[e-drug] Nigerians file case against Pfizer

["E-drug" <e-drug@healthnet.org>]

E-DRUG: Nigerians file case against Pfizer
-------------------------------------------------------------

[The case was part of a British Channel 4 documentary 'Dying for
drugs' . Pfizer tried the not approved fluoroquinolone trovafloxacin on
children with meningitis. KM]

http://tinyurl.com/2bsk5x

/Wed May 30, 12:38 PM ET/

Authorities in northern Nigeria have filed a $2 billion civil case and
were preparing criminal charges against the U.S. drug company Pfizer,
accusing it of conducting a drug experiment that led to deaths and
disabilities in a group of children more than a decade ago, according to
court papers.

A notice of intent to file criminal charges, seen Wednesday, was
submitted May 9 and the civil case was filed May 17. Officials said the
civil suit could open as soon Monday. It was not clear when the criminal
case - to be lodged against eight Pfizer officials - would begin,
officials said.

The Washington Post reported the criminal charges had been brought, but
officials in Kano said Wednesday that prosecutors had taken only a
preliminary step in that direction.

New York-based Pfizer, the world's largest drug maker, has denied any
wrongdoing. A federal court in Manhattan dismissed a 2001 lawsuit by
disabled Nigerians who allegedly took part in the study, but the case is
under appeal.

In a statement this week, Pfizer said allegations in the Nigeria cases
"are simply untrue - they weren't valid when they were first raised
years ago and they're not valid today." It also said the Pfizer study
was conducted "in a responsible and ethical way consistent with the
company's abiding commitment to patient safety."

In the civil suit, authorities in northern Nigeria's Kano state allege
Pfizer illegally conducted a drug experiment on 200 children during a
meningitis epidemic in the state's main city, also called Kano, in 1996,
resulting in deaths, brain damage, paralysis and slurred speech in many
of the children.

Pfizer treated 100 meningitis-infected children with an experimental
antibiotic, Trovan. Another 100 children, who were control patients in
the study, received an approved antibiotic, ceftriaxone - but the dose
was lower than recommended, the families' lawyers alleged.

Up to 11 children in the study died, while others suffered physical
disabilities and brain damage. But Pfizer always insisted its records
show none of the deaths was linked to Trovan or substandard treatment.

Authorities in Kano state are blaming the Pfizer controversy for
widespread suspicion of government public health policies, particularly
the global effort to vaccinate children against polio, which has met
strong resistance in northern Nigeria.

The polio vaccine boycott "by citizens of Kano state is a direct
consequence of the 1996 actions" of Pfizer, state prosecutor Aliyu Umar
said in the court documents.

Islamic leaders in largely Muslim Kano had seized on the Pfizer
controversy as evidence of a U.S.-led conspiracy. Rumors that polio
vaccines spread AIDS or infertility spurred Kano and another heavily
Muslim state, Zamfara, to boycott a long-term campaign to vaccinate
millions.

Vaccination programs restarted in Nigeria in 2004 after an 11-month
boycott. But the delay set back global eradication - the boycott was
blamed for causing an outbreak that spread the disease across Africa and
into the Middle East.