Legal Herbs information, tips and advice

Thus, CAM therapies in pediatrics are not "devoid of potential harm" (44) and indeed, in the language of the federation guidelines, may cause either direct or indirect harm. Direct harm includes "direct toxic effects, compromising adequate nutrition, interrupting beneficial medications or therapies, or postponing biomedical therapies of proven effectiveness," (16) whereas indirect harm can include an unwarranted financial and emotional burden. (16,25)

CAM THERAPIES IN PEDIATRICS: RISK OF MALPRACTICE LIABILITY

Pediatricians face 2 major legal risks when advising concerning CAM therapies: medical malpractice and professional discipline. Malpractice, whether involving conventional or CAM therapies, is defined as unskillful practice that fails to conform to a standard of care in the profession and results in patient injury. (45,46) We have found no reported malpractice decisions concerning pediatric use of CAM therapies. A recent case in adult medicine, however, suggests how courts have applied malpractice liability rules to inclusion of CAM therapies: the physician recommended ozone treatment, administered hydrogen peroxide intravenously, injected vitamin C near the patient's rectum, and treated an abscess with a charcoal poultice mixed in a coffee can. The court held this treatment to be below the standard of care, the cause of the patient's injury, and hence negligent. (47)

In addition to the legal risks involved in delivering CAM therapies to patients, there are some legal risks involved in referral to a CAM provider who turns out to be negligent. The general rule is that a physician is not liable for the negligence of the provider to whom a patient has been referred. (48,49) There are 3 exceptions: (1) the referral itself was negligent because it caused harm by delaying necessary conventional treatment, (2) the referring provider knew or should have known that the CAM provider was "incompetent," and (3) the physician had hired the CAM provider or engaged in a highly coordinated "joint treatment" with that provider. (48,49) As new models of "integrative" health care evolve, courts are increasingly likely to apply this "joint treatment" exception. (49)

CAM THERAPIES IN PEDIATRICS: RISK OF PROFESSIONAL DISCIPLINE

State medical boards may discipline physicians for professional misconduct; grounds for misconduct include malpractice. (45) In some states, the definition of professional misconduct includes any clinical practice that departs from "acceptable and prevailing standards of care." (45) Such statutory language was used in 1990 to strip the medical license of a family physician who had recommended homeopathic remedies (in re Guess). (44) In this case, the North Carolina medical board disciplined Dr Guess without any showing that his patients had been harmed by the use of homeopathy. In response, the North Carolina legislature (and at least a dozen other states) enacted a "medical freedom" statute to protect the state's physicians against the possibility of medical board discipline merely for recommending or delivering CAM therapies. (45) In addition, a number of state medical boards have adopted regulations governing use of CAM therapies and/or "integrative medicine," the judicious combination of conventional and CAM therapies. (50) Like the medical freedom statutes, such regulations clarify that incorporating CAM therapies by itself is not a sufficient departure from prevailing standards to warrant physician discipline. (21,46)

Although the federation guidelines similarly clarify that using CAM therapies in itself does not constitute grounds for discipline, the guidelines require a strong therapeutic rationale, including that the selected CAM therapies are likely to provide "a favorable risk/benefit ratio compared with other treatments for the same condition"; be "based on a reasonable expectation that it will result in a favorable patient outcome, including preventive practices"; and "be based on the expectation that a greater benefit will be achieved than that which can be expected with no treatment." (25)

The federation guidelines offer suggested language for medical boards across states. It is up to the individual state medical boards to decide whether to adopt these guidelines wholesale or fashion other, specific language to govern clinical practice involving use of CAM therapy. Again, what makes such medical board rules compelling is the board's power to discipline a physician for failure to comply with the applicable rules. In some cases, medical boards may not have regulations specifying how or when physicians may be subject to discipline for inclusion of CAM therapies, but the state legislature may have enacted a statute that sets explicit standards. We have found no reported judicial decision involving review of medical board discipline of a pediatrician under either the federation guidelines or the applicable rules of a state medical board; nor have we learned about expulsion of any AAP member for using CAM therapies.

ABUSE AND NEGLECT CONSIDERATIONS

All states have child abuse reporting statutes that require physicians to report child abuse and neglect to law enforcement officials. A pertinent legal question for pediatricians that presently lacks definitive resolution is under what circumstances parental reliance on CAM therapies might constitute abuse and neglect.

Generally, in life-threatening clinical situations involving children, parents who have rejected conventional care have faced prosecution for abuse and neglect (and/or child endangerment and homicide) and removal of the child from parental custody and transfer to a state authority such as the department of public welfare. In the most drastic cases and on clear and convincing evidence of neglect, courts have been able to terminate parental rights and allowed adoption. (51) However, when the child's condition has been other than life-threatening, courts have been reluctant to intervene and overrule parental choice of treatment for their child. As the AAP notes, "Coercion in diagnosis or treatment is a last resort." (52)

There are few cases concerning abuse and neglect involving pediatric use of CAM therapies, although some of the cases that exempt religious treatment (eg, prayer by Christian Scientists) also involve use of CAM therapies or may be relevant by analogy. These cases tend to be fact specific, with varying legal outcomes. For example, in Custody of a Minor, (53) when parents refused to allow phase III of a chemotherapy treatment for their son's acute lymphocytic leukemia and expressed a preference for dietary treatment and prayer, the court awarded legal custody of the child to the Department of Public Welfare, holding that the parents had presented "no viable alternative" to the recommended treatment.

On the other hand, in Matter of Hofbauer, (54) when the attending physician recommended that a 7-year-old child who had Hodgkin's disease be seen by an oncologist or a hematologist for radiation and/or chemotherapy and the parents took the child to a medical clinic in Jamaica for nutritional or metabolic therapy (including laetrile), the court did not find neglect. Rather, the court found that the parents had both "serious and justifiable concerns about the deleterious effects of radiation treatments and chemotherapy," that there was medical proof that the treatment being administered to the child was controlling his condition and was not as toxic as the conventional treatment, and that conventional treatments would be administered to the child if warranted. The court also reasoned that deference should be given to the parents' choices so long as they have "not been totally rejected by all responsible medical authority." (54)

In a third case, Renfro vs Renfro, divorced parents had joint custody of their son, who had received successful chemotherapy for a malignant brain tumor. (55) The father wanted to try naturopathy, chiropractic, vitamins, acupuncture, and mental imagery, whereas the mother, who sought sole custody, preferred traditional radiation therapy. Again, the court did not find neglect in the father's choice but rather reasoned that both parties had their own beliefs regarding the type of treatment that would best help their child recover.

The Renfro court stated, however, that when unconventional medical treatment hinders generally accepted medical treatment, it is not in the child's best interest. (55) Indeed, when the child is seriously ill, the AAP "considers failure to seek medical care in such cases to be child neglect, regardless of the motivation," and has called for the repeal of religious exemption laws. (56) Religious exemptions usually will not shield a parent from prosecution when the child has died or prevent the court from intervening when the parents rely solely on prayer (or, presumably, a CAM therapy) and the child's condition is life threatening. (57) To summarize these cases, courts are likely to respect parental choices that are supported by some medical authority and that present viable alternatives, so long as the child's life is not in danger and conventional care is not imminently necessary. This suggests that reliance on CAM therapies is reasonable if the CAM therapy has reasonable evidence of safety and efficacy, the child's life is not in danger, and the child's condition can be monitored conventionally, with a readiness to intervene conventionally if necessary. As the evidence for safety and efficacy of the desired CAM therapy decreases, courts are less and less likely to support use.

A useful standard summarizing the values at stake in the courts' decision-making is found in Newmark vs Williams, (58) a case involving parental choice of spiritual aid and prayer as Christian Scientists and decline of chemotherapy offering only a 40% chance of survival for a child in the advanced stage of Burkett's lymphoma. The Delaware Division of Child Protective Services had petitioned the Family Court for temporary custody of the child to authorize a nationally recognized children's hospital to treat the child with chemotherapy. The Newmark court applied a balancing test of the competing interests: (1) preserving the integrity of the family, the essential element of which is maintaining the autonomy of the parent-child relationship; (2) protecting the health and safety of children in jeopardy; (3) the right of a child to enjoy a full and healthy life; and (4) invasiveness of the treatment and the possibility of its effectiveness. (58) The Newmark court concluded that it would not authorize the state to remove a child from a loving, nurturing home and subject him, over parental objection, to an invasive regimen of treatment that offered only a 40% chance of survival. The Newmark decision suggests some courts' reluctance to intervene when parents decline conventional care that offers less than a reasonable chance of cure.

A FRAMEWORK FOR ASSESSING LIABILITY RISKS

Neither the federation guidelines nor the White House Commission's final report specifically addressed the potential impact of malpractice liability on clinical decision-making. Much of the medical literature to date ignores liability issues, whereas other articles exaggerate such concerns. For example, family preferences for CAM therapies do not necessarily evidence having "repudiated" conventional therapies "in favor of alternative approaches for which ... any evidence of efficacy or safety is lacking" (14); in fact, most adult users of CAM therapies do so in conjunction with conventional care. (1) With respect to caution, some respect may be afforded to notions of medical pluralism and patient choice without necessarily sacrificing principles of evidence-based medicine. (59,60)

For example, physicians can and, arguably, should ask their patients about use of CAM therapies as part of routine history taking. (61,62) Clinicians who are asked for referrals to CAM providers can and, arguably, should at a minimum familiarize themselves with the credentials and authorized practice boundaries of the major groups of licensed CAM providers (chiropractors, acupuncturists, massage therapists, and naturopathic physicians). (63) Finally, given the extent to which patients are taking dietary supplements on their own, clinicians can and, arguably, should "be aware of potential drug interactions, toxicity, and adverse reactions as well as treatment benefits that may be associated with plant-derived therapies" (64); inform patients that health problems from herbs can arise, among other things, from contamination, misidentification, and labeling issues (65); and, particularly in pediatric care, caution that expressing children's dosages for dietary supplements as a fraction of adult dosages is "strictly anecdotal" and therefore not evidence based. (66)

Pediatricians also can incorporate legal considerations into clinical decision-making as follows. Beyond the abuse and neglect cases discussed above, few if any reported judicial decisions have discussed specifically pediatric use of CAM therapies, a gap that may reflect the emerging "claims consciousness" of patients who use CAM therapies. (48) General principles of law, however, can serve as reasonable guides to potential liability. (45,46) Because malpractice involves lack of due care resulting in patient injury, physicians should inquire whether the medical evidence (1) supports both safety and efficacy; (2) supports safety, but evidence regarding efficacy is inconclusive; (3) supports efficacy, but evidence regarding safety is inconclusive; or (4) indicates either serious risk or inefficacy. (49) Within this framework, physicians can (1) recommend the CAM therapy, as liability is unlikely; (2) allow patient use of the CAM therapy but closely monitor efficacy, as liability is less probable; (3) allow patient use of the CAM therapy but closely monitor safety, as liability is less probable (unless safety is compromised); or (4) avoid and discourage use of the CAM therapy, as liability is likely. (49) Thus, when an oncologist recommended that an adult cancer patient forgo conventional chemotherapy and radiation treatments to follow the physician's nutritional regimen (region 4) and the patient thereby was injured, malpractice liability resulted. (67)

A key to this framework is continuing to monitor conventionally, because most CAM therapies will fall in regions 2 and 3. The caveat to this framework is that CAM therapies, like conventional therapies, can shift regions as the medical evidence changes. (49) For example, many herbal products once were considered safe (eg, St John's wort), although of uncertain efficacy, whereas now evidence of both safety under certain conditions (eg, St John's wort and indinavir) (68) and efficacy is being questioned. Again, as the evidence for safety and efficacy of the desired CAM therapy decreases, courts are less and less likely to support use. Clinicians accordingly are responsible for monitoring the literature and framing decisions accordingly. (49)

When making referrals, physicians should become familiar with the CAM provider's credentials, treatment plan, and (to the extent reasonably feasible) history of malpractice and professional discipline. If the treatment plan involves a CAM therapy in region 4, for example, then referral is probably inadvisable. These steps, among other things, should help reduce likelihood of negligence for referral to a "known incompetent." (49) This framework for delivery of CAM therapies and referral to CAM providers suggests ways to engage in sound clinical decision-making that both maximizes patient preferences and honors the duty to do no harm and minimizes liability risks.

SPECIFIC STEPS FOR ADVISING FAMILIES REGARDING CAM THERAPIES

The liability risk framework suggested above, together with the abuse and neglect considerations outlined earlier, yields specific questions and steps for pediatricians who seek to advise families regarding the use of CAM therapies in a variety of steps.

Do Parents Elect to Abandon Effective Care When the Child's Condition Is Serious or Life Threatening?

As noted above, if the child's condition is not serious or life threatening, then courts are unlikely to intervene, whereas if the condition is serious or life threatening and the parents abandon necessary conventional care, then the risk increases that legal action involving abuse, neglect, or even homicide (if death results) may involve parents and increase the physician's risk of a lawsuit for malpractice and/or an action for professional discipline. Furthermore, as mentioned, statutory reporting requirements may be triggered.

Indeed, when parental religious convictions interfere with necessary conventional care and serious harm to the child is likely to result, the AAP recommends that pediatricians request court authorization to override parental authority. (56) Such a recommendation may be appropriate as well when parental convictions regarding CAM therapies interfere with necessary conventional and serious child injury thereby is likely to result.

Will Use of the CAM Therapy Otherwise Divert the Child From Imminently Necessary Conventional Treatment?

If the child's condition is not serious or life threatening, then the use of CAM therapies for palliative care, comfort, or adjunctive treatment is unlikely to result in liability, unless the child is diverted from imminently necessary, conventional care and thereby injured. Thus, a "time-limited trial of the proposed approach" may be appropriate. (16,22) A strategy that uses a therapeutic intervention until a therapeutic plateau is reached or a reasonable period of monitoring elapses should be discussed and documented in the record. (22,49,61) If the strategy involves referral to a licensed CAM provider, then legal risk may be reduced if the steps suggested earlier are taken and with the caveat that the referring pediatrician should neither abdicate responsibility to the CAM provider nor abandon the patient but should continue conventional monitoring of the child and, as appropriate, continue conventional treatment. (49,61) Indeed, although the federation guidelines authorize referral to a CAM provider, the guidelines provide that the physician "is responsible for monitoring the results and should schedule periodic reviews to ensure progress is being achieved." (25)

Are the CAM therapies Selected Known to be Unsafe and/or Ineffective?

Having assessed and concluded that the clinical situation is not life threatening and that the patient's CAM therapy will not divert attention away from imminently necessary medical care, the pediatrician can adapt the safety/efficacy framework presented above to pediatric use of CAM therapies. Thus, depending on whether the CAM therapy is in region 1, 2, 3, or 4, the pediatrician can counsel the family accordingly. From an ethical perspective, the better the evidence of safety of the CAM treatment, the more appropriate to tolerate or support parents' decisions to use that therapy; furthermore, in the absence of efficacious conventional treatments, the greater the evidence of efficacy for the CAM therapy, the more ethically appropriate it is to tolerate or support the use of that therapy. (22,69) The converse also is true: the lower the evidence of safety and efficacy, the more appropriate to attempt to steer the family away from such a therapy, (22) mindful that sanctioning a therapy with low evidence of safety and efficacy increases liability risk. (49)

Including a CAM therapy simply to help the parents believe that "everything has been tried" is both ethically questionable and legally risky. If parents insist on using a CAM therapy with little or no evidence of safety and efficacy, despite the pediatrician's counseling to the contrary, then this should be documented carefully in the medical record and acknowledged in writing by the legally responsible party (49); to avoid potential liability for abandonment, the pediatrician who is unwilling to continue to care for the patient under this circumstance should refer the family to a clinician who is willing to continue conventional monitoring and treatment. (22)

Have the Proper Parties Consented to the Use of the CAM Therapy?

Informed consent is a prerequisite to treatment that involves CAM therapies when informing the patient about such therapies will make a difference in the patient's choice of treatment. (70) As children usually are not considered competent to give informed consent, parents or surrogates typically are asked to provide informed permission for diagnosis and treatment of children, with the assent of the child whenever appropriate. (52) In most states, as noted, adolescents within a certain age range are considered mature minors who can consent to medical treatment. A family-centered approach, using spiritual and psychological support, and attention to the child's feelings and concerns about the likely effects of continued, conventional treatment (71) are particularly appropriate to consideration of CAM therapies in the pediatric setting.

Because the absence of adequate informed consent can be a basis for a malpractice claim, (70) it is important to provide pediatric patients (and their families) with all information relevant to a treatment decision that might involve CAM therapies. Informed consent also can provide an opportunity to "show sensitivity to and flexibility toward the religious beliefs and practices of the family" (56) as well as those beliefs and practices that involve CAM therapies. Furthermore, patient consent to CAM therapies may, in some states, provide a defense to malpractice if the therapy is reasonably safe and effective and provided with careful clinical judgment. (46)

Is the Risk-Benefit Ratio of the Proposed CAM Therapy Acceptable to a Reasonable, Similarly Situated Clinician, and Does the Therapy Have at Least Minority Acceptance or Support in the Medical Literature?

To the extent that benefits outweigh risks and use of the CAM therapy has received some medical acceptance and thus is not unequivocally below the standard of care, a conclusion of negligence is less likely. (49) As well, the federation guidelines suggest that in such cases, a conclusion of professional misconduct is less likely. (25) Furthermore, if a so-called respectable minority of pediatricians nationally accept or support using a specific CAM treatment for a given condition, then the pediatrician may be able, in some states, to rely on that minority opinion and have a defense to a malpractice claim. (45,46) Conversely, subjecting the child to a serious risk without sufficient evidence of benefit for a therapy that most physicians consider dangerous or ineffective is likely to trigger professional discipline as well as potential liability. (49) Such conduct conceivably would be unethical as well. (22)

CONCLUSIONS

Pediatric use of CAM therapies raises legal as well as clinical concerns. A cautious yet balanced approach ideally can help guide the pediatrician toward clinical advice (including referral) that is clinically responsible, ethically appropriate, and legally defensible. Such an approach, embracing both clinical and legal concerns, can help to protect the child's welfare, as new parameters for integrative health care unfold.

TABLE 1. Highlights of Federation of State Medical Board
Guidelines for Physician Use of Complementary and
Alternative Medical Therapies

Criteria for discipline
 Regardless of whether physicians are using conventional treatments
 or CAM in their practices, boards are to evaluate "whether or
 not a physician is practicing appropriate medicine" by
 considering the following practice criteria. Is the treatment:
 Effective and safe (having adequate scientific evidence of
 efficacy and/or safety or greater safety than other established
 treatment models for the same condition)?
 Effective but with some real or potential danger (having evidence
 of efficacy but also of adverse side effects)?
 Inadequately studied but safe (having insufficient evidence of
 clinical efficacy but reasonable evidence to suggest relative
 safety)?
 Ineffective and dangerous (proven to be ineffective or unsafe
 through controlled trials or documented evidence or as measured
 by a risk/benefit assessment)?
Practice guidelines
 Evaluation of patients
 Parity of evaluation standards for patients whether using
 conventional medical practices or CAM
 Appropriate medical history and physical examination of the
 patient as well as an appropriate review of the patient's
 medical records required, including nonconventional methods of
 diagnosis based on the same standards of safety and reliability
 as conventional methods, and documented in the patient's medical
 record
 Medical records should also document:
 What conventional medical options have been discussed, offered,
 tried, or refused;
 Discussion of risks and benefits of the use of the recommended
 treatment; and
 That the physician has determined the extent to which the
 treatment could interfere with any other recommended or
 ongoing treatment
 Treatment plan
 Treatment should:
 Have a favorable risk/benefit ratio compared to other treatments
 for the same condition;
 Be based on a reasonable expectation that it will result in a
 favorable patient outcome, including preventive practices; and
 Be based on the expectation that a greater benefit will be
 achieved than that which can be expected with no treatment
 Consultation and/or referral to licensed or otherwise
 state-regulated health care practitioners
 The physician may refer the patient as necessary for additional
 evaluation and treatment to achieve treatment objectives and may
 include referral to a licensed or otherwise state-regulated
 health care practitioner with the requisite training and skills
 to utilize the CAM therapy being recommended; however, the
 physician is responsible for monitoring the results and should
 schedule periodic reviews to ensure that progress is being
 achieved
 Documentation of medical records
 The physician should keep accurate and complete records to include:
 The medical history and physical examination;
 Diagnostic, therapeutic, and laboratory results;
 Results of evaluations, consultations, and referrals;
 Treatment objectives;
 Discussion of risks and benefits;
 Appropriate informed consent;
 Treatments;
 Medications (including date, type, dosage, and quantity
 prescribed);
 Instructions and agreements; and
 Periodic reviews
 Records should remain current, be maintained in an accessible
 manner, and be readily available for review
 Education
 All physicians must be "able to demonstrate a basic
 understanding of the medical scientific knowledge" connected
 with any CAM therapy
 Sale of goods from physician offices
 Due to the potential for patient exploitation, physicians should
 not sell, rent, or lease health-related products or engage in
 exclusive distributorships and/or personal branding:
 Physicians should provide a disclosure statement with the sale
 of any goods, informing patients of their financial interest;
 and
 Physicians may distribute products to patients free of charge
 or at cost in order to make products readily available
 Clinical investigations
 Investigators are expected to conform to enumerated ethical
 standards

ACKNOWLEDGMENTS

This research was supported by an unrestricted educational grant from American Specialty Health Plan, operational support from the Rudolph Steiner Foundation, and a research grant from the Greenwall Foundation.

We thank Bridget Guerrera and Maria Van Rompay for research assistance.

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Michael H. Cohen, JD, MBA *; and Kathi J. Kemper, MD, MPH ([double dagger])

From the * Division for Research and Education in Complementary and Integrative Medical Therapies, Harvard Medical School, Boston, Massachusetts; and ([double dagger]) Department of Pediatrics, Brenner Children's Hospital, Wake Forest University Health Sciences, Winston-Salem, North Carolina.

Accepted for publication Jul 30, 2004. doi:/

No conflict of interest declared.

Address correspondence to Michael H. Cohen, JD, MBA, Harvard Medical School, Osher Institute, 401 Park Dr, 22W, Boston, MA 02215. E-mail: .edu