Pfizer accused of testing new drug without ethical approval

doi:10.1136/bmj.322.7280.194

BMJ 2001;322:194 ( 27 January )

News

Pfizer accused of testing new drug without ethical approval

Jacqui Wise, London
The first 150 words of the full text of this article appear below.

An official inquiry has been set up into allegations that the drug manufacturer Pfizer did not obtain official approval beforetesting a new drug on children during a meningitis epidemic inNigeria five yearsago.

The Nigerian doctor who supervised the clinical trial has said that his office backdated an approval letter and this may havebeen written a year after the study had takenplace.

Pfizer, whose headquarters are in New York city, has admitted that the local ethics approval given to conduct the trial maynot have been properly documented: "Pfizer takes this issue veryseriously and is fully cooperating with the Nigerianauthorities."

In 1996 Pfizer sent a team to Kano in the north of Nigeria during an epidemic of meningococcal meningitis. To test the efficacyof its new antibiotic trovafloxacin (Trovan) they carried outan open label trial in 200 children, half of whom were given trovafloxacinand . . . [Full text of this article]