Oh no! Not again! The venerable medical journal Pediatrics devotes an entire supplement this month to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical, and Clinical Issues in Decision-Making.
We sense from the very first sentence that we are in familiar territory:
Rapid increases the use of complementary and alternative medicine (CAM) raise important legal, ethical, clinical, and policy issues. (S150)
“Rapid increases”? And evidence of these “rapid increases?” None cited.
We do, however, see the same shopworn reference to popularity deconstructed elsewhere on SBM. What we learned by actually examining “the large 2007 US survey” which purportedly “revealed that ~4 in 10 adults and 1 in 9 children and youth used CAM products or therapies within the previous year”(S150) is that
…most hard-core CAM modalities are used by a very small percentage of the population. Most are less than five percent. Only massage and manipulation are greater than 10 percent. These numbers are also not significantly different from 10 or 20 years ago — belying the claim that CAM use is increasing.
We also find this definition of “CAM”:
a broad domain of healing resources …other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. (S150)
I’m not sure what it takes to become “intrinsic” to the “politically dominant” healthcare system. If it includes being legal, licensed or covered by public and/or private insurance, that would appear to disqualify dietary supplements, chiropractic, acupuncture, homeopathy, homeopathic products and naturopathy as “CAM” in some, or in some cases all, of the American states.
There are four main authors, one of whom will be familiar to SBM readers: Michael H. Cohen, J.D., a character in Dr. Kimball Atwood’s revelatory opus on the “CAM” shenanigans at Harvard Medical School. Cohen’s pro-CAM proclivities have been nicely set out in our friend Orac’s recent post over at Respectful Insolence: “Misinformed Consent rears its ugly head in Pediatrics,” which takes on one of the Supplement’s articles: Informed Consent: Advising Patients and Parents About Complementary and Alternative Medicine Therapies. (S187-S192)
Another author is Sunita Vohra, M.D., M.Sc., a Canadian physician affiliated with the “Complementary and Alternative Research Education (CARE) Program,” at Stollery Children’s Hospital in Edmonton, Alberta, Canada.
The authors acknowledge the contributions of the Canadian College of Naturopathic Medicine (S153) and an “anonymous pediatric chiropractic reviewer” (S204).
Cohen and Dr. Vohra have ploughed this ground before: in 2007, as co-authors of “Ethics of complementary and alternative medicine Use in children,” in Pediatric Clinics of North America. Dr. Vohra also co-authored “The use of complementary and alternative medicine in pediatrics,” as part of the Task Force on Complementary and Alternative Medicine, Provisional Section on Complementary, Holistic and Integrative Medicine, also in Pediatrics.
If you have read those articles, there is nothing new here, except an expansion of post-hoc rationalization for the use of “CAM.” As with CAM efficacy/effectiveness research, CAM legal and ethical research builds on the unshakable premise that CAM — whatever CAM is — must be included in the health care armamentarium, and then scrambles to tell us why the evidence — in this case law and ethics in addition to scientific research — mandates this conclusion, a topic to which I will return in a subsequent post.
DANGER: “CAM” in use
In the first of ten articles comprising the supplement, the authors state they
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)
As a springboard for this examination, they construct various scenarios in which a pediatrician or other physician must deal with the unfortunate presence of CAM in his patient’s case.
(In light of Dr. David Gorski’s Monday post, Defining what a ‘physician’ is, please be advised that that when I say “physician” I mean an M.D., or, in the U.S., a D.O., a definition which will remain consistent throughout my posts until further notice.)
What immediately strikes the reader of this series is the number of times the authors mention the lack of research supporting the use of CAM for pediatric patients. The articles are filled with statements such as:
- Meeting [the need for ‘sound information’ about CAM practices] is made more difficult by the relative scarcity of pediatric research in the area. (S150)
- This determination [of who should make treatment decisions] may be more challenging when considering CAM, because evidence may be lacking or less adequate than desired. (S152)
- Relatively limited research on the efficacy and safety of CAM, especially in children, means that decisions must frequently be made in conditions of uncertainty. (S152)
- [A suggested framework for advising patients about CAM] may be helpful when there is adequate reliable evidence but it is less helpful when evidence is lacking or limited, as is often the case with CAM. (153)
- Information about the safety and efficacy of CAM therapies is increasing all the time, but there are still large gaps in knowledge. (S153)
- [T]he lack of evidence about many CAM therapies and products can make assessing CAM options particularly difficult. (S153)
And that’s just the first four pages of text! (S150-S153)
Another curiosity is that the CAM used in hypotheticals designed to illustrate the authors’ points is described almost uniformly as ineffective and dangerous. Not curious in the sense that this would be unusual or surprising, but curious considering the authors’ recommendations, which we’ll get to later.
- Jenny, an HIV-positive teen, takes (unbeknownst to her treating specialists) St. John’s wort for self-diagnosed depression. This results in the possibility that “a drug-herb interaction has led to her unstable indinavir levels and decreased CD4+ T-cell counts.” (S156-160)
- Chris, who is 14 years old, is diagnosed with ulcerative colitis. His doctor recommends surgery and his parents agree that this is the best option, and all risks and benefits having been explained to both Chris and the parents. Chris, however, says he has “researched his condition and knows that other therapies, including homeopathic treatment, are available.” He is opposed to surgery and wants to consult a homeopath. (S161-S166)
- Three-year-old Angela was diagnosed at 15 months with glycogen storage disease type IV and her gastroenterologist recommends a liver transplant. After initially agreeing to put Angela on a transplant waiting list, her parents want her taken off because “they have spoken with a Chinese medicine (TCM) practitioner, who recommended specific dietary treatment, mind-body imagery, and acupuncture.” (S176-S180)
- The mother of Phoenix, age 24 months, doesn’t want him to get the MMR vaccination because “her chiropractor has discussed the issue of vaccination with her,” including the topic of vaccination safety. He discussed immune function as well and noted that treatments such as spinal manipulation and nutritional supplements, “although not an alternative to vaccination, may optimize her son’s natural immune function.” (S168-S172)
- Lindy is a teen suffering from chronic recurrent headaches. After trying other treatments, her physician refers her to an acupuncturist. The acupuncturist uses unsterilized needles and she contracts acute hepatitis B. (S182-S186)
- Michael, a 14-year-old, has “new-onset back pain with no known precipitating cause.” He goes to his mother’s chiropractor who concludes Michael has a “misaligned spine” and performs spinal manipulation on Michael twice a week for 6 weeks. Michael complains of increasing fatigue and pain, for which the chiropractor recommends nutritional supplements and relaxation techniques, having concluded that these symptoms are adverse responses to the manipulation. Michael then sees a pediatrician and is diagnosed with testicular cancer with lung and retroperineal nodal metastases. (S201-S205)
The point of these “case scenarios” is “to act as a practical anchor in the exploration of CAM policy issues and to illustrate the application of and shortcomings in existing guidance and intervention principals.” (S151) One of the purposes of these articles, the authors further explain, is to “act as a catalyst for policy development.” (S153)
A “job jar” for medicine
Their solution is to come up with a big “to do” list for pediatricians and other physicians who care for children. Here’s what the authors want you — the busy physician — and the larger medical community, including hospitals, to do:
- “Be aware of research regarding CAM use for those conditions [you treat, especially chronic health conditions] to help prevent the potential harm of adverse reactions.” (S156)
- If your patient insists on using CAM instead of “conventional” treatment, you “will need to closely monitor his condition by using conventional means.” As well, you should “attempt to ascertain whether there is evidence about its use for this condition, and assess the likely impact on his health.” (S164)
- When referring a patient to a CAM practitioner, “the physician should also learn about the proposed treatment plan to ensure that it is what was anticipated when referring and does not include practices known to be unsafe or ineffective. In addition, he should monitor the patient conventionally and treat as appropriate.” (S184)
- If the physician doesn’t want to refer a patient to a CAM provider he “should state his or her own view and reasons [and] refer the patient to another physician who may be more comfortable advising about the referral or to a regulatory authority [for the “CAM provider] or professional association [of CAM providers]. (S184)
- “There is a moral imperative [!] to develop good evidence through research into CAM therapies to facilitate informed decision-making and informed consent.” (S152)
- We must “incorporate more formal training about pediatric care into chiropractors’ education” to “reduce the risk of adverse events caused by delays in diagnosis or referral.” (S203)
- “Patient and public education campaigns” need to inform dietary supplement consumers of risks and adverse effects of supplements. (S158)
- Hospitals must institute credentialing for “CAM” providers. (S196-S198)
- And finally, because there are “divisions between …CAM practitioners and some physicians about the merits and risks of vaccination …educational programs …about vaccines and the diseases targeted should be developed.” (S168, S171). This recommendation comes in spite of the authors’ acknowledgment that “neither evidence-based teaching nor presentations from polio survivors changed chiropractic students’ perceptions of immunizations.” (S170)
It’s all your fault
And why the list? Perhaps because in the illustrative scenarios created by the authors, it isn’t the lack of sound public policy and adequate regulation which allows these CAM disasters to happen. In several of the scenarios it’s your fault, dear physician.
Who are the parents of Jenny, our HIV-positive teen, mad at about her dietary supplement — drug interaction? The government for failing to adequately regulate supplements? No. Sen. Orrin Hatch? No. Perhaps a supplement manufacturer for making overly broad claims about St. Johns wort? No. How about the manufacturer for failure to warn about drug interactions? Wrong again. They are mad at her HIV specialist because, according to the authors, although supplement — drug “interaction data are still scant, particularly from pediatric populations” the specialist who treats Jenny “should make special efforts to explore CAM use with patients during history-taking.” (S156-S158)
We next learn that this has caused the parents to lose faith in their daughter’s specialist which (the plot thickens) leaves them with “limited options” because “there may simply be no one else to provide care to Jenny.” Thus, “the onus is on her physicians to take the steps needed to begin rebuilding trust and, more broadly, to alter their practice to take the increasing prevalence of various forms of CAM use into account.” (S157) Indeed, the authors argue that “practitioners are legally obligated to inquire about the use” of supplements. (S157)
In the case of Lindy, who contracted hepatitis B from acupuncture needles, we see that it is the physician’s fault for failing “to check to determine if the practitioner is licensed by a trustworthy body, such as a professional college or regulatory body.” (S182) Well, at least, according to this vignette, Lindy’s chronic recurrent headaches “that have not been relieved by any of the medications her physician has suggested” seem to have disappeared after two weeks of acupuncture. (S182)
Then there’s little Phoenix, whose mother doesn’t want him vaccinated based on her chiropractor’s dubious advice. In the authors’ view, this simply requires “different and unique educational strategies” for chiropractors about vaccination because “one reason for this failure [of educational efforts] may be that educational programs have not addressed practitioners’ concerns, such as questions regarding safety of adjuvants and preservatives used in vaccine preparation.” (S170) An odd recommendation, seeing as how that very information is readily available to everyone else.
Jake, a six-year-old with medulloblastoma, in the case covered by Orac, suffers from chemotherapy-induced nausea and vomiting (CINV), which drugs either do not relieve or cause unpleasant side effects. His parents are also mad at their son’s oncologist because they learned on the internet about acupuncture for CINV and “are delighted to see that his nausea and vomiting are much improved after each acupuncture session.” Not only that, but “Jake begins to regain his appetite, gains weight, and generally has a better sense of well-being.” (S188)
The parents could be forgiven for attributing this positive effect to acupuncture, an effect that goes way beyond what the studies indicate would happen, even taking the most optimistic view of the authors’ evidence (S190), which Orac reviewed. We should be far less forgiving of the authors’ coming to the same conclusion when they state, in a different article following up on Jake’s progress:
We continue with the example of 6-year-old Jake’s success with acupuncture for chemotherapy-induced nausea and vomiting, described in the preceding article ….” (S194)
We’ll return to Jake’s “success with acupuncture” in the next post, when I’ll examine why the authors’ ethical, legal and medical arguments don’t support the their recommendations and offer “alternative” ideas about the locus of the solution to the CAM problem.
The authors are apparently of the view that these very serious problems with CAM — lack of evidence, incompetence of CAM practitioners and their overly-broad scope of practice, safety issues, intransigence to public health measures, ineffective treatments — are solvable if only the medical community would get off up its collective derriere and embrace CAM — monitor it, study it (post hoc), alert the public to its dangers, provide it with some additional education and training, overcome its resistance to proven public health measures, credential it, waive the usual level of evidence required to recommend therapies and forget plausibility as a basis for medicine.
They don’t ask for much, do they?