A coroner today warned that children undergoing treatment for cancer could be at risk because of the failure of scientists to share test results.
Mary Hassell is to send a prevention of future deaths report to NHS England after hearing how four children died after botched stem cell transfers at Great Ormond Street hospital.
She told St Pancras coroner’s court today there was a lack of “benchmarking” of results to allow doctors to establish whether the procedures were working.
She said: “I’m very concerned that the clinicians treating children with cancer have been unable to unlock the results of Siopen trial [performed in Vienna in 2011]. That seems to me to be a very unsatisfactory state of affairs. I’m concerned for children in the future.”
She returned narrative verdicts in relation to the deaths of Sophie Ryan-Palmer, 12, of Feltham, Katie Joyce, four, from Hoddesden in Hertfordshire, Ryan Loughran, aged one, from Bournemouth, and Muhanna Alhayany, five, who had come from Kuwait for treatment.
Some parents sobbed in court as the coroner recounted the harrowing detail of each child’s fight for life. See below for part of the narrative from Ms Hassell.
The children had various forms of cancer such as neuroblastoma and leukaemia and were given stem cell transplants, previously known as bone marrow transplants, in a bid to save their lives.
But the inquest was told that a flaw in the way the cells were frozen prevented them from regenerating each child’s weakened body.
Three of the four died at Great Ormond Street – Sophie on July 17 last year, Katie on October 6 last year and Muhanna on on August 28 last year. Ryan died on July 10 last year in a hospice in Winchester.
Ms Hassell said that only Sophie, who had acute lymphoblastic leukaemia, “might have” survived her underlying illness if she had not been given faulty stem cells. In the other three cases, “a more successful graft would not have changed the outcome”.
She said: “In conclusion, it’s unclear whether a safer graft would have changed the outcome for Sophie, but it might have.”
It was after Muhanna’s death that doctors began to wonder if there was a common link between the first three deaths. They had been puzzled why his blood count had failed to recover after the stem cell transfer.
In total, eight children at GOSH received unsuccessful stem cell transfers – the first time this had happened since the process was launched in 2003.
The fault was eventually discovered by Dr Michael Watts at University College Hospital. He found problems in the way the cells were being frozen.
“When Katie died in early October 2013, those treating her realised that there had been eight consecutive graft failures,” Ms Hassell said in her narrative.
“GOSH suspended the programme and informed the Human Tissue Authority. Four out of the eight children had died, Katie being the last.”
She continued: “The likelihood is that something changed at GOSH that year. It’s still not known what changed.
“Nevertheless, the controlled rate freezing profile in use at GOSH in 2013 did cause the engraftment failure in these four children.”
Ms Hassell said the cases highlighted the urgent need for hospitals in the UK and internationally to share results on stem cell transfers.
“Those treating children following a bone marrow transplant don’t know how many days to recovery is normal, so they don’t know what is abnormal.
“This could compromise the optimal care of some children with cancer.”
A spokeswoman for Great Ormond Street Hospital for Children NHS Foundation Trust said: “We understand that this has been an immensely distressing process for all of the families involved. These four young patients were extremely poorly children with complex conditions, and it is frustrating for everyone concerned, especially their families, for it still to be unclear exactly what caused the freezing problem and to what extent this might have contributed to one patient’s eventual outcome.
“As soon as we identified a potential problem with our stem cell freezing process in 2013, we stopped freezing cells onsite and used alternative facilities in other London hospitals while an investigation was undertaken.
“We had tested all of these cells prior to transplant, following UK national standards of testing, and the results of these tests had indicated the cells were alive and viable. Therefore at this stage there was no indication of any problem, and it was only after a period of time had elapsed that the pattern of delayed engraftment began to emerge among a group of patients.
“After a number of investigations we have now re-introduced freezing of cells at GOSH using an alternative method which, like our previous method, is in use in many hospitals across the country. We are closely monitoring this different method and are performing additional testing, over and above the national standards, to check the engraftment potential of the frozen cells.
“Throughout this whole process we have been open and honest with all four patients’ families and have shared all of the available information with them. As the evidence from our clinicians has testified, we have also worked hard to share our findings with the wider transplant community. We welcome the coroner’s recommendation to create a more standardised approach to the way the medical community shares knowledge nationally about autologous stem cell transplants in children with cancer, to raise awareness of any issues uncovered and ensure a similar problem does not occur again.”