SPIEGEL ONLINE - November 16, 2007, 02:15 PM
USING AFRICANS AS GUINEA PIGS
Nigeria Takes On Pfizer over 'Killer Drug'
By Hauke Goos
The Nigerian government is taking on Pfizer, the world's biggest pharmaceutical company. It accuses the company of using a meningitis epidemic to test an unapproved drug on Nigerian children. Eleven children who participated in the tests died and others were left with disabilities.
Anas Mohammed who was one of the children tested with Pfizer's meningitis epidemic experimental drug. He is now suffering brain damage.
There are days when Babatunde Irukera feels like nothing can go wrong -- not with the evidence that he has gathered, the letters, reports, protocols and all the witnesses. On days like this he believes that, after 11 long years, justice can finally be served for the children of Kano, for his homeland Nigeria, and for Africa.
On a morning in early October, Irukera was sitting in his hotel eating breakfast when an old man walked in. Irukera knew him -- they met the day before in court. The man was clutching a plastic bag.
He pulled a crumpled pink card from the bag, the torn-off half of a file folder. Irukera read "Pfizer Meningitis Study" in the upper left-hand corner of what was once a white label, and under that he sees a number: "Pf 0001." Patient 0001.
Babatunde Irukera is a lawyer and he is representing the state of Nigeria in a lawsuit filed against the American pharmaceuticals giant Pfizer. In 1996, tens of thousands of Nigerians fell ill during an outbreak of meningitis. Pfizer allegedly used the epidemic to test a new, unapproved drug. Eleven children died as a result, others were left deaf, blind or mentally handicapped. The case is not being tried in the US, but in Kano and the Nigerian capital Abuja.
The old man, a former journalist, had searched for two years to locate the participants in the drug test, and he finally hit pay dirt in the slums of Kano, the capital of the northern Nigerian state of the same name, where the disease took its heavy toll.
At 39, Irukera is a young lawyer. The cases he has handled so far have dealt with immigration rights and workplace discrimination. Pfizer is the largest pharmaceutical company in the world, with 100,000 employees, €32.8 billion in annual sales -- more than half the gross national product of Nigeria.
There are a total of four lawsuits filed against Pfizer, two in Kano and two in Abuja, with a civil lawsuit and criminal lawsuit each. The challenge for Irukera and his team is to match names with the numbers of the Pfizer patients and to give the names faces and real lives. In the statement of claim filed by Irukera, he wrote that Pfizer treated the patients like guinea pigs.
Pfizer responded that the mission in Nigeria was a "humanitarian gesture" -- in other words, an act of compassion.
Perfectly Timed Epidemic
In early 1996, Nigeria was hit by the one of the worst meningitis epidemics in history. Government officials have placed the final death toll at over 11,000.
At the time, Pfizer had just developed a new antibiotic called Trovan to treat a variety of infections.
Such drugs are used primarily in hospitals, mainly to treat blood poisoning. Their severe side effects make these antibiotics unsuitable for children. The risks of causing joint disease, abnormal cartilage growth and liver damage are simply too great.
As a rule, such agents are injected directly into the veins because that is the only way that they can work reliably. Initial tests had raised hopes that Trovan could be effective if swallowed in tablet form. Apparently, Pfizer hoped that this innovation would allow it to outpace market leader Bayer. The company believed that Trovan had the potential to become a "blockbuster" drug.
But Pfizer had a problem: In order to secure certification from the Food and Drug Administration (FDA) in the US, it still needed to conduct a clinical trial. Pfizer evidently hoped that it could use the study in Africa to furnish proof that the new drug was also safe for children. The meningitis epidemic in Nigeria came at just the right moment.
Such tests are extremely difficult to conduct in industrialized countries, where very few parents are willing to allow their children to take part in clinical trials. Consequently, companies often turn to poor countries and regions, such as India and South America, Bangladesh and Thailand -- and Africa. Patients in these parts of the world are so poor they don't care if the drugs they receive have been approved or not. Within just a few years, developing countries have been transformed into an enormous test laboratory.
In the spring of 1996, Pfizer offered to help the Nigerian government deal with the outbreak. In late March, a medical team headed for Africa.
When they arrived in Kano, the Americans revealed that they were not on a humanitarian aid mission, but had been sent to administer medical tests. Physicians selected 200 sick children for the study. They had to be at least three months old and younger than 18, and they could not be HIV-positive or malnourished. It takes an enormous amount of money to pave the way for launching a drug like Trovan on the market -- on average €600 million. Pfizer didn't want to make any mistakes. Half the children were given Trovan, the other half received Rocephin, a competing product from Swiss manufacturer Hoffmann-La Roche.
When word got out about the study five years later, a controversy erupted over fundamental questions, for which the Nigerian lawyer and the US drug company have totally different answers: Is it permissible to test a drug during a deadly epidemic? Is it acceptable to test drugs in the developing world that will benefit the industrialized world, using people who will never be able to afford this treatment?
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.
Babatunde Irukera is representing the Nigerian government in the case against Pfizer.
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.
Before they test a drug on children, pharmaceutical companies have to acquire the parents' consent, even in the developing world. They have to explain to the parents that this is a drug in the test phase, and that its safety and effectiveness have not yet been established. The parents must be made aware that there are alternative medicines available that have already been tried and tested. And they have to know that they have the right to exit the study at any time.
They heard on the radio about the white doctors offering help, says Zaharadeen's mother. What did the white doctors tell her? "Nothing," she says. "They wrote down Zaharadeen's name, and then they gave him a pill. Then we went home."
Right from the beginning, Zaharadeen suffered from symptoms of paralysis. The muscles in his legs felt hot, he said. Even today, the pain is sometimes so intense that he has to lie on a mattress for weeks on end.
Just one street down lives Safiya Sani Isa, whose son did not survive the test.
Pfizer is the world's biggest pharmaceutical company with a market value of €200 billion.
Did the doctors present themselves as Pfizer employees?
"No," she says. "We thought they came to help our children. We didn't know that we had a choice between them and Doctors Without Borders."
For a long time, Pfizer refused to comment on the allegations. In 2001, company employees assured a Nigerian committee of inquiry that the test "was totally devoid of any commercial undertone."
Over the past few years, Pfizer has become a household name worldwide thanks to its potency drug Viagra. Boosted by the amazing success story of this and other products, within just three years the company's market value soared from €45 billion to over €200 billion. It was not the time to answer awkward questions.
But now, with this trial about to open, Pfizer has changed its strategy. The Americans want to regain control of the situation.
All contact with the company's headquarters in New York is organized by a woman who only goes by her first name: Sharon. She asks what the caller wants, who he has met in Nigeria, and who he is going to meet. Two days later, Dr. Jack Watters from the New York headquarters calls back. He is the Vice President for International External Medical Affairs, responsible for "corporate responsibility" and "human rights."
Watters has a British accent and a pleasant voice. He promises that he will do his best to answer every question.
Of course, says Watters, the parents gave their consent, but orally. He says that an authorized nurse then signed the release form in their name.
And the side effects? The risks for bones, joints and liver, especially for children?
None of this was known at the time, says Watters. "We didn't find out about the side effects until Trovan came out on the market, two years after the clinical test."
Watters has been with Pfizer since 1994, so he should know better. He should be aware that the side effects of the drug group that Trovan belongs to were documented no later than 1992. What's more, the Pfizer employees wrote in their own test protocol in 1996 that there was a significantly higher rate of joint problems among the children who were treated with Trovan. Fifteen percent of the test patients complained of pain, noted the Pfizer researchers, three times the rate for the reference drug.
And patient 0069? The girl who was subjected to further experiments, although her condition had worsened? What was her cause of death?
Watters said that he was not familiar with the details of this particular case, sorry.
Even following specific questions submitted to the company, Pfizer refused to comment on individual cases.
Recently, Irukera met in London with lawyers from the opposing party. Afterwards, he had the feeling that they had little idea what the trial was about. "I asked them questions, and every answer that they gave to my questions made the next answer even more difficult for them," says Irukera.
Now he is waiting at the airport in Abuja. It is late in the afternoon, and he has missed one flight and the next one has been postponed due to a storm over Lagos. But Irukera is totally calm, almost elated. Everything is going according to plan.
"Pfizer treated the Nigerians in Kano as if the life of a black child was worth less than the life of a white child," says Irukera. When he moved to Chicago, he admired the US for its self-confidence, for its greatness. But the more he found out about the Trovan test, the smaller the country became in his eyes. "Suddenly the Americans realize that they are dealing with blacks in Nigeria who are intelligent -- niggers with brains," he says, and laughs.
"Why don't you do these kinds of tests on children from Manhattan?" he asked Pfizer officials.
Surviving the 'Humanitarian Gesture'
Pfizer denies all the allegations. The company says that it is totally unclear whether the children died because of the tests or the after-effects of the disease. It appears that the corporation would rather make an out-of-court settlement. It would probably amount to a legal sensation if a Nigerian court were to rule that an American company had to pay billions of dollars in compensation.
Perhaps all of this is a question of power, not law, and no lawyer can change that, no document and no victim who happened to survive.
Anas Mohammed is A. M., Pfizer's patient 0001.
Eleven years ago, his father and mother carried him to the hospital. He was five years old and weighed only 25 pounds. Now father and son are sitting on a bench in the shade. There is not a cloud in the sky and it is scorching hot outside.
Mohammed Mustapha, at the time did the doctors at the hospital explain anything to you?
Did anyone explain anything?
Did you have to sign anything?
Did you know that the doctors were not from Doctors Without Borders but from Pfizer, a pharmaceuticals company?
"No," says Mohammed Mustapha, and gives an unsure smile.
He pushes aside a straw curtain and rummages around in a box behind his bed. He is looking for the folder where he has kept Anas' medical documents all these years. Then he reappears with a white binder in his hand; he has saved every official document that he has ever received.
He still has stiff knees, says Anas, his son. For a long time, he received treatment for the condition, and things have improved with time. He survived the "humanitarian gesture," but he will never be healthy again. When he walks relatively long distances, the pain immediately returns.
Anas goes into his bedroom and after a few minutes returns with a pink plastic syringe in his hand. At the top of the syringe is a wheel, and when the plunger is pushed in, the wheel is supposed to spin and make sparks.
The wheel broke a long time ago, but Anas has kept the toy; it is the only one he has. He says that the people from Pfizer gave it to him after the final examination, as a reward.