VIAGRA: Wonder Drug or Ethical Irresponsibility?
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Transcript of VIAGRA: Wonder Drug or Ethical Irresponsibility?
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
VIAGRA
Pfizer Consumers
SocietyPhysician
s
FDASexual 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 PhysiciansWhy 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 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
Instructions to PhysiciansEfforts 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
Abuse
Dependency
“Alpha male” mentality
Side effects
Cons outweigh Pros thus far
18-45 years: 312%45-55 years: 216%
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 & ReferencesPrescribing Viagra In A Ethically Responsibile Fashion, by Eugene V. Boisaubin and Luarence B. McCullough, Journal Of Medicine and Philosophy, Taylor & Francishttp://www.naturalnews.com/001668.html http://www.medicinenet.com/impotence_ed/page6.htm#viagrahttp://www.usatoday.com/news/health/2001-03-21-viagra-abuse.htmhttp://aids.about.com/cs/druginformation/a/viagra_2.htmhttp://articlet.com/article10951.htmlhttp://www.canada.com/cityguides/winnipeg/infostory.html?id=841f6d38-2595-4a25-a202-97a82d053f0dhttp://www.consumeraffairs.com/news04/viagra_ads.htmlhttp://www.fda.gov/Drugs/ResourcesForYou/Consumers/default.htmhttp://bodyandhealth.canada.com/drug_info_details.asp?brand_name_id=1108http://www.drugs.com/viagra.html
http://www.adrugrecall.com/viagra/label-change.htmlhttp://www.pslgroup.com/dg/c5fa2.htmhttp://www.consumerinjurylawyers.com/viagra/viagra-side-effect.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.answers.com/topic/viagrahttp://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0030132http://www.emaxhealth.com/52/17244.htmlhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/default.htmhttp://www.junkscience.com/news2/viagra3.htmlhttp://www.thebody.com/content/art32246.html (The Dangers of Using and Abusing Viagra, by David Salyerhttp://www2.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/02-13-2006/0004280624&EDATEhttp://www.pfizer.com/responsibility/working_with_hcp/working_with_hcp_benefits_patients.jsp