Monday, 3 January 2011

Where Profits and Lives Hang in Balance

KANO, Nigeria -- First of six articles

By the time word of the little girl's death reached the United States, her name had been replaced by numerals: No. 6587-0069.

She was 10 years old and a scant 41 pounds. She lived in Nigeria, and in April 1996 she ached from meningitis.

An epidemic raged and scores lay dying in this frenetic city of amber dust. Somehow the girl found a refuge: a medical camp where foreign doctors had arrived to dispense expensive medicines for free.

Behind a gate besieged by suffering crowds stood two very different clinics. A humanitarian charity, Doctors Without Borders, had erected a treatment center solely in an effort to save lives. Researchers for Pfizer Inc., a huge American drug company, had set up a second center. They were using Nigeria's meningitis epidemic to conduct experiments on children with what Pfizer believed was a promising new antibiotic--a drug not yet approved in the United States.

The experimental drug was a potential blockbuster: Wall Street analysts said Pfizer might reap $1 billion a year if Trovan, as it was known, won approval for all its potential uses. Pfizer also wanted to test the drug for use against meningitis, including an epidemic strain. The company couldn't find enough patients in the United States, so its researchers had come to Kano, among the dying.

Doctors working with Pfizer drew spinal fluid from the girl, gauged her symptoms and logged her as patient No. 0069 at testing site No. 6587 in experiment No. 154-149. They gave her 56 milligrams of Trovan.

A day later, the girl's strength was evaporating, Pfizer records show, and one of her eyes froze in place.

On the third day, she died.

Pfizer records are explicit. Action taken: "Dose continued unchanged." Outcome: "Death."

Nobody can know for certain if the girl would have lived had she been taken off experimental Trovan; perhaps she was beyond all hope. Yet the circumstances of her death--while taking an unapproved drug, with alternate treatments at hand, in a hurriedly established private sector experiment--suggest much larger problems.

A Washington Post investigation into corporate drug experiments in Africa, Asia, Eastern Europe and Latin America reveals a booming, poorly regulated testing system that is dominated by private interests and that far too often betrays its promises to patients and consumers.

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