Monday, September 19, 2005

"The Constant Gardner"

A few weeks ago the Alliance for Human Research Protection posted two rave reviews of the movie, “The Constant Gardner,” one from The New Republic and the other from The Chicago Tribune. And I went to see it. The movie proved just as compelling as the reviews promised, particularly its focus on the collusion of government and pharma in testing, without consent, and, indeed with coercion, new products on poor African populations. It is a beautifully filmed and exceptionally well acted movie. I immediately told my students and colleagues in the Health Advocacy Program to go.

This week the New York Review of Books includes a review of John le Carré’s book as well as the movie by Marcia Angell, former editor of the New England Journal of Medicine, Senior Lecturer in Social Medicine at Harvard Medical School and author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It, an exceptionally clear and well researched book about pharmaceutical companies and the public.

Read this excellent review for yourself. Angell, who knows a great deal about drug company activities, confirms le Carré’s author’s note at the end of the book, "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."

According to Angell, the real fiction in the story is that drug companies would actually be threatened by knowledge of its unethical drug trials becoming public. “In fact, many of the practices that so horrified le Carré's heroine are fairly standard and generally well known and accepted,” writes Angell. “They seldom provoke outrage, let alone murder.”

Advocates and ethicists should pay particular attention to Angell’s review:

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 provinces 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. . . .

Before a study is exported to the third world, two important questions should be asked. First, would it be possible to do the research in the first world? And second, why is it being diverted to poor countries? It is sometimes claimed that research should be done where health needs are greatest—and that is certainly the case in the third world. But this view confuses research with treatment. There is a great need to apply the results of research, wherever it is conducted, to the treatment of people in the third world. Unfortunately, that is not what happens. Research findings are applied predominantly in well-to-do countries even when the research is done in poor ones. The only clinical research that clearly needs to be conducted in the third world is research on third-world diseases. Such work is amply justified, and far more of it is needed. Unfortunately, it is not a high priority either for the pharmaceutical industry or the National Institutes of Health.

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