posted
Read this disgusting article, and if you are so moved, post comments on their site.
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Set objective medical standards, get sued
The Infectious Disease Society of America attempted to set guidelines for the treatment of Lyme disease based on the best available evidence. Three years and a quarter of a million dollars of legal fees later, that decision almost looks like a mistake.
By John Timmer | Last updated February 11, 2009
The medical journal JAMA contains an article that describes a disturbing collision of medical science and the US legal system. Written by a pair of lawyers, the article describes how a national medical organization's attempts at formulating treatment standards for Lyme disease has been run off the rails by an alliance between an organization that advocates a minority medical viewpoint and a state Attorney General. Over two years later, the standards are being revised, and the organization that produced them has spent a quarter of a million dollars on legal fees.
Lyme disease, named after a town in Connecticut where it first rose to prominence, was initially difficult to diagnose and treat. The identification of the causative agent, however, has allowed the development of sophisticated tests for its presence and successful treatment with antibiotics. A subset of patients, however, report the persistence of a poorly-defined set of symptoms that persist after all signs of the bacteria's presence have been eliminated. These persistent symptoms in the absence of any evidence of infection are the source of all the trouble.
John Timmer Appreciating evolution on Darwin's 200th birthday Ars returns to the AAAS meeting Why a cold winter doesn't mean climate change is behind us Google wants in on the smart grid of the future The Infectious Disease Society of America has a membership that includes both scientists and medical professionals, and engages in both advocacy and professional development, in addition to managing some academic journals. As part of its professional role, it produces a large set of practice guidelines, which should "assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances." Lyme disease is among those for which standards are available, having been produced in 2006.
As the JAMA article describes, when examining the persistence of symptoms after the apparent end of bacterial infections, the ISDA was swayed by the facts that there was no clinical evidence for any persistent infection, and by the fact that the symptoms, which include fatigue, headaches, and generalized muscle pain, can have a wide variety of causes. It labelled those symptoms "post-Lyme syndrome," and noted that the primary "treatment" used for it--massive and persistent antibiotic doses--hasn't been demonstrated to be effective, and exposes patients and society in general to a variety of other risks. The same conclusions have been reached by the National Institutes of Health and the Centers for Disease Control.
Unfortunately, that reliance on current best evidence didn't go over well with the International Lyme And Associated Diseases Society, which believes that chronic Lyme disease is a real medical phenomenon, and maintains its own treatment guidelines, which state, "many experts believe that this condition should be treated with repeated and prolonged antibiotics." Shortly after ILADS protested, Connecticut Attorney General Richard Blumenthal (also known for his crusade against online predators on social networking sites) became involved, launching an investigation of the IDSA based on the premise that, in the process of formulating its guidelines, it violated state antitrust laws.
The lawyers who penned the JAMA piece take this argument apart. Blumenthal's reasoning was apparently that its review process unfairly excluded certain viewpoints, and its reviewers had conflicts of interest. The authors note that the authors of the competing ILADS guidelines also had conflicts, but (in contrast to the targets of the investigation), these weren't disclosed in its guidelines. From the antitrust perspective, they write, "applying the antitrust 'rule of reason,' a challenger must show that the professional organization both possesses substantial market power and that the anticompetitive effects of its standards outweigh patient benefits." Leaving aside whether voluntary guidelines have market power, they argue that the investigation failed the second test "because IDSA guidelines substantially advanced patients' interests."
Of course, a group like the IDSA has to weigh whether spending its limited finances on legal fees is in the interests of patients and the medical community. After $250,000 dollars spent, it decided to reach an agreement with the Attorney General, one that allowed Blumenthal to declare victory. A separate panel will reevaluate the 2006 standards. Blumenthal stated that the results, "can serve as a model for all medical organizations and societies that publish medical guidelines."
According to the authors, the only way in which this is a model is that this should never happen again. Referring to the advocates for the existence of chronic Lyme disease, they write, "when high-quality research repeatedly was inconsistent with the group's hypotheses, the community should have sought other answers." As for Blumenthal's office, they conclude, "when political leaders using the force of law sued IDSA for its appropriate scientific conclusions that differed with the results they desired, they abused the public good."
As we've seen in the recent uproar over vaccine safety, questionable medical ideas can persist in the public well past their scientific expiration date. But this case highlights the danger posed when legal threats become legal actions. Medical science and public health organizations shouldn't be forced to choose between spending money on defending their reliance on a scientific analysis and funding more research and public outreach.
-------------------- Sick since at least age 6, now 67. Decades of misdiagnosis. Numerous arthritic, neuro, psych, vision, cardiac symptoms. Been treating for 7 years, incl 8 mos on IV. Bart was missed so now treating that. Posts: 765 | From nw ct | Registered: Sep 2008
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-------------------- Sick since at least age 6, now 67. Decades of misdiagnosis. Numerous arthritic, neuro, psych, vision, cardiac symptoms. Been treating for 7 years, incl 8 mos on IV. Bart was missed so now treating that. Posts: 765 | From nw ct | Registered: Sep 2008
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Keebler
Honored Contributor (25K+ posts)
Member # 12673
posted
-
Thanks, Paulie - and thanks for coming back with the link. I really like having the direct link, especially if I pass it along.
But, this is not easy to read . . . argghhh! They really don't get it and have not read all the research. It sure would help if they would.
"the development of sophisticated tests for its presence"
...if only that were true.
Posts: 55 | From New York | Registered: Nov 2008
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bettyg
Unregistered
posted
paulie, read all comments; i see person finally STOPPED arguing with you!! way to go paul!
copying article here and breaking up as necessary for neuros like me!
Set objective medical standards, get sued
The Infectious Disease Society of America attempted to set guidelines for the treatment of Lyme disease based on the best available evidence.
Three years and a quarter of a million dollars of legal fees later, that decision almost looks like a mistake.
By John Timmer | Last updated February 11, 2009 8:15
The medical journal JAMA contains an article that describes a disturbing collision of medical science and the US legal system.
Written by a pair of lawyers, the article describes how a national medical organization's attempts at formulating treatment standards for Lyme disease has been run off the rails by an alliance between an organization that advocates a minority medical viewpoint and a state Attorney General.
Over two years later, the standards are being revised, and the organization that produced them has spent a quarter of a million dollars on legal fees. ----------------------------------------
Lyme disease, named after a town in Connecticut where it first rose to prominence, was initially difficult to diagnose and treat.
The identification of the causative agent, however, has allowed the development of sophisticated tests for its presence and successful treatment with antibiotics.
A subset of patients, however, report the persistence of a poorly-defined set of symptoms that persist after all signs of the bacteria's presence have been eliminated.
These persistent symptoms in the absence of any evidence of infection are the source of all the trouble.
The Infectious Disease Society of America has a membership that includes both scientists and medical professionals, and engages in both advocacy and professional development, in addition to managing some academic journals.
As part of its professional role, it produces a large set of practice guidelines, which should "assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances."
Lyme disease is among those for which standards are available, having been produced in 2006.
As the JAMA article describes, when examining the persistence of symptoms after the apparent end of bacterial infections,
the ISDA was swayed by the facts that there was no clinical evidence for any persistent infection,
and by the fact that the symptoms, which include fatigue, headaches, and generalized muscle pain, can have a wide variety of causes.
It labelled those symptoms "post-Lyme syndrome," and noted that the primary "treatment" used for it--massive and persistent antibiotic doses--hasn't been demonstrated to be effective, and exposes patients and society in general to a variety of other risks.
The same conclusions have been reached by the National Institutes of Health and the Centers for Disease Control.
Unfortunately, that reliance on current best evidence didn't go over well with the International Lyme And Associated Diseases Society,
which believes that chronic Lyme disease is a real medical phenomenon,
and maintains its own treatment guidelines, which state, "many experts believe that this condition should be treated with repeated and prolonged antibiotics."
Shortly after ILADS protested, Connecticut Attorney General Richard Blumenthal (also known for his crusade against online predators on social networking sites) became involved, launching an investigation of the IDSA based on the premise that, in the process of formulating its guidelines, it violated state antitrust laws.
The lawyers who penned the JAMA piece take this argument apart.
Blumenthal's reasoning was apparently that its review process unfairly excluded certain viewpoints, and its reviewers had conflicts of interest.
The authors note that the authors of the competing ILADS guidelines also had conflicts, but (in contrast to the targets of the investigation), these weren't disclosed in its guidelines.
From the antitrust perspective, they write, "applying the antitrust 'rule of reason,' a challenger must show that the professional organization both possesses substantial market power and that the anticompetitive effects of its standards outweigh patient benefits."
Leaving aside whether voluntary guidelines have market power, they argue that the investigation failed the second test "because IDSA guidelines substantially advanced patients' interests."
Of course, a group like the IDSA has to weigh whether spending its limited finances on legal fees is in the interests of patients and the medical community.
After $250,000 dollars spent, it decided to reach an agreement with the Attorney General, one that allowed Blumenthal to declare victory.
A separate panel will reevaluate the 2006 standards.
Blumenthal stated that the results, "can serve as a model for all medical organizations and societies that publish medical guidelines."
According to the authors, the only way in which this is a model is that this should never happen again.
Referring to the advocates for the existence of chronic Lyme disease, they write, "when high-quality research repeatedly was inconsistent with the group's hypotheses, the community should have sought other answers."
As for Blumenthal's office, they conclude, "when political leaders using the force of law sued IDSA for its appropriate scientific conclusions that differed with the results they desired, they abused the public good."
As we've seen in the recent uproar over vaccine safety, questionable medical ideas can persist in the public well past their scientific expiration date.
But this case highlights the danger posed when legal threats become legal actions.
Medical science and public health organizations shouldn't be forced to choose between spending money on defending their reliance on a scientific analysis and funding more research and public outreach.
must have been between 25=35 comments!
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bettyg
Unregistered
posted
paulie, read all comments; i see person finally STOPPED arguing with you!! way to go paul!
copying article here and breaking up as necessary for neuros like me!
Set objective medical standards, get sued
The Infectious Disease Society of America attempted to set guidelines for the treatment of Lyme disease based on the best available evidence.
Three years and a quarter of a million dollars of legal fees later, that decision almost looks like a mistake.
By John Timmer | Last updated February 11, 2009 8:15
The medical journal JAMA contains an article that describes a disturbing collision of medical science and the US legal system.
Written by a pair of lawyers, the article describes how a national medical organization's attempts at formulating treatment standards for Lyme disease has been run off the rails by an alliance between an organization that advocates a minority medical viewpoint and a state Attorney General.
Over two years later, the standards are being revised, and the organization that produced them has spent a quarter of a million dollars on legal fees. ----------------------------------------
Lyme disease, named after a town in Connecticut where it first rose to prominence, was initially difficult to diagnose and treat.
The identification of the causative agent, however, has allowed the development of sophisticated tests for its presence and successful treatment with antibiotics.
A subset of patients, however, report the persistence of a poorly-defined set of symptoms that persist after all signs of the bacteria's presence have been eliminated.
These persistent symptoms in the absence of any evidence of infection are the source of all the trouble.
The Infectious Disease Society of America has a membership that includes both scientists and medical professionals, and engages in both advocacy and professional development, in addition to managing some academic journals.
As part of its professional role, it produces a large set of practice guidelines, which should "assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances."
Lyme disease is among those for which standards are available, having been produced in 2006.
As the JAMA article describes, when examining the persistence of symptoms after the apparent end of bacterial infections,
the ISDA was swayed by the facts that there was no clinical evidence for any persistent infection,
and by the fact that the symptoms, which include fatigue, headaches, and generalized muscle pain, can have a wide variety of causes.
It labelled those symptoms "post-Lyme syndrome," and noted that the primary "treatment" used for it--massive and persistent antibiotic doses--hasn't been demonstrated to be effective, and exposes patients and society in general to a variety of other risks.
The same conclusions have been reached by the National Institutes of Health and the Centers for Disease Control.
Unfortunately, that reliance on current best evidence didn't go over well with the International Lyme And Associated Diseases Society,
which believes that chronic Lyme disease is a real medical phenomenon,
and maintains its own treatment guidelines, which state, "many experts believe that this condition should be treated with repeated and prolonged antibiotics."
Shortly after ILADS protested, Connecticut Attorney General Richard Blumenthal (also known for his crusade against online predators on social networking sites) became involved, launching an investigation of the IDSA based on the premise that, in the process of formulating its guidelines, it violated state antitrust laws.
The lawyers who penned the JAMA piece take this argument apart.
Blumenthal's reasoning was apparently that its review process unfairly excluded certain viewpoints, and its reviewers had conflicts of interest.
The authors note that the authors of the competing ILADS guidelines also had conflicts, but (in contrast to the targets of the investigation), these weren't disclosed in its guidelines.
From the antitrust perspective, they write, "applying the antitrust 'rule of reason,' a challenger must show that the professional organization both possesses substantial market power and that the anticompetitive effects of its standards outweigh patient benefits."
Leaving aside whether voluntary guidelines have market power, they argue that the investigation failed the second test "because IDSA guidelines substantially advanced patients' interests."
Of course, a group like the IDSA has to weigh whether spending its limited finances on legal fees is in the interests of patients and the medical community.
After $250,000 dollars spent, it decided to reach an agreement with the Attorney General, one that allowed Blumenthal to declare victory.
A separate panel will reevaluate the 2006 standards.
Blumenthal stated that the results, "can serve as a model for all medical organizations and societies that publish medical guidelines."
According to the authors, the only way in which this is a model is that this should never happen again.
Referring to the advocates for the existence of chronic Lyme disease, they write, "when high-quality research repeatedly was inconsistent with the group's hypotheses, the community should have sought other answers."
As for Blumenthal's office, they conclude, "when political leaders using the force of law sued IDSA for its appropriate scientific conclusions that differed with the results they desired, they abused the public good."
As we've seen in the recent uproar over vaccine safety, questionable medical ideas can persist in the public well past their scientific expiration date.
But this case highlights the danger posed when legal threats become legal actions.
Medical science and public health organizations shouldn't be forced to choose between spending money on defending their reliance on a scientific analysis and funding more research and public outreach.
paulie, how about using HEADING ... just click pencil on your top post to do this.
Set objective medical standards, IDSA gets sued article 2.11.09
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shazdancer
Frequent Contributor (1K+ posts)
Member # 1436
posted
This article is based on a recent commentary in the Journal of the American Medical Association (JAMA), called, "Science, Politics, and Values: The Politicization of Professional Practice Guidelines." The article is completely about the IDSA Lyme guidelines under investigation.
It seems to me that the JAMA article is built on a faulty premise from the 2006 guidelines:
quote:There is no convincing biological evidence for the existence of symptomatic chronic B burgdorferi infection among patients after receipt of recommended treatment regimens for Lyme disease. Antibiotic therapy has not proven to be useful...
The premise is wrong on 4 counts:
1.) There is biological evidence of persistence of the organism after brief treatment
2.) There is mounting evidence of persistence of disease after brief treatment. Anecdotal evidence and case study evidence is not strong, except when there are thousands of anecdotes and cases.
3.) Even in a few of the major randomized, double-blind, placebo controlled studies, antibiotic therapy was shown to be useful, though not always completely curative
4.) In every discussion of Lyme disease, persistence of coinfections should be taken into account. Since testing for Bb has been so difficult, we still are not certain how coinfections contribute to the persistence and severity of disease.
Posts: 1558 | From the Berkshires | Registered: Jul 2001
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bettyg
Unregistered
posted
up for weekend warriors to read this great article!!
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