Notes
INTRODUCTION
1. Joseph T. Freeman, Dr. Alfred J. Worcester: Early exponent of modern geriatrics, Bulletin NY Academy of Medicine 64, 246–251 (1988).
2. Derek Kerr, Alfred Worcester: A pioneer in palliative care, American Journal of Hospice and Palliative Care, May, 13–36 (1992).
3. Charles Crenner, Private Practice. The Early Twentieth-Century Medical Office of Dr. Richard Cabot (Baltimore: Johns Hopkins University Press, 2006).
4. Ivan Illich, Medical Nemesis: The Limits of Medicine (London: Calder and Boyars, 1975).
5. http://www.socialaudit.org.uk/6070225.htm (accessed Feb. 27, 2007); on this Social Audit website, the section entitled “No Cards Please” announces the retirement of Charles Medawar and introduces the notion of Pharmageddon.
6. Charles Medawar, Graham Dukes, Tim Reed, Andrew Herxheimer, and David Healy, “Pharmageddon,” http://www.socialaudit.org.uk/60700716.htm#Pharmageddon (accessed July 30, 2007).
7. Jason Lazarou, Bruce H. Pomeranz, and Paul N. Corey, Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies, JAMA 279, 1200–1205 (1998).
8. John Abramson, Overdosed America: The Broken Promise of American Medicine (New York: Harper Perennial, 2004).
9. Jerome Kassirer, On the Take (New York: Oxford University Press, 2006); Marcia Angell, The Truth about the Drug Companies (New York: Random House, 2006); Merrill Goozner, The $800 Million Pill (Berkeley: University of California Press, 2004); Sheldon Krimsky, Science in the Private Interest (Lanham, MD: Rowman and Littlefield, 2004); Ray Moynihan and Alan Cassels, Selling Sickness (New York: Nation Books, 2005); Jeremy Greene, Prescribing by Numbers (Baltimore: Johns Hopkins University Press, 2007); Alicia Mundy, Dispensing with the Truth (New York: St. Martin's Press, 2003); Abramson, Overdosed America; Melody Petersen, Our Daily Meds (New York: Farrar, Straus and Giroux, 2008); Alison Bass, Side Effects (Chapel Hill, NC: Algonquin, 2008).
10. Hank McKinnell, A Call to Action (New York: McGraw Hill, 2005).
11. Daniel Callahan and Angela A. Wasunna, Medicine and the Market: Equity v. Choice. (Baltimore: Johns Hopkins University Press, 2006).
12. Philippe Pinel (1809), Traité médico-philosophique sur l'aliénation mentale, in Treatise on Mental Alienation, trans. Gordon Hickish, David Healy, and Louis Charland, xiii (Chichester: John Wiley and Sons, 2009).
13. Kalman Applbaum, “Marketing Global Healthcare: The Practices of Big Pharma,” Socialist Register, http://www.mcareol.com/mcolfree/mcolfrei/visiongain/blockbuster.htm (accessed June 17, 2008).
14. Spending on pharmaceutical drugs is listed at several locations on the IMS Health website; see http://www.imshealth.com (accessed June 28, 2008).
15. http://www.imshealth.com/deployfiles/imshealth/Global/Content/StaticFile/Top_Line_DataZGlobal_Top_15_Therapy_Classes.pdf (accessed May 1, 2011).
CHAPTER 1
1. Alfred Worcester, Past and present methods in the practice of medicine, Boston Medical and Surgical Journal 166, 159–164 (1912).
2. Worcester, Past and present methods in the practice of medicine.
3. Arthur Kleinman, The Illness Narratives (New York: Basic Books, 1988).
4. Michael Oldani, Filling Scripts: A Multi-Sited Ethnography of Pharmaceuticals Sales Practices, Psychiatric Prescribing, and Phamily Life in North America (PhD dissertation, Princeton University, 2006).
5. http://www.decodog.com/invent/psychologicali.html (accessed Oct. 27, 2009); available from the author.
6. http://www.fiercepharma.com/special-reports/pfizer-top-13-advertising-budgets (accessed Oct. 10, 2010).
7. Hank McKinnell, A Call to Action (New York: McGraw Hill, 2005).
8. Charles C. Mann and Mark L. Plummer, The Aspirin Wars (New York: Alfred A. Knopf, 1991).
9. Kalman Applbaum, The Marketing Era (New York: Routledge, 2004).
10. Applbaum, The Marketing Era. See also Kalman Applbaum, Pharmaceutical marketing and the invention of the medical consumer, PLoS Medicine 3, e189 (2006).
11. Joseph Liebenau, Medical Science and Medical Industry (Basingstoke: Macmillan Press, 1987).
12. James H. Young, The Medical Messiahs: The Social History of Health Quackery in Twentieth-Century America (Princeton: Princeton University Press,1992).
13. Liebenau, Medical Science and Medical Industry.
14. Claude C. Hopkins, “My Life in Advertising” (1927), cited in James H. Young, The Medical Messiahs: The Social History of Health Quackery in Twentieth-Century America, 21 (Princeton: Princeton University Press, 1992).
15. British Medical Association, Secret Remedies (London: British Medical Association, 1909).
16. 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, 3–25 (Philadelphia: University of Pennsylvania Press, 1979).
17. British Medical Association, Secret Remedies.
18. Cited in BMJ 328:137 (2004), doi:10.1136/bmj.328.7452.1371.
19. Liebenau, Medical Science and Medical Industry; P. J. Hilts, Protecting America's Health: The FDA, Business and One Hundred Years of Regulation (New York: Alfred A. Knopf, 2003).
20. Edward S. Shorter, “Primary Care,” in The Cambridge Illustrated History of Medicine, ed. Roy Porter (Cambridge: Cambridge University Press, 1996).
21. Mann and Plummer, Aspirin Wars.
22. Giulio Mandich, Venetian patents (1450–1550), Journal of the Patent Office Society 30, 177 (1948); Frank D. Prager, The early growth and influence of intellectual property, Journal of the Patent Office Society 34, 106–140 (1952).
23. Christine MacLeod, Inventing the Industrial Revolution. The English Patent System, 1660–1800 (Cambridge: Cambridge University Press, 1988); see Section 6, An Act concerning Monopolies and Dispensations with Penal Laws, and the Forfeitures thereof (better known as the Statute of Monopolies).
24. Peter Drahos and John Braithwaite, Information Feudalism: Who Owns the Knowledge Economy? (London: Earthscan, 2002).
25. Jean-Paul Gaudilliere, How pharmaceuticals became patentable: The production and appropriation of drugs in the twentieth century, History and Technology 24, 99–106 (2008); Maurice Cassier, Brevets pharmaceutiques et sante publique en France, Enterprise et histoire 36, 29–47 (2004).
26. Intriguingly, they also argued that patenting would confer state approval on certain drugs, offering their manufacturers a commercial advantage that could lead to injuries if the true hazards of the new drugs had not been fully recognized.
27. Michael Bliss, The Discovery of Insulin (Toronto: McClelland and Stewart, 1982).
28. http://en.wikipedia.org/wiki/Jonas_Salk.
29. David Healy, The Antidepressant Era, chap. 2 (Cambridge, MA: Harvard University Press, 1998).
30. Drahos and Braithwaite, Information Feudalism. The outlines of this agreement appear to have been formulated within Pfizer in the 1980s. It took a decade to make its way into international trade agreements.
31. India adopted a patent law in sync with Western laws in 2005 but before that the TRIPS agreement, which had significant input from Western pharmaceutical companies, came into being in 1995.
32. A new molecule should not come from an already patented class of drugs, except when this particular compound from within that class can be shown to do something that other molecules in the class don't do. For example, a minor variation on the 1940s drug promazine, an antihistamine, made by adding a single chlorine ion, in 1950 produced a quite differently acting drug, chlorpromazine, the first of the antipsychotics. Another minor variation of promazine produced imipramine, the first of the antidepressants, and after that a series of other compounds were constructed that in addition to treating mental illness, by virtue of their different biological actions, opened mechanisms of the brain up to fresh investigation.
33. US Patent No. 5,229,382, filed on May 22, 1992 (a continuation of an application filed on April 23, 1991). European patent, EP-A-0,454,436, filed on April 24, 1991.
34. At the point the parent was being patented, these isomers will have been declared and activity usually assigned to one of them.
35. David Healy, Let Them Eat Prozac (New York: New York University Press, 2004).
36. David Healy, “From Mania to Bipolar Disorder,” in Bipolar Disorder, ed. Y. Latham and M. Maj (Chichester: John Wiley and Sons, 2009).
37. http://www.cafepress.com/bipolartshirts (accessed Sept. 1, 2007).
38. Staying Well…with Bipolar Disorder, Relapse Prevention Booklet (produced in association with the Manic-Depressive Fellowship sponsored by Eli Lilly and Company, 2005), 17.
39. Shankar Vedantam, “Suicide risk tests for teens debated,” Washington Post, June 16, 2006; Shankar Vedantam, “The depressionist,” Washington Post, May 26, 2009.
40. David Sheahan, “Angles on panic,” in The Psychopharmacologists, ed. David Healy, 3, 479–504 (London: Arnold, 2000).
41. See Cora's story, chap. 7.
42. Thomas Hage, The Demon under the Microscope (New York: Harmony Books, 2006).
43. Richard Harris, The Real Voice (New York: Macmillan Press, 1964), 13.
44. Harris, Real Voice, 89.
45. Cited in Harris, Real Voice, 86.
46. Harris, Real Voice.
47. Cited in Harris, Real Voice, 76.
48. Harris, Real Voice, 47.
CHAPTER 2
1. Alexis Jetter, “Pregnant pause,” Vogue, May 2009, 144-146
2. American Medical Association, Nostrums and Quackery (Washington, DC: American Medical Association Press, 1912).
3. Steven R. Belenko, Drugs and Drug Policy in America (Westport: Greenwood Press, 2000); David F. Musto, The American Disease: Origins of Narcotic Control (New York: Oxford University Press, 1987); Steven B. Karch, A Brief History of Cocaine (Boca Raton, FL: CRC Press, 1998).
4. Leo Meyler, Side Effects of Drugs (New York: Elsevier, 1952).
5. Philip Knightley, Harold Evans, E. Potter, and M. Wallace, Suffer the Children: The Story of Thalidomide (London: Andrew Deutsch, 1979).
6. Peter Temin, Taking Your Medicine: Drug Regulation in the United States (Cambridge, MA: Harvard University Press, 1980).
7. Louis Lasagna, Congress, the FDA and new drug development: Before and after 1962, Perspectives in Biology and Medicine 32, 322–343 (1989).
8. C. Robin Ganellin, “Cimetidine,” in Chronicles of Drug Discovery, ed. Jasjit S. Bindra and Daniel Lednicer, 1–37 (New York: John Wiley and Sons, 1990).
9. Matthew Lynn, The Billion-Dollar Battle: Merck v Glaxo (London: Mandarin, 1991).
10. Barry J. Marshall (ed.), Helicobacter Pioneers (Carlton South: Blackwell, 2002).
11. Leigh Thompson, memo, Exhibit 98 in Forsyth v. Eli Lilly (Feb. 7, 1990).
12. Zyprexa Product Team Off-Site. Zyprexa: MultiDistrict Litigation 1596, Document ZY201548768 (July 25, 2001).
13. Gary D. Tollefson, Zyprexa Product Team: 4 Column Summary. Zyprexa: MultiDistrict Litigation 1596, Document ZY200270343 (1997); available on http://www.furiousseasons.com/zyprexa.docs (accessed Feb. 10, 2007).
14. Christoph U. Correll et al., Cardiometabolic risk of secondgeneration antipsychotic medications during first-time use in children and adolescents, JAMA 302, 1765–1773 (2009); Christopher K. Varley and Jon McClellan, Implications of marked weight gain associated with atypical antipsychotic medications in children and adolescents, JAMA 302, 1811–1812 (2009).
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, 311–313 (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, 673–681 (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, 12–16 (2008).
26. George Ashcroft, “The receptor enters psychiatry,” in The Psychopharmacologists, ed. David Healy, 3, 189–200 (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, 170–174 (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 agonists—drugs 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, 15–16 (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, 34–42 (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, 1–10 (2010), doi:10.3233/JRS-2010–0487.
CHAPTER 3
1. Jason Dana and George Loewenstein, A social science perspective on gifts to physicians from industry, JAMA 290: 2, 252–255 (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, 551–557 (2001).
3. Meredith Wadman, The senator's sleuth, Nature 461, 330–33 (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, 1–18, 6 (1982).
8. Pierre C. A. Louis, cited in M. D. Rawlins, Development of a rational practice of therapeutics, BMJ 301, 729–733 (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, 103–105 (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, 1459–1461 (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/S0140–6736(08) 60601–7.
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, 1813–1817 (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, 173–193 (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/2006–4272bi-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, 295–30! (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, 2981–2997 (2002).
33. Healy, Let Them Eat Prozac.
34. Joseph F. Wernicke et al., Low-dose fluoxetine therapy for depression, Psychopharmacology Bulletin 24, 183–188 (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, 786–788 (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, 620–624 (1995).
41. David Healy and Marie Savage, Reserpine exhumed, British Journal of Psychiatry 172, 376–378 (1998).
42. David L. Davies and Michael Shepherd, Reserpine in the treatment of anxious and depressed patients, Lancet 117–121 (1955).
43. Michael Shepherd, “Psychopharmacology: Specific and non-specific,” in The Psychopharmacologists, ed. David Healy, 2, 237–257 (London: Arnold, 1998).
44. F. Horace Smirk and E. Garth McQueen, Comparison of rescinamine and reserpine as hypotensive agents, Lancet 115–116 (1955); Douglas C. Wallace, Treatment of hypertension. Hypotensive drugs and mental changes, Lancet 116–117 (1955).
45. Martin H. Teicher, Carol Glod, and Jonathan O. Cole, Emergence of intense suicidal preoccupation during fluoxetine treatment, American Journal of Psychiatry 147, 207–210 (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, 107–113 (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, 36–41, Jan. 7, 2008.
4. E-mail from Ian Barton to Richard Eastell and Aubrey Blumsohn, cc M. Royer, April 24, 2003.
5. Aubrey Blumsohn, Authorship, ghost-science, access to data and control of the pharmaceutical scientific literature—who stands behind the word? American Association for the Advancement of Science Professional Ethics Reports 19 (Summer 2006), http://www.aaas.org/ssp/sfr1/per/per46.pdf.
6. Claire Dyer, Aubrey Blumsohn: Academic who took on industry, BMJ 340, 22–23 (2010).
7. Rather than break the law, companies use strategies such as distinguishing between parent and local companies or company-initiated and investigator-initiated studies—conveniently some of the most awkward results may lie in studies that can be defined as other than company studies.
8. Names include Alliance, Adis Communications, Alpha-Plus, Axis Healthcare Communications, ClinResearch, Complete Healthcare Communications, Current Medical Directions, Envision Pharma, Evolution Medical Communications, Excerpta Medica, Gardiner-Caldwell, GYMR, HealthCare Project Management, Heron Evidence Development, IntraMed, Lowe Fusion Healthcare, MedBio Publications, Medical Writes, MSource Medical Development, Pacific Communications, Pharmanet, Ruder Finn, Scientific Therapeutics Information, Synapse Medical Communications, Thompson Scientific Connections, Watermeadow Medical, and Wolters Kluwer Health.
9. WPP stands for Wire and Plastics Products PLC. But it has moved so far from its original business, to being the largest advertising agency in the world, that it is only called WPP today.
10. From GYMR website (accessed Feb. 25, 2004).
11. David Healy, Let Them Eat Prozac (New York: New York University Press, 2004).
12. There are recognized quality measures for reporting the results of RCTs including, for instance, specifying the randomization procedures and the primary endpoints of the original trial protocol. In blind assessments of the reports of trials run by industry compared to independent studies, those done by industry rate higher. When it comes to box ticking, medical writers are specialists in the exercise where academics are not.
13. Bruce M. Psaty and Richard A. Kronmal, Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment, JAMA 299, 1813–1817 (2008).
14. Catherine DeAngelis and Phil B. Fontanarosa, Impugning the integrity of medical science: The adverse effects of industry influence, JAMA 299, 1833–1836 (2008).
15. See http://www.healyprozac.com for the entire document.
16. Armen Keteyian, “Suicide epidemic among veterans,” CBS News Investigates, Nov. 13, 2007, http://www.cbsnews.com/stories/2007/ii/13/cbsnews_investigates/main3496471.shtml. A CBS news investigation uncovers a suicide rate for veterans twice that of other Americans.
17. See http://www.healthyskepticism.org/presentations/2007/Study329.ppt (accessed Sept. 1, 2010).
18. Jon Jureidini, Leemon B. McHenry, and Peter R. Mansfield, Clinical trials and drug promotion: Selective reporting of Study 329, International Journal of Risk and Safety in Medicine 20, 73–81 (2009).
19. Alison Bass, Side Effects (Chapel Hill, NC: Algonquin Books, 2008).
20. Martin D. Keller, Neal D. Ryan, and Michael Strober et al., Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial, Journal of the American Academy of Child and Adolescent Psychiatry 40, 762–772 (2001).
21. See http://www.healthyskepticism.org/presentations/2007/Study329.ppt.
22. E-mail from Sally Laden to Daniel Burnham re Par 222 manuscript, Dec. 14, 2000.
23. Louis Sulman, Certain conditions in which a volatile vasoconstrictor has proved of particular value—A preliminary report, Medical Times 63, 374–375(1935).
24. Nicholas Rasmussen, On Speed: The Many Lives of Amphetamine (New York: New York University Press, 2008).
25. Rasmussen, On Speed.
26. Rasmussen, On Speed.
27. Soma Weiss, Chemical structure: biological action: therapeutic effect, NEJM 220, 906–911 (1939).
28. Rasmussen, On Speed.
29. Louis Lasagna, “Back to the future: Evaluation and drug development 1948–1998,” in The Psychopharmacologists, ed. David Healy, 2, 135–166 (London: Arnold, 1998).
30. Sandra Hempel, The Strange Case of the Broad Street Pump: John Snow and the Mystery of Cholera (Berkeley: University of California Press, 2009).
31. Robert Whitaker, Anatomy of an Epidemic (New York: Crown Publishers, 2010).
32. David Michaels, Doubt Is Their Product (New York: Oxford University Press, 2008).
33. Michaels, Doubt Is Their Product.
34. James Turk and Jon Thompson, Universities at Risk: How Politics, Special Interests and Corporatization Threaten Academic Integrity (Toronto: Lorimer Press, 2008).
35. Jason Lazarou, Bruce H. Pomeranz, and Paul N. Corey, Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies, JAMA 279, 1200–1205 (1998).
36. Charles M. Beasley et al., Fluoxetine and suicide: A meta-analysis of controlled trials of treatment for depression, BMJ 303, 685–692 (1991).
37. Ian Oswald, Letter, BMJ 303, 1058 (1991).
38. All correspondence is available on http://www.healyprozac.com.
39. M. N. Graham Dukes and Barbara Schwartz, Responsibility for Drug-Induced Injury (New York: Elsevier, 1988).
40. David Healy, Guest Editorial: A Failure to Warn, International Journal of Risk and Safety in Medicine 12, 151–156 (1999).
41. David Healy, Emergence of antidepressant-induced suicidality, Primary Care Psychiatry 6, 23–28 (2000).
42. Carl Elliott, Introduction, in Prozac as a Way of Life, ed. Carl Elliott and Tod Chambers (Durham, NC: Duke University Press, 2004). The original articles were P. Kramer, The valorization of sadness: Alienation and melancholic temperament, Hastings Center Report 30, 13–19 (2000); C. Elliott, Pursued by happiness and beaten senseless: Prozac and the American Dream, Hastings Center Report 30, 7–12 (2000); D. DeGrazia, Prozac, enhancement and self-creation, Hastings Center Report 30, 34–40 (2000); J. C. Edwards, Passion, activity and “the care of the self,” Hastings Center Report 30, 31–33 (2000); D. Healy, Good science or good business? Hastings Center Report 30, 19–22 (2000).
43. Cited in Elliott, Introduction, in Prozac as a Way of Life.
44. David Healy and Dinah Cattell, The Interface between authorship, industry and science in the domain of therapeutics, British Journal of Psychiatry 182, 22–27 (2003).
45. Aubrey Blumsohn, http://scientific-misconduct.blogspot.com(accessed Sept. 25, 2006).
46. The full letter read: “The report by the pharmaceutical industry was replete with exhortations that we should recognise the partnership industry have with academia. But it is difficult to know what kind of partnership you can have with an organisation that breaches the fundamental norms of science and threatens to sue those who point this out. Readers should be in little doubt that THES, the Lancet and BMJ soft-pedal on publication of issues like this on the counsel of their lawyers. At a recent Royal College meeting on conflict of interest, when College members expressed concern about industry suppression of data among other things, an industry spokesperson asked those assembled how Britain's leaders in that particular academic field, the 25 professors who, over and above their salaries, earned more than £150,000 per annum from links to industry, would view proposals to control conflict of interest. He also invited the College to take into account the fact that 40% of life assurance policies were invested in pharmaceutical shares and that anything that hurt industry would be bad for doctors. Where once medicine and the pharmaceutical industry were beating a way upstream in efforts to remedy some of humanity's real afflictions, industry turned into the current some years ago, dragging medicine back with it. In the process patients have been deserted in favour of a far greater number of consumers who could be super-sized on drugs they don't need for conditions like osteoporosis—if only the ‘science' can be used to scare people into consuming. This new pharmaceutical industry would no more welcome a real partnership with science than would the fast-food or tobacco industries.”
47. Jon Jureidini, Leemon B. McHenry, and Peter R. Mansfield, Clinical trials and drug promotion: Selective reporting of Study 329, International Journal of Risk and Safety in Medicine 20, 73–81 (2009). See also Melanie Newman, The rules of retraction, BMJ 341, 1246–1248 (2010).
48. David Healy, Did regulators fail over selective serotonin reuptake inhibitors? BMJ 333, 92–95 (2006).
49. Catherine De Angelis, The influence of money on medical science, JAMA 296, 996–998 (2006).
50. Cathyrn Clary, Zoloft: Publications Steering Committee Update (July 27, 2000); document made available in Szybinski Case, available from the author.
51. David Healy and Dinah Cattell, The Interface between authorship, industry and science in the domain of therapeutics, British Journal of Psychiatry 182, 22–27 (2003).
52. L. Duggan et al., Olanzapine for schizophrenia, Cochrane Database of Systematic Reviews Issue 2 (2005), art. no.: CD001359, doi:10.1002/14651858 .CD001359.pub2.
53. Clary, Zoloft: Publications Steering Committee Update.
54. American College of Neuropsychopharmacology, Preliminary report of the task force on SSRIs and suicidal behavior in youth, Neuropsychopharmacology 31, 473–492 (2006).
55. Gary D. Tollefson et al., Absence of a relationship between adverse events and suicidality during pharmacotherapy for depression, Journal of Clinical Psychopharmacology 14, 163–169 (1994); Andrew Leon et al., Prospective study of fluoxetine treatment and suicidal behavior in affectively ill subjects, American Journal of Psychiatry 156, 195–201 (1999); Charles B. Nemeroff, Michael T. Compton, and Joseph Berger, The depressed and suicidal patient: Assessment and treatment, Annals of the New York Academy of Science 932, 1–23 (2001).
56. Kimberly A. Yonkers et al., The management of depression during pregnancy: A report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists, General Hospital Psychiatry 31, 403–413 (2009).
57. Herschel S. Jick, James A. Kaye, and Susan Jick, Antidepressants and the risk of suicidal behaviors, JAMA 292, 338–342 (2004).
58. Charles M. Beasley et al., Fluoxetine and suicide: A meta-analysis of controlled trials of treatment for depression, BMJ 303, 685–692 (1991).
59. Robert D. Gibbons et al., The relationship between antidepressant prescription rates and rate of early adolescent suicide, American Journal of Psychiatry 163, 1898–1904 (2006).
60. Gardner Harris, “Senator Grassley seeks financial details from medical groups,” New York Times, Dec. 7, 2009, http://www.nytimes.com/2009/12/07/health/policy/07grassley.html.
61. Duff Wilson, “Medical Schools quizzed on ghostwriting,” New York Times, Nov. 17, 2009, http://www.nytimes.com/2009/11/18/business/18ghost.html.
62. Meredith Wadman, The senator's sleuth, Nature 461, 330–334 (2009).
63. http://www.gsk-clinicalstudyregister.com (accessed Oct. 23, 2009).
CHAPTER 5
1. Deborah Cohen, Complications: Tracking down the data on oseltamivir, BMJ 339, 1342–1347 (2009); Peter Doshi, Neuraminidase inhibitors: The story behind the Cochrane review, BMJ 339, 1348–1351 (2009).
2. Fiona Godlee, We want raw data now, BMJ 339, 1319 (2009).
3. Andrew Mosholder, Review and evaluation of clinical data, application NDA # 20–272 (11th May 1993), cited in Robert Whitaker, Mad in America (Boston: Perseus Publishing, 2001).
4. David Healy, The Creation of Psychopharmacology (Cambridge, MA: Harvard University Press, 2002).
5. Richard Harris, The Real Voice (New York: Macmillan, 1964).
6. Robert Rosenheck et al., Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: A randomised controlled trial, JAMA 290, 2693–2702 (2003); Jeffrey A. Lieberman et al., Effectiveness of antipsychotic drugs in patients with chronic schizophrenia, NEJM 353, 1209–1223 (2005); Peter B. Jones et al., Randomized controlled trial of the effect on quality of life of second vs first generation antipsychotic drugs in schizophrenia, Archives of General Psychiatry 63, 1079–1087 (2006).
7. Trevor A. Sheldon and George D. Smith, Consensus conferences as drug promotion, Lancet 341, 100–102 (1993).
8. J. F. Guest, W. M. Hart, R. F. Cookson, and E. Lindstrom, Pharmacoeconomic evaluation of long-term treatment with risperidone for patients with chronic schizophrenia, British Journal of Medical Economics 10, 59–67 (1996).
9. Stephen Almond and Orla O'Donnell, The cost-effectiveness of olanzapine compared to haloperidol in the treatment of schizophrenia in the UK. Final report prepared for Lilly Industries, Personal Social Services Research Unit, University of Canterbury (1996), PharmacoEconomics 17, 383–389 (2000).
10. Ann Mortimer et al., Consensus statement on schizophrenia standards in care for maintenance therapy and poorly responding/treatment intolerant patients, CINP meeting. International Journal of Neuropsychopharmacology 1, Abstracts Supplement (1998).
11. David Healy, Psychopharmacology and the ethics of resource allocation, British Journal of Psychiatry 162, 23–29 (1993).
12. Donald Eccleston, The economic evaluation of antidepressant drug therapy, British Journal of Psychiatry 163, Supplement 20 (1993).
13. Ffion Johnstone, Ian Rickard, and David Healy, The costs of psychotropic medication, British Journal of Psychiatry 167, 112–113 (1995).
14. See Dwight McKee and Allen Jones v. Henry Hart, Sydni Guido, Wesley Rish, Albert Masland, James Sheehan, and Daniel P. Sattele, CIVIL ACTION No. 4: CV-02–1910, in US District Court for the Middle District of Pennsylvania; M. Petersen, “Making drugs, shaping the rules: Big Pharma is eager to help states set medication guidelines,” New York Times, Feb. 1, 2004, sec. 3:1, 10.
15. Timothy Kendall, Linsey McGoey, and Emily Jackson, If NICE was in the USA, Lancet, doi:10.10116/5cE (2009); Fiona Godlee, NICE at 10, BMJ 338, 344 (2009).
16. Carroll W. Hughes et al., The Texas children's medication algorithm project: Report of the Texas consensus conference panel on medication treatment of childhood major depressive disorder, Journal of the American Academy of Child and Adolescent Psychiatry 38, 1442–1454 (1999).
17. States that adopted the guidelines include Pennsylvania, California, Colorado, Nevada, Illinois, Kentucky, New Mexico, New York, Ohio, South Carolina, Maryland, Missouri, and Washington DC; in some cases, jurisdictions within these states adopted the guidelines.
18. Rob Waters, “Medicating Aliah,” Mother Jones, May/June 2005, 50–55.
19. Duff Wilson, “Poor children likelier to get antipsychotics,” New York Times, Dec. 12, 2009, http://www.nytimes.com/2009/12/12/health/12medicaid.html?_r=2&scp=i&sq=antipsychotics&st=cse.
20. National Institute for Health and Clinical Excellence (NICE), Guidance on the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia, Technology Appraisal Guidance 43 (June 2002), available at http://www.nice.org.uk.
21. L. Duggan et al., Olanzapine for schizophrenia, Cochrane Database of Systematic Reviews Issue 2, Art. No.: CD001359 (2005), doi:10.1002/1465185 8 .CD001359.pub2.
22. David Healy et al., Lifetime suicide rates in treated schizophrenia: 1875–1924 and 1994–1998 cohorts compared, British Journal of Psychiatry 188, 223–228 (2006).
23. Joanna Le Noury et al., The incidence and prevalence of diabetes in patients with serious mental illness in North West Wales: Two cohorts 1875–1924 and 1994–2006 compared. BMC Psychiatry 8, 67 (2008), doi:10.1186/1471-244X-8–67.
24. This statement is based on my access to the data submitted to the Canadian regulator as part of a legal action on the patenting of Zyprexa.
25. This is based on conversations with some of those involved in the process.
26. Jeffrey A. Lieberman et al., Effectiveness of antipsychotic drugs in patients with chronic schizophrenia, NEJM 353, 1209–1223 (2005); Peter B. Jones et al., Randomized controlled trial of the effect on quality of life of second vs first generation antipsychotic drugs in schizophrenia, Archives of General Psychiatry 63, 1079–1087 (2006).
27. David Healy and David Nutt, British Association for Psychopharmacology consensus on statement on childhood and learning disabilities psychopharmacology, Journal of Psychopharmacology 11, 291–294 (1997).
28. Carroll W. Hughes et al., The Texas children's medication algorithm project: Report of the Texas consensus conference panel on medication treatment of childhood major depressive disorder, Journal of the American Academy of Child and Adolescent Psychiatry 38, 1442–1454 (1999).
29. “Depression: 3 million kids suffer from it. What you can do,” Newsweek, Oct. 7, 2002, 52–61.
30. Vera H. Sharav, The impact of FDA modernization act on the recruitment of children for research, Ethical Human Sciences and Services 5, 83–108 (2003).
31. Martin D. Keller et al., Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial, Journal of the American Academy for Child and Adolescent Psychiatry 40, 762–772 (2001).
32. Kendall, McGoey, and Jackson, If NICE was in the USA.
33. Graham J. Emslie et al., A double-blind, randomized placebo-controlled trial of fluoxetine in depressed children and adolescents, Archives of General Psychiatry 54, 1031–1037 (1997). The internal FDA medical review of the trial makes it clear it was a negative study.
34. Graham J. Emslie et al., Fluoxetine for acute treatment in children and adolescents: A placebo-controlled randomized clinical trial, Journal of the American Academy of Child and Adolescent Psychiatry 41, 1205–1215 (2002). It is common in clinical trials to stop previous treatments and to put everyone on placebo for a week or two before starting the trial proper. This is called either the washout or the placebo run-in period, and its stated purpose is to wash out any prior drug treatments. It is common to exclude patients responding to placebo during this period.
35. David J. Carpenter et al., Safety of Paroxetine in the Treatment of Children and Adolescents with OCD, Abstract 58, presented at the 40th annual NCDEU meeting (2001); Daniel A. Geller et al., Efficacy and Safety of Paroxetine in Pediatric OCD: Results of a Double-Blind Placebo Controlled Trial, presented at the 42nd Annual NCDEU Meeting, Session 111-16 (2002) (also presented at the APA annual meeting, Philadelphia, May 2002, NR 349); Karen D. Wagner et al., Safety and Tolerability of Paroxetine in Children and Adolescents: Pooled Results from Four Multi-center Placebo-Controlled Trials, presented at the 42nd Annual NCDEU Meeting, Session 11-61 (2002).
36. Karen D. Wagner et al., Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: Two randomized controlled trials, JAMA 290, 1033–1041(2003).
37. Wagner et al., Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder.
38. Central Medical Affairs Team, Seroxat. Adolescent Depression. Position Piece on the Phase 111 studies, Oct. 1998, SmithKline Beecham Confidential Document, available from the author. This is also available on the Canadian Medical Association Journal website. W. Kondro, Drug company experts advised staff to withhold data about SSRI use in children, Canadian Medical Association Journal 170, 783 (2004), http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19981014PositionPiece.pdf.
39. This statement is based on my knowledge of what trials had been undertaken from scrutiny of company databases and the FDA's published statements about the trials that had been submitted to them.
40. Editorial: Depressing research, Lancet 363, 1335 (2004).
41. This is based on conversations with the key players in NICE at this time.
42. Anyone involved in framing guidelines is now involved in business and their judgments can have far-reaching financial consequences, as the money involved in the patent extensions for the SSRIs demonstrates. The story of another SSRI given to children may make this clear. Celexa (citalopram) was discovered by the Danish company Lundbeck and marketed by Forrest Laboratories in the United States. In 1996, Lundbeck started a trial of Celexa in children that wasn't published until 2006. In 2002, Forrest ran another study of Celexa in children in the United States. As the controversy surrounding antidepressants for children grew, Forrest personnel made presentations of their “data” for Celexa, which appeared to show it worked and was free of risks. A ghostwritten report on the results of the second study was published in June 2004; see Karen D. Wagner et al., A randomized placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents, American Journal of Psychiatry 161, 1079–1083 (2004). There was no mention in all this of the earlier, unpublished Lundbeck study in which Celexa had failed to beat placebo and in which the rate of suicidality on Celexa was dramatically higher than on placebo (A. L. Von Knorring et al., A randomized, double-blind, placebo-controlled study of citalopram in adolescents with major depressive disorder, Journal of Clinical Psychopharmacology 26, 311–315 (2006). To the stock market analysts reviewing company share prices, Celexa looked good compared to the other drugs, which were running into trouble at the time. The Teamsters Union invested pension funds in the stock, while company board members sold stock and made money. As news of the earlier study spread, however, the value of Forrest's stock dropped. The Teamsters Union then took a securities action that resulted in a $65 million settlement in their favor (B. Maier and B. Carey, “Drug maker accused of fraud,” New York Times, Feb. 25, 2009, http://www.nytimes.com/2009/02/26/business/26drug.html?_r=3&ref=health). There is clearly a lot more at stake in these exercises than there ever had been in traditional medical trials.
43. Melanie Newman, The rules of retraction, BMJ 341, 1246–1248 (2010).
44. Erick H. Turner et al., Selective publication of antidepressant trials and its influence on apparent efficacy, NEJM 358, 252–260 (2008).
45. Jean Delay and Pierre Deniker, 38 Cas de psychoses traitées par la cure prolongée et continue de 4560 RP, C.R. Congrès Méd Alién Neurol France 50
497–502 (1952).
46. National Institute for Health and Clinical Excellence (NICE), Bipolar disorder: Clinical Guideline 38 (2006), available at http://www.nice.org.uk.
47. Sumant Khanna et al., Risperidone in the treatment of acute mania: Double-blind, placebo-controlled study, British Journal of Psychiatry 187, 229–234 (2005).
48. Sandhya Srinivasan et al., Trial of risperidone in India—concerns, British Journal of Psychiatry 188, 489–492 (2006).
49. There are two versions of the guideline. A longer technical version makes it clear childhood bipolar disorder should not be diagnosed unless children meet the criteria for the adult form of the illness; the shorter version does not mention this. The shorter version is the one that has been disseminated.
50. http://www.best-practice.net (accessed Jan. 4, 2010).
51. In the case of overactive bladder, in clinical trials patients on anticholinergic drugs like Detrusitol used in instances of what once was called urge incontinence go to the toilet one less time in forty-eight hours. Renaming the condition as overactive bladder increased the numbers of patients from twelve to thirty million in the United States with trials showing the same minimal benefit—but substantial side effects.
52. P. Colbrook, Can you ignore guidelines? BMJ Careers, 143–144 (April 9, 2005).
53. Tim Croudace et al., Impact of the ICD-10 primary health care (PHC) diagnostic and management guidelines for mental disorders on detection and outcome in primary care: Cluster randomized controlled trial, British Journal of Psychiatry 182, 20–30 (2003); Peter Tyrer, Michael King, and J. Fluxman, Treatment of common mental disorders in general practice: Are current guidelines useless? British Journal of Psychiatry 183, 78 (2003).
54. Edward Evarts, “A discussion of the relevance of effects of drugs on animal behavior to the possible effects of drugs on psychopathological processes in man.” in Psychopharmacology: Problems in Evaluation, ed. Jonathan O. Cole and Ralph W. Gerard, 284–306, esp. 302 (Washington, DC: National Academy of Sciences/National Research Council, 1959).
55. David Healy et al., Psychiatric bed utilisation: 1896 and 1996 compared, Psychological Medicine 31, 779–790 (2001).
56. Healy et al., Lifetime suicide rates in treated schizophrenia.
57. Le Noury et al., Incidence and prevalence of diabetes in patients with serious mental illness in North West Wales.
58. Craig W. Colton and Ronald W. Manderscheid, Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states, Preventing Chronic Disease, 3:2 (2006), http://www.cdc.gov/pcd/issues/2006/apr/05_0180.htm.
59. Urban Osby et al., Time trends in schizophrenia mortality in Stockholm County, Sweden: A cohort study, BMJ 321, 483–484 (2000).
60. Matti Joukamaa, Markku Heliovaara, and Paul Knekt et al., Schizophrenia, neuroleptic medication and mortality, British Journal of Psychiatry 188, 122–127 (2006); 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, 242–249 (2007); Suhanta Saha, David Chant, and John McGrath, A systematic review of mortality in schizophrenia, Archives of General Psychiatry 64, 1123–1131 (2007).
61. J. J. P. Kastelein et al., Simvastatin with or without Ezetimibe in familial hypercholesterolemia, NEJM 358, 1431–1443 (2008). Pfizer's torcetrapib was billed as doing the same, while still in development, but this development was ultimately stopped owing to a greater mortality in patients given torcetrapib; P. J. Barter et al., Effects of Torcetrapib in patients at high risk for coronary events, NEJM 357, 2109–2122 (2007).
62. Writing Group for the Women's Health Initiative Investigators, Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the women's health initiative randomized controlled trial, JAMA 288, 321–333 (2002).
63. ONTARGET, Telmisartan, Ramipril, or both in patients at high risk for vascular events, NEJM 358, 1547–1559 (2008).
64. Steven E. Nissen and Kathy Wolski, Effect of Rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes, NEJM 356, 2457–2471 (2007).
65. Committee on Finance, US Senate, Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia (2010), http://finance.senate.gov/press/Gpress/2010/prg022010a.pdf.
66. Craig J. Currie et al., Survival as a function of HbAic in people with type 2 diabetes: A retrospective cohort study, Lancet (2010), doi:10.1016/S0140–6736(09)61969–3; Advance Collaborative Group, Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes, NEJM 358, 2560–2572 (2008); Action to Control Cardiovascular Risk in Diabetes Study Group, Effects of intensive glucose lowering in type 2 diabetes, NEJM 358, 2545–2559 (2008).
67. Karen Davis et al., Mirror, Mirror on the Wall: An International Update on the Comparative Performance of American Health Care (Washington, DC: Commonwealth Fund, 2007), http://www.commonwealthfund.org/Content/Publications/Fund-Reports/2007/May; John Abramson, Overdosed America (New York: Harper Perennial, 2005).
68. American Academy of Pediatrics, “New AAP Policy on Lipid Screening and Heart Health in Children,” http://www.aap.org/advocacy/releases/july08lipidscreening.htm (accessed Dec. 15, 2009).
69. Thomas Jefferson, Peter Doshi, Matthew Thompson, and Carl Heneghan, Ensuring safe and effective drugs: who can do what it takes? BMJ 342, 148–151 (2011).
70. Doron Garfinkel, Sarah Zur-Gil, and Joshua Ben-Israel, The war against polypharmacy: A new cost-effective geriatric-palliative approach for improving drug therapy in disabled elderly people, Israel Medical Association Journal 9, 430–434 (2007); Doron Garfinkel and Derelie Mangin, Feasibility study of a systematic approach for discontinuation of multiple medications in older adults, Archives of International Medicine 170, 1648–1654 (2010).
CHAPTER 6
1. Since then the FDA has added warning labels to Singulair indicating that it may cause depression and suicidality.
2. Neil Pearce, Adverse Reaction: The Fenoterol Story (Aukland: Auckland University Press, 2007).
3. For example, diacetyl put in processed foods as a butter flavoring leads to a bronchiolitis—referred to as popcorn lung.
4. Walter O. Spitzer et al., The use of beta agonists and the risk of death and near death from asthma, NEJM 326, 501–506 (1992); Shelley Salpeter, Nicholas S. Buckley, Thomas M. Ormiston, and Edwin Salpeter, Meta-analysis: Effect of long-acting beta agonist on severe asthma exacerbations and asthma related deaths, Annals of Internal Medicine 144, 904–912 (2006).
5. John Berger, A Lucky Man (Harmondsworth, UK: Penguin Books, 1973); M. Winckler, The Case of Doctor Sachs (New York: Seven Stories Press, 1998).
6. Steven Timmermans and Marc Berg, The Gold Standard: The Challenge of Evidence Based Medicine and Standardization in Health Care (Philadelphia: Temple University Press, 2003).
7. Edward Shorter and David Healy, Shock Therapy (New Brunswick, NJ: Rutgers University Press, 2008).
8. Hillel Schwartz, Never Satisfied: A Cultural History of Diets, Fantasies and Fat (New York: The Free Press, 1986).
9. Schwartz, Never Satisfied.
10. It is, however, difficult to know with any certainty what the prevalence of anorexia nervosa was before the 1960s. Whatever the prevalence of the disorder in some absolute sense, the number of patients accessing services for treatment was minimal compared with what came later. At one point in the 1970s and 1980s, almost all heads of psychiatric departments in London were eating-disorder researchers.
11. T. R. Dawber, G. F. Meadors, and F. E. Moore, National Heart Institute, National Institutes of Health, Public Health Service, and Federal Security Agency, Washington, DC, Epidemiological Approaches to Heart Disease: The Framingham Study, Presented at a Joint Session of the Epidemiology, Health Officers, Medical Care, and Statistics Sections of the American Public Health Association at the 78th Annual Meeting in St. Louis, MO, Nov. 3, 1950.
12. Theodore Eisenberg and Martin T. Wells, Statins and adverse cardiovascular events in moderate-risk females: A statistical and legal analysis with implications for FDA pre-emption, Journal of Empirical Legal Studies 5, 507–550 (2008).
13. In men who have had a previous cardiovascular event, lowering cholesterol levels with drugs appears to reduce their risk of dying from a further cardiovascular event. Yet even in this case, it is now clear that the statin group of drugs have anti-inflammatory properties, just like aspirin, which also reduces the risk of a further heart attack, and it may be their benefits stem from this effect rather than any action on cholesterol. These drugs act on a range of systems around the body, and it may turn out that in some cases the statins can be helpful for other reasons, but despite the vast sales of these drugs today and the numbers of people taking them, there has been almost no research looking beyond blood cholesterol levels—almost certainly because this could spoil a good marketing story.
14. John Abramson, Overdosed America: The Broken Promise of American Medicine (New York: Harper Perennial, 2004).
15. Ramon Estruch et al., Effects of a Mediterranean-style diet on cardiovascular risk factors: A randomized trial, Annals of Internal Medicine 146, 1–11 (2006).
16. Isabelle Savoie and Arminee Kazanjian, Utilization of lipid-lowering drugs in men and women: A reflection of the research evidence, Journal of Clinical Epidemiology 55, 97–98 (2002); Peter S. Sever et al., Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower than average cholesterol concentrations in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid lowering arm (ASCOT-LLA), Lancet 361, 1149–1155 (2003).
17. Savoie and Kazanjian, Utilization of lipid-lowering drugs in men and women.
18. Colette B. Raymond et al., Population-based analysis of statin utilization in British Columbia, Clinical Therapeutics 29, 2107–2115 (2007).
19. Dudley Gentles et al., Serum lipid levels for a multicultural population in Auckland, New Zealand, New Zealand Medical Journal 120, 1–12 (2008).
20. Gentles et al., Serum lipid levels for a multicultural population in Auckland, New Zealand.
21. Robert A. Wilson, Feminine Forever (New York: M. Evans, 1966).
22. Gillian Sansom, The Myth of Osteoporosis (Ann Arbor, MI: Century Publications, 2003); Elaine S. Berman, Too Little Bone: The Medicalization of Osteoporosis, Journal of Women's Health and Law 1, 257–277 (1999).
23. K. Bassett, “On trying to stop the measurement of bone density to sell drugs,” in Tales from the Other Drug Wars, ed. M. L. Barer et al. (Vancouver: Centre for Health Services and Policy Research, 2000).
24. http://www.npr.org/templates/story/story.php?storyId=121609815.
25. Tamir Ali and Roger H. Jay, Spontaneous femoral shaft fracture after long-term alendronate, Age and Ageing 38, 625–626 (2009).
26. E. E. Roughead, K. McGeehan, and G. P. Sayer, Biphosphonate use and subsequent prescription of acid suppressants, British Journal of Clinical Pharmacology 57, 813–816 (2004); Redonda G. Miller et al., Incidence of gastro-intestinal events among biphosphonate patients in an observational setting, American Journal of Managed Care 10, 207–215 (2004).
27. J. J. Wolff et al., The effect of exercise training programs on bone mass: A meta-analysis of published controlled trials in pre and post-menopausal women, Osteoporosis International 9, 1–12 (1999).
28. Max Hamilton, A rating scale for depression, Journal of Neurology, Neurosurgery and Psychiatry 23, 56–62 (1960).
29. Max Hamilton, “Rating Scales in Depression,” in Depressive Illness, Diagnosis, Assessment, Treatment, ed. P. Kielholz, 100–108 (Berne: Hanns Huber Publishers, 1972).
30. David Healy, Derelie Mangin, and Barbara Mintzes, The ethics of controlled trials in prenatal depression, International Journal of Risk and Safety in Medicine 22, 1–10 (2010), doi:10.3233/JRS-2010–048.
31. Ray Moynihan and David Henry, The fight against disease mongering: Generating knowledge for action, Public Library of Science Medicine 3 (2006). All articles in this issue of the journal were on disease mongering.
32. Leonore Tiefer, Female sexual dysfunction: A case study of disease mongering and activist resistance, Public Library of Science Medicine 3, e178 (2006), doi:10.1371/journalpmed.0030178.
33. Jennifer Berman and Laura Berman, For Women Only (New York: Henry Holt, 2001).
34. Diagnostic and Statistical Manual, Third Edition (Washington, DC: American Psychiatric Association, 1980).
35. Kimberly A. Yonkers et al., The management of depression during pregnancy: A report from the American Psychiatric Association and American College of Obstetricians and Gynecologists, General Hospital Psychiatry 31, 403–413 (2009).
36. Now these drugs all carry warnings on their labels about the risk of suicide.
37. Jason Lazarou, Bruce H. Pomeranz, and Paul N. Corey, Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies, JAMA 279, 1200–1205 (1998).
38. The Institute for Safe Medication Practices, QuarterWatch 1–3 (2009), http://www.ismp.org/QuarterWatch/2009Q3.pd.
39. Thomas E. Bittker, The industrialization of American psychiatry, American Journal of Psychiatry 142, 149–154 (1985).
40. Philip M. Sinaikin, Categorical diagnosis and a poetics of obligation: An ethical commentary on psychiatric diagnosis and treatment, Ethical Human Sciences and Services 5, 141–148 (2003); Philip M. Sinaikin, Coping with the medical model in clinical practice or “How I learned to stop worrying and love DSM,” Journal of Critical Psychology, Counselling and Psychotherapy, 204–213 (2004).
41. http://www.ahrq.gov/clinic/USpstfab.htm.
42. Kimberly S. Yarnall, Kathryn I. Pollak, and Truls Ostbye, Primary care: Is there enough time for prevention? American Journal of Public Health 93, 635–641 (2003).
43. Larry Eliot and Daniel Atkinson, The Gods That Failed: How Blind Faith in the Markets Has Cost Us Our Future (London: Bodley Head, 2008).
44. James Spence, The Purpose and Practice of Medicine (Oxford: Oxford University Press, 1960).
45. James Lind, A Treatise of the Scurvy (1752; Edinburgh: Edinburgh University Press, 1953).
46. Mark Bostridge, Florence Nightingale (Harmondsworth, UK: Penguin Books, 2009).
47. L. J. Rather, Collected Essays on Public Health and Epidemiology of Rudolf Virchow (New York: Science History Publications, 1985).
48. Kenneth F. Kiple, Plagues, Pox and Pestilence: Disease in History (London: Weidenfeld and Nicolson, 1997).
49. Richard Harris, The Real Voice (New York: Macmillan Press, 1964), 64.
50. Eric Kimbuende, Usha Ranji, Janet Lundy, and Alina Salganicoff, US Health Care Costs (2010), http://www.kaiseredu.org/topics_im.asp?imID=i&parentID=61&id=358 (accessed May 6, 2011); David Leonhardt, “The choice: A longer life or more stuff,” New York Times, Sept. 27, 2006, http://www.nytimes.com/2006/09/27/business/27leonhardt.html (accessed May 9, 2011).
51. The World Health Organization's ranking of the world's health systems, http://www.photius.com/rankings/who_world_health_ranks.html.
52. Bob Roehr, Healthcare in the US ranks lowest among developed countries, BMJ 337, 889 (2008).
53. Nananda Col, James E. Fanale, and Penelope Kronholm, The role of medication noncompliance and adverse drug reactions in hospitalizations of the elderly, Archives of Internal Medicine 150, 841–845 (1990).
54. US Congress, Congressional Budget Office, Technological Change and the Growth of Health Care Spending (Jan. 2008).
CHAPTER 7
1. Padmaja Chalassani, David Healy, Richard Morriss, Presentation and frequency of catatonia in new admissions to two acute psychiatric admission units in India and Wales, Psychological Medicine 35, 1667–1675 (2005).
2. Ray Moynihan and David Henry, Disease Mongering is now part of the global health debate, PLoS Medicine (2008), doi:10.1371/journal .pmed.0050106; Steven Woloshin and Lisa Schwartz, Giving legs to Restless Legs. A case study of how the media makes people sick, PLoS Medicine (2006), doi:10.1371/journal.pmed.0030170.
3. Jerome Groopman, How Doctors Think (New York: Norton, 2007).
4. Jason Lazarou, Bruce Pomeranz, and Paul Corey, Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies, JAMA 279, 1200–1205 (1998).
5. The Institute for Safe Medication Practices, QuarterWatch 1–3 (2009), http://www.ismp.org/QuarterWatch/2009Q3.pd.
6. Other options include pharmakosepsis, pharmacoscotoma, pharmacotoxicity, pharmakonosis.
7. Annemarie Mol, The Logic of Care (London: Routledge, 2008).
8. Michael Bliss, The Discovery of Insulin (Toronto: McClelland and Stewart, 1982).
9. Edward Shorter and David Healy, Shock Therapy (New Brunswick, NJ: Rutgers University Press, 2008).
10. Thomas Hager, The Demon under the Microscope (New York: Harmony Books, 2006).
11. Jeremy A. Greene, Prescribing by Numbers: Drugs and the Definition of Disease (Baltimore: Johns Hopkins University Press, 2007).
12. Greene, Prescribing by Numbers.
13. Louis Lasagna, Congress, the FDA, and new drug development: Before and after 1962, Perspectives in Biology and Medicine 32, 322–343 (1989).
14. Greene, Prescribing by Numbers.
15. http://www.aace.com/meetings/consensus/hyperglycemia/hyperglycemia.pdf.
16. Action to Control Cardiovascular Risk in Diabetes (ACCORD), Effects of intensive glucose lowering in type 2 diabetes, NEJM 358, 2545–2559 (2008).
17. John Abrahams, Science, Politics and the Pharmaceutical Industry (London: UCL and St. Martin's Press, 1995).
18. Dwight L. Evans et al., Mood disorders in the medically ill: Scientific review and recommendations, Biological Psychiatry 58, 175–189 (2005).
19. “Best Practice: Translating Scientific Discovery into CNS Therapeutic Advantage,” http://www.best-practice.net (accessed June 6, 2008).
20. Gabrielle A. Carlson et al., Methodological issues and controversies in clinical trials with child and adolescent patients with bipolar disorder: Report of a consensus conference, Journal of Child and Adolescent Psychopharmacology 13, 13–27 (2003).
21. Peter S. Jensen et al., Consensus report on impulsive aggression as a symptom across diagnostic categories in child psychiatry: Implications for medication studies, Journal of the American Academy of Child and Adolescent Psychiatry 6, 309–322 (2007).
22. Testimony of David J. Graham MD, MPH, to Congress, Nov. 18, 2004, http://www.consumersunion.org/pub/core_health_care/001651.html.
23. Joseph S. Ross et al., Pooled analysis of rofecoxib placebo-controlled clinical trial data: Lessons for postmarketing pharmaceutical surveillance, Archives of Internal Medicine 169, 1976–1984 (2009).
24. Martin H. Teicher, Carol Glod, and Jonathan O. Cole, Emergence of intense suicidal preoccupation during fluoxetine treatment, American Journal of Psychiatry 147, 207–210 (1990).
25. David Healy, The antidepressant tale: Figures signifying nothing? Advances in Psychiatric Treatment 12, 320–328 (2006).
26. Charles M. Beasley et al., Fluoxetine and suicide: A meta-analysis of controlled trials of treatment for depression, BMJ 303, 685–692 (1991).
27. Using these data the relative risk for suicidal acts is 1.9 times greater on Prozac than placebo, with a 95 percent confidence interval from 0.2 to 16. This means while there is a chance that there is no increase in risk, the likeliest guess from these data is that the increase in risk is 1.9 fold, but the data also show it could be a 16-fold greater risk.
28. Beasley et al., Fluoxetine and suicide; emphasis added by the author.
29. David E. Wheadon et al., Lack of an association between fluoxetine and suicidality in bulimia nervosa, Journal of Clinical Psychiatry 53, 235–241
(1992).
30. Food and Drug Administration, Psychopharmacological Drugs Advisory Committee, 34th Meeting, Sept. 20, 1991.
31. David Healy, Did regulators fail over selective serotonin reuptake inhibitors? BMJ 333, 92–95 (2006).
32. Carol Bombardier et al., VIGOR Study Group, Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis, NEJM 343, 1520–1528 (2000).
33. David Armstrong, “Bitter Pill: How the New England Journal missed warning signs on Vioxx. Medical weekly waited years to report flaws in article that praised pain drug,” Wall Street Journal, May 15, 2006.
34. Louis Lasagna, “Back to the future: Evaluation and drug development 1956 to 1996,” in The Psychopharmacologists, ed. David Healy, 2 (London: Arnold, 1998).
35. Sandor Greenland, Bayesian perspectives for epidemiological research, International Journal of Epidemiology 35, 777–778 (2006).
36. Ezra Hauer, The harm done by tests of significance, Accident Analysis and Prevention 36, 495–500 (2004).
37. Charles Poole, Why published epidemiology is really junk science, Congress of Epidemiology, Toronto, June 13, 2001.
38. US Supreme Court, Matrixx Initiatives Inc. et al. v. Siracusano et al., No. 09–1156, decided March 22, 2011, 563 US.
39. Kenneth J. Rothman, Writing for Epidemiology, Epidemiology 9, 333–337 (1998).
40. Arif Khan et al., Suicide risk in patients with anxiety disorders; A metaanalysis of the FDA database, Journal of Affective Disorders 68, 183–190 (2002).
41. Khan et al., Suicide risk in patients with anxiety disorders.
42. Arif Khan et al., Suicide rates in clinical trials of SSRIs, other antidepressants and placebo: Analysis of FDA reports, American Journal of Psychiatry 160, 790–792 (2003).
43. Paul Anthony, FDA “Drug Watch ” early warnings will have lasting negative effect, PhRMA says, The Pink Sheet, no. 001, June 2005.
44. Chris Bushe and Richard Holt, Prevalence of diabetes and impaired glucose tolerance in patients with schizophrenia, British Journal of Psychiatry (Supplement 47) 184, s67–71 (2004). This entire issue of the journal was a supplement paid for by Lilly. Several if not all articles will have been authored by company personnel. The other main British journal dealing with psychotropic drugs (Journal of Psychopharmacology) also included a Lilly-sponsored symposium shortly afterward. These supplements are worth a lot of money to journals and are often not peer-reviewed. The Maudsley quote appears in several of the articles in these two supplements.
45. Joanna Le Noury et al., The incidence and prevalence of diabetes in patients with serious mental illness in North West Wales: Two cohorts 1875–1924 and 1994–2006 compared, BMC Psychiatry 8, 67 (2004), doi:10.1186/1471–244X-8–67.
46. Barry G. Firkin and J. A. Whitworth, Dictionary of Medical Eponyms (Carnforth, UK: Parthenon Publishing, 1987). This volume, ironically in this context, was made available to British doctors as an educational gift from Glaxo.
47. David Michaels, Doubt Is Their Product (New York: Oxford University Press, 2008).
48. Parents Med Guide, The use of medication in treating childhood and adolescent depression: Information for patients and families, prepared by the American Psychiatric Association and American Academy of Child and Adolescent Psychiatry (2005), http://www.ParentsMedGuide.org (accessed Feb. 1, 2005).
49. American Psychiatric Association, “APA responds to FDA's new warning on antidepressants,” news release, Oct. 15, 2004, http://www.psych.org/news_room/press_releases/04–55apaonfdablackboxwarning.pdf.
50. The session was convened on October 10—the 43rd anniversary of Kefauver's bill.
51. David Sheahan, “Angles on panic,” in The Psychopharmacologists, ed. David Healy, 3, 479–504 (London: Arnold, 2000).
52. Food and Drug Administration, Psychopharmacological Drugs Advisory Committee, 34th Meeting, Sept. 20, 1991.
53. Lyam Kilker and Michelle David v. SmithKline Beecham, First Judicial District of Pennsylvania, Civil Trial Division 1813 (Sept. 2009).
54. The Tobacco Institute Inc., Tobacco and the Health of the Nation (San Francisco: Legacy of Tobacco Documents Library, UCSF, 1969), http://legacy.library.ucsf.edu/cgi/getdoc?tid=dxb34f00&fmt=pdf&ref=results. In a quite comparable fashion, pharmaceutical companies have promoted a series of studies that apparently showed declining suicide rates in line with rising antidepressant sales during the 1990s. For a list of such studies see Goran Isacsson et al., Decrease in suicides among the individuals treated with antide-pressants: A controlled study of antidepressants in suicide, Sweden 1995–2005, Acta Psychiatrica Scandinavia 120, 37–44 (2009). This was most probably explained by factors like declining autopsy rates in the 1990s—a large number of suicides are only diagnosed at autopsy; see Svein Reseland et al., National suicide rates 1961–2003: Further analysis of Nordic data for suicide, autopsies and ill-defined death rates, Psychotherapy and Psychosomatics 77, 78–82 (2008).
55. American Psychiatric Association, “APA responds to FDA's new warning on antidepressants,” news release, Oct. 15, 2004, http://www.psych.org/news_room/press_releases/04–55apaonfdablackboxwarning.pdf.
56. US District Court for the Central District of California, Flora Motus v. Pfizer Inc. (Roerig Division), CV 00–298, Nov. 11, 1999.
57. US Court of Appeal of the Ninth Circuit, Motus F v. Pfizer Inc. (Roerig Division), No 02–55372, 02–55498, Amicus Brief D Troy et al., Sept. 3, 2002.
58. US Court of Appeal of the Ninth Circuit, Motus F v. Pfizer Inc. (Roerig Division), No 02–55372, 02–55498, Amicus Brief D Troy et al., Sept. 3, 2002.
59. Montag v. Honda Motor Co., 75 F. 3d 1414, Jan. 22, 1996, http://www.appellate.net/briefs/geieramicus.pdf.
60. Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Sept.ember 13, 2004, 435.
61. Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Sept. 13, 2004, 332.
62. Greg D. Curfman, Stephen Morrissey, and Jeffrey Drazen, Why doctors should worry about pre-emption, NEJM 359, 1–3 (2009).
63. Warner-Lambert v. Kent Supreme court docket 06–1498. See www.scotuswiki.com/index.php?title=Warner-Lambertv.Kent.
64. Wyeth v. Diana Levine. In US Supreme Court, No. 06–1249 Citations 555 US 555
65. “Supreme Court rules against Wyeth in liability case,” Reuters, March 4, 2009, http://www.reuters.com/article/domesticNews/idUSTRE5233VS20090304.
66. Clifford J. Rosen, The Rosiglitazone story: Lessons from an FDA advisory committee, NEJM 357, 844–846 (2007), 1056/nejmp078167; Steven Nissen and Kathy Wolski, Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes, NEJM 356, 2457–2471 (2007).
67. Deborah Cohen, Rosiglitazone: What went wrong? BMJ 341, 530–534, c4848 (2010).
68. Philip D. Home et al., Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): A multicentre, randomised, open-label trial, Lancet 373, 2125–2135 (2009).
69. Cohen, Rosiglitazone: What went wrong?
70. US Senate, Committee on Finance, Staff report on GlaxoSmithKline and the diabetes drug Avandia (2010), http://finance.senate.gov/newsroom/chairman/release/?id=bc56b552-efc5–4706–968d-f7032d5cd2e4.
71. Adrienne Fugh-Berman et al., Promotional tone in reviews of menopausal hormone therapy after the women's health initiative: An analysis of published articles, Public Library of Science Medicine 8, e1000425 (2011).
CHAPTER 8
1. Annemarie Mol, The Logic of Care (London: Routledge, 2008).
2. Samuel Sessions and Alan Detsky, The “Shadow Government” in Health Care, JAMA 304, 2742–2743 (2010).
3. This is similar to the use of intelligence tests for political purposes in 1920s as outlined by Steven J. Gould. The Mismeasure of Man (Harmondsworth, UK: Penguin Books, 1980).
4. Deposition of Ian Hudson in Tobin v. SmithKline Beecham, Dec. 15, 2000, 30–33 (Harlow, UK).
5. Joseph S. Ross et al., Pooled analysis of rofecoxib placebo-controlled clinical trial data: Lessons for postmarketing pharmaceutical surveillance, Archives of Internal Medicine 169, 1976–1984 (2009).
6. Philip Fine, Make Big Pharma provide their raw data, University World News, Jan. 18, 2009, http://www.universityworldnews.com/article.php?story=20090115191615198.
7. Transcript from BBC Panorama program “Secrets of the Drugs Trials,” Jan. 29, 2007, news.bbc.co.uk//i/hi/programmes/panorama/6317137.stm.
8. Jon Thompson, Patricia Baird, and Jocelyn Downie, The Olivieri Report (Toronto: Lorimer, 2001).
9. David Healy, Derelie Mangin, and Barbara Mintzes, The ethics of controlled trials in prenatal depression, International Journal of Risk and Safety in Medicine 22, 1–10 (2010), doi:10.3233/JRS-2010–048.
10. Sessions and Detsky, “Shadow Government” in Health Care.
11. Geoffrey Venning, Validity of anecdotal reports of suspected adverse drug reactions: The problem of false alarms, BMJ 284, 249–253 (1982).
12. David Healy and Dinah Cattell, The Interface between authorship, industry and science in the domain of therapeutics, British Journal of Psychiatry 182, 22–27 (2003).
13. Erick H. Turner et al., Selective publication of antidepressant trials and its influence on apparent efficacy, NEJM 358, 252–260 (2008).
14. Gonzalo Laje et al., Genetic markers of suicidal ideation emerging during citalopram treatment of major depression, American Journal of Psychiatry 164,1530–1538 (2007).
15. R. Bordet et al., Analysis of the direct cost of adverse drug reactions in hospitalised patients, European Journal of Clinical Pharmacology, 56, 935–941 (2001), doi:10.1007/s0022 80000260.
16. Sessions and Detsky, “Shadow Government” in Health Care.
17. Richard J. Wurtman and R. L. Bettiker, The slowing of treatment discovery, 1965–1995, Nature Medicine 1, 1122–1125 (1995).
18. Paul R. Gross and Norman Levitt, Higher Superstition: The academic left and its quarrel with science (Baltimore: Johns Hopkins University Press, 1994).
19. Ivan Illich, Limits to Medicine (Medical Nemesis) (Harmondsworth, UK: Penguin Books, 1976).
20. John Abramson, Overdosed America: The Broken Promise of American Medicine (New York: Harper Perennial, 2005).
21. Zyprexa: Primary Care Sales Force Resource Guide, Zyprexa MDL 1596, Plaintiffs' Exhibit 01926 (2002), 7.
22. Gardiner Harris, “Senator Grassley seeks financial details from medical groups,” New York Times, Dec. 7, 2009, http://www.nytimes.com/2009/12/07/health/policy/07grassley.html.
23. Emory University's Charles Nemeroff, Stanford's Alan Schatzberg, and Brown's Martin Keller—the “author” of Study 329.
24. Meredith Wadman, The senator's sleuth, Nature 461, 330–334 (Sept. 17, 2009).
25. Sandra Hempel, The Strange Case of the Broad Street Pump: John Snow and the Mystery of Cholera (Berkeley: University of California Press, 2009).
26. Dwight D. Eisenhower, Military industrial complex speech (1961), http://www.cnn.com/SPECIALS/cold.war/episodes/12/documents/eisenhower.speech (accessed April 21, 2002).
27. Kenneth Kiple, Plagues, Pox and Pestilence (London: Weidenfield and Nicholson, 1997).
28. Hank McKinnell, A Call to Action (New York: McGraw Hill, 2005).