Dr James Schaller
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Guidelines and Protocols
are often Trash Medicine

REDUCING UNIQUE HUMANS TO THINGS

SAMPLES OF GUIDELINE IGNORANCE

  1. No One Can Read or Experience Enough to Make Absolute Guidelines

    PubMed now has 18 million medical articles. Full-time physicians are lucky if they read five a week.

    According to Art Ayers, Medical Guidelines Lack Supporting Evidence: Medical Organizations Make Standards Based on Opinions not Evidence

    Doctors can't possibly read [all critical information]. They turn to their professional organizations for help in getting to the bottom line to tell them what to prescribe under what conditions. The organizations frequently do not have the resources to weigh all of the evidence and must rely on the experience of panels of practitioners. The problem is that the advice of the panels differs depending on which authorities are on a particular panel and since the views are not always based on a systematic review of the literature, the advice can be inconsistent with current evidence. In the worst case, the advice may be influenced by factors other than the best patient outcomes. [Some are listed below in 4)].

    Dr. Darshak Sankhavi is a pediatric cardiologist at the University of Massachusetts Medical School. In an essay in the New York Times ("Plenty of Guidelines, but Where's the Evidence?" December 9, 2008) he laments the paucity of clinical evidence that informs the US national guidelines for medical care ...

    Read more: generalmedicine.suite101.com
  2. Efforts to Create Treatment Guidelines Are Often Complicated

    Marketplace, Public Health
    Aug 18, 2009

    The development of treatment guidelines for illnesses such as diabetes is a complicated process.

    The New York Times reports: "The goal [of creating guidelines] is to improve treatment and, at the same time, save money. But setting guidelines that are good for every patient... can get messy, with some experts warning that a big national plan of this sort poses risks. A recent case involving treatment for diabetes, one of the nation's most pervasive illnesses, illustrates the difficulties."

    "Last year, a national guideline-setting group abruptly withdrew a controversial diabetes standard it adopted in 2006 that called for aggressive control of blood sugar, or glucose. The change came after a large federal study indicated that lowering glucose too quickly or too much in some patients could harm or even kill them." In medical journal articles and other expert outlets over the last year, some experts lashed out at "the group's initial decision to approve the guideline, saying they warned back in 2006 that it was medically ill-advised for some patients. ... Critics like Dr. Hayward have also suggested that pharmaceutical companies influenced the guideline so they could sell more glucose-lowering drugs like insulin. The group that set the guideline, a Washington organization called the National Committee for Quality Assurance, received about $3 million, or 10 percent of its revenue, last year from drug and medical device makers" (Meier, 8/17).

    www.kaiserhealthnews.org/Daily-Reports/
  3. Medical Research Used For Guidelines Often Flawed

    Clinical trials of many new drugs and treatments are flawed and possibly unethical, a study suggests.

    Experts in the United States have found that many researchers fail to follow international guidelines when they are carrying out studies funded by the pharmaceutical industry.

    They also fail to protect their independence and ensure that their findings are published, particularly if the results are unfavourable.

    Doctors at the Duke Clinical Research Institute surveyed 108 medical colleges across the US.

    Researchers were asked if they followed guidelines issued by the International Committee of Medical Journal Editors last year.

    These guidelines were drawn up by the editors of more than 500 medical journals across the world and are aimed at ensuring studies are robust and of a high standard.

    However, the study, which was funded by the institute, revealed that researchers rarely followed the guidelines when they were carrying out research funded by industry.

    Just 1% said they had full access to all of the data from the clinical trial. [So how can you publish or reach decisions!?] The same proportion said they were able to decide when and where the results of their studies were published. [Meaning, negative drug company results were not published?]

    http://news.bbc.co.uk/
  4. CT Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process of Infectious Diseases Society of America's (IDSA).

    • 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.
    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."
  5. Evaluation and Management Guidelines — Fatally Flawed

    Earlier this year, the Health Care Financing Administration (HCFA) and the American Medical Association (AMA), through its Current Procedural Terminology editorial panel, jointly issued draft guidelines for documenting cognitive services (evaluation and management) in the medical record. The guidelines were so stupefyingly complicated, irrelevant to actual patient care, and adversarial in intent that a grass-roots rebellion arose at the AMA's meeting in June. At the committee meeting that discussed evaluation and management guidelines, delegates from nearly every state denounced the plan heatedly, and the House of Delegates overwhelmingly passed a motion rejecting the guidelines

    http://content.nejm.org/
  6. Lumbar Fusion Guideline

    QUALIFYING STATEMENTS
    • All of the reviewed studies are significantly flawed by the use of a four-point patient satisfaction scale as the primary outcome measure. This outcome measure is not validated. Because of the use of this flawed outcome measure and because of the conflicting results reported in the better-designed studies that assess functional outcome, there is no consistent medical evidence to support or refute use of these devices for improving patient outcomes.
    • The strength of an evidence-based document is only as strong as the foundation on which it is built. This comprehensive document chronicles the state of scientific information in 2005. Many of the published reviews presented flawed results due to poorly defined outcome measures, inadequate numbers of patients, and comparison of dissimilar treatment groups. These studies of "apples and oranges" gleaned little scientific information; therefore, for the purpose of this review, the authors have discarded Class III studies whenever stronger scientific evidence was available. The result is that most of the published studies on lumbar fusion were not included on this document. When Class I or II scientific evidence was available, standards and guidelines were formulated; however, in most cases, the scientific data were only adequate to support recommendations for treatment options. The aforementioned results do not detract from the importance of this document; rather, the need for the neurosurgical community to design and complete prospective randomized controlled studies to answer the many lingering clinical questions with rigorous scientific power can clearly be seen.
    http://www.guideline.gov/

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