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Home » Food & Drug Regulation: Library » Newsbriefs

Pfizer, Kano State Reach Agreement in Trovan Case

Date Posted: July 30, 2009

Pfizer Inc. and the Kano State government in Nigeria reached an agreement to settle the government’s claims arising from the 1996 Trovan clinical study.

Under the agreement, Pfizer will:
• establish a Healthcare/Meningitis Fund which will provide financial support to participants of the Trovan study;
• provide $30 million over two years to underwrite several healthcare initiatives chosen by the Kano State government; and
• reimburse Kano State for $10 million in legal costs.

The Healthcare/Meningitis Fund will be available to all individuals who can verify participation in the Trovan study. The maximum amount that could be disbursed by the fund is $35 million, but the final amount will depend on the total number of valid claims submitted.
The fund will be administered by an independent six-member board of trustees, with three members each chosen by Pfizer and the government. The board will make the final determinations on eligibility and levels of financial support.

A separate six-member board, again selected by Pfizer and the government, will oversee the health initiatives designated by Kano State.

For its part, Kano State will dismiss both the civil and the criminal cases it filed against the company and various individuals related to the Trovan study. In the agreement, Pfizer specifically denies any wrongdoing or liability in connection with the study.

“We are especially pleased that the benefits of this settlement will be directed first and foremost to those who contracted meningitis in 1996 and also participated in the clinical study at that time,” said Pfizer Senior Vice President and Associate General Counsel Brad Lerman in a company statement. “With the procedures in place for the Healthcare/Meningitis Fund, the people of Nigeria will have confidence that the parties have taken strong steps to ensure that the funds reach only those for whom they are intended.”

In 1996, Kano State was hit with epidemics of bacterial meningitis, measles and cholera. In response, Pfizer set up a treatment center at a Kano hospital and obtained authorization from the Nigerian government to conduct a study of its recently developed antibiotic Trovan. Animal testing had raised concerns that the drug might cause adverse side effects in children, including joint disease, abnormal cartilage growth and liver damage.

According to allegations later brought against the company, members of the Pfizer medical team divided approximately 200 pediatric subjects aged one to 13 into two groups. The children exhibited symptoms of neck stiffness, joint stiffness, high fever and headaches. The team allegedly treated one group with Trovan and treated the other with low-dosage amounts of ceftriaxone, an FDA-approved treatment for meningitis. In addition, the team allegedly was slow to analyze blood samples taken from the children and did not spot negative reactions to Trovan before permanent injuries — including blindness, deafness and brain damage — were manifested in the patients.

In addition, Pfizer was alleged to have failed to obtain adequate consent from parents for the children’s participation in the experimental treatment. According to claims later brought on behalf of the children, the company failed to explain that the treatment was experimental, that the parents could refuse to allow participation and that other organizations — such as Médicins Sans Frontières (Doctors Without Borders) — were offering more conventional treatments free of charge.

The company contended the study was conducted with the approval of the Nigerian government and the consent of the participants’ parents or guardians, and was consistent with Nigerian laws. “The company believes that a mutually agreeable resolution to the Trovan cases is the best way to continue that relationship and allow Pfizer and the Nigerian governments to focus on what matters — improving healthcare for all Nigerians,” Lerman said.

For more, see the September issues of the Guide to Good Clinical Practice and FDA Enforcement Manual newsletters.

 


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