AIDS: safety, regulation and the law in procedures using blood and blood products.

The purpose of this paper is to examine issues of regulation of the market for, and use of, blood and blood products. The situation has changed since the discovery of the Human Immune Deficiency Virus (HIV), the presumed cause of AIDS, because it was recognized that some haemophiliacs were infected with HIV from transfused blood and blood products before 1985. When the danger was realized in that year, regulations were introduced internationally to prevent this, but meanwhile some haemophiliacs developed AIDS. In several countries, governments have accepted responsibility, without liability, for possible transmission of infection, and paid compensation to victims. In France three health service officials have been convicted of fraud and criminal negligence. In March 1997 a trial began in Japan of three drugs company executives accused of promoting the sale of HIV-contaminated blood products. Since then there has been a class action in the USA resulting in awards. Further issues have arisen with regard to the outcome and treatment of asymptomatic infection with HIV. The implications for public safety, and for medical and legal practice, are far reaching and reveal a need for more effective monitoring of the existing procedure for supply and clinical use of blood and blood products.

Monitoring expenditure in relation to epidemiological and demographical characteristics of AIDS in South East England.

In the UK, over 70% of AIDS, including new cases, is located in a few Districts in central London where the distribution of previously occurring and new cases is essentially confined to the original risk groups of homosexual/bisexual men, drug addicts of both sexes, and some of their sexual partners and consorts. But control policy is still based on the assumption that HIV has already spread from persons in these risk groups into the general population, and that it will spread hereafter at an increased rate because of heterosexual transmission to cause a widespread epidemic of AIDS. The basis and implications of this policy were investigated in the South East region adjacent to London. Analysis of demographic and epidemiological data shows that, with one exception, there is very little extension of AIDS from affected Districts in London to the surrounding region or even to the suburban fringe. Where AIDS is prevalent, as in this exception, the distribution follows the same, original pattern which relates essentially to risks arising from life-styles. There is no significant association between the prevalence or spread of AIDS and conventional markers of deprivation, economic and social disadvantage. Allocations of personnel, services and expenditure, assessed from returns required under the AIDS Control Act of 1987 and official registration data, continue to follow the original policy assumptions. They are therefore unrelated to the numbers of existing and new cases, disproportionate and unrealistic. Claims that this widespread excess of effort is justified by the fact that AIDS has not spread to the general population are falsified by the continuation of cases almost exclusively in risk groups. There is nothing in the data required under the Act or in registrations in this main locus of AIDS in the UK to suggest any change in this or to justify continuation of current expenditure and redundant activities. There is no evidence in these data that ethnic variations in the resident populations of Districts are associated with variations in the prevalence of AIDS. However, the larger figures available in some of the national data do indicate a disproportionate increase in some minority ethnic groups. Further detail about risks factors in these groups are required and, meanwhile, effort and expenditure should be re-orientated toward treatment, contact tracing and other public health measures for more effective containment of the continuing spread of AIDS in all the high risk groups.

The epidemiology and transmission of AIDS: a hypothesis linking behavioural and biological determinants to time, person and place.

Epidemiologically, the Acquired Immune Deficiency Syndrome, AIDS, is transmitted and distributed in the USA and Europe almost entirely in well-defined subsets of populations engaging in, or subjected to, the effects of behaviours which carry high risks of genital and systemic infections. The persons predominantly affected are those engaging in promiscuous homosexual and bisexual activity, regular use of addictive drugs, and their sexual and recreational partners. In such persons and in subsets of populations with corresponding life-styles, the risk of AIDS increases by orders of magnitude. Because of continuity of risk behaviour and of associated indicator infections, the incidence of AIDS over 3-5 year periods is predictable to within 10% of actual totals of registered cases in the USA and UK. Secondary transmission of AIDS beyond these groups is minimal or, in many locations, absent. There is no indication of appreciable spread by heterosexual transmission to the general population. The Human Immunodeficiency Virus, HIV, is transmissible to some extent in general populations, and more so among promiscuous persons. It may cause viraemia, lymphadenopathy and latent infection (HIV disease) in anyone. In persons engaging in risk behaviours which themselves alter or suppress immune responses, it can interact with MHC, antibodies to other organisms and to semen, and other allogenic antigens to initiate a programmed death of CD4 lymphocytes and other defensive cells, as in graft-host rejections. This occurs also in haemophiliacs receiving transfusions of blood products, and is more pronounced in persons with reactive HLA haplotypes. The susceptibility of particular subsets of populations to AIDS is thereby largely explained. But these changes occur in the absence of HIV, and so do Kaposi's sarcoma, lymphadenopathies and opportunistic infections which are regarded as main indicators of AIDS. The hypothesis that HIV-1 can do all this by itself and thereby cause AIDS is falsifiable on biological as well as epidemiological grounds. An alternative hypothesis is proposed, linking the incidence of AIDS to the evolution of contemporary risk behaviour in particular communities and locations in the USA, UK and probably in most of Europe. It does not pretend to explain the reported incidence of AIDS in Africa and other developing regions where data are insufficient to provide validation of the pattern of disease and contributory variables. The immediate, practical implication of this alternative hypothesis is that existing programmes for the control of AIDS are wrongly orientated, extremely wasteful of effort and expenditure, and in some respects harmful.

Scientific surveillance and the control of AIDS: a call for open debate.

This paper reviews some of the history of AIDS in order to put into perspective the claim that AIDS is or will be the pandemic plague of the twentieth century. It is concluded that AIDS shows a relatively stable and predictable pattern in the developed world, and that open and unbiased debate about AIDS is long overdue.