PA – House and Human Services Committee

 

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Lyme Disease Association Testimony & Support Documentation September 14, 2007

 The CDC says:  ^[2] Surveillance case definitions establish uniform criteria for disease reporting and should not be used as:

• the sole criteria for establishing clinical diagnoses;  

• determining the standard of care necessary for a particular patient;

• setting guidelines for quality assurance, or providing standards for reimbursement.

 

Yet, doctors are inappropriately using CDC surveillance criteria to diagnose, and insurance companies are using the criteria to deny reimbursement, thus patients are not getting diagnosed and treated.

 

Further clouding the diagnostic and treatment picture are the draconian Infectious Diseases Society of America (IDSA) 2006 treatment guidelines for Lyme, which recommend

against any long-term treatment for people who are chronically ill with Lyme,

against entire classes of antibiotics,

against alternative treatments,

against some supplements and

against individual physician discretion in diagnosis and treatment. 

To date, almost 28,000 people have signed an LDA petition opposing the IDSA treatment guidelines on humanitarian grounds. (see www.LymeDiseaseAssociation.org)

 

 

The guidelines’ development is currently under investigation by the Connecticut Attorney General, who cites exclusionary conduct and commercial interest on the part of the IDSA as reasons for possible US antitrust law violations.

 

The IDSA guidelines ignore another standard of care for Lyme addressing early infection and chronic disease published by the International Lyme & Associated Diseases Society (ILADS), a professional medical and research organization.^[3] Both sets of guidelines have passed the inclusion requirements of being evidenced-based for acceptance on the National Guidelines Clearing House website (NGC) ^[4] produced by the US Department of Human and Health Services, the American Medical Association and America’s Health Insurance Plans (a national insurance trade association, formerly the American Association of Health Plans Foundation).

 

Despite two standards of care,^[5]physicians continue to be monitored by insurance companies who often flag their antibiotic prescribing practices, saying curtail prescribing antibiotics for Lyme disease or leave the insurance plan. Some leave the plan voluntarily in response to pressure, others are forced out. Some physicians continue treating their patients without accepting insurance. Other physicians fear scrutiny from the insurance companies and stop treating Lyme disease entirely, leading to a scarcity of physicians and a “chilled” treatment climate.

 

Lack of insurance coverage leads to limited courses of antibiotics, often not effective in eradicating the Lyme bacterium which has the ability to hide inside the cells, kill human lymphocytes and certain B cells and possibly to change into other forms. Patients diagnosed and treated under restrictive IDSA guidelines sometimes become chronically ill. A study has shown that patients with Lyme disease suffer a degree of disability equal to that of patients with congestive heart failure.^[6]

Lyme patients deserve more from our health care system than denial of care that insurers and IDSA advocate. One of IDSA’s stated goals at its 2005 business meeting was opposing federal and Pennsylvania Lyme disease legislation.^[7] Patients do not have the resources nor the health to fight these giants, but this legislation ensures that patients with chronic Lyme disease can obtain treatment, that insurers are accountable for providing treatment reimbursement, and that treating doctors cannot be prosecuted for unprofessional conduct for providing longer term treatment under ILADS standard. Given that the IDSA guidelines essentially provide no treatment for patients with chronic Lyme disease, this legislation ensures that patients in need of medical care are not abandoned.

 

Other issues often cited in opposition to long-term treatment are the costs. A 1993 actuarial study of over 500 patients said to be representative of difficult cases, estimated the costs of Lyme disease to society as averaging $60,000/patient or $1 billion annually. Reported case numbers have almost tripled since that time. ^[8] Studies have shown that early Lyme disease costs are much lower than those with chronic sequelae. A 1999 CDC study had costs ranging from $161 for an early case (2-3 wks.), to $61,243 for a neurologic (11 yrs.) one.^[9] Early diagnosis and proper treatment are essential to stop the development of long-term more costly sequelae. This bill allows the doctor to exercise the clinical judgment necessary to make a timely diagnosis and prescribe a treatment which the doctor judges to be necessary for patient recovery.

Development of antibiotic resistance is another reason cited to withhold treatment, despite the fact that resistance often develops due to under usage rather than over usage of antibiotics to eradicate organisms. The Union of Concerned Scientists estimates that 70% of antibiotics in the U.S. are fed to healthy pigs, cows, and chickens to promote growth and prevent disease, and they are concerned quite concerned this may be a significant cause of resistant bacteria. ^[10] Recent studies have shown that resistant strains of bacteria most often develop in hospitals due to improper hygiene by medical personnel. Other diseases are allowed long-term treatment including tuberculosis, Q fever endocarditis,^[11] and even acne. It appears that with little outcry, animals can be fattened with antibiotics, health care workers can practice shoddy hygiene leading to resistant strains, acne sufferers can get years of treatment, but terribly sick Lyme disease patients are singled out to be left without treatment because of undocumented accusations of resistance.

 

In closing, note that this legislation is about safeguarding the right of seriously ill patients to obtain treatment under one of the standards of care. Moreover, a significant body of evidence supports the persistence of the Lyme bacteria after short-term treatment and the efficacy of longer-term treatment approaches. Significantly, the Columbia University NIH-funded long term treatment study, currently in press in the journal, Neurology, found improvement in patients on longer-term therapy. (Other studies in attached table, pp.4, 5).

 

Pennsylvania owes it to its patients and physicians to pass this bill which will simply level the playing field by providing treating physicians with a measure of protection they are entitled to, since there are two standards of care. They should not be persecuted by medical boards as they are now for simply following the standard which best improves the health of patients. Additionally, in light of the two standards of care, insurance companies should be paying for treatment that is physician-recommended and medical record documented for Lyme disease.

 

Remember, UN studies have linked a worldwide rise in Lyme cases to global warming^[12]and according to CDC stats from 1990 through 2006, Pennsylvania had 43,454 reported cases of Lyme disease, a figure which includes my own parents. With only 10% of cases that meet the CDC criteria reported, that means 434,540 Pennsylvanians developed Lyme that met the surveillance criteria over 16 years. Nobody knows how many more developed disease that did not meet that surveillance criteria, and nobody cares how many were able to receive treatment. You can change that. Thank you.

 

 

 

 

 

 

[1] P. Coulter et al, J. Clin Microbiol.. 2005Oct.; 43(10): 5080-4 Two Year Evaluation of Borrelia burgdorferi Culture and Supplemental Tests for Definitive Diagnosis of Lyme Disease

2 CDC website

3 Expert Review of Anti-infective therapy 2(1) Suppl. 2004

4 https://www.guideline.gov/

5 L Johnson, JD, MBA et al The Treatment of Lyme Disease: A Medico-Legal Assessment Ex. Rev. Anti-infect. ther. 2(4) 2004

6 Klempner, MS, et al, Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease,. N Eng J Med 2001; 345.

7 Slide presentation from 43^rd annual business meeting of IDSA, & Letters to Gov. Rendell & US Congressman Barton

8 Vanderhoof I et al, Contingencies ’93        

9 CDC Emerging Infectious Diseases; Vol.5, No.3; 1999 May-June;5(3)321-8

10 https://www.ucsusa.org/food_and_environment/antibiotics_and_food/myths-and-realities

11 Counterpoint: Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease, Antibiotic Therapy and Lyme Disease • CID 2007:45 (15 July)

[1]2 UN Intergovernmental Panel on Climate Change (IPCC) 2007

 

 

 

Lyme Disease Treatment Studies Table

No clinical studies have determined the optimal antibiotics or the optimal duration of treatment. Controlled clinical studies to date have been limited and conflicting, although two out of the three studies showed improvement on retreatment. Non-controlled studies also indicate that most patients improve with continued treatment. The controlled and non-controlled studies are described below. 

Controlled studies of Persistent Lyme Disease
Study	Treatment	Results	Comments
Cameron (2005) [1]	3 months treatment with amoxicillin	Treatment effective for 2/3 of patients with the worst quality of life as measured by SF-36	Results presented at ILADS 2005 Annual Conference.
Fallon (2004) [2]	10 weeks of IV Ceftriaxone	Cognitive improvement	Study in press, Neurology.
Krupp (2003)[3]	4 weeks of IV ceftriaxone	64% showed improvement on fatigue No improvement on cognition	Cognition finding criticized. Because subjects were not selected based on cognitive impairment, improvement on this scale would not be expected. There was insufficient statistical power to measure cognitive power.
Klempner (2001) [4]	4 weeks IV ceftriaxone then 2 months of oral doxycycline	No improvement on SF-36.	External validity of study criticized. The findings of this study’s population sample (average 4.7 years ill and 3 treatment failures) lack generalizability to the clinical patient population.[5]

 

Despite the current focus on controlled studies, some researchers note that there is a high correlation between controlled and observational studies and that they “usually produce the same results”.[6] In addition, non-controlled studies often provide more clinically-relevant treatment information because they deal with the diversity of patients seen in practice and allow for more flexibility in terms of treatment approach. 

Non-Controlled Studies Supporting Longer Treatment Approaches or Retreatment
Study	Comments
Oksi  (1999) [7]	9 of 13 patients (69%) with disseminated Lyme disease who wereinitially treated for 3 months with oral or IV antibiotics but subsequently relapsed had good response to retreatment with IV ceftriaxone for 4-6 weeks. “ [T]reatment… with appropriate antibiotics for even more than 3 months may not always eradicate the spirochete and long term antibiotics may be necessary.”
Donta (1997) [8]	277 patients with chronic Lyme treated for between 1 and 11 months: 20% were cured, 70% improved and 10% had treatment failure.
Oksi (1998) [9]	30 patients with disseminated Lyme treated for 100 days, 90% with good or excellent responses: “prolonged courses of antibiotics may be beneficial in this setting”.
Wahlberg (1994) [10]	Success rates for 100 patients with late Lyme disease: 31% (4 of 13) with 14 days of ceftriaxone; 89% (50 of 56) with ceftriaxone, then 100 days of amoxicillin and probenecid; and 83% (19 of 23) with ceftriaxone, then 100 days of cephadroxil.
Fallon (1999) [11]	18 patients retreated either with intravenous, intramuscular or oral antibiotics scored better on overall and individual measures of cognition. Those retreated with IV therapy showed greatest improvement.

The studies described above are necessarily limited to the choice of antibiotics tested and the duration that the antibiotics were given in the study. They do not tell us what would happen if patients were treated with different antibiotics or for longer periods of time. For a more detailed analysis of the treatment studies and treatment approaches, please refer to Treatment of Lyme disease–a medicolegal assessment [12] and ILADS Evidence-based guidelines for the management of Lyme disease [13].

 

References

 

1. Cameron D. Results from Lyme disease treatment trial. Columbia University/LDA Conference, Lyme & Other Tick-Borne Diseases: Emerging Tick-Borne Diseases; 2005 October 28, 2005; Philadelphia, Pennsylvania.

2. Fallon BA. Laboratory findings in chronic Lyme disease and results of the controlled treatment study. Columbia University/LDA’s Lyme & Other Tick-Borne Diseases:Technology Leading the Way Conference; 2004 October 22, 2004; Rye Town, NY.

3. Krupp LB, D Masur, J Schwartz, PK Coyle, LJ Langenbach, SK Fernquist, L Jandorf, and JJ Halperin. Cognitive functioning in late Lyme borreliosis. Arch Neurol. 1991; 48(11): 1125-9.

4. Klempner M, L Hu, J Evans, C Schmid, G Johnson, R Trevino, D Norton, L Levy, D Wall, J McCall, M Kosinski, and A Weinstein. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001; 345(2): 85-92.

5. Cameron DJ. Generalizability in two clinical trials of Lyme disease. Epidemiol Perspect Innov. 2006; 3: 12.

6. Benson K and AJ Hartz. A comparison of observational studies and randomized, controlled trials. Am J Ophthalmol. 2000; 130(5): 688.

7. Oksi J, M Marjamaki, J Nikoskelainen, and M Viljanen. Borrelia burgdorferi detected by culture and PCR in clinical relapse of disseminated Lyme borreliosis. Ann Med. 1999; 31(3): 225-32.

8. Donta S. Tetracycline therapy for chronic Lyme disease. Clin Infect Dis. 1997; 25 Suppl 1: S52-6.

9. Oksi J, J Nikoskelainen, and MK Viljanen. Comparison of oral cefixime and intravenous ceftriaxone followed by oral amoxicillin in disseminated Lyme borreliosis. Eur J Clin Microbiol Infect Dis. 1998; 17(10): 715-9.

10.     Wahlberg P, H Granlund, D Nyman, J Panelius, and I Seppala. Treatment of late Lyme borreliosis. J Infect. 1994; 29(3): 255-61.

11.     Fallon BA. Repeated antibiotic treatment in chronic Lyme disease. J Spirochet Tick Borne Dis. 1999; 6(Fall/Winter): 94-101.

12.     Johnson LB and RB Stricker. Treatment of Lyme disease–a medicolegal assessment. Expert Rev Anti-infect Ther. 2004; 2(4): 533-57.

13.     The International Lyme and Associated Diseases Society (ILADS). ILADS Evidence-based guidelines for the management of Lyme disease. Expert Rev. Anti-infect. Ther. 2004; 2(1): S1–S13.