Pfizer issued the following statement in response to legal action taken against the company by the Nigerian government

Pfizer continues to emphasize—in the strongest terms—that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian government and in a responsible and ethical way consistent with the company’s abiding commitment to patient safety.

Any allegations in these lawsuits to the contrary are simply untrue—they weren’t valid when they were first raised years ago and they’re not valid today.

The Trovan study introduced a new meningitis treatment to the region that indisputably helped save the lives of almost 200 children stricken with meningococcal meningitis, a disease that—left untreated—kills four out of every 10 people who contract it. Pfizer always acted in the best interests of the children involved, using the best medical knowledge available.

At the time of the meningitis outbreak in Kano, Trovan was in late stage development. It had been evaluated in 5,000 patients and Pfizer’s doctors had solid scientific evidence that it would provide a safe and effective treatment against the deadly disease. At a 94.4% survival rate, Trovan performed at least as well as the best treatment available.

For over 50 years, Pfizer has demonstrated an unwavering commitment to work with the government and people of Nigeria in support of programs that improve the health standards and accessibility to medical treatment in that country. Pfizer believes this partnership has been mutually beneficial in the past and will continue to be valuable in the future.

It is indeed regrettable that, more than a decade after the meningitis epidemic in Kano, the Nigerian government has taken legal action against Pfizer and others for an effort that provided significant benefit to some of Nigeria’s youngest citizens.

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 12,500 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.