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From: TSS ()
Subject: CJD fears for 50 former city patients
Date: May 30, 2005 at 6:10 am PST

Mon 30 May 2005



CJD fears for 50 former city patients

ALAN MCEWEN


UP to 50 former hospital patients in Edinburgh are feared to be at risk of having contracted the human form of mad cow disease during brain surgery.

The patients each underwent operations which used a medical procedure linked to the spread of Creutzfeldt-Jakob Disease (CJD) over a ten-year period.

The alert follows the death of a 34-year-old man in England who contracted the virus from a contaminated Lyodura graft.

The graft was withdrawn from the market nine years ago after it was linked with CJD.

Similar products have been connected to around 150 deaths worldwide, triggering a wave of lawsuits from grieving families.

It is understood most of the operations would have taken place at the Western General Hospital where the neurosurgery department is still based.

But NHS Lothian health bosses have warned that tracing the affected patients will not be possible as case notes were not stored.

In a report to the health board, Dr Charles Swainson, medical director of NHS Lothian, said: "In Edinburgh, four to five patients per year may have had this material used.

Many of the notes of these patients have been destroyed so it will make it impossible to know whether this was used. An intelligent guess might be made from the nature of the operation and the research."

Three of the surgeons from Edinburgh who are believed to have used the material retired in 1987, which could add further difficulties to assessing the extent of the problem.

Experts will be forced to make only an "intelligent guess" over whether or not people were exposed to any danger.

The National CJD Surveillance Unit, which is also based at the Western General, has been monitoring the situation since the concerns arose.

The risk of contamination from Lyodura grafts in the city is thought to stretch between 1982 and 1992 when the product was widely used.

CJD exists in different forms - sporadic, genetic, variant and iatrogenic - which are distinguished by the cause of the illness in each instance.

These cases relate to iatrogenic CJD which involves accidental transmission during medical or surgical procedures. However, a leading scientist from the surveillance unit said that the risk of any of the patients having contracted the disease was "very low".

Professor Robert Will, a neurologist, said: "Lyodura has been used in thousands of operations worldwide and there have only been 168 recorded cases of CJD, mostly in Japan, with only six or seven in the UK.

"One study from Japan concluded that the risk for anyone who had a graft was one in 2000. Research from Australia put the risk at one in 500. Either way, that makes the risk very low."

He added: "The average incubation period for CJD is eight or nine years with very long incubations lasting 20 years.

"The dangers surrounding Lyodura were realised around 1990 so the risk that someone is infected deteriorates with time. It doesn't mean they can't have been infected, it's just the chances are decreasing."

The unit, which is staffed by a team of clinical neurologists, neuropathologists and scientists specialising in the disease, has recorded 1057 deaths from different strains of CJD between 1990 and April this year. But any efforts to trace and reassure patients who may have been exposed to infected tissue are unlikely to be successful.

"The patients who had brain surgery in Edinburgh would have no idea if the Lyodura graft was used," said Prof Will. "They would not have been told. The hospital records would also probably have been destroyed so there would be no way to trace them."

Prof Will added it would probably take 25 years, until around 2015, before patients from the Capital are completely out of danger. He gave evidence at a recent coroner's inquest held into the death of 34-year-old removal man Simon Stratford, who died of CJD more than 15 years after an operation in which he was treated with infected tissue.

The father-of-four from St Neots, Cambridgeshire, needed a repair to his dura mater, a membrane lining between the skull and the brain, when he had a tumour removed at Addenbrooke's Hospital, Cambridge, in September 1987.

Between October 2002 and April 2003, Mr Stratford had problems sleeping, then lost feeling in his face and arm, and became withdrawn and angry as his condition deteriorated, losing his ability to swallow, walk and speak.

The coroner's verdict of medical misadventure may now be used by Mr Stratford's family to seek compensation from the manufacturers of Lyodura, the German firm B.Braun Melsungen.

The alarm was raised on iatrogenic CJD in the US in 1987 when a 28-year-old woman from Connecticut in the United States contracted the human form of mad cow disease, or BSE, two years after receiving an infected graft.

B.Braun Melsungen, its Japanese distributor, and the Japanese health ministry were later ordered by the courts to pay out £330,000 to the families of CJD victims in Japan, which had the largest Lyodura-associated outbreak.

PROF Wills explained that the grafts were made of dura matter which was obtained from humans, often during postmortems, and used to fill in the gaps in a patient's brain following neurosurgery.

"At some point an infected person must have had dura matter removed to make a graft and this went into the production process, contaminating other grafts," he said. "We will never know if it was one infected person or more who caused it to spread."

The CJD Incident Panel, based in London, is also being consulted over the notification of patients who may have received a Lyodura graft. The group was set up in 2000 to advise hospitals, trusts and public health teams on how to manage incidents involving possible transmission of CJD between patients. No-one from the panel could be reached for comment.

In September last year, it was revealed that around 120 Scots were to be told they are at "high risk" of having contracted the human form of mad cow disease after being treated with infected blood products.

They were among 4000 patients in the UK who may have contracted variant Creutzfeldt-Jakob disease (vCJD). All those involved are thought to be at risk after receiving blood products from donors who have since died of the condition.

http://news.scotsman.com/index.cfm?id=592012005

http://edinburghnews.scotsman.com/edinburgh.cfm?id=592012005

TSS






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