Working For Pharma Inc

Working for Pharma, Inc.

I. Company background and revealed facts

* A major pharmaceutical company that sold $8.9 billion of drugs all over the world in 1992, with profits of $3.1 billion. Headquartered in Pharmacopia, New Jersey.

* Before approving the sale of any new drug, the U.S. Food and Drug Administration requires that the drug is put through three phases of tests after being tested on animals.

Phase I: the drug is tested by healthy human individuals to determine its side effects.

Phase II: the drug is given to large numbers of sick patients by doctors and hospitals to determine its efficacy.

* The company provides food, housing, and compensation to numerous homeless alcoholics who perform short-term work for the company.

* In Phase I testing, companies must secure test subjects by advertising widely and offering payment to subjects as much as $200 a day.

* Pharma, Inc. -- Does not advertise widely.

-- Pays its volunteers only $71 a day plus free room and board (the lowest in the industry).

-- The majority of its subjects are homeless alcoholics recruited through word of mouth.

-- Provides food, housing, and compensation.

* Subjects -- Are unemployable homeless alcoholics.

-- Are quite happy to participate in an arrangement that provides them with "easy money."

-- Had no idea what kind of drug was being tested on them even though they had signed an informed-consent form.

* The Federal Drug Administration's requirements

-- Participants in Phase I tests must give their "informed consent."

-- Participants must make a "truly voluntary and uncoerced decision" when they agree to take an untested potentially dangerous drug for $85 a day.

II. Ethical issues

* Was Pharma, Inc. exploiting the homeless by using them as their "low-cost subjects"?

* Are benefits and money paid to those subjects "unacceptable and unreasonably low"?

* Did those subjects need to be more educated regarding the effects of taking the drug?

To determine the ethical issues involved in this case and the affected parties, obligations of each party are identified, and the Ethics Toolbox is applied to show ethical consequence:

III. Affected parties and obligations

* Pharma, Inc.

Advantages:

o Less risk in terms of being sued by these subjects if severely injured by the drug occurs.

o The tests run on the homeless men provide enormous benefits for society.

o In light of the difficulty of securing the test subjects, some tests might be delayed or not performed at all if it were not for the large pool of homeless men willing and eager to participate in the tests.

Obligations:

o To provide good quality drugs to consumers (society).

o To follow the requirements of the FDA regarding the use of subjects, Pharma, Inc. is required to pay each subject a reasonable amount as well as to secure subjects by educating them about the effects of the test and conducting safe tests.

o To advertise the tests widely.

* Subjects (homeless alcoholics)

Disadvantages:

o A higher risk: subjects may carry diseases that are undetectable by standard blood screening and that make them vulnerable to being severely harmed by certain drugs.

Obligations:

o Subjects have the right to be informed about the information accuracy of the test, the right to receive benefits from the test participation, and the right to be secured by the regulations or guidelines provided by FDA.

o Following the requirements of the FDA by making a truly voluntary and uncoerced decision when they agree to take an untested potentially dangerous drug for $85 a day.

IV. Ethics Toolbox

Ethical Reasoning Approaches Affected Parties Consequences

Utilitarian Pharma, Inc.

Subjects

Drug consumers This action is considered ethical. Under the determining factor of the utilitarian approach, an action is ethical when it provides the greatest benefit to the affected parties. In this case, Pharma, Inc. provides benefits to subjects, who are homeless alcoholics, and those subjects are satisfied with what they receive. Pharma, Inc. gained advantages on cost effectiveness and developed good quality drugs for the society. Last, drug consumers gained benefits