Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter May 1, 2008.
Attorney General Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Infectious Diseases Society of America's (IDSA) process for writing its 2006 Lyme disease guidelines
and the IDSA has agreed to reassess them with the assistance of an outside arbiter.
The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care.
They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions.
Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification.
The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent.
"This agreement vindicates my investigation -- finding undisclosed financial interests and forcing a reassessment of IDSA guidelines," Blumenthal said.
"My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists.
The IDSA's guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.
"The IDSA's Lyme guideline process lacked important procedural safeguards requiring complete reevaluation of the 2006 Lyme disease guidelines -- in effect a comprehensive reassessment through a new panel.
The new panel will accept and analyze all evidence, including divergent opinion.
An independent neutral ombudsman -- expert in medical ethics and conflicts of interest, selected by both the IDSA and my office -- will assess the new panel for conflicts of interests and ensure its integrity."
Blumenthal's findings include the following: * The IDSA failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel;
* Subsequent disclosures demonstrate that several of the 2006 Lyme disease panelists had conflicts of interest;
* The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA's oversight committee;
* The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group's position on chronic Lyme disease to achieve "consensus";
* The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded;
* The IDSA portrayed another medical association' s Lyme disease guidelines as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups,
and were working on guidelines at the same time. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.
IDSA has reached an agreement with Blumenthal's office calling for creation of a review panel to thoroughly scrutinize the 2006 Lyme disease guidelines and update or revise them if necessary.
The panel -- comprised of individuals without conflicts of interest -- will comprehensively review medical and scientific evidence and hold a scientific hearing to provide a forum for additional evidence.
It will then determine whether each recommendation in the 2006 Lyme disease guidelines is justified by the evidence or needs revision or updating.
Blumenthal added, "The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion.
In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions.
As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards.
"Our investigation was always about the IDSA's guidelines process -- not the science.
IDSA should be recognized for its cooperation and agreement to address the serious concerns raised by my office.
Our agreement with IDSA ensures that a new, conflicts-free panel will collect and review all pertinent information, reassess each recommendation and make necessary changes.
"This Action Plan -- incorporating a conflicts screen by an independent neutral expert and a public hearing to receive additional evidence -- can serve as a model for all medical organizations and societies that publish medical guidelines.
This review should strengthen the public's confidence in such critical standards."
THE GUIDELINE REVIEW PROCESS Under its agreement with the Attorney General's Office, the IDSA will create a review panel of eight to 12 members, none of whom served on the 2006 IDSA guideline panel.
The IDSA must conduct an open application process and consider all applicants.
The agreement calls for the ombudsman selected by Blumenthal's office and the IDSA to ensure that the review panel and its chairperson are free of conflicts of interest.
Blumenthal and IDSA agreed to appoint Dr. Howard A. Brody as the ombudsman.
Dr. Brody is a recognized expert and author on medical ethics and conflicts of interest and the director of the Institute for Medical Humanities at the University of Texas Medical Branch.
Brody authored the book, "Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry."
To assure that the review panel obtains divergent information, the panel will conduct an open scientific hearing at which it will hear scientific and medical presentations from interested parties.
The agreement requires the hearing to be broadcast live to the public on the Internet via the IDSA's website.
The Attorney General's Office, Dr. Brody and the review panel will together finalize the list of presenters at the hearing.
Once it has collected information from its review and open hearing, the panel will assess the information and determine whether the data and evidence supports each of the recommendations in the 2006 Lyme disease guidelines.
The panel will then vote on each recommendation in the IDSA's 2006 Lyme disease guidelines on whether it is supported by the scientific evidence.
At least 75 percent of panel members must vote to sustain each recommendation or it will be revised.
Once the panel has acted on each recommendation, it will have three options:
make no changes, modify the guidelines in part or replace them entirely.
The panel's final report will be published on the IDSA's website.
ADDITIONAL FINDINGS OF BLUMENTHAL'S INVESTIGATION IDSA convened panels in 2000 and 2006 to research and publish guidelines for the diagnosis and treatment of Lyme disease.
Blumenthal's office found that the IDSA disregarded a 2000 panel member who argued that chronic and persistent Lyme disease exists.
The 2000 panel pressured the panelist to conform to the group consensus and removed him as an author when he refused.
IDSA sought to portray a second set of Lyme disease guidelines issued by the American Academy of Neurology (AAN) as independently corroborating its findings.
In fact, IDSA knew that the two panels shared key members, including the respective panel chairmen and were working on both sets of guidelines a the same time -- a violation of IDSA's conflicts of interest policy.
The resulting IDSA and AAN guidelines not only reached the same conclusions regarding the non-existence of chronic Lyme disease, their reasoning at times used strikingly similar language.
Both entities, for example, dubbed symptoms persisting after treatment "Post-Lyme Syndrome" and defined it the same way.
When IDSA learned of the improper links between its panel and the AAN's panel, instead of enforcing its conflict of interest policy, it aggressively sought the AAN's endorsement to "strengthen" its guidelines' impact.
The AAN panel -- particularly members who also served on the IDSA panel -- worked equally hard to win AAN's backing of IDSA's conclusions.
The two entities sought to portray each other's guidelines as separate and independent when the facts call into question that contention.
The IDSA subsequently cited AAN's supposed independent corroboration of its findings as part of its attempts to defeat federal legislation to create a Lyme disease advisory committee and state legislation supporting antibiotic therapy for chronic Lyme disease.
In a step that the British Medical Journal deemed "unusual," the IDSA included in its Lyme guidelines a statement calling them "voluntary" with "the ultimate determination of their application to be made by the physician in light of each patient's individual circumstances. "
In fact, United Healthcare, Health Net, Blue Cross of California, Kaiser Foundation Health Plan and other insurers have used the guidelines as justification to deny reimbursement for long-term antibiotic treatment.
Blumenthal thanked members his office who worked on the investigation --
Assistant Attorney General Thomas Ryan, former Assistant Attorney General Steven Rutstein and Paralegal Lorraine Measer under the direction of Assistant Attorney General Michael Cole, Chief of the Attorney General's Antitrust Department. _View the entire IDSA agreement _ (http://www.ct. gov/ag/lib/ ag/health/ idsaagreement. pdf) - (PDF-2,532KB)
Posted by Lymetoo (Member # 743) on :
Go to Medical Questions to read all the news!!
Posted by daise (Member # 13622) on :
Hi Proudtoserve,
... And there was dancing in the streets! as much as we Lymies can imagine. WAHOO!
daise Posted by proudtoserve (Member # 14811) on :
I hope plenty of law suits start coming across their desks.
Though in reading the full report it sounds as though the attourney general is letting them off easy.
By just making them review the guidlines with a new panel.
My hope is that at least half of the new panel are LLMD's and/or LDA members.
This is probably not the end of this. It is a great first step to change.
I talked to the head of Tricare earlier this week and was told that IDSA guidlines were peer reviewed and research driven.
And until ILADS can have their standards reviewed and approved then they cannot use those guidlines.
I am looking forward to sending this update on their ALMIGHTY IDSA guidlines to the Tricare people.
I want to take a copy and personally visit the Infectious Disease Doctors that I have seen and shove it in their faces also.
GAME ON!!!!
Posted by gusgus260 (Member # 2120) on :
Up to the top!!!
Posted by kgaTX (Member # 15314) on :
this is SO wonderful! I hope this is the start of many big changes in the way the medical community views lyme.
why have I not seen this in the news? I would have thought a government & pharmaceutical corruption story would have thrived???
Posted by daise (Member # 13622) on :
Hi kgaTX,
Welcome!
I read your other 2 posts.
I'm going to PM you with ideas to explain Lyme to your husband, which I saw on another post of yours.
You asked: why isn't the good news of IDSA butt kicking, in the news. Here are some sources to delight your eye. Eye candy for Lymies:
This has both the above article plus what's on AG Blumenthal's office website:
daise Posted by lymeladyinNY (Member # 10235) on :
daise - lol, "eye candy". Posted by carly (Member # 14810) on :
quote:
why have I not seen this in the news? I would have thought a government & pharmaceutical corruption story would have thrived???
quote:
We should be hearing this when we turn on the TV or radio! It's almost like as big a news story as some celebrity gossip
I know it's "out there", and people like proud and daise and Blumenthal and many others are bringing it to the attention of many, but we shouldn't have to "look" for this information.
Anyway...Change is good (this time)
carly.
Posted by daise (Member # 13622) on :
Thanks, Carly. There are a whole lot of people and we're all pushing the rock up hill!
Proud: Yup, GAMES ON. I've had a daydream of taping AG Blumenthal's announcement to the office door of the infectious disease ducks in town.
Gonna make that a reality!
daise Posted by proudtoserve (Member # 14811) on :
Hey Daise,
quote:Daise: Yup, GAMES ON. I've had a daydream of taping AG Blumenthal's announcement to the office door of the infectious disease ducks in town.
That is a great idea, probably better than what I was going to do with it. LOL
I have already forwarded this report to those in congress that I have been talking to.
Hopefully someone will take legal action. My hope for everyone is either a class action lawsuit in which they all loose their licenses to practice medicine.
Or everyone of them go to jail and serve one year for every year of life they have STOLEN away from every Lyme patient effected by their bogus guidlines.
The IDSA should personally pay back all the cost of medical care paid out of pocket.
Pay for the rest of their lives for those soooo ill now they can no longer work.
Pay for loss of life to those families that have lost someone to Lyme.
The IDSA is guilty of MUCH more than financial gain, They are guilty of PAIN, SUFFERING and MURDER!
Sorry I tend to rant. It fuels me though.
But when I see a company like ENRON that stole money and ruined lives financially, ultimately every executive went to jail for a long time.
Then you see this case, the IDSA has ruined lives physically and mentally. People have needlessly died for crying out loud!!
And all they get is ordered to review the guidlines??
Dont get me wrong it is great that the guidlines will be changed for the better.
BUT it is not enough.
Again Sorry to be so intense but I have been very irratable lately.
Love all, Proud Posted by daise (Member # 13622) on :
Hi Proud,
Rant away! I agree with everything you said.
1.) IDSA doctors, but for a precious handful, have committed murder and / or attempted murder.
Whoever holds their liability insurance (for IDSA and also ducks in their private practice) should be forced to empty that fund, paid directly to all who have had chronic Lyme disease (and are still alive,) do have now, and will have in the next--say--five years.
2.) All LLMD's who are also ILADS members should receive compensation from that same national IDSA liability fund for all legal trouble encountered and for all personal expenses and lost time in having to deal with murderers climbing on their backs.
3.) Every dues paying duck of IDSA (but for that precious wee handful) at the very least must be put in prison for life. At the most, put before a firing squad for all to see. So that the people will see and learn and this crime against humanity will never happen again.
Ducks in other specialties will see. They'll pee their pants. They'll wonder if patients could have cells, after all. They'll wonder if patients are human--and if they can feel pain and heartache at all.
daise Posted by Lymetoo (Member # 743) on :
quote:Originally posted by daise: Hi Proud,
Rant away! I agree with everything you said.
1.) IDSA doctors, but for a precious handful, have committed murder and / or attempted murder.
Whoever holds their liability insurance (for IDSA and also ducks in their private practice) should be forced to empty that fund, paid directly to all who have had chronic Lyme disease (and are still alive,) do have now, and will have in the next--say--five years.
2.) All LLMD's who are also ILADS members should receive compensation from that same national IDSA liability fund for all legal trouble encountered and for all personal expenses and lost time in having to deal with murderers climbing on their backs.
3.) Every dues paying duck of IDSA (but for that precious wee handful) at the very least must be put in prison for life. At the most, put before a firing squad for all to see. So that the people will see and learn and this crime against humanity will never happen again.
Ducks in other specialties will see. They'll pee their pants. They'll wonder if patients could have cells, after all. They'll wonder if patients are human--and if they can feel pain and heartache at all.
daise [/qb]
Love it!
[ 05. May 2008, 11:29 AM: Message edited by: Lymetoo ]
Posted by bettyg (Member # 6147) on :
good posts here!!! way to go gang! Posted by proudtoserve (Member # 14811) on :
Hey Daise I really hope you dont mind, you helped me write the following letter to the media.
To include MSNBC, today show, nightly news, dateline.
I added your post from above into the letter. I think what you said summed it up nicely. Thank you.
quote:To Whom It May Concern:
Regarding AG Blumenthal investigation of IDSA. IDSA was found guilty of fraud, causing insurance companies to deny care, and pain and suffering. All this with no legal action forth coming against them. What does the death toll need to be before this makes the news?
In reading the full Investigative report it sounds as though Attorney General Blumenthal is letting them (IDSA) get away with this.
By just making them review the guidelines with a new panel.
My hope is that at least half of the new panel is Lyme Literate Medical Doctors (LLMD) and/or Lyme Disease Association (LDA) members. This is probably not the end of this. It is a great first step to change.
Why have we not seen this in the news more? I would have thought a government & pharmaceutical corruption story would have thrived???
I have already forwarded Mr. Blumenthal's report to those in congress that I have been talking to.
Someone should be taking legal action. My hope for everyone (Lyme victims) is either a class action lawsuit in which the IDSA doctors involved in this fraud all loose their licenses to practice medicine and/or everyone of them go to jail and serve one year for every year of life they have STOLEN away from every Lyme patient effected by their bogus guidelines.
The IDSA should personally pay back all the cost of medical care paid out of pocket. Pay for the rest of their lives for those so ill they can no longer work. Pay for loss of life to those families that have lost someone to Lyme.
The IDSA is guilty of MUCH more than financial gain; they are guilty of PAIN, SUFFERING and MURDER!
We see a company like ENRON that stole money and ruined lives financially and every executive involved went to jail.
Then you see this case, the IDSA has ruined lives physically and mentally. People have needlessly died for crying out loud!! And all they get is ordered to review the guidelines?
Don't get me wrong it is great that the guidelines will be changed for the better.
BUT it is not enough.
1.) IDSA doctors, but for a precious handful, has committed murder and / or attempted murder.
Whoever holds their liability insurance (for IDSA and also doctors in their private practice) should be forced to empty that fund, paid directly to all who have had chronic Lyme disease (and are still alive,) do have now, and will have in the next--say--five years.
2.) All LLMD's who are also International Lyme and Associated Diseases Society (ILADS) members should receive compensation from that same national IDSA liability fund for all legal trouble encountered and for all personal expenses and lost time in having to deal with murderers climbing on their backs.
3.) Every dues paying duck of IDSA (but for that precious wee handful) at the very least must be put in prison for life. At the most, put before a firing squad for all to see. So that the people will see and learn and this crime against humanity will never happen again.
Ducks in other specialties will see. They'll pee their pants. They'll wonder if patients could have cells, after all. They'll wonder if patients are human--and if they can feel pain and heartache at all.
The IDSA would like everyone to believe that this is a simple to cure disease. They state they treat based on evidence based research. What evidence? Ask their patients.
In a recent letter to congress from the IDSA one doctor is quoted as saying:
``Lyme disease is a tick-transmitted infection that can cause non-specific symptoms such as muscle and joint pain, fevers, chills, fatigue, and difficulties with concentration or memory loss.
Some patients may continue to experience these symptoms even after a course of antibiotic therapy has killed the Lyme disease bacterium. A small group of physicians have diagnosed such patients as having ``chronic'' Lyme disease.
Many of these so called ``chronic'' Lyme diagnoses are supported by laboratory tests that are not evidence based and are not regulated by the Food and Drug and Administration.''
This seems to be the biggest argument among doctors. IDSA is hammering the laboratory tests used ``that are not evidence based'' but the IDSA along with the CDC use the same tests in there diagnoses.
These patients that they talk about so haphazardly have continued not only to have symptoms but these symptoms continue to get WORSE and/or migrate to other places in the body after treatment.
This would say to any doctor that in order to have progression of symptoms you need to have growth, obviously all the bacterium were not killed.
All of the statements made by the IDSA have now been proven to be fraudulent and financially driven.
Please read the investigation report attached and help ensure this crime does not go unpunished.
Also, the interviews conducted should be with the LLMD's and ILADS members who have done the research and treated the victims. The research and treatments of which were found to be ignored by the IDSA.
Colleen said she is going to put it on military lyme as well. Posted by aklnwlf (Member # 5960) on :
This made my evening! Yeah, progress!! Posted by daise (Member # 13622) on :
Hi Proud!
Do I mind? Heck no! In fact, I already got the email from Colleen! I got a bunch of emails from Colleen.
You wrote a letter that is a wonderment. May it take flight and plant many seeds. You're going for BIG SEEDS--big national shows.
Oh ya.
Go for it!
How can we help?
daise Posted by bettyg (Member # 6147) on :
proud and daise, KUDOS TO YOU BOTH!!
this letter should be sent to ALL ON PALLONE'S AND KENNEDY'S COMMITTEE MEMBERS
PLUS ALL FEDERAL SENATORS/HOUSE REPS !!! showing S 1708 and HR 741 for the subject line, and LYME DISEASE BILL
way to go; excellent!
edited: i just copied proud's letter and sent to ALL ON MY LYME LIST GROUP!! keep it circulating this way too!! put it on OTHER LYME BOARDS!!
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