Posted 5/25/2009 1:22 PM (GMT 0)
I managed to piece this together from an article "citing" the "attack" article on the IDSA. Here is the link to the page I found this on:
http://scienceblogs.com/ethicsandscience/2009/05/evaluating_an_article_in_the_j.php
Lyme disease is one of the most controversial illnesses in the history of medicine. In 2006 the Connecticut Attorney General launched an antitrust investigation into the Lyme guidelines development process of the Infectious Diseases Society of America (IDSA). In a recent settlement with IDSA, the Attorney General noted important commercial conflicts of interest and suppression of scientific evidence that had tainted the guidelines process. This paper explores two broad ethical themes the influenced the IDSA investigation. The first is the growing problem of conflicts of interest among guidelines developers, and the second is the increasing centralisation of medical decisions by insurance companies, which use treatment guidelines as a means of controlling the practices of individual doctors and denying treatment for patients. The implications of the first-ever antitrust investigation of medical guidelines and the proposed model to remediate the tainted IDSA guidelines process are also discussed. (283)
One group of doctors, the Infectious Disease Society of America (IDSA), issued Lyme treatment guidelines in 2000 that promoted a narrow definition of the disease.1 These guidelines excluded most Lyme patients and denied them treatment for their illness. The IDSA viewpoint has been adopted without question by government agencies, insurers, medical boards and hospitals. As a result, the diagnosis and treatment of Lyme disease has been suppressed, with profound healthcare implications for patients, their families and their communities. (283)
These guidelines did not include within the accepted definition of Lyme many of the patients who had been identified as suffering from Lyme disease, and accordingly offered no recommendations for the treatment of their illnesses ... As a result of the adoption of the IDSA definition and treatment guidelines, patients who were before identified as Lyme patients have no clear diagnosis or course of treatment, a situation with profound healthcare implications for patients, their families and their communities.
When the IDSA sought to revise its Lyme treatment guidelines in 2006, patients and their treating doctors tried to obtain a voice in the guidelines process. The IDSA denied their requests for participation and limited the guidelines panel to researchers known to have a bias against the diagnosis and treatment of Lyme disease. The IDSA panel then selectively ignored evidence of persistent infection or clinical improvement in patients with persistent symptoms of the disease. (283)
[T]he IDSA's ability to further suppress the debate through its role as the gatekeepers (on editorial boards and as peer reviewers) for medical journals, medical conferences and grand rounds supported the antitrust argument when patients started complaining that they were being denied care for their disease. ...
The antitrust theory is that when a medical society has monopoly power such that its guidelines can take on the force of law, as the IDSA guidelines do, it has an obligation to ensure that the development process is fair, does not exclude competing points of view, and that its panel is not driven by commercial conflicts of interest. (283)
The increased concentration and centralisation of power in medicine was also an important factor leading up to the antitrust investigation. Twenty years ago, individual doctors had more autonomy than they do today in deciding whether to comply with medical guidelines. Medical malpractice and unprofessional conduct actions were always rooted in the standard of care, which was determined by the consensus of practising doctors, but guidelines became a vehicle for driving the standard of care. This transformed a very fluid environment where opinions in medical practice changed as individual doctors' viewpoints changed based on new information from the latest medical conference or grand rounds, the success or failure in treating patients or the latest study read by the doctors. The opinions of individual panel members on guidelines panels of powerful medical societies became a proxy for the opinions of doctors in the broader community. With "evidence-based" guidelines, someone other than the treating doctors selects, interprets and makes recommendations regarding treatment. (285)
The problem arises when the ability of the doctor to select, interpret and exercise clinical judgment is replaced by an obligation to comply with guidelines that do not work or that are not appropriate for the individual patient. Population-based treatment approaches using average results leave individual patients who are the "norm" out of the equation. (285)