Thomas A Kerns. Ethical Issues in HIV Vaccine Trials. Basingstoke: Macmillan, and New York: St Martin's Press. 1997. Pp 249 15.99. ISBN 0-333-67492-8.
In the Roman Catholic church, the procedures to decide whether a holy person should be named as a saint are lengthy and thorough, as evidence is gathered to support canonisation of the candidate. But one church official is assigned the contrary task of gathering evidence and formulating arguments against that person's canonisation. The value of this "devil's advocate" is that if the candidate is eventually elevated to the sainthood, the process will have been done as thoroughly and as critically as possible.
This is the position that Thomas Kerns adopts in Ethical Issues in HIV Vaccine Trials. In the first few pages, he acknowledges the immense burden of personal tragedy resulting from HIV(-1) infection, which is increasing daily, and lays out the many compelling reasons why large-scale vaccine trials should go ahead as quickly as possible. But the main thrust of the book is to make known the wide and varied array of ethical difficulties that could arise when HIV vaccines are tested in large numbers of uninfected people. While many of these difficulties are, as yet, speculation, a few have already arisen. So, says Kerns, these complex issues need to be considered now, in advance, by those who are designing, approving, or planning to participate in efficacy trials. For, he believes, it is only in the clear posing of good questions that any adequate answers will ever be discovered; answers that we are promised in a second book.
Kerns is an ethicist, laying out a detailed Antithesis position to the more commonly held Thesis position, from which he hopes a Synthesis can be developed. But this slim, black paperback does not contain the other-worldly commentary divorced from real life found in some ethics texts. On the contrary, the analogies are stark: the grotesque and tragic violations of human rights perpetrated in the Nazi medical experiments during World War II are our reminder that voluntary informed consent should be the paramount principle in all human research.
Informing volunteers of all potential hazards is no easy task. Even a short background to the pandemic, and some relevant biology--required by all non-medically qualified, and some that are--spans several chapters. But the elegantly simple language makes reading a joy rather than a chore. The risks are spelled out, from immunisation reactions and potential long-term health problems to instillation of a false sense of security, which could encourage risky behaviours or even worsen the pandemic.
In the global enthusiasm for HIV-vaccine research, do we consider that vaccine-trial participants may suffer discrimination because of their newly acquired antibody status, in donating blood or organs, enlisting for military service, or applying for jobs or insurance? In some communities, vaccinees may be identifiable by attending a special clinic, or need to declare their participation to explain their antibody status. And it might be assumed that these individuals chose or were chosen to enrol because they engage in risky behaviours.
This contribution is timely. Although papers and texts on HIV-vaccine trial ethics have been published since the late 1980s, there has been no mention of ethical trial design from UNAIDS or the International Aids Vaccine Initiative. But with a new, more efficacious vaccine described it seems almost every month, and thousands of volunteers enrolled in phase II clinical trials, the time for large phase III trials is almost upon us. When David Baltimore, Nobel laureate virologist, was appointed chair of the US National Institutes of Health vaccine-research committee earlier this year, to provide "leadership, direction and oversight", the accord from researchers and advocate groups was unanimous. Yet, although his leadership and direction to "ferret out" new vaccine ideas is not doubted, his failure to address publicly the ethical issues in trial design must surely be his main oversight.
Kerns gives us an excellent historical perspective, with references to unusually diverse sources. Thus we are reminded that, as always, the burdens that seem easiest to bear are those that are borne by others. Much of the brunt of human suffering caused by the pandemic has been borne by those in the developing nations, and so it will be with HIV-vaccine trials. In June, 1994, the NIH rejected applications for phase III trials in the USA with gp120 candidate vaccines, judged by today's standards as poorly immunogenic. But within 4 months, WHO's Global Programme on AIDS concluded that similar trials could go ahead in Brazil, Uganda, and Thailand. Where the situation is most dire, urgency becomes paramount, and the corners mapped out by Kerns could be cut. Will the standards of confidentiality, consent without inducement, and compensation for harm, taken for granted by people of industrialised nations, be observed in countries where the pandemic is most devastating, in countries where basic human rights are a luxury or illiteracy is the norm? And, should we insist on the same standards, or is this yet another form of imperialism?
For scientists who have spent years contributing to the development of safe, effective vaccines, or trial physicians who take great pains, despite educational, language, or time barriers, to ensure that each trial participant is fully informed, this book may strike a sour note. And the simplicity that makes these ideas accessible outside the closed ranks of the medical profession, and easy to digest in an afternoon, does not allow the uninformed to discriminate between the likely, the uncommon, and the plain ridiculous. Vaccination is highly unlikely to cause widespread autoimmunity, neurological disease, or malignancies, and some might say that such speculation will unduly harm the image of HIV vaccines, or hinder trial recruitment. At the end of this text, I was left feeling that the difficulties involved could be insurmountable, and wondering whether I had failed the acid test: would I participate, as researcher or volunteer, in an HIV-vaccine trial? Not, I decided, unless many of the safeguards described were in place. If I did so, the appendices to this book alone, including a proposed bill of rights and responsibilities for participants and a test of understanding for informed consent, would be invaluable.
If the history of HIV-vaccine trials is to be written as one of the greatest public-health successes of modern medicine, we must not lose sight of the individual. To find acceptable answers to ethical issues in HIV vaccine trials, we need the widespread public discussion that Kerns hopes for, to ensure that policy is grounded in ethical principles. I hope David Baltimore has a spare afternoon for this book.
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