Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths

Salsburg D.S. , “The Religion of Statistics as Practiced in Medical Journals,” American Statistician, 39 (1985): 220–23.

Rothman K.J. Michels K.B. , “The Continuing Unethical Use of Placebo Controls,” N. Engl. J. Med., 331 (1994): 394–98.

Sramek J.J. Cutler N.R. , letter; comment, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 62; Denny W.F. , letter; comment, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 61–62; Pohl R. Balon R. , letter; comment; discussion, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 61–62; Nash S.D. , letter; comment; discussion, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 61–62; Gilbert E.M. Packer M. , letter; comment; discussion, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 61–62; Cleophas T.J. , letter; comment; discussion, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 61–62; Taylor H.R. , letter; comment; discussion, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 60–62; Schecter C. , letter; comment; discussion, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 60–62; Cagliano S. Traversa G. , letter; comment; discussion, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 60–62; and Solomon D.A. , letter; comment; discussion, “The Use of Placebo Controls,” N. Engl. J. Med., 332 (1995): 60–62.

Markman M. , “When Regulatory Requirements Conflict with Ethical Study Design: The Case of Oral Ondansetron,” Cancer Investigation, 12 (1994): 654–56; Peterson W.L. Elashoff J. , “Placebos in Clinical Trials of Duodenal Ulcer: The End of an Era?,” Gastroenterology, 79 (1980): 585–88; Levine R.J. , “The Use of Placebos in Randomized Clinical Trials,” IRB: A Review of Human Subjects Research, 17, no. 2 (1985): 1–4; and Freedman B. , “Placebo-Controlled Trials and the Logic of Clinical Purpose,” IRB: A Review of Human Subjects Research, 12, no. 6 (1990): 1–6.

Bok S. , Lying: Moral Choice in Public and Private Life (New York: Vintage Books, 1978): At 61–68.

Levine R.J. , Ethics and Regulation of Clinical Research (Baltimore: Urban & Schwarzenberg, 2nd ed., 1986): At 229–30.

Temple R. , “Difficulties in Evaluating Positive Control Trials,” Proceedings of the American Statistical Association, (1983): 1–7.

Bailar J.C. , “Introduction,” in Shapiro S.H. Louis T.A. , eds., Clinical Trials: Issues and Approaches (New York: Marcel Dekker, 1983): 1–12; and Friedman L.M. Furberg C.D. DeMets D.L. , Fundamentals of Clinical Trials (Littleton: PSG Publishing, 2nd ed., 1985): 1–10.

Peruck S.B. Hinkle L.E. , “The Effect of Expectation on Response to Phenmetrazine,” Psychosomatic Medicine, 26 (1964): 369–73.

Dinnerstein A.J. Haim J. , “Modification of Placebo Effects by Means of Drugs,” Journal of Abnormal and Sociological Psychology, 75 (1970): 308–14.

Lasagna L. Laties V.G. Dohan J.L. , “Further Studies on the ‘Pharmacology’ of Placebo Administration,” journal of Clinical Investigation, 37 (1958): 533–37.

Schapira K. , “Study on the Effects of Tablet Colour in the Treatment of Anxiety States,” British Medical journal, 1 (1970): 446–49; Huskisson E.C. , “Simple Analgesics for Arthritis,” British Medical Journal, 4 (1974): 196–200; Lucchelli P.E. Cuttaneo A.D. Zattoni J. , “Effect of Capsule Colour and Order of Administration of Hypnotic Treatments,” European Journal of Clinical Pharmacology, 13 (1978): 153–55; and Buckalew L.W. Coffield K.E. , “An Investigation of Drug Expectancy as a Function of Capsule Color and Size and Preparation Form,” Journal of Clinical Psychopharmacology, 2 (1982): 245–48.

Schindel S. , “The Placebo Dilemma,” European Journal of Clinical Pharmacology, 13 (1978): 231–35.

Ney P.G. Collines C. Spensor C. , “Double Blind: Double Talk or Are There Ways to Do Better Research,” Medical Hypotheses, 21 (1986): 119–26.

White K. , reply to letter, “Side Effects and the ‘Blindability’ of Clinical Drug Trials,” American Journal of Psychiatry, 150 (1993): 1760–61.

Fisher S. Greenberg R.P. , “How Sound is the Double-Blind Design for Evaluating Psychotropic Drugs?,” Journal of Nervous and Mental Disease, 181 (1993): 345–50.

Kuhn T.S. , The Structure of Scientific Revolutions (Chicago: University of Chicago Press, 2nd ed., 1970).

Curson D.A. , “Does Short Term Placebo Treatment of Chronic Schizophrenia Produce Long Term Harm?,” British Medical Journal (Clinical Research Edition), 293 (1986): 726–28.

Ross S. Buckalew L.W. , “Placebo Agentry: Assessment of Drug and Placebo Effects,” in White L. Tursky B. Schwartz G.E. , eds., Placebo: Theory, Research, and Mechanisms (New York: Guilford Press, 1985): 67–82.

Friedman A.S. , “Interaction of Drug Therapy with Marital Therapy in Depressive Patients,” Archives of General Psychiatry, 32 (1975): 19–37.

Fisher Greenberg , supra note 17.

Friedman Furberg DeMets , supra note 8, at 84–88.

Lasagna L. , “The Helsinki Declaration: Timeless Guide or Irrelevant Anachronism?,” Journal of Clinical Psychopharmacology, 15 (1995): 96–98.

Pohl Balon , supra note 3.

Grunbaum A. , “Explication and Implications of the Placebo Concept,” in White L. Tursky B. Schwartz G.E. , eds., Placebo: Theory, Research, and Mechanisms (New York: Guilford Press, 1985): 9–36.

Yusuf S. Collins R. Peto R. , “Why Do We Need Large, Simple Randomized Trials?,” Statistics and Medicine, 3 (1984): 409–20.

Solomon , supra note 3.

Henry D. Hill S. , “Comparing Treatments,” British Medical Journal, 310 (1995): 1279.

Freedman B. Glass K.C. Weijer C. , “Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths,” Journal of Law, Medicine & Ethics, 24 (1996): 252–59.

Belchetz P.E. , “Drug Therapy: Hormonal Treatment of Postmenopausal Women,” N. Engl. J. Med., 330 (1994): 1062–71.

Liberman U.A. , “Effect of Oral Alendronate on Bone Mineral Density and the Incidence of Fractures in Postmenopausal Osteoporosis,” N. Engl. J. Med., 333 (1995): 1437–43.

Sambrook P.N. , “The Treatment of Postmenopausal Osteoporosis,” N. Engl. J. Med., 333 (1995): 1495–96.

Temple R. , “Government Viewpoint of Clinical Trials,” Drug Information Journal, Jan./Feb. (1982): 10–17.

Leber P. , “The Placebo Control in Clinical Trials (A View from the FDA),” Psychopharmacology Bulletin, 22 (1986): 30–32; and Addington D. , “The Use of Placebos in Clinical Trials for Acute Schizophrenia,” Canadian Journal of Psychiatry, 40 (1995): 171–76.

Blackwelder W.C. , “‘Proving the Null Hypothesis’ in Clinical Trials,” Controlled Clinical Trials, 3 (1982): 345–53.

Fleming T.R. , “Evaluation of Active Control Trials in AIDS,” Journal of Acquired Immune Deficiency Syndromes, 3 (1990): S82–S87.

Lee M.L. Lusher J.M. , “The Problem of Therapeutic Equivalence with Paired Qualitative Data: An Example from a Clinical Trial Using Hemophiliacs with an Inhibitor to Factor VIII,” Statistics in Medicine, 10 (1991): 433–41.

Rodary C. Com-Nougue C. Tournade M.F. , “How to Establish Equivalence Between Treatments: A One-Sided Clinical Trial in Pediatric Oncology,” Statistics in Medicine, 8 (1989): 593–98.

Makuch R. Johnson M. , “Issues in Planning and Interpreting Active Control Equivalence Studies,” Journal of Clinical Epidemiology, 42 (1989): 503–11; and Blackwelder , supra note 39.

Blackwelder , supra note 39.

Shapiro A.K. Morris L.A. , “The Placebo Effect in Medical and Psychological Therapies,” in Garfield S.L. Bergin A.E. , eds., Handbook of Psychotherapy and Behavior Change (New York: Wiley, 1978): 369–410.

Friedman Furberg DeMets , supra note 8, at 88–93.

Makuch R. Simon R. , “Sample Size Requirements for Evaluating Conservative Therapy,” Cancer Treatment Reports, 62 (1978): 1037–40.

Young S.N. Annable L. , “The Use of Placebos in Psychiatry: A Response to the Draft Document Prepared by the Tri-Council Working Group,” Journal of Psychiatry and Neuro-science, 21 (1996): 235–38.

Makuch Johnson , supra note 43.