Society to review Lyme disease guidelines

By STEVE NERY News Editor

Published: Sunday, May 11, 2008 5:24 PM CDT

The Infectious Diseases Society of America has agreed to reassess its controversial Lyme disease diagnostic and treatment guidelines after an antitrust investigation uncovered serious flaws with them, Connecticut Attorney General Richard Blumenthal announced May 1.

The IDSA guidelines were under fire from Lyme disease patient advocacy groups, including vocal groups in Maryland, for restricting long-term care and denying the existence of chronic Lyme disease. Blumenthal's move also could affect Congressional bills, now stuck in committees, that aim to develop better testing and treatment for the tick-borne ailment.

"My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists," Blumenthal said in a statement. "The IDSA's guidelines improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising relevant questions about whether the recommendations reflected all relevant science."

According to the IDSA guidelines, patients should receive antibiotics for no more than four weeks.

"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," according to Blumenthal's release.

Blumenthal's investigation resulted in several findings, including:

The IDSA failed to conduct a conflict of interest review for any of the panelists on the 2006 panel. Several of them had conflicts of interest, involving relationships with drug companies, diagnostic tests, patents and consulting arrangements with insurance companies.

• The chairman, who had a bias against the existence of chronic Lyme, was allowed to handpick the other members of the panel.

• In 2000, the group removed a panelist who dissented from the position of the others on chronic Lyme disease to achieve consensus.

• The panel blocked the appointments of others by saying was it was already fully staffed, even though more members were later added.

• The IDSA portrayed the American Academy of Neurology's guidelines as corroborating its own even though it knew both groups shared several authors.

The new panel, which will consist of eight to 12 members, will reassess the 2006 guidelines individually to determine if they are justified, according to Blumenthal's release. The panelists will all be screened for conflicts of interest and cannot have served on the last panel. At least 75 percent of the members will have to vote in favor of recommendation from 2006 for it to be affirmed.

"We congratulate Attorney General Blumenthal for exposing the IDSA's conflicts of interest and helping reduce the suffering of Lyme patients everywhere," said Pat Smith, president of the national Lyme Disease Association.

Lucy Barnes, director of the Lyme Disease Education and Support Groups of Maryland, said it's terrible that so many people have suffered as a result of the IDSA's restrictive guidelines. She pointed to the International Lyme and Associated Diseases Society's guidelines, available online at www.ilads.org, as a better alternative.

Barnes and other members of Lyme disease support groups hope the move will prompt the U.S. Congress to give hearings to bills designed to develop better testing and treatment of the disease. Both introduced in early 2007, Senate Bill 1708 now awaits a hearing by the Senate Committee on Health, Education, Labor and Pensions, while House Bill 741 awaits a hearing from the House Subcommittee on Health.

All of Maryland's Congressional members, including U.S. Rep. Wayne T. Gilchrest, R-Md.-1st, Sen. Barbara Mikulski, D-Md., and Sen. Ben Cardin, D-Md., signed onto the bills. Local Lyme disease groups have been urging Mikulski, a member of the health committee, to help get SB1708 a hearing. Melissa Schwartz, a spokesman for Mikulski, said only Sen. Edward Kennedy, D-Ma., the chairman of the committee, can get the bill a hearing.

The only member from Maryland on the House committee, U.S. Rep. Albert Wynn, D-Md.-4th, removed himself from all his committee assignments weeks ago as he's resigning from Congress effective in June.

The legislation would provide $20 million annually for five years to help develop better diagnostic testing and treatment, as well as $250,000 annually to fund a tick-borne diseases advisory committee. The committee, to be made up of members of the scientific committee, volunteer organizations, health-care providers, patient representatives and health department representatives, would also work to develop better reporting and enhance prevention efforts.

If not acted upon, the legislation will die at the end of the year, as a similar measure did in 2006. Volunteer groups are planning on showing up at the office of U.S. Rep. Frank Pallone, D-N.J.-6th, from 11 a.m. to 2 p.m. this Wednesday. For more information, visit www.LymeRights.org.

IDSA President Donald Poretz wrote the committee members in March opposing passage of the bills and questioning the existence of chronic Lyme disease.

"The premise for prolonged antibiotic therapy for Lyme disease is the notion that some spirochetes can persist despite conventional treatment courses, thereby giving rise to the vague symptoms ascribed to chronic Lyme disease. Not only is this assertion microbiologically implausible, there are no convincing published scientific data that support the existence of chronic Lyme disease," Poretz wrote.

Poretz's letter was dated March 21, meaning it was written after a University of California at Davis Center for Comparative Medicine study concluded that the maximum treatment recommended by the IDSA did not kill all Borrelia burgdorferi spirochetes, the tiny organisms responsible for Lyme disease, in mice in lab tests.

Instead of a federal advisory committee, Poretz proposed the Institute of Medicine of the National Academies conduct a review of Lyme disease diagnosis, treatment and prevention methods, adequacy of current treatment guidelines, treatment options for "post-Lyme disease disorder," effectiveness of current prevention methods and controversies associated with chronic Lyme disease.

Barnes also wrote the committee members, fearing that if the bills are not passed, "we are going to lose more chronically ill patients to a treatable but very serious infectious disease."

"The IDSA is so distressed by the possibility that researchers outside their tight-knit group will be allowed to sit at a table and present scientific evidence and recommendations that could prove them wrong, they are willing to fight bills and forfeit the much-needed $100,000,000 in research funding they would provide over five years, just to keep from being exposed," Barnes wrote.

Barnes cited several passages from the Food and Drug Administration, National Institutes of Health and the Centers for Disease Control which refer to the chronic Lyme disease that the IDSA denies exists.

"No patient wants to have antibiotic treatment without good reason and good science backing the protocols; and no doctor wants to prescribe treatment if it is not needed, as the IDSA would have you believe," Barnes wrote. "That deduction is as absurd and preposterous as a person wanting to have chemotherapy if they didn't need it."

Barnes also pointed out that the IDSA recommends against using several antibiotics that produce an anti-inflammatory effect except for Doxycycline, the cheapest of them all.

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