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Leslie - Interview 43

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

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Leslie was 70 in 2003 when he was invited by his GP to take part in a randomised placebo-controlled trial of rofecoxib (Vioxx) as a way of preventing prostate cancer, run by a pharmaceutical company. He was in good health, but aware of the dangers of prostate cancer for men of his age. His GP advised him that the drug should be quite safe. So he decided to take part, partly to help other men who might be affected by prostate cancer and partly because of the personal benefit of having regular check-ups during the six years of the trial.
 
Within the first few months of starting the tablets in December 2003, Leslie became increasingly unwell. He developed severe gastro-intestinal (GI) problems, including bloody diarrhoea and faecal incontinence, and had no appetite. He stopped taking the tablets at one point in May 2004, but his GP advised him to start taking them again, and to take an over-the counter remedy for diarrhoea. Even though blood tests showed many abnormal results, no immediate action was taken and in early June he was asked to come back again in a fortnight for a further test.
 
However, Leslie’s health declined rapidly and on June 9th he developed uncontrolled shaking and was taken to hospital in an ambulance. Staff at the hospital asked for the tablets to be ‘unblinded’ so they could check whether Leslie had been taking rofecoxib rather than the placebo (which he had). They immediately stopped the tablets. He was found to have a temperature of 104.9°, exceptionally low blood pressure, an abnormal heart action, severe dehydration and septicaemia. It was discovered his colon was bleeding. Gastro-intestinal bleeding was a known, though very rare, side-effect of rofecoxib, and the trial supervisor had previously noted ‘GI bleed?’ as a possibility in Leslie’s notes, but had not referred him to hospital. A specialist GI nurse later told Leslie that anyone with blood in their faeces should be referred and investigated within 14 days.
 
Although Leslie survived, he has been left with ulcerative colitis, a disease that causes ulcers in the lining of the rectum and colon, and he remained very ill for many months after discharge. This has had a particular impact on his wife, who watched him becoming more and more ill and feared for his life. Leslie feels without her care and support he might not be here today.
 
He was at first offered £2000 compensation, then £3000, but decided on his GP’s advice to contact a legal adviser and take his compensation claim to court. It took over four years to get a judgement in his favour, in which the judge ruled that, on the balance of probability, rofecoxib was likely to have been a significant cause of Leslie’s illness. The drug company originally announced it would appeal but eventually agreed £28,000 compensation in an out-of-court settlement. Rofecoxib was withdrawn from the market in September 2004 because of concerns about the increased risk of heart attack and stroke. Despite the judge’s ruling, the company still maintains that Leslie’s GI bleeding was not caused by the drug.
 
Looking back, Leslie feels his consent was not properly informed, and argues that there was already enough evidence to know that rofecoxib could have serious side-effects, but he was reassured by doctors that the drug was safe. He has major concerns about the organisation and funding of trials, and felt the staff involved were mainly driven by the need to enrol more patients and keep them in the trial, rather than his individual care needs. He feels his condition should have been more closely monitored, and that anybody who becomes as ill as he did should be withdrawn from a trial at once. Looking back he wishes he had withdrawn himself, but he trusted the doctors’ advice. Personally he would never take part in a trial again, and advises people to look very carefully and critically at any information they are given.
 

Leslie was taken off the trial by hospital staff when he became so ill he was rushed into...

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On the 9th of June 2004 I was suddenly overcome by a dreadful shaking fit — ‘rigor’ is its medical name. Every part of my body was moving violently. I could not control it; “this is it”, I thought, “my body is closing down; this is how death comes, not peacefully in bed but with agonising violence.” Fortunately, my wife and daughter showed rather more awareness than the trial supervisor and I was quickly ambulanced, lights flashing, hooters blaring, into a specialist hospital. My wife explained what had happened over the previous months and that I was on a clinical drug trial. She had had the foresight to bring the tablets with her. As it was a ‘double blind’ trial we did not know for certain whether I had been taking Vioxx or a placebo. The drug was ‘unblinded’ and, yes, I had been using Vioxx. Then followed some very anxious hours. I was treated with intravenous steroids, antibiotics and liquids in the attempt to identify the cause of the very serious septicaemia I had contracted and to remedy the severe dehydration I was exhibiting. I was found to be hypotensive (an almost non-existent blood pressure), tachycardic (an abnormal heart action), febrile (my temperature was 104.9°), anorexic, severely dehydrated and in sepsis. Blood samples were taken hourly to determine what treatment was appropriate and my condition was eventually brought under control. I have nothing but the highest praise for all those involved at the hospital — they saved my life and they comforted my wife and gave her hope. 
 
I was left not only with enduring memories of a period I would rather forget but also with a more potent legacy of my time on the trial — an incurable disease, ulcerative colitis. 
 
Of course, my story does not end there. When I saw my GP after being discharged from hospital she seemed to be genuinely sorry for what had happened. She said that she had made a terrible mistake and she had alerted other local GPs to the dangers of Vioxx. She also said that she had not referred me to hospital because she had been criticised for referring too many patients. She would have referred them to the specialist hospital where the specialist GI nurse recently told me that I should have been referred at the onset of the bloody diarrhoea and that any patient with blood in their faeces will be seen within 14 days.
 

Leslie thinks there is too much secrecy around drug company trials, and feels they are more...

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There is far too much secrecy surrounding clinical drug trials. I was not given the information that would have enabled me to make informed consent. The regulatory bodies are too closely connected with the pharmaceutical industry to exercise any control over an industry that the House of Commons Health Select Committee said is out of control. An equally supine Department of Health will not admit that the system is faulty and operates against the interests of those of the general public who are willing to put their bodies at the service of medical research.

 

So, will I ever volunteer again? No. And unless the trials are conducted more openly I can only suggest that prospective volunteers think very hard before volunteering.

 

If anything goes wrong the volunteer will be on his/her own. There will be no help from the regulatory bodies, no help from the NHS Ombudsman, no help from the Department of Health — and no legal aid, probably. I am quite sure that what happened to me was not a unique event but the drug industry very successfully hides what happens in trials — especially when things go wrong.

 

The GP/trial supervisor said that I was entitled to compensation and, some weeks after, I was offered £2000 for the ‘inconvenience’ I had sustained. I felt that ‘inconvenience’ was hardly an appropriate word to describe what had happened to me and did not accept the offer. The amount was then raised to £3000. On the advice of the GP I contacted a medical specialist solicitor. Although both the GP/trial supervisor and the drug company’s trial co-ordinator agreed that I was eligible for compensation and that Vioxx [rofecoxib] was the probable cause of my illness, it was to take me over four years before my claim came to court.

 

A volunteer may be paid for putting his/her body at the service of medical research but this does not absolve a drug company from its responsibilities should harm occur.

Volunteers should also remember that many major drug companies are now conducting their clinical trials in areas where there will be fewer questions asked should things go wrong and where they can get away with paying minimum compensation.

 

Finally, trial volunteers should be aware that they are putting their faith (and their lives) in the hands of an unscrupulous, profit-driven industry, an industry that sees volunteers as little more than test beds for their products — to be used and discarded as they see fit. The pharmaceutical industry may be ‘lethal but legal’, whilst the regulatory authorities hide behind ‘due diligence’ — ‘never explain, never apologise’ is their mantra.
 

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I was approached by my GP and asked if I would go on a clinical trial. The drug was a commonly prescribed one, an NSAID known as Vioxx or rofecoxib, originally designed to reduce pain in sufferers of osteoarthritis. It was claimed that US experience suggested that Vioxx appeared to diminish the effects of prostate cancer. My own quite extensive research has found little to suggest that any large-scale trials had been carried out. I was not pressurised by my GP who told me that Vioxx was a harmless drug similar to ibuprofen. There seemed to be little in the patient information sheet to alarm me and none of the potential side effects seemed of concern to me. I trusted my GP and I trusted the drug company as the information sheet assured me that I would be closely monitored and, should I be injured whilst on the trial, I would be compensated by the drug company’s compensation scheme, which followed the Association of the British Pharmaceutical Industry’s (ABPI) compensation guidelines. 

 

I took the first tablet in December 2003. I had signed a consent form but, on reflection, my consent could not be seen as ‘informed consent’. I knew nothing of ‘good clinical practice’, of ethics committees, of the ABPI, the MHRA (Medicines and Healthcare Products Regulatory Agency), the NPSA (National Patient Safety Agency) et al. I was told nothing of the history of the drug or of other trials involving Vioxx. The patient information sheet said that heart attacks had been recorded amongst Vioxx users but it was not known whether these had been caused by Vioxx. 
 
Footnote' Rofecoxib was withdrawn from the market in September 2004 because of concerns about the increased risk of heart attack and stroke. Leslie experienced severe gastrointestinal symptoms during the trial. The drug company disputes that these were caused by rofecoxib (Vioxx), though the judge who considered his compensation claim in court ruled that, on the balance of probability, rofecoxib was likely to have been a significant cause of his illness. The drug company originally announced it would appeal but eventually agreed £28,000 compensation in an out-of-court settlement.
 

Leslie advises volunteers to check why the research is being done and what has already been found...

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Before agreeing to go on a trial the volunteer should consider the following. Look carefully for the reasons for the trial (the protocol) to ensure that the research is meaningful and legal. The protocol, to which a volunteer has a legal right, will have been agreed (or rubber-stamped!) by an ethics committee. It is vital to know the full history of the drug, has it been trialled previously and, most importantly, check on the possible side effects. Do not assume that these will not affect you. I did — and almost died. Like me, you may be that 1 in 10,000. Check that your supervisor is actually competent. If you suffer any ill effects whilst on the trial you must be withdrawn — do it yourself, if needs be. It is vitally important that you have other contacts beside your immediate supervisor and that you have something that identifies you as being on a trial.

 

You should be given a patient information sheet and this will be your legal contract with the sponsor of the trial. Treat this with great caution and considerable scepticism. Always remember that pharmaceutical companies have their own view on what is legal and what not. The patient information sheet should be written in clear, understandable and unambiguous language. Compensation terms must be clearly stated and legally binding. You will probably be told that the company will pay compensation in accordance with ABPI compensation guidelines. They are not obliged to do so as the guidelines are not mandatory and the government via the Department of Health has no intention of making them legally binding.
 

During the trial, Leslie became more and more ill, but the trial staff didn't seem to connect his...

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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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