Last Updated Aug 18, 2008 12:11 PM EDT
This issue first emerged for GSK in July, when TradingMarkets.com reported that 12 babies had died during the trial. GSK has pointed out that 19,000 kids have received Synflorix so far and that the number of kids who have died is in fact lower than Argentina's natural child mortality rate.
Foreign drug trials are a PR tinderbox for drug companies (just ask Pfizer how its trials for Trovan in Nigeria turned out) and the Synflorix situation illustrates that perfectly. It has all the makings of a controversy for GSK -- even if the company is completely innocent.
First, there's the fact that GSK is testing Synflorix in a poorer country than the U.S. That naturally lends itself to allegations that the company is farming out the dangers to foreigners. True, but then in order to test a pneumonia vaccine you need to actually be in a country that has a significant number of pneumococcal infections, and they're harder to find in the U.S.
Second, there's the conflicted nature of local politics in foreign countries that don't have a long history of democracy. In this case, one of the lead GSK investigators is Enrique Smith, who happens to be the brother of Juan Carlos Smith, the Argentine provincial health minister. So even if GSK has done nothing wrong, it just looks... weird.
Third, there's the inconvenient timeline. Argentine authorities asked GSK to halt recruitment of new subjects in the trial, and GSK complied -- but added that it had already gotten enough of them anyway.
Fourth, GSK's independent safety monitor briefly halted the tests while it reviewed the situation, then allowed the tests to resume even though the Argentine province of Santiago del Estero is continuing its look at the trial. However, that province's health minister is Juan Carlos Smith, so even if it comes back with a legitimate finding that there's nothing wrong, people will ask questions about the role of the Smiths in the case, and why GSK continued its program even though the local government was still investigating.
In short, it's a lose-lose situation for GSK, from a PR point of view, even if Synflorix turns out to be a wonder drug.