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
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
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
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
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
