麻豆传媒

A DEADLY epidemic of bacterial meningitis sweeps through northern Nigeria. Thousands of miles away in the US, a team of researchers working for the world鈥檚 richest pharmaceutical company learns about the outbreak and decides to fly out with a promising but as yet unproven antibiotic.

The team enrols hundreds of gravely ill African children as test subjects. But not all of them recover 鈥� a few die, and some suffer lasting injuries. Soon the company is facing claims that it botched the trial and failed to tell the children鈥檚 parents about the experimental nature of the drug.

It could be the plot of a moralising, left-leaning thriller. In fact, the events are all real. The drug is called Trovan, the company is Pfizer. And 7 years on from the epidemic, lawyers seeking compensation for Nigerian families are attempting to bring the story to a dramatic courtroom finale in New York.

The Trovan affair is one of several anguished disputes in recent years that have fuelled perceptions that drug companies are trying to cut costs by moving more and more of their clinical experiments to impoverished countries, where they can dodge red tape and recruit patients desperate for medicines who won鈥檛 ask awkward questions. Is that perception fair?

It is hard to know just how many human experiments are being exported to the poor world. In most industrialised nations, companies are not obliged to publicly register clinical trials, so they don鈥檛. But one indicator 鈥� the number of overseas investigators listed in applications for new drug approvals in the US 鈥� increased sixfold from 1990 to 1999. And some high-tech western drugs are now being tested everywhere from Chile to Lebanon. Eli-Lilly, for instance, is testing a drug for septic shock in more than three dozen countries simultaneously. The globalisation of human experimentation is clearly real.

But is that such a bad thing when overseas clinical trials take medicines, equipment and know-how to parts of the world that desperately need them? It depends who you ask. Industry groups say that clinical trials are conducted to the same stringent ethical standards no matter where they take place. Human rights campaigners and some ethicists in developing countries say this just isn鈥檛 so. What is certain, and worrying, is that it is bafflingly unclear what rules are supposed to apply.

Experimental protocols are supposed to be screened in advance by two approved ethics committees, one at home, one in the developing country. But screened against which code of ethics? The Declaration of Helsinki, developed in the 1960s, has the most moral clout. Yet expert panels in recent years have produced a bewildering array of more elaborate guidelines. And they don鈥檛 all say the same thing.

Take that bedrock of ethical experimentation, informed consent. The Nigerian families鈥� lawyers claim this was lacking in the Trovan study; Pfizer insists it was given verbally. The Declaration of Helsinki mandates that consent be in writing or, if verbal, 鈥渇ormally documented and witnessed鈥�. The UK鈥檚 respected Nuffield Council on Bioethics says that 鈥渨here there is a limit to the resources and appropriately trained staff available鈥�, teams need only to witness the 鈥減rovision of information鈥� to participants, not 鈥渋ndividual wishes to participate in the research鈥�. And in a further document, the US National Bioethics Advisory Commission recommends that ethics committees be permitted to 鈥渨aive the requirements for written and signed consent documents in accordance with local cultural norms鈥�.

Or take another bone of contention from recent years: the standard of treatment given to patients in the control group. Should these patients get the same state-of-the-art, but perhaps costly and tricky-to-administer, treatment that would be offered control subjects in the west? Or a less effective, but more practical, local treatment? Take your pick.

Some say these differences are an inevitable, even healthy, sign of experts grappling with complex dilemmas and reaching different conclusions. Others see it as a messy series of fudges and loopholes that, collectively, legitimate the setting of different ethical standards in poor countries.

Either way, complaints can simply end up in limbo. In the Trovan affair, Pfizer denies any wrongdoing and says the drug performed better than any other treatment available to the stricken Nigerian children. The families鈥� lawyers dispute that. Last year an American judge ruled that untangling the truth was a job for Nigeria鈥檚 courts. So far they have failed to act, so now lawyers in New York are appealing to get the case heard back in the US. Trovan, they point out, was an American drug shipped out to Nigeria to generate data for US regulatory approval. If it is OK for the data 鈥� and potential profits 鈥� to come home, they ask, why not the accountability too?

Whatever happened 7 years ago in Nigeria, it is a reasonable question. Drug companies are not the cartoon baddies of some critics鈥� imaginations. But their PR stock is unlikely to rise if the rich world鈥檚 courts refuse even to hear the grievances of those who take part in their far-flung clinical experiments.