Trials On Heart Patients

Sir, - John Arden makes an excellent point (July 29th) when he suggests that clinical trials might be notified on a prior basis…

Sir, - John Arden makes an excellent point (July 29th) when he suggests that clinical trials might be notified on a prior basis by the media to the public so that patients when acutely ill feel less oppressed by immediate requests from their doctors to participate in one. In general, new medical treatments on test can be considered at leisure by patients invited to participate and ample opportunity exists for patients to decline to participate. This is clearly not so when the illness is acute and serious.

The particular trial to which Mr Arden refers is being conducted throughout Europe and investigates doses of a new and possibly more effective clot-dissolving drug following heart attack and compares them with an existing effective treatment. The doctor involved knew that each patient would receive an active dose of new drug and was fully informed about current knowledge of the new medicine as presented to the Irish Medicines Board.

Patient Information Sheets on experimental medicines are governed by Good Clinical Research Practice (GCP) mandated by European Union legislation, as are Patient Information Leaflets for medicines already approved and available for prescription. The sponsor, be it pharmaceutical company or independent researcher, is obliged to comply with current legislation on this aspect and it is fair to say that we must make all safety issues known to the patient prior to consumption of the medicine.

This may have the effect of alarming the patient even though the risk of such adverse events is small. Further, the patient information is considered by the Local Research Ethics Committee charged with approving (or not) the trial at the local level.

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In the case of clinical trials of medicines which must be given within six to 12 hours of the acute event, as in heart attack, it is, of course, almost impossible to pre-notify all the potential sufferers. On the other hand, many Irish patients have participated in clinical trials of new treatments following heart attack and especially the kind of treatment that was being offered to Mr Arden. Without such co-operation we would never be able to find new treatments that were an advance on what we already had available. In the case of the current protocol offered to Mr Arden, a new generation of thrombolytic treatment, hopefully superior to previous marketed treatments, was being tested.

To respond to some of Mr Arden's concerns which articulately express what an acutely ill patient must feel when confronted by the question put to him, I can only seek to reassure him as follows:

(i) All clinical trials, whether sponsored by the pharmaceutical industry or by academic institutions, undergo a rigorous process of scrutiny prior to agreement by a hospital authority by an ethics committee independent of the researchers and the sponsors. In the case of the industry, the Irish Medicines Board is also required to review and approve the study. Boehringer Ingelheim Ltd is entirely compliant with the regulations concerning the legislation with respect to new medicines or potential medicines.

(ii) All trials conducted by Irish doctors on behalf of Boehringer Ingelheim Ltd are conducted, analysed and reported according to GCP mandated by the European Union, such conduct also known to the Irish Medicines Board and to experienced investigators in Ireland. It is our obligation to ensure this or see the trial terminated in any non-complaint centre.

(iii) Indemnity or insurance cover for patients in all clinical trials of new medicines with respect to serious events arising as a result of compliance with the trial protocol is mandatory for the protection of patients entering such trials. However, certain adverse events are known to be a consequence of receiving the treatment in question. This applies to all available medicines and hence the summary of product characteristics of product characteristics provided for the doctor and the patient information leaflet provided for the patient under current legislation. No medicine is risk-free and we can therefore only explain the likely risk along with the likely benefit, in ways the patient can understand. Clearly it is not easy for the ill patient who may find the information worrisome.

(iv) All clinical trials commissioned by Boehringer Ingelheim Ltd are performed according to the Declaration of Helsinki and subsequent amendments, written to ensure that the rights of patients participating in clinical research are protected. Among these is the right of any patient to decline to participate or to withdraw at any time from participation in a clinical trial without question. This right we respect.

Finally, one must say that it is only with the participation of patients in clinical trials that we learn of more effective and safer medicines. We respect Mr Arden's decision not to enter the trial in question but we applaud his courage in addressing what the patient perceives at a distressing time when confronted with such a question. We also trust in his complete recovery from his own heart attack. - Yours, etc.,

D. M. Humphreys MB, ChB, FFPM, Medical Director, Ireland, Boehinger Ingelheim Ltd,

Sandyford, Dublin 18.