Pharmageddon (44 page)

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).