Last night in Boston on the TV program Chronicle

[Guest guest]

There was a repeat of a program on Chronicle, a program that airs in New

England on WCVB TV. It was a repeat about Lyme Disease and the long time

problems people have been having getting diagnosed and treated. It was

repeated the fact that the AG of Connecticut filed a law suit against the

medical panel that denied people what seems to be the more appropriate

treatment:

long term administration of IV antibiotics. People were denied this

treatment because of conflicts of interest.

The upshot of the program was an update on the Attorney General's action:

Conflicts of interest were exposed and a non-biased panel was put into

place to replace the old panel with conflicts of interest. The new panel

reviewed appropriate medical treatment for those suffering from the disease.

The assistance of an arbitrator was most helpful in reaching the new

guidelines for treatment. Now if we could only do this with the doctors who

are

doing the same thing with mold illnesses.

Medical societies who advance medical guidelines that fly in the face of

their Hippocratic Oath need to have to deal with serious consequences. It's

the only way to stop them. Elected officials like Connecticut's Attorney

General need to be thanked profusely and then cloned. I can think of a few

people I would like to see be replaced by a Blumenthal clone.

Mulvey son

Connecticut Attorney General's Office

Press Release

Attorney General's Investigation Reveals Flawed Lyme Disease Guideline

Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter May

1, 2008

Attorney General 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. 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 , former Assistant Attorney General

Rutstein and Paralegal Lorraine Measer under the direction of Assistant

Attorney General 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)

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