Pfizer just sent an official response to the Washington Post article on its Trovan clinical trials in Nigeria.
-AMS
Pfizer has been asked to respond to a document leaked to The Washington Post concerning a Nigerian government examination of a clinical study the company conducted in Nigeria over a decade ago. The study involved a new antibiotic, Trovan (trovafloxacin). Pfizer cooperated fully with the committee referred to in the document.The Nigerian government has neither contacted Pfizer about any of the committee’s findings nor are we aware that the committee has approved a final report. Therefore it would be inappropriate for the company to respond to specific points in the document. However, as we have stated repeatedly over the past several years, Pfizer conducted this trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigerian law and Pfizer’s abiding commitment to patient safety.Trovan Saved LivesPfizer is confident that no one associated with the Trovan clinical study—conducted in Kano, Nigeria during a meningitis epidemic in 1996—ever put a patient’s health at risk and that the company acted in the best interests of the children involved in the study, 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 unethical manner. Goal Was To Find An Effective Treatment For A Devastating Disease At the time of the epidemic—the largest in the country’s history, 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 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 it would perform as well as ceftriaxone, the best drug available at the time to treat the disease. The other treatment option during this epidemic was an injection of an oil-based depot of chloramphenicol, used since the 1950s. The development of an effective, safe and well-tolerated new treatment, especially an oral treatment, represents a significant medical advance. Oral treatment is more readily accepted by patients, is significantly easier to administer to large numbers of patients (especially applicable in epidemic settings), and eliminates the risk to patients and health care workers of hepatitis B and HIV transmission from inadvertent needle-stick injuries.Trovan achieved the highest survival rate (94.4%) of any treatment available at the Kano Infectious Disease Hospital, including ceftriaxone (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. Clinical Studies Guided by Nigerian Law, Focused On Patient Safety The experimental nature of the Trovan treatment was explained to the parent or guardian of every participating child, in two different languages—English and the local language, Hausa—by local bilingual nurses. Verbal consent was obtained in all cases. The clinical study was conducted with the full knowledge of the Nigerian government. Pfizer was guided at all times by the laws of Nigeria, advice from that country’s Ministry of Health, and the company’s commitment to patient safety. Clinical studies often 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 careers 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 is the primary reason Pfizer conducted the study in Nigeria, where the company has maintained a business presence for more than 50 years.
