Sir, - Is it appropriate, or even necessary, for a heart-attack patient, prostrate and terrified on the way to hospital, to be abruptly confronted with: "We'd like you to take part in the trial of a new type of treatment"? This was the proposition put to me by the doctor attending me in Galway University College Hospital's cardiac ambulance on March 10th, 1997.
He said the "research study" was a European project. I assumed it was some official scheme jointly run by EU health services; the sort of thing, I thought, a responsible citizen should take part in; but what about risks and side effects? He said there were, of course, risks. Already in shock from my heart attack, I at once became wary and asked him to ask me again, once they'd settled me down in the cardiology unit.
An hour later he brought me a most complicated document, headed: "Patient Information Sheet. Boehringer Ingelheim Protocol 1123.3/Genetech Protocol N0683g: a Phase II, Randomized, Open-label, Parallel Group, Multicenter, International Trial of the Safety of TNK-tPA in acute Myocardial Infarction (Assessment of the safety of a new Thrombolytic etc).".
Whose European project? Towards the end of this closelytyped two-and-a-half page "sheet" it is revealed that Boehringer Ingelheim Ltd and Genentech Inc are the study sponsors - in other words, commercial companies trying out their product on the patients of a national Irish hospital, in order to find out if it's safe . . .
The sheet says that "TNK-tPA has only been studied in 113 patients". In which countries? And what approaches were made to the 113 to persuade them to take part? Were they all accosted the way I was, strapped to a stretcher in an ambulance, sweating with pain and apprehension? Is it all altruistic, or is there a quid pro quo? Do the sponsors pay the hospitals to co-operate with this research?
Did hospital management consult the Galway doctors (from a scientific point of view) about the research, or simply decree that it was to happen and that the doctors were to carry it out?
What compensation, for myself or family, if things went wrong? The information sheet details the risks that the doctor had mentioned: "bleeding into the brain" and other unpleasant possibilities. It also adds that Boehringer Ingelheim Ltd's "no fault" insurance coverage would compensate me only for such injuries or ill effects from the trial as had not been detailed in the information sheet. The "bleeding into the brain", for example, wouldn't count . . .
Would my heart immediately benefit from Boehringer Ingelheim/Genentech's new techniques? The doctor had implied as much, emphasising the speed with which I should agree and give my signature. But according to the information sheet, some of the volunteer participant patients would get one sort of dose, and others (randomly selected) another; and "neither your doctor(s) nor you will know prior to the computer dose assignment which dose you will be given."
Should not doctors know what treatment they are about to give for a life-threatening illness? And should not their patients know that they know?
In the end I refused to take part. No doubt these sorts of test are important and necessary. But sprung upon people, particularly sick and frightened people?
So why not a series of announcements in the media to inform the public at large that heart attack treatment might possibly involve being asked to take part in a test? We would then be prepared for the invitation before we fell ill; we would already have some notion of the risks.
A final thought: was I deliberately targeted as a type who'd make no difficulty? An elderly man (66), out in the country, all on my own? I was indeed "on my own" because my wife happened to be in town; but could the hospital have imagined I was an unprotected old rural bachelor to whom "European research project" might sound so official he wouldn't presume to refuse it? - Yours, etc.,
John Arden,
Corrandulla, Co Galway.