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Clinical Practice and the
Pharmaceutical Industry
 
Pharmaceutical industries &
Sponsorship of Researches
fact that the pharmaceutical
industry now spends more on
medical research than do the
National Institutes of Health in
the United States.
Congress
The report rejected a claim by critics of the
pharmaceutical industry that drug
companies spent more on advertising than
on research and development.       The
report found that drug makers spent much
more on research. Last year,it said
companies spent $30.3bn on research and
development and $19.1bn on all promotion
activities.including $2.7bn for advertising
aimed at consumers
Cost Benefit
  Effectiveness
Promotion
Pharmaceutical industry
      sponsorship and
research outcome and quality
Physicians phamaceutical
companies interrelations

•Representatives
•Funds
   Researches
   Scientific activities
Influences on general practitioners'
decision to prescribe new drugs-the
importance of who says what.

Prosser H, Almond S, Walley T.

Prescribing Research Group, Department of
Pharmacology and Therapeutics, The Infirmary, 70
Pembroke Place, Liverpool L69 3GF and Royal
Liverpool University Hospital, Liverpool L7 8XP,
UK.
Prescribing of new drugs is not simply related to
biomedical evaluation and critical appraisal but,
more importantly, to the mode of exposure to
pharmacological information and social
influences on decision making. Viewed within
this broad context, prescribing variation
becomes more understandable. Findings have
implications for the implementation of evidence-
based medicine, which requires a multifaceted
approach.
Egyptian soc2Clinical Practice and the Pharmaceutical Industry
The methods of influence used include:
B1. Gifts (reciprocal obligations)
B2. Appeals to authority
B3. Social validation (Appeals to conformity)
B4. Liking / friendship
B5. Commitment consistency
B6. Scarcity
B7. Appeals to sympathy
B8. Magic words
B9. Images that appeal to desires
B10. Repetition for agenda setting
 
Egyptian soc2Clinical Practice and the Pharmaceutical Industry
Rules and Guidelines
on Doctors’ relations
with drug companies
Elizabeth Wager
summary

Code of conduct & complaint

Prohibit inducements

Commercially funded research
summary

Journal condition Unsupressed data

Guidance and good publication

Dialogue between the interested
parties
Egyptian soc2Clinical Practice and the Pharmaceutical Industry
Egyptian soc2Clinical Practice and the Pharmaceutical Industry
Egyptian soc2Clinical Practice and the Pharmaceutical Industry
Egyptian soc2Clinical Practice and the Pharmaceutical Industry
Pharmaceutical industry sponsorship
               and
  research outcome and quality:
        systematic review

 British Medical Journal 31may03
Joel Lexchin, associate professor1, Lisa A Bero,
professor2, Benjamin Djulbegovic, associate
professor3, Otavio Clark, chief of clinical oncology
section4

1 School of Health Policy and Management, York University,
Toronto, ON, Canada M3J 1P3,
2 Department of Clinical Pharmacy and Institute for Health Policy
Studies, University of California at San Francisco, San Francisco,
CA 94118, USA,
3 Interdisciplinary Oncology Program, H Lee Moffitt Cancer Center
and Research Institute, University of South Florida, Tampa, FL
33612, USA,
4 Instituto do Radium de Campinas, 13075-460 Campinas-SP, Brazil
Correspondence to: J Lexchin joel.lexchin@utoronto.ca
An increasing number of clinical
trials at all stages in a product's life
cycle are funded by the
pharmaceutical industry
Possibility of
Results that are unfavourable to the
sponsor—that is, trials that find a
drug is less clinically effective or
cost effective or less safe than other
drugs used to treat the same
condition—can pose considerable
financial risks to companies.
Exclusion of

Pressure to show that the drug
causes a favourable outcome may
result in
 biases in design,
 outcome,
and reporting of industry sponsored
research.
Possible biases
 I. Clinical trials
 PROSPECTIVE, RANDOMIZED,
 DOUBLE-BLIND, PLACEBO
 CONTROLLED TRIAL (RCT).
 A. STATISTICAL CONSIDERATIONS
 B. ETHICAL CONSIDERATIONS
 C. STUDY POPULATIONS
 D. ENDPOINT ASSESSMENT
 E. ANALYSIS
recent systematic review of the impact of financial conflicts
on biomedical research found that studies financed by
industry, although as rigorous as other studies, always
found outcomes favourable to the sponsoring company.
However, this review looked for papers published only in
English, excluded reports in letters and abstracts, and
looked at studies funded by other industries.
Objective

To investigate whether funding of drug studies by
the pharmaceutical industry is associated with
outcomes that are favourable to the funder and
whether the methods of trials funded by
pharmaceutical companies differ from the methods
in trials with other sources of support.
Methods
Medline (January 1966 to December 2002) and Embase
(January 1980 to December 2002) searches were
supplemented with material identified in the references
and in the authors' personal files. Data were
independently abstracted by three of the authors and
disagreements were resolved by consensus.
Results

30 studies were included. Research funded by drug
companies was less likely to be published than
research funded by other sources. Studies sponsored
by pharmaceutical companies were more likely to
have outcomes favouring the sponsor than were
studies with other sponsors (odds ratio 4.05; 95%
confidence interval 2.98 to 5.51; 18 comparisons).
None of the 13 studies that analysed methods reported
that studies funded by industry was of poorer quality.
Conclusion

Systematic bias favours products which
are made by the company funding the
research. Explanations include the
selection of an inappropriate
comparator to the product being
investigated and publication bias.
Relationships Between Authors of
Clinical Practice Guidelines and the
Pharmaceutical Industry

Niteesh K. Choudhry, MD, FRCPC; Henry
Thomas Stelfox, MD, FRCPC; Allan S.
Detsky, MD, PhD, FRCPC


   JAMA. 2002;287:612-617
Eighty-seven percent 87 % of authors had some
form of interaction with the pharmaceutical industry.

Fifty-eight percent 58 % had received financial
support to perform research and

38% had served as employees or consultants for a
pharmaceutical company.



                            JAMA. 2002;287:612-
                            617
CPG authors interacted with 10.5 different
companies. Overall, an average of 81% (95%
confidence interval, 70%-92%) of authors per CPG
had interactions.
 Similarly, all of the CPGs for 7 of the 10 diseases
included in our study had at least 1 author who
had some interaction.
 Fifty-nine 59% percent had relationships with
companies whose drugs were considered in the
guideline they authored,
 and of these authors, 96% had relationships that
predated the guideline creation process.

                              JAMA. 2002;287:612-617
Fifty-five percent of respondents indicated that the
guideline process with which they were involved
had no formal process for declaring these
relationships. In published versions of the CPGs,
specific declarations regarding the personal
financial interactions of individual authors with
the pharmaceutical industry were made in only 2
cases. Seven percent thought that their own
relationships with the pharmaceutical industry
influenced the recommendations
 and 19% thought that their coauthors'
recommendations were influenced by their
relationships.
                                JAMA. 2002;287:612-617
Interpretation bias
UKPDS
Seeing what you want to see
in randomised controlled
trials
James McCormack and Trisha Greenhalgh,

                BMJ 2000;320:1720-1723 ( 24 June)
UKPDS
Seeing what you want to see in randomised controlled trials
James McCormack and Trisha Greenhalgh




         Nevertheless, many authors, journal
         editors, and the wider scientific
         community interpreted the study as
         providing evidence of the benefit of
         intensive glucose control
Why Consider Economic
         Research

Type of Funds
   •Alone research by Pharmaceutical Lab

   •Total Funds of scientific research

   •Share witn others
ECONOMIC
     EVALUATIONS: REAL OR
     IMAGINED?
      
Correspondence to:
Michael Drummond                Marco Barbieri
       Economics
Centre for Health Economics
Health
                                Centre for


York
      
University of York              University of


Y010
       5DD,UK
Heslington, York Y010 5DD, UK Heslington, York

Tel: +44 1904 433709                    Tel: +44 1904
434264
Fax: +44 1904 433644                     Fax: +44
1904 433644
e-mail: chedir@york.ac.uk    e-mail: mb35@york.ac.uk
 
Stelfox et al. (1998)
 
Review of English-language medical
literature (1995-1996) about the safety of
calcium channel antagonists.
 
70 articles found: 30 supportive of calcium-
channels antagonist, 17 neutral, 23 critical.
96% of the supportive authors had financial
relationship with manufacturers of calcium-
channel antagonists, as compared with 60%
of neutral and 37 of the critical authors. The
association was statistically significant.
 
Cho and Bero (1996)
Comparison of drug studies published in
symposium proceedings that are
sponsored by drug companies with
articles published in their parent
medical journals.
The percentage in favour of the drug of
interest was 98% for articles with drug
companies support and 79% for articles
without drug companies support. The
difference was statistically significant.
 
 
Davidson RA (1986)
Review of randomised clinical trials in
different areas.
107 published trials were analysed. 71% of
trials favoured new therapies ; 43% of these
were funded by pharmaceutical firms. Of
31% of trials favouring the traditional
therapy, only four (13%) were supported by
drug companies. There was a statistically
significant association between the source
of funding and the outcome of the study.
 
Rochon et al. (1994)
Review of publications of
manufactures-supported trial of
NSAIDs (1987-1990)
52 publications representing 56 trials
were found. In all 56 trials the
manufacturer-associated drug was
reported as comparable (71.4%) or
superior (28.6%) to the comparison
drug.
 
Gazzaniga and Garattini (1992)
Review of 7 pharmacoeconomic studies on
cholesterol-lowering agents
Lack of methodological rigour in some part
of the analyses, but this is not necessary
linked to industrial sponsorship. The role of
sponsor played by drug companies in 5 of
the 7 studies did not seem to have
significantly affected the quality of the
results.
Sacristan et al. (1997)
Review of economic studies published over
the period 1988 to 1994 . Analysis of
publication bias.
22 out of 24 studies (83%) published in
PharmacoEconomics reported positive
results, with 83% of them sponsored by drug
companies. 34 out of 69 studies (49%)
published in general medical journals
reported positive findings, with 74% of them
sponsored by government agencies. The
difference in percentage of positive results
between PharmacoEconomics and general
medical journals was statistically significant.
 
Drummond et al. (1997)
Survey of decision-makers’ atitudes to
economic evaluation conducted in the UK.
59% of responders cited the lack of
credibility of industry-sponsored studies
as an obstacle to the use of the study,
with 8% of respondents identifying this as
the most important obstacle. By contrast,
the possibility that government studies
were not credible was identified as a
problem by only 9% of respondents, with
less than 1% identifying this as the most
important.
Azimi and Welch (1998)
Comparison of cost-effectiveness
analyses sponsored by drug companies
with those sponsored by non-profit
organisations
Industry-financed cost-effectiveness
analyses were more likely to support
additional expenditures with
investigational drugs than standard
treatments.
 
 
ECONOMIC EVALUATIONS:
REAL OR IMAGINED?

  This publication bias can
  only be addressed by
  increasing the funding for
  economic evaluations of
  medicines from other,
  mainly public, sources.
National Codes, Associattion of
British Pharmaceutical industry
(ABPI), Medicines Australia and
Pharmaceutical Research and
Manufacturers of America
France, legal code de la sante
Publique (article L4113-6) Prohibit
Physician from receiving benefits
more than 30 euros (illegal payments)
sanction 75 000 euros and a two years
prison sentence

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Egyptian soc2Clinical Practice and the Pharmaceutical Industry

  • 1. Clinical Practice and the Pharmaceutical Industry  
  • 3. fact that the pharmaceutical industry now spends more on medical research than do the National Institutes of Health in the United States.
  • 4. Congress The report rejected a claim by critics of the pharmaceutical industry that drug companies spent more on advertising than on research and development. The report found that drug makers spent much more on research. Last year,it said companies spent $30.3bn on research and development and $19.1bn on all promotion activities.including $2.7bn for advertising aimed at consumers
  • 5. Cost Benefit Effectiveness Promotion
  • 6. Pharmaceutical industry sponsorship and research outcome and quality
  • 8. Influences on general practitioners' decision to prescribe new drugs-the importance of who says what. Prosser H, Almond S, Walley T. Prescribing Research Group, Department of Pharmacology and Therapeutics, The Infirmary, 70 Pembroke Place, Liverpool L69 3GF and Royal Liverpool University Hospital, Liverpool L7 8XP, UK.
  • 9. Prescribing of new drugs is not simply related to biomedical evaluation and critical appraisal but, more importantly, to the mode of exposure to pharmacological information and social influences on decision making. Viewed within this broad context, prescribing variation becomes more understandable. Findings have implications for the implementation of evidence- based medicine, which requires a multifaceted approach.
  • 11. The methods of influence used include: B1. Gifts (reciprocal obligations) B2. Appeals to authority B3. Social validation (Appeals to conformity) B4. Liking / friendship B5. Commitment consistency B6. Scarcity B7. Appeals to sympathy B8. Magic words B9. Images that appeal to desires B10. Repetition for agenda setting  
  • 13. Rules and Guidelines on Doctors’ relations with drug companies Elizabeth Wager
  • 14. summary Code of conduct & complaint Prohibit inducements Commercially funded research
  • 15. summary Journal condition Unsupressed data Guidance and good publication Dialogue between the interested parties
  • 20. Pharmaceutical industry sponsorship and research outcome and quality: systematic review British Medical Journal 31may03
  • 21. Joel Lexchin, associate professor1, Lisa A Bero, professor2, Benjamin Djulbegovic, associate professor3, Otavio Clark, chief of clinical oncology section4 1 School of Health Policy and Management, York University, Toronto, ON, Canada M3J 1P3, 2 Department of Clinical Pharmacy and Institute for Health Policy Studies, University of California at San Francisco, San Francisco, CA 94118, USA, 3 Interdisciplinary Oncology Program, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, FL 33612, USA, 4 Instituto do Radium de Campinas, 13075-460 Campinas-SP, Brazil Correspondence to: J Lexchin joel.lexchin@utoronto.ca
  • 22. An increasing number of clinical trials at all stages in a product's life cycle are funded by the pharmaceutical industry
  • 23. Possibility of Results that are unfavourable to the sponsor—that is, trials that find a drug is less clinically effective or cost effective or less safe than other drugs used to treat the same condition—can pose considerable financial risks to companies.
  • 24. Exclusion of Pressure to show that the drug causes a favourable outcome may result in biases in design, outcome, and reporting of industry sponsored research.
  • 25. Possible biases I. Clinical trials PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL (RCT). A. STATISTICAL CONSIDERATIONS B. ETHICAL CONSIDERATIONS C. STUDY POPULATIONS D. ENDPOINT ASSESSMENT E. ANALYSIS
  • 26. recent systematic review of the impact of financial conflicts on biomedical research found that studies financed by industry, although as rigorous as other studies, always found outcomes favourable to the sponsoring company. However, this review looked for papers published only in English, excluded reports in letters and abstracts, and looked at studies funded by other industries.
  • 27. Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support.
  • 28. Methods Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus.
  • 29. Results 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality.
  • 30. Conclusion Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
  • 31. Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry Niteesh K. Choudhry, MD, FRCPC; Henry Thomas Stelfox, MD, FRCPC; Allan S. Detsky, MD, PhD, FRCPC JAMA. 2002;287:612-617
  • 32. Eighty-seven percent 87 % of authors had some form of interaction with the pharmaceutical industry. Fifty-eight percent 58 % had received financial support to perform research and 38% had served as employees or consultants for a pharmaceutical company. JAMA. 2002;287:612- 617
  • 33. CPG authors interacted with 10.5 different companies. Overall, an average of 81% (95% confidence interval, 70%-92%) of authors per CPG had interactions. Similarly, all of the CPGs for 7 of the 10 diseases included in our study had at least 1 author who had some interaction. Fifty-nine 59% percent had relationships with companies whose drugs were considered in the guideline they authored, and of these authors, 96% had relationships that predated the guideline creation process. JAMA. 2002;287:612-617
  • 34. Fifty-five percent of respondents indicated that the guideline process with which they were involved had no formal process for declaring these relationships. In published versions of the CPGs, specific declarations regarding the personal financial interactions of individual authors with the pharmaceutical industry were made in only 2 cases. Seven percent thought that their own relationships with the pharmaceutical industry influenced the recommendations and 19% thought that their coauthors' recommendations were influenced by their relationships. JAMA. 2002;287:612-617
  • 35. Interpretation bias UKPDS Seeing what you want to see in randomised controlled trials James McCormack and Trisha Greenhalgh, BMJ 2000;320:1720-1723 ( 24 June)
  • 36. UKPDS Seeing what you want to see in randomised controlled trials James McCormack and Trisha Greenhalgh Nevertheless, many authors, journal editors, and the wider scientific community interpreted the study as providing evidence of the benefit of intensive glucose control
  • 37. Why Consider Economic Research Type of Funds •Alone research by Pharmaceutical Lab •Total Funds of scientific research •Share witn others
  • 38. ECONOMIC EVALUATIONS: REAL OR IMAGINED?   Correspondence to: Michael Drummond Marco Barbieri   Economics Centre for Health Economics Health Centre for York   University of York University of Y010   5DD,UK Heslington, York Y010 5DD, UK Heslington, York Tel: +44 1904 433709 Tel: +44 1904 434264 Fax: +44 1904 433644 Fax: +44 1904 433644 e-mail: chedir@york.ac.uk e-mail: mb35@york.ac.uk
  • 39.   Stelfox et al. (1998)   Review of English-language medical literature (1995-1996) about the safety of calcium channel antagonists.   70 articles found: 30 supportive of calcium- channels antagonist, 17 neutral, 23 critical. 96% of the supportive authors had financial relationship with manufacturers of calcium- channel antagonists, as compared with 60% of neutral and 37 of the critical authors. The association was statistically significant.  
  • 40. Cho and Bero (1996) Comparison of drug studies published in symposium proceedings that are sponsored by drug companies with articles published in their parent medical journals. The percentage in favour of the drug of interest was 98% for articles with drug companies support and 79% for articles without drug companies support. The difference was statistically significant.    
  • 41. Davidson RA (1986) Review of randomised clinical trials in different areas. 107 published trials were analysed. 71% of trials favoured new therapies ; 43% of these were funded by pharmaceutical firms. Of 31% of trials favouring the traditional therapy, only four (13%) were supported by drug companies. There was a statistically significant association between the source of funding and the outcome of the study.  
  • 42. Rochon et al. (1994) Review of publications of manufactures-supported trial of NSAIDs (1987-1990) 52 publications representing 56 trials were found. In all 56 trials the manufacturer-associated drug was reported as comparable (71.4%) or superior (28.6%) to the comparison drug.  
  • 43. Gazzaniga and Garattini (1992) Review of 7 pharmacoeconomic studies on cholesterol-lowering agents Lack of methodological rigour in some part of the analyses, but this is not necessary linked to industrial sponsorship. The role of sponsor played by drug companies in 5 of the 7 studies did not seem to have significantly affected the quality of the results.
  • 44. Sacristan et al. (1997) Review of economic studies published over the period 1988 to 1994 . Analysis of publication bias. 22 out of 24 studies (83%) published in PharmacoEconomics reported positive results, with 83% of them sponsored by drug companies. 34 out of 69 studies (49%) published in general medical journals reported positive findings, with 74% of them sponsored by government agencies. The difference in percentage of positive results between PharmacoEconomics and general medical journals was statistically significant.  
  • 45. Drummond et al. (1997) Survey of decision-makers’ atitudes to economic evaluation conducted in the UK. 59% of responders cited the lack of credibility of industry-sponsored studies as an obstacle to the use of the study, with 8% of respondents identifying this as the most important obstacle. By contrast, the possibility that government studies were not credible was identified as a problem by only 9% of respondents, with less than 1% identifying this as the most important.
  • 46. Azimi and Welch (1998) Comparison of cost-effectiveness analyses sponsored by drug companies with those sponsored by non-profit organisations Industry-financed cost-effectiveness analyses were more likely to support additional expenditures with investigational drugs than standard treatments.    
  • 47. ECONOMIC EVALUATIONS: REAL OR IMAGINED? This publication bias can only be addressed by increasing the funding for economic evaluations of medicines from other, mainly public, sources.
  • 48. National Codes, Associattion of British Pharmaceutical industry (ABPI), Medicines Australia and Pharmaceutical Research and Manufacturers of America
  • 49. France, legal code de la sante Publique (article L4113-6) Prohibit Physician from receiving benefits more than 30 euros (illegal payments) sanction 75 000 euros and a two years prison sentence