Testimony on HB 798 by Rheumatology Society
On November 15, 2007, the following testimony was submitted to the Pennsylvania House of Representatives’ Health and Human Services Committee. The testimony was written by Donald Goldsmith, MD, member of the Pennsylvania Rheumatology Society.
Good Morning everyone. I’m Dr. Donald Goldsmith, Director of the Pediatric Rheumatology Section at St. Christopher’s Hospital for Children, in Philadelphia, and a Professor of Pediatrics at Drexel University College of Medicine.
I spend 60-70% of my time in active patient care for individuals from age 1 day to age 21 years, although many often like to hang around longer. The diagnosis and assessment of Lyme disease and its subsequent management is a regular part of my clinical practice, along with the many other rheumatic disorders of childhood. I also care for many children with chronic musculoskeletal pain and fatigue. I appreciate the opportunity today to talk with you this morning and address you as a representative of the Pennsylvania Rheumatology Society, a statewide organization of rheumatologists. House Bill 798 was discussed at our annual meeting last week and my comments reflect the unanimous opinion of our Society
This bill asks legislators to endorse an unrecognized and patently dangerous therapy for what is called Chronic Lyme Disease, and also to protect those practitioners who advocate for this therapy from actions that might be taken against them for medical misconduct. So, with the passage of HB 798, the Pennsylvania legislature would then both practice medicine, and indirectly endorse a treatment regimen that has been considered unnecessary and hazardous by the overwhelming majority of medical professionals. Since the last hearing on House Bill 798 in September an article has been published in the New England Journal of Medicine entitled “A Critical Appraisal of “Chronic Lyme Disease”. The New England Journal of Medicine is the most respected and most influential medical journal in the world. Its peer review process is impeccable, and its standards for accuracy are unmatched. Let me re-emphasize that, The New England Journal of Medicine is the most respected and prestigious medical journal in the world.
The paper, “A Critical appraisal of Chronic Lyme Disease”, appeared in the October 4th, 2007 issue as part of their series “Current Concepts”. There were six primary authors from centers around the world including Harvard University Medical School, Yale University College of Medicine, the University of Connecticut College of Medicine, the Centers for Disease Control (known as the CDC, a U.S. Dept of Health Facility), the Lyme Borreliosis Unit, Health Protection Agency, Microbiology Laboratory at Southampton General Hospital in England, and New York Medical College. Reviewers and participants prior to submission of the paper for publication include 22 additional members of the Ad Hoc International Lyme Disease group from the United States and Canada. This is a substantive group, eminently qualified to offer health policy guidelines. In fact, it’s simply the best collection of minds that the world could put together concerning this issue. And what were their conclusions. I quote:
“The assumption that chronic, subjective symptoms are caused by persistent infection with B. Burgdorferi (the organism that causes Lyme disease) is not supported by carefully conducted laboratory studies or by controlled treatment trials. Chronic Lyme disease, which is equated with chronic B. Burgdorferi infection, is a misnomer, and the use of prolonged, dangerous, and expensive antibiotic treatments for it, are not warranted.”
Let me rephrase the conclusion to emphasize the point of the article even more directly: the use of prolonged, dangerous and expensive antibiotic treatments for Lyme disease are not warranted.
I have also just returned from the American College of Rheumatology meeting in Boston, where more than 13,000 clinicians, physician scientists, and basic researchers from all over the world converged to present their work, discuss its implications, and then leave better prepared to serve their patients. Countless seminars and more than 2,000 peer-reviewed original scientific papers were presented.
Conclusions from the presentations concerning Lyme disease again offer no data to support the prolonged use of antibiotics for the treatment of Chronic Lyme Disease.
Here’s an example of the conclusions from one study, which analyzed 125 patients referred to a Lyme Disease Clinic in an endemic area of Lyme disease in the northeast United States.
I quote:
“In a single tertiary care Lyme disease clinic in an endemic area of the northeast United States only a small minority of physician or self referred patients were thought to have active Lyme Disease. The most common diagnosis in this cohort was Fibromyalgia and chronic fatigue syndrome.”
Let me also mention two other related and important perspectives concerning this issue. First, you may have heard of the term “Evidence Based Medicine”. The term means exactly what it says. Use the best and most accurate evidence there is to make clinical decisions. This is what is expected now for all medical practitioners and within the next few years proof of such skills will be required for continued licensure. The principles of Evidence Based Medicine are now part of each medical school curricula as well as post-graduate medical education (e.g. residency and fellowship training programs after graduation from medical school). From this discipline have emerged practice guidelines based on a rigorous methodological review of the most credible evidence from the medical literature.
The basic foundation of therapeutic medicine rests on the concept of well-designed randomized clinical trials. The public at large is thus largely protected from therapeutic misadventures. Evidence Based Medicine makes sense, and we all benefit each day from its increased implementation.
My second point is that there are significant public health and personal consequences of prolonged courses of antibiotic therapy. This practice significantly enhances the emergence of antibiotic resistance in our communities.
What’s been screaming across the newspaper and Internet headlines over the last few weeks and on “60 minutes” this past Sunday? It’s the growing public health concern and personal tragedies that have occurred as a result of MRSA infection. I’m sure that most people don’t know what MRSA really is. It’s called the super bug by the media. Just how did MRSA become so super? Let’s look at the name. The last two letters, SA, stand for Staphylococcus aureus or Staph aureus. This is a common bacteria, which is most often found on the surface of the skin. Under certain circumstances it gets into the superficial or deep layer of the skin and causes a boil or pimple. Many of you in the room likely have experienced such a so-called “staph” infection. More severe disseminated infections may also occur such as in the brain or in the lungs. Staph bacteria, fortunately, were initially very sensitive to penicillin but with overuse of penicillin the organism became resistant to penicillin, with earlier disastrous consequences. Resistance to an antibiotic means that bacteria are no longer able to be killed by that antibiotic. Fortunately another antibiotic, called “methicillin” was rapidly developed, which was then effective against Staph aureus infections. The M in MRSA stands for methicillin and the R stands for resistant. Therefore MRSA is the abbreviation for “Methicillin Resistant Staphylococcus Aureus”. The term MRSA is actually even out dated because this staph bug is also now resistant to other important antibiotics such as oxacillin and amoxicillin and is found in local communities, not just medical care settings. So MRSA is a glaring example of the consequences of the heavy and extended use of antibiotics. Antibiotics must only be used for situations if their efficacy is documented by evidence based medicine. There are almost no new antibiotics, and we must preserve the ones that we have so that they are available when we really need them. MRSA, Methicillin Resistant Staph Aureus, is a major health care problem in the United States, and an urgent public health priority. This is indeed then, “the big picture
There is no conspiracy here, no collusion; there is simply no credible evidence to support this treatment. If there were, it would be endorsed by us. Right now, however, there is continued misinformation, unfounded assertions, and a group of individuals pushing for passage of a bill, which is ungrounded and abandons the principles of Evidence Based Medicine. I am sincerely empathetic to those with chronic symptoms of fatigue and pain, but the pursuit of treatment with prolonged antibiotic therapy is not the treatment that will help you to recover.
I repeat that the world’s experts on Lyme disease have stated conclusively that there is no indication for long-term antibiotic use for the disease. With the significant potential consequences of this treatment including promoting antibiotic resistant bacteria, it is totally unjustified to endorse the proposed legislation. As physicians, we want to do the best for our patients as do legislators for their constituents. We both want what is best for our society and our state. Please do not pass legislation with such profound negative negative health implications for the individuals whom we all serve.
I sincerely thank you for the opportunity to speak with you today and I will be happy to answer your questions.
Last Updated: 8/5/2008