NatCapLyme focuses our efforts on helping people with tick-borne diseases through awareness, education, support, advocacy, and research. After careful deliberation, we issue formal position or policy statements on issues that are of critical importance to our community and our association’s mission. We invite you to read through our past position statements:
Members, Virginia House of Delegates
Health, Welfare and Initiations Committee
Virginia House of Delegates
Richmond, VA 23218
Re: H.B. 512
Dear Delegates:
I am writing as Executive Director of the National Capital Lyme & Tick-borne Disease Association (“NatCapLyme”) on behalf of the thousands of victims of Lyme disease who are citizens of Virginia. NatCapLyme has over 1800 members and Virginia chapters in Northern Virginia, the Shenandoah Valley, Central Virginia and Hampton Roads. This is in response to the letter of January 21, 2010 sent to you by Dr. Phillip Baker, Executive Director of the American Lyme Disease Foundation addressed to Sponsors and Patrons of H.B.-512.
Dr. Baker opposes enactment of H.B. 512, a bill designed to relieve the suffering of Lyme patients in this state. The bill provides that licensed physicians in Virginia may prescribe long-term antibiotics (over four weeks) as therapy for Lyme disease when the doctor believes this is medically warranted. It further provides the doctor will not be subject to discipline solely for prescribing long-term therapy, provided the therapy is properly documented and administered.
Nearly all of Dr. Baker’s assertions are a simple rehash of arguments he has previously made in various publications and op-ed pieces. The net effect of his thesis is that Lyme is an easily diagnosed and treated disease and that the peer reviewed published science fully supports his conclusion.
In fact, Dr. Baker’s conclusions are not supported by the scientific literature and fail to credit the literature that lead to different conclusions. Studies that he cites are seriously flawed and certainly are not the “unequivocal and rather convincing results” he would have his reader believe. He refers to all of the adverse consequences that could occur from extended use of antibiotics without recognizing that the bill would require proper record keeping by the administering physician and specifically makes no further change to medical practice standards. Attached to this letter is correspondence from a Virginia physician addressing the state of the literature and the studies relied upon by Dr. Baker.
In Dr. Baker’s view there is no evidence to indicate that chronic Lyme symptoms are caused by a persistent Borrelia burgdorferi infection. He asserts that H.B. 512 would prevent medical boards from disciplining physicians who implement a therapeutic approach deemed unjustified and unsafe by their peers and describes it as a chilling precedent. However, he fails to recognize and credit the experience of many other of his peers and would set a standard of care that has been rejected by the Attorney General of Connecticut, now his own home state. He fails to recognize the precedent set by a recently passed similar long-term antibiotic treatment law in Connecticut. A truly chilling precedent would be one that ties the hands of honest and skilled clinical practitioners because they cannot administer a therapy that they have seen useful and successful in treating patients with proven cases of Lyme and tick-borne disease.
Dr. Baker protests that he and other doctors who share his views are not uncaring and unconcerned. That may be true, but then what do you call someone who would restrict a physician’s careful and thoughtful use of treatment that in his clinical experience has resulted in real benefit and improvement, claiming the mantle of evidence-based medicine when there is no such unimpeachable evidence?
In fact, Dr. Baker’s letter actually highlights the need for H.B. 512 because he, unfortunately, exemplifies the unfounded narrowness of some who would unduly restrict the choices of others based on their own imperfect science. This bill is necessary because it recognizes that there is a long standing debate within the medical profession over long-term therapy for Lyme and it seeks to maintain flexibility until true evidence-based medicine is produced.
It is noteworthy that the debate stems from guidelines issued by the Infectious Diseases Society of America, which recommends against long-term therapy. As can be explained more fully, the guidelines have been the subject of long-term debate, resulting in a legal action by the State of Connecticut claiming that they are invalid because of conflicts of interest within the IDSA and among the guideline’s authors. In a settlement of these charges, the IDSA has agreed to review and reexamine the validity of the guidelines.
Nevertheless, and unfortunately, due to the prominence of some IDSA members, many state medical boards have erroneously assumed that the guidelines remain valid and even more erroneously that the IDSA intended these guidelines to be binding on the medical profession. As a result, some state medical boards have disciplined doctors for prescribing long-term therapy and this has had a very negative effect on the freedom of doctors to treat patients in the manner they believe to be justified based on their best medical judgment.
This fear of being disciplined has caused many physicians to decline to treat Lyme victims, even when they believe it to be medically required. The ones who are the real victims of this dispute are the thousands Virginians who live in constant pain and fatigue because they cannot obtain proper treatment. Even when they can find doctors willing to provide extended treatment, their insurers often rely on this debate to deny coverage.
As stated Dr. Baker erroneously believes the IDSA guidelines preclude extended treatment. In the penultimate paragraph of Dr. Baker’s letter he states that extended therapy is not a “prudent option” and then cites the IDSA as having endorsed this view. The actual position of the IDSA, as stated in the attached letter, to all the members of the U.S. Congress, and signed by the IDSA President is:
We recognize that medicine, and the application of practical guidelines, must take into account individual patient needs and circumstances. As such, we make clear that guidelines are not mandates. They are recommendations and are not intended to supersede individual physician judgment. The IDSA guidelines make no recommendations regarding insurance coverage or reimbursement for treatment.
H.B. 512 affirms the true intent of the IDSA by preserving the historical and necessary right of licensed physicians in Virginia to treat their individual patients in the manner the physician believes is best for the patient according to their best medical judgment. The bill does not declare that long-term therapy is good or bad; it merely takes the clear position that the Commonwealth of Virginia chooses to trust its physicians to exercise their good faith medical diagnosis and that their decisions should not be adversely affected by fears of disciplinary measures being urged and financed by parties, including insurers, in other states who have interests that are not beneficial to our patients.
An example of such outside party interests is shown by Dr. Baker’s opening paragraph, which states that H.B. 512 would compel insurers to pay for long-term therapy. The bill does not do this, but raising this allegation in his opening sentence indicates a primary concern superior to that of Virginia Lyme victims. The opening paragraph also states that the bill would prevent the Virginia medical board from disciplining doctors who administer long-term therapy for “chronic Lyme disease.” We hasten to point out that the bill will not prevent discipline for negligent or unprofessional therapy.
Dr. Baker states that Lyme disease is “quite easy to cure with a short course of treatment.” Unfortunately there are thousands of persons in this state who continue to suffer from chronic, disabling Lyme, who were treated unsuccessfully with the short course of treatment he advocates. They need this bill if they are to have a hope for any form of an acceptable future. It is these persons whom this bill will protect, not insurance companies who are already ably protected by well financed organizations.
It is obvious that we can argue at length on the scientific merits of long-term and short course therapy. There are all sorts of experts capable of arguing either side, with graphs, statistics, and purported studies. What is important here is that we need to create an opportunity for Virginia patients to receive adequate treatment now, before they are disabled and their lives ruined. Given the current state of the science, what is adequate should be decided by the doctors who actually treat these patients. Dr. Baker states that the “observations and anecdotal reports” of patients who claim long-term treatment has been successful “are not reliable”. This certainly is not what your constituents and many of your licensed physicians believe.
To sum up, Dr. Baker’s letter raises concerns that are not relevant to H.B. 512; ignores or understates scientific publications that conflict with his understanding of Lyme disease; and relies too heavily upon the IDSA’s highly-disputed treatment guidelines. H.B. 512 does not require physicians to treat Lyme disease in a certain way or excuse them from sanction for genuine acts of malpractice. Rather, it simply gives them and their patients the freedom to treat in accordance with an emerging school of thought that happens to disagree with Dr. Baker. We urge Virginia to provide leadership in this area, recognizing the sacrosanct nature of patient autonomy and the need for flexibility when science has not yet revealed all the answers to a vexing public health problem.
We trust you will agree that the alleviating the long-term costs of having our citizens permanently crippled or severely disabled by chronic Lyme disease, as well as the effects of their living in continuing pain, far outweigh the concerns for health insurance cost that Dr. Baker is concerned with in the last paragraph of his letter. Indeed, properly priced, the antibiotic therapy is a fraction of the cost of long-term disability to the patient, and to our larger society.
In addition to the letter of a Virginia physician opposed to Dr. Baker’s views, I have attached a patient family response to one of Dr. Baker’s prior Op-Ed articles. You will see that this is not the first time that Lyme victims have been subjected to Dr. Baker’s tactics and that he does not seek to respond to past criticism. In fact, he frequently gets the same response, and similar bills do get passed in other states and commonwealths.
We urge you to support enactment of this bill and will be pleased to furnish any additional information you may request.
Sincerely,
Monte Skall
Executive Director
As a former resident of Frank Pallone’s Congressional district, as the mother of a daughter disabled by a case of Lyme disease and three other tick-borne infections contracted in Monmouth County at age 15, and as a newly-diagnosed Lyme patient myself, I take serious issue with the assertions made by Dr. Phillip Baker in his May 21 op-ed.
As my husband, Douglas O. Walker, Ph.D. will also write to you, it is beyond our comprehension how those associated with the federal government and the Infectious Diseases Society of America (IDSA) can promulgate the untruth that no medical studies exist that support the notion of chronic Lyme infection. Dozens, if not hundreds of such studies have been published, some of them written by members of the IDSA guidelines panel recently under investigation in Connecticut. What would a thinking person make of the following statement published in the Annals of Medicine in 1999: “We conclude that the treatment of Lyme borreliosis with appropriate antibiotics for even more than 3 months may not always eradicate the spirochete” (Oksi and others 1999)? What of the studies in which Lyme spirochetes or their DNA can be cultured from patients previously treated with “adequate” courses of antibiotics (Hudson and others 1998, Oksi and others 1996)?
What about the fact that “Most, if not all, antibiotics used so far have been associated with a treatment failure in patients with erythema migrans” (Weber 1996), better known as the bull’s-eye rash stage of Lyme disease, meaning that the infection can progress beyond the skin to disseminate throughout the body and become a serious health threat? If it is difficult to treat even the rash stage, when the infection is likely to be limited to the skin surrounding the tick bite, why is it surprising to find that late stage infection embedded throughout the body is hard to treat?
What about the findings from scientists at Philadelphia’s Fox Chase Cancer Center that 74.2% of patients who had previously received three weeks to two months of antibiotics still excreted the DNA of the Lyme disease organism in their urine? Or as the doctors put it, “It is proposed that a sizeable group of patients diagnosed on clinical grounds as having chronic Lyme disease may still excrete Borrelia DNA, and may do so in spite of intensive antibiotic treatment” (Bayer and others 1996).
Would Dr. Baker and his associates question the integrity of the researchers at New York’s Albert Einstein College of Medicine who wrote, “We report an unusual patient with evidence of Borrelia burgdorferi [Lyme] infection who experienced repeated neurologic relapses despite aggressive antibiotic therapy. Each course of therapy was associated with a Jarisch-Herxheimer-like reaction,” which is unique to spirochetal infections such as Lyme. “Although the patient never had detectable free antibodies to B. burgdorferi in serum or spinal fluid, the CSF [cerebro-spinal fluid] was positive on multiple occasions for complexed anti-B. Burgdorferi antibodies, B. burgdorferi nucleic acids and free antigen,” meaning that the scientists found evidence of a persistent Lyme infection in the patient that had survived “aggressive antibiotic therapy” (Lawrence and others 1995).
Is this study not clear enough? “The persistence of Borrelia burgdorferi in six patients is described. Borrelia burgdorferi has been cultivated from iris biopsy, skin biopsy, and cerebrospinal fluid also after antibiotic therapy for Lyme borreliosis” (Preac-Mursic and others 1993)?
In 1993, IDSA author Dr. John J. Halperin co-authored an article entitled “Recurrent erythema migrans despite extended antibiotic treatment with minocycline in a patient with persisting Borrelia burgdorferi infection” in the Journal of the American Academy of Dermatology (Liegner and others 1993). The title says it all: Even “persisting Borrelia burgdorferi infections” can occur, with manifestations as odd as a recurrent bull’s-eye rash (erythema migrans). Perhaps this is why Dr. Halperin wrote in the journal Neurology, “In many instances continued infection appears to be essential for symptoms to persist, no matter how small the number of organisms, as antimicrobial therapy is generally followed by clinical improvement” (Halperin and Heyes 1992).
In 2001, IDSA guidelines author Dr, Gerold Stanek co-authored an article in the British Journal of Dermatology describing a Lyme patient previously treated with four courses of the intravenous antibiotic ceftriaxone. The authors said, “The relapses she repeatedly suffered despite initially successful antibiotic treatment could be related to the observation that Borrelia [the Lyme disease bacteria] may possibly be able to remain dormant in certain tissue compartments, thus escaping bactericidal antibiotic activity” (Breier and others 2001).
Even if the antibiotic therapy is prolonged and complicated, Lyme can survive. “Repeated antibiotic treatment [six weeks oral doxycycline, two weeks intravenous ceftriaxone, two weeks combination of oral roxithromycin/sulfamethoxazole/trimethoprim] was necessary to stop the progression of disease, but obviously did not completely eliminate B burgdorferi from all sites of infection. This was confirmed by the culture of viable B burgdorferi from a ligament sample obtained surgically . . . These data indicate that vital B burgdorferi persisted (a) despite several courses of antibiotic therapy, (b) even when clinical symptoms subsided, and (c) even when no humoral immune response was detectable by ELISA and IF [common blood testing techniques]” (Haupl and others 1993).
Many studies report the isolation of Lyme spirochetes in the joints of people previously treated with antibiotics (Nocton and others 1994, Battafarano and others 1993, Steere and others 1988, Schmidli and others 1988). Consider the poor woman who had to suffer multiple strokes before her doctors connected her condition to a previously-treated bout with “early” Lyme disease (Reik 1993).
Tragically, studies have shown that antibiotics cannot prevent a Lyme infection from crossing the placenta and infecting an unborn child, sometimes with dire or deadly consequences. “We now demonstrate B. burgdorferi in the brain and liver of a newborn whose mother had been treated with oral penicillin for LB [Lyme borreliosis] . . . The death of the newborn was probably due to a respiratory failure as a consequence of perinatal brain damage” (Weber and others 1988).
This is undoubtedly why, in calmer political times, the New England Journal of Medicine and Allen Steere himself dared to publish an article about Lyme which concluded, “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 is reminiscent of far advanced neurosyphilis . . . This last article is one of many studies that show continuing symptoms are most likely due to persistence of the spirochete” (Logigian and others 1990).
Many such studies have been published and are collected in the “Persistence” file at www.lymeinfo.net/lymefiles.htm. There you will also find data on some of the ways that the Lyme bacteria accomplishes its persistence despite intense and repeated courses of antibiotics. These include the formation of antibiotic-resistant “cyst” forms and granules, clumping together into colonies, sequestering inside normal body cells, and traditional drug resistance. In fact, one study (Mursic and others 1996) found that “Persisters isolated from a great number of patients (60-80%) after treatment with antibiotics had an atypical form,” suggesting that long-term symptoms are due to these variant forms of Lyme which require far more creative combinations of antibiotics and other therapies to defeat than the government currently offers.
Far from being an infection easily conquered by modern medicine, the Lyme spirochete has outsmarted us time and again. For some reason, which the press should work hard to uncover, Dr. Baker and his colleagues at the NIH make it sound as though it is the easiest infection in the world to cure with antibiotics. Although both the survival of Lyme after antibiotic treatment and the mechanisms by which it persists have both been documented, doctors like Dr. Baker choose to change the subject when this evidence is presented to them. Often, they attack the Lyme patient community and our doctors for daring to point out the existence of this research, which happens to describe perfectly the relapsing and excruciating nature of our symptoms. What will it take to demonstrate that the emperor has no clothes, and that the powers-that-be are seriously mistaken in their denial of chronic, persistent Lyme infections?
Internal Medicine of Northern Virginia
1860 Town Center Drive Suite 230 Reston, Virginia 20190
Voice: 703-709-1119 Fax: 703 709-7496
Samuel Shor, MD, FACP
Humera Malik, MD
www.Intmednova.com
March 14, 2011
To whom it may concern:
In response to the letter dated 1/21/2010 by Dr Phil Baker, representing the American Lyme Disease Foundation and the Infectious Disease Society of America, I would like to make several points.
1. In his statement on page one “You should understand that these legislative efforts are part of a carefully orchestrated campaign by those who mistakenly believe that chronic Lyme disease is the result of a persistent infection that requires long-term antibiotic therapy to cure. All too often, physicians as well as State and Federal legislators hear only from these special interest groups and are not aware of extensive evidence to the contrary derived from clinical trials and basic research supported by the National Institutes of Health (NIH).” He also alludes to this in his statement on page 2: “unequivocal and rather convincing results,” are actually quite controversial in their own right:
The “extensive evidence” cited by Dr. Baker relate to only 4 NIH Funded Controlled Studies:
a. Klempner MS, Hu LT, Evans J, Schmid CH, Johnson GM, Trevino RP, Norton D, Levy L, Wall D, McCall J, Kosinski M, Weinstein A. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001 Jul 12;345(2):85-92.
In fact, this paper of “two trials” evaluated a skewed population of patients who had already failed 3 courses of antibiotics, some the very medications that were used in the study. They in essence were a preselected group likely to fail.
In his peer reviewed analysis of this study Cameron DJ. Generalizability in two clinical trials of Lyme disease. Epidemiol Perspect Innov. 2006 Oct 17;3:12, this study was criticized due to flaws in design, from which generalizations to less sick individuals ought not to be made.
b. Krupp LB, Hyman LG, Grimson R, Coyle PK, Melville P, Ahnn S, Dattwyler R, Chandler B. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology. 2003 Jun 24;60(12):1923-30.
Also in a population considered far more sick, there, in fact, WERE improvements in fatigue & cognitive abilities resulting from long-term antibiotic therapy.
c. Fallon BA, Keilp JG, Corbera KM, Petkova E, Britton CB, Dwyer E, Slavov I, Cheng J, Dobkin J, Nelson DR, Sackeim HA. A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology. 2007 Oct 10; [Epub ahead of print]
Despite a selection bias of sicker patients, Dr Fallon actually did find improvements in cognition, fatigue, and body pain. The Fallon study further supports the benefits seen in the Krupp study and indicates that further benefits can be achieved with longer term antibiotic therapy
2. Dr. Baker makes the statement: “Unlike what some would have you believe, early Lyme disease is quite easy to cure with a short course of treatment with oral antibiotics such as doxycycline or amoxicillin. What is less well-recognized is that late manifestations of Lyme disease also are responsive to 3 to 4 weeks of treatment with doxycycline, amoxicillin, or Ceftriaxone.”
a. In fact the literature supports quite the contrary conclusion. In essence, the studies support a conclusion of a high failure rates in late disease when treatment is limited to short-term antibiotics. The failure rate is in the range of 25% to 71% of patients with late-stage disease.
3. Dr. Baker’s commented that: “This can result in great harm and exposes patients to unacceptable risks.” This statement is very misleading. One must conclude that the language is designed to generate fear. In the setting of appropriately selected individuals, the risks of long term antimicrobials can be minimized, allowing the opportunity to provide therapeutic gain.
4. Dr. Baker also states that advocates: “have no published data, from the results of placebo-controlled studies, that such a therapeutic approach is beneficial and safe.”
Dr. Baker fails to note that a careful review of the subsets of the aforementioned studies to which Dr Baker alludes actually does reveal therapeutic gain. In addition, the following peer reviewed publications suggest that a randomized placebo controlled study did show the effectiveness of longer term antibiotics:
a. Cameron D.Severity of Lyme disease with persistent symptoms. Insights from a double-blind placebo-controlled clinical trial. Minerva Med. 2008 Oct; 99(5):489-96.
5. Unfortunately Dr Baker mischaracterizes the debate regarding Lyme disease. Perhaps he should consider the views of Dr. David Vokman, f ormerly of the CDC and a member of the committee that generated the diagnostic criteria for the diagnosis of Lyme disease:
The recommendations from Guidelines Committees ought to be evidenced based, unbiased, and valid, not consensus dictums based on the authoritative opinions of “experts” which should be objectively evaluated and often challenged. Rather than avoid controversy and dissenting views to achieve unanimity, the Guidelines should accurately reflect confirmed medical principals and both sides of unresolved questions.
* * *
In the face of both animal and human evidence of persistent borreliosis following inadequately treated Lyme Disease, it is disappointing that Guidelines members continue to dismiss the possibility of persistent borreliosis with unreferenced assertions that it has been “discredited” by “current thinking.”
The increased incidence of Lyme disease in Virginia is alarming. Most statisticians, including the CDC, believe the actual cases of Lyme to be under reported by a factor of 10. Accordingly, the actual reported incidence in 2007 of 959 cases actually represents a professional estimate of about 9,590 NEW cases of Lyme disease in that year.
CDC Reported Lyme disease cases by state, 1999-2007
State 1999 2000 2001 2002 2003 2004 2005 2006 2007
Virginia 122 149 156 259 195 216 274 357 959
One must conclude the present guidelines do not adequately address the complexity or chronic nature of the disease burden on the Commonwealth of Virginia. I urge the legislature to pass H.B. 512 and protect clinicians who in their best judgment, using the best of their interpretation of the literature, provide courses of antibiotics that are judged to be appropriate at the point of care, even though they may exceed the present flawed “guidelines.”
Samuel Shor, MD, FACP
Associate Clinical Professor
George Washington University Health Care Sciences
Chairman: Orrock, Robert D., Sr. DelBOrrock@house.virginia.gov R 54th
Vice Chairman: O’Bannon, John M., III DelJOBannon@house.virginia.gov R 73rd
Athey, Clifford L., Jr. DelCAthey@house.virginia.gov R 18th
BaCote, Mamye E. DelMBaCote@house.virginia.gov D 95th
Bell, Richard P. DelDBell@house.virginia.gov R 20th
Bell, Robert B. DelRBell@house.virginia.gov R 58th
Crockett-Stark, Anne B. DelACrockett-Stark@house.virginia.gov R 6th
Ebbin, Adam P. DelAEbbin@house.virginia.gov D 49th
Englin, David L. DelDEnglin@house.virginia.gov D 45th
Garrett, T. Scott DelSGarrett@house.virginia.gov R 23rd
Hope, Patrick A. DelPHope@house.virginia.gov D 47th
Howell, Algie T., Jr. DelAHowell@house.virginia.gov D 90th
Massie, James P. (Jimmie), III DelJMassie@house.virginia.gov R 72nd
Merricks, Donald W. DelDMerricks@house.virginia.gov R 16th
Morrissey, Joseph D. DelJMorrissey@house.virginia.gov D 74th
Nixon, Samuel A., Jr. DelSNixon@house.virginia.gov R 27th
Nutter, David A. DelDNutter@house.virginia.gov R 7th
O’Bannon, John M., III DelJOBannon@house.virginia.gov R 73rd
Peace, Christopher K. DelCPeace@house.virginia.gov R 97th
Pogge, Brenda L. DelBPogge@house.virginia.gov R 96th
Sickles, Mark D. DelMSickles@house.virginia.gov D 43rd
Spruill, Lionell, Sr. DelLSpruill@house.virginia.gov D 77th
Stolle, Christopher P. DelCStolle@house.virginia.gov R 83rd
Nancy Duke,
Legislative Assistant
Delegate Joe T. May
33rd House District
Home Office (703) 777-1191
Richmond Office (804) 698-1033
