The new IDSA Lyme guidelines panel has been selected. The "ethics" expert disqualified any practitioner who earns more than $10,000 per year treating Lyme patients, ostensibly construing this as a conflict of interest.
This standard excludes the most experienced treating Lyme docs from the panel - and from what I understand, formed the justification, for example, for rejecting every ILADS physician who applied. Dr. Donta's application also was rejected.
For more on this subject, I have copied for you below an excerpt from Lorraine Johnson's blog on the California Lyme Disease Association (CALDA) website.
For those of you who may not know her, Lorraine is an attorney and serves as the executive director of CALDA.
Conflicting views on conflicts--throwing the baby out with the bathwater
Conflicts of interest are not good for medicine. Why?
Because when a physician has a conflict a secondary considerations (such as a lab referrals, vaccine research grants, or revenues from proprietary diagnostic tests) may compete and trump concerns about the best care for the patient.
The last Lyme disease guidelines by the IDSA suffered from an abundance of conflicts of interest and no oversight.
In fact, the Attorney General found extensive conflicts of interests among the IDSA panel that developed those guidelines.
The IDSA's new guidelines panel, which was legally mandated by a settlement with the Connecticut Attorney General, was supposed to eliminate these types of conflicts of interests and an ethicist, Dr. Howard Brody, director of the Institute for Medical Humanities at the University of Texas was chosen to oversee these conflicts.
So what's the problem? Well, expert panels are first and foremost supposed to be experts.
And, while you may not want pharmaceutical interests driving the cart, you definitely want physicians who treat the disease on the panel.
Brody rejected any applicant who made more than $10,000 a year from treating Lyme disease.
This excluded all physicians who saw more than one patient per week who had Lyme disease.
Simply put, there are no experts on this panel that treat Lyme disease or who could form meaningful ``expert opinions''.
To put this in perspective, the last IDSA guidelines panel based the majority of its recommendations on ``expert opinion''.
If there are no experts on treating Lyme disease on the panel, then what type of expert opinion can recommendations such as these be based on?
In short, Brody threw out the baby with the bathwater.
Who would expect a cardiology panel to be populated with physicians who are not cardiologists? The notion is absurd.
In law, this is known as reduction ad absurdum.
Posted by liesandmorelies (Member # 15323) on :
I totally Agree Tincup!!!!!!
OK, so how can we start bombarding them with how outrageous this is and how there are actually no "experts" on this new panel???????
Your analogy of the cardiologist should be enough to make them reconsider.
Perhaps we should start threatening them that they are trying to decide our healthcare with no experts in the field involved and that will be a huge liability for them if we were to start a huge class action law suit.
I mean my goodness, would they want to have their childrens guidlines for immunizatigons decided by a construction worker????? This is so crazy.
Is anyone thinking out there?
I am really p'd right now.
Where do we write????? Posted by Need Lots of Help (Member # 18603) on :
Oh jez...I didn't think our outlook could get any worse.
Posted by seekhelp (Member # 15067) on :
Decisions made from high above....
Posted by treepatrol (Member # 4117) on :
Conspiracy
Yep it runs deep
Posted by lymednva (Member # 9098) on :
Posted by liesandmorelies (Member # 15323) on :
we need to find a way to publically slam them through the media and show how insane this is.
Perhaps there is also a way to get notorized signatures from lyme patients, friends and family(I am talking about thousands of signatures), showing that we will be charging the IDSA with reckless behavior. Think class action. Basically if this happens, we are an unprotected class of people.
OK, I know I am ranting but you can see where my thought process is going.
This is absolutely reckless and must be stopped.
Posted by Tracy9 (Member # 7521) on :
I mean, what does Richard Blumenthal think of this? Or is he completely out of it because they came to a settlement? Does he still have any influence or say at all?
Posted by lou (Member # 81) on :
This is not surprising, expected in fact because of what the IDSA said after the settlement with CT AG. They said nothing would change, and this is their way of ensuring that it won't. The question is whether they will get away with it.
Brody doesn't sound like he is very useful.
Posted by massman (Member # 18116) on :
Slam the selections by asking if cardiology panels cannot have cardiologists on them that make more than $10,000 per year on heart disease payments.
And orthopedic panels....etc.
Posted by TerryK (Member # 8552) on :
TC wrote: The "ethics" expert disqualified any practitioner who earns more than $10,000 per year treating Lyme patients, ostensibly construing this as a conflict of interest.
See page 8, C. Must be knowledgeable in the subject of lyme disease but not necessarily an expert.
According to the agreement, the IDSA pick the panel.
Look at 3 and 4 on the bottom of page 8. Looks like the panel must include at least one doctor with clinical experience in treating lyme disease patients.
Seems like that doctor will be one who currently follows IDSA guidelines because if they didn't, they would be inundated with patients in which case they would be making more than $10,000 per year treating lyme disease.
The way they set this up is pretty clever.
Terry
Posted by adamm (Member # 11910) on :
We are holocaust victims, plain and simple.
Posted by liesandmorelies (Member # 15323) on :
If they are not able to use doctors that make more than $10k treating Lyme victims, then they must not be all that familar with Lyme. How can they call this an expert panel????
We need to slam them. Think Think Think???????
Posted by treepatrol (Member # 4117) on :
Ill bet cha
Posted by Keebler (Member # 12673) on :
-
Treepatrol,
Wow - that needs it's own thread and a team of replies. It would help to know what they've tested for but my guess is not Tick borne disease with the right labs or Cpn.
--
Does the IDSA committee have to go back the the Atty Gen. Blu. for some sort of approval of their solution as they have designed it?
[editing to add: Oh, I see that Terry already posted the answer to that.]
-
Posted by TerryK (Member # 8552) on :
Lies wrote: How can they call this an expert panel????
They aren't.
See page 8, C. Must be knowledgeable in the subject of lyme disease but not necessarily an expert.
Terry
Posted by liesandmorelies (Member # 15323) on :
Well we shouldn't settle for someone who has knowledge in a particular disease capable of setting guidelines.
Thanks for the correction Terry, I just assumed they would have experts in the field. Can't imagine why I would expect experts to write guidelines for this disease????????
I guess that would mean we are all capable of being on the panel as well. Geez
Posted by METALLlC BLUE (Member # 6628) on :
This is not good. This is bad, really bad. What are we going to do? I'm thinking.
Posted by lou (Member # 81) on :
There must be doctors who have lyme but do not treat it. They would be good to have on the panel.
Posted by bettyg (Member # 6147) on :
tree, thanks for that; i just emailed billy's wife with lyme blood testing info.
tincup, THANKS for posting latest from shiela here! i copied it to www.mdjunction.com also so this can be posted all around.
ALL LYME/CO-INFECTION PATIENTS need to organize and strike down the many injustices of this HOG WASH PANEL put together.
$10,000 ... that was NEVER in original posting!! there was no mention of $$ in original one. Posted by Allie (Member # 10778) on :
Is there a way to find out WHO is actually going to serve on the panel now that they are chosen? There are only 15 or so people. I can only assume these 15 don't want to go down like their predecessors did.
Wasn't a piece of the AG's findings related to cherry picking of scientific data used to justify "expert opinion?" This go-round, *all* doctors and the public are encouraged to supply the panel with all the latest research. This has to make a difference this time.
Doesn't it?
Please say it does...
Allie
Posted by bettyg (Member # 6147) on :
please copy shiela's info and post on ALL OTHER LYME BOARDS, and send to ALL ON YOUR OWN LYME LIST GROUPS!
we've got to get the word out and show this lymenet link here so we can try to coordinate our efforts on getting corrective action for us ALL! thanks bettyg
Posted by njlymemom (Member # 15088) on :
IDSA lists the selection of panelists for review on their website.
Weinstein was on the panel, but now is no longer listed.
I spoke to an attorney at AT Blumenthanl's office. The hearing date has not yet been set, but may take place late April.
Our experts need to come forward at this hearing to present to this panel of "experts". We will be able to view/hear this hearing via webcam. I hope this isn't too complicated for the inept computer users like myself.
I don't want to lose hope, but somehow this just feels like it will not end well. I wish there was something we could do that would make a difference.
Posted by shazdancer (Member # 1436) on :
Yes, as Terry said, this was part of the guidelines agreement, though the $10K figure was not part of the original agreement. The names of the panelists are listed at:
Our most powerful response is going to be at the public hearing that will be convened, as per the agreement.
-- Shaz
Posted by lymeout (Member # 8045) on :
Wait! Don't judge too quickly! I have been googling some of the names on the panel and have found at least two who seem to be leaning to our side in their research.
I don't think the idea of this panel was to pick experts in lyme, but rather to select people with some experience who were open-minded. Remember, their role is to examine the research and listen to the testimonies, then make decisions based on that.
Let's learn more about each of these people and share our information so that we can determine if the balance is there. For example, I did find one who sat or sits on a Blue Cross committee and has been involved with pharma; but I would want to dig deeper before protesting it. Let's do some homework!
Posted by tdtid (Member # 10276) on :
I just finished pulling myself up out of the gutter from these IV's and get back here, to have this be the first note I see.
This is so horrid.
I think the lines "Who would expect a cardiology panel to be populated with physicians who are not cardiologists? The notion is absurd." sum this up.
What kind of insanity is going on here? Thanks for giving us the update, Tincup, although it's not the one I wanted. Grrrrrrrrrrr.
Cathy
Posted by njlymemom (Member # 15088) on :
On Lorraine Johnson's blog she states "If you have information on any of the proposed panelists that you believe impairs their ability to serve on the panel impartially, please email me privately at [email protected]
So lymeout, if it looks like a panelist has a conflict with an ins. co or pharma, you may want to follow through with an email to Johnson.
Posted by KS (Member # 12549) on :
I agree with all of the concerns and frustration here. On the bright side (o.k. maybe not as bright as we'd like) this also means physicians such as Steere and WORM do not qualify either, right? The point here is not to have anyone with any prejudice one way or the other. What is important is that the ILADS folks have an opportunity to present the data, clinical experiences, etc.
Does anyone know how information is supposed to be presented and analyzed??
Posted by feelfit (Member # 12770) on :
fixed. Military reps. cover up again. I'll bet my botom teeth that nothing changes.
Posted by Lymeblue (Member # 6897) on :
Here the panelist's name:
Carol J. Baker, MD, Chair Baylor College of Medicine Houston, TX
William A. Charini, MD Peabody, MA
Paul H. Duray, MD (retired) Westwood, MA
Paul M. Lantos, MD Duke University Medical Center Durham, NC
Gerald Medoff, MD Washington University School of Medicine St. Louis, MO
Manuel H. Moro, DVM, MPH, PhD National Institutes of Health Bethesda, MD
David M. Mushatt, MD, MPH & TM Tulane University School of Medicine New Orleans, LA
Jeffrey Parsonnet, MD Dartmouth‐Hitchcock Medical Center Lebanon, NH
Cmdr. John W. Sanders, MD U.S. Naval Medical Research Center Detachment, Peru
Posted by nomoremuscles (Member # 9560) on :
No matter how you spin it, this bites.
But it's not liike we didn't see this coming.
The truth is, we will ever win with the IDSA. Period. The deck is stacked no matter what. I hope I live to eat these words, but I think any panelist, whether or not directly biased, is indirectly biased, simply by virtue of what's out there for the average physician or to read. Where would they EVEN SEE any point of view but the current dogma? All they'll see is the big easy stuff, the stuff right out there front and center, like the recent NEJM. The chronic-Lyme supportive research has been buried, and unless they comb the literature they'll never see it.
I think the way out is not by convincing the IDSA they are and have been wrong -- impossible for many reasons -- but to somehow make them irrelevant. We need to do an end run around them. We need to get our message out to the media and every doctor and government official and health professional; ingrain the message so deeply, that when they hear the hollow ringings of the IDSA they just look at them and think it's quaint. Like the ramblings of a crazy old uncle who lives up in the attic and no one pays any attention to.
Right now our crazy uncle is screaming, and everyone is listening, thinking he makes perfect sense.
Posted by sutherngrl (Member # 16270) on :
CLASS ACTION SUIT is the way to go! Maybe the attorney general that filed the lawsuit in the first place is a good person to contact to guide us in the right direction.
We cannot sit back and let them do this. The analogy of the cardiologist is great. How can you have a group of people making guidelines to follow for treatment of LD, that has no Lyme expert on the board? It is too ridiculous.
Posted by LLYME (Member # 18687) on :
In the CNN article it says they have a facebook and myspace page. We should post on their page saying to test for Lyme.
Posted by bettyg (Member # 6147) on :
llyme,
i wrote feedback comments on article for billy/nikki, and sent her an email at home with more details on lyme
western blot igm/igg and co-infection testing at igenex, calif.
Posted by liesandmorelies (Member # 15323) on :
A couple of people on a panel of 15 who may lean our way, is not going to get the job done.
This whole thing is insane.
Although I agree with not judging quickly and there may be one or two that are leaning our way, time is of the essence. Do you really think not having ppl who treat Lyme regularly are going to really understand the nitty gritty of our disease???? And, whose understanding of Lyme do you think the "majority" of the panel will understand?
By using the 10k rule, that would basically keep all the doctors who regularly treat Lyme patients out of the picture and they know it.
I'm not going to be nice about this disease any more. This may be our only time. There was absolutely no balance in the last panel and based on this rule it appears to smell like a rat to me.
Posted by liesandmorelies (Member # 15323) on :
I also think we should send thoudands of letters to these panelists. Maybe if they personally read our story's and see our children's pictures this will help some.
If they don't change things, then they will have to live with the guilt of thousands of personal testimonies that were trying to show them the light.
Thank you for posting their names.
Posted by liesandmorelies (Member # 15323) on :
Nomoremuscles,
Of course I also think you are absolutely correct. We need to do your plan as well. That is why I mentioned media etc...
But, we do want this panel to know we are holding them responsible and that we are not going away until they change these guidelines and bills are passed as well.
Posted by Robin123 (Member # 9197) on :
I'd like to know who put the 10K exclusion rule in the agreement. That alone excludes clinical practitioners who know what treatments work or don't work for Lyme patients.
How does that rule jive with the paragraph above it that says they are looking for a panel that will "reflect a balanced variety of perspectives and experiences...ranging from clinical experience in treating patients with Lyme disease...".
How can anyone have adequate clinical experience in treating Lyme patients with a 10K cap?
We go to LLMD doctors for care. How can their input be excluded from this advisory panel whose purpose is to advise on how to treat patients?
This doesn't make any sense (said Alice in the rabbit hole)...
Posted by Tincup (Member # 5829) on :
QUICK NOTE- in response to-
"I also think we should send thoudands of letters to these panelists. Maybe if they personally read our story's and see our children's pictures this will help some."
I know that some folks are not pleased right now. BUT...
Please do not take ANY action until the ones who have the knowledge and experience... and who have been dealing with this from Day 1 (getting the ducks in a row) have time to consider all the options and get back to us.
A few actions here and there will not make the same forceful impact as one big movement would... and...
There is a chance things could be made worse by those who don't know all the facts, myself included.
So I respectively ask that we think, research, discuss and contemplate... but do not take action yet.
Thanks!
Posted by Tincup (Member # 5829) on :
I wrote this the other day ... might be worth repeating here.
As patients we are not to interfere or try to intervene with the IDSA guideline review process... especially not by contacting the mediator or panel members.
I know it is hard to understand for some, including me, but attempting to make contact with those involved in the Attorney General's legal process and his ordered review (think of this like you would a court order) ...
Would be similar to folks contacting the judge in a murder trial behind the scenes and asking what he is doing or what is going on.
I would hope everyone would respect the official process and wait for news to come down from the top.
Posted by liesandmorelies (Member # 15323) on :
Good points Tincup,
I just hope that this panel really knows the truth about this disease and is completely aware of the thousands and thousands if not millions who have this disease.
Sometimes when people have to read True story's and accounts of what is really going on it can be mind opening. Currently mainstream doctors are told that Chronic Lyme does not even exist and that untreated Lyme can be easily treated with short courses of abx which we know it can't. We are also told that if the symptoms are still there then it's something else.
If there are only one or two who "may" be on our side, then I believe nothing will change.
Needless to say, I think now that these names are out for the public to see(they are on the IDSA public website), this panel will receive letters from those who believe in Chronic Lyme and those who don't. I am involved in a couple other sites and ppl are already talking about this and people are angry.
I do understand you point though.
This is just so very frustrating.
Posted by liesandmorelies (Member # 15323) on :
Robin,
Excellent point about the 10k cap and clinical treatment.
How can you really understand a disease if you can only treat up to 10k worth. For goodness sakes, one case could be that much in no time at all.
Posted by lou (Member # 81) on :
I would like to think that personal appeals to people on this panel would help to shape their views, but I don't. It has never had the slightest influence in the past with the IDSA, Wormser, Steere, Sigal. In fact, Steere showed such a letter to a journalist with the comment that the writer was mentally unbalanced.
Posted by liesandmorelies (Member # 15323) on :
Lou,
Sadly but true, you are probably correct.
However, If Steere said that to about me, I would sue his bottom for slander.
I was just thinking that perhaps these new panelists who are getting into this mess presumably for the first time, would benefit from hearing true story's, but than again, we are talking about the IDSA Posted by liesandmorelies (Member # 15323) on :
Okay, I found this very interesting and I agree we need to make sure we do our research for before we freak out right? Lets start with the first name on the list
Carol J Baker MD
I google her name and Lyme and up pops this. So you tell me what you think???? Click on the link and read the whole thing. Do you think she doesn't have a bias????
http://www.pediatrics.org/cgi/content/full/105/1/142 located on the World Wide Web at: The online version of this article, along with updated information and services, is rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275. Grove Village, Illinois, 60007. Copyright � 2000 by the American Academy of Pediatrics. All and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk publication, it has been published continuously since 1948. PEDIATRICS is owned, published, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly Downloaded
Posted by liesandmorelies (Member # 15323) on :
Here's the abstract from my above post.
AMERICAN ACADEMY OF PEDIATRICS Committee on Infectious Diseases Prevention of Lyme Disease ABSTRACT. Lyme disease is currently the most frequently reported vector-borne illness in the United States, accounting for more than 95% of such cases. The purpose of this report is to provide recommendations for preventing Lyme disease, including the use of Lyme disease vaccine. Individuals can reduce their risk of Lyme disease by avoiding tick-infested habitats when in endemic areas. If exposure to tick-infested habitats cannot be avoided, individuals may reduce their risk of infection by using repellents, wearing protective clothing, and regularly checking for and removing attached ticks. Morbidity from Lyme disease can be reduced significantly by detecting and treating the infection in its early stages; early and appropriate treatment almost always results in a prompt and uncomplicated cure. A Lyme disease vaccine (LYMErix, SmithKline Beecham, Collegeville, PA) was licensed by the US Food and Drug Administration on December 21, 1998, for persons 15 to 70 years of age. This vaccine seems to be safe and effective, but whether its use is cost-effective has yet to be clearly established. Use of this vaccine causes false-positive enzyme immunoassay results for Lyme disease. Lyme disease can be diagnosed in vaccinated persons by immunoblot testing. Decisions about the use of this vaccine should be based on an assessment of a person's risk as determined by activities and behaviors relating to tick exposure in endemic areas. This vaccine should be considered an adjunct to, not a replacement for, the practice of personal protective measures against tick exposure and the early diagnosis and treatment of Lyme disease. CDC, Centers for Disease Control and Prevention; DEET, n,ndiethyl- m-toluamide; Osp, outer surface proteins; rOspA, recombinant OspA; GMT, geometric mean antibody titer; ELISA, enzyme-linked immunosorbent assay. Lyme disease, a tick-borne zoonosis caused by the spirochete, Borrelia burgdorferi, accounts for more than 95% of the reported vector-borne illness in the United States (Centers for Disease Control and Prevention [CDC], unpublished data, 1998).1-3 Since national surveillance for Lyme disease in the United States began in 1982, the number of reported cases has increased about 25-fold, with a mean of approximately 12 500 cases reported annually between 1993 and 1997 (CDC, unpublished data, 1998).3 In the United States, more than 90% of the cases of Lyme disease are reported from approximately 150 counties in 13 states located along the northeastern and mid-Atlantic seaboard and in the upper north-central region (CDC, unpublished data, 1998)3 (Fig 1). Persons of all ages are thought to be equally susceptible to infection, but the highest reported rates of Lyme disease occur in children 2 to 15 years of age and in persons 30 to 55 years of age and older.3 The principal risk factor for acquiring Lyme disease in endemic areas of the United Sates is residence in suburban or rural areas that are wooded or overgrown with brush and infested by infected vector ticks.4,5 Most cases are believed to result from periresidential exposure to infected ticks by persons engaged in recreational, leisure, or property maintenance activities.6-8 Persons who engage in recreational activities away from home (eg, hiking, camping) and in outdoor occupations (eg, landscaping, forestry) also may be at increased risk of acquiring Lyme disease.9-11 PREVENTION OF TICK BITES The ticks that can transmit Lyme disease (Ixodes scapularis, also known as the black-legged or deer tick in the eastern United States, and Ixodes pacificus, also known as the western black-legged tick in the western United States) are found in wooded areas, high grasses, marshes, gardens, and beach areas. In endemic residential areas, clearing brush and trees, removing leaf litter and woodpiles, and keeping grass mowed may reduce tick exposure by removing habitats suitable for ticks and their reservoir hosts.12 Area application of pesticides to residential properties is effective for suppressing vector ticks but may be harmful to other wildlife and people.13 Exclusion of deer from residential yards by fencing and maintaining tick-free pets also may reduce tick exposure.14 Heavily infested tick habitats, such as wooded areas, should be avoided if possible. If not possible, then use of wide trails, not straying off the trail, and not sitting on the ground may decrease exposure. Careful attention also should be given to clothing worn in these areas. Clothing should be light-colored to make tick identification easier. Long sleeves and long pants that are tight at the wrists, ankles, and waist, and long pants tucked into light colored socks are preferable. A hat should be worn in densely wooded areas. Tick and insect repellents that contain n,n-diethylm- toluamide (DEET) applied to the skin provide additional protection but require reapplication every 1 to 2 hours for maximum effectiveness. Although serious neurologic complications in children resulting from the frequent and excessive application of DEET-containing repellents have been reported, they are rare, and the risk is low when these compounds The recommendations in this statement do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. PEDIATRICS (ISSN 0031 4005). Copyright � 2000 by the American Academy of Pediatrics. 142 PEDIATRICS Vol. 105 No. 1 January 2000 Downloaded from www.pediatrics.org by on January 28, 2009 are used according to product label instructions.15-17 Therefore, DEET should be applied sparingly, according to product label instructions, only to exposed skin, and not to a child's face, hands, or skin that is irritated or abraded. After the child returns indoors, treated skin should be washed with soap and water. Concentrations of DEET greater than 30% usually are not necessary. Permethrin (a synthetic pyrethroid) is available in a repellent spray for application to clothing only and is particularly effective because it kills ticks on contact. Persons should be taught to inspect themselves and their children's bodies and clothing daily after possible tick exposure. Special attention should be given to the exposed hairy regions of the body where ticks often attach, including the heads and necks of children. Because animal studies indicate that transmission of B burgdorferi from infected ticks usually requires a prolonged duration of attachment ($48 hours), ticks should be removed promptly.18,19 The body of the tick should not be squeezed during removal. It should be grasped with a fine tweezers as close to the skin as possible and removed by gently pulling the tick straight out without twisting motions. If fingers are used to remove ticks, they should be protected with gloves or facial tissue and washed after removal of the tick. Analysis of ticks to determine if they are infected is not indicated because the predictive values of such tests in relation to the development of human disease are unknown. MANAGEMENT OF TICK BITES In many areas of the United States, the economic impact of inappropriate use of prophylactic antimicrobial agents and serologic testing for Lyme disease after deer tick bites has been substantial.20 Antimicrobial Prophylaxis Routine use of antimicrobial agents to prevent Lyme disease after a deer tick bite, even in highly endemic areas, is not recommended because it is of unproven value and is associated with potential risks and costs.21-24 Most deer ticks (70%-80%), even in highly endemic areas for Lyme disease, are not infected with B burgdorferi,24 and the risk of infection after a recognized deer tick bite in an endemic area is estimated to be only about 1.4%.23 Furthermore, almost all persons who become infected from a recognized deer tick bite will develop erythema migrans at the site of the bite, which is easily recognized and diagnostic of early Lyme disease. Children with this stage of disease can be treated easily and effectively with little risk of long-term complications.25 Based on current data, the risk of developing late Lyme disease from a recognized deer tick bite that was not treated with an antimicrobial agent and was not followed by the appearance of erythema migrans is extremely low.20 Three prospective controlled studies comparing placebo and antimicrobial prophylaxis management of tick bites have been unable to demonstrate the effectiveness of antimicrobial prophylaxis for preventing Lyme disease because of the low risk of infection or disease.23 Because the majority of tick bites are unrecognized, empiric therapy after recognized tick bites is unlikely to reduce the overall number of cases.22 Furthermore, the nature and duration of a prophylactic regimen have not been established, and prophylactic antimicrobial agents may be associated with adverse reactions and increased health care costs. Serologic Testing Serologic testing for Lyme disease at the time of a recognized tick bite is not recommended.20 There is little or no chance that a patient would have detect- Fig 1. National Lyme disease risk map. For methods used for creating this map, see: Centers for Disease Control and Prevention. Recommendations for the use of Lyme disease vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 1999;48(RR-7):21-24. AMERICAN ACADEMY OF PEDIATRICS 143 Downloaded from www.pediatrics.org by on January 28, 2009 able antibodies to B burgdorferi from a new infection at the time of the tick bite, and antibodies present at the time would likely represent a false-positive result or evidence of an earlier infection. Although some physicians obtain a serum sample at the time of a tick bite and 6 to 8 weeks later for antibody testing to provide reassurance in the absence of erythema migrans and antibiotic therapy, this practice usually is unnecessary, especially with evidence that the tick was attached for less than 48 hours, and the results may be misleading because of the inaccuracy of serologic testing for Lyme disease in many laboratories. There is a high probability of a false-positive serologic test result for Lyme disease when the probability of the presence of Lyme disease is low.26 LYME DISEASE VACCINE Animal studies have demonstrated that purified recombinant proteins, particularly of certain outer surface proteins (Osp) of B burgdorferi, such as Osp A, B, and C, induce antibody responses that are highly protective.27 The most extensively studied of the single Osp vaccines and the one currently licensed contains recombinant OspA (rOspA), which is highly protective in the mouse model when the challenge strain is homologous or closely related to the isolate from which the OspA was derived.28,29 However, when the challenge strain is different from the isolate from which the OspA was derived, protection to challenge is minimal or nonexistent. MECHANISM OF ACTION The rOspA vaccine seems to have a unique mode of action.30 Antibodies directed against the OspA are lethal to the organism, although the exact mechanism by which the antibody kills B burgdorferi is unknown. OspA is expressed by B burgdorferi residing in the midguts of dormant ticks, but expression is later downregulated in response to a blood meal.31 Therefore, patients with natural B burgdorferi infection have little exposure to OspA and minimal or absent antibody responses to OspA. Data from animal models suggest that protective OspA antibodies from the immunized host destroy B burgdorferi in the midgut of the tick, preventing transmission to the host. The vaccine-induced protection thus occurs primarily before the B burgdorferi enters the host. Antigenic differences in OspA have been observed between and within B burgdorferi genospecies, including B burgdorferi sensu stricto, Borrelia afzelii, and Borrelia garinii. In addition, strains with mutations, frame shifts, or recombinations between OspA and Osp B have been isolated. Therefore, there has been concern that a single OspA antigen cloned from a single isolate, may be insufficient to provide broad cross-protective immunity, and it may be necessary to use different OspAs in the development of vaccines intended for use in North America and Europe. 27 However, the diversity of OspA among isolates is greatest among European strains. Isolates in the United States seem to be much more homogeneous, suggesting that a single OspA antigen may be sufficient for a vaccine in this country. CLINICAL TRIALS IN HUMANS Early clinical trials, including subjects with a history of Lyme disease, demonstrated that rOspA was immunogenic and well-tolerated.32 rOspA Lyme disease vaccines have been produced by 2 manufacturers and field tested for safety and efficacy in humans. 33,34 Both vaccines are made from a rOspA expressed in Escherichia coli and purified. A lipid moiety was added after translation. LYMErix (Smith- Kline Beecham, Collegeville, PA) is prepared by using the OspA gene from B burgdorferi and contains 30 mg of purified rOspA lipidated protein combined with 0.5 mg of aluminum adjuvant. LYMErix is the only licensed Lyme disease vaccine at this time. The recommendations in the present statement apply only to the use of LYMErix; supplemental information will be provided as additional Lyme disease vaccines are licensed. A vaccine produced by Pasteur Me�rieux Connaught (Swiftwater, PA), ImuLyme, contains 30 mg of purified rOspA lipidated protein without adjuvant and is under review by the US Food and Drug Administration. ROUTE OF ADMINISTRATION, IMMUNIZATION SCHEDULE, AND DOSAGE Three doses of 0.5 mL (30 mg) of rOspA vaccine administered by intramuscular injection are required for optimal protection; the second dose is given 1 month later, and a third dose is given 12 months after the first dose. Dosages should be timed so that the second and the third doses are given several weeks before the start of the Lyme disease transmission season, which usually begins in April. Preliminary data suggest that other immunization schedules (eg, 0, 1, 6 months) are safe and induce antibody responses similar to the 0, 1, 12 month schedule.35 However, at this time, only the 0, 1, 12 month schedule is approved by the US Food and Drug Administration. EFFICACY Steere and coworkers33 conducted a multicenter, double-blind, randomized, placebo-controlled trial involving 10 936 subjects between 15 and 70 years of age. LYMErix or placebo was administered at enrollment and 1 and 12 months later. In the first year after 2 injections, the vaccine efficacy for preventing clinical Lyme disease was 49% (95% confidence interval, 15%-69%). In the second year after the third injection, the vaccine efficacy for preventing clinical Lyme disease was 76% (95% confidence interval, 58%-86%). Serologic testing was performed on study subjects at entry and 12 and 20 months later to detect asymptomatic infections with B burgdorferi. The efficacy of this vaccine for preventing asymptomatic infection was 83% in the first year after 2 doses and 100% in the second year after 3 doses. There was no evidence that the vaccine produced partial protection or mild or asymptomatic disease that could be reactivated later.36 IMMUNOGENICITY In the study by Steere and coworkers,33 a subset of adult subjects was evaluated longitudinally over 20 months for serum concentrations of anti-OspA anti- 144 PREVENTION OF LYME DISEASE Downloaded from www.pediatrics.org by on January 28, 2009 bodies. At month 2 (1 month after the second injection), the geometric mean antibody titer (GMT) of immunoglobulin G anti-OspA antibodies was 1227 enzyme-linked immunosorbent assay (ELISA) units per milliliter. At month 12 (before the third injection), the GMT was 116 ELISA units per milliliter. At month 13 (1 month after the third injection), the GMT was 6006 ELISA units per milliliter, but by month 20, the GMT was 1991 ELISA units per milliliter. Although not yet established, attempts are being made to determine a correlate of protection.37 Whether protective immunity will last longer than 1 year beyond the month 12 dose is unknown. These data suggest that boosters beyond the month 12 booster may be necessary.33,37 However, additional data are needed before recommendations about immunization with more than 3 doses of rOspA vaccine can be made. SAFETY The rOspA vaccine seems to be safe. In the study by Steere and coworkers,33 soreness at the injection site was the most frequently reported adverse event, reported without solicitation by 24% of the recipients of vaccine and 8% of the recipients of placebo (P , .001). Redness and swelling at the injection site also were reported in significantly more recipients of vaccine (2%) than of placebo (1%). In addition, significantly more recipients of vaccine than placebo reported systemic symptoms (eg, myalgias, achiness, fever, chills), but none of these symptoms was reported by more than 3% of the subjects in either group. These adverse reactions usually occurred within 48 hours after immunization and lasted a median of 3 days. The type and frequency of symptoms 30 days or more after the injections did not differ significantly between recipients of vaccine and placebo. Symptoms were usually mild or moderate in severity, and the severity usually did not increase with subsequent injections. No hypersensitivity reactions were noted. There was no evidence that the rOspA vaccine exacerbated prior Lyme arthritis, caused arthritis in subjects with a history of Lyme disease or those without such a history, or caused neurologic disease. The possibility that a rOspA vaccine could predispose to arthritis in selected persons with a genetic predisposition to this disorder exists, but no evidence of this effect has been noted. Approximately 10% of adults and fewer than 5% of children with Lyme arthritis develop inflammatory joint disease that does not respond to antimicrobial agents and typically affects 1 knee for months to years.38,39 Because of the increased frequency of certain HLA-DR4 alleles in these patients, an autoimmune mechanism has been proposed. Gross and coworkers40 showed that the immunodominant T-cell epitope of OspA bound by the HLA-DRB1*0401 molecule was antigenically cross-reactive with human leukocyte function- associated antigen-1, which could be a potential autoantigen. Persons with antibiotic treatment-resistant Lyme arthritis generated responses to OspA, human leukocyte function-associated antigen-1, and their closely related peptide epitopes, supporting a possible autoimmune mechanism involving OspA antigen associated with B burgdorferi. Arthritis occurred no more often in vaccine recipients than in the placebo recipients, including patients who had had Lyme disease and those who carry the HLA DR4 allele, although the number of such patients was limited. Thus, there is no evidence that rOspA vaccine predisposes to chronic arthritis. Safety and efficacy of rOspA vaccine has not been established in persons older than 70 years of age or younger than 15 years of age. Therefore, this vaccine is licensed only for use in persons 15 to 70 years of age. Studies are in progress to determine the safety and immunogenicity of rOspA vaccine for children 5 to 15 years of age.41 DIAGNOSIS OF LYME DISEASE IN VACCINE RECIPIENTS Recipients of the rOspA vaccine have a positive ELISA test result because whole-cell B burgdorferi is used as the antigen. The interpretation of Western immunoblot results are not affected by immunization because antibody to specific protein antigens allows identification of non-OspA antibodies, and antibody to OspA is not part of the criteria for a positive immunoblot result.42 Therefore, immunoblot testing for non-OspA antibody reactivity is essential for establishing or excluding the diagnosis of Lyme disease in rOspA vaccine recipients. COST-EFFECTIVENESS ANALYSIS Although the cost of Lyme disease has been evaluated, 43 there are few published cost-effectiveness analyses of using rOspA vaccines to prevent Lyme disease. A recent analysis by the CDC indicates that the cost of immunizing exceeds the cost of not immunizing unless the incidence of Lyme disease is more than 1% per year.44 This analysis did not consider the costs of overdiagnosis and incorrect treatment of disorders falsely attributed to Lyme disease. Most endemic states and counties report Lyme disease incidence rates that are well below 1% per year. However, some studies suggest that only 10% to 15% of physician- diagnosed cases of Lyme disease are reported to state authorities in highly endemic areas.45,46 ASSESSING THE RISK OF LYME DISEASE The decision to recommend Lyme disease vaccine should be based on a determination of risk of being bitten by tick vectors infected with B burgdorferi. This likelihood is affected by the density of vector ticks in the environment, the prevalence of B burgdorferi infection among those ticks, and individual behavior. The geographic areas of the United States with a high density of infected vector ticks are concentrated within a few northeastern and north-central states (Fig 1). However, the risk of Lyme disease within these states differs greatly, not only from one county to another, but even within counties and townships. Detailed information on the distribution of Lyme disease risk within specific areas is best obtained from local and state health departments. The accompanying map (Fig 1) identifies counties as high, moderate, low, or no risk for Lyme disease based on density of infected vector ticks and reported human cases. Activities that involve frequent or prolonged ex- AMERICAN ACADEMY OF PEDIATRICS 145 Downloaded from www.pediatrics.org by on January 28, 2009 posures to tick-infested habitats (eg, wooded, brushy, or overgrown grassy areas) substantially increase risk. Avoidance of tick-infested habitats and use of repellents may substantially reduce risk. When preventive measures have failed, morbidity from Lyme disease can be reduced substantially by detecting and treating persons with Lyme disease in the early stages. Because of the limited time of exposure, travelers to endemic areas generally are expected to be at lower risk of Lyme disease than persons who permanently reside in those areas. The desirability of immunization for travelers to areas of high risk during Lyme disease transmission season depends on the anticipated exposure to vector ticks. Travelers may obtain some protection from 2 doses of vaccine, but a full series of 3 doses, beginning 1 year before anticipated exposure, is necessary to achieve optimal protection. The Lyme disease vaccine should be considered an adjunct to, not a replacement for, the practice of personal protective measures against tick exposure and the early diagnosis and treatment of Lyme disease. Decisions about immunization to prevent Lyme disease should be based on an assessment of risk of exposure to infected ticks, use of personal protective measures against tick bites, and vaccine efficacy and costs. Lyme disease vaccine does not provide protection against other tick-borne diseases. RECOMMENDATIONS FOR PREVENTION OF LYME DISEASE 1. Attempts to minimize exposure to vector ticks in residential areas is encouraged. Heavily tick-infested areas should be avoided, if possible. If not possible, then personal protective measures (eg, wearing specific types of clothing, use of repellents, frequent checks for ticks), and early detection and treatment of disease manifestations are encouraged. 2. Routine use of antimicrobial agents to prevent Lyme disease after a deer tick bite, even in highly endemic areas, is not recommended. Serologic testing for Lyme disease at the time of a recognized tick bite also is not recommended. 3. Use of Lyme disease vaccine a. The vaccine should be considered for administration to the following persons who are 15 years of age or older: 1) Those who reside, work, or recreate in geographical areas of high or moderate risk (Fig 1) and whose activities result in frequent or prolonged exposure to vector ticks. 2) Those who visit geographical areas of high risk (Fig 1) during the peak Lyme disease transmission season and whose activities result in frequent or prolonged exposure to vector ticks. b. The vaccine may be given to persons who reside, work, or recreate in geographical areas of high or moderate risk and whose activities result in some, but neither frequent nor prolonged, exposure to vector ticks. However, the benefits of vaccine for these persons compared with those of personal protective measures and early treatment of Lyme disease are unclear. c. The vaccine is not recommended for the following: 1) Those who reside, work, or recreate in areas of high or moderate risk but who have minimal or no exposure to infected ticks. 2) Persons who reside, work, and recreate in geographical areas of low or no risk (Fig 1). 3) Children younger than 15 years of age until data about the safety and immunogenicity of this vaccine in this age group are available and the US Food and Drug Administration has approved the product for use in this age group. d. Persons with a history of Lyme disease Immunization should be considered for persons with a history of Lyme disease who are at continued high risk. However, persons with antibiotic treatment- resistant Lyme arthritis should not be immunized because of the association between this condition and immune reactivity to OspA. Persons with chronic joint or neurologic illness related to Lyme disease, as well as those with second or third degree atrioventricular block were excluded from the phase III safety and efficacy trial, and, thus, the safety and efficacy of Lyme disease vaccine for such persons is unknown. e. Simultaneous administration with other vaccines The safety and efficacy of the simultaneous administration of rOspA vaccine with other vaccines have not been established. Administration of rOspA vaccine should not interfere with the administration of routinely recommended immunizations. If rOspA vaccine is to be given concurrently with other vaccines, each should be administered in a separate syringe at a separate site. f. Persons with immunodeficiencies Data are lacking on the safety and efficacy of rOspA vaccines in persons with immunodeficiencies. General guidelines for administration of inactivated or subunit vaccines should be followed (see current edition of the Red Book). g. Vaccine use in pregnancy Because the safety of rOspA vaccine administered during pregnancy has not been established, immunization of women known to be pregnant is not recommended. A vaccine pregnancy registry has been established by SmithKline Beecham Pharmaceuticals. In the event that a pregnant woman is immunized, health care professionals are encouraged to register this immunization by calling (800) 366-8900, extension 5231. Committee on Infectious Diseases, 1998-1999 Neal A. Halsey, MD Jon S. Abramson, MD P. Joan Chesney, MD Margaret C. Fisher, MD Michael A. Gerber, MD S. Michael Marcy, MD Dennis L. Murray, MD Gary D. Overturf, MD Charles G. Prober, MD Thomas N. Saari, MD Leonard B. Weiner, MD Richard J. Whitley, MD Ex-Officio Georges Peter, MD 146 PREVENTION OF LYME DISEASE Downloaded from www.pediatrics.org by on January 28, 2009 Larry K. Pickering, MD Carol J. Baker, MD Liaison Representatives Anthony Hirsch, MD AAP Council on Pediatric Practice Richard F. Jacobs, MD American Thoracic Society Noni E. MacDonald, MD Canadian Paediatric Society Martin G. Myers, MD National Vaccine Program Office Walter A. Orenstein, MD Centers for Disease Control and Prevention Peter A. Patriarca, MD US Food and Drug Administration N. Regina Rabinovich, MD National Institutes of Health Ben Schwartz, MD Centers for Disease Control and Prevention Consultant Edward B. Hayes, MD Centers for Disease Control and Prevention REFERENCES 1. Nadelman RB, Wormser GP. Lyme borreliosis. Lancet. 1998;352:557-565 2. Shapiro ED. Lyme disease. Pediatr Rev. 1998;19:147-154 3. Dennis DT. Epidemiology, ecology, and prevention of Lyme disease. In: Rahn DW, Evans J, eds. Lyme Disease. Philadelphia, PA: American College of Physicians; 1998:7-34 4. Falco RC, Fish D. Ticks parasitizing humans in a Lyme disease endemic area of southern New York State. Am J Epidemiol. 1988;128:1146-1152 5. Maupin GO, Fish D, Zultowsky J, Campos EG, Piesman J. Landscape ecology of Lyme disease in a residential area of Westchester County, New York. Am J Epidemiol. 1991;133:1105-1113 6. Orloski KA, Campbell GL, Genese CA, et al. Emergence of Lyme disease in Hunterdon County, New Jersey, 1993: a case-control study of risk factors and evaluation of reporting patterns. Am J Epidemiol. 1998;147:391-397 7. Cromley EK, Cartter ML, Mrozinski RD, Ertel SH. Residential setting as a risk factor for Lyme disease in a hyperendemic region. Am J Epidemiol. 1998;147:472-477 8. Lane RS, Manweiler SA, Stubbs HA, Lennette ET, Madigan JE, Lavoie PE. Risk factors for Lyme disease in a small rural community in northern California. Am J Epidemiol. 1992;136:1358-1368 9. Kitron U, Kazmierczak JJ. Spatial analysis of the distribution of Lyme disease in Wisconsin. Am J Epidemiol. 1997;145:558-566 10. Schwartz BS, Goldstein MD, Childs JE. Antibodies to Borrelia burgdorferi and tick salivary gland proteins in New Jersey outdoor workers. Am J Public Health. 1993;83:1746-1748 11. Smith PF, Benach JL, White DJ, Stroup DF, Morse DL. Occupational risk of Lyme disease in endemic areas of New York State. Ann N Y Acad Sci. 1988;539:289-301 12. Schulze TL, Jordan RA, Hung RW. Suppression of subadult Ixodes scapularis (Acari: Ixodidae) following removal of leaf litter. J Med Entomol. 1995;32:730-733 13. Curran KL, Fish D, Piesman J. Reduction of nymphal Ixodes dammini (Acari: Ixodidae) in a residential suburban landscape by area application of insecticides. J Med Entomol. 1993;30:107-113 14. Hayes EB, Maupin GO, Mount GA, Piesman J. Assessing the effectiveness of local Lyme disease control. J Public Health Manage Pract. 1999;5:86-94 15. Centers for Disease Control. Seizures temporally associated with use of DEET insect repellent: New York and Connecticut. MMWR Morb Mortal Wkly Rep. 1989;38:678-680 16. Fradin MS. Mosquitoes and mosquito repellents: a clinician's guide. Ann Intern Med. 1998;128:931-940 17. Brown M, Hebert AA. Insect repellents: an overview. J Am Acad Dermatol. 1997;36:243-249 18. Piesman J. Dynamics of Borrelia burgdorferi transmission by nymphal Ixodes dammini ticks. J Infect Dis. 1993;167:1082-1085 19. Piesman J, Mather TN, Sinsky RJ, Spielman A. Duration of tick attachment and Borrelia burgdorferi transmission. J Clin Microbiol. 1987;25:557-558 20. Fix AD, Strickland GT, Grant J. Tick bites and Lyme disease in an endemic setting: problematic use of serologic testing and prophylactic antibiotic therapy. JAMA. 1998;279:206-210 21. Magid D, Schwartz B, Craft J, Schwartz JS. Prevention of Lyme disease after tick bites: a cost-effectiveness analysis. N Engl J Med. 1992;327:534-541 22. Dennis DT, Meltzer MI. Antibiotic prophylaxis after tick bites. Lancet. 1997;350:1191-1192 23. Warshafsky S, Nowakowski J, Nadelman RB, Kamer RS, Peterson SJ, Wormser GP. Efficacy of antibiotic prophylaxis for prevention of Lyme disease. J Gen Intern Med. 1996;11:329-333 24. Shapiro ED, Gerber MA, Holabird NB, et al. A controlled trial of antimicrobial prophylaxis for Lyme disease after deer-ticks bites. N Engl J Med. 1992;327:1769-1773 25. Gerber MA, Shapiro ED, Burke GS, Parcells VJ, Bell GL, and the Pediatric Lyme Disease Study Group. Lyme disease in children in southeastern Connecticut. N Engl J Med. 1996;335:1270-1274 26. Seltzer EG, Shapiro ED. Misdiagnosis of Lyme disease: when not to order serologic tests. Pediatr Infect Dis J. 1996;15:762-763 27. Wormser GP. Lyme disease vaccine. Infection. 1996;24:203-207 28. Fikrig E, Barthold SW, Kantor FS, Flavell RA. Protection of mice against the Lyme disease agent by immunizing with recombinant Osp A. Science. 1990;250:553-556 29. Schaible UE, Kramer MD, Eichmann K, Modolell M, Museteanu C, Simon MM. Monoclonal antibodies specific for the outer surface protein A (OspA) of Borrelia burgdorferi prevent Lyme borreliosis in severe combined immunodeficiency (SCID) mice. Proc Natl Acad Sci U S A. 1990;87:3768-3772 30. de Silva AM, Telford SR III, Brunet LR, Barthold SW, Fikrig E. Borrelia burgdorferi OspA is an arthropod-specific transmission-blocking Lyme disease vaccine. J Exp Med. 1996;183:271-275 31. Schwan TG, Piesman J, Golde WT, Dolan MC, Rosa PA. Induction of an outer surface protein on Borrelia burgdorferi during tick feeding. Proc Natl Acad Sci U S A. 1995;92:2909-2913 32. Schoen RT, Meurice F, Brunet CM, et al. Safety and immunogenicity of an outer-surface protein A vaccine in subjects with previous Lyme disease. J Infect Dis. 1995;172:1324-1329 33. Steere AC, Sikand VK, Meurice F, et al, and the Lyme Disease Vaccine Study Group. Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. N Engl J Med. 1998;339:209-215 34. Sigal HL, Zahradnik JM, Lavin P, et al, and the Recombinant Outer- Surface Protein A Lyme Disease Vaccine Study Consortium. A vaccine consisting of recombinant Borrelia burgdorferi outer-surface protein A to prevent Lyme disease. N Engl J Med. 1998;339:216-222 35. Van Hoecke C, Lebacq E, Beran J, Perenti D. Alternative vaccination schedules(0, 1, 6 months versus 0, 1, 12 months) for a recombinant OspA Lyme disease vaccine. Clin Infect Dis. 1999;28:1260-1264 36. Steigbigel RT, Benach JL. Immunization against Lyme disease: an important first step. N Engl J Med. 1998;339:263-264 37. Parenti DL, Gillet M, Sennewald E, et al. Correlate of protection for Lyme disease (LD) using LYMErix recombinant adjuvanted Borrelia burgdorferi outer surface lipoprotein A (L-OspA) vaccine. In: Program and abstracts of the 36th Annual Meeting of the Infectious Diseases Society of America; November 12-15, 1998; Denver, CO. Abstract 704 38. Steere AC, Levin RE, Molloy PJ, et al. Treatment of Lyme arthritis. Arthritis Rheum. 1994;37:878-888 39. Gerber MA, Zemel LS, Shapiro ED. Lyme arthritis in children: clinical epidemiology and long-term outcomes. Pediatrics. 1998;102:905-908 40. Gross DM, Forsthuber T, Tary-Lehmann M, et al. Identification of LFA-1 as a candidate autoantigen in treatment-resistant Lyme arthritis. Science. 1998;281:703-706 41. Feder HM, Beran J, Van Hoecke C, et al. Immunogenicity of a recombinant Borrelia burgdorferi outer surface protein A vaccine against Lyme disease in children. J Pediatr. 1999;135:575-579 42. Zhang YQ, Mathiesen D, Kolbert CP, et al. Borrelia burgdorferi enzymelinked immunosorbent assay for discrimination of OspA vaccination from spirochete infection. J Clin Microbiol. 1997;35:233-238 43. Maes E, Lecomte P, Ray N. A cost-of-illness study of Lyme disease in the United States. Clin Ther. 1998;20:993-1008 44. Meltzer MI, Dennis DT, Orloski KA. The cost effectiveness of vaccinating against Lyme disease. Emerg Infect Dis. 1999;5:321-328 45. Coyle BS, Strickland GT, Liang YY, Pena C, McCarter R, Israel E. The public health impact of Lyme disease in Maryland. J Infect Dis. 1996; 173:1260-1262 46. Meek JI, Roberts CL, Smith EV, Cartter ML. Underreporting of Lyme disease by Connecticut physicians, 1992. J Public Health Manage Pract. 1996;2:61-65 AMERICAN ACADEMY OF PEDIATRICS 147 Downloaded from www.pediatrics.org by on January 28, 2009 DOI: 10.1542/peds.105.1.142 Pediatrics 2000;105;142-147 Committee on Infectious Diseases Prevention of Lyme Disease & Services Updated Information http://www.pediatrics.org/cgi/content/full/105/1/142 including high-resolution figures, can be found at: Supplementary Material http://www.pediatrics.org/cgi/content/full/105/1/142/DC1 Supplementary material can be found at: References http://www.pediatrics.org/cgi/content/full/105/1/142#BIBL at: This article cites 44 articles, 24 of which you can access for free Citations s http://www.pediatrics.org/cgi/content/full/105/1/142#otherarticle This article has been cited by 5 HighWire-hosted articles: Subspecialty Collections http://www.pediatrics.org/cgi/collection/office_practice Office Practice following collection(s): This article, along with others on similar topics, appears in the Permissions & Licensing http://www.pediatrics.org/misc/Permissions.shtml tables) or in its entirety can be found online at: Information about reproducing this article in parts (figures, Reprints http://www.pediatrics.org/misc/reprints.shtml Information about ordering reprints can be found online: Downloaded from www.pediatrics.org by on January 28, 2009
Posted by lou (Member # 81) on :
Think you should send this to Lorraine. Her position on false positives and on a vaccine that harmed some people should be relevant to her ability to sit on the panel.
Posted by lymeloco (Member # 7192) on :
Dr.William A. Charini, is an infectious disease doctor. How is that not a conflict?
Posted by liesandmorelies (Member # 15323) on :
Yes, I agree Lou I will send this on to Lorraine..
Although this is an old abstract, this harmed people and now this same person is going to decide how I am supposed to be treated???
Dr. Carol Baker was also the president of the IDSA in 2001 I believe.
Posted by lymeloco (Member # 7192) on :
Most of these people are associated with infectious diseases and many have Harvard and Yale ties. I see little chance that they are going to give the medical literature a fair hearing and it is most unlikely that they treat chronic lyme disease.
So, anyone out there that has dug up prejudicial info on any of these people should be sure to send it on to lorraine, who is gathering it:
While I do not know anything specific about the doctor listed from Duke, Duke in general has been extremely anti-Lyme. I got into a heated editorial exchange with a Duke ID doctor who decided to take exception to a short article in a newspaper advising area residents to beware of Lyme Disease (which was actually a little AP article like you see all the time in newspapers). An editor loved the exchange and ended up assigning a reporter to do a story. The reporter did a 2 page article, pics and all, and featured the stories of area Lyme patients.
If you called Duke ID department to this day and ask if they treat Lyme Disease, they would say "no" and refuse to schedule an appointment.
That being said, I will see if I can find any info on this Duke doc.
Posted by lymeloco (Member # 7192) on :
Interesting ... provided he isn't a "plant" from the powers that be at Duke. Looks promising, as long as he is able to offer HIS OWN opinion and not the opinion of OTHERS. Look at the title of the article listed at the end .. interesting - a comparison of malaria and babs. Gotta look that one up.
Paul M. Lantos, MD Departments / Divisions: Medicine / General Internal Medicine Hospital Medicine / Duke Hospital Medicine Program Pediatrics / Infectious Diseases Address: DUMC 100800 Durham, NC 27704
Office Telephone: 919-681-8263
Fax Telephone: 919-668-5394
Training:
MD, University of Connecticut School of Medicine, 2000
Residency:
Internal Medicine/Pediatrics, University of Connecticut School of Medicine, 2004
Fellowship:
Pediatric Infectious Diseases, Children's Hospital Boston and Harvard Medical School (Massachusetts), 2007
Clinical Interests: Hospital medicine, consultative general internal medicine for inpatients, medical education, tropical medicine and international health, malaria and other parasitic diseases, tick-borne diseases such as Lyme disease, mosquito-borne diseases such as encephalitis
Research Interests: Tropical and parasitic diseases, travel medicine, mosquito-borne diseases (including malaria, dengue, and encephalitis), tick-borne infections (including babesiosis, Lyme disease, Rocky Mountain Spotted Fever, and ehrlichiosis), HIV / AIDS, infections in immunocompromised hosts, and general infectious diseases of newborns and children.
Representative Publications: Krause PJ, Daily J, Telford SR, Vannier E, Lantos P, Spielman A. Shared features in the pathobiology of babesiosis and malaria. Trends Parasitol. 2007 Dec;23(12):605-10. (2007) Abstract
Posted by Ocean (Member # 3496) on :
Makes sense, don't put any experts on the panel.
Ya think they lined up a bunch of dermatologists for the panel for the American Heart Assoc? Now THAT would cause a public outcry.
What a shame... esp with the possible new health care system coming in, LLMD's will have even less leverage, if any at all.
Posted by METALLlC BLUE (Member # 6628) on :
I'll spend the next few weeks researching each physician and organizing a summary report, as well as references to the sources in order to confirm their positions and bias.
One name at a time isn't too hard to do. I just spend two days doing each one, and I can probably go over just about everything.
Posted by METALLlC BLUE (Member # 6628) on :
I'm reviewing RateMD.com too because I'm finding patient reports. They are a sign of the physicians quality of care and methodology.
Posted by bettyg (Member # 6147) on :
if you want background on these panel folks, go to ACTIVISM and read lynn shepler's post!! informative!!
many conflicts of interest and being IDSA members as well as infectious drs! Posted by Tincup (Member # 5829) on :
Wow.. you guys are great!
Look at all this come together, plans and ideas! I am overwhelmed!
I've been back and forth reading your comments all day.. and can't address everything tonight of course.. I am SO exhausted.... but..
I got a call a couple of hours ago... and there will be a press release coming out in the next day or two (if all goes well).. and some ideas on what can be done to get the most bang for our buck.
Some actions are NOT recommended.. for a bunch of good reasons.. and some are thought to be better for the cause.
Right now I was told that contacting the AG or the omnebudsman thingy, is not the best idea. There are good reasons that I will share more about later.
Your choice as to what you want to do though... but I am going to wait till all the big whigs have what they need (research/info) to make the best informed decisions.. and share that info before I take action.
BTW- I told them of your work here... and said it was bountiful to say the least! They were impressed and WILL be wanting it for review. So don't quit researching and posting.
Dig baby dig.
Thoughts are right now that someone will be collecting your research as it comes to light (assuming you don't mind of course)... and then a BIG fat letter will be headed to those who will hopefully pay attention and those who should see it.
I'd chat more but I am past ready to drop.
Posted by Briannh (Member # 17555) on :
quote:Originally posted by liesandmorelies: This is from the Lahey Clinic in Massachusetts. Dr. Chirini is an Infectious Disease Doctor there. I will send this on too.
This one will make your hand stand up on your neck!!!
I am in the process of filing a complaint against the lahey clinic ID dept. for their false advertising of being a Lyme competent hospital and that i was turned away despite being very ill with Lyme disease.
I will spare all the detail but i was seen on November 10th very sick with a positive Lyme test from Quest. i was told their stand is that anyone that takes 20 days of doxy should be cured of Lyme period, and if symptoms persist after that, than it is something other than lyme.
They ran no tests of their own, did nothing. This delayed me getting proper treatment and as a result i got sicker.
ETA: They all work as a team there. In addition, the Dr I saw at the lahey warned me that if i saw a particular well known LLMD in mass, that i would be seriously harmed by his treatment.
Posted by METALLlC BLUE (Member # 6628) on :
Here is more information on Paul Lantos. Dr. Lantos wrote a chapter discussing his experiences that led him to medicine and the mini-bio is in-depth and personal. He is the survivor of holocaust victims from his family, and is quite impressive in his desire to help people.
Baker is biased and Pro-IDSA, - Her stance on vaccination with Lyrix as well as pro-vaccination in other areas is clear. She has led conferences which discussed "Lyme Disease physicians who treat patients for years with Ceftriaxone, and the societies conflicts associated with this group. She has published numberous reports on the government pub-med database indicating her position on duration of tick attachment, the effectiveness and accuracy of Western Blot and Assay, as well perpetually indicating that the bullseye rash is nearly always present, and if it is not, then Lyme Disease is not of concern.
Lantos is Unbiased, -- History of intense interest in vector borne diseases of all types, ranging from tropical diseases: malaria, etc, through Lyme Disease and tick-born infections. His history suggests a personal desire to help people, and he has an intense interest in protecting and healing children.
Charini is Pro-IDSA. Patient reports indicate that he's a semi-effective clinician who sometimes hits and misses with his patients. Most patients however would not recommend him to their family members.
Manuel Moro, DVM, MPH, Ph.D. appears to be pro ILADS, with fundamental research and discussions at lectures alongside multiple researchers who have discovered aspects of Lyme and co-infections that cause Chronic Disease and persistent.
I'm going to collect all the sources and piece together and summarize why it is clear they are leaning to one side or the other, or are center and unbiased.
These are very vague reports. I am only searching for names, addresses, phone numbers, specialities, and interests right now. I am not researching indepth, so any information is things I stumbled across "before" I've actually started digging for actual facts.
Posted by Cold Feet (Member # 9882) on :
Brian, we should talk! After all, look at my signature!
I've talked to many patients in the past few years have been neglected by the doctors at Lahey; some cases were incredibly negligent.
Even when found positive by EM (rash) and blood tests, patients wil get a few weeks of doxy; sometimes four weeks.
I've written the CEO there complaining about the specifics -- but nothing changed. I did get a nice letter from their "patient advocates" explaining their concerns...but the neglect continues.
It is very interesting how much detail Lahey puts on their web site now - complete with photographs of infected blood cells! Very odd, given their crappy diagnostics and treatment guidelines.
Sorry to hijack the thread. PM me if I can help.
Posted by liesandmorelies (Member # 15323) on :
WOW!!!!
I think I opened pandoras box. I agree with Tincup that we should sit tight and keep digging. Get our ducks in order.
It's amazing what you can find when you look through the magnafying glass.
You guys are the best.
Sometimes I sit here with this disease and the whole thing seems so sureal. I can't believe that we have to deal with all this nonsense let alone the symptoms of this horrible disease to boot.
I am encouraged by what I am seeing here though.
Posted by METALLlC BLUE (Member # 6628) on :
Ok, I'm almost done with the summary list. It was actually easy to get most of their e-mail addresses and positions, but now the hard part is documenting "everything" to prove it, which will take days.
Weinstein is perhaps the most outspoken of the new panel regarding his bias. On so many levels he's expressed the standard IDSA perspective. However, it's the dogmatic way in which he expresses it which clearly indicates his mind has already been made up, regardless of the research indicating otherwise.
He said this on the New York Medical College website:
"Over the years, testing for Lyme has become controversial, which disturbs Dr. Weinstein. Since he was a member of the committee that developed the standards for Lyme testing--now referred to as the Dearborn criteria and used throughout the nation--he is especially perturbed when the tests are maligned as unreliable. "What is unreliable is the interpretation of results by doctors and patients," he claims. "A patient can have nine negative tests and then one positive one and the diagnosis is mistakenly confirmed...The best test would be to culture the bug, like you do for a urinary infection. But the Lyme bug is slow growing and you have to decide whether to treat or not before the culture is finished. Besides, the lab test to grow the bug is not very sensitive and too many patients have negative cultures of the skin or blood for it to be a routine test."
Then he says:
But overall, 70 to 80 percent will have a positive test one to two months after being infected, says Dr. Weinstein, and in late Lyme arthritis, the test is virtually always positive months after the infection.
The studies he performed: Double Blind Placebo trials referenced and relied heavily on panelist members research from the "Prior IDSA" panel. He also worked with Mark S. Klempner, M.D on a major NIH study well known, extremely well known to be a pro-IDSA advocate.
He also worked with Yale-New Haven Hospital in Connecticut (Janine Evans, M.D. She was involved in studies referenced by the IDSA in creating their guidelines. A study called:
The consequences of overdiagnosis and overtreatment of Lyme disease: an observational study. Ann Intern Med 1998; 128:354-362.
She was also involved in another study used by the IDSA panels original guidelines called:
Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med 2001; 345:85-92.
I also found this -- just for kicks, on the IDSA guide site. They sure do spend a lot of time trying to get Chronic Lyme Disease laws blocked.
Advocacy Efforts
IDSA Sends Letter Opposing Lyme Disease Legislation in House and Senate 3/21/2008
IDSA Members Testify before the Pennsylvania House Health and Human Services Committee on Appropriate Treatments for Lyme Disease 11/15/2007
IDSA Sends Letters to the NGA and NCSL Regarding Problematic Lyme Disease Legislation 08/07/2007
IDSA Urges the Massachusetts Joint Committee on Public Health to Oppose House Bill 3768 07/12/2007
IDSA Sends Letter Urging Maine Legislators Urging to Invite Board-Certified ID Physicians to Testify at Lyme Disease Hearing 07/03/2007
IDSA Sends Letter Urging Rhode Island State Senators to Amend Joint Resolution 5676 06/19/2007
IDSA Urges Pennsylvania State Senators to Oppose Enactment of Lyme Disease Legislation 04/10/2007
IDSA Sends Letter to Educate Members of Congress on our Lyme Disease Guidelines 01/07/2007 Articles
IDSA Stands Up For Lyme Disease Guidelines Summer 2007
IDSA Releases Updated Lyme Disease Guidelines Fall 2006
IDSA Works to Inform Public About Lyme Disease Summer 2006
[ 01-29-2009, 01:06 PM: Message edited by: METALLlC BLUE ]
Posted by lymeloco (Member # 7192) on :
I noticed the same thing. The IDSA is doing everything to block these bills. They will never admit they were wrong and are all covering their butts. WHY????
Instinctively, I do beleive the only way in the long run that we will win this is to go around them. The more and more ppl that get on board with what we are trying to do will really help.
Also, it's funny that Weinstein does not tell the truth about the nine tests that are negatvie. Those are usually the 9 that are the baisic elisa(they don't do the western blot) unless the basic is positvie and lets not even talk about all the bands they removed. why did they remove those? GEEZ
Good work!!!!
Posted by lymeloco (Member # 7192) on :
Additional news. Both Gerald Medoff and Carole Baker were given Mentor Awards by the IDSA in 2008.
Posted by Dekrator48 (Member # 18239) on :
Hi,
I also find this process to be a travesty.
Who will be testifying at the hearings? Do we know how many ILADS MD's will be testifying? Can we testify???? How are the people testifying chosen??
It is vitally important that alot of solid information is presented showing how many people have required long term Rx to recover.
In reading the review information on the IDSA site it says, "IDSA guidelines-like all medical societies' guidelines-are voluntary.They are for the benefit of physicians seeking the best possible advice from experts in the field."
Now, I ask you...how can the guidelines contain the best possible advice from experts in the field if they are not set by THE BEST EXPERTS IN THE FIELD....notably the MD's who treat thousands of lyme patients???
If the MD's who treat the most patients are not highly involved in the process and not included on the panel who votes on all changes, then the chances of getting the best advice from the best experts is very low.
It also says in the IDSA article that Howard Brody, MD PhD was jointly selected by the Office of the AG and IDSA as an Ombudsman. He will have a LIMITED role focusing on screening potential conflicts of interest. He will have no involvement in the operation of the panel. Only ONE person with a LIMITED role, will focus on screening for conflicts of interest!!!
It seems that the IDSA president has already determined that questions about the guidelines will be put to rest. He says so in the article!!
He also writes that, "The IDSA Lyme disease guidelines recommend against long-term antibiotic therapy, an unproven and potentially dangerous treatment. A small group pf physicians outside the medical mainstream and their patients endorse such long-term treatment, despite the compelling medical evidence that it is ineffective and can have serious life threatening complications-and, furthermore, is extremely expensive."
Now...doesn't that just get your dander up???
A small group of physicians and patients...?????
They need to see all the signatures of all the LLMD's and their patients, and they need to hear our voices!!!!!!!!!!!!!
We must find the best and most effective way to make sure that we are all heard....especially lots of testimony from LLMD's who have treated thousands of us!!!
Posted by bettyg (Member # 6147) on :
wow, you folks have been busy researching!! what a team effort.
tc, i edited my other post removing comment about contacting ombudsman, etc. BEFORE you posted latest news here from shiela....
Posted by Geneal (Member # 10375) on :
Whoa!
I feel like someone that has had a piece of candy
Dangled in front of my face,
Only to be eaten by the one holding it!
Is this panel just another front for the ongoing
Monopoly of the Holier Than Thou IDSA and Insurance companies?
It makes me sick.
I am ready and willing to take whatever actions necessary
To thwart this mockery of an "objectve" panel.
I will continue to watch and monitor.
I am looking forward to taking action when the time is deemed right.
(We shouldn't have to).
Hugs,
Geneal
Posted by Robin123 (Member # 9197) on :
Metallic Blue - thx for your great work! Just to let you know, Dr. Weinstein is no longer on the panel list.
Posted by METALLlC BLUE (Member # 6628) on :
Robin, where did you confirm this? And do you know who else is on the list?
Posted by METALLlC BLUE (Member # 6628) on :
Ok, I'm done with the summaries. Here are the preliminary results.
All e-mail addresses were found for all panel members (except Weinstein, who is apparently assumed to no longer be on the list (I must confirm it up the chain)
All phone numbers were found
All addresses were found
All specialities were found
All interests in research of conditions found
All subjective indications of bias/non-bias/unknown-bias were defined after extensive research. More research may alter the "unknown" individuals, and there is a very low probability of altering those with known bias for either ILADS or IDSA given statements they have made or research they have conducted.
Now the data on subjective recognition of what I've seen in the research on Chronic Lyme Disease or persistent borrelia burdorferi infection must be cross referenced once more to confirm the status of each members "assumptions, or bias" based on their stance on traditionally held values of prior IDSA guidelines or prior ILADS guidelines. If the individual falls in neither category and has never worked on cases of Lyme Disease -- I "presume", though can't prove, that they are unbiased nor pro-IDSA/ILADS, and thus are listed as unknown. Those who are unbiased are those who have neither made statements for or against IDSA or ILADS notions of the disease, but who have done research on Lyme Disease, and continue to "openly" confirm that they don't know the answers but are still in process, thus they are confirmed as unbiased.
Here is the preliminary list of bias and the physicians specialities and interests. I will not provide any other information on the physicians, that data will be supplied to the lead advocates handling the proactive advance to ensure this panel dose not proceed with the bias of the prior IDSA panels without balance.
Dr. Carole Baker Pediatric Infectious Disease Vaccination, Group B streptococcus Pro IDSA
Dr. William Charini Infectious Disease & Internal Medicine HIV Pro IDSA
Dr. Paul Duray Dermapathology Lyme Disease, Cancer/Lymphoma Unbiased
Dr. Paul Lantos Pediatric Infectious Disease & IM Vector Born Disease Unbiased
Dr. Gerald Medoff Infectious Disease histoplasma capsulutum, Candida, mycoes Unknown
Dr. Manuel Moro DVM, MPH, PhD Infectious diseases/zoonoses Tick Born Disease Pro ILADS
Dr. David Mushatt Infectious Disease HIV & Mycobacteria Pro IDSA
Dr. Jeffrey Parsonnet Infectious Disease HIV, Sepsis, Toxic Shock Pro IDSA
Dr. John Sanders Infectious Disease Vector Disease, traveler's diarrhea Unknown
Dr. Arthur Weinstein Rheumatology Lyme Disease, Lupus, Gout, Pro IDSA
All data has been collected with an unbiased point of view on my part. Data is only compared once more, in contrast to IDSA guidelines or ILADS guidelines, or neither.
Example: A physician states that Lyme Disease is cured in almost all case with a short course of antibiotics regardless of whether they have late stage Lyme Disease or Acute Lyme Disease
This physician would of course be listed as a pro-IDSA individual.
Example: A physician states that Lyme Disease is treated based on a clinical diagnosis. Test results are tools that help in supporting the diagnosis, but unreliability in the available testing requires a full patient history, test results, objective clinical presentations including rash, swollen joints, bells palsey, or subjective complaints which have not been adequately diagnosed inspite of widespread testing. Antibiotic treatment will be used to gauge whether the patient has a Herxheimer reaction or reports improvements. Brain SPECT scans and further Western Blot testing may be used through a specialty lab that works with Tick-Born Illness.
This physician is obviously follows a pro-ILADS position.
Example: Physician lectures with both IDSA and ILADS physicians, and discusses the "unknown" aspects of what is seen objectively through scientific testing, experiments and so forth. "I see patients with a particular array of abnormalities in tissues. I have found Spirochettes within tissues in acute cases but I have not seen them once the patient is treated with Antibiotics, however that doesn't mean they aren't there, we are still in the midst of understanding this complicated disease."
This physician is obviously unbiased, and neither supports the IDSA position nor ILADS position.
Posted by TerryK (Member # 8552) on :
Page 8, B Must not have previously published a particular viewpoint on lyme disease diagnosis or treatment.
I'd save all the documents that you find to your hard drive. I expect as soon as they get wind of this they will remove as much info from the internet as they possibly can if they haven't already.
Terry
Posted by Tincup (Member # 5829) on :
More work done. GREAT! I will try to read it all soon.. probably not tonight. But do know your work IS being noticed!!!
I just learned an update will be out shortly that will answer some of your questions.. hopefully tonight.
As soon as it is available.. I will post it on a new post. This one is getting sooooooo long! That's good though! Keep it up!!!
Posted by Robin123 (Member # 9197) on :
Metallic, Phyllis Mervine, pres of CALDA, said so in two threads in Activism: in the CALDA's New Blogs thread and the Update on IDSA Guidelines Review Panel one, that Dr Weinstein is no longer on the panel.
Posted by liesandmorelies (Member # 15323) on :
I agree with Terry,
Everyone save everything and anything to your hard drive. Also, I recommend making copies and keeping in a binder as well.(you never know)
If any of them do try to rid evidence it will make them look all the more guilty if we can show that they did that.
Posted by Tincup (Member # 5829) on :
UPDATE- JUST posted. A list of question and answers to help explain.
Thank you Robin. Now, onto further research to support bias based on playing by their rules.
quote: The ethicist did not consider short term treatment bias (e.g. "IDSA speak") as a ground for exclusion from the panel.
This is going to be hard to work with. If a physicians behavior and thought process agree with the currently flawed guidelines of the IDSA, then It's going to create a vacuum and objective and subjective truth will be obscured and easily manipulated. Working around such obstacles while difficult, should be something I can do. They gave us enough "rules" where we should be able to pin down enough conflicts of (COI). or Unbiased views.
The interesting irony here is that we're now seeing the stark contrast between tangible conflicts of interest and philosophical conflicts, such as those of dogmatic fervor among scientists caught up in scientific revolutions.
I speak often here about Thomas Khune, who wrote "The Structure Of Scientific Revolutions -- a famous essay in which he discusses the mechanics of how science progress, and how the individuals who make up the community of scientists come to hold to, or move onto new theories as prior theories are unsustained by information.
Physicians gain bias and often cling to old theories in-spite of objective evidence to the contrary, as a consequece of having spent entire careers focused on their particular theory. Attachments form, and any opposition which betrays that dogma is met with disagreement, and resistence.
All theories in history moved through a scientific revolution in order that the be firmly established among the mainstream. To be widely agreed upon, this process must take place.
The stage of Tick-born illness: Lyme and associated diseases (including other vectors) causing the same illness -- are under heavy scrutiny now, as an entire theory is being challenged. The IDSA point of view is being challenged by new information which is constantly coming in.
As a consequence, those with bias, who are able to control the mechanisms of how the theory itself is sustained, can act in ways which rebuke studies in opposition. The dogmatic bias leads researchers to some unconsciously create studies that appear quite objective, but are already subjectively tainted by the facts they use to obscure the conclusion.
Examples of this are seen across nearly all the double blind placebo controlled trials that were done for Chronic Lyme disease. One single mono therapy was used in one case, or perhaps patients were selected with a control group having Fibromyalgia, etc. If patients actually got worse, it was seen as a failure rather than the potentiality of a patients healing crisis. Studies that were in danger of coming to conclusions that oppose the view point of the bias physician were sometimes "prematurely ended." to prevent a complete evaluation and understanding among peers.
And so, a very large portion of what we call "Bias" is being directly ignored and catogorized in exactly the same way Dr. Steere defined patients with "major and minor" symptoms in early Lyme Disease. Those who didn't have the rash, swollen joints, or late stage manifestions such as encephalitis, heart block, Endocarditis, or Facial Palsey, were seen as having "minor" problems, and were relegated to fitting outside the "Lyme Disease" diagnostic and treatment criteria. These patients could have severe cognitive deficits, intense neuropathy and pain, digestive abnormalities, and debilitating crippling fatigue -- to the point many were bedridden from symptoms, but they weren't included, because they were defined as "minor."
Defining parameters in such a way for a panel is no different than for the definition of a disease. However, again, if I'm forced to oblige that they've put a prisoner in charge of running the prison, I'll do my best to work with it.
I would feel the same way if they put all ILADS doctors on the panel. It would not be appropriate. Scientific objectivity is crucial, but so is scientific subjectivity and experience. The panel must be balanced in order for us to actually progress in formulating appropriate guidelines based on all of those accounts.
quote: The ethicist determined that Carol Baker did not have a conflict of interest and did not regard her organizational affiliation (past president IDSA) as a conflict.
Interesting. So, an individual who was given an award in over a number of years by her organization (2008 most recently) isn't going to be recognized as biased towards toeing the line for her organization, one that not only has she led, but that rewards her? Having been a past president who has conducted campaigns against physicians who treated patients outside the confines of the guidelines that she oversaw during her presidency in 2001, is a conflict of interest. Perhaps not financially, but philosophically. However, if I can't apply such logic, another route will be taken.
quote: The ethicist rejected physicians who derived more than $10,000 per year from treating Lyme patients from the panel on the basis of a conflict of interest.
This one is easier than people think. I know a lot of researchers who don't see patient, but who are doing a lot of research on Lyme Disease without bias -- who have come to multiple conclusions (Most of which indicate that they "don't know". Paul Duray is one example. Moro is another example, his Pro-ILADS perspective isn't a bias if the same rules apply that apply to the IDSA, because he's simply making statements, not actually inherently conflicted by the rules layed forth by the ethicist.
So, there are plenty of other researchers to replace conflicted members.
quote:
The settlement agreement does require that the panel be balanced. We believe that the panel cannot be balanced unless treating physicians are included in the panel and that the concept of bias (beliefs, opinions, predispositions) matters in this context.
Some treating physicians are on the panel, they just aren't heavily experienced, nor are they experts. There are also physicians who previously treated patients but no longer do. I agree with the philosophical aspect of bias as indicated above, however since they have already made a decision, we must work around it. We've got libraries, countless scientific journals, databases -- and an entire internet to scour for each individuals name. Finding facts in accordance with the agreement between the IDSA and AG should be possible if people take the time to look.
Let's get to work.
Posted by METALLlC BLUE (Member # 6628) on :
Ok, here are the rules I'm applying from the agreement directly. I have broken down the agreement to only the factors that apply to us in researching the panel members. This information will help you understand what is and isn't relevant in your own report.
Break each down, research each and apply it to each panel members.
quote: CHAIRPERSON
1: Chairperson have been determined to be without any beneficial or financial interest related to LD, any financial relationship with an entity that has an interest in LD and any conflicts of interest.
Agreement defines conflict of interest as:
2: Financial/beneficial interest -- products, concepts addressed, competing products/concepts that might bias his or her judgment.
3: The cap chosen arbitrarily defining an interest in products or concepts in guidelines should not exceed 10,000, else may constitute bias.
4: No publication of a particular view in diagnosis or treatment
5: Knowledge must be present, though expertise unnecessary
6: Experienced in reviewing and interpreting literature (Med/Sci)
7: Complete tasks in timely manner/Consider varying points of view, bring groups of individuals to consensus.
8: Must not have served on "ANY" Lyme Disease guidelines panel (Including other associations, including Neurology, etc
Does Dr. Baker meet these rules. Some are purely speculative or subjective. Try to adapt the information based on your personal opinion of what is timely, argumentative/leadership oriented qualities, and unbiased perspective (perhaps use my prior definition)
quote: REVIEW PANEL MEMBERS
1: SPGC choose group "balanced variety of perspectives relevant disciplines, clinical experience in treating patients, as well as investigating best way to diagnose and treat it (and other ID's)
2: One M.D. must have clinical experience in treating LD patients.
3: Must not served on "any" LD panel
Do all panel members meet criteria set forth for the Chairperson and Panel Members
quote: PANEL OPERATIONS
1: Comprehensive search/retrieval of medi/sci literature.
2: IDSA must provide outside individuals/organizations an e-mail to collect info that will be given to/considered by review panel.
3: 60 day period precedes panel's gathering.
4: Open public hearing held w/ in-person review panel. Written/oral data on topic of LD.
5: All can apply, but clinicians/researchers have preference.
6: Divergent view points will be given time to present data.
7: IDSA can permit minimum of 2006 guideline panel members opportunity to present their view.
8: All conflicts of interest are "NOT" grounds for denial to present for oral/written presentation to panel.
9: Video broadcast live will occur on IDSA website.
Data for you the individual, or your organization to utilize in assisting to balance this panel and ensure it meets it's obligations.
quote: PANEL WEIGHING EVIDENCE
1: Decide whether 2006 LD GL med/sci justified with all data collected.
2: 75% majority for any conclusion by voting members.
The panel will decide on additional factors not listed that basically represent any changes that should be made to parts or all or none of the 2006 guidelines. This includes new information, whether the 2006 guide was "optimal" factors such as changes that alter quality of life etc, have any new relevant data need be incorporated etc.
quote: PAST & PRESENT FINANCIAL RELATIONSHIPS MUST BE LISTED INCLUDING:
1: Pharmaceutical,
2: Medical devices,
3: Biotechnology,
4: Medical consulting companies in which you or your immediately family have or had financial, equity, or intellectual property interests, currently and in the 2 years prior to date of collection of this letter.
5: Fees for consulting, speaker's bureaus, advisory boards, or committees, paid fees, direct or indirect to you or through university account under your control.
6: Stop options, patent rights of you or family in pharmaceutical, medical device/biotech companies. Patent numbers required.
7: Grants or contracts that provide salary support paid to you through institution or supports your research without salary support, currently in the 2 years prior to date of this doc. Only research related to Lyme Disease.
8: List government, foundation sources, name of private companies, names of individuals, partnership or trust or any entity related.
9: Insurance consulting and medical consulting contracts.
10: Estimate of percentage of your clinical practice devoted to diagnosis and treatment of patients with LD.
12: Estimate revenue of such services as last entry.
13: Did you serve in last 2 years, owner, officer, director, partner, manager, employee of any pharma, medical device or biotech comp?
14: Last 2 yrs, receive payment for advocacy role in gov, or non-prof org that could be reasonable considered related to LD.
All applicants must reveal all data pertaining to the above information. Try to gather all this information. See where they "actually" fall based on their history and accumulated data. Cross reference all family members, as well as panel members with the prior 2006 guidelines panel members. Degrees of separation can surprisingly turn up conflicts you would otherwise miss.
Posted by lou (Member # 81) on :
Yes, I think our best contribution at this point is to find statements that reflect diagnosis and treatment bias at the outset, and send them on to Lorraine for consideration. I am sure they are already hard at work, but there are many of us, and we could dig up useful info.
That 75% agreement number probably was what they were aiming at in their selection of panel members. Just ensure those panelists are in the IDSA pocket, and they are home free.
It is doubtful that anyone in the general public or from other sciences would think this process is fair and likely to do an honest job.
There needs to be a plan b.
Posted by Tincup (Member # 5829) on :
Lou is right.. and a plan B and C,D, E are in the works.
Posted by Robin123 (Member # 9197) on :
Yay! - and now for Plan F: a Fairy godmother waves her wand over the who-o-o-o-o-le world, and suddenly everyone Understands what's going on,
gets Protected, Tested and Treated and Cured, and all the ticks get Knocked Out with the Alaskan cedar nootkatone compound. And maybe some from Lapland and Siberia too.
This is called a guided visualization, or maybe it's misguided? I dunno.
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