Another drug trial disaster in Britain

A 27-YEAR-OLD man has died in a government-funded medical trial, in which at least two other patients were given overdoses. Gary Foster, a graphic designer who was planning to get married this month, was on seven occasions given double the amount of chemotherapy he should have been prescribed. His mother, Colleen Foster, said: "Gary was slowly poisoned to death."

The mistakes raise questions about the safety of medical trials in Britain two years after the notorious "elephant man" trial, which was supposed to have led to tighter supervision. Six men nearly died after their bodies swelled horrifically after taking the experimental drug TGN1412.

University College London Hospitals NHS Trust (UCLH), one of Britain's largest trusts, has been forced to suspend the trial although it is continuing at other UK hospitals. Foster's death was due to a fundamental error in the setting-up of the trial on the hospital computer system. A second UCLH patient was affected by the same error, but survived.

Another patient, who died at a different hospital, and whose name has not been disclosed, also received an overdose of the drug bleomycin. In that case, the overdose was due to an error by a nurse or doctor rather than a basic flaw in the setting-up of the trial. According to the Medical Research Council (MRC), the government-funded organisation which ran the trial, the drug was not the direct cause of his death.

When the MRC suspected that patients had been given overdoses, instead of calling UCLH immediately, it posted a letter on October 3, 2007. An inquest into Foster's death heard that a nurse failed to open the letter until October 16, two days after his death. The family concede that by October 3 it was too late to save Foster because he was already dying of organ failure caused by the overdoses.

Foster, from Waltham Abbey, Essex, was eager to join the medical trial in June 2007. He had just been diagnosed with testicular cancer, and he had a 60% chance of survival. The disease has a survival rate of about 95% if caught early. Doctors told Foster that, if he was accepted for the trial, his chances of survival would increase.

Colleen Foster said: "The trial sister said: `Good news, Gary, you have been selected for the trial.' At UCLH they said, `Don't worry, testicular cancer is curable. We will monitor Gary for 10 years - you don't have to worry.' They made us feel so confident." His fiancee, Paula Collins, 35, added: "When Gary became involved in the trial, we thought it was fantastic news because we thought Gary's chance of survival would be greater and the care would be better."

The trial, called TE23, was testing whether a combination of five existing chemotherapy drugs was better at treating testicular cancer than the standard treatment of three drugs. Foster was in the group receiving the new therapy. From June until mid-September 2007 he made regular trips to UCLH in central London, to receive the drugs. On seven occasions between July and September last year, he received 30,000 units of one of the drugs, bleomycin, instead of 15,000. Foster and his family had no idea the drugs they believed were saving his life were killing him. Colleen Foster said: "We just thought Gary was getting tired because of the chemotherapy."

Eventually Foster developed a dry cough, a symptom of lung damage, caused by an overdose of bleomycin. An inquest heard that the cough should have been recognised by doctors and nurses as a warning sign that the bleomycin was damaging his lungs. Despite the cough, Foster was given a final dose. The coroner ruled that Foster died as a result of lung damage caused by an overdose of bleomycin. The coroner also found that the instructions for the trial had been wrongly set up on the electronic prescribing system at UCLH.

Colleen Foster said: "An overdose gives the impression that it was a one-off. It was seven times. Every week my poor Gary was going into hospital, we thought he was getting better but, actually, he was being slowly poisoned and poisoned to death." Eventually he became so ill that he was transferred to intensive care and put on a ventilator, but attempts to save him were in vain. Foster's family blame his death on a trial they say was set up in a hurried and piecemeal manner.

Collins said: "Checks should have been carried out. It is incomprehensible that they were dealing with the most dangerous medicines and they were so blase. It was so slapdash. "We had dreams and lots of plans together," she said. "Gary also had his own ambitions. We were supposed to be getting married on Saturday September 6, instead, on the Tuesday before, we were at the inquest. He was such a lovely person. He was so well liked and had so many friends."

"We do need trials but there need to be more controls," Collins added. "I would encourage other people thinking about taking part in trials to proceed with caution. I would hate to think of anyone else going through what we have gone through." .....

The MRC said it had reviewed its trial procedures as a result of the tragedy and introduced additional checks. It said it followed its normal procedures by posting its concerns rather than making an emergency phone call. "During the processing of the forms for the UCLH patients, a possible dosing error for these two patients was spotted. A query form was then returned to the hospital." Dr Stephen Harland, who was in charge of the trial at UCLH and supervised Foster's care, declined to comment....

Source






Australia: A bigger hospital is better?

Public hospitals are impersonal and bureaucratic enough as it is and a bigger hospital is going to be even more so. And the bigger the bureaucracy the more error-prone it is. But both in Australia and in Britain the move is to phase out lots of small hospitals and build a few huge ones

A NEW children's super hospital in Brisbane would save lives, foster research and improve training opportunities, says a respected specialist. As a turf war intensified between doctors over the merger of the Royal Children's and Mater Children's hospitals, Melbourne intensive care specialist Frank Shann said having a single facility was overwhelmingly the best choice for patients.

Professor Shann, who has consulted on children's hospital care worldwide, said bigger institutions delivered better quality care and at lower cost. "Very large centres that do a lot of work have lower mortality rates," he said. "The more you do, the better at it you get." Professor Shann said the existing public children's hospitals were both too small to offer advanced intensive care training for doctors. "Queenslanders who want to train in intensive care of children have to train in other states," he said.

Although some doctors have warned of an exodus of specialists from Queensland if the merger goes ahead, Professor Shann predicted it would attract better qualified staff.

A group of University of Queensland researchers last week warned the pending closure of the Royal Children's Hospital at Herston, in Brisbane's inner north, would cripple research into a vast array of diseases. But Professor Shann said the existing children's hospitals generated far fewer research papers than stand alone facilities in other states. "There'll be a bigger group of people working together rather than having two small groups. You can bounce ideas off each other," he said. "If you have an interest in a particular group of patients ... you'll also double your exposure to those patients."

The Queensland Government has pledged to build a $100 million research facility close to the new hospital but has yet to secure funding. Acting Premier Paul Lucas yesterday accused critics of being afraid of change. "The Government is not doing this to annoy people. The Government is doing this for all the mums and dads out there who expect to have world's best practice in our children's hospital," he said. Mr Lucas defended the current plans, saying all the evidence and analysis showed the Government was on the right track.

Source