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