Investigation begins into clinical trial deaths

The health inspectorate is to begin an immediate investigation into the death of 24 patients during clinical trials into treating acute pancreas infections. ‘It will not be a standard probe.
There is talk here of a major calamity,’ a spokesman told Trouw.

On Wednesday Utrecht teaching hospital said that the nationwide research project had led to an ‘unexpectedly higher death rate’ among patients treated with probiotics.
Twenty-four patients (16%) of patients treated with probiotics.died compared to nine (6%) in the control group. The trials involving 296 people, took place at 15 hospitals between 2004 and 2007.
Probiotics, often used in food supplements, are bacteria or yeasts which are said to combat the growth of harmful bacteria in the gut.
Foreign research using rats had indicated that probiotics do reduce pancreatitis, which affects some 3,000 people in the Netherlands a year.
During the research patients were given probiotics via drip feeds in the hope this would boost their resistance to harmful bacteria.
Doctors have been recommended not to give probiotics to patients with organ failure, those in intensive care or being drip-fed.
Labour MPs have called for an investigation into how much patients had been told about the risks before signing up for the trials.
‘We have been concerned for some time about the quality of information given to students who take part in clinical trials, MP Chantal Gill’ard told Trouw.

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