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£   Y...
Our Stakeholder Model              Pfizer        Consumers  Society              VIAGRA           Physicians             S...
Issue Identification - Overview
Ethical Responsibilities of DrugManufacturers£   Duty of care to the health & safety of all£   Disclosure of risk involved...
Ensuring Product Safety£   Assumptions made:      £   Legally approved by FDA      £   Consumers’ responsibility    Pfizer...
The “Do No Harm” Principle
What has Pfizer done?£   Clinical trials:    £   21 randomized trials that        took place over 6 months    £   Tested o...
What has Pfizer done?“It is not possible to determine whether such cases –  the reported deaths and other serious conseque...
How Safe is Safe?             £   Concept of acceptable risk             £   Consider sufferers             £   Is it base...
Disclosure of Information
Product Labeling£   Why is it so important?£   It is the most basic and    direct method a company    uses to communicate ...
Product Labeling£   Label updated within 8 months of its approval in 1998£   Updated again in 2005 and in 2007 to include ...
Included in the Product Labelnow:
Product LabelingDisclosure of risks through product labeling                 is ENOUGH
Instructions to PhysiciansWhy is it so important?  Viagra is only available through prescription.“And theres only one way ...
Instructions to PhysiciansEfforts by Pfizer:  “In May 1998, Pfizer issued a "Dear Doctor" letter  warning of the large and...
Instructions to PhysiciansEfforts by Pfizer:
Instructions to Physicians£   Efforts by Pfizer:£   Provided detailed prescription information£   http://www.pfizer.com/fi...
Instructions to PhysiciansDisclosure of risks through instructions to     physicians meets bare minimum          More coul...
Recommendations£   Imperative to impose stringent guidelines on physicians:    £   1. Trained to detect underlying conditi...
Recommendations
Limitations£   Issues of human sexuality are    complex & very personal-    might exceed physician’s own    knowledge & ex...
FDA & Viagra
How Drugs Get Approved by theFDA
FDA & ViagraSo should the FDA require the pharmaceutical industry    to conduct more elaborate pre-market testing, or   in...
Pre-testing
Recommendations£   More illustrative    sample groups in    clinical trials£   More thorough    examination of those    wi...
Limitations              £   Responsibility of                  manufacturers to design                  effective trials ...
Evaluation
Monitoring Use of Viagra?£   Currently only    “monitored” through    prescriptions£   May infringe privacy
EthicalityAlthough legal, is it ethical for drug manufacturers to develop and market a drug that promises enhanced     sex...
More consequences                             18-45 years:  312%                             45-55 years:  216%£   Abuse...
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 se...
Viagra is NOT a Wonder Drug£   Line drawn between Pfizer, physicians, consumers
Conclusion
Credits & Referenceshttp://www.adrugrecall.com/viagra/label-change.html         Prescribing Viagra In A Ethically Responsi...
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VIAGRA: Wonder Drug or Ethical Irresponsibility?

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VIAGRA: Wonder Drug or Ethical Irresponsibility?

  1. 1. VIAGRA:Wonder Drug or Ethical Irresponsibility?
  2. 2. What is Viagra? – The hard facts
  3. 3. However...
  4. 4. Death£ Controversy£ Pfizer denies complete responsibility£ Deaths were linked to heart attacks or strokes£ Yet, FDA considered drug safe
  5. 5. Our Stakeholder Model Pfizer Consumers Society VIAGRA Physicians Sexual FDA partners
  6. 6. Issue Identification - Overview
  7. 7. Ethical Responsibilities of DrugManufacturers£ 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. 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. 9. The “Do No Harm” Principle
  10. 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. 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. 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
  13. 13. Disclosure of Information
  14. 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. 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. 16. Included in the Product Labelnow:
  17. 17. Product LabelingDisclosure of risks through product labeling is ENOUGH
  18. 18. Instructions to PhysiciansWhy is it so important? Viagra is only available through prescription.“And theres only one way to get one. Talk to your doctor. He can prescribe VIAGRA if he thinks its right for you.” Viagra.com
  19. 19. Instructions to PhysiciansEfforts 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
  20. 20. Instructions to PhysiciansEfforts by Pfizer:
  21. 21. Instructions to Physicians£ Efforts by Pfizer:£ Provided detailed prescription information£ http://www.pfizer.com/files/products/uspi_viagra. pdf
  22. 22. Instructions to PhysiciansDisclosure of risks through instructions to physicians meets bare minimum More could be done.
  23. 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
  24. 24. Recommendations
  25. 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
  26. 26. FDA & Viagra
  27. 27. How Drugs Get Approved by theFDA
  28. 28. FDA & ViagraSo should the FDA require the pharmaceutical industry to conduct more elaborate pre-market testing, or increase monitoring of customers’ use of the drug?
  29. 29. Pre-testing
  30. 30. Recommendations£ More illustrative sample groups in clinical trials£ More thorough examination of those with psychological conditions that give rise to ED
  31. 31. Limitations £ Responsibility of manufacturers to design effective trials £ Sample size & associated costs
  32. 32. Evaluation
  33. 33. Monitoring Use of Viagra?£ Currently only “monitored” through prescriptions£ May infringe privacy
  34. 34. EthicalityAlthough 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. 35. More consequences 18-45 years:  312% 45-55 years:  216%£ Abuse£ Dependency£ “Alpha male” mentality£ Side effects Cons outweigh Pros thus far
  36. 36. Intention£ Hard to quantify initially£ But, it is possible that Pfizer aims to treat ED AND make a profit
  37. 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. 38. Viagra is NOT a Wonder Drug£ Line drawn between Pfizer, physicians, consumers
  39. 39. Conclusion
  40. 40. Credits & Referenceshttp://www.adrugrecall.com/viagra/label-change.html Prescribing Viagra In A Ethically Responsibile Fashion, byhttp://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.htmlhttp://www.bnet.com/blog/drug-business/pfizer-seeks-non-prescription-status-for-viagra-despite-health-risk-worries/4200http://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-viagrahttp://www.answers.com/topic/viagra http://aids.about.com/cs/druginformation/a/viagra_ 2.htmhttp://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0030132http://www.emaxhealth.com/52/17244.html http://articlet.com/article10951.html http://www.canada.com/cityguides/winnipeg/infostory.hhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/default.htmhttp://www.junkscience.com/news2/viagra3.html http://www.consumeraffairs.com/news04/viagra_ads.htmhttp://www.thebody.com/content/art32246.html (The http://www.fda.gov/Drugs/ResourcesForYou/ConsumersDangers of Using and Abusing Viagra, by David Salyer http://bodyandhealth.canada.com/drug_info_details.asp?bhttp://www2.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/02-13-2006/0004280624&EDATE http://www.drugs.com/viagra.htmlhttp://www.pfizer.com/responsibility/working_with_hcp/working_with_hcp_benefits_patients.jsp
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