Some perspective on the current “AIIMS paediatric clinical trial deaths” story

Many media outlets and blogs are frothing over the news item about 49 babies dying in clinical trials at the All India Institute of Medical Sciences (AIIMS). However,over at the PharmHouse, Seeji provides some much-needed rationality and perspective on the story.

Why not go over there and read what he says…

My comment to his post reads: “Thank you and well done for posting a bit of rationality amongst all the media hysteria surrounding this news item.

“Some of the reports I’ve read state that the mortality rate for all patients treated at AIIMS (not just children) is 4%. Between this and your data of national infant mortality of 5-7%, the 1.2% mortality rate in this data is surprisingly good. If you extrapolate from these (very rough, I know), the expected number of deaths should have been between 165 and 290. However, I can’t imagine the mass media rushing to use a headline like “Over 100 babies saved by taking part in clinical trials”!

“The other key point that the mass media appears to have missed is that it is surely better to treat children with medicines that have been explicitly studied in other children, not simply prescribed off-label based on extrapolations from studies conducted in adults. Children’s physiologies are very different from those of adults. It is even more of a scandal than this claims to be that as much as 70% of prescriptions to children are off-label because insufficient paediatric studies have been carried out. This is a situation that the USA and the EU have started to put right with legislation over the past decade.

“It is disappointing that every other report or comment that I’ve seen on this item takes a sensationalist view rather than your more rational one.”

CRO globalisation the “pipeline saviour”?

Over on the Blogging Biotech blog, Mary Canady has written about the globalisation of the CRO sector and how this could work for the benefit of pharma and biotech pipelines. She makes some interesting points, but a more efficient clinical research sector also has some long-term implications for drug discovery.

Why not head over there now and see what you think?

My comment was: “The importance of CROs having global reach while maintaining close links with pharma HQs has been great for the extablised players, who have gradually moved into Eastern Europe, India etc over the past 5-10 years. This hasn’t been lost on the new generation of local CROs springing up in these regions, which had their initial growth from subcontracting from global CROs but are now emerging from their own countries and merging with other small/medium CROs from other countries (including developed countries) in an attempt to take on the big players at their own game of “global reach, local touch”.

“The upshot of this will certainly be cost-containment for pharma, but the big question is how much of this will get reinvested into smarter drug discovery and earlier, more demanding go/no-go questions being asked of compounds, and more efficient scientific and operational models for how the clinical programme is conducted.

“The even bigger question is whether having a clinical research operation that is more efficient at weeding out compounds that don’t meet the (more exacting) modern standards for safety and efficacy will improve or actually damage the size of the pipeline. You’ve got to have good compounds going into testing to be able to withstand the attrition that a good clinical research operating is always going to deliver…”