Running head: PFIZER'S DRUG-TEST

Pfizer's Drug-Test Strategy in Nigeria

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BUS 616: International Business
Dr. XXX
June 28, 2014





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Pfizer's Drug-Test Strategy in Nigeria

What are the different phases that a Drug Company goes through in order
to bring a new drug product to market in the U.S. and Europe?
Before companies can make new medicines available, lengthy tests and evaluation of its
effects on people is necessary before granting marketing approval. In the United States when a
new drug or intervention is believed to be able to treat a specific disease state or medical
condition, the Food and Drug Administration (FDA) is required to ensure that its quality, safety
and effectiveness meets strict guidelines and standards. The FDA is a safety agency that is
tasked with protecting public health when drug companies seek to introduce new medications
into the market. In Europe, the European Agency for Evaluation of Medicinal Products
(EAEMP) is charged for this same type approval. The authorization process is comparable in
both the U.S. and in Europe, whereby a rigorous process, both time consuming and costly, must
be passed for a final product to enter mass production and distribution
A series of applications must be filled out in different phases of receiving FDA approval.
During the Investigational New Drug (IND) phase, pre-clinical studies are included identifying
the results from potential test- tube trials, as well as vitro and final studies of animal experiments
if applicable. This stage assists drug-developing companies in determining whether the drug
warrants further development or not (FDA, n.d.). It is the responsibility of the company seeking
to market a drug, to test it and submit evidence that it is safe and effective.
If approved to begin running clinical trials, four phases in a series of specific steps of
clinical trials, are designed to test very specific outcomes and effects. In phase I, investigators
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determine if the drug will generally be safe for people to take. As pre-clinical testing may have
answered some important questions, "it is in this phase of the trial that the medication is tested
for overall safety, establishing a safe range of dosages, and determining whether there are any
immediate side effects" (Rossen, n.d.). In phase I, a relatively small number of people, generally
around a sample of 100 or less, are used. As each phase is successfully passed, more and more
quantities of people are allowed for the drug manufacturer to test on. Phase 3 introduces
placebo's, and trials successfully making it to phase 4, identify rare but significant side effects, in
possible sub-populations, and other patients having other specific medical conditions (Rossen,
n.d.).
Once all testing is complete, a final New Drug Application (NDA) is submitted with full
information on manufacturing specifications, stability and bio-metric data, and the method of
analysis of each of the dosage forms the sponsor intends to market, package and label for both
physician and consumer, and the results of any additional toxicological studies not already
submitted in the IDA (FDA, n.d.). The time and effort required to bring a new drug or treatment
to the marketplace can be long and exhausting. However, the sensitivity and importance of
safeguarding human life, by taking necessary safety precautions when launching new
medications and treatments is critical.

Did Pfizer behave unethically by rushing to take advantage of an
epidemic in Nigeria to test experimental drugs on children?
Pfizer had been developing a new antibiotic, Trovan, to cover a wide range of bacterial
infections in both adults and children. However, Pfizer was having a hard time capturing the
data needed for the child clinical trials due to the insufficient numbers of sick children in the
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U.S. to test the drug on. Nigeria on the other hand, was suffering from a meningitis epidemic
predicting to have a death toll of 16,000 people if gone untreated. With no other resolution in
sight, a clinical trial drug like Trovan could prove to be successful, thus minimizing the demise
of the epidemic . However, the statement from the Pfizer researcher "this was a quick way to
test the drug on a large number of sick children", made it appear that Pfizer was more concerned
with getting the data it needed than solving Nigeria's problem. Organizations have an ethical
responsibility when dealing in international business, especially when involving human rights
(Hill, 2011). Pfizer behaved unethically by rushing to take advantage of the epidemic in Nigeria
in order to get the numbers they needed to present to the FDA.

Should it have been less opportunistic and proceeded more carefully?
Depending on one's philosophical approach to ethics, business decisions can be formed
that may favor one school of thought to another. In other words, while some companies seek
opportunities like this to get a head, others may view this unethical and risky and decide against
going to Nigeria all together. For example, the straw men position of the Friedman Doctrine is
to increase company profits and shareholder wealth, as long as the game is played within the
rules of law. Under this concept, Pfizer did the right thing by closing the gap in its Trovan
studies on children.
Utilitarian approaches contend that the best decisions are those that produce the greatest
good for the greatest number of people (Hill, 2011). There is some grey area here, and the
decision that needed to be made is not so clear under this methodology. If successful, the drug
could be beneficial to many people around the world. The issue becomes, how to balance the
risk of whether to proceed or not, and who is to gain?
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Rights theories hold human beings in high regards, proposing that a minimal degree of
fundamental rights, privileges and morally acceptable behavior should transcend national
boundaries and cultures (Hill, 2011). Organizations adopting a Rights theory would have taken
more time and proceeded more carefully in order to uphold the safety and protection of all of the
children involved in the study.

Were corners cut with regard to patient consent in the rush to establish a trial?
Pfizer's dispensing of antibiotic Trovan to sick children was allegedly without the
consent of the parents. It was Pfizers unethical decision to take the riskier decision and chose to
ignore the childrens personal safety in testing. Etkin (2008) states that the Pfizer trial, which
left some children dead, blind, deaf, paralyzed, or brain damaged did not get appropriate consent
from parents, the hospital, or permission from the appropriate government approvals (Etkin,
2008). For what appears to be monetary gain and corporate self-serving reasons, the disregard to
getting patient, or parent consent was a violation of ethics. Pfizer took advantage of the
meningitis outbreak in Nigeria, leveraging their size and power on an underprivileged,
underserved, underdeveloped country in order to quickly capture the data it needed for its
research. Pfizer executives deny the allegations and claim they "followed international protocols
providing for verbal consent in situations where you are dealing with a population that cannot
read or write" (Big pharma, 2008).

Did doctors keep patients on Trovan too long when
they should have switched them to another medication?
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Eleven children died, due to the improper application of Trovan. While some evidence
alludes to the fact that some patients were on the medication for too long, and Pfizer withheld
alternative treatment that could saved their lives, Pfizer should have taken extra precautions to
ensure the safety and welfare of those on Trovan by stopping the treatment. Pfizer states it was
the meningitis that ultimately caused the harmful effects. A decade later, Pfizer agreed to a $75
million settlement to the Nigerian government to end a long courtroom battle between the two
entities. A Nigerian spokesperson stated that big companies should be held accountable for their
ill actions, and people all around the world deserve the same level of protection (Stephens,
2009).

Is it ethical to test experimental drugs on children in a crisis setting in the
developing world where the overall standard of health care is so much lower
than in the developed world and proper protocols might not be followed?
Our personal ethical code exerts a profound influence on the way we behave as business
people (Baale & Akanmu, 1995). The ethical obligations of Pfizer, as well other companies for
that matter, depends on one's own cultural perspective. This makes ethical and moral issues
difficult to tackle, with no clear cut right or wrong answer. What is considered normal practice
in one nation, may be unethical in another (Hill, 2011).
Pfizer should have been more sensitive to the differences in health care standards and
better prepared to offer viable, safe solutions to the Nigerian children first, with a secondary
objective of capturing relevant data to take back to the U.S. The same set of guidelines, rules,
and precautions that are implemented in the U.S. should also have been followed in Nigeria.
Lawsuits later filed against Pfizer case, where Attorney Kusal said it best, "It is important for
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U.S. companies to be held accountable in our courts for their conduct that harms unprotected
foreign nationals" (Mokhiber, 2003).
















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References:
Baale, L., & Akanmu, O. (1995). Nigeria: Rx marketing in a depressed economy.
Pharmaceutical Executive, 15(11), 74. Retrieved from
http://search.proquest.com/docview/216419561?accountid=32521
Big pharma in the spotlight over offshore trials. (2008). Inpharma Weekly, (1622), 2.
Etkin, S. (2008). Pfizer in Hot Water Over Nigerian Pediatric Trial. Applied Clinical Trials,
17(2), 24.
Hill, W.L. (2011). International business: Competing in the global marketplace (8
th
ed.). New
York: McGraw-Hill Irwin. ISBN: 978-0-07-813719-8.
Mokhiber, R. (2003). The Pfizer-Nigeria Case. Multinational Monitor, 24(11), 30.
Rossen, K. (n.d.). Phases of Clinical Trials. Retrieved from: https://suite.io/kenneth-
rosen/1bbt2nq
Stephens, J. (2009). Pfizer to Pay $75 Million to Settle Nigerian Trovan Drug-Testing Suit. The
Washington Post. Retrieved from: http://www.washingtonpost.com/wp-
dyn/content/article/2009/07/30/AR2009073001847.html
U.S. Food and Drug Administration (n.d.). How Drugs are Developed and Approved. Retrieved
from:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandAp
proved/default.htm