MBC Agenda

1. MBC Agenda • CALDA Lorraine Johnson, JD, MBA 10 min Executive Director of CALDA • Two standards of care • From emerging practices to mainstream • Specialty bias position statement • ILADS Dr. Raphael Stricker, M.D. 10 min Dr. Steven Harris, M.D. • Presentation of physician statements • Discussion of magnitude of problem • Questions and Answers 10 min For additional information contact Lorraine Johnson at 323-461-6184.

2. Summary Slide • Lyme Disease Background • Two Standards of Care • Specialty Bias • Who Reviews Whom? • How Medicine Evolves • Medical Boards--Two Standards of Care • Non-Mainstream Treatments Are More Likely to be Targets for MBC Action • How Real Is This Problem? • Conclusion

3. Lyme Disease Background • Tick-borne disease • Three stages of illness • Late stage most difficult to treat • Standard treatment protocols fail in 26-53% of patients • Patients have a disability equal to that of congestive heart failure • Treatment heterogeneity • Uncertain science • Two treatment approaches

4. Two Standards of Care

5. Specialty Bias Considerable specialty bias exists in the treatment of Lyme disease. A diagnosis or treatment approach under one standard of care is frequently repudiated by physicians following the other standard of care.

6. Who Reviews Whom?

7. How Medicine Evolves

8. Medical Boards--Two Standards of Care • The clearest analysis of the issues is presented by the Hearing Committee in the Burrascano case in New York: This appears to be a highly polarized and politicized conflict, as was demonstrated to this Committee by expert testimony from both sides, each supported by numerous medical journal articles, and each emphatic that the opposing position was clearly incorrect… What clearly did emerge however, was that Respondent’s approach, while certainly a minority viewpoint, is one that is shared by many other physicians. … We are also acutely aware that it was not this Committee’s role to resolve this medical debate… • They conclude: The issues raised in this case pertained primarily to the medical debate in this field, rather than a demonstrated lack of competency by the Respondent.

9. Why Outliers are “low hanging fruit” easy to spot and target. A sicker population group means more adverse events Insurers target expensive care Investigators may be unaware that different treatment approaches exist. Physicians may be unaware or may disagree with treatment approach. Non-Mainstream Treatments Are More Likely to be Targets for MBC Action

10. How Real Is This Problem? • In New York roughly 50% of all Lyme literate physicians have been targeted by the medical board • 5 states are actively pursuing or have passed legislation specifically to protect physicians from actions by the medical board • California: 1 in 10; almost 2 in 10.

11. Conclusion • First, when two standards of care exist, the appropriate review standard for unprofessional conduct is whether the physician’s actions conformed with either standard of care. • Second, Lyme disease cases to an infectious disease physician for an expert opinion about an opposing school of thought is unacceptable. • Finally, the selection between legitimate treatment approaches belongs to the patient. State review processes should insure that they are not discriminatory and that patient’s autonomy in selecting between legitimate treatment options is preserved.

12. Potential Solutions • Educate MBC and investigators that two standards of care exist (Action Alert; internal memos) • Educate physicians throughout state that two standards of care exist (Action Alert) • Provide all investigators pursuing action against physicians treating Lyme disease with a copy of the ILADS guidelines and information regarding two standards of care. • Refer cases of Lyme disease to physicians who have knowledge of the two standards of care for evaluation under the standard of care chosen by the patient • Amend Business & Professions Code §2234.1 covering Non-conventional and alternative medicine • Establish committee consisting of some MBC members, CALDA members and ILADS members to consider and evaluate solutions for presentation to the Board.

13. Estimates of the number of patients in the state annually range from 970 (10 times reported cases) to 2600 (physician estimates)—given the failure rates, prevalence is much higher • Outcomes research is limited and conflicting. NIAID has only funded three double-blind placebo-controlled treatment outcome studies for long-term treatment of persistent Lyme disease. The findings of two studies (Klempner and Krupp) are contradictory, with one indicating that continued treatment is beneficial for treating fatigue and the other indicating that it is not.[10, 18, 19] The third NIAID funded study has recently been completed and preliminary results support continued antibiotic treatment for patients with persistent Lyme disease.[11]

14. Reading of Physician’s Statements