Pfizer Statement Concerning 1996 Nigerian Clinical Study:
"Our study saved lives and was conducted ethically and responsibly."
Trovan Saved Lives
Pfizer is confident that no one associated with the Trovan clinical study-conducted in Kano, Nigeria more than a decade ago-ever put a patient's health at risk and that the company acted in the best interests of patients, using the best medical knowledge available.
Trovan unquestionably saved lives, and Pfizer strongly disagrees with any suggestion that the company conducted its study in an inappropriate or unethical manner.
Goal Was To Find Effective Treatment For Devastating Disease
At the time of the epidemic in 1996-the largest in the history of Nigeria, according to health officials-Pfizer believed that Trovan would provide a life-saving treatment for meningococcal meningitis that was afflicting tens of thousands of Nigerians. The goal of the study was simple-to find an effective treatment for a disease that was having a devastating effect on the people of sub-Saharan Africa.
Trovan (trovafloxacin) was in late stage development and had been evaluated in 5,000 patients. Pfizer had scientific evidence that the medicine was effective and undertook the clinical study to determine if Trovan would be an improvement over cephtriaxone, the best drug available to treat the disease at the time.
Trovan performed extremely well. The medicine achieved the highest survival rate of any treatment available at the Kano Infectious Disease Hospital (94.4%), including cephtriaxone (93.8%). For patients receiving treatment at the hospital who were not in the Pfizer program, the survival rate was 89.9%. Meningococcal meningitis is a disease that, if left untreated, kills approximately four out of every 10 people who contract it.
Pfizer Met International Standards Governing Conduct of Clinical Studies
The experimental nature of the Trovan treatment was explained to the parent or guardian of every participating patient, in two different languages-English and the local language, Hausa-by local bilingual nurses. Consent was obtained in all cases. The clinical study was conducted with the full knowledge of the Nigerian government. At all times Pfizer was guided by the laws of Nigeria, advice from that country's Ministry of Health, and international standards on the conduct of clinical studies.
Clinical studies present challenges, particularly when they are conducted in extremely difficult conditions like those that existed in Kano in 1996. The focus always is to develop medicines that will improve the lives of patients. That's what the 13,000 dedicated people who work in Pfizer's research labs worldwide spend their lives trying to accomplish. In the case of Trovan, all the scientific information available at the time indicated that the drug offered tremendous potential as a life-saving treatment for a deadly disease. That's why Pfizer conducted the study in Nigeria, where the company has maintained a business presence for more than 50 years.