Read Management Focus: Pfizer’s Drug-Testing Strategy in Nigeria in Chapter 4 of your text and write a three- to four-page paper, excluding the title and reference pages, that answers the following:
- Explain 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.
- Analyze whether or not Pfizer behaved unethically by rushing to take advantage of an epidemic in Nigeria to test experimental drugs on children.
- Analyze whether or not corners were cut with regard to patient consent in the rush to establish a trial.
- Determine if Pfizer should have been less opportunistic and proceeded more carefully.
- Examine whether doctors kept patients on Trovan too long or if they should have switched them to another medication. Include possible additional strategies.
- Analyze the ethical nature of testing experimental drugs on children in a crisis setting in the developing world. Keep in mind that the overall standard of health care in the developing world is significantly lower than in the developed world, and proper protocols might not be followed.
Your paper should be formatted in APA format as outlined in the Ashford Writing Center. In addition to the required text, provide at least two additional scholarly sources to support your paper.
Case study is here:
MANAGEMENT FOCUSPfizer’s Drug-Testing Strategy in NigeriaThe drug development process is long, risky, and expensive. It can take 10 years and cost inexcess of $500 million to develop a new drug. Moreover, between 80 and 90 percent of drugcandidates fail in clinical trials. Pharmaceutical companies rely upon a handful of successes topay for their failures. Among the most successful of the world’s pharmaceutical companies isNew York–based Pfizer. Given the risks and costs of developing a new drug, pharmaceuticalcompanies will jump at opportunities to reduce them, and Pfizer thought it saw one.Pfizer had been developing a novel antibiotic, Trovan, that was proving to be useful intreating a wide range of bacterial infections. Wall Street analysts were predicting that Trovancould be a blockbuster, one of a handful of drugs capable of generating sales of more than $1billion a year. In 1996, Pfizer was pushing to submit data on Trovan’s efficacy to the Food andDrug Administration (FDA) for review. A favorable review would allow Pfizer to sell the drugin the United States, the world’s largest market. Pfizer wanted the drug to be approved for bothadults and children, but it was having trouble finding sufficient numbers of sick children in theUnited States to test the drug on. Then a researcher at Pfizer read about an emerging epidemicof bacterial meningitis in Kano, Nigeria. This seemed like a quick way to test the drug on a largenumber of sick children.Within weeks a team of six doctors had flown to Kano and were administering the drug, inoral form, to children with meningitis. Desperate for help, Nigerian authorities gave the goaheadfor Pfizer to give the drug to children (the epidemic would ultimately kill nearly 16,000people). Over the next few weeks, Pfizer treated 198 children. The protocol called for half thepatients to get Trovan and half to get a comparison antibiotic already approved for the treatmentof children. After a few weeks, the Pfizer team left, the experiment complete. Trovan seemed tobe about as effective and safe as the already approved antibiotic. The data from the trial wereput into a package with data from other trials of Trovan and delivered to the FDA.Questions were soon raised about the nature of Pfizer’s experiment. Allegations chargedthat the Pfizer team kept children on Trovan, even after they failed to show a response to thedrug, instead of switching them quickly to another drug. The result, according to critics, wasthat some children died who might have been saved had they been taken off Trovan sooner.Questions were also raised about the safety of the oral formulation of Trovan, which somedoctors feared might lead to arthritis in children. Fifteen children who took Trovan showedsigns of joint pain during the experiment, three times the rate of children taking the otherantibiotic. Then there were questions about consent. The FDA requires that patient (or parent)consent be given before patients are enrolled in clinical trials, no matter where in the world thetrials are conducted. Critics argue that in the rush to get the trial established in Nigeria, Pfizerdid not follow proper procedures, and that many parents of the infected children did not knowtheir children were participating in a trial for an experimental drug. Many of the parents wereilliterate, could not read the consent forms, and had to rely upon the questionable translation ofthe Nigerian nursing staff. Pfizer rejected these charges and contends that it did nothing wrong.The FDA approved Trovan for use in adults in 1997, but it has not approved the drug foruse in children. Trovan was launched in 1998, and by 1999 there were reports that up to 140patients in Europe had suffered liver damage after taking Trovan. The FDA subsequentlyrestricted the use of Trovan to those cases where the benefits of treatment outweighed the riskof liver damage. European regulators banned sales of the drug.
Book is listed below
Hill, W.L. (2011). International Business: Competing in the global marketplace (8th ed.). New York: McGraw-Hill Irwin. ISBN: 978-0-07-813719-8