AG forces review of IDSA Lyme guidelines

[Guest guest]

From: Carol Olsen

Via: CO-CURE

AG forces review of IDSA Lyme guidelines

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The following is the report from the California Lyme

Disease Association (CALDA) regarding the decision

reached after CT Attorney General Blumenthal's

investigation of the Infectious Disease Society of

America's (IDSA) Lyme recommendations. AG

Blumenthal sued the IDSA for anti-trust violations.

Carol Olsen

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California Lyme Disease Association

News Alert

May 1, 2008

Settlement Announced in Landmark Investigation of

Lyme Disease Diagnosis and Treatment Guidelines

Patients' Rights Groups Applaud Connecticut Attorney

General Blumenthal's Settlement in Anti-trust Case

Against Powerful Medical Society

Hartford, CT - Patients' rights groups today hailed

Connecticut Attorney General Blumenthal's

announcement of a settlement in a landmark

antitrust investigation into the Lyme treatment

guidelines of the Infectious Diseases Society of

America (IDSA).

" My office uncovered undisclosed financial interests

held by several of the most powerful IDSA panelists, "

said Blumenthal. " 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 groundbreaking settlement announced today

forces a complete review of the IDSA guidelines by a

new panel free from conflicts of interest, specifically

excluding previous panel members. This panel will

consider a range of scientific evidence in a public

forum broadcast live over the internet and will be

overseen by a specialist in financial conflicts of

interest in medicine.

" This settlement makes it clear that the IDSA

guideline development process was corrupted by a

commercially driven panel that excluded evidence

supporting longer term treatment of Lyme disease, "

said attorney Lorraine , Executive Director of

the California Lyme Disease Association (CALDA).

" This settlement allows suppressed scientific

viewpoints and evidence to be heard, and it is

promising news for patients. "

This is the first-ever antitrust investigation against

a medical society's guidelines development

process.

" We congratulate Attorney General Blumenthal for

exposing the IDSA's conflicts of interest and helping

reduce the suffering of Lyme patients everywhere, "

said Pat , president of the national Lyme

Disease Association (LDA). Diane Blanchard,

co-president of Time for Lyme in Connecticut agrees.

" The IDSA guidelines are dangerous for patients who

suffer longer-term Lyme symptoms that do not fall

within the IDSA's narrow disease definition, " Ms.

Blanchard added.

The IDSA guidelines are treated as mandatory within

the medical community. More than 50 physicians

who use longer-term treatment approaches have

been investigated or sanctioned by state medical

boards. The guidelines can also result in financial

problems for patients, since insurance companies

refuse to reimburse for longer-term treatment and

pharmacies may refuse to fill prescriptions.

The majority of individuals involved in the IDSA

guidelines development process held direct or

indirect commercial interests related to Lyme

vaccines, patents, and/or test kits, and did not take

the opinions or experiences of the competing Lyme

groups into account.

While the announcement of a settlement comes as a

huge relief to suffering Lyme patients, the case has

much broader implications for a health care system

that often contends with conflicts-of-interest in

guideline processes - guidelines which are often

used by insurance companies to limit diagnosis and

treatment options.

" Today's settlement marks an important victory for

all patients who suffer Lyme disease, but it is also a

victory for anyone concerned about health care, "

said . " Commercially driven guidelines that

limit patient treatment options are a major issue

today in healthcare, and this decision marks an

important step towards addressing it. "

The national Lyme Disease Association, (LDA),

CALDA, and Time for Lyme are non-profit

organizations that were founded by individuals who

had personal experience with Lyme disease, in order

to address the lack of education and support

services available for this newly emerging infection.

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.

To view the entire IDSA agreement, go to the

Attorney General's website.

http://www.ct.gov/ag/cwp/browse.asp?A=2795