Course Authors
Maxwell J. Mehlman, J.D.
Professor Mehlman reports no conflict of interest.
Estimated course time: 1 hour(s).
Albert Einstein College of Medicine – Montefiore Medical Center designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
In support of improving patient care, this activity has been planned and implemented by Albert Einstein College of Medicine-Montefiore Medical Center and InterMDnet. Albert Einstein College of Medicine – Montefiore Medical Center is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Upon completion of this Cyberounds®, you should be able to:
Discuss the nature and uses of complementary and alternative therapies
Discuss the ethical and legal challenges presented by the use of these modalities
Discuss how to minimize the legal risks of employing these modalities.
Complementary and alternative medicine ("CAM") interventions include homeopathy; naturopathy; acupuncture and other therapies based on Chinese or Ayurvedic medical systems; mind-body interventions such as meditation and faith-based healing; herbal remedies and dietary supplements; manipulation treatments such as chiropractic and massage; and energy therapies such as qi gong and the use of electromagnetic fields.(11)
Integrative medicine is the combined use of mainstream with complimentary and alternative medicine. The Association for Integrative Medicine website specifically mentions massage, counseling, Reiki, yoga, shiatsu, biofeedback, chiropractic, hypnosis, homeopathy, naturopathy, cranio-sacral therapy and arts therapies.
The use of CAM is growing significantly in the United States. Between 1990 and 1997, visits to alternative medicine providers increased by almost 50 percent and, by the end of that period, exceeded the number of annual visits to primary care physicians.(6)
Is CAM Safe and Effective?
CAM interventions often lack evidence of safety and efficacy in the form of well-designed and properly conducted scientific studies. [The National Center for Complimentary and Alternative Medicine (NCCAM) defines "integrative medicine" as a combination of mainstream medical therapies and CAM therapies "for which there is some high-quality scientific evidence."(11) This implies that "integrative" practitioners may be more scrupulous about the need for scientific evidence of safety and efficacy than other CAM practitioners.]
There are a number of reasons why CAM interventions often lack evidence of safety and efficacy in the form of well-designed and properly conducted scientific studies. On philosophical grounds, certain CAM practitioners may not believe in the scientific method, or they may feel that there are other equally persuasive methodologies that produce valid and reliable evidence. Clinical studies also are extremely expensive.
Yet some CAM interventions have been in existence so long that they are not patentable, or are in such common use that they cannot be protected by trademark registration and/or by franchising. This creates a "free rider" problem, since there is nothing to prevent those who have not subsidized the testing from marketing the interventions.
One alternative would be for groups such as trade associations to pool industry funds to finance studies. Another option is for the government to sponsor safety and efficacy investigations. For this purpose, the NIH established an Office of Alternative Medicine in 1993, which Congress elevated to the status of a center in 1998. The National Center for Complementary and Alternative Medicine now has a budget of over $100 million, most of which is spent on extramural safety and efficacy research.(11)
Legal Consequences for a CAM Provider
The fact that CAM interventions are not regarded as mainstream medicine and often lack scientific evidence of safety and efficacy raises important ethical and legal issues for individuals who provide CAM to patients. From a legal standpoint, the first question is whether the individual is practicing medicine without a license; if so, he or she could be subject to criminal prosecution.
A naturopath who ran the "Christian Health Institute and Wellness Center," for example, was indicted for practicing medicine without a license when he examined an undercover investigator, pronounced that the agent had "a clogged colon, weak kidneys, and aluminum in his body," recommended that he watch his diet, take certain vitamins and dietary supplements, and sold him $265 worth of "inner cleansers" and "Swedish elixirs" (on top of the $300 charge for the examination).(13)
Another naturopath hooked a child up to a machine in her basement, and told the child's mother that the child, who was suffering from ear aches, had a tapeworm and a brain aneurysm, then hooked up the mother, told her she had breast and ovarian cancer as well as a brain aneurysm, and charged her over $500. The naturopath was arrested after another patient, who had paid $1,265, complained to the authorities, and an undercover policeman, after being hooked up to the machine, was told that his stomach, liver, and pancreas were in a "precancerous state."(9)
A third naturopath was convicted of practicing without a license and involuntary manslaughter following the death of an eight-year old child with Type I juvenile diabetes whose mother, on the naturopath's advice, had stopped giving her insulin and instead administered "Arnica liquid extract" and "Chelation Packets," among other things.
Even a practitioner who is licensed as a provider of CAM services, such as a licensed chiropractor, may be subject to prosecution or disciplinary action if he or she exceeds the scope of the license. In Foster v. Georgia Board of Chiropractic Examiners, for example, a licensed chiropractor was penalized for dispensing "nutritional substances" to patients.(8)
Malpractice or Standard of Care?
Assuming the practitioner is a licensed physician, the question is whether the use of CAM subjects him or her to disciplinary action or civil liability for malpractice. In Painter v. Abels, for example, a physician was disciplined for employing an "Electro Dermal Screening" mechanism and prescribing a "serum" of alcohol and water and a 30-day supply of a "Herbal Detoxification Program," although the court struck down the sanctions because of a procedural irregularity.(14)
A crucial determination is whether the use of CAM is malpractice. Clearly the fact that the intervention lacks scientific evidence of safety and efficacy does not make its use negligent per se. If that were the case, providers of mainstream care themselves would face an overwhelming risk of liability, since many of their interventions have never been tested under adequate and well-controlled conditions. Hence the call for more "evidence-based medicine." Instead, liability will depend on whether the practitioner has met the requisite legal standard of care, typically, whether he or she has behaved the way a reasonable practitioner would behave under the same circumstances.
Standard of care, in turn, breaks down into two further issues: Was the type of intervention reasonable, and did the practitioner perform the intervention in a reasonable manner? The standard will vary according to the nature of the practitioner's license, so that a physician will be held to the standard of a reasonable physician, but a licensed chiropractor, for example, will be held to the standard of a reasonable chiropractor.
It is also important to realize that "reasonable" does not mean "mainstream." If that were the case, then physicians could not try new approaches without violating the standard of care. Instead, in most jurisdictions, the reasonableness of the practitioner's non-mainstream behavior will be measured according to whether a "respectable minority" of practitioners would employ the same approach, a matter that must be proven through expert testimony.
Evidence that tends to support a finding that an approach is employed by a respectable minority include the impressiveness of the credentials of those who endorse the CAM approach; the existence of a plausible scientific rationale for the effectiveness of the intervention; the existence of literature in respectable journals supporting the use of the intervention; and a plausible explanation why the CAM approach was employed (e.g., it had fewer potential side effects than the mainstream approach; after being adequately informed, the patient preferred the CAM approach; the mainstream approach had been tried and had failed).
In a civil suit, moreover, the patient must prove that the use of CAM caused him or her harm, either directly (that is, by causing greater harm than if a mainstream approach had been used) or by precluding the use of safe and effective mainstream medicine.
Some states, including New York, Massachusetts, Ohio and Florida, have enacted "access to medical treatment" laws that provide some protection for CAM providers. These laws provide, for example, that a licensed physician who uses CAM is not negligent if the benefits and risks from CAM are reasonable when compared with the risks and benefits of conventional care.
Informed Consent and CAM
Another set of issues involves informed consent. A competent patient, or someone authorized to decide on the patient's behalf, must be adequately informed about the risks and benefits of CAM and of the available, reasonable alternatives. The precise legal standard varies depending on the jurisdiction, but the prevailing standard is that the patient must be given the information that a reasonable patient would need, which the fact-finder must determine without the aid of expert testimony.
(Other standards are the "reasonable physician" or "professional" standard, where the patient must be given the information that a reasonable physician would give, as established through expert testimony; and the "actual patient" standard, which is highly deferential to the patient's self-proclaimed need for the information and, like the reasonable patient standard, is not dependent on expert testimony.)
A study in 1998 found that patients who opted for CAM generally were better educated than patients in general, suggesting that the practitioner should err on the side of providing more rather than less complete or complex information.(2)
It is clear that a physician who offers a patient the option of CAM must inform the patient of the availability of mainstream alternatives. What if, however, the physician does not believe that a CAM intervention is appropriate?
Q. Does a physician have to inform a patient about CAM?
A. The current view of the courts is that a physician must only inform patients about alternatives that the physician believes would be beneficial. In Moore v. Baker, a patient sued her physician after she became disabled as the result of a carotid endarterectomy, claiming that the physician had failed to inform her of the alternative of chelation therapy. A state statute required physicians to inform patients about alternatives "that are generally recognized and accepted by reasonably prudent physicians." The court dismissed the plaintiff's claim, stating that the plaintiff had failed to show "that reasonably prudent physicians generally recognize and accept this alternative."(10)
The court in Vandi v. Permanente Medical Group went even further and held that a physician did not have to tell patients about alternatives (in that case, not a CAM intervention but a CT scan or MRI) that the physician did not feel were "medically indicated."(18) In Schiff v. Prados, a California court ruled that a physician did not have a duty to inform patients about an alternative cancer treatment, "antineoplaston," made from substances distilled from human urine. The court rested its decision on a California law that prohibits the sale or distribution of a cancer treatment that is not the subject of an approved NDA ("new drug application") or IND ("investigation new drug" exemption) from the FDA.(15)
Therapeutic Nihilism or Experimentation?
The American Academy of Pediatrics (AAP) has taken a somewhat more liberal approach, recommending that practitioners be open to a family's interest in pursuing CAM alternatives for their child. The AAP urges physicians to "avoid therapeutic nihilism," provide families with information on "a range of treatment options," refrain from dismissing CAM "in ways that communicate a lack of sensitivity or concern for the family's perspective," and "recognize feeling threatened and guard against becoming defensive."(1)
The AAP statement goes on to suggest that the physician offer to assist in monitoring and evaluating the response "[i]f a CAM approach is endorsed." But the AAP also makes it clear that the physician must inform families if there is a lack of scientific support for a CAM alternative and must identify the potential risks and side effects.(1) An important source of information is CAM on PubMed, which provides abstracts or citations to scientific studies on CAM from the National Library of Medicine.
The informed consent requirement mandates that the practitioner inform the patient that the efficacy and/or safety of the CAM intervention have not been established by well-designed and properly conducted scientific studies. This raises the question of whether the use of CAM should be regarded as experimentation even when the practitioner is not proposing to enroll the patient in a formal clinical trial.
If the use of CAM is deemed experimentation, then a number of safeguards to protect the patients as subjects are triggered, such as review of the experiment by an institutional review board. The distinction between experimentation and treatment is not a clear one, however; generally speaking, if the purpose of the intervention is to benefit the patient, the intervention is regarded as therapeutic innovation, while an intervention intended primarily to provide evidence about the intervention for the benefit of others is experimentation.(12)
Does Informed Consent Remove Liability?
Another question is whether obtaining the patient's informed consent to the use of CAM relieves the practitioner of liability for malpractice for employing a CAM intervention, assuming that the delivery of the CAM intervention is performed properly. In other words, if the patient is adequately informed and selects a CAM option, can the practitioner successfully assert that the patient has assumed the risk of CAM? And what if, as part of the informed consent process, the patient expressly agrees not to hold the practitioner liable for the use of CAM?
In the classic case of Tunkl v. Regents of the University of California, the California Supreme Court in 1963 ruled that an agreement by a patient not to sue a hospital for malpractice was unenforceable because it was contrary to public policy.(17) But in Schneider v. Revici, a patient who preferred to try Dr. Revici's treatment for breast cancer, which consisted of selenium and dietary modification, rather than undergo surgery, had signed a form stating that Dr. Revici had informed her that his approach had not been approved by the FDA and that, in return for employing it, she agreed to release him from all liability.(16)
The court in Schneider held that this agreement was not automatically invalid, and that the jury could consider whether the patient in fact had assumed the risk of treatment and, therefore, was barred from suing Dr. Revici. And in Charell v. Gonzalez, a patient suffering from uterine cancer who had refused chemotherapy and radiation treatments in favor of the defendant's "hair test" followed by a regimen of dietary modification and coffee enemas sued the defendant when her cancer metastasized, leaving her blind and with severe back problems. The court allowed the jury to determine that, by availing herself of this treatment, the plaintiff had implicitly assumed the risk, as a result of which the jury reduced her damages by 49 percent.(4)
The Charell case is especially noteworthy for several reasons. First, the court decided that the patient had assumed the risk even though the defendant had not provided her with appropriate information regarding the risks of his approach and the alternatives. The defendant's omission was overridden, in the court's opinion, by the fact that the plaintiff was well educated and had independently obtained substantial information about the defendant's treatments. Second, the plaintiff won damages despite the fact that New York has a law in effect that permits physicians to use "whatever medical care, conventional or non-conventional, which effectively treats human disease." Third, the court noted that, since a physician is negligent if he or she deviates from accepted medical standards, a practitioner of non-conventional medicine by definition would seem to be negligent. The court advised non-conventional practitioners to protect themselves from liability by having patients sign releases as in the Schneider v. Revici case.
Fraud, Quackery and True Beliefs
One of the major ethical challenges in the use of CAM is to avoid the appearance of fraud or quackery. The most obvious instance of fraud or quackery would be if the patient could prove that the practitioner knew that an intervention was worthless but provided it anyway.
But note that "worthless: is not the same as lacking pharmacologic activity. Pharmacologically-inert substances can produce a placebo effect that provides patients with clinically significant relief from symptoms and improvement in health status.(7) If a practitioner provides an intervention to the patient that yields such a placebo effect, it can be argued that this is not quackery at all, but the use of suggestion to stimulate the body's ability to manufacture therapeutic or analgesic substances. Of course, the intentional use of a placebo raises difficult ethical issues of its own, in particular, whether it is ethical to withhold from the patient the knowledge that it is a placebo that is being employed.
Difficult ethical issues also arise when practitioners, despite the lack of good scientific evidence, sincerely believe that their CAM interventions are safe and pharmacologically effective. From an ethical and legal standpoint, the practitioner has an obligation to engage in a candid informed consent process with patients, informing them that the intervention is not mainstream, describing what is and is not known about the intervention and the empirical basis for this knowledge, and delineating the alternatives.
Practitioners must avoid allowing a financial interest in the intervention to bias their presentation of this information to patients. In the Charell case, for example, the trial judge permitted the jury to award punitive damages to the plaintiff, holding that the jury was entitled to find "that the defendant's intent in dealing with the plaintiff was motivated by greed..."(4) But financial factors also can influence mainstream practice. Moreover, the appellate court in Charell vacated the lower court's award of punitive damages, stating, among other things, that the defendant's conduct in providing CAM "was not so wantonly dishonest."(5)
Avoiding Legal Liability
To summarize, practitioners who wish to make CAM available to their patients should make sure that the CAM interventions are within the scope of practice for their licenses. Practitioners should only recommend CAM interventions that they feel are medically reasonable, and should be able to articulate specific, defensible reasons for making such recommendations. Practitioners must inform patients of the risks and benefits of the CAM interventions that they recommend, including the fact that the interventions are considered to be CAM and a candid description of what is and is not known about their safety and efficacy. Practitioners should consider having patients sign written consent forms in which the patients acknowledge that they understand that they have chosen a CAM intervention.
A practitioner who does not believe that a CAM alternative is reasonable for a patient should not recommend it. If the patient brings it up, the practitioner should discuss the possibility of CAM candidly and be attentive to the reasons that the patient is interested in CAM. If the practitioner still does not feel that the CAM intervention is an appropriate option for the patient, the practitioner should offer to transfer the patient's care to another practitioner.