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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 - (PDF-2,532KB)

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