Leslie - Interview 43  

Leslie - Interview 43

Age at Interview: 75
Sex: Male
Background: Leslie is a retired lecturer. Married with 4 adult children. Ethnic background/nationality: White British.

Brief outline:Leslie took part in a placebo-controlled drug trial of rofecoxib (Vioxx) for prostate cancer prevention. He became extremely ill, but doctors monitoring his progress did not pick up his symptoms. He took the drug company to court, and won compensation.

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Male
During the trial, Leslie became more and more ill, but the trial staff didn’t seem to connect his symptoms with an effect of the trial drug estimated to affect only 1 in 10,000 patients.

 



I was on a clinical drug trial sponsored by one of the world’s major drug companies and I was being supervised by a supposedly competent GP. As the weeks passed by, January, February, March... I became increasingly unwell. I was being allowed to die and nothing was being done to stop my illness. I felt that I was on an accelerating path to death, unable to convince the supervisor how ill I was, whilst my wife could only look on whilst, inch by inch, I grew more ill and despondent. I should have taken myself to hospital, I now realise this, but I still put my faith in my doctor. 
 
In spite of having very severe bloody diarrhoea for several weeks and in spite of the supervisor noting ‘GI [gastrointestinal] bleed?’, no action was taken. Such diarrhoea may presage bowel cancer and should result in an urgent hospital referral. This basic medical procedure was ignored. By May I had become anally incontinent with foul-smelling faeces. I was virtually housebound and unable to eat anything more than an occasional egg. My wife was distraught: she was watching me die, slowly but inexorably. We were convinced that the tablets were the cause of my illness. Our view was ignored. What did we know? Who were we to tell the doctor what we thought? 
 
The trial information sheet notes that ulcers and bleeding in the gut was a rare (1 in 10,000) side effect of rofecoxib. It seemed that neither the GP nor the trial doctor saw me as that 1 in 10,000. For a couple of days mid-May I stopped taking the tablets but I was advised to restart. The trial doctor did, however, take a stool sample. Two days later he prescribed codeine phosphate — a standard drug for diarrhoea, I understand. The stool sample showed ‘normal’ and ‘no action’ was taken. So, to put it bluntly, he seemed to be seeking for some reason to explain my bloody diarrhoea but was happy to accept the results of the stool test. He took no further action. He had seen me, spoken to me, had a perfunctory poke in my stomach area. He had the result of the test and that was as far as he would go. I was still anally incontinent; I was still losing weight; I was still desperately ill — but ‘no action’.
 
At the beginning of June we entered the grand finale — I needed help, urgently. I could not contact my GP on Friday, the 4th of June, and I had to wait an agonising 2½ days before I was able to speak to her. I had no other contacts, no one else to turn to. I did not even have any indication that I was on a drug trial. I learned, too late, that these are a legal requirement. So, on the 7th of June I did contact the doctor. What follows may seem to be unbelievable: it is true. I told her that I felt much worse; that the diarrhoea still persisted up to a dozen times a day; that I was unable to eat — please, please, help me. She said that she would prescribe Fybogel granules — this is an over-the-counter remedy which I had tried many weeks before. She then, incredibly, suggested that I drink a bottle of Guinness. ‘Guinness is good for you’, so went the old advertisement. Not for me it wasn’t. But we were desperate, clutching at any straw. My wife rushed out to buy a bottle; I drank it. We later thought about this. What on earth was a responsible GP doing when she prescribed strong stout to someone suffering a very severe stomach condition? And what on earth was I doing to actually drink it? But we were doing what the doctor ordered, like good trusting patients. Blood test results that showed ten readings well out of acceptable limits were ignored and I was asked to return to the surgery in a fortnight to have a further test. I would, I am convinced, have been dead before then. 

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