Drug Trial Payout For Ely Man

WHEN Ely man Leslie Thomas decided to take part in a medical trial, little did he know that six months later he would be fighting for his life. Mr Thomas, 75, was invited to join the trial by his family GP. The doctor wrote to Mr Thomas and asked if he wo

WHEN Ely man Leslie Thomas decided to take part in a medical trial, little did he know that six months later he would be fighting for his life.

Mr Thomas, 75, was invited to join the trial by his family GP. The doctor wrote to Mr Thomas and asked if he would be willing to take part in the UK clinical study run by American firm Merck Sharp and Dohme Limited.

The drug was Vioxx, an anti-inflammatory also known as Rofecoxib. The study aimed to establish whether the drug could decrease the risk of prostate cancer.

Mr Thomas, who lives with his wife Norma in Chelmer Way, said: "I received a letter from my GP and we went to see her, to find out more, and we were told that I would be closely monitored.

"Prostate cancer is a major killer and I thought to myself 'For once in my life, I want to do something useful for fellow man'.

"I had a full medical and even had a prostate biopsy, which was clear. My health was good for my age.

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Mr Thomas, a retired lecturer, took the first tablet in December 2003. The study was a blind trial: half the participants would take Vioxx, the other half would take a placebo.

Mr Thomas said: "By March, I had begun to feel lethargic. We are keen ramblers but I couldn't even walk into town. I got severe diarrhoea, which was black because it had so much blood in it.

By June, six months after starting the trial, Mr Thomas was close to death.

His wife returned home from the shops one day to find him shaking uncontrollably. He was in shock from blood poisoning.

"I had a temperature of 104.9," he said, "and my heart rate was abnormal."

The couple's daughter called an ambulance and Mr Thomas was admitted to Addenbrooke's Hospital in Cambridge.

Mrs Thomas said: "It was terrible. I thought he had cancer, he was so ill. For six months I thought I was watching him die. In retrospect we know we should have gone to A&E sooner, but we put our faith in the medical profession."

"I was out of it," said Mr Thomas. "I spent three weeks in Addenbrooke's. I was on a drip, which was giving me fluids and IV antibiotics. I had septicaemia from the bleeding in my gut. It could have killed me."

When Mr Thomas was discharged, he got in touch with the drug company and asked for compensation.

He said: "They offered me �2,000 for my 'inconvenience' - our GP recommended that we go and see a solicitor."

This marked the start of an epic five-year legal battle. Mr Thomas said: "I was taking on a multi-billion dollar company. We had an ordinary solicitor and one barrister. They had a whole team of lawyers, a top QC and they flew people in from America."

After a two-week hearing, the judge took two months to make his decision. He found in the Thomas's favour, a landmark ruling, but the drug company immediately lodged an appeal against the decision, delaying the final outcome of the case yet further.

Mr Thomas said: "We only found out in January that we had won. We were shopping in the Grafton Centre when my mobile phone rang. Not many people have my mobile number so I knew it must be the solicitor. He said 'Are you ready for some good news?' Merck had withdrawn their appeal and offered me �28,000 compensation. They also had to pay my costs.

"In America, they have been paying out millions of dollars, but complainants are more aggressive over there.

"�28,000 is not much for what I went through but at least we won. It ended up costing them a quarter of a million pounds. If they had offered me �10,000 compensation at the start, we probably would have accepted it but �2,000 was an insult."

Mr Thomas has been left with an incurable intestinal disease, a painful legacy for trying to do the right thing.

He said: "It took me two years to recover and it affected me mentally. I now have a condition called ulcerative colitis. There's no cure for it but it can be held in check by taking medication everyday."

After his experience, Mr Thomas now wants people to be more aware of the risks of taking part in medical trials.

He said: "People don't really know what they are letting themselves in for. 90 per cent of trials go without any problems and you assume that nothing is going to happen. I was told there was a one in 10,000 chance that I could suffer a complication. But the drug company couldn't accept that I was the one in 10,000. They told me that ulcers and bleeding in the gut are rare but they have now updated their information to include these as possible side-effects."

Sue Ashwell, chief pharmacist at NHS Cambridgeshire, told the Ely Standard:

"All clinical trials, including those that take place in Cambridgeshire, are controlled by a nationally determined process. However, NHS Cambridgeshire is happy to investigate any complaint that a patient may have on any aspect of treatment or care that is provided to them."

The drug company, Merck Sharp and Dohme Limited, did not want to comment on the case.