The world's largest drug company is embroiled in a global controversy over whether it tested an unapproved drug on sick children in Nigeria without their full understanding. The case involving Pfizer raises questions about how to protect human subjects as American companies conduct more and more drug trials around the world. VOA's Leta Hong Fincher has this report.
In 1996, a meningitis epidemic hit the Nigerian state of Kano. Researchers from the American company, Pfizer, treated 100 Nigerian children with the experimental drug, Trovan. The Nigerian government and the Kano state government are suing Pfizer over the drug trial. They say it caused the deaths of 11 children and seriously disabled others.
The Plaintiff's Attorney, Peter Safirstein says, "What Pfizer did here is despicable and reprehensible and what they did here was to take advantage of young children and use them for an unauthorized and unapproved medical experiment."
Safirstein, of the law firm Milberg Weiss, is representing 30 Nigerian families in a lawsuit filed in New York. He says Pfizer did not inform the children that they were taking part in a medical experiment and that there were other alternative medications available at the time.
Pfizer has filed its own lawsuit, charging that the report on which the Nigerian government based its claims against the company is illegal and inaccurate. And the company says on its Web site that any deaths during the clinical trial were the direct result of the illness and not the treatment provided to patients.
Pfizer vice president Dr. Jack Watters also released a video statement. "This trial was conducted with the full approval of the Nigerian government, with the consent of the parents, the guardians of the children, and in consistency with the laws of Nigeria," he said.
Whatever the outcome of the lawsuits, the Pfizer case illustrates the difficulty in protecting human subjects as more and more drug trials are conducted around the world.
International standards such as the Declaration of Helsinki govern the ethics of drug trials. But some health experts say these regulations are weak and have no enforcement mechanism.
"It will always be tempting for any for-profit corporation to go to that place where regulation is the weakest, to that place where human subjects' protections are the worst, really going to the place with the lowest ethical standards, a kind of race to the ethical bottom," says, Dr. Peter Lurie, who is deputy head of health research at the advocacy group, Public Citizen, in Washington. "That temptation will always be there until such time as we have strong international standards. We don't have them now."
Dr. Lurie argues that many citizens of developing countries with poor health infrastructures are desperate for medical treatment and vulnerable to exploitation. "To the extent that they [trial participants] are motivated by desperation and needing to get treatment, to the extent that they believe that they will benefit from being in the trial even though that may not be the case, those are bad reasons for people to be in trials."
Alan Goldhammer is a regulatory official for the Pharmaceutical Research and Manufacturers of America, a lobbying group in Washington.
He says drug trials in developing countries are critical to researching treatments for diseases such as bacterial meningitis, which is rare in the United States. "Our companies are developing new pharmaceuticals for a worldwide market. They are also trying to make every effort to address diseases that are common in developing countries and certainly many new antibiotics that are being developed will have good therapeutic use in those countries."
Goldhammer says another reason American companies conduct trials in developing countries is to try to cut the time and cost required for drug development. "It's running now [at] about 800 million dollars to develop a new drug and it's anywhere from 12 to 14 years and clearly for patients who need new therapies this is too long and too costly. So we're looking at a variety of ways to try to shorten the time period and reduce the cost."
Dr. Ezekiel Emanuel is head of clinical bioethics at the National Institutes of Health, the primary U.S. medical research agency.
He says the vast majority of drug research does not exploit human subjects. But he says researchers should provide what he calls "fair benefits" to the participants in a drug trial. "Is the community in which you're doing a trial getting other health benefits? Are there economic benefits? Are you preparing the community to be able to do a lot more research and maybe engage in the research enterprise? Are you training people?" he said.
As for Pfizer's 1996 trial of Trovan in Kano, the Nigerian government says the drug company did not behave ethically. It is seeking compensation for the children and families of those involved.