September 17, 2007
Honorable Jon S. Corzine, Chairman
Health and Human Services Committee
National Governors Association
444 North Capitol Street, NW, Suite 267
Washington, DC 20001
Re: Nationwide Lyme Disease Epidemic
Dear Governor Corzine:
I am a chronic Lyme disease patient and advocate who founded a 501(c)3 nonprofit, public charity in 2005 called Lyme Education Awareness Program, L.E.A.P. Arizona. Our charity provides education to the public about tick-borne infections and financial assistance to patients for their treatment and necessities of life. I receive requests for information and financial assistance from Lyme disease patients from many states. As a national Lyme disease patient advocate, I am responding to correspondence sent to you on August 7, 2007 from Dr. Henry Masur, President of the Infectious Diseases Society of America (IDSA).
Legislation that favors healthcare choices is in the best interest of chronic Lyme disease patients. Citizens suffering from late-stage Lyme disease, a virulent bacterial infection, should have the right to treatment options that include long-term antibiotics. This treatment decision should be made jointly by the patient and their treating physician. According to the American Medical Association’s (AMA) Informed Consent Guidelines, it is the responsibility of each physician to provide all treatment options to their patients, regardless of cost or whether such treatments are covered by insurance.
Honorable Jon S. Corzine
September 17, 2007
Page Two
Physicians access information from medical organizations such as the Infectious Diseases Society of America. It is for this reason that the IDSA should abide by AMA Informed Consent Guidelines by disseminating information to physicians that encompass all treatment options, not only those written by their guideline authors. Informed consent is an important principle that the IDSA is blatantly ignoring. The IDSA is wrenching healthcare choices from the hands of those who should be making those choices, that is, the individual physicians and their patients. Lyme disease patients and their physicians have the right to choose for themselves the course of therapy they think is most beneficial.
The IDSA has made it their business policy to interfere with Lyme disease legislation that affords patients and their treating physicians to retain these individual healthcare choices. Treatment for chronic disease is a personal matter that does not need to be authoritatively determined by a few individuals with conflicts of interest speaking on behalf of the IDSA. Most people readily learn about the disease that afflicts them, whether it is Lyme disease, cancer, diabetes or other debilitating condition. Misdiagnoses prompt Lyme disease patients to become quite educated with regard to their illness. In addition, the majority of Lyme disease patients are knowledgeable of several treatment options that are available to them.
Lyme patients know that they have a choice of short or long-term antibiotics for treatment of their disease. Cancer patients have the right in choosing to undergo chemotherapy or radiation treatments, therapy that brings them close to death’s door, and they are not stripped of the right to make those healthcare choices for themselves. I feel comfortable in speaking on behalf of chronic Lyme disease patients, many of whom have suffered without being diagnosed or given any treatment at all for years, in saying that they also deserve to undergo treatment of their choice without interference from the IDSA.
The IDSA is oblivious to the excruciating musculoskeletal pain, crushing fatigue and debilitating cognitive dysfunction that chronic Lyme disease patients are forced to endure due to the IDSA’s treatment-restrictive guidelines that are utilized by insurance companies and promoted by the Centers for Disease Control and Prevention (CDC). The IDSA’s ongoing effort to minimize our suffering is obvious in their constant referral to “so called chronic Lyme disease.” The IDSA’s inference that our daily sufferings are either figments of our imaginations, fictitious diagnoses by our physicians or an infection that just doesn’t exist is ludicrous, and in my opinion, appears to be inhumane malicious criminal intent against a patient community as a whole.
With regard to the 14-member IDSA panel and the review of research by these IDSA guideline authors, it is evident that they did indeed deem some Lyme-related research as not meeting “rigorous scientific standards.” It is astounding that some of the research the IDSA panel members chose to ignore was their very own. Let me provide you with a few examples.
Honorable Jon S. Corzine
September 17, 2007
Page Three
This is an abstract from a published article co-written by Allen C. Steere, one of the authors of the 2000 and 2006 IDSA Treatment Guidelines, in the New England Journal of Medicine, Nov 22; 323(21):1438-44, which refers to a study of Borrelia burgdorferi:
“These chronic neurologic abnormalities began months to years after the onset of infection, sometimes after long periods of latency, as in neurosyphilis…The typical response of our patients to antibiotic therapy supports the role of spirochetal infection in the pathogenesis of each of the syndromes described here…The likely reason for relapse is failure to eradicate the spirochete…This last article is one of many studies that show continuing symptoms are most likely due to persistence of the spirochete.”
I ask you, doesn’t Dr. Steere adequately describe “so called chronic Lyme disease” as persistence of infection?
The following is from another published article by Dr. Allen C. Steere:
Steere, AC., 1995, Musculoskeletal manifestations of Lyme disease. American Journal of Medicine, 1995, 88:4A-44S-51S.
“…a 1-month course of oral antibiotics may not always eradicate viable spirochetes.”
Also from Steere:
Steere, AC., et al., 1994, The long-term clinical outcomes of lyme disease. A population-based retrospective cohort study. Annals of Internal medicine, 121(8)560-7.
“Ten of the 38 patients with Lyme disease reported relapses within 1 year of treatment…and had had repeated antibiotic treatment (5 patients with intravenous ceftriaxone). …Patient 4, in addition, had had second degree atrioventricular block with acute Lyme disease that resolved with penicillin treatment. Her irregular rhythm recurred 2 years later, resolved temporarily with ceftriaxone treatment, but progressed to complete heart block requiring a pacemaker. …Patient 12…was treated with 2 weeks of parenteral penicillin. She later developed a progressive speech disorder, bradykinesia, and abnormal ocular motor function. Magnetic resonance imaging of the brain showed scattered white matter lesions in the hemispheres and pons…she was re-treated with 2 weeks of parenteral ceftriaxone in 1989 that had no effect on her neurologic symptoms. During the time of observation, this patient died. At autopsy…[using] Dieterle silver stain, a spirochete was present in the cortex and another was exterior to a leptomeningeal vessel.”
Is this the “Post Lyme Syndrome” that the IDSA guidelines refer to?
From Raymond J. Dattwyler, another author of the 2000 and 2006 IDSA Treatment Guidelines:
Honorable Jon S. Corzine
September 17, 2007
Page Four
Dattwyler, RJ., et al., 1988, Seronegative Lyme disease. Dissociation of specific T-and B-lymphocyte responses to Borrelia burgdorferi. New England Journal of Medicine, 1988, 319(22):1441-6.
[From the abstract:] “We studied 17 patients who had presented with acute Lyme disease and received prompt treatment with oral antibiotics, but in whom chronic Lyme disease subsequently developed.”
“…chronic Lyme disease subsequently developed.” Is this the Post Lyme Syndrome referred to by the IDSA guidelines?
This scientific published research by Drs. Steere and Dattwyler, members of the esteemed IDSA panel, for some odd reason does not meet the IDSA’s “rigorous scientific standards” and does not support the IDSA hypothesis that chronic Lyme disease does not exist. The IDSA guideline authors demonstrated that chronic Lyme disease is caused from persistent bacterial infection. So, the IDSA guideline panel ignored published research from its own members in the formulation of their 2000 and 2006 guidelines for the treatment of Lyme disease.
If the IDSA chooses to ignore research and publish treatment guidelines by falsifying their panel’s own research, that is their choice, unfortunate as that may be taking into consideration the damage the guidelines inflict upon patients who become victims of such misguided medical advice. In my opinion, the IDSA and its guideline authors are exposing themselves to legal liability for medical malpractice by ignoring research performed by its own guideline authors. Now that the IDSA and guideline authors are embroiled in a legal civil investigation by Connecticut Attorney General Richard Blumenthal, their aggressive position against state legislation that provides for individual healthcare choices, although not a new position for them, becomes a brazenly bold move. Letters such as Dr. Masur’s should cause serious reflection and inquiry into the possible motives behind such a business policy.
Rebuttal to specific points in Dr. Masur’s letter:
-There is no widespread concensus within the medical and scientific community about appropriate treatment for Lyme disease. There is only one treatment guideline being forced upon physicians. This so-called concensus is not based upon all the research and guidelines that are available. If the CDC provides only one published guideline on their website, namely the IDSA guideline currently under investigation for possible antitrust violations, when there is actually another published treatment guideline from the International Lyme and Associated Diseases Society (ILADS) that should also be made available to physicians and patients, this constitutes a failure to provide informed consent by the CDC. There cannot be a concensus when all the options are not placed on the table for intelligent discussion and decision.
Honorable Jon S. Corzine
September 17, 2007
Page Five
-Realistically, it is quite difficult to obtain a Lyme disease diagnosis from an infectious disease specialist specifically because they defer to the IDSA treatment guidelines. Therefore, Dr. Masur’s assertion that IDSA members “care” for Lyme patients does not stand up to logic. If the IDSA guidelines state that chronic Lyme disease does not exist, contrary to their authors’ own research, then their own 8,000 members will most likely NOT diagnose a case of chronic Lyme disease, resulting in patients going for years without diagnosis and treatment, which is the crux of our problem.
-“Some patients may continue to experience these symptoms even after a course of antibiotic therapy has killed the Lyme disease bacterium.” First of all, I challenge Dr. Masur to present to both of us the test that can be performed that proves that all Lyme bacteria are killed after one course of antibiotic therapy. There is no definitive test that proves such a claim. Repeated courses of antibiotics must be given based upon the patient’s continued symptoms or relapses.
-One of the authors of the American Academy of Neurology (AAN) Lyme treatment guidelines is an author of the IDSA guidelines, also, John J. Halperin, M.D. I assert that the IDSA has attempted to bolster their biased position by enlisting the assistance of the AAN in publishing treatment guidelines that copycat those of the IDSA. The AAN Press Release dated May 23, 2007, a copy of which is enclosed, states:
“Patients who have received acceptable antibiotic regimens for Lyme disease sometimes have persisting symptoms, often referred to as Post-Lyme syndrome (PLS). This guideline states that long-term use of antibiotics does not improve the outcome in people with chronic symptoms after customary treatment of Lyme disease. Specifically, further treatment does not improve overall health quality of life, memory, or depression.”
I must emphatically testify that long-term antibiotics have enabled me to not only walk again and function at 50% of my ability prior to contracting Lyme disease, which is an obvious improvement in the quality of my life, but have also improved my memory, other cognitive functions and depression. What causes me consternation now are these aggressive efforts by the IDSA and AAN to obliterate my experience with chronic Lyme disease and long-term antibiotic treatment, along with not some, but thousands of other patient experiences, as though we count for absolutely nothing. The focus should be on listening to the patients, not pushing them aside and perpetuating their suffering. Patients are losing their health, their jobs, their homes, their marriages and their families.
I am the first to acknowledge that long-term antibiotics do not always cure a long-standing Lyme infection. I am not yet cured myself and truly doubt if I ever will be cured at this late stage. However, long-term antibiotics should not be withheld from patients due to uncertain outcome. This therapy can be managed by physicians and could be managed even better if patients were not forced to administer and watch over their ports themselves, because insurance denies home health coverage based upon IDSA diagnosis and
Honorable Jon S. Corzine
September 17, 2007
Page Six
treatment guidelines. It would be considered barbaric to deny cancer patients additional treatment when they relapse, even treatment that is deadly in and of itself. It is ironic that we now have interventions that force children to undergo dreadful and ravaging chemotherapy treatments, yet the IDSA is battling Lyme patients in receiving long-term antibiotic therapy. We are quite able to assess and accept the risks ourselves without this pseudo-paternal intervention from Dr. Masur/IDSA.
Research is not being performed to find better treatment options. This is extremely unfair to patients. Of course, there are risks associated with all treatments. There are risks associated with all surgeries. However, patients should have the choice of accepting risks through informed consent with their treating physicians. I ask you to seriously question why the IDSA is on such a fervent mission to prevent patients from obtaining medicine that truly does improve their quality of life. What is driving Dr. Masur to fight such an inhumane battle against those whom his members serve? Could it be the close financial associations shared by the IDSA guideline authors in the form of patents for Lyme disease test kits, vaccine development and research grants for studies that further their personal gain and do nothing to improve the situation for patients?
These are valid questions that hopefully will be answered through Mr. Blumenthal’s investigation. I am hoping that this investigation will open the door to legal remedies for the many patients who have been harmed by the IDSA guidelines and a few of the guideline authors for many years now. Lives are being ruined and lost due to deliberate neglect in providing informed consent. Dr. Masur would have you believe that Lyme disease patients must be sacrificed on the altar for the good of all in protecting fallout from drug-resistance. Dr. Masur conveniently omitted any attacks against long-term antibiotics commonly used to treat tuberculosis and even acne. Lyme patients are requesting the same treatment afforded those with other infections requiring long-term antibiotic treatment. For instance, I have heard reports of acne patients receiving months of oral antibiotic prescriptions for Doxycycline, a common antibiotic used to treat Lyme infections.
I appreciate your consideration of the position I have outlined on behalf of Lyme disease patients. I am requesting equitable healthcare options as afforded to other patient groups through enacted legislation that allows patients and their treating physicians to pursue all treatment options available. I am also requesting that the IDSA cease from further efforts at sabotaging legislation that will allow Lyme disease patients to make personal healthcare choices. If further information is needed, I would be more than willing to provide it to you.
Sincerely,
Tina J. Garcia
President
Enclosures:
Letter to Governor Corzine from Dr. Henry Masur, IDSA President
http://www.idsociety.org/WorkArea/showcontent.aspx?id=6452
American Academy of Neurology Press Release dated May 23, 2007
http://www.aan.com/press/index.cfm?fuseaction=release.view&release=514
American Medical
Association Informed Consent Guidelines
http://www.ama-assn.org/ama/pub/category/4608.html
Invasion of
Human Neuronal and Glial Cells by an Infectious Strain of
Borrelia burgdorferi
Jill A. Livengood
and Robert D. Gilmore, Jr.
Centers for Disease Control and Prevention, Division of Vector-borne Infectious
Diseases, 3150 Rampart Road, CSU Foothills Campus, Fort Collins, CO
80522,
USA Received 13 June 2006; accepted 30 August 2006.
Available online 22 September 2006.
http://www.canlyme.com/intracellular_invasion_borrelia_2006.pdf
cc: President George W. Bush
Secretary Michael Leavitt, U.S. Department of Health and
Human Services
Anthony S. Fauci, M.D., Directory, National Institute of Allergy &
Infectious Diseases
Senator John McCain
Senator Jon Kyl
Senator Edward Kennedy
U.S. Arizona Representative Jeff Flake, 6th District
U.S. Arizona Representative Trent Franks, 2nd District
U.S. Arizona Representative Gabrielle Giffords, 8th
District
U.S. Arizona Representative Raul Grijalva, 7th District
U.S. Arizona Representative Harry E. Mitchell, 5th
District
U.S. Arizona Representative Ed Pastor, 4th District
U.S. Arizona Representative Rick Renzi, 1st District
U.S. Arizona Representative John Shadegg, 3rd District
Matt Salo, HHS Committee Director, NGA
Kathleen Nolan, Health Division Director, NGA
Julie Gerberding, M.D., Centers for Disease Control and Prevention
Lyle R. Petersen, M.D., Centers for Disease Control and Prevention
Governor
Janet Napolitano
Arizona Senate Health Committee Members
Carolyn S. Allen, Chairman
Tom O’Halleran, Vice Chairman
Paula Aboud
Amanda Aguirre
Meg Burton Cahill
Barbara Leff
Thayer Verschoor
Arizona House of Representatives Health Committee
Bob Stump, Chairman
Rick Murphy, Vice Chairman
Nancy K. Barto
David Bradley
Jennifer J. Burns
Trish Groe
Phil Lopes
Linda Lopez
Lucy Mason
Lena S. Saradnik