Jump to content
IndiaDivine.org

Investigation Reveals Flawed Lyme Disease Guideline Process

Rate this topic


Guest guest

Recommended Posts

Guest guest

________________________________

 

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 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.

 

To view the entire IDSA agreement, go to the Attorney General's website.

 

http://www.ct.gov/ag/cwp/view.asp?a=2795 & q=414284

 

 

 

 

 

Link to comment
Share on other sites

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...