Our Review Summary
This was a trial of the drugs tenofovir and emtricitabine (in the combination sold as Truvada) in 12 monkeys, lasting 4 months. However, data on the effectiveness of treatment in humans is lacking. Even replicate trials in non-human primates is lacking. While it is true that this treatment shows promise, data supporting the use of this treatment in humans remains to be established. Further – the basis of the main portion of this article derives from an oral presentation at a meeting, the results of which have not undergone peer review. Woloshin and Schwartz published an article in JAMA a few years ago entitled, “Media Coverage of Scientific Meetings: Too Much, Too Soon?” That theme might appropriately be applied to this story.
The enthusiasm engendered in this story may be premature and – worse – misleading.
Criteria
Satisfactory
The wholesale cost estimate for a month of Truvada given in the article is $650; estimated costs per day when sold in the third world was $0.87 (which calculates out to $26.46/month). (Wholesale costs for a month’s worth of tenofovir, is given at $417. This was not the treatment being reported on, although the story mentions some trials with this drug that are currently underway. The story did mention that tenofovir has been shown partially successful as a preventative in monkeys.)
Not Satisfactory
This was a trial in 12 monkeys, lasting 4 months. However, data on the effectiveness of treatment in humans is lacking. Even replicate trials in non-human primates is lacking. While it is true that this treatment shows promise, data supporting the use of this treatment in humans remains to be established. Further – the basis of the main portion of this article derives from an oral presentation at a meeting, the results of which have not undergone peer review.
Not Satisfactory
The story didn’t mention the side effects associated with either of the two medications that are combined in Truvada. These include nausea, vomiting and loss of appetite; more serious but less common is impaired kidney function. In addition, use of these medications is associated with decreased bone density and redistribution/accumulation of body fat. No mention was made that long-term effects of these pharmaceuticals is not known.
Not Satisfactory
The evidence presented was clearly mentioned in the article as being from a study of a small number of monkeys. The data were from a study of 12 rhesus macaque monkeys; 6 of the monkeys received the treatment and did not become HIV infected despite weekly rectal exposure to virus. 5 of 6 control monkeys that did not get treatment became infected. Follow-up for 4 months have found the treatment monkeys were still uninfected.
However, by citing the enthusiasm as electrifying the field, the story seems to lose sight of the fact that this was a trial in 12 monkeys for a few months. There is no evidence in humans.
Not Satisfactory
The epidemic is huge and the ability to prevent would be terrific. The article is sensational, however, calling the infection fatal, when, in fact, the disease is treatable, so the exaggeration may be termed disease mongering.
Not Satisfactory
The basis of the main portion of this article derives from an oral presentation at a meeting, the results of which have not undergone peer review. The story could have developed sources working on vaccine development. They might not dismiss the potential of a vaccine so quickly.
Not Satisfactory
The story dismisses other transmission prevention as impractical. That’s not universally true. And the story should have developed the vaccine option more fully and in a balanced manner.
Satisfactory
Both the individual medications tenofovir and emtricitabine and the combination sold as Truvada are FDA approved medications; however their use by individuals as an HIV infection preventative is an off-label use (i.e. not FDA approved) at this time. Off-label use is permitted (something the story didn’t develop) but there would be concerns about haphazard use, or use for longer than was studied in the trial.
Satisfactory
The story made clear that this was a trial of using the drugs as a means to prevent HIV infection as opposed to their current use in HIV treatment.
Not Applicable
We can’t judge if this story relied solely or largely on a news release. It is a concern, though, that it appeared to be derived from a talk at a scientific conference. It hasn’t been published nor peer-reviewed.
Total Score: 3 of 9 Satisfactory
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