Fri, Aug 03, 2007 page10

• Pfizer under fire over Nigerian drug trials

  • AP
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  A security guard in the dusty Nigerian city of Kano is living with tragedy -- a 14-year-old son whose dazed eyes, uneven gait and slow speech signal brain damage.

  Mustapha Mohammed says he knows who to blame -- Pfizer Inc, the world's largest drug maker.

  New York-based Pfizer is facing four court cases -- two filed by the federal government, two by the state in recent months -- in Nigeria over a decade-old drug trial that included Mohammed's son.

  The company, which denies any wrongdoing, is accused of using a 1996 meningitis epidemic to push through a sloppily managed study without the full understanding of parents or proper regulatory approval, contributing to death in some and infirmities in others.

  Whether Pfizer acted improperly, the fallout provides a case study of the ethical dilemmas that arise when Western medical priorities run into Third World poverty and ignorance. The communication gap between those handing out medical alms and those receiving has bred mistrust and anger in Kano -- with damaging, far-reaching effect.

  In 2003, residents of Kano and the state of the same name boycotted a polio vaccine effort on charges that it was a Western plot to make Africans infertile. The Pfizer uproar has been cited as one reason for suspicion about Western medicine.

  Without mass vaccination, polio exploded in Nigeria and eventually spread to 25 previously polio-free countries.

  Though the meningitis epidemic is long over and the polio vaccination program is back on track, suspicions persist.

  permission

  Mohammed is sure no one asked his permission to test a drug on his child. But he also wasn't asking many questions when he rushed his son to the hospital in 1996.

  "We were desperate for drugs. We just took it in good faith," said Mohammed, who lives in a tiny house off a dirt road in one of Kano's poorer neighborhoods. Mohammed -- who can't read or write -- only later found out that the pink paper he kept with Pfizer's name and treatment dates meant his son had been in the study.

  Pfizer says it explained the study to families using practices in line with US and international guidelines, even employing local, Hausa-speaking doctors and nurses. Written permission was obtained when possible, or oral consent if they were illiterate.

  Across town, Abu Abdullahi Madaki can't be sure if her daughter Firdausi took part in the Pfizer study. Citing privacy concerns, Pfizer has declined to release the names of the 200 children it treated.

  All Madaki knows is she took a feverish 8-month-old infant to the hospital in 1996, and now her daughter suffers severe brain damage that left her unable to sit up or talk.

  Meningitis -- a brain infection -- leaves 10 percent to 20 percent of survivors with mental damage, hearing loss or learning disabilities, according to the WHO.

  But Madaki said: "My younger sister had meningitis, but it was nothing like this. My younger sister is now a mother with children."

  Madaki, who is illiterate, said she'd always felt that the hospital did something wrong, and decided when she heard about the charges against Pfizer on the radio that her daughter must have been in the study.

  Pfizer says it brought the drug -- an antibiotic called Trovan -- to Nigeria as a humanitarian effort. Trovan had already gone through human trials in the US. It was a tablet, which could be easier to use with children than the standard meningitis treatment -- a painful injection.

  "When this epidemic occurred, the government asked people to come and help them," said Ngozi Edozien, regional director of the Pfizer branch that covers Nigeria. She said Pfizer wanted to help, but could only offer Trovan through a clinical trial because the drug was not yet approved.

  pulled

  Trovan was approved in the US in 1997, but later pulled from the market in favor of other similar drugs because it was shown to cause serious liver damage.

  The Kano trial showed a similar survival rate for the 100 children on Trovan with the 100 on the standard treatment. Five of the children on Trovan died, compared with six in the control group -- rates comparable to those of Western hospitals, according to Pfizer.

  More than 11,000 children died in Nigeria during the epidemic.

  It's hard to know if truly "informed consent" is possible during a health care crisis among a widely uneducated, isolated population.

  "If you're sick and trying to get health care and somebody says to you, `Do you want to be in a research study?' If somebody is not familiar with the idea of a research study, it becomes more difficult for them to evaluate," said Benjamin Wilfond, head of Seattle's Treuman Katz Center For Pediatric Bioethics.

  But if the people of Kano were uninformed, it's not just a US drug company that's to blame. Lawyers for the study families say the government failed to guard its citizens.

  Ali Ahmad, who brought a class action suit on behalf of Kano subjects against Pfizer in the US, said he also wanted to sue the Nigerian government, but no government workers would testify.

  The US suit was turned down for lack of jurisdiction, though Ahmad plans to appeal.

  He argues that the Nigerian government is now taking advantage of the families' plight to enrich itself. A victory in the Nigerian cases will go not to families but to government coffers in a country that watchdog groups routinely call one of the most corrupt in the world.

  Government lawyers say they were slow to file charges because the details of the 1996 trial have been hard to get from Pfizer. They claim that the administration was duped along with the study subjects.

  "What the government did was to give Pfizer the benefit of the doubt, and obviously naively trusted Pfizer," said government prosecutor Babatunde Irukera.
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