CAMLAW: Complementary and Alternative Medicine Law Blog

Ethics in Pediatric CAM Care

Michael has published a new study with Kathi J. Kemper, MD, a leading pediatrician in integrative care. The study published in the journal Contemporary Pediatrics offers a number of cases showcasing a framework for legal and ethical analysis by clinicians advising concerning use of CAM therapies in pediatrics.

The article suggests ways in which pediatricians can reflect on the ethical issues inherent in modern clinical practice. First pediatricians need to continue to study and learn the rapidly growing scientific evidence concerning the safety and effectiveness of relevant complementary as well as mainstream therapies. Second, common sense dictates that physicians balance the risks and benefits of any therapy before recommending a course of action, and should continue to monitor patients appropriately. Third, pediatricians should discuss with patients any information that is material to treatment decisions, whether treatment options involve traditional or CAM therapies. Finally, according to the article, an awareness of professional guidelines and the four basic principles of biomedical ethics - autonomy, non-maleficence, beneficence, and justice - create a firm foundation from which to explore the fascinating and rapidly changing field of comprehensive, integrated pediatric care.

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

Here is the full article from that site (copyright 2004 Advanstar Communications, reprinted with permission from the editor of Contemporary Pediatrics):

Ethics meet complementary and alternative medicine: New light on old principles

Mar 1, 2004

By Kathi J. Kemper, MD, MPH, and Michael Cohen, JD, MBA, MFA
As more young patients have CAM therapies integrated into their care, it's inevitable that you'll grapple with a range of ethical issues in practice. Here, compelling clinical scenarios are touchstones for the authors' review of guidelines and principles that can help you make ethical decisions about your patients' use of CAM.

Case 1. Eight-year-old Freddie, a patient in the bone marrow transplant unit, suffers from severe nausea from his chemotherapy. Freddie does not want to take any more medicines than he already is taking. His mother, who has been reading extensively on the World Wide Web, requests that the acupuncturist from the pain service be consulted about providing acupuncture to help manage Freddie's symptoms.

Case 2. Three-year-old Madison comes to the clinic for a well-child check-up. She has normal growth and development and no known allergies. On exam, her pediatrician notes otitis media in the right ear. Madison is asymptomatic, however, so the pediatrician recommends watchful waiting. Madison's father says he'd like to try homeopathic remedies because he read in a magazine that homeopathy worked better than placebo for children with an ear infection.

Case 3. Fifteen-year-old Sarah is HIV-positive and is on a complex medical regimen that includes protease inhibitors. On your routine interval history, Sarah reveals that she started taking St. John's wort two months ago for mild depression after her boyfriend broke up with her. She says she feels less depressed now.

Case 4. David is a 17-year-old high-school athlete who has moderate, persistent asthma. He has an asthma action plan, has done a good job addressing allergic triggers, and takes good care of himself. David feels great and now wants to try natural remedies such as ephedra. He admits that he has not been using his steroid inhaler consistently since he started taking what he describes as "herbal remedies" last week.

The rapid growth in the use of complementary and alternative medicine (CAM) presents physicians with many opportunities for continuing education and reflection. Patients typically seek CAM because these therapies are consistent with their values and world view (natural, ecological, empowering).1 They also tend to view CAM providers as being patient-centered, dedicated to the whole person and their overall health and well-being, and more individualized in their treatment than mainstream providers. Of course, these are ideals of conventional medicine as well.2

Patients' goals in using CAM are generally symptom relief (many turn to CAM because they want to try every reasonable option before giving up) and health promotion. Most patients do not expect CAM alone to cure them.3 By definition, patients who use CAM (or their parents who choose it for them) and who see a pediatrician are engaging in integrated, rather than alternative, care.

When it comes to integrating CAM into mainstream practice, at least four dilemmas confront the pediatrician:

• There is an insufficient research base for making evidence-based decisions about treating conditions with CAM

• When such research-based information does exist, the pediatrician may still lack knowledge about the safety and effectiveness of CAM therapies because medical education has, historically, not included CAM topics

• Physicians typically have not been adequately educated about the scope of practice, licensing requirements, and credentialing of CAM therapists,4 which raises concerns about patient safety and legal liability when recommending CAM therapies or therapists5

• Physicians may be uncertain about how to translate well-established principles of medical ethics into this new domain of practice

The purpose of this article is to orient pediatricians to ethical principles as applied to simple clinical cases involving integrative medicine. Readers interested in in-depth coverage of licensing, credentialing, and legal issues are referred to several recent reviews.4-7

Common sense and professional guidelines
The first ethical guideline in CAM is to seek reliable, evidence-based information about the safety and effectiveness of CAM therapies and therapists. The American Academy of Pediatrics's (AAP's) 2001 policy statement, "Counseling Families Who Choose CAM for their Children," recommends that pediatricians "seek information," "evaluate the scientific merits of specific therapeutic approaches," and "identify risks or potential harmful effects."8 A commitment to continuing education is cited in Principle 5 in the preamble to the American Medical Association policy statement on medical ethics (excerpts from the AMA statement appear in the box below).9 These recommendations are also reflected in the Federation of State Medical Boards (FSMB) policy statement, "Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice."10 Implicit in all of these guidelines is the old adage, "good ethics begin with good facts" (personal communication, Norman Fost, 1983).

The second guideline is to apply common sense to balancing risks and benefits when making therapeutic decisions (see Table 1).11 The four cases described at the beginning of this article provide examples of situations in which common sense can be readily applied to decision making about different CAM therapies: Case 1--safe and effective; Case 2--safe but effectiveness unknown; Case 3--unsafe but possibly effective; and Case 4--unsafe and likely ineffective.


Click here to view full-size graphic

In Case 1, a review of the literature on acupuncture for nausea associated with chemotherapy reveals that it is likely to be helpful and has an extremely low risk of harm, particularly in patients with an adequate platelet count.12 Freddie's platelet count is 135 x 103/µL. It would, therefore, be reasonable and ethical to support the request of Fred's mother.

In Case 2, a review of recent data suggests that homeopathic treatment of otitis media is safe but that its effectiveness is uncertain.13 The pediatrician can, therefore, ethically accept the choice that Madison's father has made, while offering to follow up if she becomes symptomatic.

In Case 3, however, even though St. John's wort may help treat Sarah's mild depressive symptoms,14 it poses a moderate risk of decreasing a therapeutic serum level of the protease inhibitors.15 The pediatrician may want to consult with a psychiatrist about the need for antidepressant medication or alternative nonmedical treatments for depression (psychotherapy, exercise, fish oil) that are less likely to interfere with protease inhibitors. If the patient elects to continue the St. John's wort, the pediatrician will need to monitor her serum level of the protease inhibitors closely.

Last, Case 4 illustrates the most feared situation posed by the growing use of CAM therapies--the patient who abandons an effective, possibly life-saving therapy in favor of an unproven or unsafe alternative. The pediatrician's clear duty here is to discourage David from keeping to his decision to abandon the inhaled steroid, at the same time respecting familial and cultural values. Maintaining an ongoing, respectful relationship is a potent way to prevent patients from abandoning effective care.

Variables to consider
The common sense weighing of risks and benefits is complicated by situation-specific variables. These variables include patient characteristics such as personal beliefs, cultural values and practices, and therapeutic goals. The type and severity of illness may also affect decision making.

The efficacy and safety of a particular treatment may or may not be well described for large populations. Even when such data are known, application of population data to individual patients requires inference and implies some degree of uncertainty. The tolerance of the patient, family, and provider for uncertainty varies from one situation to another. All of the variables just mentioned complicate the application of specific rules to individual situations. In complex situations, applying ethical tenets may add clarity to common sense.

Ethical principles pertinent to CAM
The AAP, AMA, and FSMB guidelines cited earlier were crafted within the context of history, Western philosophy, and contemporary clinical practice. Among the many modern biomedical ethical frameworks that inform these guidelines are the four principles outlined by Beauchamp and Childress--autonomy, nonmaleficence, beneficence, and justice (Table 2).16 The following cases briefly illustrate these four principles.

TABLE 2
The four basic principles of bioethics
Respect for autonomy

Nonmaleficence

Beneficence, or "promote patient welfare"

Justice

Source: Beauchamp T, Childress J16


Case 5. Audrey is a 16-year-old with a history of frequent migraine headaches. Her previous physician had prescribed prophylactic propranolol, but Audrey had two emergency room visits for migraine within six months of starting therapy, and she began to complain of fatigue and nausea. Her sleep was disrupted by vivid dreams, her mother noticed that she had become very moody, and her grades dropped. Distressed by her daughter's symptoms, the mother did a Web search and discovered that many of Audrey's symptoms could be attributed to the medication.17 Further searching revealed that hypnosis and biofeedback could prevent migraine, but the previous pediatrician had not mentioned these treatment options.

What are the pediatrician's responsibilities to inform patients about treatment options? Are pediatricians obligated to discuss complementary therapies?

The first of Beauchamp and Childress's principles--autonomy--implies specific rules for ethical physician behavior. For example, because autonomous decisions require sufficient understanding, physicians are expected to provide information about all relevant treatment options to allow the patient to offer informed consent.18-20 Withholding information, or not being knowledgeable enough to provide complete information, seriously undermines trust, the patient's ability to offer informed consent, and patient autonomy. One of the primary reasons patients seek CAM therapies is because they are perceived as empowering (allowing greater autonomy); CAM users tend to be especially interested in, and seek out, health information. The traditional principle of informed consent obligates physicians to provide patients all the information that is material to a decision to consent to or forgo a specific therapy or course of treatment.19

Given the rapid growth in the breadth and depth of medical knowledge, including knowledge about CAM therapies, physicians are increasingly unlikely to know about all potentially relevant treatment options. They may, therefore, unintentionally not be providing complete information. There are many therapies for which physicians do their best to keep up, but cannot. However, as noted in the AMA guidelines (see "Pertinent excerpts from the American Medical Association Principles of Medical Ethics)," physicians are ethically obligated to continue to learn and update medical knowledge relevant to their scope of treatment.9

In Case 5, the new pediatrician, having learned of Audrey's interest in specific CAM therapies for migraine headaches,21 is ethically obligated to learn about the safety and effectiveness of hypnosis and biofeedback, as well as the potential risks (e.g., side effects of propranolol17) and benefits of more mainstream medical therapies. Informed consent requires clear communication of such risks and benefits to the patient.22

Assessing and communicating risks and benefits can also help manage liability concerns.11 The physician is not obligated to provide CAM services (just as you are not obligated to perform surgery or provide in-depth psychotherapy) but should be familiar with local providers who can assist a family that wishes to pursue reasonable treatment options.

Case 6. Jason is a 10-year-old competitive tennis player who recently developed a painful elbow. After a thorough examination and radiography, the pediatrician diagnoses lateral epicondylitis (tennis elbow). Jason's mother, a clinical psychologist, wants to try acupuncture because she is concerned about potential renal damage and gastrointestinal irritation associated with nonsteroidal anti-inflammatory medications. The pediatrician has heard other patients speak favorably about a Mr. Chen, who practices acupuncture just blocks away in Chinatown. The pediatrician does not know anything about Mr. Chen's training or licensure, but assumes he learned about acupuncture in China.

The second of the Beauchamp and Childress principles is nonmaleficence, more widely known as "do no harm." This principle is translated into specific ethical and legal rules related to not causing pain or suffering, not causing offense, and not risking harm through negligence or carelessness. Although the AMA guidelines allow a physician to refer a patient to another health-care provider, they specify that referrals should be based on that practitioner's competence and ability to perform the service. The physician, then, must be confident that the services provided on referral will be performed competently and in accordance with legal requirements. Furthermore, the physician must have a reasonable expectation that the type of service offered will benefit the patient.

Current evidence suggests--but does not conclusively show--that acupuncture is beneficial for patients suffering from tennis elbow. But before referring Jason to Mr. Chen, the pediatrician is obligated to learn, at a minimum, whether Mr. Chen has a state license to practice acupuncture. If Mr. Chen is unlicensed or has a significant history of malpractice liability or professional discipline, or if his expertise or ability has otherwise been brought into question, the pediatrician might be considered liable for negligence if Jason suffers complications of the treatment (pneumothorax, retained needle, significant bleeding, infection from inadequate sterile technique).5,11 Referral to practitioners for whom no state licensing requirements exist (e.g., naturopaths in some states, "energy" healers, homeopaths, and others) is even more problematic. The AMA code of medical ethics specifically states, "Physicians should be mindful of state laws which prohibit a physician from aiding and abetting an unlicensed person in the practice of medicine, aiding or abetting a person with a limited license in providing services beyond the scope of his or her license, or undertaking the joint medical treatment of patients under the foregoing circumstances."9

In addition to issues related to referring patients to CAM practitioners, be aware of ethical imperatives (nonmaleficence) when discussing and recommending dietary supplements such as herbal remedies. Because such remedies are not regulated as stringently as pharmaceutical medications, the risk of contamination, adulteration, and inadequate potency is much greater. Routinely ask about patients' use of herbs and other dietary supplements that could harm their health directly (side effects) or indirectly (interactions with medications); counsel them appropriately; and document your conversations in the medical record.

Case 7. Eleven-year-old Rachel has Crohn's disease that is moderately well managed. She is very devout; her grandfather is a rabbi who recommends that she pray daily to ask for understanding, patience, and perseverance in the face of her affliction, and for compassion to serve others in theirs. Today, she was brought to the emergency room, having fractured her leg at the beach. The resident, who has taken her history and performed the physical exam, comes to you for advice. He notes that she was coherent during the history, but while he was examining her, she closed her eyes, rocked back and forth, and softly recited prayers. "It's crazy," the resident snaps. "I mean, I know she was praying and everything, but does she really think God is going to come down here to the ER and fix her leg? You know, religion is the opiate of the people. It just keeps them ignorant and passive instead of being responsible for their own lives."

What ethical obligations does the attending physician have in this situation?

Core curriculum goals of cultural competency are based on ethical principles of respect for autonomy, nonmaleficence, and the third basic principle of medical ethics, beneficence--promoting patient welfare. This implies a specific obligation to protect and defend the rights of others.

The AMA guidelines explicitly state that the patient has the right to courtesy, respect, and dignity. Therefore, even if religious beliefs and practices had no known health benefit, patients have the right to be respected rather than disparaged. In the case of religiosity, however, there is abundant evidence that patients who are active members of a religious group and who regularly engage in religious or spiritual practices such as devotional reading and prayer are healthier and have, on average, a better prognosis than those who are less devout.23,24 The principle of beneficence directs physicians to not only tolerate and respect religious beliefs but to support and promote them in patients already engaged in these spiritual practices. Note, however, that substantial controversy surrounds the question of whether it is ethical for a physician to recommend spiritual or religious practices to a patient who is not already engaged in those activities.25 Therefore, one of the objectives in teaching this resident how to care for patients like Rachel is to promote understanding and respect for patients' religious and cultural beliefs.

Case 8. Your hospital's chief executive officer is interested in offering highly marketable CAM services that appeal to well-educated, upper-income patients who can pay out of pocket (health insurance reimburses unevenly for CAM therapies). But your department chief, who is committed to serving the underserved, is uncomfortable devoting limited resources to developing CAM services for the affluent.

What ethical principles might guide the department chief in her negotiations?

Justice, the fourth primary ethical principle, means that social benefits (such as health care) and social burdens should be distributed fairly, and that there should be equal access to, and a decent minimum standard of, care.26 The AMA code of ethics states that, "The patient has a basic right to have available adequate health care."9 Many physicians, public health leaders, and ethicists believe, however, that the ethical principle of justice extends beyond "adequate" care to "fair and equitable" care that includes access to comprehensive, high-quality services and the freedom to choose among qualified providers.27 Although these arguments are typically marshaled in support of universal health insurance and access to mental health services, dental services, long-term and chronic care, and prescription drug benefits, they can reasonably be applied to CAM services that are safe and effective as well.

Epidemiologic studies have repeatedly shown that CAM services--in particular, professionally provided services such as acupuncture, biofeedback, hypnosis, and massage--are used more commonly by well-educated patients of moderate or high income than by patients with fewer resources. Preliminary studies also reveal a geographic concentration of licensed, professional CAM providers in wealthy neighborhoods, with unlicensed, lay practitioners concentrated in less affluent communities. Furthermore, as the public learns about the limited federal control over the quality of herbal remedies, wealthier families seek products with greater quality control (e.g., those made in Germany) while the poor purchase less expensive products of dubious quality.28 Recent immigrants with limited education and other resources may be especially likely to use patent medicines (herbs) that are contaminated with lead, other heavy metals, and pharmaceuticals, thus increasing the risk of adverse effects.

Scientific arguments about the relative costs and benefits of various medical services for diverse patient populations are beyond the scope of this article. However, if professionally provided and more expensive CAM services are more effective and have fewer risks than less expensive services, the current distribution of CAM services appears to fail the test of "fairness." Decisions about which services to provide at each institution are complex, but an argument grounded in bioethics could well be made for offering CAM services for which there is adequate scientific evidence of safety and efficacy to patients regardless of their ability to pay.

For the most part, ethical dilemmas concerning "justice" typically confront physicians as citizens of our greater society rather than during moment-to-moment clinical practice.

Providing ethical, integrative medicine
As increasing numbers of children have complementary therapies integrated into their care, you will be given abundant opportunity to reflect and act on the ethical issues inherent in modern clinical practice. What should your response be?

• You should study the rapidly growing scientific evidence concerning the safety and effectiveness of relevant complementary, as well as mainstream, therapies.

• Apply common sense to balance the risks and benefits of any therapy before recommending a course of action, and continue to monitor patients appropriately.

• Discuss with patients and their parents any information that is material to treatment decisions, whether treatment options involve traditional or CAM therapies.

• Be aware of relevant professional guidelines and the four basic principles of biomedical ethics--autonomy, nonmaleficence, beneficence, and justice. Doing so creates a firm foundation on which to explore the fascinating and rapidly changing field of comprehensive, integrated pediatric care.

REFERENCES

1. Astin JA: Why patients use alternative medicine: Results of a national study. JAMA 1998;279:1548

2. Thorne S, Best A, Balon J, et al: Ethical dimensions in the borderland between conventional and complementary/ alternative medicine. J Altern Complement Med 2002;8:907

3. Kemper KJ, Wornham WL: Consultations for holistic pediatric services for inpatients and outpatient oncology patients at a children's hospital. Arch Pediatr Adolesc Med 2001;155:449

4. Eisenberg DM, Cohen MH, Hrbek A, et al: Credentialing complementary and alternative medical providers. Ann Intern Med 2002;137:965

5. Cohen MH: Legal issues in complementary and integrative medicine. A guide for the clinician. Med Clin North Am 2002;86:185

6. Cohen MH: Beyond complementary medicine: Legal and ethical perspectives on health care and human evolution. 2000, Ann Arbor, University of Michigan Press

7. Adams KE, Cohen MH, Eisenberg D, et al: Ethical considerations of complementary and alternative medical therapies in conventional medical settings. Ann Intern Med 2002;137:660

8. American Academy of Pediatrics: Counseling families who choose complementary and alternative medicine for their child with chronic illness or disability. Committee on Children With Disabilities. Pediatrics 2001;107:598

9. American Medical Association, Council on Ethical and Judicial Affairs: Code of medical ethics: Current opinions with annotations. 1998, Chicago, Ill.

10. Federation of State Medical Boards: Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice, www.fsmb.org , Federation of State Medical Boards

11. Cohen MH, Eisenberg DM: Potential physician malpractice liability associated with complementary and integrative medical therapies. Ann Intern Med 2002;136:596

12. NIH Consensus Conference. Acupuncture. JAMA 1998;280:1518

13. Jacobs J, Springer DA, Crothers D: Homeopathic treatment of acute otitis media in children: A preliminary randomized placebo-controlled trial. Pediatr Infect Dis J 2001;20:177

14. Behnke K, Jensen GS, Graubaum HS, et al: Hypericum perforatum versus fluoxetine in the treatment of mild to moderate depression. Adv Ther 2002; 19:43

15. Schulz V: Incidence and clinical relevance of the interactions and side effects of Hypericum preparations. Phytomedicine 2001;8:152

16. Beauchamp T, Childress J: Principles of Biomedical Ethics, ed 5. 2001, New York, Oxford University Press

17. Hutchison T, Shahan DE: DrugPoints System (TIM). 2003, Micromedex.

18. Weir M: Obligation to advise of options for treatment--medical doctors and complementary and alternative medicine practitioners. J Law Med 2003;10:296

19. Ernst E, Cohen MH: Informed consent in complementary and alternative medicine. Arch Intern Med 2001; 161:2288

20. Brophy E: Does a doctor have a duty to provide information and advice about complementary and alternative medicine? J Law Med 2003;10:271

21. Olness K: Managing headaches without drugs. Contemporary Pediatrics 1999;16(8):101

22. Cohen MH: Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health and Human Healing in Human Transformation. 2003, Ann Arbor, Mich., University of Michigan Press

23. Koenig H, McCullough M, Larson D: Handbook of Religion and Health. 2001, New York, Oxford University Press

24. Levin J: God, faith and health: Exploring the spirituality-healing connection. 2001, New York, John Wiley and Sons

25. Sloan RP, Bagiella E, VandeCreek L, et al: Should physicians prescribe religious activities? N Engl J Med 2000;342:1913

26. Rawls J: A Theory of Justice. 1991, Cambridge, Mass., Harvard University Press, p 986

27. Mappes T, DeGrazia D: Biomedical Ethics, ed 5. 2001, Boston, McGraw Hill

28. Lee AC, Highfield ES, Berde CB, Kemper KJ: Survey of acupuncturists: Practice characteristics and pediatric care. West J Med 1999;171:153

DR. KEMPER is Caryl Guth Chair for Holistic and Integrative Medicine and professor, pediatrics, public health sciences, and family medicine at Wake Forest University Health Sciences, Winston-Salem, N.C., and an instructor in pediatrics at Harvard Medical School. She has nothing to disclose in regard to affiliation with, or financial interests in, any organization that may have an interest in any part of this article.
MR. COHEN is assistant professor of medicine, Harvard Medical School, Boston, and director of legal programs, Harvard Medical School Osher Institute and Division for Research and Education in Complementary and Integrative Medical Therapies. He is recipient of research grants from the National Center for Complementary and Alternative Medicine and the National Library of Medicine of the National Institutes of Health, and from American Specialty Health Plan.

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KEY POINTS
Ethical guidelines for CAM
Whenever one of your patients is using or considering using CAM, you should:

• Seek reliable, evidence-based information about the safety and effectiveness of those CAM therapies and the therapists providing those services

• Apply common sense when balancing risks and benefits in making therapeutic decisions

• Realize that weighing risks and benefits is complicated by situation-specific variables, including the patient's beliefs; cultural values and practices; therapeutic goals; and the type and severity of illness

• When considering issues related to CAM and your patient's use of these therapies, apply the four basic principles of biomedical ethics--autonomy, nonmaleficence, beneficence, and justice

• Discuss with the patient any information that is pertinent to treatment decisions


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Pertinent excerpts from the American Medical Association Principles of Medical Ethics
Preamble:

V. A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated.

E-10.01 Fundamental elements of the patient-physician relationship

1. The patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives.

2. The patient has the right to make decisions regarding the health care that is recommended by his or her physician.

3. The patient has the right to courtesy, respect, dignity, responsiveness, and timely attention to his or her needs.

E-3.04 Referral of patients

A physician may refer a patient for diagnostic or therapeutic services to another physician, limited practitioner, or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient. As in the case of referral to physician-specialists, referrals to limited practitioners should be based on their individual competence and ability to perform the service needed by the patient. A physician should not so refer the patient unless the physician is confident that the services provided on referral will be performed competently and in accordance with accepted scientific standards and legal requirements.

E-3.041 Chiropractic

It is ethical for a physician to associate professionally with chiropractors provided that the physician believes that such association is in the best interests of his or her patient. A physician may refer a patient for diagnostic or therapeutic services to a chiropractor permitted by law to furnish such services whenever the physician believes that this may benefit his or her patient. Physicians may also ethically teach in recognized schools of chiropractic.

Source: American Medical Association, Council on Ethical and Judicial Affairs: Code of medical ethics: Current opinions with annotations. 1998, Chicago, Ill.

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