Topic: Star Democrat- IDSA- Attorney General article
Tincup
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This was in the Star Democrat newspaper in Easton, Maryland.
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.
The Star-Democrat * PO Box 600, Easton, MD 21601 Phone (410) 822-1500 * Fax (410) 770-4019
quote: "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.
posted
Loved the Article, very well written!!!
Posts: 263 | From Georgia | Registered: Feb 2006
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AliG
Frequent Contributor (1K+ posts)
Member # 9734
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This brought tears to my eyes!
I'm thanking God for all the people whose contributions made this article possible. You are ALL beautiful!!!
I only wish this SAME EXACT article could be published in every single paper across the country!
Magnificent work!
Thank you! You vocal activist, you!
Ali
-------------------- Note: I'm NOT a medical professional. The information I share is from my own personal research and experience. Please do not construe anything I share as medical advice, which should only be obtained from a licensed medical practitioner. Posts: 4881 | From Middlesex County, NJ | Registered: Jul 2006
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Lyme disease care under fire Medical groups differ on courses of treatment By Robert Miller Staff Writer Article Last Updated: 05/12/2008 04:14:20 AM EDT
In the battle over how best to treat Lyme disease, a new settlement between Attorney General Richard Blumenthal and a major medical group might seem to offer at least a little hope of expanded treatment for those with the tick-borne disease.
That, however, would involve a change in the lines of debate over the disease, and it's not clear there will be any yielding.
The settlement, reached this month between Blumenthal and the Infectious Diseases Society of America, provides for a review of the IDSA's guidelines for treating Lyme disease -- guidelines that a second group of doctors, the International Lyme and Associated Diseases Society, say are strict and inflexible to the point of harming some patients.
But the IDSA's guidelines will remain unchanged until that review ends. And while the review process will include the participation of an ombudsman, the guarantee that opposing voices will get their say, and hearings that will be broadcast on the Internet, they may not yield a single change, said Dr. Eugene Shapiro, a pediatrician, epidemiologist and professor of investigative medicine with the Yale School of Medicine in New Haven.
Asked last week if the IDSA guidelines could remained unchanged after the review, Shapiro said flatly, "Yes."
"If the scientific data recommends a change, we'll be happy to change," Shapiro said. "But we have 25 years of research on Lyme disease. We feel very comfortable the guidelines will stand up to any scientific scrutiny."
Doctors who are opposed to the IDSA guidelines said they believe there's at least a chance their position -- that infection from the Lyme disease bacteria Borrellia burgdorferi can create a chronic illness that needs long-term treatment with antibiotics -- will gain some credence with the review panel.
"I hope it will lead to an improvement to patient care," said Dr. Steven Phillips of Wilton, who
has been one of the doctors opposing the strict guidelines in favor of those in which doctors can tailor treatment to individual patients.
Phillips is a past president of the International Lyme and Associated Diseases Society, which believes there is ample scientific evidence to treat people for chronic Lyme disease.
"We've looked at the same evidence as IDSA and come up with significantly different conclusions," said Dr. Daniel Cameron of Mount Kisco, N.Y., the current president of the group.
This isn't a merely a spat between two opposing medical groups.
In a press release, Blumenthal's office pointed out that insurance companies now use the IDSA guidelines to restrict care for patients and refuse to pay for long-term antibiotic care.
"It's a good way to have people denied insurance," said Maggie Shaw of Newtown, a member of that town's Lyme Disease Task Force. "It also puts the fear factor in doctors.
"Here are two standards of care, but only one gets recognized," Shaw said. "It's because of the stranglehold the IDSA has on this."
The settlement between Blumenthal and the IDSA came after Blumenthal sued the group -- which represents about 8,000 infectious disease specialists in the United States -- in 2006 for antitrust violations.
Blumenthal said his investigation discovered many examples of conflicts of interest among the doctors who wrote the IDSA guidelines. He also said they refused to "accept or meaningfully consider" any evidence concerning chronic Lyme disease in writing the 2006 guidelines and blocked the appointments of scientists and physicians who differed with the IDSA view that all Lyme disease can be treated with two to four weeks of antibiotics and that chronic Lyme disease does not exist.
"Our focus has not been on medicine but the process," Blumenthal said. "There may have been violation of the law and it's my job to enforce the law."
Dr. Sam Donta, a Massachusetts-based infectious disease specialist, was on the panel that drew up the IDSA guidelines. Donta said he refused to sign off on the guidelines when the group refused to acknowledge that chronic Lyme disease is a problem.
--The issue should not be whether there's chronic Lyme disease, but why we're seeing these patients," he said
The review process established in the settlement, Blumenthal said, will be "fair, open and free of conflict." Donta said Friday he hopes to serve on the panel.
But in its own press release on the settlement, the IDSA emphatically denies there was any "significant" conflict of interest on the part of any of the doctors who wrote the 2006 guidelines, or that they excluded conflicting points of view while writing them.
In fact, Shapiro said, having stricter guidelines means doctors who follow the IDSA protocols see patients fewer times and prescribe only short-term regimens of generic antibiotics.
Shapiro said the IDSA agreed to the settlement simply to end any attempt by Blumenthal to take the case to court.
"The alternative was spending a lot of money in an expensive lawsuit," he said.
Shapiro said all the scientific evidence on long-term treatment of Lyme disease, including five double-blind studies in which some patients got antibiotics and others a placebo, show that long-term antibiotics did not cure the symptoms that people include in the diagnoses of Lyme disease.
"It's not that data isn't there. It is," he said, pointing out that 95 percent of all Lyme cases are successfully treated with only two or three weeks of standard antibiotics.
But Cameron said the double-blind studies, all with a small number of patients, only show that Lyme disease is complicated.
"The evidence is quite mixed," he said.
And the trials often look at the effect of just one type of antibiotic on patients, Donta said.
"If one doesn't work, do you say all antibiotics don't work?," he asked. "If one cancer drug stops working, do you not try and find another? There's insufficient information in the guidelines for physicians to make a decision."
Phillips of Wilton said many peer-reviewed articles published in medical and scientific journals make the case that chronic Lyme disease does exist.
What they hope the new review of the IDSA guidelines do, they said, is take all this into account and give doctors a chance to treat each case individually, rather than with a one-size-fits-all approach.
"Let the doctors have some flexibility," Cameron said.
LYME DISEASE The most common tick-borne illness in the United States.
Caused by a bacterial spirochete, Borrelia burgdorferi.
Spread to humans by the bite of the black-legged tick, aka the deer tick.
Can cause fever, headache and muscle ache in early stages.
Often, but not always, is accompanied by a rash spreading from the site of the tick bite.
In most cases is cured by a few weeks of antibiotics.
If untreated or undertreated, Lyme infection can cause arthritic pain and swelling of the knees and joints.
Number of reported U.S, cases in 2006: 19,931.
Number of cases that might actually exist could be up to 10 times the number of reported cases.
There is debate whether chronic Lyme disease -- a long-term infection that can cause fatigue, memory loss, depression, loss of vision and hearing, arthritis and heart ailments -- exists.
-------------------- Neil Posts: 697 | From Tucson, AZ USA | Registered: Apr 2002
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bettyg
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could someone find the direct link of this outstandingm, fairly written article by steve nervy, and post it here.
i'd email him a note IF someone might do that!! thanks~ my plate is full with my newbie packages and llmd names to those needing it and many pms!
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Tincup
Honored Contributor (10K+ posts)
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lymie tony z
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Member # 5130
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Initially I was elated but then the other shoe drop syndrome rushed over me when I read about the letters that were written to the house committee on Energy and Commerce and was dumped....
Soooooo.....what....do we have to go to Washington and demonstrate, or what?
I know I would like to butt some heads together in a few places not the least of which is D.C..
zman
-------------------- I am not a doctor...opinions expressed are from personal experiences only and should never be viewed as coming from a healthcare provider. zman Posts: 2527 | From safety harbor florida(origin Cleve., Ohio | Registered: Jan 2004
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