A summary of the IDSA Lyme evidence hearing
On July 30, 2009, a newly formed panel from the Infectious Diseases Society of America (IDSA) heard 8 hours of testimony from 18 presenters representing various viewpoints on Lyme disease diagnosis and treatment. This was the first time the two sides of the Lyme controversy have been given equal time in front of a conflict-free evidence-review panel. And it’s the first time that a medical guidelines hearing has been broadcast over the Internet for all the stakeholders to hear, from patients to researchers to treating physicians.
Over the past decade, two opposing camps have emerged in the battle over this tick-borne illness. One camp is represented by the group of 14 academic researchers who wrote the 2006 IDSA Lyme guidelines. They maintain that Lyme disease is ‘hard to catch and easy to cure’ because the infection is rare, easily diagnosed and cured with two to four weeks of antibiotics. This group claims that chronic infection by the Lyme spirochetal bacterium, Borrelia burgdorferi, is rare or nonexistent.
The opposing camp is represented by the International Lyme and Associated Diseases Society (ILADS), led by a group of community-based physicians. Its members argue that Lyme disease is not rare and tick bites often go unnoticed, especially since commercial laboratory testing for Lyme disease is inaccurate. Consequently, the disease is often not recognized and may persist in a large number of patients, requiring prolonged antibiotic therapy to eradicate persistent infection with the evasive Lyme spirochete.
This hearing came about as the result of an antitrust settlement initiated by Connecticut Attorney General, Richard Blumenthal in 2007. During his investigation, the Attorney General found substantial conflicts of interest among the 2006 panel members, who held commercial interests in diagnostic tests, vaccines, and insurance. In addition, he found that this panel had suppressed scientific evidence and had excluded opposing views from the panel.
After watching the entire hearing, my overall impression was that the community-based ILADS physicians gained significant ground in the evidence-based debate with the 2006 IDSA guidelines authors. The most compelling takeaway messages were:
1. THE GUIDELINES ARE TOO RIGID GIVEN THE STATE OF THE SCIENCE.
The science on diagnosing and treating Lyme disease is still uncertain, and we need guidelines that allow physicians freedom to treat until this disease is better understood. Based on a national patient survey conducted by Lorraine Johnson of CALDA, it was found that 58% of Lyme patients remained ill after the IDSA’s recommended treatment and 60% improved with longer courses of antibiotics. Even though the IDSA Lyme guidelines are supposed to be voluntary, they are widely used by insurance companies to restrict physicians’ ability to exercise clinical judgment, depriving seriously ill patients of the only available treatment option (long-term antibiotics) that can get them back to leading normal lives.
2. LONG TERM ANTIBIOTICS HELP SOME PATIENTS.
A meticulous dissection of the 4 peer-reviewed studies used by the IDSA to deny longer courses of antibiotics showed that 2 of those studies had serious design flaws and the other 2 actually showed that patients improved after 6 weeks of IV antibiotics. Given that these 4 studies were based on a total of only 207 patients and a single antibiotic, it was clear that much more treatment research is needed. The other revision that most of the expert panelists seemed to back is Dr. Volkman’s strongly held belief that the “two pill Lyme cure” recommended in the IDSA guidelines fails 80% of the time, and it should be removed from the guidelines. (Volkman Ph.D., M.D., is an Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook.)
3. CHRONIC LYME IS CAUSED BY PERSISTENT INFECTION.
Benjamin Luft, MD, from SUNY Stony Brook presented compelling evidence showing that the Lyme bacteria can persist in the body beyond the IDSA-recommended 2 to 4 weeks of antibiotics. He cited the Barthold (UC Davis) mouse study and other studies that demonstrated the multiple strategies that the organism uses to escape detection by the immune system. Overall, the weigh of evidence for the existence of chronic Lyme far outweighed the IDSA “expert opinion” that the symptoms that linger beyond treatment are due to a “medically unexplained symptom” (MUS), labeled as “Post-Lyme Syndrome” by the IDSA authors.
4. MORE ACCURATE TESTS ARE NEEDED.
Dr. Ray Stricker, as well as a number of other presenters, showed that the two-tier surveillance Lyme test system endorsed by the IDSA, though highly specific, lacks the sensitivity required for an accurate diagnostic test, missing 88 out of every 200 Lyme patients. This results in thousands of Lyme patients being misdiagnosed and undercounted. (The CDC admits that U.S. Lyme cases are being underreported by 6- to 12-fold each year.) The CDC spokesperson, Barbara Johnson, Ph.D., however, stood by these tests, even though the expert panel seemed shocked that the CDC’s endorsement was based on a decade-old study that looked at a mere 26 patients.
During the hearing, the 9 expert reviewers listened intently and asked many astute questions. This panel will now spend a few months assessing all information submitted before and during the hearing to determine whether the existing guidelines should be maintained, modified or entirely rewritten. The panel expects to complete its review by the end of the year.
Although I’m optimistic that anyone listening to all eight hours of testimony will see the urgent need to rewrite the guidelines in a major way, I worry that the officers and lawyers running this commercially-driven medical society may water down the conclusions to protect the society from lawsuits. All of the panel’s conclusions could be reversed if the IDSA officers assign a biased team of writers to execute the recommendations.
Three days after the hearing, my worst fears were realized when the IDSA President, Anne Gerson, M.D., said this, as if the hearing never happened:
“The physicians and scientists who wrote the Infectious Disease Society of America’s (ISDA) guidelines thoroughly reviewed all the medical evidence and took great care to address the claims made by the small minority of physicians who advocate long-term antibiotic use.”
“The notion that the authors had financial conflicts of interest is absurd to anyone who has read the guidelines, which recommend generic tests and a short course of generic drugs.”
As the researcher for UNDER OUR SKIN who spent years uncovering the invisible conflicts of the 2006 IDSA guidelines authors, my conclusion is that the battle over these guidelines is not over conflicts surrounding the cure – a prompt course of off-patent antibiotics. (A curative dose of doxycycline or amoxicillin can be purchased at Walmart for $4.)
This conflict is all about a small group of academic researchers controlling every aspect of a disease for profit. They ignored or creatively interpreted new scientific data to protect their lucrative revenue streams from vaccine trials, arthritis/lupus/fibromyalgia clinical trials and government grants.
My impressions of the hearing and hopes for a happy ending were summed up nicely by Lorraine Johnson, the champion of the Lyme patients who organized much of the ILADS evidence:
“This hearing shows that the weight of the science falls on the side of providing patients with treatment options. The speakers supporting the 2006 guidelines relied heavily on conjecture, belief and reputation, advancing an unsubstantiated somatic disorder hypothesis for possible explanations of why patients remain ill. Hypothesis, conjecture and beliefs are not science and hopefully this panel will recognize that and gut these guidelines.”
And here is my favorite quote of the day, which came from Dr. Ken Liegner, a Lyme-literate physician from Armonk, New York:
“This is a formidable pathogen. We should be humble before this disease.”
Finally, on a possibly hopeful note, the IDSA just requested from Open Eye Pictures nine copies of UNDER OUR SKIN which will be given to each of the panelists. In addition, we offered to screen the film and speak with it at the October IDSA conference in Philadelphia. Though we’re skeptical this will happen, we’re happy and humbled that the film is proving its potential to affect policy and people’s lives.
You can view video footage of the hearing and download hearing presentations by clicking here.
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You write: “my conclusion is that the battle over these guidelines is not over conflicts surrounding the cure”
Certainly! The fact that the IDSA panelists are NOT conflicted regarding treatment is loudly touted by the IDSA to disguise the major source of their conflict: Lyme vaccines.
A viable Lyme vaccine would be a multi-billion-dollar payoff for one or more big pharm corporations. IDSA panel-chairman Wormser, and most of the panelists, have made good money off vaccine-makers. So have IDSA apologists and Lyme-treatment naysayers like Hopkin’s Auwaerter, who also receives vaccine-pharm money.
The mystery to me was always this: why are there TWO schools regarding Lyme, when there are at least SIX different points of controversy? The eye-opener for me came when I drilled down into the science: the IDSA position on EACH of those points happens to coincide with the case whereby a Lyme vaccine is going to be feasible.
By contrast, the ILADS positions map to the microbiology of Lyme, and the evidence.
Thus, only two schools. One follows the big money, the vaccine money. The other follows the evidence.
TY so much for this very encouraging update!
Congratulations to you, Andy and your team, Kris.
This is a pivotal invitation and would have been unimaginable at one time. The walls are coming down a row at a time, so that truths can be presented and speak for themselves.
I am touched b/c once again, the work of Open Eye is being used to reach even farther across the barriers.
I pray that the panel members would truly be open to the truths that are presented through your work and the lives of those who were willing to tell their story in representation for all of those who have and continue to suffer deeply and unnecessarily.
I pray that the IDSA accepts your gracious invitation to make this documentary available to all of the physicians in attendance at the Philly conference. They need to be equipped with all of the information available to them in order to discern the truth for themselves.
If they accept ur invite and u feel it might be beneficial for a PA family (or several)to be available as ‘live’ stories, let me know!
Bear, Heth and I send our very best to each of u!
Blessings!
Thank you also, Andy, Kris, Kathy, Eve and everyone at Open Eye Pictures for all that you are doing with Under Our Skin. I do believe God is using this film to move mountains and we are praying for the IDSA panelists to see the truths revealed in the movie as well as all the compelling evidence presented at the hearing for chronic lyme.
THANK YOU!!!
Lauren
Excellent post. Hopefully, Andy, Kris, & co. can acquire footage of the hearings. IDSA is temporarily housing them in public archives. However, I have concerns that this will not be permanently access to the public. The footage, for instance, might be removed (for legal reasons) once the IDSA finalizes its Lyme vaccine plans.
Thank you Kris.
Even when sometimes your great and long time efforts and research to uncover the truth about lyme disease, seems to be dismissed by the dark interests of some not very good people; the outcomes and rewards cane be seeing in the great amount of people and doctors that are becoming aware of the real LYME, thanks to The film, and the work of organizatiosn as ILADS, and many others.
well done..
I know what’s needed for IDSA to take Lyme seriously: one of their own family members – especially anyone under 18 – will have to fall ill with Lyme and any number of coinfections. And then not get better on their recommended short course of antibiotics. Or better yet, some Senator’s, Governor’s, or Congressman/woman’s child/children. Ever notice how a serious disease isn’t taken seriously until someone famous or of public note gets it?
Kudos once again to Open Eye (along with AG Blumenthal) for helping, in such a short time, to create so much long-overdue momentum.
Just my $0.02, but folks should be careful not to oversimplify here. In addition to the pharmaceutical interests working against us, do not take your eye off insurers either. It is likely no accident that the minimalistic model of Lyme advanced by IDSA is the best ECONOMIC model that insurers could possibly hope for at this time, maximizing denials of coverage. And Blumenthal’s findings remind us that some panel members consult for insurers.
There are other potentially unfriendly forces lurking as well. Never forget we are battling on several fronts!
Good luck and good health all…
I am pleased that the other scientific view was allowed to be voiced at last! I have had what I thought was CFIDS for 25 years…two years ago i tested positive for elisa, western blot, and igg. this past year , i tested positive for rocky mountain spotted fever and erlichia. My doctor dropped me after the ID DOC said i did not have lyme, and later with the rocky mtn fever, his colleague would not acknowledge it either. I have been lucky enough to find a nurse practioner who had lyme herself and treats it. Slowly, i can see some improvement. However, none of this is covered, as the hmo docs won’t acknowledge it… my husband is angry about all the money he is spending, and so am I. Thanks to all who witnessed at this forum!!
sincerely yours,
jane merrifield-beecher
Thanks for the information and the summaries. Very helpful. Keep the villains’ feet to the fire. I appreciate your efforts.
Thank you so much for all the amazing work you have done that is profoundly impacting every aspect of this disease and debate. How encouraging to hear that the IDSA has requested copies of the film. Wow.
A dear friend of mine who is very sick with this disease was on the phone several times this past week with Blue Shield of California. They denied her physicians order for antibiotics. When push came to shove, the representative clearly explained that their denial was based completely on the IDSA’s guidelines. Too bad that conversation wasn’t recorded and played at the hearing. These authors know full well that their guidelines dictate to insurance companies what will be covered or not. Yes, the insurance companies are major players.
Anyway, thanks again for the dedication you and the team at Open Eye have shown to the general public in this incredible effort to educate.
I was one that needed long term antibiotics IV. I am not cured but at least I can think and walk. thank you all you wonderful people trying to get medical help to all of those sick and infected. I know this is transmitted outside of tick transmission. I had blood and bodyfluid exposre while doing home care over about a month with a very ill patient that later died.
It is sexually transmitted and I believe transmitted through mucous membranes. Eyes nose sexual transmission etc.
Thanks. You need to do another documentary.
I would love it.
After watching “Under Our Skin” for the forth or fifth time (I pushed for a screening in my town, where it was held over for three weeks because of so much interest) it finally dawned on me to ask the obvious question: Is there a similar controversy over Lyme in Europe? Is treatment easy to obtain there? Is research being conducted? What is happening in other parts of the world affected by Lyme? Hopefully they are not looking to the US for direction!
Europe mostly follows the IDSA dogma on Lyme, from what we’ve observed. The exception seems to be Germany and Norway. For more reading, look up Straubinger in Germany on persistence and Brorson in Norway.
After being on IV antibiotics for 11 months followed by orals for another 4 1/2 months I had the stupid need of seeing a neurologists. Why I say stupid is he nearly went into a “Lyme Rage” because I was still taking antibiotics and stated the neurologists go along with the IDSA guidelines and he could only treat me if I quit taking the antibiotics. Well my problem is I’ve already burned thru the other 6 or 8 neurologists in my area do to misdianoses. When they found out I had tested ppositive for Lyme, there theory of me being a “Whack job” was disproven. None of them want to see me again because of Lyme.
Then I went to a Rheumatologist/immunologists, told her I had tested positive for Lyme 1 1/2 years ago. But I came to see her for my hand deformities I had developed. She referred me right on out of her office. She couldn’t do it fast enough.
It seems to me Lyme Disease has so much controversy, there really aren’t many or even a few Docs that want to touch me. They are really nice until they read my pt. info. and ask me a few questions. Then it’s “the hustle” I really think the Isda has bullied us right out of healthcare. What about there hippocratic oath?
I was a RN and now I’m embarassed even to claim that, and I loved being a nurse and making a difference.
Thanks for the 2 groups for trying or should I say ILADS for trying. I really think it was a feible attempt given by IDSA. I know we Lyme suffers are the sacrificial Lambs.
Hey if money gets there attention, lets do a class action lawsuit and get Gloria Allred on our side. Boy I think she could get those “Good ole Boys” to change there minds if the suffers were the ones to profit from the vaccine since we are being used as there poster cildren now!
Thanks Gayle with Lyme in Iowa
In response to Gayle’s comment. All I have thought about for the last four years is class action lawsuit. would that look good on the pervious panel and Drs. who violate the hippocratic oath. I’m wait’n for the day…I will be present.In my dreams I’m putting the handcuffs on.
Two things- first, thank you SO much for this film. My husband went with me to understand better what I’ve gone through for 16 years now- boy, did his eyes open. Second, class action lawsuit??? Heck yeah! I picked up my medical records today and buried deep was the memo from 15 years ago and the local lyme “expert” saying that I definitley didn’t have it- (completely disregarding 3 previous positive tests!) and in writing says it was all in my head but… maybe we should keep an eye on her in case they missed something. Talk about CYA. Again, thank you for the film. I continue with my Biaxin and Plaquenil and hope insurance will continue to pay for the next 5 months worth.
It’s way past time for a class action lawsuit against IDSA and all the providers who have denied adequate treatment to anyone with Lyme’s disease!!
First of all, why do we continue to try to convince IDSA they’re wrong? They know they’re wrong already, they just refuse to give up their huge meal tickets.
As part of the new Health Care Reform Plan, the goal should be to get rid of the current members of the IDSA panel and replace them with true scientists and medical professionals who are not BOUGHT by the insurance and pharma companies. Better yet, Get rid of IDSA all together. Convince congress to adopt a new panel to set new guidelines that actually help people. Have new Lyme treatment guidelines written into the new health care rules. Insuance companies should not be dictating what doctors can prescribe, PERIOD! The introduction of HMOs in the 60’s and 70’s was supposed to REDUCE health care costs by promoting preventative medicine for everyone, but obviously health care costs have done nothing but skyrocket since then while coverage has gone down. More people than ever are paying for their own anitbiotics and other treatments that HMOs refuse to cover.
It’s NOT RIGHT. It’s time for a paradigm shift in Lyme disease treatment and health care coverage in the US! Let’s get it done!
Thank you for for making this film, as it is continuing to create waves in the IDSA. It’s amazing how this epidemic is still being denied by ANY federal health agency, that mainstream MD’s can’t treat us, and after mid-diagnosis for the last 8 years, i want this to come out of the closet so to speak…like HIV. This movie is the expose on Lyme Disease just as “And the Band Played On” was for awareness on HIV. I thank you again. I also have documentation from IDSA doctors that can prove they denied my Lyme Disease. Class action Lawsuit–Tell Me Where to Sign Up. Healings for Your Body,and Let’s Kick More Ass all.
Liza
To say “thank you” doesn’t seem enough for the work you have done with “Under Our Skin” and the continuing work all of you do. I have seen the movie 3 times. The feeling of anger and fustration never go away!
At a town meeting in Red Bank, NJ, Congressman Pallone stated that the plan for Health Care Reform was put together largely by him.
The largest contributors to his campaign fund are insurance companies and health professionals. Mr Pallone killed the Lyme Bill from 2008 by refusing to sign. Apparently his “doctor” neighbors told him it was a bad bill. As an author of the Reform Plan, we need to check for what he has added to reward his largest donators! The fox guarding the henhouse expression comes to mind.
We must keep up the fight!
To use a quote from NJ (#3 in the US for reported Lyme cases) tourism add,
IDSA, insurance companies, and Congressman Frank Pallone…perfect together!
Kathleen
[...] Click here for: a summary of the IDSA Lyme evidence hearing [...]
Callie76 wrote about one of IDSA family members getting sick with lyme and them giving them the standard course recommended by IDSA. I believe in my heart that they would not do that. They would definitely secretly give that family member a longer course of antibiotics. At one time I read about a doctor talking about a colleague about this disease where the other doctor insisted that the standard course was sufficient. The punch line is some years later he ran into the same doctor whose family member did get sick with lyme. You guessed it the doctor prescribed antibiotics until all symptons were gone.
We would never hear about this and I cannot find it, but if I do I will post this story. I feel that something is going to happen and it will be a eye opener to the citizens of this country about the face of this disease.
I think a lawsuit is definitely necessary. No matter how convincing the hearing was, nothing will change until the IDSA panel members are behind bars. I don’t want money, I want them sentenced as criminals for crimes against humanity. No amount of moneey is going to bring back our loved ones who have passed. No amount of money will ease the pain of countless parents who have lost children due to these guidelines. They are murderers and deserve the death penalty, but I know that would never happen.
i was finally diagnosed with lyme disease as well as my husband in 1990 in pennsylvania.i was fortunatly{after seeing 14 doctors} treated by a lyme literate dr with 6 months of iv rocephin and my husband had 42 days of iv rocephin. elk county where we live is number 1 in the state with the most cases per population.we have not seen this documentary but wish to secure it to show in our most endemic area.god bless all of you who are trying to help all of us post lyme victims.we have cardiac, arthritic and neurological aftereffects .
IDSA review panel. The Fox looking out for the chicken?
The IDSA has dropped the online record of the presentations made in July 2009 at the public hearing. We have major legislation in PA moving right now, and want to refer to these documents/video footage. Do you know how to get access to these? are they now posted anywhere through the UOS website? thx so much, Julia
The IDSA presentations are still up on the site:
http://www.idsociety.org/Content.aspx?id=15026
When those go down, you can look them up on the CALDA site:
http://www.lymedisease.org/news/idsa_lyme_hearing/174.html
I called around today: No response yet from IDSA on how they’re going to fix their voting irregularities.
I am curious why we can’t sue them ourselves as the patients? If we had a large case of their not paying attention to science then don’t we have a (something, where a whole bunch of us are lumped together, cant thing of the name right now sorry) case for discrimination or something? If all us Lymies signed up for it then it seems we could all have some power in the courts and it may be helpful. Why is it only the attorney general can sue, why cant we? I know there are lawyers in our camp cant they help us sue them?
[...] info: (1) Steere, AC New England Journal Medicine Nov 22, 1990; 323(21): 1438-44 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, [...]