So what is integrative medicine? When you strip away the rebranding and co-opting of features and treatments of mainstream medicine, you are left with the usual list of pseudoscientific practices that have been trying to insert themselves into mainstream medicine for decades through a series of marketing and propaganda strategies. Bravewell has positioned itself at the forefront of that effort.
Among these pseudoscientific practices listed in a chart from the report included by Dr. Gorski in his post were acupuncture, TCM, reiki, therapeutic touch, naturopathy, homeopathy and reflexology.
Dr. Novella continued,
At the end of the report, under the category ‘next steps,’ they write:
‘Providing funding for analysis of these data, which could provide important information about the efficacy of integrative medicine approaches as well as the treatment of chronic health conditions, should be a priority for funding sources and institutions.’
Let me translate that for you, in the context of the whole report: Isn’t it wonderful that integrative medicine methods are being used, now let’s go see if they actually work. If there is anything that defines alternative, complementary, integrative medicine it’s putting practice before evidence. In fact, the evidence is irrelevant to practice. Practice is philosophy-based, not science-based. Evidence is an obstacle, used only for marketing purposes, not for determining which treatments are effective. That is why they keep trying to redefine scientific evidence in medicine. They need science to change to accommodate their treatments, not conform treatments to the science.
And, as Dr. Atwood noted, in response to the claim that the IM practitioner “puts the patient at the center:”
That implies ‘patient-centered care,’ which requires that practitioners provide honest, comprehensive information about the methods in question. IM practitioners are universally dishonest about such matters. They have to be, because otherwise they’d have to tell patients the truth: that the methods are worthless.
Which, in my mind, brings up an interesting legal and ethical issue of consequence to the “integrative physician:” Does an M.D. or D.O prescribing a “CAM” treatment have a legal or ethical duty to disclose scientific implausibility as a part of informed consent process? How about lack of efficacy? My answers are “yes” and “yes.”
Informed Consent: Legal and Ethical Duty
First, a brief review of the law of informed consent. An early, and often quoted, formulation of informed consent came from the eloquent pen of Judge Benjamin Cardozo, then sitting on the Court of Appeals of New York, later to become an associate Justice of the U.S. Supreme Court.
Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damages. (1)
Courts today characterize the unconsented treatment as the tort of battery – an intentional, unconsented to touching — rather than an assault. Actions for battery may be brought when there is no patient consent or where the physician goes beyond the scope of the consent. (2)
Typical of these are “wrong site” surgery cases where the patient, for example, has consented to a right knee replacement and the surgeon instead replaces the left knee. Or, in an example of “beyond the scope of consent,” a surgeon gets into a case and decides an operation different from the one the patient consented to is necessary. The latter example can be effectively eliminated by written consent covering this situation signed by the patient prior to surgery.
However, in certain cases insufficient disclosure can negate consent, thereby subjecting the physician to an action for battery. According to the Restatement (Second) of Torts, Section 892B(2) (1979),
If the person consenting to the conduct of another is induced to consent by a substantial mistake concerning the nature of the invasion of his interests or the extent of the harm to be expected from it and the mistake is known to the other or is induced by the other’s misrepresentation, the consent is not effective for the unexpected invasion or harm.
Translation: if the physician knows he is mistaken in informing the patient about the treatment, or misrepresents the treatment to the patient, the patient has not effectively consented to the treatment.
As the jurisprudence of informed consent continued to develop in the last century, courts also recognized a negligence theory upon which plaintiffs could recover for lack of informed consent. Where the patient consents to a certain treatment and the physician in fact performs that treatment, but fails to disclose a material risk to the patient, and that risk materializes, the patient can sue for negligence in failing to warn of the risk. The physician’s duty to disclose has been expanded to include disclosure of other treatments available for the patient’s condition, and the risks and benefits of each. (3)
One important distinction between a battery theory of recovery and a negligence/malpractice theory should be noted. A patient cannot recover for negligence unless he has actually been harmed in some way – e.g., an undisclosed but known risk of spinal surgery causes paralysis. Under a battery theory, the unconsented touching is harm in and of itself, although the plaintiff would still have to prove damages.
When risks and benefits of a proposed treatment are disclosed, as well as the risks and benefits of other possible treatments, the patient is able to make an autonomous choice. But this leaves an important question undecided: who makes the decision as to what sort of information should be disclosed? Two standards have emerged and jurisdictions are now about evenly split between the two.
Under the “physician standard,” a physician has a duty to disclose information that a reasonably prudent physician in the same or similar circumstances would disclose. Expert testimony is required to establish the standard. Under the “patient standard,” a physician has a duty to disclose information that a reasonably prudent patient in the same or similar circumstances would consider material in making a decision about whether to consent to the proposed medical or surgical procedure. (4)
While cases brought under either standard most typically revolve around a failure to disclose risk, it is important to remember the linchpin of informed consent is patient autonomy, not a mere risk/benefit analysis. This respect for patient autonomy is not simply a legal duty the breach of which will subject the physician to liability. It is also an ethical duty which must be observed whether or not actionable harm ensues. The fact that the patient doesn’t sue the physician for battery or malpractice does not retroactively absolve the physician from breach of this ethical duty. As Beauchamp and Childress state:
Respect for autonomy obligates professionals in health care and research involving human subjects to disclose information, to probe for and ensure understanding and voluntariness, and to foster adequate decision-making.
Further, in applying the moral duty of veracity to health care professionals, Beauchamp and Childress continue:
Veracity in the health care setting refers to comprehensive, accurate, and objective transmission of information, as well as to the way the professional fosters the patient’s or [research] subject’s understanding. Three arguments contribute to the justification of obligations of veracity. First, the obligation of veracity is based on respect owed to others. . . . [R]espect for autonomy provides the primary justificatory basis for rules of disclosure and consent. . . . Second, the obligation of veracity has a close connection to obligations of fidelity and promise keeping. . . . By entering into a relationship in therapy or research, the patient or subject enters into a contract or covenant that includes a right to the truth regarding diagnosis, prognosis, procedures, and the like . . . . Third, relationships between health care professionals and their patients and between researchers and their subjects ultimately depend on trust, and adherence to rules of veracity is essential to foster trust.(5)
Law of Informed Consent and CAM
As has been discussed many times at SBM, complementary, alternative, and integrative medicine proponents have co-opted science-based modalities, such as nutrition, exercise and stress reduction, as their own:
That’s what we here at SBM mean when we describe the ‘bait and switch’ of CAM/IM. Plausible, potentially science-based treatments are reborn as CAM/IM and then used as evidence that CAM works. They’re also the Trojan horse that CAM/IM proponents use to trick the guardians of SBM into bringing into fortress of academia. After these modalities have been accepted as ‘CAM,’ out jumps the real woo, such as ‘energy healing,’ to take over.
Here our discussion will be confined to the “real woo” and the physician’s duty of disclosure.
One feature of CAM that should be immediately obvious to the physician trained in “conventional” medicine is that CAM modalities are not based on the same sort of logically cohesive, science-based understanding of human functioning that they learned in medical school. (To say the least.) Of course, this should be a big red flag.
However, should that not be enough to stop the M.D./D.O. in his/her tracks, it is fairly simple to look at the evidence, or lack thereof, for the efficacy of CAM treatments. As has also been discussed extensively on SBM, the evidence just isn’t there for acupuncture, naturopathy, reiki, reflexology, homeopathy, subluxation-based chiropractic, and so on. We also know that lack of plausibility must be factored into any review of efficacy literature, as positive results must be viewed with reference to implausibility. In fact, SBM has made it easy for the practicing physician. He doesn’t even have to bother with PubMed or Medline searches. Much of the evidence has been expertly distilled right here on this blog.
Returning to the questions presented, must the M.D. or D.O. legally disclose the lack of plausibility and efficacy evidence for CAM procedures before recommending or performing them?
In answering that question, consider this hypothetical. An FDA-approved drug – we’ll call it “Mendax” — is later discovered to have gained that approval through manipulation of data in clinical trials. Those trials actually show that Mendax lacks efficacy for its proposed use. But the deception goes even deeper than that. The description of Mendax’s proposed mechanism of action is shown to have been falsified. As it turns out, it is implausible that Mendax would work as proposed. Although Mendax has been removed from the market, Dr. A has a supply of trial packets of Mendax furnished by a drug rep prior to removal from the market.
Putting aside other legal and ethical questions raised by prescribing a drug removed from the market, would a reasonably prudent physician in the same or similar circumstances disclose the fact that Mendax’s proposed mechanism of action is implausible and that it is not efficacious for its intended use? Would the reasonably prudent patient want to know this information in making an informed choice as to whether to take Mendax?
When put in the context of “conventional” medicine, these questions seem silly. Of course the physician would have to disclose this information. Of course the patient would want to know this in order to make an informed choice. What, then, is it about CAM treatments that would change the answer to these questions? What about CAM might exempt a physician from the duty to disclose implausibility and inefficacy?
The only possible argument I can think of is the fact that the CAM modality in question might be within the legal scope of practice of the physician or the CAM practitioner to whom the patient is referred. But that would require reading into all the physician and CAM practice acts an implied statutory abrogation of the well-developed law of informed consent. Under normal rules of statutory construction, one could not read such a purpose into these statutes without a more explicit directive to do so on the part of the state legislatures. In other words, if the state legislatures were aiming to substantially alter the law of informed consent, they would have said more directly that is what they were doing. (6)
Ethical Duty of Informed Consent and CAM
Although it is not my field, medical ethics appears, not surprisingly, to require the same result. Professor Kathleen M. Boozang has written that certain treatments should not be offered to patients, even if the physician believes they are unlikely to result in harm to the patient. According to Prof. Boozang, these include any treatment which:
a. is implausible on a priori grounds (because its implied mechanisms or putative effects contradict well-established laws, principles, or empirical findings in physics, chemistry or biology),
b. lacks a scientifically acceptable rationale of its own,
c. has insufficient supporting evidence derived from adequately controlled outcome research, or
d. has failed in well-controlled studies done by impartial evaluators and has been unable to rule out competing explanations for why it might seem to work in uncontrolled settings. (7)
Prof. Boozang refreshingly calls such treatments “quackery” and says unequivocally that “doctors should not truck with quackery” and that “physicians should not offer or accede to patient demands for unproven treatments.” (8) In an observation that tackles head on the notion that patients see CAM as more responsive to a need for intangibles like comfort, she states:
Patients have a range of expectations of their physicians, with different patients looking for different things, which may include hope, compassion and comfort. However, patients universally seek effective and safe treatment; they want to be cured. Consequently, the legal and ethical systems that establish the parameters within which physicians practice must demand at the very least that physicians utilize their skills and knowledge to offer patients treatment which they reasonably believe will actually treat the condition from which they suffer. This minimum requirement precludes physicians form offering as medicine something that is not – even if it will, in a psychological or emotional sense, make the patient ‘feel better.’ To do otherwise misleads the patient about what ultimately matters — that she is receiving treatment for her condition. . . . The very fact that it is a physician who prescribes the therapy will endow the treatment with a false sense of legitimacy. . . . [Patients] do not expect physicians to succumb to fads or illegitimate pressure to provide treatment that has no reasonable chance of helping the patient. In medicine, that hope is inspired by scientific proof, whether or not the treatment is conventional or alternative. (9)
If offering CAM to patients is ethically contraindicated, and the basis of that conclusion is, in part, a physician’s fiduciary obligation to be truthful with their patients, and the corresponding desire of patients for treatments that are actually beneficial, then, a fortiori, a physician offering implausible and unproven CAM treatments would have an ethical obligation to tell patients about that very implausibility and lack of efficacy.
The intrusion into “conventional” medicine of implausible and unproven treatments by supporters of CAM, and those who will benefit from their support, does not alter the ethical and legal obligations of physicians to be truthful with their patients. Medical ethics demand that such treatments not be offered. If they are recommended, ethically the physician has, at the very least, a duty to disclose implausibility and lack of evidence of effectiveness. Legally, physicians offer such treatments at the risk of being sued for battery based on the claim that patient consent is nullified by misrepresentation if implausibility and lack of effectiveness are not disclosed. Alternatively, if the CAM treatment results in harm, physicians risk suit under a negligence theory. It should be easy enough to prove by expert testimony, under the physician standard of disclosure, that implausible and ineffective treatments would not be offered by a reasonably prudent physician. Under the patient standard, a jury would be hard pressed to conclude that a reasonable patient would find it immaterial to that the proffered treatment lacked scientific plausibility and evidence of effectiveness.
(1) Schloendorff v. The Society of New York Hospital, 211 N.Y.125, 129-30 (1914).
(2) Jesson LE, Tovino SA, Complementary and Alternative Medicine and the Law, Carolina Academic Press (2010), 157-178.
(5) Beauchamp TL, and Childress, JF, Principals of Biomedical Ethics, Oxford University Press (5th Ed. 2001), 64, 283-284.
(6) See, e.g., TVA v. Hill, 437 U.S. 253, 189-191 (1978).
(7) Boozang, KM, Western Medicine Opens the Door to Alternative Medicine, 24 Am. J. L. and Med. 185, 204 (1998).
(8) Id., at 204, 208.
(9) Id., at 205, 209.