Pfizer facing four court cases in Nigeria

Heidi Vogt

KANO, Nigeria — A security guard in this dusty Nigerian city is living with tragedy — a 14-year-old son whose dazed eyes, slow speech and uneven gait 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 Nigerian government and two by officials in the northern Nigerian state where Mohammed lives — over a decade-old drug study 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 drug study that contributed to death in some cases and infirmities in others.

The fallout provides a case study of the ethical dilemmas that arise when Western medical priorities run into Third World poverty — dilemmas complicated by a lack of understanding of Western medicine in the stricken regions. The communication gap between those handing out medical alms and those receiving them has bred mistrust and anger in Kano — with damaging, far-reaching effect.

The Pfizer case was cited as one reason that residents of Kano and the state of the same name boycotted a polio vaccine in 2003, fearing it was a plot to make Africans infertile. 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, misinformation and suspicion persist.

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 U.S. and international guidelines, even employing Nigerian nurses and doctors who spoke Hausa, a main Nigerian language. Written permission was obtained when possible, or oral consent if parents 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 World Health Organization.

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. She 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 been tested on humans in the U.S. It was a tablet, which could be easier to use with children than the standard meningitis treatment — a painful injection.

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

“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 study because the drug was not yet approved.

Edozien argued that approval to use Trovan to treat epidemic meningitis would not have been a windfall for the company, but for the poor countries that face the disease. She also noted that Pfizer donated medical supplies and equipment to the government to help in the epidemic.

Trovan was approved in the U.S. in 1997 for a number of infections, though not for meningitis. It was later pulled from the market because it was shown to cause serious liver damage.

Death rates were similar among the 100 children taking Trovan and the 100 Pfizer gave the standard meningitis treatment. Five of the Trovan subjects died, compared with six in the control group — rates comparable to those of Western hospitals, according to Pfizer.

Still, families and the government argue that Pfizer kept some children on Trovan even though their condition was worsening, that the doses of the standard treatment should have been higher and that dubious procedures used in pushing the experiment through mean Pfizer should be held accountable for any future health problems in those it treated.

It’s hard to know if truly “informed consent” is possible during a health care crisis among a widely isolated population unfamiliar with Western medicine.

“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 not properly informed, it’s not just a U.S. 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 U.S., said he also wanted to sue the Nigerian government, but no government workers would testify.

The U.S. suit was turned down in New York for lack of jurisdiction, though Ahmad said lawyers are in the process of appealing and re-filing the case.

He argues that the Nigerian government is now taking advantage of the families’ plight to enrich itself. A victory in the Nigerian cases will not mean money for families, he says, but for government coffers in a country that watchdog groups routinely call one of the most corrupt in the world.

The federal government is seeking $7 billion in damages and the state government $2 billion. They each have filed one criminal case and one civil suit.

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.

Six years after the meningitis outbreak, a Kano doctor printed out a series of diatribes he found on the Internet calling the polio vaccine a Western plot to reduce the world’s Muslim population. Many of the area’s influential Muslim clerics took up the cause and led a 16-month boycott.

Local officials say Kano was primed to believe the rumors. Residents already found it strange that they were given free polio doses but nothing for bigger killers like malaria and measles. And the Pfizer controversy was still simmering.

“When people heard about [the Pfizer charges], they started really hiding their children,” said Alhahi Ibrahim Jibrin Mai-Anguwa, head of a 3,000-person neighborhood ward in Kano.

The state governor stopped the vaccination program while doses were sent abroad for testing, a move that shocked the West but may actually be the bright spot in Kano’s story — an official listening to the concerns of his constituency. When test results confirmed the vaccine was safe, people began to embrace it again.

But some damage can’t be erased.

Twice a week, mothers arrive in the physical therapy ward of a Kano hospital carrying children with the jerking legs and lifeless arms of polio for massages and sessions under heat lamps.

Four-year-old Fatima Yau, whose mother refused to have her immunized in 2003, lies on the examination table with legs splayed out flat and unresponsive.

Her mother says she’s hopeful for Fatima’s future. Her daughter just started school. She’s carried to classes each morning on an older sibling’s back.

(Associated Press)