MEDICAL MATTERS: The premier international medical journals regularly publish ground-breaking research. It is often the result of multicentre international trials based on the experiences of tens of thousands of patients.
Inevitably, most of the big breakthroughs involve new heart and anti-cancer drugs. But lots of other research takes place on a smaller scale; the results are unlikely to make the headlines, but the benefits for patients locally can be no less dramatic. There is also a big difference between the kind of research done by large pharmaceutical companies as they develop drugs and the kind of research questions posed by doctors trying to refine the best use of established medication.
All medical research in the Republic is presently subject to the Clinical Trials Act 1987 and a 1990 amendment, but the implications of an EU directive that will become law here in May next year are causing concern for some doctors involved in what is called investigator-led research.
The EU clinical directive has been in development for several years. Legislators who formulated it were driven by a desire to regulate large pharmaceutical-industry trials. It seems that investigator-led research, however, including that on issues with no direct commercial benefit, is now under threat.
Dr Brian Moulton, chief executive of the Irish Clinical Oncology Research Group, has grave reservations about the local interpretation of the directive and its translation into Irish law by the Department of Health and Children. In its current format it will bring about key changes to the way we do research, he says.
One area of concern is the directive's definition of sponsors. In the past the sponsor has been the pharmaceutical company that has funded the study. Now it will be the Irish doctor running the study, who will face huge cost and legal implications as a result. Moulton believes this will lead to a decline in investigator-led trials in favour of research led by pharmaceutical companies.
Another problem, he says, will be a fundamental change to the way research ethics committees operate. Each hospital in the Republic has such a committee; the doctor-investigator's proposal must have it approved by the committee before the research can go ahead. Now it is proposed that a supervisory ethics body will be appointed. "It is unclear how this body will be established and under whose authority it will act," says Moulton. He is concerned that the body will not be established by May and that all clinical trials here will have to stop, at least in the short term.
Dr Joan Gilvarry, director of human medicines at the Irish Medicines Board, shares the ethics concern. "The big difference in the new law will be regional or national ethics committees. This is the Department of Health's remit and it must be in place by May," she says.
Dr John Kennedy, a consultant oncologist at St James's Hospital in Dublin, is a typical "investigator" whose future the Irish Clinical Oncology Research Group is concerned about. "The EU directive has many good things - for example, ensuring that research has to be carried out to a certain standard. But by applying standards appropriate for new drug research to investigator-led studies, this could be a disaster," he says.
How might it affect patients? Kennedy gives an example of people on standard treatment for a particular cancer. "Say I want to assess the benefits of performing a PET scan after three days of treatment, to see if I can improve their treatment regimen. The new regulations place such an administrative burden on doctors like me that the amount of clinical research work will fall, and it will impinge negatively on patients."
About a quarter of the 200 or so clinical trials approved by the Irish Medicines Board each year could be threatened by the new directive. According to the oncology research group, it will not only affect patients but also damage doctors' careers.
Ireland Inc may also suffer. Moulton questions how it will look if the Republic, as Europe's leading manufacturer of pharmaceuticals, appears no longer to be facilitating some forms of clinical research.
It is sobering to think that many of medicine's recent research advances, such as the discovery of the benefits of aspirin in treating heart disease or of tamoxifen in the prevention of breast cancer, would be difficult to carry out in the EU in the future.
We will have until May next year to get this important issue sorted out.
You can e-mail Dr Muiris Houston at mhouston@irish-times.ie. He regrets he cannot answer individual queries