Ethical Issues in HIV Vaccine Trials

Thomas Kerns

Chapter 1

Where stands the pandemic now?

The Thesis position urges that "In the face of so much growing personal tragedy associated with HIV infection, and in the face of such a rapidly expanding global pandemic, waiting any longer to initiate phase I and II trials for HIV vaccines would simply be wrong." In order to have any notion of the full force of this claim, we will need to have some elementary understanding of the present scope and predicted future course of the HIV/AIDS pandemic.
It is difficult, however, to convey any full sense of the enormity of a pandemic.
Because it is so difficult, I often ask students in my courses on Medical Ethics and the AIDS pandemic to read Daniel Defoe's A Journal of the Plague Year. In this novel the impact of the Black Death in London that year (1665) comes across most clearly in the day to day details. We see infected mothers and their children shut up inside their houses, with guards stationed in front to insure that they do not come out. We see carts full of bodies being wheeled off in the early morning hours to stinking mass graves just outside town. We see the weekly mortality sheets recording the numbers of dead for the previous week. We see people packing their goods into a cart and leaving town to live elsewhere if they can afford to do so. We see people losing faith in their God, and then we see others believing even more strongly and praying even more fervently than they prayed to their God before. We see individuals responding daily to the threat of coming down with a mortal sickness that they've seen their friends and family members die of only days ago. We see people who are healthy today coming down with the sickness and dying before tomorrow's supper. These daily details bring home to readers the impact of living in the midst of an epidemic of lethal infectious disease.
Similarly, daily details of what it is like to live in the midst of the AIDS pandemic can be seen in the daily events recorded in biographical and autobiographical writings of people like Robert O'Boyle, Paul Monette, Barbara Peabody, Anne Richardson, Dietmar Bolle, and countless others who have effectively chronicled their own and others' personal experiences with AIDS. It is these personal accounts of living with a new truth (or perhaps with an old truth never before fully understood) that bring the reality of the epidemic alive for us. These authors do an enormous service for those who do not live directly in the front lines of the pandemic.
Yet at some point the impact of the pandemic must be somehow reduced to numbers, laid out in the stark black suit of quantity, if we are ever to adequately characterize its scope.
The Tenth International Conference on AIDS, held in Yokohama in August of 1994, tried to do just that. During that conference, the following summary of the pandemic's extent and demography was distributed by Dr Jonathan Mann (Director of the Global AIDS Policy Coalition at Harvard, and first Director of the World Health Organization's Global Programme on AIDS) and Daniel Tarantola, also of Harvard's GAPC. The numbers are stark and the passage is lengthy, but please read these data carefully. The statistics tell a powerful story.

As of 1 January 1994, the Global AIDS Policy Coalition estimated that 22.2 million people worldwide had been infected with HIV since the beginning of the pandemic. Of these, 20 million were adults (11.3 million men and 8.7 million women) and 2.2 million were children. The largest numbers of HIV-infected people were in sub-Saharan Africa (15.5 million; 70 percent of global total) and Southeast Asia (3 million; 14 percent). The number of HIV-infected people in Southeast Asia now exceeds the total of infected people in the entire industrialized world. Thus, the large majority of HIV infections (20.2 million; 91 percent) have occurred in the developing world. Worldwide, an estimated 16.2 million people were living with HIV or AIDS on 1 January 1994.
The global total of cumulative HIV infections in adults has more than doubled in four years, from nearly 10 million in 1990 to 20 million in 1994....
During 1993, over 3.7 million new infections occurred worldwide in adults and children - over 10,000 a day. Sub-Saharan Africa contributed 1.8 million infections (49 percent) to the global total and Southeast Asia had 1.5 million (40 percent). During 1993, the industrialized world accounted for over 200,000 new infections (6 percent); clearly the burden of new HIV infections is increasingly borne by developing countries (over 3.5 million, or 94 percent). Globally, during 1993, 1.4 million women were newly infected, representing 40 percent of all new adult infections that year....
Globally, during 1993, over 350,000 children were born with HIV infection....
The epidemic has not been stopped in any country; the cumulative number of HIV infections continues to rise relentlessly....
The gap between the expanding pandemic and the response is growing rapidly and dangerously, [and] efforts in prevention and care are becoming fragmented....
[T]he current global AIDS strategy...is not sufficient to meet the challenges of the pandemic....

In Thailand, for example, as in some other developing countries, the epidemic is almost out of control. The infection rate, says Dr. Prayura Kunasol, head of Thailand's Department of Communicable Disease Control, "has hit 20 percent among young military recruits - and 8 percent amount pregnant women - in the country's northern Chang Mai province. AIDS patients now occupy half of Chang Mai's hospital beds".
Although HIV began to spread widely in Thailand only as recently as 1987, already infection levels are approaching 23 percent of the reproductive age population. The three factors that are largely responsible for this discouraging situation in Thailand are: a) the rapid growth of HIV infection nationwide, b) the fact that infection is not limited to identifiable "risk groups" (for example, gay men or injection drug users) but is spread throughout the "general population," and c) the presence of a large infected but still symptom-free (hence unidentifiable) population of HIV carriers, most of whom do not realize that they are infected, and who will then probably be spreading the virus to their sex partners. HIV positive women who become pregnant also risk spreading the infection to their fetuses. These three features are not unique to Thailand, but actually characterize many Asian countries.
In India, for example, "studies have documented infection rates of 50-75 percent among IV-drug users in some provinces", and in Bombay "the rate [of HIV infection] among prospective blood donors shot from less than 1 percent in 1992 to 5 percent last year". This figure has tremendous consequences for protecting the quality of the national blood supply, especially since in India blood-testing facilities outside of major cities are rare. India simply cannot afford to test any more than a small fraction of blood donations at present.
Nor are India and Thailand unique. Drug use, commercial sex and general ignorance about the risks of HIV transmission unfortunately are commonplace in many countries, both industrial and developing. Economic difficulties exacerbate the problems. Cambodia, for example, does indeed have a national AIDS prevention program, but it has not been implemented because of lack of funding.
These examples are from Asia, but the situation in South America is not much better, and the situation in Africa is very much worse. No statistic tells it as clearly as this one: "Less than ten per cent of the world's population but more than 60 per cent of the world's HIV-infected people are African."
Thus, if we had to sum up the state of the global epidemic so far, we would have to say that it is getting worse by the day. In the US it is estimated that there is one new HIV infection every 9 or 10 minutes. That statistic, tragic though it is, is not as dramatic as the statistics for the whole globe. When I began teaching courses on Medical Ethics and AIDS in 1987, I could accurately tell students that, according to the most current data, there was a new HIV infection somewhere in the world every 30 seconds. A few years later I could tell students that there was one new infection every 20 seconds. When I taught the course in early 1994 I could tell them there was a new infection every 10 seconds. According to the figures above which were released at the Yokohama conference, there is now a new HIV infection somewhere in the world every 8.5 seconds.
Nor do these numbers take into account the dramatic resurgence of "the white plague," tuberculosis, which has been recrudescing in direct proportion to the global increase in HIV disease. HIV disease, or in fact any immunodeficiency condition regardless of its cause, is a direct correlate to the increase in active TB cases. In fact, of all the opportunistic infections associated with AIDS, tuberculosis is the most common, worldwide, and is the only OI that puts non-HIV-infected persons at any significant risk.
What is also true, though not so commonly known, is that the presence of active tuberculosis infection(indeed, the presence of any active mycobacterium infection) in an individual HIV+ person appears to speed the progress of HIV infection in that individual so that they proceed to active AIDS much more rapidly. It can be said, therefore, that HIV is a catalyst for the increase of TB in a community, and that TB is a catalyst for the increase of AIDS both in individuals and in communities.

This is indeed a bleak picture of an epidemic that C. Everett Koop, former US Surgeon General, has called "the number one health problem on this planet".

Epidemiological statistics are not, of course, the only measure of an epidemic. AIDS, we have discovered, is at least as much a social, political, and economic problem as it is a medical problem. In fact every major epidemic is a social and political problem as much as it is a medical problem. Writing in 1976, five years before the first case of AIDS had been noticed or identified, historian William McNeill tried to describe the effects of epidemics in past ages:

The disruptive effect of...epidemic[s] is likely to be greater than the mere loss of life, severe as that may be. Often survivors are demoralized, and lose all faith in inherited custom and belief which had not prepared them for such a disaster.... Population losses within the twenty to forty age bracket are obviously far more damaging to society at large than comparably numerous destruction of either the very young or the very old. Indeed, any community that loses a substantial percentage of its young adults in a single epidemic finds it hard to maintain itself materially and spiritually. When an initial exposure to one civilized infection is swiftly followed by similarly destructive exposure to others, the structural cohesion of the community is almost certain to collapse.

His concern is shared by others. Susan Sontag, in her literary study, AIDS and Its Metaphors, quotes a German AIDS specialist, Dr Eike Brigitte Helm, who says that "in a number of parts of the world AIDS will drastically change the population structure. Particularly in Africa and Latin America. A society that is not able, somehow or other, to prevent the spread of AIDS has very poor prospects for the future." Then Jonathan Mann tells us that in fact not one society so far has succeeded in preventing the spread of AIDS. "No community or country in the world already affected by AIDS can claim that HIV spread has stopped."
We have here, it seems, the makings of a syllogism. It looks something like this:

Premise: Any society that cannot prevent the spread of AIDS has very poor prospects for the future.

Premise: Every society already affected by AIDS has failed to prevent the spread of AIDS.

The conclusion to this little syllogism would seem to be momentous:
Every society already affected by AIDS has poor prospects for the future.

A conclusion of this sort may perhaps be slightly hyperbolic for some societies, but is probably an accurate conclusion for others.
In underdeveloped communities, for example, whether in developing nations or developed nations, AIDS is expected to have widespread devastating consequences. Social structures and economic support systems in these communities have less "give" in them because there are fewer redundant systems to use for backup when a main system fails. Furthermore, because AIDS strikes at the young adult population, that is, at those persons in a society who are producing a large percent of the goods and services for the community, and who are also the parents and breadwinners in families, the economic consequences to these societies, which are already severe, are only expected to get worse.
There may be labor shortages, for example, and these shortages could slow down or even reverse recent development gains. Furthermore, "economies may be further damaged by declines in foreign investment or by a drying up of tourism. In many Asian societies, the elderly are dependent on their working sons and daughters for support. When their children die, not only will the elderly often find themselves unsupported, but they may have to take responsibility for their orphaned grandchildren." Thus, the direct impact on families and on the raising of children (who are the community's future) can be expected to be significant.
Globally, in economic terms, the costs are surprisingly large. The United Nations Human Development Report 1994 features a prominent sidebar titled "HIV and AIDS - a global epidemic," in which is summarized some of the information you've just read. Then they present some calculations of economic impact:
Costs of the epidemic, of course, include a wide variety of factors. There are direct medical and hospitalization costs, research costs, prevention costs, public health program costs, education costs, and many others, and there are also the indirect costs of years of potential life lost (YPLL), of lost productivity, and of the further consequent economic fallout from that lost productivity. The United Nations Development Programme attempted to quantify these costs. They calculated some conservative estimates of what these costs have totaled to date, and what they might be expected to rise to in the future. Here are their figures:

The cumulative direct and indirect costs of HIV and AIDS in the 1980s have been conservatively estimated at $240 billion. The social and psychological costs of the epidemic for individuals, families, communities and nations are also huge - but inestimable....
The global cost - direct and indirect - of HIV and AIDS by 2000 could be as high as $500 billion a year - equivalent to more than 2% of global GDP.

This conservative estimate of the annual costs of this pandemic by the year 2000, only four years away, is staggering and can be expected to have serious economic implications for the whole globe. It certainly lends credence to the assertion that something must be done to stem the problem. The epidemic does not look like it will go away on its own.
The United Nations has once again recognized the world wide impact of this pandemic and has announced a major reorganization of its global efforts at controlling the disease. In place of the WHO's Global Programme on AIDS (which will soon no longer exist), there will be an overall, high-level coordinating agency (to be called the "UN Programme on HIV/AIDS," headed by Belgian scientist, Dr Peter Piot, that will have the function of bringing together and focusing the efforts of all the various United Nations agencies that deal with AIDS. UN agencies that currently deal with AIDS include the World Health Organization, the United Nations Development Program (UNDP), the United Nations Population Fund (UNFPA) UNESCO, UNICEF, and the World Bank. (The UN is to be applauded for its long recognition that AIDS, in addition to its dimension as a medical problem, is also a social, economic, educational, research and political problem as well.) The announcement of this major organizational change in the WHO's approach to the AIDS pandemic

marks the first time in the 50-year history of the UN that any disease or health crisis has been elevated to such a level. This is occurring because the international community has never before faced such an intractable, rapidly expanding and economically costly new disease crisis.

 

To sum up, the social, psychological, public health, and economic consequences from this epidemic are already tragic, and are expected to become much more severe in many parts of the world. The Thesis position holds that something dramatic must be done soon.

 

 

(For citations and references, please see the printed version of this book)


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EVT Table of contents
EVT Introduction | EVT chapter 1 | EVT chapter 2 | EVT chapter 3
EVT chapter 4 | EVT chapter 5 | EVT chapter 6 | EVT chapter 7 | EVT chapter 8
EVT chapter 9 | EVT chapter 10 | EVT chapter 11 | EVT chapter 12 | EVT chapter 13
EVT chapter 14 | EVT chapter 15 | EVT chapter 16 | EVT chapter 17 | EVT chapter 18
EVT chapter 19 | EVT chapter 20 | EVT chapter 21 | EVT chapter 22 | EVT chapter 23
EVT chapter 24 | EVT chapter 25 | EVT chapter 26 | EVT chapter 27
EVT Appendices | EVT Bibliography | Lancet Review of EVT

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