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Using Africans as 'Guinea Pigs': Nigeria Takes On Pfizer over Controversial Drug Test

By Hauke Goos

Part 2: Whose Life Should Be Put on the Line?

Clearly, drugs have to be tested on people before they can be put on the market, and this involves a certain amount of risk. No one disputes that. The central question, however, is who should take the risks and whose life should be put on the line during these tests.

It is a warm morning in early October and Irukera is standing at the window of his ninth-floor office in Lagos and gazing at the sea. He hears the honking of mopeds, taxis and buses, he sees trucks and hawkers walking among the vehicles, selling everything from bananas and pruning sheers to phone cards.

Irukera is wearing a light-blue shirt with an immaculate white collar, a matching tie and a dark suit. If Hollywood ever decides to make a movie about the case, Denzel Washington would be perfect for the role.

In two hours, he plans to fly to Kano, the center of the epidemic 11 years ago, for an important court date. He wants to expand the lawsuit against Pfizer. This is a tactical legal petition, a warning signal to Pfizer. "So they understand how big their problem is," he says.

Irukera left his home country Nigeria 11 years ago. He and his wife emigrated to the US, where she completed an MBA and he pursued his career in law. In 1996, he passed his bar examination and is now a partner in a Chicago law firm. In the taxi to the airport, he has a mobile phone in his left hand and a Blackberry in his right hand. It's 2:30 p.m. and the first e-mails are arriving from Chicago. Irukera has dual nationality. He is fighting for his old homeland and challenging his new one.

In 1996, Trovan had never been tested orally on children suffering from meningitis. Often, meningitis patients suffer from nausea, and there is a high risk that they will vomit up the drug before it has a chance to take effect. Doctors treating the patients have very little time to prevent brain damage; only injections can allow them to be sure that the drug works quickly. Why in the world would they give these children Trovan orally?, Irukera asked himself. He realized that this just might be the case of his career.

It would appear that the Pfizer team broke a number of fundamental rules. Patient 0069, for instance, a little girl, received 56 milligrams of Trovan on the first day of treatment. Although her condition rapidly deteriorated, the doctors maintained this dose. On the third day, the girl died. International guidelines for clinical studies specify that patients who do not react to a test drug should be immediately removed from the study -- particularly since Rocephin, a reliable medicine, was available.

Irukera says that he thought long and hard over what could be said in favor of Pfizer in this situation, adding after a short pause, "I couldn't think of anything."

'We Are Human Beings'

In early May 2007, Nigeria filed a lawsuit against Pfizer. The statement of claim contains 85 charges, including fraud and deceit, fraudulent concealment, and conspiracy to commit an actionable wrong. Irukera believes he hasn't left anything out. The trials are still in the preparatory phase; Pfizer appears to be doing everything that it can to stall for time.

The next morning, in front of the courthouse in Kano, a representative of the public prosecutor's office is waiting for Irukera. The public prosecutor has decided to amend the charges against Pfizer to include manslaughter. Irukera smiles.

He is wearing a robe, a stand-up collar and a wig. After he enters the courtroom, Irukera slips the Blackberry back into his pocket. While he is presenting the case, the Pfizer lawyer, who is sitting beside him, suddenly offers him a deal. If Irukera withdraws his petition, he whispers, Pfizer would withdraw its own petition, which is lying prepared on the table. Irukera pauses for a moment, leans over to his colleague, and the two men speak in hushed tones. Then Irukera stands up straight again and continues with his presentation, as if there had never been an interruption.

After the proceedings, as he emerges again from the courtroom, someone from the People's Salvation Party is busy talking to a group of journalists in front of the building. The man is wearing a cap and a loose-fitting, traditional African robe. "This trial will go on forever," he says in a booming voice, and notes that the Americans have an army of lawyers who know all the tricks. "We Africans have no chance." He goes on to say that American companies are ruthless, "they don't care if 20,000 people die, as long as the profits roll in."

Following the court appearance, the public prosecutor holds a short press conference. He says that they have succeeded in identifying some of the numbers and initials on the lists of patients. "We are not numbers," he says. "We are human beings."

The next morning, Irukera flies to the capital Abuja, a 40-minute flight from Kano. He has an appointment with Idris Mohammed, the man who may be his star witness. Mohammed, 65, is a professor of medicine -- a stocky, affable gentleman who coordinated the relief work for the government at the time. Aside from meningitis, aid workers were fighting measles and cholera. It was, says Mohammed with a thin smile, a less than ideal situation for testing a new drug. Mohammed was the official who demanded letters of authority from Pfizer, and when these could not be produced, he ordered that the testing be stopped.

Back then, the team from the US company moved into the Infectious Diseases Hospital in Kano, directly adjacent to Doctors Without Borders. The parents of the sick children evidently believed that the Pfizer staff were members of the aid organization. It was not until Doctors Without Borders threatened to leave that Pfizer moved to two rooms in a ward that was a bit farther away, a one-story wing of the building with barred windows. A wire-mesh door shielded the team from the patients, who were crowded into the courtyard. The Pfizer physicians also hung a screen in front of the door.

Mohammed says that he met with the head of the American team right at the start. He asked him for whom the drug was intended, and explained that virtually no one in Africa could afford it. The doctor responded that the drug had been developed for the US and rich countries in Europe.

Once, says Mohammed, he saw how a young Pfizer physician removed cerebrospinal fluid from a child roughly four years old. It takes three, four drops at the most to diagnose meningitis. But according to Mohammed, he observed the doctor take more than 50 drops.

Mohammed was afraid that the life of the child was in danger. Cerebrospinal fluid protects the brain from concussions; it works as a shock absorber. An adult has approximately 120 to 200 milliliters of the liquid; a child has significantly less. If too much is removed, there is a risk that the brain stem may be pushed into the opening of the spinal chord. This can damage vital centers in the brain stem, in the worst case leading to paralysis or death.

"How much brain fluid do you think a child like this has?" asked Mohammed.

"Plenty," said the doctor.

"How much is 'plenty,' in your opinion?"

"More than a liter."

An hour later the child died.

Pfizer ignored Mohammed's calls to discontinue the testing. It wasn't until mid-April, after the 200th child had been treated, that the team packed their bags and flew home, says Mohammed. "The 'humanitarian gesture' ended right at the height of the epidemic."

Back then, meningitis spread through slums on the outskirts of Kano. The journey there is through dusty roads with deep potholes, past fruit stands, mosques and people collecting refuse. Men doze in the shade of gaunt trees; goats graze at a filling station. On a billboard, a sports accessories company advertises with the slogan "Celebrate. Success."

Zaharadeen Abdullah lives nearby in a small, narrow street. He is 18 years old and was seven when he caught meningitis. Zaharadeen is the sixth of 10 children; his parents can neither read nor write.

Article...

© SPIEGEL ONLINE 2007
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