LYMEPOLICYWONK: Congressmen Call For Removal of Outdated IDSA Guidelines from National Guideline Clearinghouse
On January 17, 2012, Congressmen Smith, Wolf, and Gibson called on the National Guidelines Clearinghouse (NGC) to remove the IDSA’s outdated Lyme guidelines. We applaud them! But, this, of course, is the middle of the story not the beginning, so let’s go back.
In early September, LymeDisease.org asked the IDSA whether it was in the process of reviewing its outdated guidelines. The IDSA merely referred us to their website, which said its guidelines were current and refused to provide any further information. We then contacted the NGC who told us they planned to continue listing the 2006 IDSA guidelines until 2015. We have been working behind the scenes with Lyme disease groups, including Time for Lyme, the International Lyme and Associated Diseases Society, the national Lyme Disease Association, and other patient groups and individuals, including David Roth to focus attention on this issue.
We have also been in communication with the IDSA and NGC since that time. Our last letter to the NGC on January 3rd, explained in detail how the continued posting of the IDSA guidelines violated the NGC’s own rules for listing outdated guidelines. After we sent our last letter, advocates began reaching out to legislators seeking their assistance in addressing this problem. Currently, we are awaiting a response from the NGC as to whether they will remove the IDSA guidelines from their site. We expect to hear from them shortly.
Why is this important?
Treatment guidelines are tremendously important in determining your medical treatment options. All important treatment guidelines are listed by the NGC. NGC requires that guidelines be updated every 5 years.
The IDSA has not revised its guidelines for more than 5 years. Nevertheless, the NGC recently permitted them to continue listing the guidelines without updating them because the IDSA guidelines had been reviewed in the antitrust hearing settlement hearing. This is wrong because:
1. The IDSA antitrust review panel was not empowered to revise the guidelines;
2. The IDSA antitrust review panel only had authority to review the guidelines for compliance with the legal standard set for them in the settlement agreement.
3. The IDSA antitrust review process recommended over 25 changes to the guidelines—none of which have been implemented. You might recall that there was a split vote on the settlement panel regarding whether lab testing should be mandatory for a diagnosis of Lyme disease.
4. The 2006 guidelines do not reflect new science including the Barthold mouse study and the Embers monkey study, both of which demonstrate persistent infection—a fact denied by the 2006 guidelines.
The IDSA guidelines result in patients being denied necessary care. They are used by insurers to deny patients reimbursement for care and by the IDSA as a club to drive out its competitors in unprofessional conduct actions.
We will keep you posted on this as more information becomes available and let you know what actions are needed. Meanwhile, a copy of the letter from Congressmen Smith, Wolf, and Gibson is set forth below.
———————————————————————————————————-
January 18, 2012
Vivian H. Coates, MBA
Vice President, Information Services and Health Technology Assessment
ECRI Institute
5200 Butler Pike
Plymouth Meeting, PA 19462-1298
Dear Ms. Coates:
As your organization is currently contracted by the U.S. Department of Health and
Human Services’ Agency for Healthcare Research and Quality (AHRQ) to maintain the National
Guidelines Clearinghouse (NGC), we write to you as representatives of areas that have a large
and growing Lyme disease problem. Our constituents have again contacted us about an issue that
needs immediate attention to protect their welfare.
As you no doubt know, the Lyme disease guidelines of the Infectious Diseases Society of
America (IDS A) have been highly controversial and have been responsible for insurance
company denials of Lyme disease treatments. We have recently been informed that these
guidelines have been re-instated on the NGC Web site, notwithstanding the fact that they are
more than 5 years old and, hence, are no longer current. Our constituents are concerned that
these guidelines have not been subject to a complete review for currency and that the
methodology of any review has not been disclosed as required by the NGC’s guidelines.
Our understanding is that the recently re-submitted guidelines are based on the July 2010
Final Report of the Lyme Disease Review Panel of the Infectious Diseases Society of America,
which specifically was “not charged with updating or rewriting the 2006 Lyme disease
guidelines.” This aforementioned review panel was convened pursuant to an agreement between
the Connecticut Attorney General and the IDS A to end the Attorney General’s antitrust
investigation into the IDSA’s 2006 Lyme disease guidelines. The 2010 panel recommended
more than 25 revisions to the guidelines, which have not been addressed. We have been
presented with considerable evidence that the NGC process, which requires that guidelines be
reviewed for currency and disclosure of the methodology for the process, was not complied with
before reinstating the guidelines until 2015.
We urge you to follow NGC currency compliance procedure and remove the guidelines
until they have been fully reviewed and revised. The mission of the NGC is “to provide
physicians and other health professionals, health care providers, health plans, integrated delivery
systems, purchasers, and others an accessible mechanism for obtaining objective, detailed
information on clinical practice guidelines and to further their dissemination, implementation,
and use.” Only a careful and transparent procedure will remove the cloud that has hung over
these guidelines.
Thank you for your serious consideration. We look forward to your reply.
CHRISTOPHER H. SMITH, Member of Congress
FRANK WOLF, Member of Congress
CHRIS GIBSON, Member of Congress
The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org, formerly CALDA. Contact her at lbjohnson@lymedisease.org.
Brilliant! Lorraine, Phyllis, et al, please let us know if we can help with this effort.
Monique Dubos
President, Minnesota Lyme Association
Many thanks and please keep up the good work for people with Lyme Disease all over the world.
This is great. Keep them on their toes. They can't get away with this for much longer with groups like this holding them to their responsibilites!
The grossly outdated IDSA guidelines are no longer reflecting current scientific evidence regarding the seriousness of Lyme and TBD's- now in epidemic proportions in many states-PA. taking the lead. Lyme disease is rarely considered in the differential diagnosis of someone severely symptomatic, and undiagnosed- the diagnosis remaining a mystery. The IDSA restrictive, outdated guidelines are harming hundreds of thousands of people, who remain undiagnosed and untreated. Guidelines are to appropriately and accurately guide and lead others, much as a compass directs a ship's captain. They are a moral compass in the practice of medicine. The immorality here is devastating, with the health and well-being of patient's significantly compromised. Would you encourage your patients to take outdated medications? Would you tell a family member or close friend to follow your guidelines if they have a "mystery" disease that crosses systems of the body, and a history of tick infestation? I don't buy outdated canned goods or use outdated medicine as as professional nurse. I want the BEST practice. The IDSA's guidelines are not best practice!!! I want facts, not opinions. I have them, do you? I am required as a Registered Nurse to attain 30 CEU credits every two years to renew my license, and remain current and informed. What are your requirements for keeping up to date, so you don't guide others incorrectly and cause MISTAKES?? Mistakes that harm, injure patients- even resulting in death due to complications involving Lyme and TBD's. Misinformation is TRAGIC. Stay tuned and don't mis-use guidelines. We are depending on you.
Since I have been diagnosed with chronic Lyme Disease and the diagnosis is CDC Positive. I am very interested in any news related to the aforementioned IDSA Guidelines relating to the treatment of Lyme Disease.
It appears that I have had this disease for almost thirty-five years.
I spent many summers in Connecticut, mostly In the towns of Lyme and Chester.
I have born the cost of most of my medical treatments and doctors visits (well over two thousand dollars per month.)
I am on two antibiotic infusions daily soon to go to three.
I consider the IDSA to be "in cahoots"
with my insurance providers, (Medicare and Anthem), by allowing loop holes for denial of my treatment for Chronic Lyme. I take this personally, because these guidelines are thrust upon me personally.
The refusal to offer any coverage for my Home IV administration for my treatment, which has been prescribed by my Doctor is an injustice.
I cannot help but feel that the IDSA should be professionally admonished for their adhering to "out dated" guidelines based on individual board members personal opinions.
A Flaw is A Flaw! What more must be done to convince the Medical Profession that the IDSA Guidelines as written, are nothing more than Smoke and Mirrors!
I have now been in treatment for close to two years and I can clearly state that I Have made great strides in battling this disease.
Not a week goes by without hearing about another new case of Lyme Disease in my community.
Just for the record, my spouse and twenty-three year old daughter also are CDC positive for Lyme.
Again just for the record, my next door neighbors, husband and wife, both are CDC positive for Lyme.
Just this week, my next door neighbors on the other side of our home, are seeking Lyme testing for "Lyme Like" symptoms.
I would be very interested in anyone who would consider initiating a class action suit naming the Infectious Disease Society Of America and the board members who still support the "Out Dated" Guidelines. These "flawed" guidelines have hurt so many Lyme Patients and Doctors. A Class Action could possibly correct an injustice and clear a path for progress in curing all Lyme disease.
A law suite, just might get their (ISDA)attention (again).
In the Meantime, It appears that we could write to our Congressional representatives and ask for their support in forcing an "update" or repeal of the present IDSA GUIDELINES FOR THE TREATMENT OF LYME DISEASE.
New guidelines should include the recognition of Chronic Lyme Disease.
So much new information is out there with new research in understanding Lyme disease. surely, this minute group of supposedly Prestigious Professionals in the field of Infectious diseases cannot have all the answers to Lyme disease!
If I seem a little crass, it is because I am under the influence of Chronic Lyme disease and I feel the affects every day. I wish that each IDSA member could walk in my shoes and truly "feel" what this disease can do to an individual, their family and their friends.
Thank You,
JB a Lyme patient.
I feel much better now!
lorraine, outstanding work monitoring things so they DON'T GET BY WITH SQUAT!
especially after the 2,000+ comments on what to improve on idsa site/their mission!
bettyg, iowa lyme activist
Many thanks to you Lorraine. We too in France have inaccurate Lyme guidelines based on the 2006 IDSA ones. I am longing eagerly for this reviewing of the IDSA opus!
Sylvie, PhD, Paris, France
My 15 yr old Daughter suffers from chronic lyme and has been being treated since July (Never found a tick).I watch her suffer DAILY .We recently ended up in the ER (one of many visits ) and i am appalled and disturbed at the Medical communities outlook of Lyme (IDSA).This has been a nightmare for my daughter and my heart aches for her… she has a very long road ahead. Thankyou for what you are doing !!!
Thank you for everything that you do.
My hat's off to you Lorraine! The IDSA is a criminal organization as far as I am concerned! As you so clearly stated;
many people are very ill; including myself, and are being mistreated,misdiagnosed, and generally abused by the old school protocol.Here on Cape Cod; we're treated like lepers in the medical community; and it's a "hot spot" for tick activity. Keep the pressure on!
Lyme/Assoc. Diseases Conference in S.F. was EXCELLENT!
Thanks Congressmen Smith, Wolf, and Gibson, and Lorraine!!!
STOP Mental and Physical Torture of SOCIETY – even prosecution for seeking choice of healthcare and RN education under (ILADS) Standard of Care w/ false imprisonment 'Delusional-Somatic type' Denied Due Process – denied rights, privileges and immunities under (ADA) federal law.
I hope the groundbreaking new book TREATMENT OF CHRONIC LYME DISEASE by Burton A. Waisbren (founding and current member of the ISDA) is helpful. He basically says the ISDA has it all wrong and it needs to be fixed because this disease is REAL and many are suffering at their hands.
Though I didn’t know it at the time, I presented my GP with 5 of the top ten listed symptoms of Lyme all at once when I first contracted the disease last summer. While setting up some standard blood work he ask me if I also wanted a Lyme test. Fortunately, I said yes! Treatment did not begin until 5 days later when the ELISA test came back positive, even though I had multiple secondary rashes during all that time. The western blot came back inconclusive at the time but turned positive when I retested a month later. I had 21 days of Doxycycline, after which I was informed the Lyme was cured and that I now had immunity from the disease for life. Now, months later, many of the same symptoms have returned and I fear that the antibiotic treatment was too short in duration to eradicate the disease, even though it was early stage. I know the standard explaination for this situation is called PTLDS but my symptoms have endured. I post this to tell people that there are many doctors who know little about Lyme and you to be very aware of the symptoms, as well as seeking out a Lyme Literate doctor for treatment without delay. If your doctor is a staunch supporter of IDSA guidelines, best to seek a Lyme Literate doctor immediately!
Thanks for all you do with Lyme Disease. My sister has chronic Lyme Disease and has been battling this disease for the last year and half. She is now on IV antibiotics. She was bitten by a tick and never saw the bite till it was to late. She is having a really tough time and cannot work. I hope they do change and update things because it more and more people are getting Lyme Disease.The government NEEDS to help these people who suffer from this.
Thank You.
What may I ask are the 25 recommended changes? A link to where they are published would be appreciated? Also for those of us horrible at writing letters, do you have one can revise a little and send to help? And an Address because I would like to snail mail it so it is paper and in their hands for at least a minute.
Thanks,
Conny
I picked up my granddaughter tonight from saratoga hospital, after she tried to pick upa knife and hurt herself. the lyme disease is taking over ever bit of her life, she cant go to school anymore and she cries all the time she has cognitive problems heart problems tremors, she cant walk shes in a wheel chair and tonight when she went to the hospital they were going to send her to utica or ny city, whats wrong with this picture does any one care except her family which is falling apart because we dont know what to do anymore and the hospitals and some doctors dont care or are miss informed, the doctors thar see the big picture are harassed and tormented by their superiors for doing the right thing. please help us we are are grateful for anything thing that can be done to help these people who are suffering so, thanks for all you are doing and for all you will do. thank you
Any response to this yet???
Science is always moving forward; too many people are suffering because of these outdated guidelines. Bring them up to date.
Although we are getting the run around by many Drs we too belive my 38 year old daughter has lymes. She has had 3 lyme tests all negative but last 1 came back with 2 bands of activity. dr still denies its lymes. She has not been able to work for months and has 2 small children she sometimes can not take care of. She no longer has insurance and is no longer married. She needs help before she looses her home. She has all the other symtoms and lives on pain pills just to get by. Needs a Dr that will take public assistance.This is ridiculous we can send men to the moon but can’t help these patients!!!!!!!