LYMEPOLICYWONK: IDSA Violates Settlement Agreement Voting Procedures
On Monday, February 1, 2010, the Connecticut Attorney General sent a letter to the IDSA expressing “concern” over “improper voting procedures” used by the IDSA in the Lyme guidelines review voting process. The IDSA may soon approve hearing determinations based on this improper voting procedure. The Attorney General requested that the IDSA redo the vote to comply with the Settlement Agreement. The four-page Attorney General letter was released in response to a Freedom of Information Request made on behalf of patient groups for information regarding the IDSA’s compliance with the Settlement Agreement.
What happened? The IDSA used an “improper voting procedure,” based on a process of its own design, which blatantly violates the Settlement Agreement and undermines the integrity of the voting process. The IDSA consented to the voting procedure in the Settlement Agreement and confirmed its understanding of the required voting procedure in an internal memo from the IDSA to the panel before the panel met. The Attorney General’s letter and the IDSA internal memo to the panel can be downloaded by clicking the link below this post..
What voting process was required and how was it violated? The Settlement Agreement requires a two step voting procedure, with each step requiring a supermajority vote (6 of 8 panelists). The first vote asks the question whether each of the contested guideline recommendations is “medically/ scientifically justified in light of all of the evidence and information provided.” This vote requires a supermajority of the panel (6 of 8) in order for a guideline recommendation to stand. In essence, it asks “did the panel that adopted the 2006 guidelines get it right”? The second vote, also by supermajority, determines whether the guidelines require no changes, partial revision or complete revision.
The IDSA’s flawed voting procedure combined the two voting steps into one. First, the panel failed to conduct the vote to determine whether the science was sufficient to support the guideline recommendations. Next, the panel substituted its own procedure for the second step in the voting and required a supermajority for any change. This process effectively flipped the supermajority requirement to favor no change to the guidelines.
From the get-go, two significant points stand out:
· The IDSA failed to voluntarily comply with the Settlement Agreement in good faith.
· Absent oversight by the AG pursuant to the Settlement Agreement, the IDSA would have carried out a corrupted process that blatantly violates the agreement—and it might never have been discovered.
Patient groups are appalled that so far the IDSA, which should conduct an honest review and assessment of the evidence supporting the IDSA recommendations, has chosen to manipulate the voting requirement to influence the outcome, in clear violation of the Settlement Agreement and the scientifically based review and voting process which it provides. This turns evidence-based medicine on its head.
Can the process be saved? Patient groups, along with the public at large, expected that the IDSA would comply with the Settlement Agreement in good faith. It is, after all, a settlement agreement with the Attorney General of the State of Connecticut. When the IDSA panel so deliberately violates the voting procedures, as expressly confirmed by the words of the IDSA’s own internal memo, and refuses to comply with the Attorney General’s request, there can be only one conclusion: The ability of the IDSA to run this process with integrity is extremely suspect and any outcome must be viewed critically.
Other examples of abuse by IDSA of settlement process: This is not the first time legitimate questions have been raised regarding the IDSA’s willingness and reliability in performing its obligations with integrity under the settlement process. For instance, the IDSA was charged with selecting the panel and chose to exclude divergent viewpoints (including physicians who treat chronic Lyme disease). One panelist was removed by the panel after patients complained because he had served on another Lyme guidelines’ panel− a direct violation of the settlement agreement. Another panelist had also served on a previous Lyme guidelines’ panel, but despite patient complaints, was not removed.
Patient organizations call upon the IDSA to hold an individual vote on whether each of the guidelines’ recommendations is medically/scientifically justified in light of all the evidence as requested by the Attorney General. If IDSA fails to do so in good faith, patients continue to rely upon the Attorney General to continue to enforce the Settlement Agreement.
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An example of the IDSA manipulation of the voting procedure.
The guidelines mandate that Lyme cannot be diagnosed without a confirming diagnostic test.The tests are known to be insensitive and flawed. Requiring a positive test means that many patients with Lyme disease will fail to be diagnosed. One panel vote described in the AG’s letter was whether this recommendation should be revised. Four of the eight panel members voted for change, without the panel first having voted to determine whether the recommendation was supported by the science. As the AG’s letter points out, this clearly means that had the panel voted in accordance with the Settlement Agreement, this recommendation would have failed as not properly supported by the medical/scientific evidence. Why? A vote to uphold this recommendation would have required 6 votes; however, the 4 votes calling for revision (even
though predicated on a flawed procedure) plainly indicates insufficient evidence to support the recommendation. Thus, (a) the IDSA failed to vote to determine whether the science supported the recommendation, (b) substituted its own procedure regarding revision (requiring a supermajority vote to revise), and (c) thereby manipulated the voting requirements to achieve a result in its favor.
You can follow additional comments on Lyme policy at www.lymepolicywonk.org. You can contact Lorraine Johnson, JD, MBA at lbjohnson@lymedisease.org.
Looking forward to see those people in jail.
They deserve it.
I pray to god that their is a god from every single relegion as well as the people that choose not to be. Let all be their at the gate and see how they can answer their criminal activities and get out of it this time.
Lorraine, THANK YOU for updating us all so promptly and for having testified last July.
We appreciate your tireless efforts; i've not had a chance to read the 18 pages of pdf file yet, but this whole thing stinks! HOG WASH ~~
would it also help if EACH of us contacted our federal senators/house reps about today's newest outrage?
thank you for your wonderful daily reports you write on behalf of ALL LYME & CO-INFECTION PATIENTS. 🙂 hugs
i also agree with the 1st poster above; they deserve to go to jail.
BettyG, iowa lyme activist
I should know, but let me ask the question. Does the ISDA have authority to determine diagnostic and treatment standards as a result of medical tradition, appointment by a federal regulatory body or by law?
This is so very disappointing to those of us around the world who were looking to the IDSA for their help and expertise in combatting this vile disease. Our only hope now seems to be that the shame of this revelation will add further balast to this leaky hulk and maybe free us from the blight of these dread guidelines.
I am appalled that with this act, these people are allowed to stay in this process at all. It is shameful. These are not stupid people – certainly they understood the agreement they signed….so the only other alternative is they are corrupt. They have shown themselves to be not worthy of any trust and that they hold 100,000s of people lives in their hands is immoral and unjust.
It was clear to me from the beginning these crooks were going to stick to their ridiculous guidelines. By not allowing anyone on the panel with differing views on lyme disease was a big clue that no matter what studies they were shown they were going to stay with their position. This is a corrupt group and we need to continue our fight for better tests and treatment.
My 10 year old son would like to speak in front of this panel of criminals, as HE calls them! "Anyone who continually denies my mom the treatment she needs to live, knowing the whole time they are withholding lifesaving treatment – they are a criminal! My mom has to fight for any health coverage, she can't pay our bills, we live in a barn on my Grandparents property and she has several college degrees and was super business woman at 2 fortune 500 companies before Lyme Disease took over," 10-year-old Ezekiel Kinney says of his and his mom's troubles. "I would like to stand before them and tell them in my own words what Lyme Disease has done to the best mom in the world, at one time before I was born she was a strong Junior Olympic swimmer for 18 years! Now she cries a lot and we have a hard time paying bills and even finding food. These grown up so called adults are horrible people who worry only about their jobs and their money and not about good – no, great – people like my mom!"
Sincerely,
Rebecca Kinney – Chronic Lyme Disease Sufferer
Ezekiel Kinney – Innocent, Helpless, Bystander
Greg Kelly
good question. The thing is they are not elect and not appointed. Guidelines written by medical societies that have monopoly power take on the force of law because they are broadly followed. This would be fine if they recognized legitimate controversy and allowed physicians to exercise clinical discretion. These don't and because of that they tie the hands of doctors.
Lorraine
This is terrible
this is terrible
My dear friend has been told recently she has, "MS due to Lyme Disease." I've read being afflicted with Lyme often results in misdiagnosis, that here in SE-WI we have a high prevelance of MS cases, and that Lyme Disease can be transmitted by bodily fluids. Bear in mid, I'm playing catchup so as to be a better advocate for my friend, so I know not all the TRUE facts. What concerns me now are the voting irregularities pertaining to science-based ONLY changes needed in the treatment GUIDELINES which by use of the "word", might mean those guidelines are NOT a set of legally-recognized- enforceable STANDARDS. As this issue greatly impacts the health & welfare of thousands of other sufferers,PLUS, those patients'families' well being and financial security too, I would like to know if anyone who IS NOT party to a potential lawsuit, has submitted an Amicus Curiae Brief (Friend of the Court Lawsuit), to call the Court's attention to this matter which might otherwise escape its attention & to aid the court in gaining the information it needs to make a proper decision or to urge a particular result on behalf of the public who will be affected by the resolution of the dispute. Also, I would imagine this very issue would compel many to seek non-FDA approved pharmaceuticals manufactured and sold by foreign entities. As such, a LACK of full transperency as to whether any or all of the IDSA members might profit as a result of voting irregularities, appears to be of grossly criminal behavior.
Willy is right. This is appaling. Their corruption is terrible. They're hindering the work of good doctors. There needs to be some kind of check in the system to prevent this from happening.
Alex K.- Lyme Disease Fighter
It is horrific for those who are looking to the ISDA for help when combating the disease and yet given a scolding for contracting the disease, a slap to the face and told to leave. Can the Department of Health be asked to mediate? Looks like the ISDA is looking the other way, telling everyone it’s their way or the highway.
Legally, what can be done about this? It is a sad day and a slap in the face for Lyme disease patients. The integrity and intent of the committee is called into question as well. Any entity that blatantly denies treatment to someone who depends on it to stay alive is criminal.
There is no cure or treatment for Lyme Disease and all the tests don’t work. The Lyme Disease spirochete hides under a coating bio film and cannot be detected. This spirochete immunocompromizes the system so there are no antibodies being produced. There is no effective antibody test and no effective cure. Unless a cure is found that will kill the spirochete, and antibiotics are no good against a spirochete that has its own phylum. Yes, there is palliative care like pain pills, aspirins, muscle relaxer etc. BUT NO CURE. If a cure is ever discovered, then it becomes necessary to be able to prove once and for all that one has the disease so they can receive proper treatment covered by insurance.