbala Kingebeni P, Mondonge V, Muyembe JJ, Bertherat E, Briand S, Cabore J, Epelboin A, Formenty P, Kobinger G, González-Angulo L, Labouba I, Manuguerra JC, Okwo-Bele JM, Dye C, Leroy EM. Ebola virus disease in the Democratic Republic of Congo. N Engl J Med. 2014;371:2083-91.”
- March 25, 2015 at 5:58 am
People and politics do not vibe well together. I think of what the HIV community went through. Or how people could not talk about cancer. Even how gay or interracial marriage was wrong. People are so hard headed and not quick to lend a hand or test their own beliefs with a few simple google searches.
- March 27, 2015 at 1:03 pm
I’m at the point where I think someone should send them about a million-or-so youngun’s to their meeting and let them loose. Then, like the rest of us, go undiagnosed, misdiagnosed, called insane, crazy, delusional, a drug-addict looking for pain meds, for about 4-7 years which is OUR average before we get diagnosed or treated. THEN let them back into the room to decide how they would like to “revise the lyme guidelines.” Hmmm, think they would change their tune then? I NEVER wished this on anyone but now? Yep, they can get it and they can also bring home a dozen or so of the buggers so they can watch their children and grandchildren suffer and scream in pain….let’s see how fast things would get done then. I’m so sick of this cra* and so sick of BEING sick I don’t care who I insult anymore. All of them should rot as far as I’m concerned! Gee…think my snarkiness has anything to do with the amount of PAIN I’m in pain AGAIN today???? Arghhhhh.
- March 30, 2015 at 5:46 am
7 years. yup. smh
- March 28, 2015 at 2:37 am
I have been sick from this disease since the late 80’s. Many doctor visits, job loss, financial ruin, all in my head, sent to home for the mentally disabled for 6 wks., put on disability, two total hip replacements, re-infected in 2010, 7 knee drains, 2 elbow drains, 2 picc lines installed and removed after 30 days each, (doctor following IDSA guidelines) hence 30 days each, and 3 yrs. of oral treatment (doxycycline and naturals). Presently, still fluid retention in right knee with pain in other joints and neck and lower back pain w/neuro symptoms also. My hope is that one day “NOBODY” will have to write the paragraph that I have just written. We need help and we need it now!
- April 7, 2015 at 4:15 pm
Time to stop sweeping this debilitating disease under the rug. Train doctors to treat Lyme disease. And people, rise up, and protest, start marches, and write every legislator and politician in this country. Only when we act, will Lyme disease get the attention it desperately needs.
- April 9, 2015 at 7:14 am
I have always said I wouldn’t wish this on my worst enemy, but I think the time has come that those that are preventing innocent people from getting proper treatment should live this life. That is if you can call it a life. It sickens me what people will do for the love of money. Not just to us , but innocent children that have a life to look forward to without pain, fatigue, cognitive issues, and more.
The government is not without guilt. Nor are the societies that look after diseases of unknown origin. MS is a billion dollar disease with money going back into the pot to raise more awareness. The Stop MS NOW and Flee or fight campaign is a joke, but hey, it generates $$$$. After all that’s what makes the world go around. Until people stop listening to their dogma on the theories of why MS occurs and buy into their therapies will things change. Because after all they are just THEORYS, and many drugs are now being proven not to work. I use MS as an example because I was misdiagnosed with it in 1995, but sick before that. Many can tell the same story so I won’t bore people with details. Bottom line things have to change and if it takes getting bitten so be it. Unfortunately things are slow here in Canada.
- April 7, 2016 at 8:17 am
After 18 months after being bitten, I finally had a great rheumo who agreed at my pleading to prescribe a western blot test. By this point I had already been shadily diagnosed with UNCURABLE syndromes that were based on symptoms with NO known cause or acceptable, workable, treatment. Yeah right…..I knew it was LYME at the root. We always go back home to visit CT every June when ticks are prevalent, but we live in FL so that’s not a common thought for dr’s to test here. My western blot came out CDC positive. Rheumo was only going to put me on 3 weeks of antibiotics, I insisted on 6 weeks. Thankfully, symptoms subsided about 3 weeks into treatment and I felt amazing 95% back to normal……fast forward to 2 months post treatment and my symptoms came back! I need more antibiotics and for a longer duration. The govt. needs to stop lying to people, they have proven that this spirochete is not as easy to get rid of after being in the body for over 1 year. I will be following a natural protocol of anti-microbials, anti-virals, anti-fungals in hopes I will rid myself of this nasty bacteria once and for all. BUT MEDICAL dr’s are NOT helping because of the lame CDC guidelines and insurance WONT pay for any further treatment.
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