So what happened to the AIDs vaccine?

HIVYou might remember all the hullabaloo last month about the HIV vaccine developed by the US military and tested on 16,000 people in Thailand.  Hailed as an “HIV breakthrough” and a “historic milestone“, the initial press release of the study certainly had the media convinced that a prevention for AIDs was just around the corner.

Now the research has been presented in full at the AIDS Vaccine 2009 Conference in Paris and in the New England Journal of Medicine, and reactions are far more circumspect.

Granted, the vaccine in question is the first ever to provide any kind of protection against HIV, but it only prevented HIV-1 infection in 31.2% of participants. 74 of the 8198 volunteer who received the placebo vaccine became infected with HIV-1, but 51 of the 8197 people who were given the vaccine still managed to get infected – a difference of only 23 people.

I’m not really sure what happened with this story.  Did it get press released before publication and before anyone had a good look at all the data?  To be fair the initial news stories were pretty good in their reporting of the research, but why is the story doing the rounds again?

New Scientist is on the ball with this.  In September they published an article “What to make of the HIV vaccine ‘triumph’“, in which they point out that “the victory was won by the slenderest of numerical margins.”

In addition, New Scientist provides some sort of answer to my previous question.  Says the article: “The result was disclosed at the earliest available opportunity at the request of the Thai collaborators, says Merlin Robb, deputy director for clinical research at the MHRP.  “The Thai Ministry of Public Health was very anxious to let the volunteers in Thailand know the result as soon as possible, instead of waiting for a scientific conference,” says Robb. “This reflects our commitment to the volunteers and transparency in all aspects of this trial,” he said.”

So what’s with this jumping of the gun and presenting research before it’s been published in a peer review journal?  But researchers live in a “publish or perish” environment and are in constant fear of being “pipped to the post”.

The BMJ says “We do not want material that is published in the BMJ appearing beforehand, in detail, in the mass media” and “The BMJ does not want to publish material that has already appeared in full elsewhere“. And the New England Journal of Medicine cites their “Ingelfinger rule“, which “requires that author-researchers not release the details of their findings to the mass media before their work undergoes peer review and is published.”

I don’t think this research would have subsequently been published in the NEJM if the authors had in fact broken the embargo, so there must have ben some intense behind the scenes bargaining to get the paper released early – but only a month early.

I’m not really sure what point I’m trying to make here, but I think it’s certainly interesting that this paper made a bug splash a month before the full data was published then did the rounds again.

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Junior doctors pressed into taking HIV tests

Blood testJunior doctors are undergoing HIV tests as part of pre-employment occupational health checks without being made aware that such testing is not mandatory, according to research published in the Journal of Medical Ethics.  Many junior doctors interviewed by Lee Salkeld and colleagues held the misperception that HIV testing was compulsory and felt unable to decline the test.  In addition, interviewees felt that they had not been provided with enough information about the test or about the impact of a positive result.

According to guidance published by the Department of Health in 2007, all new healthcare workers need to undergo tests for tuberculosis and hepatitis B, and should be immunised as necessary. Only those who will perform exposure-prone procedures – i.e. people who will undertake invasive procedures where there is a risk that the patient’s open tissues could be exposed to the blood of the worker – are required to have an HIV test.

Several of the 24 junior doctors (foundation years 1 and 2) and doctors in specialty training (years 1, 2 and 3) interviewed by Salkeld et al., however, commented that the requirement of an HIV test was simply presented as just another part of a long list of tests that were necessary.

This lack of pre-test discussion meant that most of the doctors were unclear about the implications of a positive HIV test. One even asked: “I wonder if they’d have sacked me if it was positive. No one really explained what would happen if it were positive either—would my bosses have been told about it?”

The DoH guidance suggests that healthcare workers could benefit from these regulations “both personally and professionally”.  Most of the junior doctors interviewed by Salkeld et al. thought that HIV testing was for the benefit of patients, though; few mentioned the benefit to themselves of knowing their HIV status and being able to access treatment should they be HIV positive. 

There have been only two cases of HIV transmission from doctors to patients worldwide – one involving an orthopaedic surgeon and the other an obstetrician, neither of whom were practising in the UK. The risk of HIV transmission from healthcare worker to patient is eximated to be between 1 in 42,000 and 1 in 420,000, although the risk of patient-to-doctor transmission is 1 in 300.

Given these figures, the authors ask “is this somewhat utilitarian Department of Health policy justifiable?”
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Salkeld L et al. (2009) HIV testing of junior doctors: exploring their experiences, perspectives and accounts Journal of Medical Ethics 35 (7): 402-406. DOI: 10.1136/jme.2008.027052

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