I quote extensively from the article:
Pfizer has reached a broad agreement to pay millions of dollars to Nigeria's Kano state to settle a criminal case alleging that the drug company illegally tested an experimental drug on gravely ill children during a 1996 meningitis epidemic.Comment: Randomized, blinded, case-control drug trials provide a standard against which other knowledge sources can be measured. Clearly one wants to assure the safety, efficacy and effectiveness of a drug before turning it loose in the hands of millions of doctors on tens of millions of patients. Yet there are unavoidable risks in carrying out the drug trial.
The details remain private, but sources close to the negotiations said the total payments -- including those to the children, their families, the government and the government's attorneys -- would be about $75 million under the current settlement terms.......
Nigerian authorities say Pfizer's infamous trial of the antibiotic Trovan killed 11 children and disabled scores more. The world's largest drug company says the deaths and injuries were the result of meningitis.......
Pfizer defended its drug trial in a 2007 statement, saying it was conducted safely, legally and "with the full knowledge of the Nigerian government." The company said Trovan demonstrated the highest survival rate of any treatment at the field hospital......
Details of the drug trial were first made public more than eight years ago in a Post investigative series. The articles reported that the trial did not conform to U.S. patient-protection standards and that the oral form of the drug used in the trial had not been previously tested in children. Pfizer had no signed consent forms for the children, the articles said, and the company relied on a falsified ethics approval letter. Researchers also gave children substandard doses of a comparison antibiotic, the articles added.
Consequently, the ethics of drug trials are important. My friends at the Fogarty International Center and others at Johns Hopkins University and other centers are working to help researchers in developing countries to learn about the ethics of biomedical research. Indeed, intergovernmental organizations are doing similar work.
Ethics in different societies come from different philosophical bases. There are also differences in the literacy of patients and their families and the social organization in which permission is granted, not to mention the differing epidemiological and economic conditions.
I am delighted that the press is covering charges of misconduct, and that governments are prosecuting those accused of misconduct, but it seems to me that charges are not proof, that legal systems are not always as fair and just as one would hope and even the best make mistakes, and that companies sometimes settle cases without admitting guilt. It is not a bad idea to withhold judgment on what we read in the newspaper. JAD
1 comment:
Good thing they are settling out of court. Taking an objective and dispassionate look at the cases in court, it would not have been easy for the government to prove its case against Pfizer since the trials were permitted in writing by both the federal and Kano governments and indeed the National Agency for Food and Drugs Administration and Control. Added to this is the fact that Pfizer recorded a 94.4 percent survival rate. I am happy for the people of Kano and the government. My only worry is that the settlement funds must be properly monitored. Too often in Nigeria, funds are diverted to purposes other than what they are meant for.
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