Informed Consent: If You Come to a Fork in the Road, Take It

Renault: "And what in Heaven's name brought you to Casablanca?"

Rick: "My health. I came to Casablanca for the waters."

Renault: "Waters? What waters? We're in the desert."

Rick: "I was misinformed."

This excerpt from the immortal film classic "Casablanca"¹ is arguably one of the best examples of the corruption of the principle of "informed consent." So goes the argument in health care delivery systems, in which much recent discourse about the lack of informed consent has been vehemently vented upon chiropractors and manipulation of the cervical spine.²

It goes without argument that patients need to be given full disclosure about the risks and benefits of any health care treatment, whether in clinical practice or in clinical trials, which is what the Nuremberg Code³ and Declaration of Helsinki^3,4 are all about, anyway. It should also be readily apparent that the most accurate estimates that can be made from prospective studies on the risks of arterial dissections, following manipulation of the cervical spine, of 0.175 to 2.56 per million, pale when juxtaposed to the reported risks of death from (a) GI bleeding due to the use of NSAIDs (400 times greater),⁷ or (b) spinal surgery (700 times greater).⁸ The burning question here is: Are patients in treatment routinely apprised of these greater risks by their physicians, allopathic or otherwise? And is much being said to alert the patient to the fact that spontaneous arterial dissections appear to be occurring at rates equal to or as much as 10 times higher than those attributed to chiropractic manipulations?^9-11 To use a popular expression: I don't think so.

What information has the public been inundated with lately? Beginning with the interminable Lana Lewis inquest in Toronto, we have had more than our deserved fill of seriously flawed clinical information about manipulation of the cervical spine, without anything resembling full disclosure of its benefits.^2,12-17 Fortunately, I have recently been able to provide substantially more balanced perspectives on this particular issue.^18,19 However, the problem remains one of public awareness of valid scientific information. Just as a self-test, for example, how many of the following important clinical observations found in research do you believe have found their way into the media and public awareness?

Headache: According to a systematic review of the literature from Duke University, nonpharmacological treatments "may be the first choice for most patients ... pharmacological treatments are not suitable for all patients, nor are they universally effective. Drug treatments may also produce undesired side-effects."²⁰

Carpal Tunnel Syndrome: In patients with carpal tunnel syndrome, self-reported physical and mental distress decreased significantly in both medicated and manipulated groups, with adverse medical effects noted in 20 percent of the medical cohort.²¹

Infantile Colic: Infants 2-10 weeks old showed vastly superior responses to manipulation compared to medication (dimethicone) over a two-week course of treatment, with symptoms worsening in 25 percent of the medicated group.²²

Back Pain: Patients with chronic back pain undergoing spinal manipulation display uniformly superior responses in pain, global and functional responses compared to patient groups given acupuncture or medication (COX-2 inhibitors).²³

If you guessed more than one, you, like Rick in Casablanca, are "misinformed."

Now, consider the medical side of the ledger, and look at how some practices have done complete about-faces - and sometimes more than once:

Leeches: Considered versatile in the 19th century, they became regarded as slimy bloodsuckers and now are being explored for treating arthritis.^24,25

Electroshock: Once common, it fell out of favor in the 1970s and is now re-emerging.²⁴

Prempro: Once common, it is now considered a possible risk.²⁴

Botox: Once taboo, it is now a fad for plastic reconstruction.²⁴

Thus, we can see how therapeutic practices outside of the chiropractic arena can appear to be capricious, rather than immutable. Under these circumstances, the public has every right to challenge prevailing beliefs - if given the proper research information. But under the current regime, that is clearly not the case. Returning to our topic of informed consent, there is a far more noteworthy issue that has to be raised, concerning the public's entitlement to all treatment alternatives. In a previous article,²⁶ I addressed the groundbreaking legal decision handed down by Justice Pollock in New Jersey that clearly indicated patients needed to be informed of all treatment alternatives, including no treatment:

"Like the deviation from the standard of care, the doctor's failure to obtain informed consent is a form of medical negligence (emphasis mine). Recognition of a separate duty emphasizes the doctor's obligation to inform, as well as treat, the patient. ... The choice is not for the physician, but the patient in consultation with the physician. By not telling the patient of all medically reasonable alternatives, the physician breaches the patient's right to make an informed choice."²⁷

So, in terms of informed consent, the argument that some chiropractors are alone in their dereliction of providing patients with proper information regarding the risks and benefits of treatment is completely without merit when we consider the larger picture of health care delivery - which is cropped indeed! It is clear that in health care delivery systems, the American public is insufficiently informed. The current state of affairs cannot be more eloquently expressed than by the following passage:

"Medicine is a peculiar combination of science and fashion, half penicillin, half shoulder pads. It takes what is known at the moment, combines the knowledge with what the public wants, and comes up with a product."²⁴

Put simply, a falling tide beaches all boats. Put another way, until the public is better informed, it will have to endure an oft-quoted axiom by my personal hero, Yogi Berra: "If you come to a fork in the road, take it."²⁹

References

1. Warner Brothers, 1943.
2. Chiropractic technique may pose stroke risk: Neurologists warn patients about neck rotation. WHDH-TV telecast, Nov. 25, 2003.
3. Annas GJ, Grodin MA. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York, NY: Oxford University Press, 1992.
4. Vastag B. Helsinki discord? A controversial declaration. Journal of the American Medical Association 2000;284 (23):2985-2985.
5. Dvorak J, Orelli F. How dangerous is manipulation of the cervical spine? Manual Med 1985;2:1-4.
6. Haldeman S, Carey P, Townsend M, Papadopoulos C. Arterial dissections following cervical manipulation: The chiropractic experience. Canadian Medical Association Journal 2001;165(7):905-906.
7. Gabriel SE, Jaakimainen L, Bombardier C. Risk of serious gastrointestinal complications related to use of nonsteroidal anti-inflammatory drugs: A meta-analysis. Annals of Internal Medicine 1991; 115(10):787-796.
8. Bigos S, Bowyer O, Braen G, et al. Acute Low Back Pain in Adults: Clinical Practice Guideline No. 14. AHCPR Publication No. 95-0642. Rockville, 1994, Agency for Health Care Policy and Research, Public Health Services, U.S. Department of Health and Human Services.
9. Shievink WT, Mokri, B, O'Fallon WM. Recurrent spontaneous cervical-artery dissection. New England Journal of Medicine 1994;330:393-397.
10. Shievink WT, Mokri B, Whisnant JP. Internal carotid artery dissection in a community: Rochester, Minnesota, 1987-1992. Stroke 1993;24:1678-1680.
11. Giroud M, Fayolle H, Andre N, Dumas R, Becker F, Martin D, Baudoin N, Krause D. Incidence of internal carotid artery dissection in the community of Dijon (letter). Journal of Neurology and Neurosurgical Psychiatry 1994;57:1443.
12. Brody J. When simple actions ravage arteries. New York Times, April 30, 2001.
13. Bill Carroll Show. CFRB-AM 1010 radio, Feb. 6, 2002, posted on the Internet.
14. Evenson B. National Post, Feb. 7, 2002.
15. Hamburg J. Medical Minute, WOR-AM 710 radio, Feb. 22, 2002.
16. Jaroff L. Back off, chiropractors! TIME.com, Feb. 27, 2002.
17. A different way to heal. Episode of "Scientific American Frontiers" Public Broadcasting System telecast, June 4, 2002.
18. Rosner A. Spontaneous cervical artery dissections: another perspective. Journal of Manipulative and Physiological Therapeutics 2004; In press.
19. Rosner A. CVA risks in perspective. Manuelle Medizin 2003;41:215-223.
20. MCCrory DC, Penzien DB, Hasselblad V, Gray RN. Evidence report: behavioral and physical treatments for tension-type and cervicogenic headache. Des Moines, IA: Foundation for Chiropractic Education and Research, Product No. 2085, 2001.
21. Davis PT, Hulbert JR, Kassak KM, Meyer JJ. Comparative efficacy of conservative medical and chiropractic treatments for carpal tunnel syndrome: a randomized clinical trial. Journal of Manipulative and Physiological Therapeutics 1998;21(5) :317-326.
22. Wiberg JMM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. Journal of Manipulative and Physiological Therapeutics 1999;22(8):517-522.
23. Giles LGF, Muller R. Chronic spinal pain: A randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine 2003;28(14): 1490-1503.
24. Patchett A. Estrogen, after a fashion. New York Times Magazine, July 28, 2002, pp. 11-12.
25. Michalsen A, Moebus S, Spahn G, Esch T. Longhorst J, Dobos GJ. Leech therapy for symptomatic treatment of knee osteoarthritis: results and implications of a pilot study. Alternative Therapies in Health and Medicine 2002;8(5):84-88.
26. FCER Forum: Matties v. Mastromonaco, D.O.: The right to be informed, or research findings come home to roost. Dynamic Chiropractic, March 25, 2000;18(13).
27. J. Pollock, writing for unanimous court, Jean Matthies v. Edward D. Mastromonaco, DO, decided July 8, 1999.
28. Berra Y. The Yogi Book: "I Really Didn't Say Everything I Said!" New York, NY. Workman Publishing Company Inc., 1998.