Africa blamed for tolerating unethical clinical trials

By Ntaryike Divine Jr

Breakthroughs in medicine usually usher in moments of celebration, but the mandatory preface to such achievements and their commercialization – drug trials on human subjects – has frequently backfired in Africa and the Third World.

Critics have argued that there has been exploitation of Africans in clinical trials, especially by pharmaceutical companies from Europe and the United States. They say bad news linked to clinical trials conducted in Africa dwarfs the good tidings. Some have likened the practice to the “pharmaceutical colonization of Africa.”

But many don’t agree. A leading bioethics expert at the World Conference of Science Journalists in Doha, has urged decision-makers to assume their responsibilities and halt the blame-blitz on the West. Professor Ames Dhai, director of the Steve Biko Center for Bioethics in South Africa, says Africa has allowed itself to be used.

“I think we need to blame ourselves if nothing is changing. Why have we as African countries allowed this perpetuation of exploitation? And I think it’s time we stopped blaming the West and started looking at ourselves and how we can approach he issue,” she told a forum of mostly developing world reporters at the conference on June 28.

A Witwatersrand University lecturer, she blamed poor governance, corruption, conflicts, illiteracy and drug-naiveté as the reason for Africa’s powerlessness against “imperialist funders, pharmaceutical industries and research institutions.” They offshore clinical trials to the continent “with little or no consideration for ethics or the relevance of the drugs to the needs and pathology of trial subjects,” she said.

Until about 1995, clinical trials were mainly conducted in Europe, the U.S. and Japan. Experts estimate more than 100,000 trials are now underway worldwide yearly, with 10 per cent of them in the developing world and one per cent in Africa.

Sonia Shah, author of the book Body Hunters, and one of three panelists at the Doha discussion, said the reasons for outsourcing of trials to the developing world are clear. Costs of are lower than in the West, ignorance means few lawsuits happen, side effects from test drugs are under-reported, and volunteers subjects are generally happy to co-operate. And above all, she said, ethics are feeble or nonexistent.

“Informed consent is not being done well and sometimes patients enrolled in clinical trials in developing countries are misinformed to think they are actually getting therapy,” she said. Some are coerced, and clinical trial committees stand back “because they get benefits and just rubberstamp approvals,” she said.

In 2005 protest about ethical flaws forced the suspension in Cameroon and Cambodia of clinical trials for an antiviral medication developed by Gilead Sciences in the U.S. to combat AIDS.

But limited counseling of the trial participants and a lack of public information culminated in an uproar. Those involved were accused of “using Cameroonians as guinea pigs for profit-making experiments” and had to leave the country. Some critics said the government was in league with the researchers and kept quiet. Today, most Cameroonians are skeptical about drug trials.

In Nigeria in 2001, 30 families sued the Pfizer company over trials of Trovan, an antibiotic intended to battle meningitis. Tests had been carried out during a 1996 epidemic and 11 children out of the 200 tested died, while others ended up with brain damage and paralysis. (No court found Pfizer liable, and the legal action ended in February of this year with a joint statement that said, “The cases have been amicably resolved after many years of litigation.”)

After the Nigerian families went to court, Muslim leaders in the north of the country launched a successful boycott against polio vaccinations. It was so successful that polio spiked, and spilled over to Nigeria’s neighbours and beyond.

But despite such events, another school of thought argues that drug trials bring benefits to the continent. Professor Mona Khana of the University of Illinois said Africa can still gain from trials.

She told the Doha session that local people are part of the workforce for the trials, “So they’re actually doing a service by employing people and that does service to the community and helps bring medical care.”

The former CBS and Wall Street Journal reporter said African decision-makers must legislate requirements that drug trial funders invest in local research expertise, and bring equipment and programs to benefit the locals. She urged that trial subjects be treated in keeping with international norms like those in the Helsinki Declaration, as well as local guidelines where they exist.

Most Third World journalists leaving the discussion predicted continuing debate on who conducts trials in Africa and the developing world, and for what purpose.