Medical Ethics of Complementary and Alternative Medicine (3)

JAMA -- Abstract: Ethical Issues Concerning Research in Complementary and Alternative Medicine, Franklin G. Miller, PhD; Ezekiel J. Emanuel, MD; Donald L. Rosenstein, MD; Stephen E. Straus, MD



JAMA. 2004;291:599-604.



The use of complementary and alternative medicine (CAM) has grown dramatically in recent years, as has research on the safety and efficacy of CAM treatments. Minimal attention, however, has been devoted to the ethical issues relating to research on CAM. We argue that public health and safety demand rigorous research evaluating CAM therapies, research on CAM should adhere to the same ethical requirements for all clinical research, and randomized, placebo-controlled clinical trials should be used for assessing the efficacy of CAM treatments whenever feasible and ethically justifiable. In addition, we explore the legitimacy of providing CAM and conventional therapies that have been demonstrated to be effective only by virtue of the placebo effect.

Medical Ethics of Complementary and Alternative Medicine (2)

An issue which can be raised regarding complementary and alternative medicine is whether the physician’s advice to patients encouraging use of the modalities involved and their use is indeed ethical. Adams, Cohen, Eisenberg and Jonsen writing in the Annals of Internal Medicine present some criteria which if considered may pave the way to ethical use in appropriate patients. The following is the abstract from the Annals article. ..Maurice.

From the Annals of Internal Medicine, 15 October 2002 | Volume 137 Issue 8 | Pages 660-664



Ethical Considerations of Complementary and Alternative Medical Therapies in Conventional Medical Settings



Karen E. Adams, MD; Michael H. Cohen, JD, MBA, MFA; David Eisenberg, MD; and Albert R. Jonsen, PhD





Increasing use of complementary and alternative medical (CAM) therapies by patients, health care providers, and institutions has made it imperative that physicians consider their ethical obligations when recommending, tolerating, or proscribing these therapies. The authors present a risk–benefit framework that can be applied to determine the appropriateness of using CAM therapies in various clinical scenarios. The major relevant issues are the severity and acuteness of illness; the curability of the illness by conventional forms of treatment; the degree of invasiveness, associated toxicities, and side effects of the conventional treatment; the availability and quality of evidence of utility and safety of the desired CAM treatment; the level of understanding of risks and benefits of the CAM treatment combined with the patient’s knowing and voluntary acceptance of those risks; and the patient’s persistence of intention to use CAM therapies. Even in the absence of scientific evidence for CAM therapies, by considering these relevant issues, providers can formulate a plan that is clinically sound, ethically appropriate, and targeted to the unique circumstances of individual patients. Physicians are encouraged to remain engaged in problem-solving with their patients and to attempt to elucidate and clarify the patient’s core values and beliefs when counseling about CAM therapies.

Medical Ethics of Complementary and Alternative Medicine (1)

To begin this topic, first we should understand what is complementary and alternative medicine (CAM) and how it has been applied to treat patients including its use along with conventional medicine. To help explain CAM, the following is an informational fact sheet publication by the U.S. National Institutes of Health. (Please note that in this post, the URL resources listed have not been linked.) I will be presenting the ethical issues of CAM in later postings. ..Maurice.

What Is Complementary and Alternative Medicine (CAM)?



On this page:



* What is complementary and alternative medicine?

* Are complementary medicine and alternative medicine different from each other?

* What is integrative medicine?

* What are the major types of complementary and alternative medicine?

* What is NCCAM's role in the field of CAM?

* Definitions





There are many terms used to describe approaches to health care that are outside the realm of conventional medicine as practiced in the United States. This fact sheet explains how the National Center for Complementary and Alternative Medicine (NCCAM), a component of the National Institutes of Health, defines some of the key terms used in the field of complementary and alternative medicine (CAM).[These definitions are found at the bottom of this fact sheet.]



What is complementary and alternative medicine?



Complementary and alternative medicine, as defined by NCCAM, is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.1,2 While some scientific evidence exists regarding some CAM therapies, for most there are key questions that are yet to be answered through well-designed scientific studies--questions such as whether these therapies are safe and whether they work for the diseases or medical conditions for which they are used.



The list of what is considered to be CAM changes continually, as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge.





Are complementary medicine and alternative medicine different from each other?



Yes, they are different.



* Complementary medicine is used together with conventional medicine. An example of a complementary therapy is using aromatherapy to help lessen a patient's discomfort following surgery.



* Alternative medicine is used in place of conventional medicine. An example of an alternative therapy is using a special diet to treat cancer instead of undergoing surgery, radiation, or chemotherapy that has been recommended by a conventional doctor.





What is integrative medicine?

Integrative medicine, as defined by NCCAM, combines mainstream medical therapies and CAM therapies for which there is some high-quality scientific evidence of safety and effectiveness.





What are the major types of complementary and alternative medicine?



NCCAM classifies CAM therapies into five categories, or domains:



1. Alternative Medical Systems



Alternative medical systems are built upon complete systems of theory and practice. Often, these systems have evolved apart from and earlier than the conventional medical approach used in the United States. Examples of alternative medical systems that have developed in Western cultures include homeopathic medicine and naturopathic medicine. Examples of systems that have developed in non-Western cultures include traditional Chinese medicine and Ayurveda.



2. Mind-Body Interventions



Mind-body medicine uses a variety of techniques designed to enhance the mind's capacity to affect bodily function and symptoms. Some techniques that were considered CAM in the past have become mainstream (for example, patient support groups and cognitive-behavioral therapy). Other mind-body techniques are still considered CAM, including meditation, prayer, mental healing, and therapies that use creative outlets such as art, music, or dance.



3. Biologically Based Therapies



Biologically based therapies in CAM use substances found in nature, such as herbs, foods, and vitamins. Some examples include dietary supplements,3 herbal products, and the use of other so-called natural but as yet scientifically unproven therapies (for example, using shark cartilage to treat cancer).



4. Manipulative and Body-Based Methods



Manipulative and body-based methods in CAM are based on manipulation and/or movement of one or more parts of the body. Some examples include chiropractic or osteopathic manipulation, and massage.



5. Energy Therapies



Energy therapies involve the use of energy fields. They are of two types:



* Biofield therapies are intended to affect energy fields that purportedly surround and penetrate the human body. The existence of such fields has not yet been scientifically proven. Some forms of energy therapy manipulate biofields by applying pressure and/or manipulating the body by placing the hands in, or through, these fields. Examples include qi gong, Reiki, and Therapeutic Touch.



* Bioelectromagnetic-based therapies involve the unconventional use of electromagnetic fields, such as pulsed fields, magnetic fields, or alternating-current or direct-current fields.





What is NCCAM's role in the field of CAM?



NCCAM is the Federal Government's lead agency for scientific research on CAM. NCCAM is dedicated to exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals.







Notes



1 Conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Other terms for conventional medicine include allopathy; Western, mainstream, orthodox, and regular medicine; and biomedicine. Some conventional medical practitioners are also practitioners of CAM.



2 Other terms for complementary and alternative medicine include unconventional, non-conventional, unproven, and irregular medicine or health care.



3 Some uses of dietary supplements have been incorporated into conventional medicine. For example, scientists have found that folic acid prevents certain birth defects and that a regimen of vitamins and zinc can slow the progression of an eye disease called age-related macular degeneration (AMD).



Definitions



Acupuncture ("AK-yoo-pungk-cher") is a method of healing developed in China at least 2,000 years ago. Today, acupuncture describes a family of procedures involving stimulation of anatomical points on the body by a variety of techniques. American practices of acupuncture incorporate medical traditions from China, Japan, Korea, and other countries. The acupuncture technique that has been most studied scientifically involves penetrating the skin with thin, solid, metallic needles that are manipulated by the hands or by electrical stimulation.



Aromatherapy ("ah-roam-uh-THER-ah-py"): involves the use of essential oils (extracts or essences) from flowers, herbs, and trees to promote health and well-being.



Ayurveda ("ah-yur-VAY-dah") is a CAM alternative medical system that has been practiced primarily in the Indian subcontinent for 5,000 years. Ayurveda includes diet and herbal remedies and emphasizes the use of body, mind, and spirit in disease prevention and treatment.



Chiropractic ("kie-roh-PRAC-tic") is a CAM alternative medical system. It focuses on the relationship between bodily structure (primarily that of the spine) and function, and how that relationship affects the preservation and restoration of health. Chiropractors use manipulative therapy as an integral treatment tool.



Dietary supplements. Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product (other than tobacco) taken by mouth that contains a "dietary ingredient" intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements come in many forms, including extracts, concentrates, tablets, capsules, gel caps, liquids, and powders. They have special requirements for labeling. Under DSHEA, dietary supplements are considered foods, not drugs.



Electromagnetic fields (EMFs, also called electric and magnetic fields) are invisible lines of force that surround all electrical devices. The Earth also produces EMFs; electric fields are produced when there is thunderstorm activity, and magnetic fields are believed to be produced by electric currents flowing at the Earth's core.



Homeopathic ("home-ee-oh-PATH-ic") medicine is a CAM alternative medical system. In homeopathic medicine, there is a belief that "like cures like," meaning that small, highly diluted quantities of medicinal substances are given to cure symptoms, when the same substances given at higher or more concentrated doses would actually cause those symptoms.



Massage ("muh-SAHJ") therapists manipulate muscle and connective tissue to enhance function of those tissues and promote relaxation and well-being.



Naturopathic ("nay-chur-o-PATH-ic") medicine, or naturopathy, is a CAM alternative medical system. Naturopathic medicine proposes that there is a healing power in the body that establishes, maintains, and restores health. Practitioners work with the patient with a goal of supporting this power, through treatments such as nutrition and lifestyle counseling, dietary supplements, medicinal plants, exercise, homeopathy, and treatments from traditional Chinese medicine.



Osteopathic ("ahs-tee-oh-PATH-ic") medicine is a form of conventional medicine that, in part, emphasizes diseases arising in the musculoskeletal system. There is an underlying belief that all of the body's systems work together, and disturbances in one system may affect function elsewhere in the body. Some osteopathic physicians practice osteopathic manipulation, a full-body system of hands-on techniques to alleviate pain, restore function, and promote health and well-being.



Qi gong ("chee-GUNG") is a component of traditional Chinese medicine that combines movement, meditation, and regulation of breathing to enhance the flow of qi (an ancient term given to what is believed to be vital energy) in the body, improve blood circulation, and enhance immune function.



Reiki ("RAY-kee") is a Japanese word representing Universal Life Energy. Reiki is based on the belief that when spiritual energy is channeled through a Reiki practitioner, the patient's spirit is healed, which in turn heals the physical body.



Therapeutic Touch is derived from an ancient technique called laying-on of hands. It is based on the premise that it is the healing force of the therapist that affects the patient's recovery; healing is promoted when the body's energies are in balance; and, by passing their hands over the patient, healers can identify energy imbalances.



Traditional Chinese medicine (TCM) is the current name for an ancient system of health care from China. TCM is based on a concept of balanced qi (pronounced "chee"), or vital energy, that is believed to flow throughout the body. Qi is proposed to regulate a person's spiritual, emotional, mental, and physical balance and to be influenced by the opposing forces of yin (negative energy) and yang (positive energy). Disease is proposed to result from the flow of qi being disrupted and yin and yang becoming imbalanced. Among the components of TCM are herbal and nutritional therapy, restorative physical exercises, meditation, acupuncture, and remedial massage.





For More Information



Sources of NCCAM Information



NCCAM Clearinghouse



Toll-free in the U.S.: 1-888-644-6226

International: 301-519-3153

TTY (for deaf and hard-of-hearing callers): 1-866-464-3615



E-mail: info@nccam.nih.gov

Web site: nccam.nih.gov

Address: NCCAM Clearinghouse, P.O. Box 7923, Gaithersburg, MD 20898-7923



Fax: 1-866-464-3616

Fax-on-Demand service: 1-888-644-6226



The NCCAM Clearinghouse provides information on CAM and on NCCAM. Servics include fact sheets, other publications, and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.



Sources of Information on Dietary Supplements



Office of Dietary Supplements, NIH

Web site: ods.od.nih.gov

E-mail: ods@nih.gov



ODS supports research and disseminates research results on dietary supplements. It produces the International Bibliographic Information on Dietary Supplements (IBIDS) database on the Web, which contains abstracts of peer-reviewed scientific literature on dietary supplements.



U.S. Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Web site: www.cfsan.fda.gov

Toll-free in the U.S.: 1-888-723-3366



Information includes "Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information" (www.cfsan.fda.gov/~dms/ds-savvy.html) and updated safety information on supplements (www.cfsan.fda.gov/~dms/ds-warn.html). If you have experienced an adverse effect from a supplement, you can report it to the FDA's MedWatch program, which collects and monitors such information (1-800-FDA-1088 or www.fda.gov/medwatch).



This publication is not copyrighted and is in the public domain. Duplication is encouraged.



NCCAM has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your primary health care provider. We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy in this information is not an endorsement by NCCAM.



NCCAM Publication No. D156

May 2002

READ THIS:The Course of The Topics Here

I want to take a moment to explain to my new visitors what has been the direction of the topics here since I started the blog in July 2004. What I have written,provided excerpts and links to resources, is all about the various ethical issues that arrive from the doctor-patient relationship and the some of the issues in the general topic of medical professionalism. Starting with the first posting about the office visit (at the bottom of the Main Page), I have tried to develop each posting in some form of continuity. Soon, I will migrate to other bioethical issues. Please write me e-mail or as a comment to this posting about what issues in bioethics that you have concern and would like me to cover. Thank you.. Maurice.

E-Mail in Medical Practice: My View

There is not enough time spent in face to face communication between patient and physician in the doctor-patient relationship. So many of the conflicts, errors and misunderstandings in medical practice are clearly related to deficiencies in communication. Even telephone communication may be inadequate in certain clinical situations. With the introduction of e-mail communication in medical practice, these obstructions to good medical care of the patient can only worsen unless attention is taken by both sides to avoid the wrong kind of e-mail communication.



My view is that the use of e-mail in medical practice should be very limited to simply the transmission of data between patient and physician where no discussion, explanation or detailing is necessary. In this context, the data the physician would send to the patient might include appointment dates or changes, laboratory values or results about which the patient would already be aware of the clinical significance, non-personal general health information and so forth. The data the patient would send to the physician might include appointment date requests or changes, specific self-monitoring information (such as blood sugars or weights)or non-urgent followup symptom reporting.



Issues of privacy of information also must be considered. It may be necessary to transmit this data only on secure server websites. Since consultations via e-mail should not be an e-mail activity, professional compensation specifically for appropriate use of e-mail would not be of significance.



Though, to some, my view of e-mail in medical practice might seem unduly constrained and conservative, I believe anything beyond the functions that I have written would be harmful to the profession. ..Maurice.

Electronic Communication Between Physician and Patient

Lets go back to the topic of ethical issues in doctor-patient relationships and think about the increasing role of the use of e-mail in medical practice. The National Center for Ethics in Healthcare of the Veterans Health Administration in July 2004 issued a report by their ethics panel, which speaks to this role. The benefits and cautions are presented after consideration of the ethical issues involved and recommendations (pasted below) are made. The VA is developing a website called My HealtheVet to help support this new kind of communication.

For the full report go to National Center for Ethics Veterans Health Administration

and click on “Online Patient-Clinician Messaging”. Let me know how you feel about the use of e-mail and web posting as a means of communication between patient and doctor. ..Maurice.

Excerpts from VAH Report



Surveys repeatedly show that patients want to be able to communicate with their clinicians online. And online patient-clinician communication is widely held to have significant potential to enhance patient-clinician relationships, promote greater involvement by patients in their own care (including self-monitoring), and ultimately improve the outcomes of care. Concerns have been raised, however, about patient privacy, the effects of online communication on patient-clinician relationships, and the potential impact on clinicians’ workload and reimbursement.

This report by VHA’s National Ethics Committee (NEC) examines the nature of online communication and explores the ethical challenges of online communication between patients and clinicians. It offers the following recommendations to assure the ethical practice of online patient-clinician messaging within VHA:



(1) Clinicians and health care organizations should ensure that online communication takes place only when the confidentiality and security of personal health information can be reasonably assured. Once implemented nationally, My HealtheVet will provide the foundation for a secure environment required for responsible online communication between patients and clinicians.



(2) Clinicians should ensure that patients who do not interact electronically receive the same quality of care as their online peers. Online communication should not be allowed to exacerbate existing inequalities in health care by discriminating against those who have no or limited access to online communication.



(3) Clinicians should be aware of the potential effects of online messaging on the patient-clinician relationship and take steps to avoid “depersonalization.” Just how online interaction affects patient-clinician relationships is an empirical question that is still unsettled.



(4) Participation in online messaging should be voluntary for both patients and clinicians. As VHA gains more experience with this medium, requiring clinician participation may some day be justified. However, patient participation should remain voluntary.





(5) Clinicians should assure that patient participation in online communication is well informed. Clinicians should enter into an explicit agreement with patients, either orally or in writing, regarding the terms and conditions that will govern their online communication. However, there is no need to require patients to sign an informed consent form.



(6) Clinicians should limit their online communication with patients to appropriate uses. Online communication should not be used to initiate a patient-clinician relationship, to handle situations of an urgent nature, or to convey information that is highly sensitive. Messages should be carefully worded and organized to ensure effective communication, and should conform to organizational standards with regard to message handling.



(7) Health care organizations should recognize online interactions with patients as part of clinicians’ professional activities in institutionally appropriate ways.This may be accomplished, for example, by formally scheduling time for messaging, or by adopting the recently proposed AMA CPT code for online evaluation and management of patients to capture data regarding online patient communication, evaluation, and management as a professional clinical activity.

Physician As Patient (2)

What is the VIP syndrome? The Very Important Person (VIP) syndrome is a pattern of behavior by both the ill physician and his/her healthcare providers that may be deleterious to the established standards of medical care. From the ill physician’s point of view, his or her illness as a physician requires special attention by the caregivers not given to the other patients. The physician is to be treated as a professional and is to be kept fully informed about all the clinical details and is to be consulted as a colleague by the treating physician. The ill physician may request that appointments or lab tests take priority over others for personal convenience. When hospitalized, the physician may be demanding about which nurses are assigned and how they respond to requests. Also, the family of the sick doctor may be similarly demanding.



I suspect that the VIP behavior by the ill physician is not as common as the potential for altered behavior by the treating physician. Unless the treating physician has had lengthy experience caring for medical colleagues, the experience of being a doctor’s doctor can be emotionally traumatic with anxiety, uncertainty, anger and guilt. From the outset, history taking of the doctor may be more incomplete than the average patient since there may be a tendency to avoid asking important but personally embarrassing questions such as involving mental illness, family problems, sex or drug and alcohol use. Physical exams of the ill physician may be more casual and pelvic, breast or rectal exams may be omitted. Testing may be inadequate especially if the appropriate test is uncomfortable. Telling the ill physician the diagnosis and treatment options may be difficult if the treating physician is personally uncomfortable with the conclusion and identifies with a patient with whom he or she has professionally interacted. All of these VIP elements do nothing but worsen or delay proper diagnosis and treatment



Proper communication with the ill physician is essential and probably the most important thing that a treating physician can do is at the outset to make it clear that the sick doctor is going to be treated as a patient and not as a doctor.



For more reading on this topic: "’Doctoring’ Doctors and Their Families” by Stuart A. Schneck, MD

JAMA. 1998; vol.280, pages 2039-2042.