Nigeria files criminal charges against Pfizer over clinical trial
Joe Stephens, Washington Post
Wednesday, May 30, 2007
Washington -- Officials in Nigeria have brought criminal charges against pharmaceutical giant Pfizer Inc. for the company's alleged role in the deaths of children who received an unapproved drug during a meningitis epidemic.
Authorities in Kano, the country's largest state, filed eight charges this month related to the 1996 clinical trial, including counts of criminal conspiracy and voluntarily causing grievous harm. They also filed a civil lawsuit seeking more than $2 billion in damages and restitution from Pfizer, the world's largest drug company.
The move represents a rare -- perhaps unprecedented -- instance in which the developing world's anger at multinational drug companies has boiled over into criminal charges. It also represents the latest in a string of public relations blows stemming from the decade-old clinical trial, in which Pfizer says it acted ethically.
The government alleges that Pfizer researchers selected 200 children and infants at a makeshift epidemic camp in Kano and gave about half of the group an untested antibiotic called Trovan. Researchers gave the other children what the lawsuit describes as a dangerously low dose of a comparison drug made by Hoffman-Laroche. Officials say Pfizer's actions resulted in the deaths of an unspecified number of children and left others deaf, paralyzed, blind or brain-damaged.
The lawsuit says the researchers did not obtain consent from the children's families, and also says the researchers knew Trovan to be an experimental drug with life-threatening side effects that was "unfit for human use."
Pfizer and its doctors "agreed to do an illegal act," the criminal charges state, and behaved "in a manner so rash and negligent as to endanger human life."
Suspicion stirred by news of the drug trial has been so intense in Kano, the lawsuit says, that parents refused to allow their children to be immunized against polio last year, frustrating a program aimed at wiping out one of the disease's last refuges.
In a written statement, Pfizer said the company believes it did nothing wrong and emphasized that children with meningitis have a high fatality rate.
"Pfizer continues to emphasize -- in the strongest terms -- that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian government and in a responsible and ethical way consistent with the company's abiding commitment to patient safety. Any allegations in these lawsuits to the contrary are simply untrue."
Anger at deadly Nigerian drug trials
By Senan Murray
BBC News website, Kano
In school, Anas Mohammadu's mates call him "horror" and make fun of him. When the 14-year-old goes to bed at night, he dreams of becoming a soldier. His father, Muhammadu Mustapha, knows his son's dream is unlikely to come true. "It's only a pipedream. You don't become a soldier with weak and wobbly legs and a permanently drooling mouth," he says bitterly. "He tires too quickly. The other day, he was trying to draw water from a well and the small bucket almost pulled him into the well." But Anas is lucky to be alive.
Deformities
Many other children who were used in the controversial 1996 drug trial by US pharmaceutical giant Pfizer died. Anas, then only three years old, was the first child to be given the experimental antibiotic Trovan at the Infectious Diseases Hospital, Kano, during the drug trial. Pfizer tested the then unregistered drug in Nigeria's north-western Kano State during an outbreak of meningitis which had affected thousands of children. Officials in Kano say more than 50 children died in the experiment, while many others developed mental and physical deformities. But Pfizer says only 11 of the 200 children used in the drug trial died.
"From our records, the fatalities were only 11, but the survival rate was 94 per cent," Pfizer spokesman in New York, Bryant Haskins, told the BBC News website. Following pressure from rights groups and families affected by the trial, the Nigerian government set up an expert medical panel to review the drug trial. The experiment was "an illegal trial of an unregistered drug", the Nigerian panel concluded, and a "clear case of exploitation of the ignorant".
'Verbal consent'
Pfizer denies any wrongdoing and reiterates its position that its trial of Trovan was conducted in accordance with Nigerian regulations. "These allegations against Pfizer, which are not new, are highly inflammatory and not based on all the facts," Mr Haskins, recently told Reuters news agency. He also said the trial had helped save lives. The company has previously said that "verbal consent" had been obtained from the parents of the children concerned and that the exercise was "sound from medical, scientific, regulatory and ethical standpoints".
But Mr Mustapha is still burning with anger. "My son was ill and we took him to the hospital like any other family would. Then the Americans and some local Nigerian doctors injected Anas with this evil drug." Another man, Hassan Sani, says his daughter Hajara, 14, was also given the drug. He says the pill made his daughter deaf and unable to speak, and he wants the doctors involved to be treated as criminals. "The American doctors took advantage of our illiteracy and cheated us and our children. We thought they were helping us," Mr Sani says. "We did not suspect that our children were being used for an experiment. They have cheated us and our children. All I can say is that God will judge them according to their evil deeds. "Where there is a crime, there must be punishment."
'Charges'
After more than a decade of silence, the Nigerian government has decided to sue Pfizer, seeking $7bn (£3.5bn) in damages for the families of children who allegedly died or suffered seeking $7bn side-effects in the the experiment. Mr Sani says compensation will not be enough. "In addition to the compensation, they should be killed like the children they have killed," he says.
The Pfizer experiment was cited by many as a reason for the mass rejection of polio vaccinations in many parts of northern Nigeria in recent years. Some local Islamic preachers said there was a western plot to sterilise Muslim women. After several tests were carried out to proving the vaccine's safety, the programme has now been resumed.Whether the families ever receive compensation, it will never be enough to bring back Anas's lost dreams of becoming a soldier.
