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Thursday, 3 October, 2002, 17:26 GMT 18:26 UK
Leukaemia alert over gene therapy
Rhys Evans
Rhys Evans was cured of the condition earlier this year
Gene therapy trials in the UK will be closely monitored after a child undergoing treatment in France developed cancer.

Members of the Department of Health's gene therapy advisory committee (GTAC) said on Thursday they had decided against halting trials.

Both France and the United States have suspended gene therapy trials in children with potentially life-threatening x-Severe Combined Immunodeficiency syndrome (x-SCID).


In light of this case, GTAC has recommended that additional measures be put in place

Prof Norman Nevin, GTAC chairman

It came as doctors revealed that a three-year-old undergoing treatment in Paris had developed leukaemia.

The infant was one of eight children being treated at Necker-Enfants Malades clinic in Paris for x-SCID.

Mutated gene

Children with x-SCID or "bubble boy" disease are born without an immune system.

The condition, which is caused by a single mutated gene, means children must live in sterile conditions or risk picking up a life-threatening infection.

The treatment has been carried out successfully in the UK.

Earlier this year, doctors at Great Ormond Street Hospital in London cured 18-month old Rhys Evans, from Cardiff, of the condition. He celebrated his second birthday this week.

The three-year-old who has developed leukaemia received gene therapy in his first month of life.

The treatment was considered to have worked well. He had fought off an infection last spring that could have threatened his life.

However, in recent months his body started to produce too many white blood cells which is similar to children who develop leukaemia.

Dr Bobby Gaspar
Dr Gaspar said trials should continue
According to doctors, the boy is responding well to chemotherapy.

But members of the GTAC said extra precautions would now be taken in the UK.

In a statement, the committee said trials at Great Ormond Street Hospital, which currently involve three children and one adult will be allowed to continue.

Committee chairman Professor Norman Nevin said: "GTAC has carefully reviewed all the available evidence.

"In balancing the potential risks and benefits to these children, and in weighing up alternative treatment options, we have decided that, at this time, it would be unjustifiable to withdraw GTAC'S approval of the two Great Ormond Street studies.

"However, in light of this case, GTAC has recommended that additional measures be put in place."

Expert review

A sub-committee is being established to review all UK studies involving this type of gene therapy.

Families with children eligible to enter the trials will also be fully counselled about this new development so that their choice of treatment can be as informed as possible.

Professor Nevin said that cancer was always seen as a possible side-effect of this type of gene therapy.

He added: "As with all innovative treatments, there will always be the potential for side-effects."

Dr Bobby Gaspar of Great Ormond Street Hospital welcomed the committee's decision.

"If we stop these studies now we will be denying extremely effective therapy to children and they may suffer as a result of not receiving this therapy. Ethically we believe it is the right thing to go one," he told the BBC.

That view was echoed by Marie Evans, the mother of Rhys who has undergone the treatment.

"If they stop something just because one child has an adverse effect at the end of the day medicine and the world just doesn't go on," she said.

 WATCH/LISTEN
 ON THIS STORY
The BBC's Karen Allen
"This latest setback is a real confidence blow for everyone involved"
Norman Nevin, Gene Therapy Advisory Board
"We have to weigh up the benefit against the possible risk"
See also:

03 Oct 02 | Health
03 Apr 02 | Health
03 Oct 02 | Health
03 Apr 02 | Health
27 Apr 00 | Science/Nature
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