Although religious interference in clinical trials is regrettable, there are many significant secular obstacles too, writes John Crown
The issue of religious interference in cancer clinical trials is symptomatic of a larger problem facing academic medicine in Ireland, a problem which is, in truth, mostly secular. Let us first discuss the religious issue.
It has been argued that sectarian considerations should not influence treatment in publicly-funded hospitals, institutions which after all provide a service to persons of all faiths and of none. The contrary position is that the religious proprietors of Catholic hospitals should be allowed to insist on adherence to Catholic ethos.
Kevin Myers has gone further in suggesting that our university-affiliated Catholic teaching hospitals are inappropriate venues for cancer trials which mandate contraception.
The notion that cancer centres should effectively excuse themselves from clinical trials would be considered unethical in most medical communities. Clinical research is an essential, intrinsic part of contemporary cancer treatment. It is not some optional extra. Why? Despite dramatic advances, current cancer treatments remain unsatisfactory, and mortality rates are too high.
We have finally entered a new era of molecular ("magic bullet") treatment, however, an era where smart bombs like tarceva (the drug which was the focus of the recent controversy), herceptin and glivec are replacing blunderbusses like chemotherapy. This is the wrong time to stifle research.
A patient who joins a trial of an unproven treatment makes a brave decision, which might be of benefit to others. It will virtually certainly be of benefit to her, and to her treating institution. She will be treated according to the rigour and discipline of a protocol which was likely designed by leading international experts.
Trials patients tend to do better than patients receiving routine care. Additional support staff are available to them.
Involvement in clinical research also brings institutional benefits. St Vincent's Hospital has benefited from nearly €3 million worth of free drugs provided as clinical trials supplies. The research process funds extra healthcare employment. Most importantly, research offers hope to patients who are often staring into the abyss of despair. My own belief is that institutions which will not allow clinical trials, should not treat cancer at all.
In identifying the obstacles to clinical research in Ireland, we are operating in a target-rich environment. Although religious interference is regrettable, most obstacles are in fact wholly secular.
The EU Clinical Trials Directive has grotesquely complicated the clinical trials approval process.
In addition, hospital ethics committees and Government regulatory agencies, which are charged with the twin tasks of protecting both patients and institutions from the enthusiasm of self-interested investigators, and the financial interests of drug companies, sometimes seem to forget that they must also act to protect patients from disease. They must not impede research for frivolous reasons. I regret to say that this is not always the case.
Since my return to Ireland, I have seen several critically important trials stalled at the approval stage, or suspended, for reasons which had nothing whatsoever to do with patient safety. In one case, an ethics committee blocked several cancer trials (including one which ultimately led to one of the most important breakthroughs in oncology history), on the ground that it might perhaps have been more appropriate for cancer patients to be referred to the hospice.
In another incident, all clinical research in an entire teaching hospital and medical school was systematically blocked for a year for administrative reasons which had nothing whatsoever to do with patient benefit. A medical school that does not do research would be no better than an off-shore degree mill, a medical grind school rather than a university.
How did these situations arise? While negative influences have been appropriately highlighted in recent weeks, it must be conceded that the normal dialectic of the research debate has also been subverted in Ireland by the relative weakness of another crucial constituency - the academic medical sector.
Despite the presence of truly gifted, internationally-recognised physician/researchers in critical university positions in Ireland, academic medicine is desperately underdeveloped in this country. The meagre medical school presence in our teaching hospitals resembles a partially-tolerated graft, rather than an organic part of these allegedly academic institutions.
Unlike other countries, medical schools don't own hospitals, and have minimal input into their management. Very few of our teaching hospital consultants have meaningful university appointments. The great majority are instead health service employees. Much of our profession also exhibits a fundamental lack of esteem for clinical research. Most consultants are wholly disengaged from the research process.
Those who are involved undertake it after fulfilling public and private clinical duties in the challenging Irish healthcare environment. Research is seen, alas, by too many senior consultants as a frivolity, something you did as a young trainee in America before you came home to make money.
There are other constituencies which do not wish to see academic medicine developed. I believe that many officials in the Department of Health would be wary in the extreme about the development of a truly muscular, powerful meritocratic academic medical sector. It is not so long ago that a minister for health suggested we were appointing too many consultants with huge curricula vitae and international reputations.
The logic seemed to be that we should instead appoint those who had trained in our woefully inadequate domestic training programmes, and then only if they had no international reputations and small curricula vitae. Many bureaucrats would prefer that doctors were a gagged, enfeebled and disenfranchised group of technicians, who would work with docility, and in silence, in a system run by the only "self-disinterested visionaries" in the healthcare system, namely themselves.
There have been improvements in recent years. Developments such as the Irish Clinical Oncology Research Group, which has provided access to cancer trials throughout the country, and increased Government funding for research are welcome.
However, translating the possible benefits of research to our patients will require a more fundamental cultural reform of the academic medical sector, and I believe in the ownership and governance of our academic hospitals.
John Crown is a consultant medical oncologist at St Vincent's University Hospital in Dublin