by David Healy
If, as commonly believed, both markets and science deliver progress, it seems inconceivable to many that the domain in which markets and science interact to the greatest extent would be one characterized by decline rather than progress. But when it comes to pharmaceuticals, because of prescription-only arrangements, the current operation of patent laws, the sequestration of trial data, the ease with which medical experts can be seduced by junk epidemiology, and the extent to which bad data has driven out good data, this is not a market that can respond to patient pressure. It is a market where patient pressure is perverted by pharmaceutical marketing campaigns, where outcomes can get worse with no apparent consumer (medical) concern, a market in which the mental sets of consumers (doctors) have been captured so that it is difficult for them to conceive of alternatives to those being sold to them, a market in which there is almost no possibility of discrepant data emerging to trigger a thought that might be unwelcome to a pharmaceutical company, a rigged market that operates in terms of five-year plans. Indeed, it is a polity, rather than a market, that in its control of information is perhaps best described as totalitarian.
Hitherto one of the major selling points of the Western way of doing things has not been the availability of consumer products such as Levi jeans so much as progress in health—our children have been less likely to die in infancy or childhood, our men and women less likely to succumb to a crabbed age and more likely to live beyond the traditional three-score and ten years. But there is a growing disenchantment with the Western way of doing things. And there is a growing likelihood that we in the West will be regarded as the new barbarians as we feed antipsychotic drugs to infants and envisage children as young as eight years old being put on drugs like the statins. Even though we have an increasing number of hospitals that look more like hotels, complete with gourmet meals and the latest online entertainment, there will be many who view these as the products of a healthcare system that is losing sight of some of the most precious things about being human, a system in which values are becoming valueless, a system in which ticking boxes is more important than trust in people, a system that, as a result, is losing its abilities to heal.
After Cora descended into Hades, in the face of Demeter's insistence, Zeus buckled and she returned as Persephone, bringing life back to the planet with her. After a wondrous period of time in the middle of the twentieth century when we combined to force open the gates of Hades and rescue children who might otherwise have died, today's Demeters find themselves faced with pharmaceutical companies adept at using a mother's wish to get the best possible treatment for her family, including the child in her womb, to expand their markets. In a tale of almost mythic resonance in its own right, Estes Kefauver, using the example of children deformed by thalidomide, attempted to restore wonder and force Hades back but ended up being outflanked. If with Demeter we hold that care of the sort outlined in these pages is the heartbeat of our world, we need to take up Kefauver's cause and see it through. Whether that heart continues to beat is up to each of us.
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 Associat
ion, 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 Psychopharmacologi
sts, 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.