Case: Pfizer's Drug-Testing Strategy in Nigeria

The drug development process is long, risky, and expen- sive. It can take 10 years and cost in excess of $500 mil- lion to develop a new drug. Moreover, between 80 and 90 percent of drug candidates fail in clinical trials. Phar- maceutical companies rely upon a handful of successes to pay for their failures. Among the most successful of the world's pharmaceutical companies is New York- based Pfizer. Given the risks and costs of developing a new drug, pharmaceutical companies will jump at oppor- tunities to reduce them, and Pfizer thought it saw one.

Pfizer had been developing a novel antibiotic, Trovan, that was proving to be useful in treating a wide range of bacterial infections. Wall Street analysts were predicting that Trovan could be a blockbuster, one of a handful of drugs capable of generating sales of more than $1 billion a year. In 1996, Pfizer was pushing to submit data on Trovan's efficacy to the Food and Drug Administration (FDA) for review. A favorable review would allow Pfizer to sell the drug in the United States, the world's largest market. Pfizer wanted the drug to be approved for both adults and children, but it was having trouble finding suf- ficient numbers of sick children in the United States to test the drug on. Then a researcher at Pfizer read about an emerging epidemic of bacterial meningitis in Kano, Nigeria. This seemed like a quick way to test the drug on a large number of sick children.

Within weeks a team of six doctors had flown to Kano and were administering the drug, in oral form, to children with meningitis. Desperate for help, Nigerian authorities gave the go-ahead for Pfizer to give the drug to children (the epidemic would ultimately kill nearly 16,000 people). Over the next few weeks, Pfizer treated 198 children. The protocol called for half the patients to get Trovan and half to get a comparison antibiotic already approved for the treatment of children. After a few weeks, the Pfizer team left, the experiment complete. Trovan seemed to be about as effective and safe as the already approved antibiotic. The data from the trial were put 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 charged that the Pfizer team kept children on Trovan, even after they failed to show a re- sponse to the drug, instead of switching them quickly to another drug. The result, according to critics, was that 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 some doctors feared might lead to arthritis in children. Fif- teen children who took Trovan showed signs of joint pain during the experiment, three times the rate of children tak- ing the other antibiotic. 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 the trials are conducted. Critics argue that in the rush to get the trial established in Nigeria, Pfizer did not follow proper procedures, and that many par- ents of the infected children did not know their children were participating in a trial for an experimental drug. Many of the parents were illiterate, could not read the consent forms, and had to rely upon the questionable translation of the 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 for use in children. Trovan was launched in 1998, and by 1999 there were reports that up to 140 patients in Europe had suffered liver dam- age after taking Trovan. The FDA subsequently restricted the use of Trovan to those cases where the benefitsof treatment outweighed the risk of liver damage. European regulators banned sales of the drug.

Read the above case "Pfizer's Drug-Testing Strategy in Nigeria" and write a 2-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 the marketplace 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 point.