A YOUNG widow has revealed that her husband died in a government-funded drug trial — the second victim to be identified.

Gareth Kingdon, 39, who was father of a seven-month-old boy, was poisoned by one of the drugs being tested as a new treatment for testicular cancer.His widow Victoria, also 39, from Tunbridge Wells, Kent, said this weekend that he might still be alive if doctors had withdrawn the medication, bleomycin, when signs of side effects first emerged.

She argued that doctors at the Royal Marsden hospital, London, should have noticed signs of lung damage and stopped the drugs. He developed a persistent dry cough, a sign of damage caused by bleomycin, yet they continued to administer the drug for about another month. He was transferred to a critical care unit shortly after the last dose in November 2006.

Two months ago The Sunday Times reported that Gary Foster, 27, had died after he was given an overdose of bleomycin at University College London hospital (UCLH) in 2007. The publicly funded Medical Research Council, which is running the trial at several hospitals across Britain, has admitted that two other men were given overdoses.

After Foster's death the trial was suspended at UCLH — where there had been a computer error in setting up the dosage control. The revelation that another patient had died a year earlier raises questions about whether it should be continued at other hospitals.

The deaths also raise broader safety concerns two years after the "elephant man" case, which was supposed to have led to tighter supervision. Six men nearly died when their bodies swelled horrifically after taking an experimental drug in trials conducted on the site of Northwick Park hospital, London, by Parexel, the testing company. All the men suffered multiple organ failure.

Kingdon, who was a senior tax executive at the Ford motor company, was diagnosed with testicular cancer in the summer of 2006. His family were given documents that put the normal survival rate at 50%. They say doctors told them that his chance of beating the cancer if he took part in the trial of a new treatment was about 90%.

The trial, TE23, is testing whether a combination of five existing chemotherapy drugs, including bleomycin, is better at treating testicular cancer than the standard treatment of three drugs. Victoria Kingdon, a former marketing manager, said her husband joined the trial in August 2006 and developed a cough two months' later: "Gareth was showing signs of toxicity from the bleomycin. He had a dry persistent cough from early October. I even have the cough medicine he was prescribed.

"The last cycle of chemotherapy was early to mid-November 2006. They should have stopped his entire last cycle. If they had done that, Gareth may very well have been with us today."

She added: "Gareth was so sick, I said to him, 'How can they think you are well enough to have chemotherapy today?' but they went ahead with the last round," she said. "Gareth went into the critical care unit shortly after the last dose was administered."

The couple's son, Gus, was seven months old when Gareth Kingdon died. Victoria Kingdon was fighting breast cancer at the time, which, she said, had hindered her ability to seek justice for her husband. After having a mastectomy she is clear of the disease and is seeking legal advice.

Kingdon acknowledges that bleomycin is an effective drug if monitored closely.

Between 1%-2% of patients taking bleomycin die of the damage it causes to their lungs.The Medical Research Council has declined to disclose how many of the 59 patients in the TE23 trial have died from toxicity caused by bleomycin.

Kingdon said: "We were, like the Foster family, delighted that Gareth got invited to participate in the trial. There is a contract of trust between patient and doctor, however, and where I think mistakes may have been made is in the vigilance to look for symptoms like the dry cough that both Gary Foster and Gareth suffered and to act on them quickly."

Mark Bowman, a solicitor with the law firm Field Fisher Waterhouse, who had acted for Foster, said: "As soon as someone develops toxicity, doctors should stop giving bleomycin. That appears not to have happened, which is of concern."

The Royal Marsden NHS Foundation Trust said: "We would like to again pass on our sincere apologies to Mr Kingdon's family for their sad loss." It declined to comment on the cause of his death. The Medical Research Council has reviewed its trial procedures and introduced additional checks since the deaths. It pointed out that deaths from cancer drug toxicity are an acknowledged hazard.

It added that the trial had been monitored by an independent committee and that it would be stopped early if there were concerns about a higher number of deaths than had been expected.

Letter from the MRC

Sir,

Clinical trials provide a robust way of improving treatments for patients. The information they generate saves countless lives. It is a tragic fact that during clinical trials, as in normal practice, some patients will die due to their disease. It is also the case that many treatments for cancer cause severe and sometimes life-threatening side-effects. All our clinical trials are rigorously peer-reviewed and tightly regulated. The MRC is very grateful to the many patients who volunteer to take part in clinical trials while suffering from devastating and life-threatening diseases.

In your article (Widow exposes cancer drug trial death, last week) you referred to an ongoing Medical Research Council clinical trial, known as TE23. This trial is designed to compare the existing standard chemotherapy regimen for the treatment of advanced testicular cancer to an alternative combination of existing drugs to see if this is more effective than the current standard treatment. Both treatments involve bleomycin - currently a standard drug for this type of cancer.

In this clinical trial, as in all others sponsored by the MRC, and in accordance with international standards, the accumulating trial data is reviewed by an independent group – the Independent Data Monitoring Committee (IDMC). This group is provided with information on the outcomes of all trial participants and provides a clear, independent perspective in reaching conclusions about the trial. If, as the trial progresses, there are significant concerns about patient safety or toxicity or if one treatment is clearly better or worse than another, this committee will recommend that the trial is modified or stopped. Serious side effects in clinical trials are also reported to the Medicines and Healthcare products Regulatory Agency (MHRA) which can stop a trial at any time. The IDMC for this trial last met on 19 November 2008, reviewing all the data and recommended that the trial continued.

Your article mentioned that the MRC had withheld information about the number of patients who had died from bleomycin-related toxicity. But while a trial is underway, its coordinators (in this case the MRC Clinical Trials Unit) routinely reveal interim outcome data only to the Independent Data Monitoring Committee. This is internationally accepted practice. The MRC would be strongly criticised if it departed from it. Following completion of the trial, information concerning the outcomes for those in each arm is published, and patients are informed if they wish.

TE23 is a trial in men with advanced cancer. Unfortunately with standard treatment up to half may die of their disease and a small number will experience life-threatening toxicities. We extend our sympathy to those families whose relatives have died while they were in the TE23 trial.

The MRC’s procedures are rigorous, with internationally agreed safeguards in place to protect patients. Our ambition is clear: to help fight life-threatening diseases and improve the prospects and quality of life for patients.

Professor Janet Darbyshire
Director, MRC Clinical Trials Unit
London

Dr Catherine Elliott
Head of Clinical Research Support and Ethics
MRC Head Office, London

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