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Stanford Report, November 8, 2000

U.S. ethical standards infeasible in poor countries, professor says

BY LISA TREI

It is unrealistic to apply U.S. ethical standards for medical research trials to poor African countries reeling from an AIDS pandemic, argues Associate Professor of Medicine David Katzenstein.

More than 25 million people in sub-Saharan Africa have HIV, the virus that causes AIDS, but 95 percent have not been tested and do not know they are infected.

In such a context, the use of clinical research trials involving placebos, the concept of informed consent and the notion of patient confidentiality have far different ramifications in poor countries than in rich ones, Katzenstein said during a talk at last Friday's Ethics@Noon weekly speaker series.

"This is the worst epidemic we've seen in modern times," said Katzenstein, who has done research in Zimbabwe on mother-to-child transmission of HIV. "Thirty million people will die prematurely due to HIV, without us doing anything."

In Africa, the male-to-female ratio of HIV infection is about 1 to 1, and the median age for infection is the early twenties, he said. The prevalence of HIV in antenatal women is more than 30 percent in South Africa, Botswana, Zimbabwe and Malawi. In the United States and Europe, the rate of untreated mother-to-child transmission of HIV is 15 to 25 percent. But that figure jumps to more than 30 percent in Africa, Katzenstein said, largely due to breast-feeding.

"In the United States, the recommendation if you are HIV-positive is that you formula-feed your infant," Katzenstein said. "In much of the world, that's potentially not possible and potentially dangerous: Safe water supplies are not available, and formula is expensive. [In Africa,] there are very strong advocates for breast-feeding even though one-third of transmission [of HIV] is through breast-feeding. The ethical question is whether you should tell a mother that she is putting her child at risk when there is no other viable alternative. Why make someone feel bad about something when you can't do anything about it?"

Furthermore, research in the United States has shown that HIV-infected pregnant women who are treated with an intense regimen of AZT, a drug that has proved effective in controlling the virus, can reduce the rate of HIV transmission to their infants from 24 percent to just 8 percent. But a course of AZT costs from $800 to $1,500 -- a figure that cash-strapped African governments cannot pay. "Does a U.S. standard [of treatment] apply in resource-poor countries?" Katzenstein asked. And what are the implications for providing treatment that is not sustainable in the long term?

Katzenstein says women in Africa with HIV are willing to participate in clinical trials involving the use of placebos because it gives them a chance at getting medical treatment when the alternative would be no intervention at all. "The 'p' word [for placebo] has become a scary word in medical ethics," he said. "It is not considered to be a nice thing to do to people with serious diseases. But a 50 percent chance at getting something is way better than zero."

The notion that individuals have given informed consent and are participating completely voluntarily in a study is another standard that is unrealistic to expect in developing countries, Katzenstein said. Pregnant women are not paid to participate in trials but they may be guaranteed a level of basic prenatal care and free delivery of their babies if they do. They also may be paid a bus fare that can equal several days' wages for visiting a clinic. "How do you draw the line?" he asked. "What is a coercive inducement? That's a difficult question to answer."

The concept of confidentiality that has been developed in the United States in response to concerns from HIV-infected people about potential loss of employment and health insurance works counterproductively in getting people tested in Africa. "If we start off saying that this is a big secret, how can anyone not think that this is a really bad thing that should be avoided?" he asked.

Katzenstein said all parties are partly to blame for the low percentage of people who know they are infected with HIV in Africa. "There's very little discussion of the issue in the hyperendemic environments because the solutions are so difficult that denial is the easiest way out," he said. "Women know they have a one-in-three chance of having it -- it's on the front page of newspapers." If testing is offered to women, Katzenstein said, only 40 percent will participate, even if they are guaranteed treatment -- with no placebos -- that will prevent their infants from getting infected. Of those who are tested, only half will return for the results, he said.

The crisis is compounded due to strong social pressure on adults in Africa to have children. "It's a big question of personal identity," Katzenstein said. "In the Shona language in Zimbabwe, for example, you are only regarded as a person after you are a parent. When you are introduced, the first question asked is, 'What is the name of your oldest child?' so that you can be addressed as the father or mother of that child. That's the priority in your life. I would argue that there is an epidemic and people are dying, and that should be your first priority. But it's amazing that there is resistance to that."

Ethics@Noon is a weekly brown bag forum presented by the Program in Ethics in Society. On Nov. 10, William Hurlbut, lecturer in Human Biology, will give a talk called "Evolution, Empathy and Ethics." The discussion will take place in Building 100, Room 101K.


David Katzenstein