Drug Testing in Nigeria

Operational Analysis

Strategic Analysis

In the article analyzed, Drug testing in Nigeria, the researchers, Debora Spar and Adam Day, describe the situation of a clinical test of an experimental drug, Trovan, conducted in a Third World country under suspect conditions, with shoddy supervision and for questionable reasons. Though the Trovan trial was perhaps exceptional, it is also considered an example of what can happen when pharmaceutical corporations conduct research on humans in poor countries with bad supervision.

A nervous system infection, Meningitis can kill a child in a matter of hours if left untreated. It killed more than 12,000 children in six months in and around Kano, a mostly Muslim city. Pfizer, a pharmaceutical giant drug company saw this scenario as an opportunity to do clinical research on 200 live humans, while possibly helping sick people. Half of the 200 children received Trovan and the other half received a "proven meningitis treatment," ceftriaxone, though they administered a dose lower than recommended. Pfizer has maintained its records demonstrate that not one of the deaths could be linked to Trovan or to substandard treatment, and that the clinical study shows there is a better survival rate for patients on Trovan than for patients who receive the standard drug. Survivors sometimes sustain brain damage or other complications from the disease, even if they are "cured" (AP, p. 1).

Nigeria alleges Pfizer did not obtain the required approval for tests, nor did it get proper consents from patients. Pfizer countered by saying the alleged victims were affected by meningitis and not the drug, and that Trovan saved many lives (Oboh, p. 1).

There was a compelling reason to look at Trovan because it was an oral formulation, it was known to have shown efficacy in meningitis and was a five-day treatment so it was perfect for an epidemic setting," Edozien told Reuters (Oboh, p. 1).

In the United States, blockbuster drugs are like gold. The financial analysts said Pfizer would make $1 billion per year if Trovan won approval by the FDA for use against several ailments. Pfizer wanted to test its use against meningitis, and in Africa there was an epidemic of it. Meningitis is rare in the United States, so researchers came to Kano to test it against the dying (Stephens, p. 1). But a hostile reception was faced by Pfizer in Kano, which has a history of rejection of Western medicine. The state government actually banned vaccines against polio in 2003 for nine months, saying the immunization campaign was a U.S.-led plot and the vaccine caused HIV and infertility. This caused a resurgence of the polio disease in Africa.

Background

In January of 1996, a bacterial meningitis epidemic swept across Nigeria. The deadly infection of brain and spinal cord began killing hundreds of children and adults in a land already besieged by cholera and measles epidemics. Some lay on the bare ground writhing with convulsions, doctors recalled. By February, 120 new patients were arriving daily at Kano's stinking, poorly equipped hospital for infectious diseases. Other aid organizations rushed in supplies of approved drugs to hospitals in Nigeria, but U.S.-based Pfizer quickly found a trial drug and chartered a plane to bring its own labs and doctors to the suffering. There, Pfizer gave ill children doses of its experimental drug, Trovan, without parental consent. They went so far, according to the lawsuit filed in New York in 2001, as to under-dose one group of children as a control group. As a result 11 children died, 5 on Trovan and 6 in the control group; many others continued to live but with physical disabilities and brain damage (AP, p. 1). The statistics of this study are quite interesting in that they show equal results for Trovan as for the control group, though there are those who are bemoaning the overall lack of correct supervision, which may shed doubt on the value of the research statistics.

In the court case open against Pfizer, Ngozi Edozien, managing director of the U.S. pharmaceutical company in West Africa, says it was answering an international call for help during a meningitis epidemic among children in Nigeria. The northern state of Kano has joined Nigeria in suing Pfizer for $8.5 billion (Oboh, p. 1).

In 2005, a judge threw out the case, when it was first brought to courts in the United States. He said it should instead be heard in Nigeria. But in October, 2007, Pfizer will be defending itself in two courts, civil and criminal, against charges brought by the Kano state government, while the federal government has brought civil and criminal charges as well (Oboh, p. 1).

Trovan was a drug which had been clinically tested on some 5,000 people before being used in Nigeria. It was licensed for use on adults by the U.S. Food and Drug Administration beginning a few months after it was the subject of this trial, and was a Pfizer's top-selling drug briefly. But the authorities have put severe restrictions on its use since it has been found "to cause serious liver injuries in some patients" (Oboh, p. 1).

Mustapha Maisekili is the father of two victims in the Kano trial. His two young daughters were suffering from the flu-like symptoms typical of meningitis. But they were talking and walking when he took them in to the Infectious Diseases Hospital. They died a couple of weeks later. It appears most of the victims have lost any hope of getting justice on this issue. "If we are compensated through the court judgment we shall be relieved somehow. Most of us are living hand-to-mouth." (Oboh, p. 1)

Another little Nigerian girl's death has made the news in the United States; she is only known as No. 6587-0069. Ten years old and weighing only 41 pounds, she contracted meningitis and found herself in a medical camp where Pfizer doctors had come to give the ill meningitis children antidotes for free. Doctors Without Borders had erected a treatment center, trying to save lives behind a gate besieged by sick people. Next to them, researchers for Pfizer Inc. had set up a second center and, according to some of the doctors who work for Doctors Without Borders, to be using Nigeria's meningitis epidemic to experiment on children with a drug that was not yet approved in the United States.

At testing site No. 6587, the doctors drew spinal fluid from the little girl, wrote down her symptoms and logged her in as patient No. 0069. They administered 56 milligrams of Trovan. A day later her strength was disappearing and one of her eyes froze in place, the Pfizer records show. She died on the third day. Pfizer records were clear. Action taken: "Dose continued unchanged." Outcome: "Death" (Stephens, p. 2).

Another one of the major issues examined was an ethical one, in that though she may have been beyond all hope, no one will know if the girl might not have lived had she been taken off the experimental drug and had been given a proven remedy. The circumstances suggest a big problem involving the ethics of a large corporation (Stephens).

In Africa, Eastern Europe, Latin America and Asia, a booming, poorly regulated testing system dominated by private interests often betrays patients and consumers alike. Experiments occur too often that involve risky drugs, dispensed with little oversight, and poorly educated, impoverished patients who are sometimes tested without their knowledge that they are human guinea pigs. A hollow promise of quality medical care sometimes proves fatal (Stephens, p. 1).

In this environment, drug makers cross national borders easily with little governmental red tape. The U.S. Food and Drug Administration has limited authority and not enough resources to police experiments overseas, so U.S. drug giants pay foreign doctors to test human subjects in countries in Eastern Europe and the Third World, using these human subjects to produce new drugs which are new sources of income. But in a way it is the fault of the lobbyists for disease victims and Congress that they are under pressure to develop new medicines quickly. Patients in wealthy countries will purchase new drugs provided by these foreign trials in poor countries that utilize huge pools of human guinea pigs (Stephens, p. 1).

No matter where one lives, the FDA requires patients in such tests to consent fully to experiments if results are used to win approval for marketing in the U.S. While many tests in many of the Third World countries are conducted conscientiously and expedite the making of life-saving drugs, investigations have found that in other instances the rules are bent or ignored. Industry guidelines have no regulations for conducting meningitis experiments for an antibiotic in a short-staffed, squalid medical camp amid a terrible epidemic, while lacking the most basic of diagnostic equipment.

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