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A healthy father of three has died after taking part in the clinical trial of a new drug.
Peter Munro, 48, died in his home in Edinburgh three days ago after allegedly suffering two heart attacks in less than two weeks.
Mr Munro, a keen exerciser with no history of cardiac problems, was reportedly paid £2,000 to take part in the trial of RhuDex, a new drug treatment for rheumatoid arthritis, at the Charles River clinic, in Tranent, outside Edinburgh. His family are pursuing legal action over his death and have demanded that the clinic be closed.
The tragedy is likely to raise fresh concerns over the safety of testing medicines in clinical trials. Six healthy volunteers almost died two years ago after receiving TGN 1412, a rheumatoid arthritis and leukaemia drug.
Yvonne Munro, Mr Munro's sister, said: “He was a healthy man who never had problems with his heart, he kept fit, and he ate well. He only took part in the trials to clear his debts. The clinic should be closed down.”
Ms Munro, 36, claimed that the clinic had failed to get in touch with the family after he died and condemned them for their indifference to their loss. “They said in newspaper reports that they are sorry, but they have not said sorry to us,” shesaid.
Mr Munro, who walked up to eight miles every day and was an enthusiastic bodybuilder, was among a handful of volunteers who had been participating in the trial of RhuDex, a new rheumatoid arthritis treatment developed by the German pharmaceutical company MediGene, at the Charles River clinic.
He first complained of feeling unwell just over a week ago after presenting at the clinic for a repeat dose of the drug. Staff carrying out a routine check on his heart discovered an abnormality and transported him to the Edinburgh Royal Infirmary, where doctors told him that he had suffered a cardiac arrest.
He had been recovering at his home in Edinburgh for five days when he fell ill on Saturday. Kylie Hemming, his partner of three years, called an ambulance, but paramedics informed her before they left that he was dead.
Ms Hemming, 19, said yesterday that she had been checking on Mr Munro when he appeared to take a seizure.
“It happened really quickly,” she said. “He looked alright, but when he sat up his arms went into spasms. His mouth started foaming and his jaw dropped. He was making noises and trying to say something, but I don't know what he said.”
Ms Hemming revealed that the couple had clashed over his participation in previous drug trials.
“I didn't know until he died he had been involved in more trials,” she said. “He told me he was doing other work, because he knew I wouldn't like it.”
Edinburgh Royal Infirmary is carrying out a post mortem to establish the cause of Mr Munro's death.While it is not yet known if the tragedy is linked with the drug tests, it will almost certainly prompt fresh fears over the safety of clinical trials.
Six men fell seriously ill after suffering an adverse reaction during the testing of TGN 1412, an arthritis drug made by the collapsed German company TeGenero. Ryan Wilson, 24, lost some of his fingers and all of his toes following the trials, and Nav Modi, 26, was dubbed “the Elephant Man” when his head swelled to twice its normal size.
A spokesman for MediGene said yesterday that 80 people had received RhuDex before the group in Edinburgh took the drug. “We don't know what he [Mr Munro] died of, but we do know that he suffered a heart attack so are investigating in correlation with authorities whether it was related to the trial.”
He said that all testing of the drug had now stopped.
A spokeswoman for Charles River clinic confirmed that the Edinburgh trial had been suspended and offered its “deepest sympathy” to Mr Munro's family.
“Our study participants play a critical role in advancing new therapeutics for patients who need them. We provide the highest quality of care to all of our study participants,” she said.
Mr Munro is separated from the mother of his three sons. She now lives in Wales with the youngest two children.
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