Better Health: Smart Health Commentary Better Health (TM): smart health commentary

Article Comments

Should Children Receive Medical Treatments That Have No Evidence Of Efficacy?

In November, the journal Pediatrics published an entire supplement devoted to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical and Clinical Issues in Decision-Making. 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.

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 Orac and Drs. Novella 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. 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.

Conclusion

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.

Notes

  1. 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
  2. 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

*This blog post was originally published at Science-Based Medicine*


You may also like these posts

Read comments »


Comments are closed.

Return to article »

Latest Interviews

How To Make Inpatient Medical Practice Fun Again: Try Locum Tenens Work

It s no secret that most physicians are unhappy with the way things are going in healthcare. Surveys report high levels of job dissatisfaction burn out and even suicide. In fact some believe that up to a third of the US physician work force is planning to leave the profession…

Read more »

Caring For Winter Olympians In Sochi: An Interview With Team USA’s Chief Medical Officer Dr. Gloria Beim

I am a huge fan of the winter Olympics partly because I grew up in Canada where most kids can ski and skate before they can run and partly because I used to participate in Downhill ski racing. Now that I m a rehab physician with a reconstructed knee I…

Read more »

See all interviews »

Latest Cartoon

Richmond, VA – In an effort to simplify inpatient medical billing, one area hospitalist group has determined that “altered mental status” (ICD-9 780.97) is the most efficient code for use in any patient work up.

“When you enter a hospital, you’re bound to have some kind of mental status change,” said Dr. Fishbinder, co-partner of Area Hospitalists, PLLC. “Whether it’s confusion about where your room is located in relationship to the visitor’s parking structure, frustration with being woken up every hour or two to check your vital signs, or just plain old fatigue from being sick, you are not thinking as clearly as before you were admitted. And that’s all the justification we need to order anything from drug and toxin screens, to blood cultures, brain MRIs, tagged red blood cell nuclear scans, or cardiac Holter monitoring. There really is no limit to what we can pursue with our tests.”

Common causes of mental status changes in the elderly include medicine-induced cognitive side effects, disorientation due to disruption in daily routines, age-related memory impairment, and urinary tract infections.

“The urinalysis is not a very exciting medical test,” stated Dr. Fishbinder. “It doesn’t matter that it’s cheap, fast, and most likely to provide an explanation for strange behavior in hospitalized patients. It’s really not as elegant as the testing involved in a chronic anemia or metabolic encephalopathy work up. I keep it in my back pocket in case all other tests are negative, including brain MRIs and PET scans.”

Nursing staff at Richmond Medical Hospital report that efforts to inform hospitalists about foul smelling urine have generally fallen on deaf ears. “I have tried to tell the hospitalists about cloudy or bloody urine that I see in patients who are undergoing extensive work ups for mental status changes,” reports nurse Sandy Anderson. “But they insist that ‘all urine smells bad’ and it’s really more of a red herring.”

Another nurse reports that delay in diagnosing urinary tract infections (while patients are scheduled for brain MRIs, nuclear scans, and biopsies) can lead to worsening symptoms which accelerate and expand testing. “Some of my patients are transferred to the ICU during the altered mental status work up,” states nurse Anita Misra. “The doctors seem to be very excited about the additional technology available to them in the intensive care setting. Between the central line placement, arterial blood gasses, and vast array of IV fluid and medication options, urosepsis is really an excellent entré into a whole new level of care.”

“As far as medicine-induced mental status changes are concerned,” added Dr. Fishbinder, “We’ve never seen a single case in the past 10 years. Today’s patients are incredibly resilient and can tolerate mixes of opioids, anti-depressants, anti-histamines, and benzodiazepines without any difficulty. We know this because most patients have been prescribed these cocktails and have been taking them for years.”

Patient family members have expressed gratitude for Dr. Fishbinder’s diagnostic process, and report that they are very pleased that he is doing everything in his power to “get to the bottom” of why their loved one isn’t as sharp as they used to be.

“I thought my mom was acting strange ever since she started taking stronger pain medicine for her arthritis,” says Nelly Hurtong, the daughter of one of Dr. Fishbinder’s inpatients. “But now I see that there are deeper reasons for her ‘altered mental status’ thanks to the brain MRI that showed some mild generalized atrophy.”

Hospital administrators praise Dr. Fishbinder as one of their top physicians. “He will do whatever it takes to figure out the true cause of patients’ cognitive impairments.” Says CEO, Daniel Griffiths. “And not only is that good medicine, it is great for our Press Ganey scores and our bottom line.”

As for the nursing staff, Griffiths offered a less glowing review. “It’s unfortunate that our nurses seem preoccupied with urine testing and medication reconciliation. I think it might be time for us to mandate further training to help them appreciate more of the medical nuances inherent in quality patient care.”

Dr. Fishbinder is in the process of creating a half-day seminar on ‘altered mental status in the inpatient setting,’ offering CME credits to physicians who enroll. Richmond Medical Hospital intends to sponsor Dr. Fishbinder’s course, and franchise it to other hospitals in the state, and ultimately nationally.

***

Click here for a musical take on over-testing.

See all cartoons »

Latest Book Reviews

The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

Read more »

Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

Read more »

Unaccountable: A Book About The Underbelly Of Hospital Care

I met Dr. Marty Makary over lunch at Founding Farmers restaurant in DC about three years ago. We had an animated conversation about hospital safety the potential contribution of checklists to reducing medical errors and his upcoming book about the need for more transparency in the healthcare system. Marty was…

Read more »

See all book reviews »