24 deaths at probiotics trial for pancreatitis, translation

January 24, 2008

Translation of the article:

http://www.nu.nl/news/1403412/83/24_Doden_bij_Nederlands_wetenschappelijk_onderzoek_%28video%29.html

first published: 23.Jan 2008 09:38

last edited: 23 Jan2008 16:33

24 deaths in Dutch scientific research/clinical trials

Utrecht. A Dutch scientific research project re the workings of

probiotics in the slowing down of pancreatitis has resulted in the death

of 24 Dutch patients in the period 2004-2007

This was made public by the Universitair Medisch Centrum Utrecht

(UMC) on Wednesday.

..

According to the hospital, a number of the deceased would probably still

be alive had they not taken the probiotics. The hospital

could not say how many people would have survived.

Bacteria

Probiotics are good bowel bacteria which stop the growth of harmful

bacteria. A total of 296 patients participated. They were treated in 15

Dutch hospitals including all 8 of the University Medical Centers.

Devastated

On Tuesday, the families of the deceased have been informed about the

dramatic results of the trials.

According to the UMC, the researchers are devastated. Based on

small scale research in other countries, the expectations were that

de probiotics would decrease the inflammation.

Claims

A spokesperson for the UMC could not confirm whether the families

would qualify for damages.

All patiens who participated in the trial signed a contract before

the start.

The spokesperson said that trial went ahead and didn't show any problems.

It is just that the results are dramatically different from what was

expected.

Danger

The researchers learnt in October of 2006 that probiotics could cause a

danger. According to the spokesperson, colleagues in

Tschechia -involved in a similar research project - were immediately

alerted. The research in Tschechia was stopped at once.

The spokesperson of the UMC said that probiotics are also in products

like Yakult which one can purchase at any supermarket. The products

are said to promote bowel function.

The spokesperson does not expect that probiotics will cause any harm for

healthy people. 'But seriously ill people in intensive care are advised

not to use probiotics.'

Upset

Biotechnologiebedrijf Winclove, the company that provided the probiotics

for the failed clinical trials says to be upset about what has taken

place.

'We follow the advice of the researchers and we do not use the product

any more in certain situations' according to director Luuk van

Duijn of the company in Amsterdam

Van Duijn says that the 3 situations in which the use of the food

supplement could be harmful, are:

for people who suffer from organ failure,

for people in intensive care and

supplementation of probiotics for people who are being tube-fed.

'As it stands now, we will not participate in research when any of these

3 situations are present' according to Van Duijn.

Van Duijn emphasises that probiotics is a general term for

food supplements which all have their own specific characteristics.

'We developed this product in collaboration with the hospital, with

specific characteristics.'

'It has only been used in this situation. The harmful effects are not

applicable to other probiotics and other circumstances', according to Van

Duijn. 'Not for as far we know now.'

The 'Inspectie voor de Gezondheidszorg (IGZ)', a bureau involved

with control in health care , is going to focus on research into

the workings of probiotics. This was announced by a spokesperson

for IGZ on Wednesday.

January 24, 2008

I wonder what happened to the other 273 patients?

Jane

-

Hanneke

Translation of the article:http://www.nu.nl/news/1403412/83/24_Doden_bij_Nederlands_wetenschappelijk_onderzoek_%28video%29.htmlfirst published: 23.Jan 2008 09:38 last edited: 23 Jan2008 16:33 24 deaths in Dutch scientific research/clinical trialsUtrecht. A Dutch scientific research project re the workings of probiotics in the slowing down of pancreatitis has resulted in the death of 24 Dutch patients in the period 2004-2007This was made public by the Universitair Medisch Centrum Utrecht (UMC) on Wednesday.. According to the hospital, a number of the deceased would probably still be alive had they not taken the probiotics. The hospital could not say how many people would have survived.BacteriaProbiotics are good bowel bacteria which stop the growth of harmful bacteria. A total of 296 patients participated. They were treated in 15 Dutch hospitals including all 8 of the University Medical Centers.