In November, the journal Pediatrics published an entire supplement devoted to The authors purport to have “examined current legal, ethical, and clinical issues that arise when considering CAM use for children and identified where gaps remain in law and policy.” (S150) Their aim is to “illustrate the relevance and impact of identified [ethical, legal and clinical] guidelines and principles,” to recommend responses, identify issues needing further consideration, and thus “assist decision makers and act as a catalyst for policy development.” (S153)
Unfortunately, as we saw in Pediatrics & “CAM” I: the wrong solution, the authors’ solution for the “issues that arise when considering CAM use for children” consist, in the main, of placing a huge burden on the practicing physician to be knowledgeable about CAM, keep up with CAM research, educate patients about CAM, warn patients about CAM dangers, refer to CAM practitioners, ensure that CAM practitioners are properly educated, trained and credentialed, and so on.
Limit CAM? Not happening
Curiously absent are recommendations placing responsibility on those who profit from the sale of CAM products and services — the dietary supplement manufacturers, homeopaths, acupuncturists, and the like — whose actions are directly responsible for the deleterious effects on patients’ health detailed in the supplement articles and described in the earlier post.
Apparently the authors’ view is that there is no accommodation to CAM too onerous to ask the practicing physician or the patient to bear. Even though they plainly locate the problems they describe — a missed diagnosis, ineffective treatments, drug therapy interactions, poor advice — in the CAM services and products themselves, suggesting that these services and products be limited or eliminated never seems to cross their minds.
It is not as if they are unaware that regulation of CAM is less than ideal. In discussing credentialing of CAM providers, they suggest:
Hospitals should be aware of the scope of CAM providers’ practice authorized by legislation and ensure that therapies provided on-site comply with regulatory requirements. Uncertainty about safety or efficacy may affect decisions about the scope of practice permitted on site. Institutions may narrow CAM providers’ scope of practice in the hospital from that authorized by their governing statute. If there is not convincing evidence of efficacy for some part of CAM providers’ practices, some American health care institutions limit them to what is supported in the literature. (S197)
In other words, the authors know that while the safety and efficacy of “some” CAM practices is questionable, these practices are nevertheless permitted by CAM practice acts. Yet they fail to recommend that the problem be treated at its source, by limiting or removing the statutory authority to engage in those practices.
The authors also state “there is a moral imperative to develop good evidence through research into CAM therapies to facilitate informed decision-making and informed consent.” (S152) (They offer no suggestions as to who should pay for this research.) This “moral imperative” exists, according to the authors, because those who make treatment decisions for children, when considering CAM, may be confronted with situations in which “evidence may be lacking or less adequate than desired.” (S152)
Would it be too much to suggest that perhaps we simply not allow health care products and services where “evidence may be lacking or less adequate than desired”? That we as a society could require a plausible basis in science and maybe even a bit of evidence of effectiveness before allowing therapies and products to be used on actual patients, especially children?
Given the authors’ stated desire to inform public policy, one would assume they would make compelling arguments for their exoneration of all responsibility for CAM providers and sellers of CAM products. Perhaps we could respect the authors’ conclusions if they at least undertook this discussion and then argued against any limitations on CAM. But they do not. No matter how effectively their own examples demonstrate CAM’s untoward effects on patients and their families, they avoid any such discussion.
For example, in a scenario involving an HIV-positive teen, Jenny, whose undisclosed St. Johns wort use interferes with her drug treatment (S155-S160), there is no recommendation that the Dietary Supplement Health and Education Act be amended to require perfectly reasonable steps such as pre-market testing for safety and efficacy, or warnings on supplement labels of possible drug interactions. Instead, the authors conclude it is the physician’s responsibility to know of this possible interaction, to inquire about the patient’s supplement use, to recommend discontinuation of the supplement, to find another treatment for her self-diagnosed depression, and so on.
Likewise, in another hypothetical, the parents of three-year-old Angela want to use Traditional Chinese Medicine in lieu of her physician’s suggestion that she undergo a liver transplant for glycogen storage disease type IV, a rare genetic disorder. The authors’ solution to this dilemma is to have the physician treat the parents’ preference as a serious option and undertake research on TCM for glycogen storage disease type IV. As one might expect, “there are no specific data [about TCM] for Angela’s condition to help guide her.” (One is tempted to say, “Duh!”) Therefore, the physician should then “tell the parents what she has learned about the lack of evidence supporting the use of TCM for this condition.” (S178) If the physician decides a transplant is “the only reasonable choice” and the parents continue to refuse “conventional” treatment, “child welfare authorities will have to be involved.” (S178)
While the authors are willing to place this enormous burden on the practicing physician, there is no corresponding recommendation for TCM practitioners or policy makers. Would it not be perfectly reasonable to greatly reduce the scope of practice of TCM so that this sort of choice is removed from the realm of possibilities? (Perhaps the authors hold out the possibility that someday we’ll discover TCM cures glycogen storage disease type IV?) Why not recommend that TCM professional organizations enact a code of ethics which would prevent any TCM practitioner from ever suggesting TCM is an appropriate remedy for glycogen storage disease type IV? Why not preclude TCM practitioners from treating pediatric patients altogether, or only upon the recommendation of an M.D. or D.O.?
Similarly, in the case of fourteen-year-old Chris, who wants to see a homeopath instead of having surgery for ulcerative colitis (S161-S166), the authors never even explore the possibility that perhaps, as a matter of public policy, we should not license homeopaths nor allow the sale of homeopathic products, even while they admit that homeopathic products are not effective. (There is no discussion of why they can’t be effective.) No, their recommendation is:
The physician [after researching the issue] should share the lack of efficacy data and reassuring safety data about homeopathy with Chris. If he is [legally] able to make his own decisions, this will assist in ensuring that his consent is both properly informed and voluntary. If he insists on homeopathy, the physician will need to closely monitor his condition by using conventional means. (S164)
Policy solutions: wrong again.
The authors’ avoidance of placing any burden on those who profit from the sale of CAM goods and services could be excused if they were simply focusing on what practicing physicians might do when confronted with the unfortunate presence of CAM in their patients’ cases, leaving broader policy solutions for another day. However, that is not the case.
In only one instance out of the 10 articles comprising the supplement do the authors suggest that CAM providers themselves take responsibility for reducing the unfortunate consequences of their actions. In response to a case in which a chiropractor fails to diagnose testicular cancer in a teenage boy and fails to refer the boy to a physician when chiropractic proves ineffective for his symptoms, the authors recommend that “incorporating more formal training about pediatric care into chiropractors’ education could reduce the risk of adverse events cause by delays in diagnosis or referral.” (S203)
This is not a good suggestion, as essentially what they are asking is to make chiropractors capable of differential diagnoses for pediatric conditions, a skill that can’t just be tacked onto chiropractic education with a course or two. But at least it does raise the possibility that some responsibility for CAM’s ill effects lies with the CAM practitioners themselves and that they should do something about it.
Another suggested policy change — this as a solution to parents’ reluctance to have their children vaccinated — is a no-fault system of vaccine compensation. (S167-S174) Again, while credit is due for the rare suggestion that does not further burden the practicing physician, this is another bad idea.
The authors observe that “the need to establish a causal link between the vaccine and the harm suffered still limits eligibility” for compensation and propose “no-fault compensation in those rare instances when serious injury occurs” (S170) although this suggestion is truncated later in the article to “a no-fault compensation if a child should suffer a vaccine-related injury” (S171).
This proposal is curious, to say the least. First, in the U.S., there is already a no-fault administrative system for certain vaccines if the claimed side effect is one recognized by a statutory index and occurs within a specified time frame. If the criteria for one of these “table claims,” as they are called, is met, there is a statutory presumption of eligibility for compensation. If the claimed injury is “off table,” there is no presumption of causation and the claimant must satisfy a preponderance of the evidence standard to recover. However, instead of having to resort to the courts under traditional tort principles, cases are heard before Special Masters, with relaxed rules of evidence, assured payment to plaintiffs’ attorneys, and other plaintiff-friendly provisions.1
In any event, an exclusively no-fault system is simply inappropriate for putative vaccine-injury claims because of the speculative connection between vaccination and injury in many cases. The traditional tort system is meant to place financial responsibility for injury on the party who caused the injury instead of the injured party. No-fault systems are designed to eliminate the requirement that the injured party prove causation where there is an identifiable event in which the injury occurred — a car crash or an industrial accident, for example. In the no-fault vaccine injury system, the “table claims” are based on scientific evidence of a plausible connection between the vaccination and the injury, and thus fit a no-fault scheme.
In no-fault systems, certainty of recovery for the injured replaces the uncertainty of the fault-based tort recovery system. As a trade-off, insurers and their insureds benefit from the cost savings introduced when fault-based litigation is reduced or eliminated. In addition, costs are spread among all drivers, in the case of no-fault auto insurance, or, in the case of workers’ comp, all employers, thereby reducing the individual cost to any one driver or employer.
The authors want to extend this no-fault system to all vaccine claims. Presumably, any illness occurring at any time after any vaccination would subject the vaccine manufacturer to liability under the authors’ proposed no-fault scheme. The very reason the vaccine manufacturers themselves pushed for a statutory solution to the traditional tort system for adjudicating claims was that, in exchange for considerable concessions, an element of predictability would be introduced to the number of potential claims and the amount of liability. A no-fault system would reintroduce a huge element of unpredictability — chaos wouldn’t be too strong a term — into the vaccine injury compensation system, as there would be no way to predict the number of claims or the extent of injuries for which manufacturers could be held responsible. We would be back to where we started when the Vaccine Act was adopted in 1986, with only a handful of manufacturers producing vaccines, and those threatening to cease production.
Discussion ≠ Recommendation
As we’ve seen, the authors go to great lengths to accommodate CAM by creating a lot of extra work for the physician. At the same time, they avoid even suggesting any reasonable limitations on CAM practices and products or, for the most part, suggesting that CAM providers and sellers of CAM products themselves do anything to avoid the injuries they cause. We have also seen that they arrive at this solution, not by thoroughly discussing and then rejecting any limitations on CAM, but simply by avoiding discussion of such possibilities altogether.
But let’s give the authors one last chance: do they deserve credit at least for coming up with solutions that are compelled by their analysis of legal and ethical principles, even if their solutions avoid directly addressing the deficiencies of CAM? In other words, do they at least get some credit for effectively arguing for their conclusions? Again, no.
This is not to say that they don’t do a serviceable job of covering the basics in some of the articles. They do. There are decent discussions of the basic law of negligence, court intervention when parents refuse effective treatments for their sick children, malpractice, informed consent, hospital credentialing, the decisional capacity of children, and other subjects of interest to the practicing physician. The problem is, however, that their explication of these basics does not, in my view, compel the results they suggest.
For example, in discussing Chris, the teen who wants to forgo surgery for ulcerative colitis and see a homeopath, the authors review the law on decisional capacity of patients. (S163-S164) But nothing in that discussion requires the conclusion that the physician go to the trouble of researching the efficacy of homeopathy. Yet that is what the authors have the physician doing. (Helpfully, the authors tell us that “[t]here are few data regarding the use of homeopathy for irritable bowel disease to gauge potential efficacy.”(S164.))
Likewise, there is a discussion of hospital credentialing in another article (S194-S196), which leads to this suggestion:
It would be prudent for hospitals and health facilities to consider adopting a formal protocol and/or formal processes to establish what CAM therapies and products to allow or make available on-site, which kinds of CAM practitioners can provide them, under what conditions they may be provided, and how they will function and interact with patients, other health care providers, and the institution. (S196).
And exactly why would this be “prudent?” What in their discussion of credentialing leads to the notion that allowing CAM in the hospital is “prudent?” Nothing.
In one instance, the authors try to manipulate the law into compelling the physician to advise patients about an acupuncture treatment for chemotherapy induced nausea and vomiting (CINV) as part of the informed consent process. (S189-S191) In a review of the law of informed consent, they find no precedent for requiring such a disclosure, yet somehow come to the conclusion that evidence for acupuncture for CINV is “likely sufficient to make its disclosure material to patients’/parents’ decision.” (S191) This conclusion is based on the authors’ overconfident view of the evidence, a deficiency discussed by and Drs. and Crislip.
Like their evaluation of the evidence, their discussion of the law of informed consent is superficial at best and fails to take into account its complexity or its variations among jurisdictions.2 In fact, the only cases and treatises cited by the authors for their sweeping generalization are Canadian, which would have no applicability in the U.S. In my opinion, it is irresponsible to suggest to the physician-reader that he may be subject to a malpractice action for not discussing acupuncture as an alternative to drug treatments for CINV based on such a facile discussion of the medical evidence and legal precedent.
This Pediatrics supplement presents CAM for the most part as ineffective and sometimes dangerous. But instead of arguing for reasonable limitations on, or elimination of, CAM products and services, the main message is that physicians must accommodate CAM in their practices, even to the point of referring patients to CAM practitioners. This is the wrong solution to CAM.
This is the same sort of attitude CAM proponents tried to incorporate into the College of Physicians and Surgeons of Ontario’s (CPSO) draft policy on “non-allopathic” medicine, the subject of Dr. Novella’s post yesterday and an earlier post by Dr. Gorski. Fortunately, as noted in those posts, physicians pushed back against the recommendations. This resulted in changes to the more blatantly CAM-friendly proposals.
Dr. Novella recommended that “physicians, individually and as a profession, should actively advocate for and promote the science-based standard in medicine — in academia, regulation, and practice.” In publishing this supplement, Pediatrics has certainly failed physicians and the profession in this regard.
- See, Robert L. Rabin, The Association of American Law Schools 2011 Annual Meeting: Section on Torts and Compensation Schemes Symposium: The Vaccine No-Fault Act: An Overview, 8 Ind. Health L. R. 267 (2011), for an explanation of the current vaccine compensation system and a discussion of its origin. Return to text
- See, Jaime Staples King and Benjamin W. Moulton, Rethinking Informed Consent: The Case for Shared Medical Decision-Making, 32 Am. J. L. and Med. 429 (2006), for a review of the law of informed consent in various jurisdictions. Return to text