The treatment of Lyme disease:

1. By Lorraine Johnson, JD,MBA & Ray Stricker, MD ILADS Annual Scientific ConferenceOctober 24, 2004Rye, New York The treatment of Lyme disease: A medicolegal assessment

2. evidence beliefs actions

3. Evidence Flawed tests insure uncertainty • Without adequate diagnostic tests to demonstrate active infection with B. burgdorferi, it is difficult to determine: • Who has the disease • Whether a course of treatment is effective • And when the disease has been “cured”—the end point of treatment

4. Top tier evidence: Limited & Conflicting YES NO MAYBE SO Fallon Klempner Krupp 65% improve (fatigue) None improve (cognitive) Improvement on SF-36 and other measures No better than placebo

5. Evidence Where do you draw the line? Randomized, controlled trials Nonrandomized, controlled trials Cohort or longitudinal studies Case-control studies Case reports Individual patient presentation Doctor’s experiences, beliefs, & skills ResearchGeneralBeliefs AveragesStatistical lives Clinical JudgmentSpecificActionsThe patientIdentified lives

7. Evidence + probability = Clinical judgment High Evidence Risk of Treatment TreatmentZone Low Odds of infectionSeverity of Illness High

8. Lyme disease risks of treatment small & severity of illness great • Severity: • equal to congestive heart failure • Treatment alternatives: • None

9. Beliefs “If scientists think lawyers can present one-sided cases, they may wish to rediscover themselves.”Ralph Nader

10. IDSA IDSA ILADS ILADS Opinion is deeply divided Physicians Patients

11. All medical practices must fall within the standard of care • Defined as “the care and skill ordinarily exercised in like cases by reputable members of the profession” • It applies to • Malpractice • Medical boards • Insurance (medical necessity) • Guidelines are not the standard • May be evidence of standard if widely followed • Standard requires exercise of clinical judgment

12. There can be more than one standard of care • Most states have some version of the “two schools of thought” doctrine which requires that a respectable minority use practice • “Where there is more than one recognized method of diagnosis or treatment and no one of them is used…uniformly by all practitioners of good standing, a physician is not negligent if, in exercising their best judgment, they select one of the approved methods…”

13. The standard of care is a numbers game The Many Battle Field The Few

14. IDSA ILADS How ILADS can help drive the standard of care • Increase membership base by • Training • Certifying doctors • Providing job opportunities to doctors • Increase reputation by • Publishing guidelines & articles • Professional seminars • Getting guidelines on NGC • Conferences • Public relations spending

15. Beliefs No consequences Who’s right? Expert opinion IDSA v ILADS Academic v community physicians Actions Consequences Who decides? Public Policy Physician Insurer Patient Actions Truth or consequences?

16. When science is uncertain, what we should DO is not a matter of science, but a matter of policy Law Science Uncertain Health Care Policy Medical Ethics

17. Medical Ethics Patient autonomy is knowing where the doctor ends & the patient begins • A person is autonomous if that person is self-governing • Autonomy underlies the legal concept of informed consent • An autonomous action must be • Intentional • Undertaken with understanding • Not determined by controlling influences

18. American Medical Association “[A]s part of the process of giving patients informed consent to treatment, physicians should disclose all available treatment alternatives, regardless of cost, including those potentially beneficial treatments that are not offered under the terms of the plan”AMA Council on Ethical and Judicial Affairs

19. Law Informed consent law varies widely Weak disclosure Strong disclosure Invasive Surgery No treatment Experimental Controlled studies Routine treatment Risks/Benefits--Proposed treatment--Alternative treatments--No treatment

20. Informed consent: “Self determination ought not be blind” “Physicians may neither impose their values on their patients nor substitute their level of risk aversion for that of their patients…The choice is not for the physician, but the patient in consultation with the physician. By not telling the patient of all medically reasonable alternatives, the physician breaches the patient’s right to make an informed choice.” Matthies v. Mastromonaco, 733 A. 2d 456 (N.J. 1999)

21. Health Care Policy Small area variations drive health care policy decisions

22. Preference sensitive care variance is solved by more research & patient choice

23. When two treatment approaches exist the solution is patient preference In some cases, the principal cause of variation is that there is substantial uncertainty about the risks and benefits of the treatment options because there have been no clinical trials to determine the facts. The fundamental problem, however, is the failure to involve the patient in a meaningful way in the choice of treatment. Decisions should belong to the patient, but provider opinion tends to dominate. For this reason, we believe there is widespread misuse of preference- sensitive care. Wennberg, J. 2002 Legislative Testimony

24. When two standards of care exist the treatment choice belongs to the patient Policy Issues

25. Summary When two standards of care exist: • Practice under either standard is not malpractice. • The choice between the two properly belongs to the patient under the principle of autonomy. The choice does not belong • to the doctor • to the insurer (unless contract so specifies.) • To exercise autonomy, patients must be informed about alternatives. • Patient preference and outcomes research are the appropriate solutions to small area variations caused by scientific uncertainty and risk/benefit trade-offs.