Complementary and Alternative Medicine: Health Law & Policy 2007 (HPM 218)

Complementary and Alternative Medicine: Health Law & Policy (HPM 218, 2007) at the Harvard School of Public Health - course website. Course materials follow.

Complementary and Alternative Medicine: Health Law & Policy (2007) (HPM 218)

* Complementary and Alternative Medicine: Health Law & Policy - Health Policy & Management 218 - Syllabus (2007)

Dates: Jan. 8, 9, 10, 11, 12, from 9 am - 12 pm (room at HSPH to be announced).

Confirmed speakers thus far:

Monday, January 8
Robert Scholten, MLS
Harvard Medical School Osher Institute
"Complementary, alternative and integrative medicine: strategic policy issues at the interface of academic medicine and industry" and other topics.

Tuesday, January 9
Daniel L. Shapiro, PhD
Harvard Law School, Harvard Negotiation Project
"'Beyond reason:' alternative dispute resolution, alternative health, and the emotions."

Wednesday, January 10
Paula M. Gardiner, MD
Harvard Medical School Osher Institute
"Clinical and Research Overview of Dietary Supplements and Dietary Supplement Regulation."

Thursday, January 11
David S. Rosenthal, MD
Professor of Medicine, Harvard Medical School
Department of Medicine, Brigham and Women's Hospital
Harvard University Health Services
Society of Integrative Oncology
"Integrative Oncology"

More to come....

* Course Description:
This course introduces students to controversies in health law and policy surrounding the judicious integration into mainstream health care of modalities that have historically been outside of biomedicine, and are generally known as "complementary and alternative medical" (CAM) therapies (e.g., therapies as chiropractic, acupuncture, massage therapy, and herbal medicine). "Integrative medicine," as this is sometimes known, has been steadily moving from "marginal to mainstream," with increasing representation in hospitals and pervasive interest among clinicians, patients, and professional health care organizations.

According to the report by the Institute of Medicine, entitled Complementary and Alternative Medicine (Washington, D.C.: National Academy of Sciences, 2005): "The goal should be the provision of comprehensive medical care that is based on the best scientific evidence available regarding benefits and harm, that encourages patients to share in decision making about therapeutic options, and that promotes choices in care that can include CAM therapies, when appropriate."

The course will explore the significance of this statement through topics such as: definition and prevalence of CAM therapies; theory and practice of major CAM therapies; research methodologies, state of the science, and the role of evidence-based medicine in evaluating CAM therapies; licensing and regulation of CAM providers; professional discipline of physicians offering CAM therapies; credentialing and liability management strategies by health care institutions integrating these therapies; malpractice liability and informed consent issues; federal regulation of (and institutional policy involving) dietary supplements; emerging federal policy and state legislative developments; and related ethical and bioethical questions.

Readings are drawn from medical, public health, health policy, and sociological literature, as well as statutes, cases, and books and articles about law. Students are expected to write an 8 to 10 page final paper and present a synopsis in class. No previous background in law is required, although HPM 213c and 215d are recommended.

Regarding required and recommended materials, the information below contains links to other posts on this site, which will then contain internal links providing either files that can be downloaded, or abstracts and additional information about sources.

Note - due to the short time frame, students are welcome to start on, and seek feedback regarding, papers prior to the course's opening on Jan. 8.

Required Materials:

1. Michael H. Cohen, Complementary & Alternative Medicine: Legal Boundaries and Regulatory Perspectives (Baltimore: Johns Hopkins University Press, 1998). This book examines the core legal and regulatory issues in integration of complementary and alternative medical (CAM) therapies into clinical care and in public health; these issues include state medical licensing laws, scope of practice boundaries, malpractice liability, food and drug law, professional discipline, and questions of third-party reimbursement.

2. Cases, statutes, articles listed below, some with links.

   Ethical Issues in CAM
* Adams KE, Cohen MH, Jonsen AR, Eisenberg DM. Ethical considerations of complementary and alternative medical therapies in conventional medical settings. Ann Intern Med; 2002;137:660-66. See Ethics in CAM: A Balancing Test.

* Cohen MH, Legal and ethical issues in complementary medicine: a U.S. perspective, Med J Australia 2004;181:3:168-169. See U.S. v. Australia Complementary Medicine Law: Informed Consent, Licensure, Liability.

* Ernst EE, Cohen MH, Stone J. Ethical problems arising in evidence-based complementary and alternative medicine. See Ethics in CAM: An International Perspective.

   Hospital Policy Concerning Alternative Therapies and Integrative Medicine

* Cohen MH, Sandler L, Hrbek A, Davis RB, Eisenberg DM. Policies Pertaining to Complementary and Alternative Medical Therapies in a Random Sample of 39 Academic Health Centers. Alt Ther Health Med 2005;11:1:36-40. See Integrative Care Centers in Academic Medical Centers Lack Consensus Policies.

* Cohen MH, Hrbek A, Davis R, Schachter S, Kemper KJ, Boyer EW, Eisenberg DM. Emerging credentialing practices, malpractice liability policies, and guidelines governing complementary and alternative medical practices and dietary supplements recommendations: a descriptive study of 19 integrative health care centers in the U.S. Arch Int Med 2005;165:289-295.

   Licensure of CAM Providers and Credentialing Physicians Offering CAM Therapies

* Eisenberg DM, Cohen MH, Hrbek A, Grayzel J, van Rompay MI, Cooper, RA. Credentialing complementary and alternative medical providers. Ann Intern Med; 2002;137:965-973. See Credentialing CAM Providers.

* Credentialing Physicians as Holistic and Integrative Medicine Doctors

   Malpractice Liability Issues (Negligence)

* Charell v. Gonzales, and Schneider v. Revici. See Important Court Cases.

* Cohen MH, Eisenberg DM. Potential physician malpractice liability associated with complementary/integrative medical therapies. Ann Intern Med; 2002;136:596-603. See Physician Malpractice Liability In Complementary and Integrative Medical Therapies.

* Ernst EE, Cohen MH. Informed consent in complementary and alternative medicine. Arch Intern Med 2001;161:19:2288-2292. See Informed consent in complementary and alternative medicine.

    Pediatric Inclusion of Complementary and Alternative Medical Therapies

* Cohen MH, Kemper K. Ethics in complementary medicine: new light on old principles. Contemporary Pediatrics 2004;21(3):61-72. See Ethics in Pediatric Care.

* Cohen MH, Kemper KJ. Complementary therapies in pediatrics: A Legal Perspective. Pediatrics, 2005; 115: 774 - 780. See Complementary Therapies in Pediatrics: A Legal Perspective.

* Cohen MH, Kemper KJ, Stevens L, Hashimoto D, Gilmour J, Pediatric use of complementary therapies: ethical and policy choices. Pediatrics. Electronic Pages.2005; 116: e568 - e575. See Pediatric Use of Complementary Therapies: Ethical and Policy Choices.

Physician Discipline for Using CAM Therapies

* See Federation of State Medical Board Guidelines.

    Physician-Patient Negotiation of CAM

* Cohen MH, Negotiating integrative medicine: a framework for provider-patient conversations. Negotiation Journal 2004;30:3;409-433. See Negotiating Integrative Medicine.

Note: Perhaps not surprisingly, I'm an author or co-author of many of the above papers. My apologies if I seem to have over-cited my own work; there are, however, relatively few other choices regarding legal, regulatory, and ethical issues relating to integrative medicine and co-authors from Harvard and other institutions also feature in these publications. For those desiring sources describing the state of the evidence concerning safety and efficacy (or lack thereof) of specific CAM therapies; discussions of why patients seek CAM; detail on research methodology used to investigate CAM (and challenges related thereto); data concerning prevalence, cost, and patterns of use; and other such information, the Institute of Medicine Report contains a comprehensive discussion with references.

Highly Recommended:

1.Institute of Medicine, Complementary and Alternative Medicine (Washington, D.C.: National Academy of Sciences, 2005).

2. Mary Ruggie, Marginal to Mainstream (Cambridge: Cambridge University Press, 2004). Ruggie's book explores the sociology of CAM, including relevant research issues and material about integrative medicine clinics.

3. Michael H. Cohen, Healing at the Borderland of Medicine and Religion (University of North Carolina Press, 2006).

4. For those interested in mental health care:

Textbook of Integrative Mental Health Care by James Lake, MD (Thieme, 2006).

For those interested in legal and social issues relating to the design, implementation, and operation of integrative medicine clinics, particularly in academic medical centers:

The Practice of Integrative Medicine: A Legal and Operational Guide (Springer, 2006).

Contact the instructor.