What to do with Lyme treatment guidelines?
Recommendations on whether or not to revise or rewrite expected later this year
6 comments below
Last May, Connecticut Attorney General Richard Blumenthal launched an anti-trust investigation into the potential conflicts of panel members who led the writing of the Infectious Disease Society of America's (IDSA) 2006 guidelines for treating Lyme disease. “Medical guidelines have profoundly powerful consequences for countless lives, driving doctors' treatment decisions and insurance company coverage determinations,” Mr. Blumenthal said in a statement released the day of the hearing. “Such significant clinical standards deserve the most intensive scrutiny from all perspectives — physicians, scientists and patients — before they are published.”
Shelter Island has among the highest Lyme disease incidence rates in New York State.
Mr. Blumenthal's findings of actual conflicts of interest led to a public hearing in Washington D.C. last Thursday during which a new panel heard testimony on why the guidelines should or should not be changed. Most at issue was whether, or how, chronic Lyme disease could be defined. If it cannot be defined, definitive guidelines cannot be written on how to treat it.
The new panel heard from 18 experts, two of whom were on the 2006 panel. When the final report is issued, which is expected by the end of the year, the IDSA review panel can recommend no changes be made, revisions to certain sections or a complete re-write of the guidelines. “Should our review panel recommend a change, IDSA will convene a separate panel to carry out that task,” Review Panel Chair Carol Baker stated in a press release prior to the hearing.
Though he did not attend the hearing, Mr. Blumenthal watched via webcast, which is available for viewing on IDSA's website at idsociety.org/Content.aspx?id=15026. Afterwards, he told the Greenwich Time newspaper, “The panelists seemed to be listening very intently, asking probing and perceptive questions, which augurs well for the outcome.”
What that outcome will be remains to be seen. Those arguing to change the guidelines and those advocating for keeping them were far apart on basic issues. Dr. Gary Wormser, who chaired the 2006 IDSA panel, quoted the guidelines when he said during the hearing, “IDSA considers adherence to these guidelines to be voluntary.”
That statement ran in direct contradiction to the words of Lorraine Johnson, CEO of the California Lyme Disease Association. The “highly restrictive” IDSA guidelines, she said, “preclude the meaningful exercise of clinical judgment” and “deprive patients of treatment options.”
That is because, she went on to say, the guidelines “are treated as mandatory” by health and disability insurers, medical boards, physicians, hospitals and even school systems and child care agencies.
“My patients are being denied treatment based on the IDSA guidelines,” added physician Daniel Cameron of the International Lyme and Associated Diseases Society (ILADS).
The other main disagreement between the two sides was on whether there is such a thing as chronic Lyme disease and if there is, how to treat it.
There is no real definition of chronic Lyme disease, Dr. Eugene Shapiro, a 2006 IDSA panel member, said. Though patients may exhibit chronic symptoms, he added, they may show no objective signs of Lyme disease. If there is such a thing as chronic Lyme disease, Dr. Wormser said, “reinfection needs to be excluded.”
It can be, said a former ILADS president, Raphael Stricker. He said persistent infection causing persistent symptoms is plausible. In those cases, prolonged treatment is relatively safe and justifiable. Dr. Wormser said the few studies that do suggest persistence of Lyme symptoms are either unconfirmed or could not be replicated when attempted.
Going a step further was Arthur Weinstein of Georgetown University's medical school. He said post-Lyme syndrome should not be defined separately. Further studies, he said, could “shed light on its pathophysiology and appropriate treatment.”
To those who disagree, or who would argue that extensive treatment is necessary, said Dr. Phillip Baker of the American Lyme Disease Foundation, “it is incumbent upon them to design and conduct a randomized, placebo-controlled trial ... to demonstrate efficacy and safety. If that can be done, I am certain that the results would be accepted by the medical and scientific community and this controversy would come to an end.”
Dr. Steven Phillips of ILADS said the IDSA selectively chose its evidence. Pointing to evidence not cited in the guidelines, he said there is such a thing as persistent Borrelia burgdorferi infection, even after single and multiple rounds of recommended antibiotic therapy.
That treatment might not work if the patient is misdiagnosed, Dr. Sunil Sood of Schneider Children's Hospital in Manhasset said. He told a story of a patient being “stymied by a diagnosis of ‘chronic Lyme disease.'” She received supporting treatment, he said, during which she became “more anxious” and experienced symptoms ranging from vision changes, “weird hallucinations,” involuntary muscle twitches, headaches described as “a stab in the dead center of the brain” and nerves “on fire.”
The patient had no known tick bites, he said, and after a Lyme disease serology her physical examination returned “completely normal.”
He recommended she discontinue antibiotic treatment and told the panel, “I can only hope that she ultimately took my advice. The fault is not hers, nor of her parents. The problem is the refusal of her physicians to use the evidence-based IDSA 2006 guidelines.”
This is not an argument that will end any time soon, regardless of the panel's recommendations on changing the current IDSA guidelines.
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6 comments found
The guidelines should be re-written and the panel who originally wrote them should be brought to justice : 9/22/2009
The scientific evidence for Chronic Lyme disease and the PERSISTENCE of the COMPLEX Borrelia Spirochete is DETAILED and VAST, unlike that of the IDSA and their devoted followers viewpoint, that this bacteria is "hard to catch and easy to cure". Please see http://www.lymeinfo.net/medical/LDPersist.pdf for 70 studies which show the persistence of the bacteria. You may also like to look at a study titled "Rapidly progressive frontal-type dementia associated with Lyme disease" which demonstrates a tragic case of a gentleman diagnosed with Dementia after being treated with a course of antibiotics for Lyme Disease. He showed improvement whilst on antibiotics but relapsed when the antibiotics were stopped. He was institutionalised for the psychiatric condition but soon died. The authors of this study concluded that "Lyme disease must be considered even in cases with purely psychiatric presentation, and prolonged antibiotic therapy may be necessary" The IDSA continues to cite the following study to support its view that "long-term antibiotics are not beneficial in treating Lyme disease", the very study performed by Klempner ("Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. New England Journal of Medicine, June 12, 2001") which has been trashed by an independent research group (amongst others) as being flawed and "bad science". Various organisations are often cited to substantiate the IDSA guidelines, namely the CDC, ALDF and EUCALB - when those very organisations actually hold no independent viewpoint at all but merely voice and duplicate that of the IDSA Lyme disease panel. Different organisations are being cited to give the appearance of wider and more authoritative backing from different, independent sources when the membership of these organisations actually contains the very same people amongst their number and, therefore, disqualify them as an independent source. There is no corroborating evidence from varying authoritative points of reference, then, to support this view promulgated by IDSA; there is, in fact, only one point of reference – the guidelines as set out by the IDSA Lyme disease panel, which is currently under investigation for GROSS conflicts of interest!
Chronic Lyme is Very Real : 9/1/2009
As I was growing up I watched my mom suffer for 15 years misdiagnosed with "fibromyalgia" as she got worse and worse. Eventually she had to quit her job as a nurse and couldn't get out of bed. One day she heard about Lyme disease and found a doctor who was willing to treat her. She is now a completely different person from the woman I grew up with. I want to cry when I think of all the infected people who are ignorant of their disease or denied treatment because of people like Dr. Eugene Shapiro who thank God was kicked off of the IDSA panel. Everyone Needs to watch the documentary "Under Our Skin."
What to do? : 8/20/2009
It is so sad anyone has to ask. But I will tell you what to do with the guidelines and the incompetent individuals who herald them to be current and good. Firstly let me say there are thousands of patients who tell the same story-not diagnosed till bed ridden or wheelchair bound. If you don't believe me ask them. They are all over the internet and in every state. Fire the ones who refuse to keep up with the medical knowledge and could care less. Put some people in the know in they're place and get these people the help they need to become productive individuals. If I was running the business of providing the most crucial treatment guidelines based on evidence this is what I would have to do.
Chronic Lyme : 8/14/2009
I live in Ohio, but got Lyme when I was in CT. 18 years ago. I don't understand why my doctor who knows me best, and went to medical school, cant decide what is best for me. As for the "PANEL", what right do they have to make hundreds of thousands of people suffer like this, because of their theory? What they believe is not proven. There is loads of evidence to say they are wrong. You'd go to jail if you treated a dog like this in this country, but a human who is experiencing tremendous disabeling pain has no rights? Doesn't this "PANEL" see that several hundred thousand Lyme patients are sick, If they can't see that I don't want them making decisions about my health care. I also don't understand all this concern about antibiotics! They are in our meat , eggs, the dish soap, and every other cleaning product, but I have to travel out of state to get antibiotics for my Lyme Disease? I never thought this would happen in America. Are the panel members willing to get infected with Lyme and are they willing to wait six years like I had to wait to be treated, and are they willing to be denied medical treatment and have their doctors license taken away for treating them? I think the PANEL belongs in Jail. This is a crime.
chronic lyme : 8/14/2009
I have suffered with Lyme Disease symptoms for the last 12 years... I can survive without antibiotics for a few months at a time... The spirochtes attack my bladder along with causing the usual pain and cognitive disabilites.. After a few weeks on antibiotics my Lyme cystitis subsides and my fatigue bouts decrease... That is my experience of Chronic Lyme Disease
Solution : 8/13/2009
I am sure that Rae lapides has the answer to this problem. she is very good at giving out info that experts do not agree with...
