Authors: David Healy
15
. Terence Young,
Death by Prescription
(Toronto: Key Porter Books, 2001).
16
. Lynn,
The Billion-Dollar Battle
, 18.
17
.
http://www.mcareol.com/mcolfree/mcolfrei/visiongain/blockbuster.htm
(accessed June 17, 2008).
18
. Lilly documents,
Cross-Brand Segmentation.
Zyprexa: MultiDistrict Litigation 1596, Document ZY200085380 and Document ZY200083203 (2000); available on
http://www.furiousseasons.com/zyprexa.docs
(accessed Feb. 10, 2007).
19
. Lilly documents,
Cross-Brand Segmentation.
Zyprexa: MultiDistrict Litigation 1596, Document ZY200085380 and Document ZY200083203 (2000); available on
http://www.furiousseasons.com/zyprexa.docs
(accessed Feb. 10, 2007).
20
. Lynn,
The Billion-Dollar Battle
, 19.
21
. Edward Shorter,
From Paralysis to Fatigue: A History of Psychosomatic Illness in the Modern Era
, 311â313 (New York: Free Press, 1992).
22
. Francoise Simon and Philip Kotler,
Building Global Biobrands
, 147 (New York: Free Press, 2003).
23
. Julie M. Donohue, Merisa Cavasco, and Meredith B. Rosenthal,
A decade of direct-to-consumer advertising of prescription drugs
, New England Journal of Medicine 357, 673â681 (1991).
24
. Pfizer's Lyrica emerged for fibromyalgia at this point.
25
. Glen Spielmans,
Duloxetine does not relieve painful physical symptoms in depression: A meta-analysis
, Psychotherapy and Psychosomatics 77, 12â16 (2008).
26
. George Ashcroft, “The receptor enters psychiatry,” in
The Psychopharmacologists
, ed. David Healy, 3, 189â200 (London: Arnold, 2000).
27
. Jeremy Greene,
Prescribing by Numbers
(Baltimore: Johns Hopkins University Press, 2007).
28
. Steven Woloshin and Lisa M. Schwartz,
Giving legs to restless legs: A case study of how the media makes people sick
, PLoS Medicine 3, 170â174 (2006), doi:10.1371/journal.pmed.0030170. Just as GERD has been extended to infantile colic, so has restless legs to what used to be called growing pains in children, who accordingly now are likely to be treated with dopamine agonistsâdrugs that come with a risk of cardiovascular collapse and death.
29
. Peter Kramer,
Listening to Prozac
(New York: Viking Press, 1993).
30
. E. Fuller Torrey,
The going rate on shrinks: Big pharma and the buying of psychiatry
, The American Prospect, 15â16 (July 2002).
31
. Daniel Bell,
The cultural contradictions of capitalism
(New York: Basic Books, 1995); Thomas Franks,
Commodify your Dissent
(New York: Norton, 1999); Joseph Heath and Andrew Potter,
The Rebel Sell: How the Counterculture Became Consumer Culture
(Chichester: Capstone, 2005).
32
. Dora B. Weiner,
The Citizen-Patient in Revolutionary and Imperial Paris
(Baltimore: Johns Hopkins University Press, 2002).
33
. Laurie Garrett,
Betrayal of Trust: The Collapse of Global Public Health
(New York: Hyperion, 2000).
34
. Merrill Goozner,
The $800 Million Pill
(Berkeley: University of California Press, 2004).
35
. British Medical Association,
Secret Remedies
(London: British Medical Association, 1909).
36
. L. Kilker v. SmithKline Beecham d/b/a GlaxoSmithKline, First Judicial District of Pennsylvania, Civil Trial Division no. 1813 (Sept. 3, 2009).
37
. John H. Coverdale, Laurence B. McCullagh, and Frank A. Chervenak,
The ethics of randomized placebo controlled trials of antidepressants with pregnancy women: A systematic review
, Obstetrics and Gynecology 112, 1361-1368 (2008); Anne Drapkin Lyerly et al.,
Risk and pregnant body
, Hastings Center Report 39, 34â42 (2009) ; David Healy, Derelie Mangin, and Barbara Mintzes,
The ethics of randomized placebo controlled trials of antidepressants with pregnant women
, International Journal of Risk and Safety in Medicine 22, 1â10 (2010), doi:10.3233/JRS-2010â0487.
CHAPTER 3
1
. Jason Dana and George Loewenstein,
A social science perspective on gifts to physicians from industry
, JAMA 290: 2, 252â255 (2003).
2
. Michael A. Steinman, Michael G. Shlipak, and Steven J. McPhee,
Of principles and pens: Attitudes of medicine house staff toward pharmaceutical industry promotions
, American Journal of Medicine, 110, 551â557 (2001).
3
. Meredith Wadman,
The senator's sleuth
, Nature 461, 330â33 (Sept. 17, 2009).
4
. James Lind,
A Treatise of the Scurvy
(1752; Edinburgh: Edinburgh University Press, 1953), 145.
5
. Philippe Pinel,
Traité médico-philosophique sur la manie
(1800), trans. D. Davis (London: Cadell and Davies, 1806).
6
. Philippe Pinel,
Traité médico-philosophique sur l'aliénation mentale
(1809), trans. Gordon Hickish, David Healy, and Louis C. Charland (Chichester: John Wiley and Sons, 2009).
7
. Pierre C. A. Louis, cited in A. M. Lilienfeld,
Ceteribus paribus: The evolution of the clinical trial
, Bulletin of the History of Medicine 56, 1â18, 6 (1982).
8
. Pierre C. A. Louis, cited in M. D. Rawlins,
Development of a rational practice of therapeutics
, BMJ 301, 729â733 (1990).
9
. L. M. Lawson (1849), cited in Charles E. Rosenberg, “The therapeutic revolution: Medicine, meaning and social change in nineteenth-century America,” in
The Therapeutic Revolution
, ed. M. J. Vogel and C. E. Rosenberg, 20 (Philadelphia: University of Pennsylvania Press, 1979).
10
. Rabies turned out to be caused by a virus rather than a bacterium.
11
. Roy Porter,
The Greatest Benefit to Mankind
(London: Fontana Press, 1999).
12
. Martha Marquardt,
Paul Ehrlich
(New York: Henry Schumann, 1951).
13
. Paul De Kruif,
Microbe Hunters
(New York: Harcourt, 1926).
14
. Sandra Hempel,
The Strange Case of the Broad Street Pump: John Snow and the Mystery of Cholera
(Berkeley: University of California Press, 2009).
15
. Lawrence Altman,
Who Goes First? The Story of Self-Experimentation in Medicine
(New York: Random House, 1987).
16
. Sanjeebit J. Jachuk, H. Brierley, S. Jachuk and P. M. Willcox,
The effect of hypotensive drugs on the quality of life
, Journal of the Royal College of General Practitioners 32, 103â105 (1982).
17
. Ronald Fisher,
The Design of Experiments
(Edinburgh: Oliver and Boyd, 1935).
18
. Steven T. Ziliak and Deirdre N. McCloskey,
The Cult of Statistical Significance: How the Standard Error Cost Us Jobs, Justice and Lives
(Ann Arbor: University of Michigan Press, 2008).
19
. A phrase widely attributed to Charlie Poole.
20
. Gordon C. Smith and Jill P. Pell,
Parachute use to prevent death and major trauma related to gravitational challenge
, BMJ 327, 1459â1461 (2003).
21
. Thomas Hager,
The Demon under the Microscope
(New York: Harmony Books, 2006).
22
. Philip J. Deveraux and the POISE Study Group,
Effects of extended release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): A randomized controlled trial
, Lancet 371 (2008), doi:10.1016/S0140â6736(08) 60601â7.
23
. Marc A. Pfeffer, Emmanuel A. Burdmann, Chao-Yin Chen et al.,
A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease and anemia
, NEJM 361 (2009), doi:10.1056/NEJMoa0907845; Philip A. Marsden,
Treatment of anemia in chronic kidney disease: Strategies based on evidence
, NEJM 361 (2009), doi:10.1056/NEJMe0909664.
24
. Bruce M. Psaty and Richard A. Kronmal,
Reporting mortality findings in trials of rofecoxib forAlzheimer disease or cognitive impairment
, JAMA 299, 1813â1817 (2008).
25
. Harry Collins and Trevor Pinch,
Dr. Golem. How to Think about Medicine
(Chicago: University of Chicago Press 2005).
26
. Mary Robertson and Michael Trimble,
Major tranquilizers used as antidepressants
, J Affective Disorders 4, 173â193 (1982).
27
. David Healy,
Let Them Eat Prozac
(New York: New York University Press, 2004).
28
. The data for this figure stem from the FDA's review of antidepressants drugs. M. Stone and L. Jones, Clinical Review (2006), 31;
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006â4272bi-index.htm
.
29
. Neither the data nor the arguments here apply to severe cases of depression in secondary care, melancholia for instance. This works to the advantage of companies, who can portray the much smaller placebo response in melancholia as good evidence that antidepressants do in fact work.
30
. David Healy,
The assessment of outcome in depression: Measures of social functioning
, Reviews in Contemporary Pharmacotherapy 11, 295â30! (2000).
31
. Daniel Kahnemann, Paul Slovic, and Amos Tversky,
Judgment under Uncertainty: Heuristics and Biases
(Cambridge: Cambridge University Press, 1982).
32
. ALLHAT (The antihypertensive and lipid-lowering treatment to prevent heart attack trial),
Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs. diuretic
, JAMA 288, 2981â2997 (2002).
33
. Healy,
Let Them Eat Prozac
.
34
. Joseph F. Wernicke et al.,
Low-dose fluoxetine therapy for depression
, Psychopharmacology Bulletin 24, 183â188 (1988).
35
. Jean Thuillier,
Ten Years that Changed the Face of Mental Illness
, trans. Gordon Hickish (London: Martin Dunitz, 1999).
36
. David J. Osborn et al.,
Relative risk of cardiovascular and cancer mortality in people with serious mental illness from the United Kingdom's General Practice Research Database
, Archives of General Psychiatry 64, 1123-1131 (2007); Sukanta Saha, David Chant, and John McGrath,
A systematic review of mortality in schizophrenia
, Archives of General Psychiatry 64, 1123-1131 (2007).
37
. Archibald Cochrane,
Effectiveness and Efficiency
(London: Nuffield Provincial Hospitals' Trust, 1972).
38
. “Percentage of practice that is evidence based” (Sheffield University website):
http://www.shef.ac.uk/scharr/ir/percent/html
(accessed Oct. 30, 2009).
39
. Iain Chalmers, Kay Dickerson, and Thomas C. Chalmers,
Getting to grips with Archie Cochrane's Agenda
, BMJ 305, 786â788 (1992).
40
. David L. Sackett, Brian R. Haynes, Gordon Guyatt, and Peter Tugwell,
Clinical Epidemiology: A Basic Science for Clinical Medicine
(Boston: Little Brown, 1985); David L. Sackett and William M. Rosenberg,
The need for evidence-based medicine
, Journal of the Royal Society of Medicine 88, 620â624 (1995).
41
. David Healy and Marie Savage,
Reserpine exhumed
, British Journal of Psychiatry 172, 376â378 (1998).
42
. David L. Davies and Michael Shepherd,
Reserpine in the treatment of anxious and depressed patients
, Lancet 117â121 (1955).
43
. Michael Shepherd, “Psychopharmacology: Specific and non-specific,” in
The Psychopharmacologists
, ed. David Healy, 2, 237â257 (London: Arnold, 1998).
44
. F. Horace Smirk and E. Garth McQueen,
Comparison of rescinamine and reserpine as hypotensive agents
, Lancet 115â116 (1955); Douglas C. Wallace,
Treatment of hypertension. Hypotensive drugs and mental changes
, Lancet 116â117 (1955).
45
. Martin H. Teicher, Carol Glod, and Jonathan O. Cole,
Emergence of intense suicidal preoccupation during fluoxetine treatment
, American Journal of Psychiatry 147, 207â210 (1990).
46
. Charles Medawar and Anita Hardon,
Medicines Out of Control?
(Amsterdam: Aksant, 2004).
47
. Austin Bradford Hill,
Reflections on the controlled trial
, Annals of the Rheumatic Diseases 25, 107â113 (1966).
CHAPTER 4
1
. These include commercial/financial, legal, and patent departments, as well as the relatively separate manufacturing operations.
2
. CenterWatch,
State of the Clinical Trials Industry
(Boston: CenterWatch, 2009).
3
. Kurt Eichenwald and Gina Kolata, “A doctor's drug studies turn into fraud,”
New York Times
, May 17, 1999; Steve Stecklow and Laura Johannes, “Questions arise on new drug testing. drug makers relied on clinical researchers who now await trial,”
Wall Street Journal
, Aug. 15, 1997; Carl Elliott, “Guinea pigging. Healthy human subjects for drug safety trials are in demand. But is it a living?”
New Yorker
, 36â41, Jan. 7, 2008.