Some people do it for the money, some people do it for a glimpse of hope for a cure while others do it just to volunteer. For whichever reason you do it, do find out more about the consequences of going for it.

Clinical trial programs are where new drugs or treatment are tested out on actual people before the drug or treatment is released commercially into the market. The purpose of the trial is to note and monitor the possible side effects that it can have on a random sample. These drugs are usually quite safe, but may at times be deadly, just like a previous incident involving a clinical trial in London, where a few people had adverse reactions to the extent that some lost their limbs.

In New York, where a clinical trial for HIV vaccination was carried out, many volunteers reported social stigma from friends and relatives who knew about their participation. In some cases, their HIV results came out positive, probably because of a false-positive results.

It was also reported that some contracted full-blown HIV, but it was not mentioned if it was a result of their participation. However, the PI chided that the test providers should always confirm if the patients had participated in any HIV-related trials, which I thought was rather irresponsible if he had not briefed the volunteers first.

He, and the volunteers, should realise that in the real world, people just by what your test results say, not by any other facts that may be present.

NEW YORK – MANY volunteers who take part in clinical trials of experimental HIV vaccines report negative social consequences because of their participation in the studies, according to a new report.

‘Since a majority of the negative social impact events were due to negative reactions from friends and family who misinterpreted what a preventive HIV vaccine trial entails, trial sites need to continue their educational efforts with both study participants and with local communities emphasizing that you cannot become HIV-infected from the vaccine itself and that these trials seek HIV-negative individuals to participate,’ Dr Jonathan Fuchs said.

Dr Fuchs, from the San Francisco Department of Public Health, and his associates evaluated the negative social impacts reported by 5417 mostly male volunteers in an HIV vaccine efficacy trial.

Just under 1000 volunteers reported negative social events during 36 months of follow-up.

Most such events were negative reactions from friends, family, and partners, the authors report in the Journal of Acquired Immune Deficiency Syndromes. These reactions were primarily attributed to a misunderstanding of the volunteer’s HIV status or risk of infection.

Less than 1 per cent of the group reported problems with disability or life insurance, employment, medical or dental care, health insurance, government agencies, or housing.

Among the 368 participants who became infected with HIV after enrolment in the trial, only 12 reported a negative social incident, the investigators say. Most involved personal relationships, such as friends or family members asserting that the vaccine caused the individual to become HIV-infected or more susceptible to infection.

Although the vaccine could affect HIV test results, none of the HIV antibody-related negative social events reported by 29 volunteers were attributed to vaccine-induced antibody results, the researchers note.

‘A substantial proportion of vaccinees may test ‘false-positive’ on a standard HIV antibody screening test,’ Dr Fuchs explained. ‘Providers should remember to first ask whether their patients have participated in an HIV vaccine trial before they perform HIV testing, to avoid potential misinterpretation of antibody results and possible social harm.’ — REUTERS

Article obtained from on 30th November 2007

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