• The Promise and Peril of Evidence Based Clinical Standards
  • September 15, 2010
  • Law Firm: Holland Hart LLP - Denver Office
  • A key component of the governments efforts to bend the cost curve for health care is the use of technology and new health delivery structures to introduce “evidence based” clinical standards for the treatment of patients.  Technology will be useful in determining the most clinical effective modalities of treatment and in monitoring the implementation of the guidelines across the spectrum of health car providers. It is an idea that on the surface makes a great deal of sense.  Providers should be held accountable to implement those methods of treatment that have shown themselves to be the most effective and cost efficient in the treatment of chronic disease disease syndromes.

    of the ongoing questions and concerns is who is to decide on those standards; is the decision process free from economic interests and does the process calcify a standard that would benefit from ongoing analysis and experimentation. certainly the idea that “best clinical practices” be determined and implemented sounds in common sense, but there are significant questions about what are the best clinical practices. There is an estimate that only 20% of medicine is based upon the results of “double blind” scientific studies.
     
    Take for example the furor over the development of standards for the treatment of chronic lyme disease.  Two different infectious disease societies have come up with two different standards. The Infectious Disease Society of America (“IDSA”) came up with a 30 day protocol for the treatment of the disease with antibiotics and considers any lingering problems to be a “self perpetuating autoimmune  response.” On the other hand, the International Lyme and Associated Disease Society (“ILADS”) asserts that the duration of treatment should be determined by the individual patient’s treatment response and believes there to be insufficient evidence for standardized treatment protocols for the disease at this time.  Guess which one insurance companies have tended to adopt and which one the determine to be “experimental.” Several years ago the Connecticut Attorney General undertook an extensive investigation of the IDSA  based on complaints of bias and conflict of interest among those involved in developing the standard resulting in an agreed upon  re-evaluation which adopted the same standard.

    Those who provides services, pharmaceuticals and medical devices all have a vested interest that can be radically effected by the adoption of a particular standard.  It will be essential to monitor the adoption standard to assure that a particular protocol is based on real, not manufactured evidence and that the standard is regularly reviewed to account for the development of new evidence.   Perhaps the more difficult problem will be to keep the process from being infected by the enormous pressures of the economic interests that are involved/

    Lyme Disease is America's most common and fastest growing vector-borne disease. The spiral-shaped bacteria, Borrelia burgdorferi (Bb), which causes Lyme Disease, can be spread by the bite of ticks carried by birds, deer, house pets and rodents. It can be transmitted through human blood and from mother to child in utero. According to the CDC, "Typical symptoms (cdc.gov/ncidod/dvbid/lyme/ld&under;humandisease&under;symptoms.htm) include fever, headache, fatigue, and a characteristic skin rash called erythema migrans (cdc.gov/ncidod/dvbid/lyme/ld&under;LymeDiseaseRashPhotos.htm). If left untreated, infection can spread to joints, the heart, and the nervous system. Lyme disease is diagnosed (cdc.gov/ncidod/dvbid/lyme/ld&under;humandisease&under;diagnosis.htm) based on symptoms, physical findings (e.g., rash), and the possibility of exposure to infected ticks; laboratory testing is helpful in the later stages of disease."