Shortly before I started work on my book The Truth About the Drug Companies: How They Deceive Us and What to Do About It,1 a friend gave me John le Carré’s newly published novel, The Constant Gardener, and urged me to read it right away. I did as I was told, and found the tale apposite, to put it mildly.
The villain is a global pharmaceutical company called Karel Vita Hudson (KVH). The heroine, Tessa Quayle, is the wife of a low-level British diplomat stationed in Nairobi, Kenya. She stumbles across evidence that KVH is testing a dangerous tuberculosis drug, called Dypraxa, on powerless and unsuspecting poor Africans, and not reporting the resulting deaths. When she threatens to expose the company, she is brutally murdered, and the British government colludes in the cover-up. Her husband, Justin Quayle, a seemingly docile civil servant at first, becomes obsessed with finding out why his wife was murdered and by whom. He finally does, and at the end of the book, he too is murdered. In between the deaths, we follow Justin’s gradual awakening to the ruthless activities of a corporation too powerful to be accountable to anyone.
Now The Constant Gardener has been released as a film, starring Ralph Fiennes and Rachel Weisz and directed by Fernando Meirelles. It is both better and worse than the book. Visually, it is stunning. The many aerial shots of Kenya show the stark beauty and sweep of the African countryside, and the film also conveys in its urban scenes the miserable overcrowding and hopeless poverty in Nairobi, something the book only suggests.
Where the film most improves on the book is in its treatment of the main characters. Fiennes and Weisz portray the relationship between Tessa and Justin as touching and believable, something the book fails to do. Le Carré presents Justin as self-contained to the point of inertness and seemingly with no serious interests beyond his garden. It hardly seems plausible that such a man would throw over his career, and risk his life, to investigate the death of his wife. In this film, Justin is revealed as not so much passive and narrow as controlled and quietly determined. And Weisz portrays Tessa, a passionately uninhibited champion of the poor and downtrodden, as a shrewder and more perceptive woman than the one we find in le Carré’s book; she does not share her discoveries about the drug companies with her husband for fear of compromising him. As in the book, Tessa’s murder takes place at the beginning, and we come to know her through flashbacks. But Fiennes’s face at hearing of her death, controlled and virtually immobile, somehow manages to convey the enormity of his loss as well as his determination to find out the truth about her death.
The film falls far short of the book, however, in telling us what KVH (for some reason renamed KDH in the film) was up to; it never explains why every institution that might have interfered with the company, including the British government, was colluding with it. We only get hints. We are told in passing that KDH and the people it controlled coerced poor Africans into acting as guinea pigs by denying them medical care unless they took part in company experiments; but we learn little about the rules which prevent that sort of coercion in prosperous countries but not in poor ones. We’re told that deaths were covered up—literally; bodies were thrown into a lime pit and their existence denied. But we learn little about why that was done, or why companies conduct clinical trials (that is, tests on human beings) in the first place, and why they find it advantageous to do so in Africa.
Since the film tells us very little about the motives of the drug company, we are left with a story that has plenty of passion and intrigue but is played out in something of a historical vacuum. In fact, most viewers would probably conclude that insofar as we do learn anything about KDH, its deadly practices are wildly implausible, in no way representative of real drug company behavior. After all, in the real world, we don’t hear of pharmaceutical whistle-blowers being murdered, and there have been several whistle-blowers recently.
But le Carré himself cautions us against drawing any such conclusions. In an author’s note at the end of the book he makes a grudging disclaimer to the effect that no person or organization in the book is based on an actual person or organization. He also makes it clear, however, that he is obliged to say this “in these dog days when lawyers rule the universe.” He adds, “But I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with reality, my story was as tame as a holiday postcard.”
Quite so. Le Carré obviously did careful research, and the book is rich in details about ordinary drug company practices. Without being pedantic, he has his characters explain how drug companies distort research to make their drugs look safer and more effective than they are; how they can get away with this more easily in poor regions of the world; and how they use their vast wealth to influence governments and the medical profession and any other institutions that might interfere with their single-minded pursuit of profits. On the basis of the research I did for my book I believe that most of the background facts about drug company behavior in The Constant Gardener, however hard to believe, are correct.
Yet the story is based on the premise that a pharmaceutical company would be so threatened by disclosures of its activities that it would have someone killed. That is what is fantasy. In fact, many of the practices that so horrified le Carré’s heroine are fairly standard and generally well known and accepted. They seldom provoke outrage, let alone murder. A company like KDH would not kill someone like Tessa even if it were willing to do so; it wouldn’t have to. Her concerns would have seemed isolated and futile, and the companies would hardly have taken notice of them.
There is no question that the US and other rich countries have been conducting more and more clinical research in Africa and other parts of the third world. Although exact figures are hard to come by, it is likely that tens of thousands of studies sponsored by first-world drug companies and governments are now underway in Africa, parts of Latin America and Asia, and the former Soviet Union. Most of this research is intended to find new treatments for use in well-to-do countries. After all, that is where the paying cus-tomers are. In this sense, third-world countries are being used as laboratories for first-world needs. Relatively few studies are devoted to finding treatments for the diseases that plague poor countries, such as malaria, sleeping sickness, and schistosomiasis. The big companies are more interested in the usual first-world conditions, like high cholesterol, obesity, and arthritis.
The rapid movement of drug studies to third-world countries began in 1980, when the US Food and Drug Administration (FDA), in considering applications to approve new drugs, first agreed to accept foreign trials as evidence of safety and effectiveness. Before a company can sell a drug in the US (or market an old drug for a new use), it must get approval from the FDA, which means it must demonstrate in clinical trials that the drug is reasonably safe and effective. Nearly every large drug company, wherever it is located, wants to get into the US market, because that is the major source of profit for pharmaceuticals.
Probably close to half of all clinical trials are now conducted in the third world, although there is no way to know for sure. The reasons are clear. It is cheaper and in many respects easier and faster to do them there. A huge new industry has arisen that conducts third-world research for drug companies (like le Carré’s fictional research firm, ThreeBees). These companies, called contract research organizations, or CROs, hire local doctors to find people who will take part in clinical trials, and while the payments to the doctors per patient are lower than in first-world studies, by local standards they are munificent. Doctors can multiply their income tenfold or more. Patients, too, are readily enticed by small amounts of money and promises of free care. In fact, as in le Carré’s story, enrolling in a trial may be the only way they can get any care at all.
This system makes a mockery of the notion of informed consent—the requirement that subjects be given full information about the nature of the research and have the right to refuse to participate, without penalty or consequences for their usual health care. That requirement is enforced in the US and other well-to-do countries, and partly for that reason, drug companies are having a hard time getting enough volunteers for the growing number of clinical trials. Not so in the third world, where authoritarian regimes and corrupt local government officials and health authorities are eager to be paid off by first-world organizations and to have good relations with them. They “encourage” entire villages or prov-inces to enroll in research programs, while local doctors enrich themselves by providing human subjects.
Perhaps the most important reason for conducting human research in Africa and other poor regions outside the US is that it is a way of circumventing FDA regulations. In the US, drug companies are required to file “investigational new drug applications” (INDs) with the FDA before they begin human testing of a drug they hope to get approved. The applications give detailed descriptions of the proposed research, including plans for obtaining informed consent and for monitoring the progress of the study. Companies must also provide evidence that ethics committees (called institutional review boards, or IRBs) have been set up to review each clinical trial. These committees are supposed to ensure that risks to human subjects are, in the words of the applicable federal regulations, “reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result,” and further, that all risks are “minimized.” The FDA can deny approval of the IND or request changes in the proposed research. It may also conduct on-site inspections of the trials.
The requirements for foreign research are much looser. In fact, the FDA may not even know about such trials until after they are completed, when the company applies for final approval of a new drug. Only then—when there is no longer an opportunity to verify the information—does the company have to describe the way in which the research was conducted, or say whether there was ethics committee approval and informed consent. Furthermore, the FDA rarely conducts on-site inspections abroad. While it conducts very few in the US, there is always the possibility that it will decide to do so. For research done in the third world, the agency simply takes the word of the sponsors of the research.