Drug trial patient dies from multi-organ failure


Rebecca Cole

A WOMAN died while trialling a new experimental drug, an inquest heard.
Heather Valerie Owen, of Coed Y Go, Oswestry, died of multi-organ failure at Royal Shrewsbury Hospital on August 24 after developing a number of viral infections.
Dr Atheer Al-Ansari, a consultant rheumatologist at the Orthopaedic Hospital in Gobowen who cared for her during the trial, said he was “shocked” by her condition and had never seen a patient with three such serious infections before.
Mrs Owen, 62, suffered from rheumatoid arthritis and had been taking part in a clinical study of new drug MK8457 to see if it could help ease her symptoms.
But seven weeks after starting the medication she began experiencing adverse symptoms including chest pains, fever and shortness of breath and was later admitted to the Shrewsbury hospital with a chest infection.
Dr Al-Ansari said: “Infections are usually one of the concerns and I explained that to her
“But the benefit to risk ratio was favourable.”
He assured the hearing he had made it clear from the beginning she should stop taking the medication if she suffered any ill effects.
However, Heidi Knight, on behalf of Mrs Owen’s family, claimed that on the August weekend she became ill, Dr Al-Ansari told her to keep taking the pills.
He replied: “I spoke to Mrs Owen three times that weekend and repeated that she ought to stop the drugs.”
He also sent a letter to her GP advising the same.
Mrs Owen was the only UK participant out of 60 patients taking part in the worldwide study, run by a healthcare company called MSD, and according to Dr Al-Ansari none of the others had suffered serious infection.
Dr Catherine Whittall, research programme manager at the Orthopaedic Hospital, confirmed Mrs Owen fully understood the risks and was happy to take part in the study.
“Mrs Owen never expressed any concern about being on the trial and Dr Al-Ansari always kept her up to date with the risks and benefits,” she said.
The inquest heard Dr Al-Ansari had ordered the study to be discontinued and the Orthopaedic Hospital at Gobowen had since carried out its own internal review into the circumstances around Mrs Owen’s death.
Following the advice of pathologist Dr Huyam Abdelsalem, Shropshire coroner John Ellery ruled Mrs Owen had died from multi-organ failure due in part to rheumatoid arthritis and its treatment.

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