Driven to service whose needs?
On clinical trials as marketing instruments




        Trudy Dehue, professor of
      The...
RCT
         Randomised clinical trial
  Randomly
  composed

Experimental                         Test
  group(s)



  Co...
Randomised clinical trial (RCT)

Phase I: small group of subjects; safety check.

Phase II: larger group of subjects; test...
Good, P. (2006)

A manager’s guide
to the design and
conduct of clinical
trials.




                  4
Contract Research Organisations (CROs)




                                         5
6
7
Contract Research Organisations (CROs)




                                         8
9
When researchers are driven to service
companies’ needs

-trials become demonstrations

-research becomes marketing

-arti...
When researchers are driven to service
companies’ needs

-trials become demonstrations

-research becomes marketing

-arti...
12
13
14
British Medical Journal, 2008, 377, p.603




        British Medical journal,
                                           ...
Richard Smith         Fiona Godlee (2008)
(2005)                ‘The evidence that
‘Medical journals     industry funding
...
“It is simply no longer possible to believe much
of the clinical research that is published, or to
rely on the judgment of...
BMJ, 8 December 2009

"The current system isn’t working. Worse than that, it gives
                                       ...
Food and Drug Administration




College ter Beoordeling van Geneesmiddelen
                                              ...
20
When researchers are driven to service
companies’ needs

-trials become demonstrations

-research becomes marketing

-arti...
When researchers are driven to service
companies’ needs

-trials become demonstrations

-research becomes marketing

-arti...
Minutes Dutch parlement, 2009
Law on medical scientific research




                                     23
24
www.quintiles.com
www.parexel.com




                  27
www.testim.com




                 28
29
30
In Phase IV your focus
is on generating
market uptake for your
product (...).

Covance can help
launch your product
(...)....
32
Umbach,
 2007




      33
34
35
Simon & Kotler
   (2003)




                 36
37
38
When researchers are driven to service
companies’ needs

-trials become demonstrations

-research becomes marketing

-arti...
When researchers are driven to service
companies’ needs

-trials become demonstrations

-research becomes marketing

-arti...
Uit Pharmaceutical Executive, 2008
42
January 17 2008   Volume 358:252-260 Number 3




Selective Publication of Antidepressant Trials
   and Its Influence on A...
Article handed out by Janssen-Cilag at
2010 international psychiatry conference.
 Research sponsored by Janssen-Cilag.



...
When researchers are driven to service
companies’ needs

-trials become demonstrations

-research becomes marketing

-arti...
When researchers are driven to service
companies’ needs

-trials become demonstrations

-research becomes marketing

-arti...
Bleidt & Montagne (1997),
         p.251-252



  ‘The direction provided by
marketing is crucial to designing
           ...
Bleidt & Montagne (1997),
p.254

on ‘pre-approval marketing
activities’:

‘This goal is accomplished
through presentation ...
Social Studies of Science, 2004, 34, 187-218




         On clinical trial researchers
        acting as mediators betwee...
www.kendle.com




                 50
Berlin


         51
PLoS Medicine, september 2009 and
september 2010




                                    52
PLoS Medicine, september 2010
BMJ, 4 april 2009, vol 388, p. 804-807




                                            54
www.esf.org/fileadmin/links/EMRC...
Recommendation

 CROs should be driven to service the
    needs of civilians rather than
    pharmaceutical companies.


 ...
Driven to service whose needs?
On clinical trials as the population’s instruments




          Trudy Dehue, professor of
...
Trudy Dehue - Selling Sickness 2010
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Trudy Dehue - Selling Sickness 2010

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  • One of the most heralded marketing ploys ever to hit southeast Michigan (USA) area is a radio ad that is clearly intended to scare the listener into believing that undetected disease is lurking in their body. It strongly implies that the Sword of Damocles is hanging overhead and concludes in a deep, serious, probing voice, 'Do YOU have a Beaumont doctor?' Pervasive 'learned helplessness' with respect to caring for one's health apart from the 'salvation of modern medicine'. Persistent, intentional attacks to destroy one's confidence in even the most fundamental abilities of the body to restore homeostasis. And now the target is CHILDREN. Common sense health and hygiene practices have been supplanted by 'sickness management' from cradle to grave.
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Trudy Dehue - Selling Sickness 2010

  1. 1. Driven to service whose needs? On clinical trials as marketing instruments Trudy Dehue, professor of Theory and History of Science 1
  2. 2. RCT Randomised clinical trial Randomly composed Experimental Test group(s) Control Test group 2
  3. 3. Randomised clinical trial (RCT) Phase I: small group of subjects; safety check. Phase II: larger group of subjects; test for intended e and side-effects Phase III: repeat phase II with a larger group of subjects. Phase IV: post- (or peri-) marketing research; control for effects and safety in various populations a with long-term use. 3
  4. 4. Good, P. (2006) A manager’s guide to the design and conduct of clinical trials. 4
  5. 5. Contract Research Organisations (CROs) 5
  6. 6. 6
  7. 7. 7
  8. 8. Contract Research Organisations (CROs) 8
  9. 9. 9
  10. 10. When researchers are driven to service companies’ needs -trials become demonstrations -research becomes marketing -articles become advertisements -authors become authorities 10
  11. 11. When researchers are driven to service companies’ needs -trials become demonstrations -research becomes marketing -articles become advertisements -authors become authorities 11
  12. 12. 12
  13. 13. 13
  14. 14. 14
  15. 15. British Medical Journal, 2008, 377, p.603 British Medical journal, 15
  16. 16. Richard Smith Fiona Godlee (2008) (2005) ‘The evidence that ‘Medical journals industry funding are an extension of biases the design the marketing arm and reporting of of pharmaceutical clinical research is companies’ overwhelming’
  17. 17. “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines” (Marcia Angell, former editor of The New England Journal of Medicine in The New York Review of Books, 2009).
  18. 18. BMJ, 8 December 2009 "The current system isn’t working. Worse than that, it gives 18 a false sense of security"
  19. 19. Food and Drug Administration College ter Beoordeling van Geneesmiddelen 19
  20. 20. 20
  21. 21. When researchers are driven to service companies’ needs -trials become demonstrations -research becomes marketing -articles become advertisements -authors become authorities 21
  22. 22. When researchers are driven to service companies’ needs -trials become demonstrations -research becomes marketing -articles become advertisements -authors become authorities 22
  23. 23. Minutes Dutch parlement, 2009 Law on medical scientific research 23
  24. 24. 24
  25. 25. www.quintiles.com
  26. 26. www.parexel.com 27
  27. 27. www.testim.com 28
  28. 28. 29
  29. 29. 30
  30. 30. In Phase IV your focus is on generating market uptake for your product (...). Covance can help launch your product (...). 31
  31. 31. 32
  32. 32. Umbach, 2007 33
  33. 33. 34
  34. 34. 35
  35. 35. Simon & Kotler (2003) 36
  36. 36. 37
  37. 37. 38
  38. 38. When researchers are driven to service companies’ needs -trials become demonstrations -research becomes marketing -articles become advertisements -authors become authorities 39
  39. 39. When researchers are driven to service companies’ needs -trials become demonstrations -research becomes marketing -articles become advertisements -authors become authorities 40
  40. 40. Uit Pharmaceutical Executive, 2008
  41. 41. 42
  42. 42. January 17 2008 Volume 358:252-260 Number 3 Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy Erick H. Turner, M.D., Annette M. Matthews, M.D., Eftihia Linardatos, B.S., Robert A. Tell, L.C.S.W., and Robert Rosenthal, Ph.D. 43
  43. 43. Article handed out by Janssen-Cilag at 2010 international psychiatry conference. Research sponsored by Janssen-Cilag. 44
  44. 44. When researchers are driven to service companies’ needs -trials become demonstrations -research becomes marketing -articles become advertisements -authors become authorities 45
  45. 45. When researchers are driven to service companies’ needs -trials become demonstrations -research becomes marketing -articles become advertisements -authors become authorities 46
  46. 46. Bleidt & Montagne (1997), p.251-252 ‘The direction provided by marketing is crucial to designing trials (...)’ 47
  47. 47. Bleidt & Montagne (1997), p.254 on ‘pre-approval marketing activities’: ‘This goal is accomplished through presentation of clinical information at scientific meetings, using posters and other exhibits, and the publication of articles in scientific journals’. 48
  48. 48. Social Studies of Science, 2004, 34, 187-218 On clinical trial researchers acting as mediators between producers and consumers 49
  49. 49. www.kendle.com 50
  50. 50. Berlin 51
  51. 51. PLoS Medicine, september 2009 and september 2010 52
  52. 52. PLoS Medicine, september 2010
  53. 53. BMJ, 4 april 2009, vol 388, p. 804-807 54 www.esf.org/fileadmin/links/EMRC/FL_IDCT.pdf
  54. 54. Recommendation CROs should be driven to service the needs of civilians rather than pharmaceutical companies. Hence, financially independent agencies should act as an interface between clinical trialists and pharmaceutical companies. 55
  55. 55. Driven to service whose needs? On clinical trials as the population’s instruments Trudy Dehue, professor of Theory and History of Science 56

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