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VIAGRA:
Wonder Drug or Ethical Irresponsibility?
What is Viagra? – The hard facts
However...
Death


£   Controversy
£   Pfizer denies complete
    responsibility
£   Deaths were linked to heart attacks
    or strokes
£   Yet, FDA considered drug safe
Our Stakeholder Model


              Pfizer        Consumers




  Society              VIAGRA           Physicians




             Sexual
                                FDA
            partners
Issue Identification - Overview
Ethical Responsibilities of Drug
Manufacturers

£   Duty of care to the health & safety of all
£   Disclosure of risk involved
£   Dealing with this risk best
£   Thorough research of the drug & its effects on all
    stakeholders
£   Organizational ethics
Ensuring Product Safety

£   Assumptions made:
      £   Legally approved by FDA
      £   Consumers’ responsibility

    Pfizer’s responsibility:
      £   Manufacture products that meet safety standards
      £   To minimize the risks and ensure the utmost safety of
          consumers
The “Do No Harm” Principle
What has Pfizer done?

£   Clinical trials:
    £   21 randomized trials that
        took place over 6 months
    £   Tested on > 3,000 patients
        aged 19-87
£   Was this enough?
£   Inherent limitations of pre-
    testing
What has Pfizer done?


“It is not possible to determine whether such cases –
  the reported deaths and other serious consequences-
  are directly linked to Viagra”


                                                  Pfizer
How Safe is Safe?

             £   Concept of acceptable risk
             £   Consider sufferers
             £   Is it based on personal
                 judgment?
             £   Difference between accepted &
                 expected ethical standards in
                 society
Disclosure of Information
Product Labeling


£   Why is it so important?

£   It is the most basic and
    direct method a company
    uses to communicate
    information about its
    product to its consumers
Product Labeling



£   Label updated within 8 months of its approval in 1998
£   Updated again in 2005 and in 2007 to include potential
    visual & aural loss
Included in the Product Label
now:
Product Labeling




Disclosure of risks through product labeling
                 is ENOUGH
Instructions to Physicians
Why is it so important?

  Viagra is only available through prescription.

“And there's only one way to get one. Talk to your
 doctor. He can prescribe VIAGRA if he thinks it's
 right for you.”
                                                   Viagra.com
Instructions to Physicians

Efforts by Pfizer:

  “In May 1998, Pfizer issued a "Dear Doctor" letter
  warning of the large and sudden drops in systemic
  blood pressure occurring in the majority of patients
  taking Viagra®. Doctors were advised to consider the
  cardiac status of patients that were being prescribed
  Viagra®.”
                                             Adrugrecall.com
Instructions to Physicians
Efforts by Pfizer:
Instructions to Physicians


£   Efforts by Pfizer:
£   Provided detailed prescription information
£   http://www.pfizer.com/files/products/uspi_viagra.
    pdf
Instructions to Physicians


Disclosure of risks through instructions to
     physicians meets bare minimum


          More could be done.
Recommendations


£   Imperative to impose stringent guidelines on physicians:

    £   1. Trained to detect underlying conditions instead of simply
        prescribing Viagra to overcome ED

    £   2. Comprehensive evaluation & counseling of patient
Recommendations
Limitations

£   Issues of human sexuality are
    complex & very personal-
    might exceed physician’s own
    knowledge & experience
£   Patients may not be completely
    truthful
£   Atypical behaviours may be
    downplayed
FDA & Viagra
How Drugs Get Approved by the
FDA
FDA & Viagra



So should the FDA require the pharmaceutical industry
    to conduct more elaborate pre-market testing, or
   increase monitoring of customers’ use of the drug?
Pre-testing
Recommendations

£   More illustrative
    sample groups in
    clinical trials
£   More thorough
    examination of those
    with psychological
    conditions that give
    rise to ED
Limitations


              £   Responsibility of
                  manufacturers to design
                  effective trials
              £   Sample size & associated
                  costs
Evaluation
Monitoring Use of Viagra?



£   Currently only
    “monitored” through
    prescriptions
£   May infringe privacy
Ethicality



Although legal, is it ethical for drug manufacturers to
 develop and market a drug that promises enhanced
     sexual performance but could also cause life-
               threatening side effects?
More consequences

                             18-45 years:  312%
                             45-55 years:  216%
£   Abuse

£   Dependency

£   “Alpha male” mentality

£   Side effects


                                            Cons outweigh Pros thus far
Intention




£   Hard to quantify initially
£   But, it is possible that Pfizer aims to treat ED AND
    make a profit
However…



£   Ethical if developed properly

£   Cannot rule Viagra out as some genuinely need it

£   ED is viewed as a very serious condition

£   Impacts lives of sufferers & those around them
Viagra is NOT a Wonder Drug
£   Line drawn between Pfizer, physicians, consumers
Conclusion
Credits & References
http://www.adrugrecall.com/viagra/label-change.html         Prescribing Viagra In A Ethically Responsibile Fashion, by
http://www.pslgroup.com/dg/c5fa2.htm                        Eugene V. Boisaubin and Luarence B. McCullough,
http://www.consumerinjurylawyers.com/viagra/viagra-side-effect.html Of Medicine and Philosophy, Taylor & Francis
                                                            Journal
                                                            http://www.naturalnews.com/001668.html
http://www.bnet.com/blog/drug-business/pfizer-seeks-non-prescription-status-for-viagra-despite-health-risk-worries/4200
http://www.pfizer.com/files/products/uspi_viagra.pdf        http://www.medicinenet.com/impotence_ed/page6.htm#v
                                                            http://www.usatoday.com/news/health/2001-03-21-viagra
http://www.answers.com/topic/viagra                         http://aids.about.com/cs/druginformation/a/viagra_
                                                            2.htm
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0030132
http://www.emaxhealth.com/52/17244.html                     http://articlet.com/article10951.html
                                                            http://www.canada.com/cityguides/winnipeg/infostory.h
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/default.htm
http://www.junkscience.com/news2/viagra3.html               http://www.consumeraffairs.com/news04/viagra_ads.htm
http://www.thebody.com/content/art32246.html (The           http://www.fda.gov/Drugs/ResourcesForYou/Consumers
Dangers of Using and Abusing Viagra, by David Salyer        http://bodyandhealth.canada.com/drug_info_details.asp?b
http://www2.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/02-13-2006/0004280624&EDATE
                                                            http://www.drugs.com/viagra.html
http://www.pfizer.com/responsibility/working_with_hcp/working_with_hcp_benefits_patients.jsp

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VIAGRA: Wonder Drug or Ethical Irresponsibility?

  • 1. VIAGRA: Wonder Drug or Ethical Irresponsibility?
  • 2. What is Viagra? – The hard facts
  • 4. Death £ Controversy £ Pfizer denies complete responsibility £ Deaths were linked to heart attacks or strokes £ Yet, FDA considered drug safe
  • 5. Our Stakeholder Model Pfizer Consumers Society VIAGRA Physicians Sexual FDA partners
  • 7. Ethical Responsibilities of Drug Manufacturers £ Duty of care to the health & safety of all £ Disclosure of risk involved £ Dealing with this risk best £ Thorough research of the drug & its effects on all stakeholders £ Organizational ethics
  • 8. Ensuring Product Safety £ Assumptions made: £ Legally approved by FDA £ Consumers’ responsibility Pfizer’s responsibility: £ Manufacture products that meet safety standards £ To minimize the risks and ensure the utmost safety of consumers
  • 9. The “Do No Harm” Principle
  • 10. What has Pfizer done? £ Clinical trials: £ 21 randomized trials that took place over 6 months £ Tested on > 3,000 patients aged 19-87 £ Was this enough? £ Inherent limitations of pre- testing
  • 11. What has Pfizer done? “It is not possible to determine whether such cases – the reported deaths and other serious consequences- are directly linked to Viagra” Pfizer
  • 12. How Safe is Safe? £ Concept of acceptable risk £ Consider sufferers £ Is it based on personal judgment? £ Difference between accepted & expected ethical standards in society
  • 14. Product Labeling £ Why is it so important? £ It is the most basic and direct method a company uses to communicate information about its product to its consumers
  • 15. Product Labeling £ Label updated within 8 months of its approval in 1998 £ Updated again in 2005 and in 2007 to include potential visual & aural loss
  • 16. Included in the Product Label now:
  • 17. Product Labeling Disclosure of risks through product labeling is ENOUGH
  • 18. Instructions to Physicians Why is it so important? Viagra is only available through prescription. “And there's only one way to get one. Talk to your doctor. He can prescribe VIAGRA if he thinks it's right for you.” Viagra.com
  • 19. Instructions to Physicians Efforts by Pfizer: “In May 1998, Pfizer issued a "Dear Doctor" letter warning of the large and sudden drops in systemic blood pressure occurring in the majority of patients taking Viagra®. Doctors were advised to consider the cardiac status of patients that were being prescribed Viagra®.” Adrugrecall.com
  • 21. Instructions to Physicians £ Efforts by Pfizer: £ Provided detailed prescription information £ http://www.pfizer.com/files/products/uspi_viagra. pdf
  • 22. Instructions to Physicians Disclosure of risks through instructions to physicians meets bare minimum More could be done.
  • 23. Recommendations £ Imperative to impose stringent guidelines on physicians: £ 1. Trained to detect underlying conditions instead of simply prescribing Viagra to overcome ED £ 2. Comprehensive evaluation & counseling of patient
  • 25. Limitations £ Issues of human sexuality are complex & very personal- might exceed physician’s own knowledge & experience £ Patients may not be completely truthful £ Atypical behaviours may be downplayed
  • 27. How Drugs Get Approved by the FDA
  • 28. FDA & Viagra So should the FDA require the pharmaceutical industry to conduct more elaborate pre-market testing, or increase monitoring of customers’ use of the drug?
  • 30. Recommendations £ More illustrative sample groups in clinical trials £ More thorough examination of those with psychological conditions that give rise to ED
  • 31. Limitations £ Responsibility of manufacturers to design effective trials £ Sample size & associated costs
  • 33. Monitoring Use of Viagra? £ Currently only “monitored” through prescriptions £ May infringe privacy
  • 34. Ethicality Although legal, is it ethical for drug manufacturers to develop and market a drug that promises enhanced sexual performance but could also cause life- threatening side effects?
  • 35. More consequences 18-45 years:  312% 45-55 years:  216% £ Abuse £ Dependency £ “Alpha male” mentality £ Side effects Cons outweigh Pros thus far
  • 36. Intention £ Hard to quantify initially £ But, it is possible that Pfizer aims to treat ED AND make a profit
  • 37. However… £ Ethical if developed properly £ Cannot rule Viagra out as some genuinely need it £ ED is viewed as a very serious condition £ Impacts lives of sufferers & those around them
  • 38. Viagra is NOT a Wonder Drug £ Line drawn between Pfizer, physicians, consumers
  • 40. Credits & References http://www.adrugrecall.com/viagra/label-change.html Prescribing Viagra In A Ethically Responsibile Fashion, by http://www.pslgroup.com/dg/c5fa2.htm Eugene V. Boisaubin and Luarence B. McCullough, http://www.consumerinjurylawyers.com/viagra/viagra-side-effect.html Of Medicine and Philosophy, Taylor & Francis Journal http://www.naturalnews.com/001668.html http://www.bnet.com/blog/drug-business/pfizer-seeks-non-prescription-status-for-viagra-despite-health-risk-worries/4200 http://www.pfizer.com/files/products/uspi_viagra.pdf http://www.medicinenet.com/impotence_ed/page6.htm#v   http://www.usatoday.com/news/health/2001-03-21-viagra http://www.answers.com/topic/viagra http://aids.about.com/cs/druginformation/a/viagra_ 2.htm http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0030132 http://www.emaxhealth.com/52/17244.html http://articlet.com/article10951.html http://www.canada.com/cityguides/winnipeg/infostory.h http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/default.htm http://www.junkscience.com/news2/viagra3.html http://www.consumeraffairs.com/news04/viagra_ads.htm http://www.thebody.com/content/art32246.html (The http://www.fda.gov/Drugs/ResourcesForYou/Consumers Dangers of Using and Abusing Viagra, by David Salyer http://bodyandhealth.canada.com/drug_info_details.asp?b http://www2.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/02-13-2006/0004280624&EDATE http://www.drugs.com/viagra.html http://www.pfizer.com/responsibility/working_with_hcp/working_with_hcp_benefits_patients.jsp