How Current Informed Consent Protocols Flunk the Sham Surgery Test: A New Frontier in Medicine and...

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How Current Informed Consent ProtocolsFlunk the Sham Surgery Test: A NewFrontier in Medicine and Ethics

Elana A. Bertram*

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131Part I – Understanding Experiments . . . . . . . . . . . . . . . . . . . . . . . . . . 136 R

A. How Placebo-Controlled Experiments Came to Be . . . . 136 R

B. The Influence of Evidence-Based Medicine . . . . . . . . . . 142 R

Part II – Understanding Sham Surgery . . . . . . . . . . . . . . . . . . . . . . . . 144 R

A. How a sham surgery is different from a sugar pill . . . 136 R

B. How sham surgeries are used in clinical trials . . . . . . 142 R

Part III – Understanding Informed Consent . . . . . . . . . . . . . . . . . . . 151 R

A. The History of Informed Consent . . . . . . . . . . . . . . . . . . 136 R

B. Perspectives on the Scope of Informed Consent . . . . . . . 142 R

C. Limitations on the Protection of Informed Consent . . 161 R

D. The Problems with Informed Consent . . . . . . . . . . . . . . . 162 R

Part IV – Argument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 R

A. Sham surgeries are different from placebo controlsbecause of the increased risks . . . . . . . . . . . . . . . . . . . . . . 136 R

B. In light of these increased risks, sham surgerycomplicates disclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 R

C. Informed consent protocols as currently used fail toprotect sham surgery patients . . . . . . . . . . . . . . . . . . . . . . 161 R

D. Improving patient protection requires strengtheninginformed consent protocols . . . . . . . . . . . . . . . . . . . . . . . . . 162 R

* Candidate for Juris Doctor, Quinnipiac University School of Law May, 2011,with a concentration in Intellectual Property Law. She earned her B.S. in biologicalsciences from Mount Holyoke College in 2004. She is Editor-in-Chief of the QuinnipiacHealth Law Journal. Ms. Bertram would like to extend thanks to her faculty advisor,Prof. Neal R. Feigenson, J.D.

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132 QUINNIPIAC HEALTH LAW [Vol. 14:131

Introduction

If someone offered you cash and lifetime medical care inexchange for cutting into your knee to test a new knee-paintreatment, you would probably ask him questions, evaluate therisks, and either refuse to participate or accept the money andthe risks. This is a classic example of informed consent. If youor your physician documented that consent, the surgeon wouldhave an affirmative defense if you sued him for medical malprac-tice. Without your informed consent, the physician contactedyour body without permission, making him prima facie liable formedical malpractice. But a blinded clinical trial to test the effi-cacy of a surgical procedure does not work this way. In a blindedtrial, some patients receive the experimental therapy, that is, the“real” surgery. Other patients undergo a “sham” surgery, whichis a procedure that closely mimics the therapeutic interventionbut lacks the experimental element. A procedure is consideredto be a “sham surgery” when, in an experimental clinical trial,1

1) the patient is led to believe that he is having a surgical proce-dure, 2) the patient is anaesthetized as if he were undergoingsurgery, 3) the expected body part is incised and stitched to ap-pear as if the surgery took place, but no actual procedure wasperformed, and 4) the patient receives the same follow-up care,such as painkillers, anti-inflammatory drugs, and physical ther-apy as if he had undergone the surgical procedure.2 The patientunderstands3 that he is participating in a clinical trial of a newkind of knee surgery, and his physician has probably explainedthe common risks and typical side effects. Additionally, to con-

1 The scope of this note is limited to activities that can clearly be defined asclinical trials. Clinical trials are typically run at large teaching hospitals or specialtymedical centers and follow the standard protocols of Institutional Review Board (IRB)approval. See 45 C.F.R. § 46.109 (2005). One-on-one “experiments” where a physiciantries an untested therapy on a specific patient are not discussed in this note.

2 Sharona Hoffman, The Use of Placebos in Clinical Trials: Responsible Research or Un-ethical Practice?, 33 CONN. L. REV. 449, 453-54 (2001). See generally Nancy M. P. King, TheLine Between Clinical Innovation and Human Experimentation, 32 SETON HALL L. REV. 573(2002).

3 While empirical measures of patient understanding are explored, infra Part III,this note presumes that the average physician conducts himself in a way that he believesis in compliance with the informed consent doctrine. That the informed consent doc-trine falls short of protecting patients in specific circumstances is not meant to impli-cate the physicians executing it.


2010] INFORMED CONSENT FLUNKS 133

form to standard protocol,4 the physician must explicitly say thatthe treatment is experimental.5 Contemporary research into in-formed consent decision-making indicates that the patient ex-pects to receive the purportedly-beneficial experimentaltreatment and weighs his decision to participate accordingly. Inspite of the physician’s disclosures, the patient subconsciouslycounts on a greater benefit. The physician conducting the studycannot reveal that a patient is in the sham surgery cohort:6 ei-ther the trial protocol would be breached by unblinding the ran-domized cohort or patients would be scared away because therisks would outweigh any benefit to them.7

Sham surgeries occupy a grey area in medical science. Theyare not quite placebo8 and not quite therapy, blending the ad-vantages and disadvantages of both. In sham surgeries, the pa-tient is exposed to a high risk with no expected benefit. Further,contemporary informed consent disclosures9 do not protect thepatient from his own false expectations of receiving the thera-peutic treatment.

Furthermore, sham surgeries are contrary to American reg-ulations10 governing human experimentation for two distinctreasons: the patient cannot give adequately-informed consent toa sham surgery, and the risks they impose on the patient out-weigh the benefit to that patient. The act of concealing from apatient whether he is receiving an experimental surgical treat-

4 See Angela R. Holder, Physician’s Failure to Obtain Informed Consent to InnovativePractice or Medical Research, 15 AM. JUR. PROOF OF FACTS 2D 711, § 3 (1978).

5 See Id. § 8.6 A cohort is “a group of individuals entered into a prospective study or clinical

trial. The term always carries the connotation that individuals are observed over a pe-riod of time.” DORLAND’S ILLUSTRATED MEDICAL DICTIONARY 350 (2003).

7 See infra Part III for a full explanation of informed consent protocols. Briefly,the physician must describe the procedure and its expected risks, any alternative ther-apy, and allow the patient to refuse treatment at any time if the patient chooses. Noreasonable patient would take part in a study where the risks grossly outweighed thebenefits. Similarly, no reasonable physician will allow a patient to participate in aclinical trial without some belief that the patient understands and appreciates the riskshe is undertaking.

8 A placebo is “a dummy treatment administered to the control group in a con-trolled trial in order that the specific and nonspecific effects of the experimental treat-ment can be distinguished.” DORLAND’S ILLUSTRATED MEDICAL DICTIONARY 1298 (2003).

9 Code of Medical Ethics: Opinion 2.07 – Clinical Investigation, AMA: AMERICAN

MEDICAL ASSOCIATION, http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion207.shtml (last visited Jan. 20, 2011).

10 Basic Health & Human Services Department Policy for Protection of HumanResearch Subjects, 45 C.F.R. §§ 46.101–.124 (2010).



ment or a sham surgery is distinct from the act of concealingwhether he is receiving an active medication or a pharmaceuticalplacebo. In a pharmaceutical trial with two cohorts, the patientsin both cohorts participate in essentially the same activities, suchas ingesting a pill each day and reporting for regular check-upsand tests. In a sham surgery, patients undergo only one of twodifferent surgeries: one that might help and one that probablywill not. The published sham surgery-controlled trials suggestthat the patients largely believe they have consented to the “real”surgery and not the sham.11 This highlights the failure of theexisting informed consent protocols to protect those patientsgiven the higher risk of experimental surgeries compared tonon-invasive experiments.

Sham surgeries are also contrary to the principles of the Nu-remberg Code12 and modern medical ethics because they

11 See, e.g., infra notes 208-209. R12 An excerpt from the Nuremberg Code (directives for human experimentation):

1) The voluntary consent of the human subject is absolutely essential. Thismeans that the person involved should have legal capacity to give consent;should be so situated as to be able to exercise free power of choice, withoutthe intervention of any element of force, fraud, deceit, duress, over-reach-ing, or other ulterior form of constraint or coercion; and should have suffi-cient knowledge and comprehension of the elements of the subject matterinvolved as to enable him to make an understanding and enlightened deci-sion. This latter element requires that before the acceptance of an affirma-tive decision by the experimental subject there should be made known tohim the nature, duration, and purpose of the experiment; the method andmeans by which it is to be conducted; all inconveniences and hazards rea-sonable to be expected; and the effects upon his health or person whichmay possibly come from his participation in the experiment.The duty and responsibility for ascertaining the quality of the consent restsupon each individual who initiates, directs or engages in theexperiment. . . .2) The experiment should be such as to yield fruitful results for the good ofsociety, unprocurable by other methods or means of study, and not randomand unnecessary in nature.3) The experiment should be so designed and based on the results ofanimal experimentation and a knowledge of the natural history of the dis-ease . . . that the anticipated results will justify the performance of theexperiment.4) The experiment should be so conducted as to avoid all unnecessary phys-ical and mental suffering and injury.5) No experiment should be conducted where there is an a priori reason tobelieve that death or disabling injury will occur; except, perhaps, in thoseexperiments where the experimental physicians also serve as subjects.6) The degree of risk to be taken should never exceed that determined bythe humanitarian importance of the problem to be solved by theexperiment.7) Proper preparations should be made and adequate facilities provided to



subordinate the patient’s best interest to benefit the public.Sham surgeries expose patients to risks that can be consideredunnecessary because the physician expects that the sham surgerywill not produce a therapeutic benefit. The appropriate mea-sure of whether a particular patient’s participation in a clinicaltrial is “ethical” is a balancing test weighing the risk of harm tothat patient against the potential benefit to that patient.13 On oneside of the balancing test is a high risk of harm, such as infec-tions and neurological damage;14 on the other side of the bal-ancing test is a “zero expected benefit.” In a sham surgery, thereis no expected benefit by design, therefore it is “unethical” ac-cording to current medico-legal precedent.

This note will explore the shortfalls of the existing informedconsent protocols and analyze how patient autonomy can be vio-lated by sham surgery-controlled trials. Part I lays out a concisehistory of clinical experimentation and how placebos are em-ployed. Part II explains how sham surgery-controlled trials aredifferent from placebo-controlled trials. Part III, focuses on theinformed consent doctrine and how it applies to experimentalmedicine. Concluding in Part IV, the note demonstrates thatcurrent informed consent procedures are not adequate for sham

protect the experimental subject against even remote possibilities of injury,disability, or death.8) The experiment should be conducted only by scientifically qualified per-sons. The highest degree of skill and care should be required through allstages of the experiment of those who conduct or engage in theexperiment.9) During the course of the experiment the human subject should be atliberty to bring the experiment to an end if he has reached the physical ormental state where continuation of the experiment seems to him to beimpossible.10) During the course of the experiment the scientist in charge must beprepared to terminate the experiment at any stage, if he has probable causeto believe, in the exercise of the good faith, superior skill and careful judg-ment required of him that a continuation of the experiment is likely to re-sult in injury, disability, or death to the experimental subject.

Nuremburg Code, NATIONAL INSTITUTES OF HEALTH: OFFICE OF HUMAN SUBJECTS RE-

SEARCH, http://ohsr.od.nih.gov/guidelines/nuremberg.html (last visited Aug. 31,2010).

13 Office for Human Research Protections, U.S. Dept. of Health & Human Ser-vices, Institutional Review Board Guidebook: Chapter III Basic IRB Review, OHRP ARCHIVE,http://www.hhs.gov/ohrp/archive/irb/irb_chapter3.htm (last updated 1993).

14 Risks in the days after any surgery include blood clots, infection, failure of thesurgical site to heal, and complications from general anesthesia, which can includebrain damage and death. Surgery, MERCK MANUAL HOME EDITION, http://www.merck.com/mmhe/sec25/ch301/ch301a.html (last visited Aug. 31, 2010).



surgery-controlled experiments, and suggests that investigatinginstitutions should strengthen informed consent protocols.

Ultimately, sham surgery control groups should not be per-mitted in experimental trials until institutional informed con-sent protocols are strengthened because the risks to the humanparticipants are too great given the demonstrable misapprehen-sions of clinical trial participants.15 Informed consent protocolsfirst gained worldwide attention as a result of the abuses in Nazimedical laboratories before and during World War II, whereconsent was, to put it lightly, not required.16 As a result, the Nu-remberg Code was passed, requiring physicians to obtain a pa-tient’s informed consent prior to engaging in any invasivemedical experimentation and to refrain from engaging in thatexperimentation if the risks to that patient outweighed potentialbenefits to that patient.17 In order to protect patients from be-ing taken advantage of, the power to refuse to undergo a proce-dure must rest with them. A reasonable patient would onlyrefuse free treatment if he understood the risks of that treat-ment, which is part of the informed consent procedure. Shamsurgery consent protocol as currently used does not help the pa-tient make an informed decision about whether the “benefit” ofa zero-benefit invasive experimental treatment outweighs therisks. Informed consent protocols must help patients under-stand the risks of sham surgeries better than they do today tofulfill the obligations set out by the Nuremberg Code.

Part I – Understanding Experiments

A. How Placebo-Controlled Experiments Came to Be

We are accustomed to presuming medicines are proven ef-fective before they are administered to humans. The practice ofcomparative study of treatments has been in existence sincebefore the time of Hippocrates.18 The first instance of a compar-

15 See infra Part III.16 Baruch C. Cohen, The Ethics of Using Medical Data from Nazi Experiments, 19 J.

HALACHA & CONTEMP. SOC’Y 301 (1990), available at http://www.jlaw.com/Articles/NaziMedEx.html.

17 Nuremburg Code, supra note 12. R18 See ROBERT E. ADLER, MEDICAL FIRSTS: FROM HIPPOCRATES TO THE HUMAN GEN-

OME (2004). See generally FIELDING H. GARRISON, AN INTRODUCTION TO THE HISTORY OF

MEDICINE (4th ed. reprt. 1963).



ative trial may be found in the Bible. Around 600 BC, a pharaohis described to have experimented with two groups of slaves todetermine which of two diets produced healthier servants.19

One group of slaves was provided a “royal” diet including meatand wine, whereas the slaves in the second group were providedonly vegetables and water.20

The late 1800s saw an advancement in these comparativestudies with the development of placebos, commonly called“sugar pills,” for use in comparative trials for new pharmaceuti-cal treatments.21 Physicians would make comparative observa-tions between patients and treatments, taking note of thebenefits and side effects22 experienced by both patients takingthe non-therapeutic placebo and the presumed-therapeutic ex-perimental treatment. If the experimental treatment producedbetter results than the sugar pill, the experimental treatment wasdeemed effective. Randomization is the means of assigning ei-ther a treatment or placebo without the patient knowing whichtreatment he was receiving to control for the placebo effect.This process developed around 1900.23 Randomization allowedphysicians to determine whether the experimental treatment washelping because the placebo effect was blunted.24 If all the pa-tients believe they are getting the experimental treatment, it iseasier to measure the effects of that treatment. If all the patientsimprove equally, it is presumed that the experimental treatmentis no more effective than the placebo.25 Conversely, if only thosepatients randomly receiving the experimental treatment im-prove, that treatment is deemed effective.26 With computer

19 A History of Clinical Research, CLINICALRESEARCH.COM, http://www.clinicalresearch.com/Research/Pages/HistoryofClinicalResearch.aspx (last visited Aug. 31,2010).

20 Daniel 1:11-16. After 10 days, the slaves eating vegetables appeared healthier.Id.

21 Clinical Trials/Drug Trials – The Past and The Future, MEDINDIA, http://www.medindia.net/patients/patientinfo/clinical_trials.htm (last visited Aug. 31, 2010).

22 In medical literature, “side effects” is synonymous with the contemporary “ad-verse drug reaction” and describes those negative symptoms experienced as a result oftaking a medical intervention. They are typically negative and can be deadly. JonathanR. Nebeker, et al., Clarifying Adverse Drug Events: A Clinician’s Guide to Terminology, Docu-mentation, and Reporting, 140 ANNALS INTERNAL MED. 795, 795, 798 (2004).

23 Clinical Trials/Drug Trials, supra note 21. R24 Hoffman, supra note 2, at 453-54. R25 Id.26 Id.



modeling and statistics, this process now captures precise dataon experimental treatments.27

The placebo, from the Latin “I shall please,” acquired a badreputation colloquially as an ineffective treatment.28 However,administering a placebo is not equivalent to administering noth-ing at all. It is intended to simulate the entire treatment processlacking only the experimental element.29 The goal is to establishthrough statistical analysis of the results that the experimentaltreatment is likely to affect most patients.30 Placebo controls areimportant to clinical trials because patients on placebo treat-ments often improve.31 This is usually attributed to the “expec-tation benefit” associated with a confident physician’s care,regular attention and sympathy, and the belief on the part of thepatient that he will improve.32 This is known as the “placeboeffect” and it must be taken into account in a statistical analysisof the efficacy of an experimental treatment.33 The placebo ef-fect is real: between 35% to 75% of patients in the placebo co-horts of clinical trials report some improvement.34 As such, it’sunfair to say that patients in the placebo cohort of a trial get“nothing,” because there is a chance that their symptoms will bealleviated by the placebo effect. Patients receive care and atten-tion above and beyond what they would have if they were not ina clinical trial, but they also absorb some of the risks inherent inparticipating in a trial, such as the risk of harm resulting fromthe care or therapy they would not otherwise have gotten.35

Experimental treatments must be compared against some-thing to be measured accurately, and the yardstick can be eitherno-treatment or a known treatment. It is not a fair comparisonto administer an experimental treatment along with the pursu-

27 See David L. Sackett, Why Randomized Controlled Trials Fail But Needn’t: 2. Failure toEmploy Physiological Statistics, or the Only Formula a Clinician-Trialist is Ever Likely to Need (orUnderstand!), 165 CAN. MED. ASSOC. J. 1226 (2001).

28 Margaret Talbot, The Placebo Prescription, N.Y. TIMES, Jan. 9, 2000 (Magazine), at35.

29 Hoffman, supra note 2, at 452-53. R30 Id. at 452-53.31 Id. at 454-56; Talbot, supra note 28. R32 Anup Malani, Regulation with Placebo Effects, 58 DUKE L.J. 411, 412-13, 439-40

(2008).33 Id. at 412-13; Hoffman, supra note 2, at 454-56. R34 Hoffman, supra note 2, at 456; Talbot, supra note 28. R35 Hoffman, supra note 2, at 453. R



ant exams, consultations, and tests, only to measure it againstpatients who are experiencing similar exams. That would makeit difficult to determine which of the variables introduced in theexperiment caused the improvement. The best way to distin-guish how much the experimental treatment is helping the pa-tient, separate from that patient’s participation in the clinicaltrial, is to have a placebo cohort that experiences everything theexperimental cohort does, save the actual experimental treat-ment.36 Because both cohorts of the study do not know whetherthey are receiving a placebo or the experimental treatment, theyare equally susceptible to the placebo effect, which essentiallycancels itself out of the data.

Despite the mathematical logic of this, a major criticism ofplacebo-controlled trials is the so-called “nocebo effect.”37 Whena patient’s expectation of adverse events due to treatmentmanifests in spite of their not receiving the active treatment,they can have a reverse placebo effect or “nocebo effect.”38 Forexample, a patient given a sugar pill who has been warned it maycause gastrointestinal upset may experience gastrointestinal up-set, even though there is no pharmacological reason that theyshould.39 The nocebo effect has two downsides: it can con-found the results of a clinical trial by raising the incidence ofadverse events in both the treatment and placebo cohorts, but italso exposes patients getting the so-called “safe” placebo to realside effects.40 Some ethicists argue that those patients receivingplacebos have consequently been exposed to unnecessary risksthat conflict with ethical standards of treatment.41 This theorybrings the main objection to sham surgery (high risks with noexpected benefit) back to non-surgical placebos, an even moreextreme position than contemporary medical ethics.

36 In clinical trials of new pharmaceutical treatments, the companies spend signifi-cant time and resources developing “sugar pills” that are identical in nearly every way tothe experimental pill. Not just size and color, but taste, aftertaste and accurate imprintsare matched. See infra note 51. R

37 John Cloud, The Flip Side of Placebos: The Nocebo Effect, TIME, Oct. 13, 2009, availa-ble at http://www.time.com/time/printout/0,8816,1929869,00.html.

38 Id.39 Malani, supra note 32, at 431. R40 Id. at 430-31.41 Hoffman, supra note 2, at 496. R



Despite the nocebo effect, use of placebos in randomizedclinical trials (RCTs) has become an integral part of the “goldstandard” of evaluating treatments since the 1940s.42 An RCT isthe industry standard for establishing the efficacy ofpharmaceuticals43 and also where pharmaceutical companiesspend the bulk of their R&D money.44 Quantitative comparisonbetween the experimental cohort and the placebo cohort is pos-sible because the patients in both cohorts have nearly identicalexperiences; everything from the numbers of blood tests drawnto the amount of time nurses spend questioning the patient ismeted out evenly. Randomization eliminates one major con-found of the data set by ensuring the placebo effect will applyequally to the placebo cohort and the experimental cohort.45

The best way to run an RCT is “double-blind,” where neither thepatient nor the clinicians administering any of the tests or examsknow if the patient is receiving the experimental treatment.46

Researchers employ the double-blind randomized controlledstudy to . . . measure those benefits and side effects which areattributable to the active ingredients in a drug, blocking outthe patient’s response to everything else – relief at receivingtreatment from a competent expert, physician-inspired hope,hospital-induced anxiety, confidence about recovery becauseof the rigor and unpleasantness of the therapy, etc.47

Before the 1900’s, “good medicine” was largely defined bythe physicians themselves and the story they told about how theywould cure the patient.48 Now, Western society measures “goodmedicine” against the results from RCTs. If a new procedure ormethod tested in a RCT improves patients on an objectiveendpoint more than a placebo procedure, the medical consen-

42 Charles Weijer, I Need a Placebo like I Need a Hole in the Head, 30 J.L. MED. &ETHICS 69, 69 (2002).

43 Id.44 CONGRESSIONAL BUDGET OFFICE, RESEARCH AND DEVELOPMENT IN THE PHARMA-

CEUTICAL INDUSTRY 3-5 (2006), available at http://www.cbo.gov/ftpdocs/76xx/doc7615/10-02-DrugR-D.pdf.

45 Hoffman, supra note 2, at 453-54. R46 Id.47 Kathleen M. Boozang, Is the Alternative Medicine? Managed Care Apparently Thinks

So, 32 CONN. L. REV. 567, 600 (2000).48 ROGER FRENCH, MEDICINE BEFORE SCIENCE: THE BUSINESS OF MEDICINE FROM THE

MIDDLE AGES TO THE ENLIGHTENMENT 10-12 (2003).



sus is that the new procedure should be used.49

Clinical trials are expensive, complex undertakings onwhich patients’ lives and researchers’ careers can hinge.50 Re-search physicians want to be sure that the patients in the trial areappropriate, so they screen potential participants carefully.51 Re-search physicians want to be confident that the participants willboth benefit from and tolerate the treatment if they are random-ized into the treatment cohort, and that they will not suffer un-necessarily should they only receive the placebo.52 These factorsweigh heavily on the decision to approve and fund the re-searcher’s proposed trial.53 As discussed below, any research in-volving a human subject must weigh the risks of harm to thatpatient against the benefits to that patient; therefore the risksposed by not treating a patient for the purpose of controlling atrial must be limited. It is important in most clinical trials thatthe participants not be too ill,54 lest they deteriorate to the pointwhere they might withdraw from the study and alter the statisti-cal calculations. In long-term or higher-risk clinical trials, pa-tients are carefully screened for concomitant conditions andtheir entire therapeutic regimen may be synchronized with theclinical trial protocol.55

49 Another motivation to run RCTs is to prove the efficacy of treatments becauseinsurance companies will only reimburse for those treatments which are objectivelymeasured to “work”. See In Fight for Life, Insurer No Help, SAN FRANCISCO GATE, Feb. 12,2006; Mitchell Sugarman, Permanente Physicians Determine Use of New Technology: KaiserPermanente’s Interregional New Technologies Committee, 5 PERMANENTE J. 46, 47 (2001).

50 M. Bernstein, Ethical Guideposts to Clinical Trials in Oncology, 13 CURRENT ONCOL-

OGY 55, 57, 58 (2006).51 See, e.g., Traumeel for Pain After Fracture of Neck of Femur, CLINICALTRIALS.GOV,

http://clinicaltrials.gov/ct2/show/NCT00307905 (last visited Jan. 8, 2011); Light Ther-apy in the Treatment of Leg Pain, CLINICALTRIALS.GOV, http://clinicaltrials.gov/ct2/show/NCT00253981 (last visited Jan. 8, 2011); A Study to Evaluate the Efficacy and Safety ofFondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or OtherType of Immobilization for a Below-knee Injury Not Needing Surgery (Fondacast), CLINICALTRI-

ALS.GOV, http://clinicaltrials.gov/ct2/show/NCT00843492 (last visited Jan. 8, 2011).52 See Office for Human Research Protections, U.S. Dept. of Health & Human Ser-

vices, Institutional Review Board Guidebook: Chapter III Basic IRB Review, OHRP ARCHIVE,http://www.hhs.gov/ohrp/archive/irb/irb_chapter3.htm (last updated 1993).

53 Id.54 There is much debate surrounding allowing access to experimental cancer

drugs for the terminally ill. Some patients and physicians argue that it is unfair towithhold potentially lifesaving drugs from patients who are “too sick” to participate inclinical trials and do not have a long enough prognosis to see the drug marketed. SeeCompassionate Drug Use, AMERICAN CANCER SOCIETY, http://www.cancer.org/docroot/ETO/content/ETO_1_2x_Compassionate_Drug_Use.asp (last visited Sept. 9, 2010).

55 Sackett, supra note 27, at 1229-30. R



Randomization using statistical methods requires a certainnumber of patients to validate any result.56 Large trials are re-quired and need to be centrally organized and standardized.57

Although some argument has been made against RCTs,58 includ-ing calling for a ban of sugar pill placebos as too deceptive,59 thecommon understanding is that placebo controls are the best wayto evaluate experimental treatments despite the moderate risks.Sham surgeries, on the other hand, remain controversial.

B. The Influence of Evidence-Based Medicine

The FDA is the administrative agency that publicizes thesafety of medicines and medicinal procedures. Our faith inmodern medicine has evolved to the point where patients hesi-tate to accept a treatment that was not “FDA-approved.” TheFDA will not approve a new drug or medical device unless it hasbeen proven to be more effective than a placebo in large com-parative studies as described above.60 Medicines were largely un-governed until 1938,61 when the FDA designated some drugs as“prescription-only.”62 Prior to that, few medicinal substanceswere studied in what we understand as the scientific method.63

With the commercial success of penicillin in the 1940s, the gen-eral public called for more treatments for more ailments and the

56 STEPHEN B. HULLEY ET AL., DESIGNING CLINICAL RESEARCH: AN EPIDEMIOLOGIC

APPROACH 139-50 (1988).57 R. Peto, et al., Design and Analysis of Randomized Clinical Trials Requiring Prolonged

Observation of Each Patient: II. Analysis and Examples, 35 BR. J. CANCER 1, 16-21 (1977).58 Placebo-controlled RCTs have come under criticism from both ends of the med-

ical ethics spectrum, for being underinclusive by excluding therapies that would helpsome patients but are not statistically “better” than placebo, and for being overinclusiveby letting risky drugs enter the market based on trial statistics rather than real-worldoutcomes. See John P.A. Ioannidis, Why Most Published Research Findings Are False, 2 PLOSMED. 696 (2005).

59 Hoffman, supra note 2, at 465-71. R60 New Drug Application (NDA): Introduction, FDA: U.S. FOOD AND DRUG ADMINISTRA-

TION, http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm (lastupdated Aug. 20, 2010).

61 FDA History – Part II: The 1938 Food, Drug, and Cosmetic Act, FDA: U.S. FOOD AND

DRUG ADMINISTRATION, http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054826.htm (last updated Jun. 18, 2009).

62 FDA History – Part III: Drugs and Foods Under the 1938 Act and Its Amendments,FDA: U.S. FOOD AND DRUG ADMINISTRATION, http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm055118.htm (last updated Jun. 18, 2009).

63 See, e.g., Medicine: Penicillin’s Progress, TIME, Jun. 7, 1943, at 70, available athttp://www.time.com/time/printout/0,8816,884982,00.html.



FDA stepped in to ensure that those medicines were closely scru-tinized. The scientific method, as applied to RCTs, has been suc-cessful over time. Congress continually expanded the authorityof the FDA from 1906 until the 1980s through “discrete legisla-tion that focused on detailed definitions [of drugs’ effects],”64

broadening their power from foodstuffs to prescriptionmedicines and supplements.65 The FDA now requires RCTsdemonstrating the efficacy of new treatments in a large numberof patients before they can be approved and marketed.66

In the 1990s, a push towards “evidence-based” medicine(EBM) was “fueled by an explosion of high-quality clinical trialsand improvements in information systems.”67 EBM is a newterm for the 200-year-old idea that the best treatment is the onewith the most medical evidence in its favor.68 Proponents ofEBM want to perform only those treatments which are proveneffective by empirical studies, thereby minimizing the costs andmaximizing the benefits to the patients.69 The volumes of infor-mation generated from published clinical trials are a good placeto start looking for this medical evidence,70 but more data areneeded to compare non-identical treatments and therapies thatare no longer patented.71 EBM is valuable because it disprovescertain treatments’ efficacy by comparing known therapies

64 Susan Bartlett Foote & Robert J. Berlin, Can Regulation be as Innovative at Scienceand Technology? The FDA’s Regulation of Combination Products, 6 MINN. J. L. SCI. & TECH.619, 629 (2005).

65 Id. at 623-29.66 See Manthan D. Janodia, Drug Development Process: A review, PHARMAINFO.NET

(Dec. 25, 2007), http://www.pharmainfo.net/reviews/drug-development-process-review.

67 David A. Feldstein, Evidence-Based Practice: What a Start and ‘Oh, the Possibilities’,104 WIS. MED. J. 14, 14 (2005).

68 See David L. Sackett et al., Evidence-Based Medicine: What It Is and What It Isn’t, 312BRIT. MED. J. 71, 71-72 (1996). See generally Lars Noah, Medicine’s Epistemology: Mappingthe Haphazard Diffusion of Knowledge in the Biomedical Community, 44 ARIZ. L. REV. 373(2002). Noah notes a shift in judicial scrutiny standards comparable to the EBM move-ment in medical community. Id. at 382. After Daubert v. Merrill Dow, 509 U.S. 579(1993), the consensus of the scientific community, or “how we’ve always done it” givesway to the weight of the available evidence. Id. at 379.

69 Noah, supra note 68, at 465. But cf. Sackett et al., supra note 68, at 71 (noting Rthat EBM is based on both individual clinical expertise and external clinical evidence).

70 See Sackett et al., supra note 68, at 72. See generally Feldstein, supra note 67. R71 Pharmaceutical companies are the major sponsors of pharmaceutical trials,

even after a drug has been approved. Once the drug no longer has patent protection,it is “generic” and it is much more difficult to organize and fund a clinical trial compar-ing two generic treatments. What Are Generic Drugs?, FDA: U.S. FOOD AND DRUG ADMIN-

ISTRATION, http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsing



against experimental therapies and a placebo.72 This compari-son frequently reveals that neither the new nor the “old” thera-pies are more effective than placebo.73 As a result, some of thesetreatments are no longer reimbursed by insurance companiesand are now rarely performed.74

Part II – Understanding Sham Surgery

In order to test novel surgical procedures quantitatively andsatisfy the demands of EBM, practitioners must use some kind ofcontrol. Sham surgery RCTs use a non-therapeutic surgery inthe place of a sugar pill and apply the same principles of a pla-cebo-controlled trial in determining if the experimental surgicaltreatment performs better than the “placebo” surgery.75 A pa-tient who joins an RCT for a surgery and never receives any sortof surgery will realize that they are in the control cohort and maynot experience the placebo effect. In theory, a sham surgicalprocedure would then fill the role of a sugar pill for the pur-poses of controlling the trial and preserving randomization.76

However, sham surgery carries many more risks to the patient.77

Informed consent, explored in Part III, can address these risks tosome extent, but there remain ethical concerns about perform-ing one surgical procedure on a patient when they have con-sented to another one. Incising the body causes a vastlydifferent physiological response than ingesting a sugar pill.78

Sham surgery RCTs are designed to control for a majority ofphysiological responses except those elicited by the experimen-tal treatment.79 Pain, inflammation, and other healing re-

MedicineSafely/UnderstandingGenericDrugs/ucm144456.htm (last updated May 12,2009).

72 Noah, supra note 68, at 390-91. R73 See, e.g., Bruce J. Moseley et al., A Controlled Trial of Arthroscopic Surgery of Osteoar-

thritis of the Knee, 347 NEW ENG. J. MED. 81, 81 (2002); see also infra note 104. R74 Kay Lazar, Cutting Question, BOSTON GLOBE, Aug. 24, 2009, http://www.boston.

com/lifestyle/articles/2009/08/24/studies_challenge_vertebroplasty_yet_patients_and_doctors_say_it_works?mode=pf.

75 Hoffman, supra note 2, at 453. R76 Id. at 453-54.77 “Procedures are not products in the same sense as drugs and devices.” Nancy

M. P. King & Gail Henderson, Treatments of Last Resort: Informed Consent and the Diffusionof New Technology, 42 MERCER L. REV. 1007, 1013 (1991).

78 See discussion of wound response, infra text accompanying notes 93-97. R79 See E Ernst & K L Resch, Concept of True and Perceived Placebo Effects, 311 BRIT.

MED. J. 551, 551 (1995).



sponses are intended consequences, not accidental side effects.Patients in the control cohort believe they are receiving the ex-perimental surgery and thus experience the placebo effect be-cause a sham surgery looks and feels convincing, therebyvalidating the statistical comparison between experimental andnon-treatment cohorts.80

A. How a sham surgery is different from a sugar pill

Sham surgeries invade the body, causing a systemic re-sponse that increases the risks of side effects faced by patients.81

Sham surgeries are not neutral – they cause actual physiologicalchanges in the body which are not due to the placebo effect.Sham surgeries also pose the same risks as an experimental treat-ment, but with no expected or intended therapeutic benefit.

While a sugar pill placebo may be free of side effects,82 itcannot be said that a sham surgery does not manifestly affect thebody on a cellular level. These changes are not a result of theplacebo effect; rather they are a direct result of the treatment.This could benefit the patients in the sham cohort in the casewhere their symptoms improve in spite of not receiving the ex-perimental treatment. This would tend to disprove the efficacyof the experimental treatment.83 Additionally, the patient re-ceiving sham surgery is exposed to a higher risk of negative sideeffects from the sham surgery simply because they are havingsurgery.84 Sham surgery RCTs are designed to justify the ex-pense of novel surgical treatments: surgical procedures are tens

80 Hoffman, supra note 2, at 453. R81 For example, a patient who receives a sham surgical procedure must deal with

the same risks of infection, scarring, and pain related to having a “real” surgery in addi-tion to missing out of the supposed benefit of the “real” surgery. See supra note 14. R

82 See discussion of placebo effect and nocebo effect, supra Part I.83 Because EBM adheres strictly to what can be measured and compared, a trial

result where both cohorts improved equally, even if dramatically, tends to disprove theefficacy of the experimental treatment compared to the control treatment. That meansthat, even though the majority of patients improved compared to their prior condition,there is no evidence in favor of the experimental treatment. This could lead to per-fectly-useful treatments being discounted because the researchers have not isolated andtested the right element of the surgery to get the right data. Essentially, many shamsurgery RCTs would have to be conducted to determine which sham surgery RCTshould be compared to the experimental treatment. This increases the costs exponen-tially and exposes many more patients to the high risks of sham surgery without anyexpected benefit.

84 See generally Surgery, supra note 14. R



to hundreds of times more expensive than pharmaceuticals, andare often much riskier. In this climate of EBM, health carepayors have a strong incentive to reimburse only treatments thatare proven to help.85 RCTs have disproven the efficacy of popu-lar treatments with alarming frequency.86 Patients benefit themost from treatments that help their symptoms, not just makethem “feel” better; therefore there is a strong incentive to provethat new treatments truly help.

Triggering the body’s responses to the act of surgery in thecontrol cohort gives researchers a better measure of how muchthe surgical procedure itself is actually affecting the symptoms.A simple example of this is a three-armed study of arthroscopicknee surgeries in patients with osteoarthritis.87 One group ofpatients underwent an innovative debridement (scraping) pro-cedure, one group underwent a simple saline lavage (rinsing),and the third group was merely anaesthetized and incised to ap-pear as though they had undergone one of the procedures.88

The researchers were hoping to demonstrate that lavage was su-perior to debridement and the sham control.89 Shockingly, thepatients in the sham control group had equal results, both sub-jectively and objectively, to the patients who underwent eitherthe lavage or debridement.90 These results spurred a follow-upstudy, which produced evidence that surgery does not help os-teoarthritis patients any more than physical therapy alone.91

This pair of trials led many doctors to stop recommendingdebridement.92

While any surgery carries a risk of side effects, sham sur-geries cause a physiological response in addition to the psycho-logical response of a placebo effect. When blood vessels areruptured, a rapid chemical cascade called the “wound response”

85 Boozang, supra note 47, at 612. R86 Noah, supra note 68, at 405. R87 Moseley et al., supra note 73. R88 Id. at 82.89 Id.90 Id. at 85-87. That is, the patients reported feeling better (subjective) on a com-

parable rate over time and were able to perform basic range of motion and strengthexercises (objective) equally well at 8 weeks post surgery. Id. at 84-85.

91 Alexandra Kirkley et al., A Randomized Trial of Arthroscopic Surgery for Osteoarthritisof the Knee, 359 NEW ENG. J. MED. 1097 (2008).

92 E.g., Gabe Mirkin, Arthroscopic Knee Surgery is Usually Useless, DRMIRKIN.COM,http://www.drmirkin.com/joints/1259.html (last visited Sept. 11, 2010).



begins.93 Proteins in the plasma become immediately “acti-vated” and start blood coagulation and repair.94 Many sub-stances are attracted to the damaged area, like serotonin andgrowth hormone inhibitors.95 These proteins are attracted tothe site of the injury,96 regardless of how it was injured; that is,the cells and proteins do not differentiate between a surgical in-cision and a cut from the slip of a kitchen knife.97 Further, anti-inflammatory medications administered post-surgery dissipatethroughout the entire body and work on many different cells.98

The post-sham surgery protocol for recovery in a good studywould be identical to the post-surgical protocol.99 Physical ther-apy carries minor risks, but, if applicable, should also benefit pa-tients who underwent a sham surgery.100 Therefore, the sameprocedures that are reducing variation in treatment to best eval-uate the experimental procedure are also exposing those pa-tients in the sham surgery group to additional risks.

B. How sham surgeries are used in clinical trials

Although the scientific method, embodied by RCTs, hasbeen used to establish the efficacy of pharmaceuticals for at leastfifty years, it is still rarely applied to novel surgical treatments.The development of surgical procedures,101 unlike new medical

93 Wound Healing, HORST IBELGAUFTS’ COPE: CYTOKINES & CELLS ONLINE PATH-

FINDER ENCYCLOPEDIA, http://www.copewithcytokines.de/cope.cgi?key=wound%20healing (last modified Jan. 2002).

94 Id.95 Id.96 Id.97 See Id.98 See John Vane & Regina Botting, Inflammation and the Mechanism of Action of Anti-

Inflammatory Drugs, 1 FASEB J. 89 (1987).99 Weijer, supra note 42, at 70 (“First, if blinding is to be preserved, patients in the R

placebo arm must undergo similar procedures to the patients in the experimentalarm.”).

100 See, e.g., Arthroscopic Shoulder Surgery for Shoulder Dislocation, Subluxation, and Insta-bility: Why, When and How it is Done , UW MED.: ORTHOPAEDICS & SPORTS MED., http://www.orthop.washington.edu/shoulderscope (last updated Dec. 31, 2009) (discussingthe benefits and risks of physical therapy after arthroscopic shoulder surgery).

101 It is against FDA policy to claim that a medical device like a laser scalpel is“approved” for certain kinds of surgery, but the illegality lies in the mislabeling, not themisuse of the laser. So long as the patient gives consent, the surgeon can use whatevertools he chooses to perform whatever surgery he sees fit. The tools of the trade likespecialized lasers and cutting tools are “medical devices” under the purview of the FDA,but what those tools are cutting is not. See FDA’s Role, FDA: U.S. FOOD AND DRUG ADMIN-

ISTRATION, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/



devices and pharmaceuticals,102 are largely unsupervised by theFDA.103

Surgeries have traditionally been developed more simplythan pharmaceuticals. A surgeon has an idea, such as scrapingthe damaged cartilage out of an injured knee, and then needs totest his idea. He will inform a few selected patients of his newtreatment theory and obtain their consent to perform it onthem. After becoming convinced this procedure will help pa-tients, he might publish a paper or teach apprentices for a fee,but he will rarely “market” his surgical idea; it becomes acceptedas the mainstream treatment for injured knees through aca-demic channels.

One of the biggest obstacles in justifying sham surgeries isthat scientists have not yet determined precisely how the surgerycauses improvement in some patients. A radical example high-lighting this was a recent study in patients with Parkinson’s dis-ease.104 These patients were enrolled in a trial to test the efficacyof fetal stem cells implanted in the area of their brain which de-teriorates in Parkinson’s disease.105 All the patients’ skulls weredrilled as if the fetal cells would be implanted, but the controlcohort did not receive fetal cells.106 The results of the study werenot as the researchers expected: there was a great improvementin both cohorts, but no significant difference between the shamand the experimental cohorts.107 With a sugar pill placebo in an

SurgeryandLifeSupport/LASIK/ucm061319.htm (last updated Jun. 23, 2009) (statingthat the FDA does not have authority to regulate a doctor’s practice).

102 What Does the FDA Regulate?, FDA: U.S. FOOD AND DRUG ADMINISTRATION, http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm (last updated Aug. 19,2010).

103 The FDA does not prevent consumers from purchasing products, it preventscompanies from marketing their products, and in the case of prescription-restrictedproducts sanctions companies for selling those products. FDA to Prohibit Sale of Fish OilCapsules, WASH. POST, Jul. 17, 1990 (ordering a cessation of shipments of fish oil supple-ments touted to lower cholesterol on the label. The ban was withdrawn in 2004, how-ever fish oil products remained on the market during the ban with the claim oflowering cholesterol removed); see also Laurel Cohen, The Truth About Omega 3 Fish Oil(Oct. 31, 2009), http://www.articlesbase.com/supplements-and-vitamins-articles/the-truth-about-omega-3-fish-oil-1403491.html.

104 Curt R. Freed et al., Transplantation of Embryonic Dopamine Neurons for Severe Par-kinson’s Disease, 344 NEW ENG. J. MED. 710 (2001); see also Alex John London & Joseph B.Kadane, Placebos That Harm: Sham Surgery Controls in Clinical Trials, 11 STATISTICAL METH-

ODS IN MED. RESEARCH 413 (2002).105 Freed, supra note 104, at 710. R106 Id.107 Id. at 717.



RCT, researchers can, within reason, control the variables so thatthe most important difference between the placebo cohort andthe experimental cohort is the pill itself. The placebo control issupposed to stimulate the placebo effect, not eliminate it.108 Butwith a sham surgery, the wound response blurs the line betweenplacebo effect and actual effects. For example, in a recent studyon vertebroplasty, a procedure that was purported to alleviateback pain by cementing vertebrae together, both patients whoreceived the sham treatment and those who received the experi-mental treatment improved equally well.109 It always makesheadlines when an established procedure fails to provide resultsbetter than the placebo.110 However, in many studies, the proce-dure does not “fail” in the sense that it does not help; it only“fails” in the sense that the RCT does not prove the experimen-tal treatment to be better because patients in both the treatmentcohort and sham surgery cohort experienced improvement intheir symptoms.111 This can hardly be classified as a “failure” tothe patients who participated in the experiment and now feelbetter. But, as a statistical analysis, this would fail to prove thatthe experimental treatment is better than the control. A trialtesting the hypothesis that the experimental treatment is betterthan the control treatment cannot produce other data, whichmeans if the experimental treatment is not better than the con-trol cohort, it does not matter that both groups improved. Fur-thermore, some novel ideas like minimally-invasive surgeries,when tested in RCTs, do not perform as well as the more-invasivesurgical procedures.112 Modern science has not yet separatedthe myriad of variables introduced in a surgical procedure to de-termine which are effective in ameliorating symptoms.113

108 See supra Part I. The idea is that both cohorts will experience the placebo effectequally, thus cancelling the effects in the data analysis.

109 David F. Kallmes et al., A Randomized Trial of Vertebroplasty for Osteoporotic SpinalFracture, 361 NEW ENG. J. MED 569 (2009).

110 See Joseph Pereira & Keith J. Winstein, Spine Surgery Found No Better Than Placebo,WSJ.COM (Aug. 6, 2009, 11:33 AM), http://online.wsj.com/article/SB10001424052970203674704574332771250497610.html.

111 Id.112 E.g., John Fauber, Robotic Prostate Surgery Not Better at Reducing Side Effects, Study

Finds, JSONLINE (Oct. 13, 2009), http://www.jsonline.com/features/health/64092427.html; Ed Edelson, Minimally Invasive Surgery Not Better for Sciatica, BLOOMBERG BUSINESS-

WEEK (Jul. 7, 2009), http://www.businessweek.com/lifestyle/content/healthday/628787.html.

113 Examples of confounding variables could include the wound response, the vary-



A good placebo-controlled study on an effective medicaltreatment should demonstrate that, even though the body’s re-sponses to a placebo are powerful, the experimental treatment iseven better than the body healing itself. Those drugs and thera-pies are welcome additions to the market because they are de-monstrably helpful.114 With a sham surgery, there is more goingon physiologically than the expectation response, and so thevalue of data obtained through them is diluted. The crucial dif-ference between a placebo-controlled trial and a sham surgery-controlled trial is that, in a placebo-controlled trial, the majorityof the risks are associated with the experimental treatment. Theexperimental treatment, of course, carries a potential benefit be-cause it is the cure being tested. The sugar pill does not have ahigh potential benefit but it also does not carry high risks. In asham surgery-controlled trial, the risks apply nearly equally toboth procedures, where the potential for benefit probably onlyapplies to the experimental cohort.

For example, vertebroplasty, as explained above, was per-formed at a rate of over 100,000 patients per year.115 In thatstudy, both groups demonstrated “a substantial reduction in vari-ous measures of disability and pain. . . . But the [survey results]were a statistical tie – the actual procedure yielded no gain be-yond the placebo effect of the sham surgery.”116 But this studyconflates the placebo effects of the sham surgery with the actualeffects; the trial cannot control for the fact that something otherthan the cementing procedure might be what ameliorates the

ing effect of anti-inflammatories on different patients, or even differences in how twonurses treated their respective assigned patients. In order to isolate the one variableabout which the question “is this better than the control treatment?” is asked, all theother variables should be ruled out. With a pharmaceutical, this is not difficult: pa-tients either get the active ingredient or they do not. In the case of sham surgery, thiswould require many surgery trials to isolate which part of the surgical procedure isreally conferring the benefit.

114 On the other hand, the first surgery to be discontinued due to poor perform-ance in a sham-controlled trial was called internal mammary ligation, a procedure usedto treat angina. King & Henderson, supra note 77, at 1020. This result, from 1959, is Rcredited with establishing the need for controlled evaluations of surgical procedures.Id.

115 Susan Jeffrey, Long-Term Data Confirm Benefit of Vertebroplasty for Back Pain ReliefAfter Osteoporotic Vertebral Collapse, MEDSCAPE MED. NEWS (Mar. 31, 2008), http://www.medscape.com/viewarticle/572291.

116 Pereira & Winstein, supra note 110. R



patients’ discomfort.117 Different explanations for why patientsin both cohorts improved could be the placebo effect, thewound response, or that the trial failed to isolate the correct vari-able to test and some element common to both surgeries causedimprovement. It is impossible to determine this from data withequally-positive or equally-negative response rates.118

Vertebroplasty is performed less frequently today, in spite of thefact that some patients attest to its success in their particularcase.119

Although sham surgery controls can do some good by dem-onstrating which surgical procedures are not worth the risks, themethod is not without its costs. They have real side effects notpresent in sugar pill placebo-controlled trials which pose a highrisk of harm to the shammed patients, often without a correlatedexpected benefit. On the one hand, we are all safer becausesome kinds of surgical procedures, now disproven, are no longerperformed.120 On the other hand, patients’ bodies are not labo-ratories; there are ethical and legal limits to what can be done toa human subject. Medical knowledge is inarguably increasedwith data like that derived from the vertebroplasty study. How-ever, research on human subjects in America is governed bymore than the push for “progress.”121 As explained below, theNuremberg Code and its legislative progeny require that re-searchers not pose unreasonable risks of harm on participants inclinical trials without their “informed consent.”

Part III – Understanding Informed Consent

The legal propriety of any medical procedure, whether in aclinical or experimental setting, depends upon the patient’s in-

117 Some scientists believe that the anaethesia itself is what “resets” the nerves caus-ing some kinds of back pain and reduces discomfort, rather than the surgical interven-tion. Pain Relief Could be Easy With a Simple Injection, SCIENCEDAILY (Dec. 3, 2004), http://www.sciencedaily.com/releases/2004/11/041123213234.htm.

118 However, as far as the FDA is concerned, a treatment that is no better thanplacebo is no treatment at all. Therefore, it will be difficult to use the results from atrial like the above-mentioned vertebroplasty study as a means to justify that either thesham procedure or the treatment are worth reimbursement from health care payors.

119 Multi-Center Data in Large Series of Patients Show Vertebroplasy Provides Dramatic andLasting Pain Relief for Vertebral Compression Fractures, MED. NEWS TODAY (Feb. 18, 2010),http://www.medicalnewstoday.com/articles/179498.php.

120 But cf. NOVA scienceNow: Leeches (PBS television broadcast Jul. 23, 2008).121 See infra Part III.



formed consent to that procedure. At the basic level, informedconsent is the disclosure of the risks of harm and the possibilityof no therapeutic benefit by the physician, as well as explicit,documented acceptance of those risks by the patient.122 If thepatient can demonstrate that the physician administered a treat-ment to which the patient did not consent or about which thepatient did not understand the consequences, that physiciancould be found liable for malpractice and battery.123 “Informedconsent” is a moving target, however, because patients often donot later remember what they agreed to at the time.124 The im-portant question is that the patient understood at the time to whathe was consenting. However if later the patient does not remem-ber or claims to not have understood, this becomes a harderquestion to resolve. Informed consent protocols are usually in-stitutionalized and are suggested by the National Institutes forHealth, a major source of funding for clinical research.125 Physi-cians do not need to deceive patients for the patient to fail tounderstand what the physician was trying to convey.126 It is diffi-cult to ascertain how effective current informed consent proto-cols are, and so it is problematic to use them bearing in mindthe heightened level of risk associated with sham surgery.

122 For a template of a clinical trial informed consent document, written for re-searchers, see Consent, Assent, and Waivers, U. WASH.: HUM. SUBJECTS DIV. (HSD), http://www.washington.edu/research/hsd/topics/Consent,+Assent+and+Waivers (last visitedJan. 20, 2011). But see infra notes 202-209, that patients do not often recall the critical Rparts of what they have signed when asked later.

123 Because courts have deemed patients unable to bargain with physicians over thequality of medical services, physicians’ performance is regulated under the tort rulesthat govern professional malpractice as opposed to expectation damages. It follows,then, that questions of patient autonomy would be analyzed as malpractice as well.Marjorie Maguire Schultz, From Informed Consent to Patient Choice: A New Protected Interest,95 YALE L.J. 219, 223 (1985). Although physicians conducting experiments, by defini-tion, do not know all the side effects of the experimental treatment, a diligent effortmust be made to warn patients of the risks and the patient must be allowed to withdrawfrom the trial at any time.

124 See infra notes 202-09. R125 Guidelines for Writing Informed Consent Documents, NAT’L INST. HEALTH: OFF. HUM.

SUBJECTS RES., http://ohsr.od.nih.gov/info/sheet6.html (last modified Dec. 28, 2006).126 A willfully-deceptive informed consent protocol would be malpractice. Physi-

cians generally do disclose, in varying detail, the experiment’s purpose, procedure, andexpected risks. They should emphasize that there is a chance the patient will not re-ceive the experimental treatment, but what remains unclear is if patients truly compre-hend this. See K.P. Weinfurt et al., Patient Expectations of Benefit from Phase I ClinicalTrials: Linguistic Considerations in Diagnosing a Therapeutic Misconception, 24 THEORETICAL

MED. & BIOETHICS 329 (2003).



A. The History of Informed Consent

The idea of holding physicians responsible for giving un-wanted treatment is less than 100 years old. In 1914, Justice Car-dozo was the first American jurist to call an unauthorizedsurgery a “trespass,” finding the physician liable for damages.127

Since this case, courts have refined the distinction between es-sential consent, failure of which results in a claim for battery,and informed consent, failure of which gives rise to a claim fornegligence.128 A California court was the first to hold a physi-cian negligent for failing to inform his patient of the risks of adiagnostic procedure and coined the phrase “informed consent”in 1957.129 Courts have been “quick to accept uncertainty as ajustification for flexing and softening the standards of profes-sional competence” in malpractice cases.130 Courts are muchmore ready to punish a physician for being sloppy than for beingwrong, which gives patients better protection in the long run.Courts recognize that, unlike contract sales, nothing in healthcomes with a warranty. Public policy encourages physicians toact according to their training and best judgment. Courts willoften fail to find malpractice when the formalities of informedconsent are observed even if the outcome was undesirable. Theformalities of informed consent take on high importance inRCTs because there is a more contractual feel than in clinicalmedicine. The patient bargains for no-cost, innovative treat-ment and in exchange undergoes tests and is exposed to risks.

Historically, physicians have “been reluctant to disclose risksand share decisionmaking” because their training emphasizestaking active responsibility.131 Physicians are also trained to putforward a “face of decisiveness” in the face of medical uncer-tainty about the right solution to the patient’s problem.132

There is often no one “right” answer to a medical problem.Moreover, at the beginning of an RCT designed to determine if

127 Schloendorff v. Soc’y of N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914).128 Grant H. Morris, Dissing Disclosure: Just What the Doctor Ordered, 44 ARIZ. L. REV.

313, 319 (2002).129 Salgo v. Leland Stanford Jr. Univ. Bd. Trustees, 317 P.2d. 170, 181 (Cal. Dist. Ct.

App. 1957).130 Schultz, supra note 123, at 271. R131 Id. at 249.132 Id. at 270.



a novel idea is a valid treatment, there is no answer at all. It isunderstandable that physicians have different reasons why theymay not engage in as thorough an informed consent procedureas lawyers might like: sometimes the risks are unknown, some-times a rare risk manifests in an unexpected patient, or it may bethat the physician is expecting the patient to trust him despitethe risks. Emphasis in medical literature has been on obtainingairtight documentation of informed consent for use in the caseof a lawsuit rather than ensuring the patient truly comprehendsto what he is consenting.133

The prevailing legal standard for evaluating a failure of in-formed consent in a tort claim for medical malpractice is the“reasonable patient” standard, which is, had the undisclosed riskbeen disclosed, a reasonable patient would have chosen not toundergo the procedure, and therefore would have avoided therisk.134 The patient must prove more to succeed on a directclaim for failure of informed consent.135 He must prove that theprocedure carried a specific, undisclosed risk; that the physicianfailed to disclose that risk; that the risk materialized; and that theharm suffered by the patient was something that would not havehappened had the patient refused the procedure.136 This mightseem like a high burden of proof, but the physician need onlyfail to disclose one known risk, however unlikely, to be liable.137

When the American Medical Association was founded in1847, its first code of ethics encouraged physicians to use hopeand cheer to help a patient through his suffering.138 As the phi-losophy of self-determination spread with the Industrial Revolu-tion, so too did the notion that a patient had the right to know

133 See, e.g., Robert H. Ossoff et al., Deciphering the “Black Box”: Compliance and theOperating Room, Part I, 11 J. HEALTH CARE COMPLIANCE 59 (2009).

134 See Wagner v. Roche Lab., 671 N.E.2d 252 (Ohio 1996) (finding a failure towarn of a risk of Accutane in a clinical trial when a chemically-similar product wasknown to produce the risk); Wells v. Ortho Pharm. Corp., 788 F.2d 741 (11th Cir. 1986)(finding manufacturer had a duty to warn of a possible risk of birth defects notwith-standing FDA’s determination that the spermicide did not cause birth defects).

135 Anna C. Mastroianni, Liability, Regulation and Policy in Surgical Innovation: TheCutting Edge of Research and Therapy, 16 HEALTH MATRIX 351, 386 (2006).

136 Id.137 Id. The standard of care for malpractice is evaluated with a “reasonable practi-

tioner in like circumstances” standard. This can be proved either by showing a faultydecision to perform a procedure or an inadequate performance of that procedure. Id.

138 W. John Thomas, Informed Consent, the Placebo Effect, and the Revenge of ThomasPercival, 22 J. LEGAL MED. 313, 315 (2001).



the risks of treatment and to refuse those risks.139 In response tothe abuses of human research subjects under Nazi Germany,140

the Nuremberg Code was ratified in 1947.141 It was the firstworld-wide requirement of a patient’s informed consent to par-ticipate in medical experiments.142 The Nuremberg Code out-lined ten requirements all medical experimentation with humansubjects must meet, the primary being “voluntary consent . . . . tomake an understanding and enlightened decision.”143 Thetheme throughout these requirements is that the patient canonly consent to procedures he understands, and that the re-searcher should only propose procedures when the risk of harmis minimal compared to available alternatives.

The United States adopted the Nuremberg Code into regu-latory law in 1953,144 codifying all ten precepts.145 Chief amongthem are informed consent and the physician’s duty to minimizeharm to participants in clinical research.146 In 1964, the Decla-ration of Helsinki was adopted into international law by theEighteenth World Medical Association General Assembly.147

139 Id. at 325-29.140 Cohen, supra note 16. Experiments included vivisections without anaesthesia, R

exposure to extreme cold, and inducing injuries similar to what soldiers at war mightexperience.

141 Nuremburg Code, supra note 12. R142 Jochen Vollmen & Rolf Winau, Informed Consent in Human Experimentation Before

the Nuremberg Code, 313 BRIT. MED. J. 1445 (1996).143 TRIALS OF WAR CRIMINALS BEFORE THE NUREMBERG MILITARY TRIBUNALS UNDER

CONTROL COUNCIL LAW NO. 10, VOL. II at 181-82 (U.S. Government Printing Office1949).

144 See 45 C.F.R. § 46.101 (2001). Even so, the notorious Tuskegee Syphilis Experi-ment (“TSE”) continued to receive funding from the National Institutes of Health(NIH) until 1972. See JAMES JONES, BAD BLOOD (Simon & Shuster, Inc. 1993) (1981).The TSE was a forty-year study involving nearly 400 poor black men diagnosed withsyphilis and funded by the NIH. Id. At the outset, the known treatments for syphiliswere ineffective, but even after penicillin was discovered to cure syphilis, the men weredenied treatment with penicillin in order to document the effects of “untreated”syphilis. Id. No surgical treatments, or indeed any experimental therapies, were in-volved. Id. A commission investigating this and other incidents published the BelmontReport in 1979, again requiring that patient autonomy be protected by insisting oninformed consent to any medical treatment. OFFICE OF HUMAN SUBJECTS RESEARCH,DEPT. HEALTH, EDUC. & WELFARE, THE BELMONT REPORT: ETHICAL PRINCIPLES AND

GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH (1979).145 See 45 C.F.R § 46.116 (2005).146 Dani Veracity, Human Medical Experimentation in the United States: The Shocking

True History of Modern Medicine and Psychiatry (1833-1965), NATURALNEWS.COM (Mar. 6,2006), http://www.naturalnews.com/019189.html.

147 The Declaration of Helsinki was binding on all U.N. participants under the pur-view of the World Health Organization. See WORLD HEALTH ORGANIZATION, CONSTITU-



This established a strict standard whereby placebo use is neverconsidered ethical when there are alternatives to the experimen-tal treatment available.148 This changed the meaning of “pla-cebo” in the context of RCTs to include “usual care.”149 Forexample, a trial to test an emphysema medication cannot assignthe patients in the placebo cohort only an inert inhaler withoutother bronchodilators because there are effective non-experi-mental treatments available.150 The study must provide the pla-cebo-cohort patients, at the very least, the medication they werealready taking.151 Regardless of whether the experimental treat-ment fails to provide a benefit to those patients in the treatmentcohort, it is unethical to deny treatment to a patient in the pla-cebo cohort when they have a known medical problem. Thisrequirement is at odds with what a researcher is asking from asham surgery patient. Sham surgery is decidedly not “usualcare” for a medical condition. The appropriate control, accord-ing to the guidelines of the Declaration of Helsinki, would be anon-invasive treatment such as physical therapy. This highlightsone of the ways that a sham surgery is not conceptually inter-changeable with a placebo.

A Congressional act in 1974 established the National Com-mission for the Protection of Human Subjects of Biomedical andBehavioral Research.152 The requirement of Institutional ReviewBoards (IRBs) was declared by the NIH in 1975.153 The reviewprocess encompasses every aspect of the proposed clinical

TION OF THE WORLD HEALTH ORGANIZATION (2006), available at http://www.who.int/governance/eb/who_constitution_en.pdf.

148 Hoffman, supra note 2, at 474. R149 “Usual care” was strictly interpreted after the Declaration of Helsinki to mean

the “best-proven method” of treatment, but the standard has become more flexiblesince then. See supra note 147. Physicians recognize that there different kinds of pa- Rtients with the same experimental problem and a “one size fits all” control cohort maynot serve the patients well. Now, “usual care” typically means how the patient wouldhave been treated had they never enrolled in the study. Liza Dawson et al., ConsideringUsual Medical Care in Clinical Trial Design, 6 PLOS MED. 1, 1 (2009).

150 All patients in the trial will receive either the experimental treatment and usualcare, or a placebo and usual care.

151 See Bartolome Celli et al., Mortality in the 4-year Trial of Tiotropium (UPLIFT) inPatients with Chronic Obstructive Pulmonary Disease, 180 AM. J. RESPIRATORY CRITICAL CARE

MED. 948, 949 (2009).152 History of Research Ethics, U. NEV. LAS VEGAS: OFF. RES. INTEGRITY – HUM. SUB-

JECTS RES., http://research.unlv.edu/ORI-HSR/history-ethics.htm (last visited Jan. 20,2011).

153 Veracity, supra note 146.



trial.154 Prior to any experiment’s approval by an IRB, a copy ofthe informed consent form must be presented by theresearcher.155

Today, Institutional Review Boards (IRBs) establish what is“ethical” for a clinical trial. IRBs are the juries of the medicalworld. The researchers typically acquire funding and subjectsthrough a relationship with a teaching hospital or medical clinic.These clinics must have IRBs who are responsible for vetting theexperimental trials before a clinical trial is approved by its spon-sors.156 The IRB is a committee composed of both medical andethical experts and at least one layman.157 However, once a trialhas the blessing of an IRB, it is legally “ethical” and consideredsanctioned by the clinic sponsoring the study.158 For this reason,most IRBs act prudently. However, the debate rages over what isand is not ethical, particularly related to the subject of sham sur-geries. All of the sham surgery trials discussed in this note wereconducted at well-known institutions and received IRB approvalprior to enrolling patients.159

B. Perspectives on the Scope of Informed Consent

From a patient’s perspective, there are few differences be-tween a research scientist with a medical degree conducting aclinical trial and a physician who is treating patients. Some com-mentators analyze the ethics of clinical trials separate from ther-apeutic care, stating that the purposes, methods, andjustification of risks are different because experimental medicineis designed to ultimately benefit the population at large, not just

154 See 45 C.F.R. 46.111 (2001). IRBs should ensure the study design minimizesrisks to the patients and, “[i]n evaluating risks and benefits, the IRB should consideronly those risks and benefits that may result from the research . . . . The IRB should notconsider possible long-range effects of applying knowledge gained in the research . . . .”Id.

155 Sheet 3 – Criteria for Institutional Review Board (IRB) Approval of Research InvolvingHuman Subjects, NAT’L INST. HEALTH: OFF. HUM. SUBJECTS RES., http://ohsr.od.nih.gov/info/sheet3 (last visited Jan. 20, 2011).

156 Robert W. Jackson & Bruce Moseley, Debate on the Use of Arthroscopic Surgery onOsteoarthritis of the Knee, 16 BUMC PROC. 27, 28 (2003).

157 Adam O. Goldstein et al., Consent Form Readability in University-Sponsored Research,42 J. FAM. PRAC. 606 (1996).

158 See supra note 155. R159 See Moseley et al., supra note 73; Kirkley et al., supra note 91; Freed et al., supra R

note 104. R



the patient receiving the treatment.160 The legal literature onthe topic is often bifurcated, calling participants in clinical trials“research subjects” as distinct from “patients” in a therapeuticsetting. The argument that a researcher has a lower duty ofcare161 to his research subject than a physician does to his pa-tient has been tested in the courts, but the defense that a “re-search subject” is not a “patient” has not succeeded.162 Moderntort policy holds both research physicians and clinical physiciansaccountable for the health of patients under their care, whetherthey are “just supervising” a clinical trial or truly treating a pa-tient. While it may be true that physicians conducting clinicaltrials have a different relationship with trial participants thanthey do with “normal” patients, clinical research scientists are ex-plicitly governed by the ethical standards of the NurembergCode, codified in federal regulations.163 According to the Code,the research protocol must ensure that no procedure is donewithout a patient’s informed consent and ensure that risks to theparticipating patients are “minimized.”164 Minimized risk is de-fined as “the probability and magnitude of harm or discomfortanticipated in the research are not greater . . . than those ordina-rily encountered in daily life or during the performance of rou-tine physical . . . examinations or tests.”165 This is the standardto which research scientists are bound, regardless of the ex-pected benefit to the corpus of medical knowledge.

Medical ethicists are divided when defining a physician’sethical duty to his patient and how much information must be

160 Franklin G. Miller, Sham Surgery: An Ethical Analysis, 3 AM. J. BIOETHICS 41, 42(2003).

161 In this context, “duty of care” encompasses all the responsibilities laid out in theNuremberg Code. Patients do not deserve a lower level of consent or a higher level ofrisk merely because they are volunteering to participate in an experiment.

162 Daum v. Spinecare Med. Grp., 61 Cal. Rptr. 2d 260 (Cal. Ct. App. 1997). Apatient had consented to a spinal surgery, but without discussing it with that patient,the surgeon changed both the extent of the surgery and the type of device to be im-planted. Id. at 262-63. The surgeon substituted a device still considered an “experi-mental or investigational device” by the FDA at the time. Id. at 264. The patientdeveloped a severe, permanent disability. Id. The court held that disclosure of medicalrisks must “conform . . . to the needs and understanding of patients.” Id. at 270. Thecourt was less concerned with the investigational status of the device than the lack ofdisclosure. Id.

163 See 45 C.F.R. § 46.101-.124 (2001).164 45 C.F.R. § 46.111(a)(1) (2001).165 45 C.F.R. § 46.102(i) (2001).



disseminated to and understood by the patient before his con-sent is considered “informed.” Medical ethicists and legal schol-ars have written extensively on the moral issues surrounding theuse of placebo treatments in both a clinical setting and experi-mental setting.166

The general ethical standard for a clinical trial is “clinicalequipoise, meaning a state of honest, professional disagreementamongst the community of experts [as to a] preferred treat-ment” and a weighing of the risks to the patient against the ben-efits to both the patient and to the scientific community atlarge.167 This is the guiding standard, but it is also very subjec-tive. In fact, the term “clinical equipoise” is often used as a faitaccompli, that is, simply by saying researchers have appliedclinical equipoise, the analysis is concluded without further ex-planation.168 Without further explanation, the use of the termlacks meaning.

The majority of medical ethicists suggest relying on the sta-tus quo to evaluate the clinical equipoise of proposed sham stud-ies, namely Institutional Review Boards (IRBs).169 A protocol isapproved so long as the members of the IRB see that the bene-fits outweigh the risks.170 IRBs are already required for any phar-maceutical or medical device trial involving human subjects, soall research institutions have them in place.171 Applying this the-

166 Most notably, sham surgeries are explicitly excluded from most analyses of theethics of therapeutic placebos. See, e.g., Mastroianni, supra note 135, at 357; cf. Adam J. RKolber, A Limited Defense of Clinical Placebo Deception, 26 YALE L. & POL’Y REV. 75, 83(2007) (noting that the American Medical Association’s definition of “placebo” doesnot include sham surgeries, although most researchers construe placebos more broadlyto include sham surgeries). “Protocols involving sham surgeries should be subjected tothe highest level of scrutiny since they expose patients to the risk of anesthesia anddeep incisions.” Hoffman, supra note 2, at 496. R

167 Nicolas Fillion, Clinical Equipoise and the Ethics of Adaptive Clinical Trials 2(May 24, 2010) (unpublished paper) (on file with author), available at http://www.nfillion.com/docs/adaptive.pdf; see also Benjamin Freedman, Equipoise and the Ethics ofClinical Research, 317 NEW ENG. J. MED. 141 (1987).

168 Paul B. Miller & Charles Weijer, Fiduciary Obligation in Clinical Research, 34 J.L.MED. & ETHICS 424 (2006).

169 See 45 C.F.R. § 46.109 (2005).170 45 C.F.R. § 46.111(a)(2) (2005); see also Hoffman, supra note 2, at 500 (arguing R

that specific guidelines regarding the appropriate utilization of placebo controls wouldallow IRBs to accurately judge the safety of clinical trials); Mastroianni, supra note 135, Rat 441 (discussing the Boston Children’s Hospital’s voluntary program of institutionaloversight for surgical innovation, which includes a mechanism to help surgeons identifyprocedures that should be formally reviewed by an IRB).

171 See supra text accompanying note 153. R



ory would bring sham surgery trials into the mainstream withoutany additional precautions. This perspective is based on the pre-sumption that current informed consent protocols for clinicaltrials would be adequate for sham surgery trials.

A substantial minority of medical ethicists view informedconsent more liberally. They stretch the definition of informedconsent to the point where the patient is consenting, essentially,to be healed.172 The patient makes “only one key decision, toplace herself in a given doctor’s care, thereby delegating all sub-sequent authority to the doctor.”173 Thus, if the physician sharesthat intent, there is no problem in failing to inform the patientabout details of treatment.174 This perspective takes into ac-count that modern science has not yet clarified the healing pro-cess and gives physicians leeway to mislead, deceive, or otherwisefail to disclose risks or benefits if, in that physician’s medicaljudgment, it would serve the patient.175 This is called “therapeu-tic privilege,” which is a hotly debated topic in clinical medicineas well as experimental medicine.176 Explicit informed consentand patient autonomy is not valued highly by scientists holdingthis view. Proponents of this approach believe that the physi-cian, not the patient, should perform the risk-benefit balancingtest because the patient cannot make those sophisticated medi-cal decisions himself.177 Applying this view to sham surgerycould lead to fewer explicit disclosures about the risks and alower threshold for informed consent.

A third approach is the free-market approach supported bySt. Louis University School of Law professor Robert Gatter,which nearly eliminates the disclosure function of informed con-sent formalities.178 Gatter rejects that modern patients trust anyone expert more than another because of patients’ near-unlim-ited access to information to evaluate treatment options them-

172 Schultz, supra note 123, at 221. R173 Id.174 See Kathleen M. Boozang, The Therapeutic Placebo: The Case for Patient Deception, 54

FLA. L. REV. 687, 745-46 (2002).175 Schultz, supra note 123, at 221-22. R176 Noah, supra note 68, at 368. R177 Id.178 Robert Gatter, Faith, Confidence, and Health Care: Fostering Trust in Medicine

Through Law, 39 WAKE FOREST L. REV. 395 (2004).



selves.179 He does not see a benefit to concealing informationfrom a patient, unlike the minority approach explained above,since the patient is likely to discover information about risks andside effects independent of the physician.180 Gatter believes thatpatients are capable of weighing the risks and benefits ade-quately themselves and do not need their physician filtering in-formation for them.181 It may at first appear that this perspectivedoes not value informed consent, but Gatter is careful to explainthat informed consent is still important. He sees informed con-sent as inevitable, and encourages physicians to disclose informa-tion to patients.182 Patients will educate themselves about boththe objective results of past empirical studies and the “green teaworked for me” testimonials, both bolstering some expectationsand diluting others,183 resulting in no net loss of placebo effect.Although Gatter did not comment on sham surgeries explicitly,applying this theory to sham surgeries would assume patientstaught themselves about the risks they would face in a surgery.

These three main views of informed consent in the experi-mental setting fail to establish adequate guidelines for what sortof consent is required for sham surgeries. Some treatises on theethics of the placebo effect explicitly exclude sham surgeriesfrom their recommendations or address the topic only in foot-notes.184 Because sham surgery trials have not been tested incourts, it is difficult to predict if sham surgeries will be viewed aslegally distinct from placebo-controlled trials. To date, thecourts have not yet heard this issue because instances of shamsurgery trials are still rare.185

C. Limitations on the Protection of Informed Consent

Current U.S. policy, as embodied by the American Medical

179 Id. at 421-22.180 Id. at 422.181 Id. at 421-22.182 Id. at 422, 424.183 See, e.g., Green Tea Blocks Benefits of Cancer Drug, SCIENCEDAILY (Feb. 5, 2009),

http://www.sciencedaily.com/releases/2009/02/090203162355.htm.184 See supra note 166. R185 See Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair

or Replace Knee Cartilage, FDA: U.S. FOOD AND DRUG ADMINISTRATION (Jul. 2007), http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm078710.pdf.



Association186 and federal regulations,187 restricts the use of pla-cebos in the clinical setting but allows the use of sham surgery inclinical trials when the clinician feels the benefits outweigh therisks. The underlying idea is that, so long as the harm to theshammed patients is “minimized,” the trials are ethical.188 Thisnebulous standard gives physicians leeway to interpret what“minimized harm” is.

Sham surgeries present a unique conundrum to the in-formed consent doctrine because they require that the patientconsent to being tricked. A “trick” sham procedure carries withit a very high risk profile and a very low chance of benefitting thepatient. Despite the discussions in Part II about the placebo ef-fect being amplified by the body’s natural healing process, a phy-sician cannot rely on the chance a patient might have anunintended benefit when informing his patient of the risk pro-file of the sham surgery. The surgery poses known risks and theprobability of benefit to the patient consenting to the sham islow, therefore the informed consent process includes the patientconsenting to taking a chance that he will face very high riskswith no benefit. On the contrary, the risky element of a sugarpill placebo-controlled trial is normally also the potentially-bene-ficial experimental treatment. This tests the limits of informedconsent as it is currently understood.

D. The Problems with Informed Consent

The definition of informed consent is not as simple as itseems.

Patients receive information; consent forms get signed. Butrarely do doctors sit down with patients and provide themwith thorough explanations of treatment options and thenseek their consent to one or another. Instead, information isoften given to patients not to enable them to choose, but toencourage them to cooperate with doctors and to complywith decisions that have already been made, not by patients as

186 AMA CODE OF MED. ETHICS E-2.076 (2003), available at https://ssl3.ama-assn.org/apps/ecomm/PolicyFinderForm.pl?site=www.ama-assn.org&uri=%2fama1%2fpub%2fupload%2fmm%2fPolicyFinder%2fpolicyfiles%2fHnE%2fE-2.076.HTM.

187 45 C.F.R. § 46.111(a)(2) (2005).188 § 46.111(a)(1).



law envisions, but by doctors.189

In the best case scenario, informed consent involves “conversa-tion, negotiation, reflection, and debate among the patient, thedoctor, and possibly many other persons.”190 At the opposite ex-treme, the “doctor makes a recommendation and announces itto the patient in the manner of a fait accompli and obtains thepatient’s signature on a piece of paper, thus formally ratifyingthe decision.”191

“[I]t is well documented that patients retain only a smallpercentage of what their physicians tell them, and many are in-timidated by the physician when discussing surgery.”192 Indeed,empirical studies have demonstrated a low level of patient recall.It is challenging to measure how much a patient understood atthe time they signed the consent form because recall, compre-hension, and even whether or not information was conveyed tothem accurately are hard to measure after the fact.193 In onestudy, 68% of participants in a clinical trial about heart attacktreatments claimed “partial understanding” or “no understand-ing at all” when asked if they comprehended the consent proce-dures.194 Another survey of patients in cancer research trialsfound “major deficiencies” in patient knowledge, including thepatients not realizing that the treatment was experimental andthe uncertainty that they specifically would benefit.195 Thisbrings into question how physicians are presenting informationto study participants.

A physician may argue that it is unfair to presume a patientcould ever comprehend the risks and benefits of a medical pro-cedure for the simple reason that they are not physicians. Riskanalysis in medical procedures is complex and uncertain, whichis why physicians may prefer to make those decisions. Some phy-

189 Alan Meisel & Loren H. Roth, Toward an Informed Discussion of Informed Consent:A Review and Critique of the Empirical Studies, 25 ARIZ. L. REV. 265, 334 (1983).

190 Id. at 337.191 Id.192 Daum v. Spinecare Med. Grp., 61 Cal. Rptr. 2d 260, 268 (Cal. Ct. App. 1997).193 Meisel & Roth, supra note 189, at 290. R194 Rita Yuval et al., Patient Comprehension and Reaction to Participating in a Double-

blind Randomized Clinical Trial (ISIS-4) in Acute Myocardial Infarction, 160 ARCHIVES INTER-

NAL MED. 1142 (2000).195 Steven Joffe et al., Quality of Informed Consent in Cancer Clinical Trials: A Cross-

Sectional Survey, 358 LANCET 1772, 1775 (2001).



sicians even go so far as denigrate signing a consent form as arote “medical Miranda warning.”196 But if the patient does notunderstand197 what is about to be done to him, his consent can-not be “informed.”198 This seems to set the bar unreasonablyhigh.

The most common way that researchers document patients’consent to treatment is through written explanatory documentsand signed consent forms which detail specific informationabout the study, as required by the US Department of Healthand Human Services.199 Although the reading level of the aver-age American is a 6-7th grade level, one study found that theconsent forms from five different research universities were writ-ten at a 10th grade level or higher.200 This article acknowledgeda further complication: a patient’s ability to read is only tangen-tially related to their ability to comprehend what they are agree-ing to.201 Studies have demonstrated that most patients do notrecall the details of their discussions of risks of procedures, evenwhen they sign a consent form.202 A 2008 study of cancer pa-tients found that only 25% of those surveyed could correctlyidentify why they were participating in a clinical trial.203 In aprospective study designed to test patient recall, the “under-standing of fundamental aspects of the trial following a standard

196 Alan Meisel & Mark Kuczewski, Legal and Ethical Myths About Informed Consent,156 ARCHIVES INTERNAL MED. 2521, 2522 (1996).

197 The cornerstone of informed consent is capacity. A person deemed “incompe-tent” by adjudication or minority status cannot give consent. From this, it can be de-duced that there is a minimum level of understanding required before a patient canlegally give consent. This is referred to in the literature as a patient’s “capacity,” ageneral term which refers to a clinician’s judgment that the patient can or cannot do aspecific task. Jennifer Moye & Daniel C. Marson, Assessment of Decision-Making Capacityin Older Adults: an Emerging Area of Practice and Research, 62 J. GERONTOLOGY: PSYCHOL.SCI. 3, 3 (2007). Although this is a legal decision, it is typically made by a medicalclinician with the help of family members or other caregivers. Id. The field of “capacitystudy” has emerged since the 1970s, largely focusing on psychiatric patients and theelderly. Id. at 4. Some empirical studies have looked into quantifying capacity and, byextension, measuring informed consent, but this is an area of medicine that is indefi-nite. Meisel & Roth, supra note 189, at 271-72. R

198 Meisel & Kuczewski, supra note 196, at 2524. R199 Goldstein, supra note 157. R200 Id.201 Id.202 Joffe et al., supra note 195, at 1775-76. R203 F. J. Hlubocky et al., A Study of Informed Consent (IC), Age, and Cognitive Perform-

ance (CP) Among Advanced Cancer Patients in Phase I Trials, 26 J. CLIN. ONCOLOGY no.9523(ASCO Annual Meeting Abstracts Supp. 2008).



consent process was poor.”204 Even though the volunteer pa-tients in this study were graduate-level medical students, 20%were unable to recall any side-effects that the researchers hadwarned them about.205 Another study looked at patients gettingbreast reduction surgeries, believing that “when surgery is fornon-life threatening problems the patient . . . must accept theresponsibility of only signing their consent when they feel theyhave understood possible complications.”206 However, that studyalso found low retention rates of side effects “despite discussionof major complications.”207 Another small but notable studydone in 1965 with fourteen “neurotic” patients explicitly told theparticipants they were taking a sugar pill.208 Not only did thir-teen of the fourteen see an improvement of symptoms, but six ofthe fourteen told the researchers they believed they were receiv-ing an active drug!209 Whether it is due to an inability to under-stand, a desire not to understand, a failure to remember, oroutright duress, patient consent to experimental procedures isnot durable over time.

Worse yet, patients do not want to learn that they have re-sponded to a placebo even after the trial is over. The research-ers studying fetal stem cells in Parkinson’s disease bargainedwith participants that, should the experimental treatment be suc-cessful, patients who only got the sham surgery would be eligibleto receive the experimental treatment later.210 However, thestudy results did not warrant performing the experimental pro-cedure.211 When patients were informed they would not get thefetal stem cell implants because they didn’t work, patients were furi-ous, claiming they never would have consented to participate if

204 P. Fortun et al., Recall of Informed Consent Information by Healthy Volunteers inClinical Trials, 101 QJM 625, 628 (2008).

205 Id.206 Y. Godwin, Do They Listen? A Review of Information Retained by Patients Following

Consent for Reduction Mammoplasty, 53 BRIT. J. PLASTIC SURGERY 121, 124 (2000).207 Id.208 Lee C. Park & Lino Covi, Nonblind Placebo Trial: An Exploration of Neurotic Patients’

Reponses to Placebo when its Inert Content is Disclosed, 12 ARCHIVES GEN. PSYCHIATRY 336(1965).

209 Id. at 338-39. One study participant believed that the doctor only told him hewas receiving a placebo so that he would think that he was helping himself, when actu-ally he received an active drug. Id. at 339.

210 Ruth Macklin, The Ethical Problems with Sham Surgery in Clinical Research, 341 NEW

ENG. J. MED. 992, 994 (1999).211 Id.



they were not sure they would get the “real” treatment.212 Like-wise, some patients take it personally when told that their origi-nal symptoms were “all in their head” because they responded tothe placebo.213 The physician is put in the awkward position ofchoosing to over-inform the patient and risk his refusal to par-ticipate in the study or suit after the trial, or under-inform thepatient and expose the physician to legal risks in the case of apoor outcome.

The current lack of confidence in written consent formsshould be enough to warn physicians against using this methodalone in sham surgery-controlled trials. The difficulties in ob-taining and measuring informed consent introduce two separateproblems for patient autonomy in the case of sham surgery.First, the patient may agree to a procedure without understand-ing the high risks he will be exposed to, negating the Nurem-berg Code because the physician is performing a procedurewithout voluntary informed consent. The physician cannotprove that the patient consented if the patient cannot describethe reason he was undergoing a surgical procedure or the riskshe is consenting to assume. Second, even if the patient does un-derstand the risks, he may not comprehend his chances of re-ceiving a sham surgery in place of the treatment surgery. Thepatient’s hope that he is receiving the experimental therapy trig-gers the placebo effect, but it also might cause him to accept ahigher risk profile than he would if he knew he was only gettinga sham surgery. More investigation into the best ways to dissemi-nate information to patients, particularly very ill patients desper-ate for a cure, is required to address this issue completely.

Research physicians need better guidance on how to tailorinformed consent procedures to suit the needs of both their pa-tients and their sponsors. If sham surgeries become more wide-spread, it is likely that the current procedures will not protectpatients and those patients, in turn, will bring lawsuits againstthe sponsoring institutions that sanctioned the studies. The for-

212 Peter A. Clark, Placebo Surgery for Parkinson’s Disease: Do the Benefits Outweigh theRisks?, 30 J.L. MED. & ETHICS 58, 61 (2002); see also Hoffman, supra note 2, at 483. R

213 Talbot, supra note 28. A study of hormone replacement therapy for women who Rsuffered severe PMS made headlines when researchers disclosed to the women whoimproved on placebo that they had, in fact, improved on a placebo and likely did notneed hormone replacement. Id.



malities of informed consent do not appear to conform to theNuremberg Code in the case of sham surgery-controlled RCTsbecause patients are not adequately informed to appreciate therisks and weigh them against the likelihood of receiving a non-beneficial sham procedure.

Part IV – Argument

As evidenced by nearly every study on the topic, patients donot understand or do not remember what they are consentingto, why they are consenting, and what the risks of participationare. Without truly informed consent, research physicians cannotmove forward with a flawed informed consent procedure intothe high-risk realm of sham surgery-controlled trials. The ethi-cal “floor” set in place by the Nuremberg Code and its legislativeprogeny was intended to ensure that patients could balance therisk of harm against benefits. It may be that current informedconsent protocols are at an appropriate balance for non-invasivecomparative trials.214 However, as it stands today, patients areunable to perform the balancing test in the case of sham sur-geries because sham surgeries pose additional risks and compli-cate disclosure.

A. Sham surgeries are different from placebo controls because ofthe increased risks

The risk-benefit balance is different for a patient who is onlyreceiving a sugar pill placebo than one who is undergoing asham surgery. Exposing a patient to that higher level of riskshould engender a higher level of disclosure, or at the very least,the physician ensuring the patient understands he really mightundergo an entire surgical procedure without receiving the ther-apeutic intervention. When the results of the fetal stem celltrial215 did not support the experimental treatment’s further use,the shammed patients were “outraged”216 and indicated theywould not have participated in the study had they known they

214 Certainly, most case law on the topic involves egregious violations such as failureto inform a patient that he was even participating in an experimental procedure. Daumv. Spinecare Med. Grp., 61 Cal. Rptr. 2d 260 (Cal. Ct. App. 1997).

215 Freed et al., supra note 104. R216 Hoffman, supra note 2, at 483. R



would not get the “real” therapy.217 This supports the idea thatpatients presume a benefit from participation in a clinical trial.Although these patients realized that the sham surgery wouldnot benefit them, they were relying on the possibility that theexperimental therapy would benefit them later.

Modern science does not yet understand which element ofsome kinds of surgery is the effective element. Physicians cannotin good faith tell patients in the sham surgery cohort of a shamsurgery-controlled clinical trial that they are receiving non-treat-ment because it is possible that the sham surgery contains thateffective element.218 It is conceivable that a patient would un-derstand that he runs the risk of getting an experimental drugor no drug at all, but the physician cannot tell this patient he isgetting “no surgery at all.” He is getting some aspects of surgery,namely the risky ones like anesthesia and incisions, but the phy-sician does not think they will be effective for the patient’s prob-lem. If the sham surgery has no beneficial effect, the physician isexposing the patient to a risk of harm without any expected ben-efit, something medico-legal ethics does not currently allow.

The uncertainties219 inherent in sham surgeries leave thedoor open to abuse. Without a clear line delineating whichtypes of sham surgeries are ethical and which are not, it is easy tosay that a “simple” surgery or a “minor” sham with minimal pre-dicted risks is different from a vivisection on a prisoner of war. Inlight of what we know about weaknesses in obtaining informedconsent from patients, the difference is not distinct enough toknow when patients are protected and when they are not. A pa-tient’s body is his alone, and whether the surgery is on a hang-nail or a kidney, nonconsensual surgery is unlawful.

217 Id.218 As evidenced by the examples above, such as the arthroscopy and vertebroplasty

studies where both the control and experimental cohorts experienced comparable im-provements, some element of both the experimental and sham procedures inducedimprovement, but the data collected from those studies does not reveal which one. Seesupra text accompanying notes 115-19. R

219 It is always possible that technology like computer modeling will improve to apoint where researchers can determine which elements are the effective ones andwhich ones need to be controlled, but that level of precision is not available today.



B. In light of these increased risks, sham surgery complicatesdisclosure

In order to permit a physician to operate on another per-son, that patient deserves the highest assurance that his partici-pation is fully informed and he understands what he is agreeingto. Sham surgeries, after all, have no predictable benefit and arenot much different from the example at the beginning of thisarticle. A sham surgery is not designed to heal the patients re-ceiving it; it is designed to offset experimental variables in a com-parison RCT. As such, the research physician is asking forsomething very dear from the patient: a donation of his right toremain free of the trespass of surgery with no anticipated benefitto himself.

In all clinical trials, some level of informed consent is “anecessary but not sufficient justification” for risks to the pa-tient.220 If the physician tells the patient that he is getting thesham procedure for the purposes of encouraging the patient toweigh his risks and benefits more accurately, the clinical proto-col will be breached and the whole purpose of the sham surgerywill be undermined. Sham surgeries and placebo cohorts aredesigned to eliminate all but one variable, the experimentaltreatment. Without the expectation response in the non-treat-ment cohort of a trial, the experimental treatment would lookabnormally successful and the placebo cohort would have failedto offset some variables. Informing the patient that he is gettingthe sham surgery in order to help him decide destroys any pur-pose for performing the surgery.

To extrapolate from the data on informed consent amongmedical students, who are in an excellent position to compre-hend both the underlying purposes and the formalities of in-formed consent, the average patient is not going to be able toweigh both the risk-benefit analysis of a sham surgery and anexperimental surgery. They will likely conflate the two, and typi-cally they presume a higher benefit by comparing a known riskagainst the assumed benefit of the experimental treatment.221

The risks of the sham surgery, which are not offset by any ex-

220 Carl H. Coleman, Duties to Subjects in Clinical Research, 58 VAND. L. REV. 387, 448-49 (2005).

221 Weinfurt, supra note 126. R



pected benefit, are therefore presumed to be lower than theyare. This results in a patient consenting to a procedure he doesnot understand or appreciate. Through no fault of the researchphysician, the patient has foiled informed consent through hisown psychology.

Additionally, physicians conducting clinical trials also de-serve some assurance that, when a patient participates in aclinical trial, the physician is relieved of some of the liability forunpredictable risks. It would be challenging to get any kind ofindemnity or medical malpractice insurance for clinical trials ifparticipants could bring lawsuits for any of the enumerated risksthey allegedly consented to, arguing later that they did not “un-derstand.” Aside from the concerns about informed consentgenerally, in the case of sham surgeries, the physician and hissponsors are exposed to huge financial risks if a participant candemonstrate that he was harmed by a sham surgery that he didnot consent to. It is important for the protection of both pa-tients and physicians that informed consent protocols bestrengthened before moving forward into the realm of shamsurgery.

C. Informed consent protocols as currently used fail to protectsham surgery patients

It may seem reasonable to permit a “minor” sham surgerylike arthroscopic knee surgery to go forward based on a flawedinformed consent protocol. Without further action on the partof the legislature or medical governing bodies like the AMAthere is no barrier to “major” sham surgeries like heart trans-plants and sham brain surgery.222 Some scientists would arguethat determining a safer way to transplant organs would be a sig-nificant benefit to the population at large. But this is not theessential question: the essential question is, are the risks to thepatient minimized? Our culture and our legislature have deter-mined that human beings are not “guinea pigs” to be experi-mented on to satisfy medical curiosity: patients have a right toknow what is being done to them and a right to refuse anyprocedure.

222 Such as the sham brain surgery conducted for the experimental treatment forParkinson’s Disease. See Freed et al., supra note 104. R



Patients often volunteer to participate in clinical trials be-cause they hope to get state-of-the-art medical treatments.223

Even if they do not get the experimental treatment, they oftenreceive diagnostic or ancillary treatments free of cost.224 Asdemonstrated in Part I, the patient may benefit from the placeboeffect, something he could not have received without participa-tion in the clinical trial.

In the worst-case scenario, the patient is harmed by thesham surgery itself. If he has a negative result from either thesham surgery or from forgoing other known treatments for thechance to participate in the clinical trial, he has been harmedbeyond the standard of things ordinarily encountered in dailylife or routine tests.225 His body has been invaded, and he suf-fered a likely physiological adverse event. Unlike the nocebo ef-fect, an adverse result from a sham surgery is likely to be a trueadverse event, such as an infection.226 Even though the noceboeffect is linked with significant adverse events, it has not yet beenlinked with contracting serious infections.227

As enthusiastically as some medical ethicists defend shamsurgery controls, they have lost sight of both the “ethical floor”imposed by the Nuremberg Code and the probability that theyare opening Pandora’s Box of ever-more-invasive sham surgeries.To properly analyze theoretical ethics, one considers both theextreme examples228 and the probable.229 Consider the exam-ple of organ donation, where a donor consents to a major surgi-cal procedure with no expected benefit to donor.230 The

223 Coleman, supra note 220, at 396. R224 See What Participants Need to Know About Clinical Trials, MERCK MANUAL HOME

EDITION, http://www.merck.com/mmhe/sec25/ch307666/ch307666c.html (last visitedJan. 21, 2011).

225 Id.226 E.g., Daum v. Spinecare Med. Grp., 61 Cal. Rptr. 2d 260, 266 (Cal. Ct. App.

1997) (describing patient’s “deep bone infection, which would probably persist for therest of his life.”).

227 Cloud, supra note 37. R228 This is the essence of the “slippery slope” argument: if the worst-case scenario is

unacceptable, working backwards from that to find an acceptable level of risk demon-strates where the “ethical floor” should rest.

229 Miller, supra note 160, at 44 (“[T]he fundamental ethical query should be Rwhether it is ever ethical to use sham surgery as a control in a randomized clinicaltrial.”).

230 Currently, it is against the law to sell any human organs America. For variousreasons, a healthy person can consent to an inter vivos donation of an organ without



consent process is long and elaborate because of the high risk todonors.231 To be in accord with this level of consent, a shamsurgery involving major organs should carry a very high burdenof informing the participant. However, a high level of patientinformation could risk unblinding an RCT, thereby renderingthe patient’s participation moot. Alternatively, the sham surgerycould go as expected, but the patient experiences no improve-ment of his symptoms and now requires a second major surgeryto treat his condition. Thus, even by failing to harm him, thesham surgery has caused the patient to suffer the risks of addi-tional procedures.232

The Nuremberg Code was enacted to protect the partici-pants in research trials by allowing human experimentation onlywhen a specific balance of risks and benefits is met. Accordingto the Code, the risk to the patient can only be mitigated bygenuine233 informed consent, regardless of the intended benefitfor humanity at large. The argument that risk to the participantmust be balanced with “answering valuable scientific ques-tions”234 contradicts what the Nuremberg Code and Americanlaws dictate. Current informed consent protocols are weak, andthe high risks of sham surgeries warrant better protection forboth patients and the institutions sponsoring trials. Althoughsham surgery-controlled RCTs have the potential to reveal muchinformation about the value of novel surgical procedures, thisexcitement must be tempered with a serious regard for patientautonomy. The benefit to the medical community cannot beused as an overriding directive to outweigh the risk of harm tothe individual participants: this is the essential abuse the Nu-remberg Code was trying to prevent. Sham surgery-controlledtrials should not go forward unless and until informed consent

remuneration. National Organ Transplant Act of 1984, Pub. L. No. 98-507, 98 Stat.2339 (1984); Organ Procurement and Transplant Network, 42 U.S.C § 274 (2008).

231 Organ and Tissue Donation from Living Donors, ORGANDONOR.GOV, http://organdonor.gov/donation/typesofdonation.htm (last visited Jan. 21, 2011).

232 Postoperative Care, MERCK MANUAL FOR HEALTHCARE PROFESSIONALS, http://www.merck.com/mmpe/sec22/ch335/ch335f.html (last visited Jan. 21, 2011).

233 The Nuremberg Code specifically warns against duress and coercion. Althoughthe idea of critically-ill patients desperate for relief is only touched on briefly in thisnote, there is a heated debate in medical literature about access to drugs for the termi-nally-ill. See supra note 12. R

234 Miller, supra note 160, at 45. R



protocols more accurately inform patients of the real risks theyare facing.

D. Improving Patient Protection Requires StrengtheningInformed Consent Protocols

Current informed consent protocols fail in light of theheightened risks of sham surgery. Therefore, it is unethical touse sham surgery controls without more patient protection. Theliterature surrounding sham surgery is pulling in two main direc-tions: scientists who want to expand science and have fewer fet-ters on how they conduct human experiments, and ethicists whosee the dangers of allowing someone to consent to harm. At pre-sent, the medical mainstream235 is trending towards allowingmore sham surgeries. If sham surgery RCTs are undertakenwithout an improved informed consent protocol, they violatefederal regulations regarding human experimentation.

Surgical procedures cause a complex, systemic response andit is difficult to isolate the variable that causes the ameliorationin the patient. This might explain why many vertebroplasty pa-tients report a sudden, lasting cessation of back pain eventhough the cementing process “doesn’t work”: something otherthan the cement is making them improve.236 The scientific wayto uncover the cause of the improvement is to run a series ofsurgical clinical trials. Each trial would eliminate only one varia-ble until enough patients have failed to get relief in one cohort.After that, it can then be safely assumed that the variable theydid not receive is the true active treatment. Most in vivo labsalready use this systematic scientific method, but the test subjectsare literally domestic animals, bred or purchased for the pur-pose of being tested. The very essence of the Nuremberg Codewas to prevent humans from ever being treated in this way.237

A mere 60 years ago, civilized people were horrified by thetorturous experiments perpetrated on prisoners of war in WorldWar II and moved to prevent these atrocities from happeningagain. These guidelines have made drastic improvements in pa-

235 Encouraged by the health care payors who determine which treatments to reim-burse based on EBM. See supra note 49. R

236 See supra notes 116-17. R237 Evelyne Schuster, Fifty Years Later: The Significance of the Nuremberg Code, 337 NEW

ENG. J. MED. 1436 (1997).



tient autonomy and ensure that almost all participants in legiti-mate clinical trials have some idea of what is happening to themand some ability to refuse participation.

The topic of sham surgeries is still relatively new and there-fore somewhat obscure. This note is one of the early forays intoexamining sham surgery through a legal lens. It demonstratesthat current informed consent protocol is not in accord with reg-ulations on human experiments. Perhaps, after a public discus-sion, Congress will determine that medical progress should notbe impeded by imperfect informed consent and that the value tothe population at large does, in fact, trump the risk of harm toany one individual. This would mean scaling back the protec-tions of the Nuremberg Code in order to require a lower level ofconsent for all human experiments. As it stands today, a physi-cian conducting a sham surgery is violating the principles of theNuremberg Code by engaging in precisely the kind of experi-mentation it forbids.

There could be many ways to strengthen informed consentprotocols so that they protect patients and physicians. Amandatory waiting period before beginning treatment couldgive patients more time to digest the information, but this wouldbe a luxury in the case of a terminal patient or one in considera-ble pain. Bringing in an additional counselor in conjunctionwith the physician who can “translate” from medical jargon to layterms could also add transparency. It is evident that, while muchinquiry is made into how and when informed consent protocolsfail, little is known about why. Isolating the aspects of informedconsent protocols that need improvement could likewisestrengthen the protections of informed consent to the pointwhere they would be sufficient to allow sham surgery-controlledtrials.

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