Why the Church is not to blame in Mater hospital drugs trial row

THE Church is in the doghouse again. You can’t do worse, in public relations terms, than to have people think you would put their lives at risk.

And that is the position in which the Mater hospital found itself last week after it delayed approval for trials of a new lung cancer drug, Tarceva.

Bad enough that this delay, in theory at least, might prevent a cancer sufferer from getting a helpful drug treatment. But the reason for the decision compounded the hospital’s image problem. The leaflet to be read and accepted by patients testing the drug specified that, to avoid pregnancy, they should use contraception. Although the leaflet included abstinence from sex as a possibility, the committee seems to have held up the trials on the grounds that any promotion of contraception would contravene the hospital’s Catholic ethos.

There are deep undercurrents of discontent in sections of Irish society, prominently represented in the media, around the Church’s past heavy-handedness in preaching about sexuality.

These come quickly to the surface when a controversy like this happens. Politicians like Mary O’Rourke and Liz McManus got busy painting the affair as another mother and child debacle. Factor in the outrage of prominent doctors - St Vincent’s Hospital oncologist Dr John Crown weighed in with the charge that the decision was ‘sectarian’ - and the Church’s humiliation was complete.

Doctors, after all, are the patient’s friend. They KNOW. You just can’t trust Catholic hospitals, can you?

It’s a calumny, actually. Nothing like the full truth came out last week.

The Church’s role in this issue has not only been principled - it is also practical in terms of women’s freedom and health. Other, more self-interested, parties have contributed to this controversy. But they have not been questioned.

Everybody agrees on a number of things. New drugs need to be tested. Some of the people testing them may need treatment themselves, and may benefit if the drug is successful. Women testing these drugs should not get pregnant because of the risk of severe damage to the unborn child. Dr John Crown laid great emphasis on some of these points on RTÉ’s Questions and Answers programme last Monday night - even if he made it sound as though doctors were the only ones who thought of these things.

But there has been a mish-mash of half-truth and misrepresentation. It might surprise you to know, for starters, that the committee which ultimately held up the drug trial did not have a single professional ethicist. And how many priests and nuns, do you think, were in on that decision? Not one. You weren’t told that.

In truth, those ultimately responsible for this problem are the pharmaceutical companies and the Government. It can be said that the Mater committee was naive in delaying approval for these particular drug trials. Because, whatever the hospital might think of a leaflet advising women to use contraception, there was at least the acknowledgement of women’s freedom to choose abstinence as a means of avoiding pregnancy while testing a cancer drug. That acknowledgement isn’t always included in the leaflets given to drug trial participants.

The drugs companies are very anxious, if only to avoid litigation, to make sure that women of child-bearing age who are testing their drugs do not get pregnant. As a result, they tend to be very prescriptive in the protocols they issue to govern the testing process. Some require that women use contraception.

They are often silent about the possibility of abstinence as a reasonable alternative. In one case, a leaflet said that a commitment to abstinence would not be sufficient.

Clearly, the drugs companies believe in the belt-and-braces approach to preventing pregnancy. But they may be acting unethically. Take the case of a drug for HIV-positive patients being tested in a Catholic hospital some years ago. The drug would be taken by underage girls who were of child-bearing age. The leaflet specified the use of contraception. Did the pharmaceutical company give any thought to the consequences for any sexual partner of that underage girl who was HIV positive? Or was their only concern that she wouldn’t get pregnant? Let’s be grateful for the ethics people.

Isn’t it also ironic that after years of telling us that the Church should get out of the bedroom, the media should now allow pharmaceutical companies to enter that same bedroom with impunity? What business is it of theirs what means a woman uses to avoid pregnancy?

SHOULDN’T they be silent on the issue? Catholic hospitals would settle for that - yet they are portrayed as villains. Some pharmaceutical companies insist on dictating the terms - yet they escape the media’s wrath.

A Catholic hospital has, of course, moral concerns around advising its patients to use contraception. Whether it is widely understood or not, everybody knows the Church’s view.

But there are other reasons why women might not want to use certain types of contraception. The possible health downsides may be one. The unforeseen consequences of taking contraceptive pills in conjunction with a new drug under trial is another. And there is the very reasonable concern that some of these ‘contraceptives’ don’t always act in a contraceptive way but are ‘abortifacient’ - they can prevent implantation of the newly conceived human being. Should women with such moral or health concerns be denied access to the drugs trials? Of course not. Yet that would be the logic of some of these drugs companies.

But none of this, not even the Mater hospital controversy, would ever arise if individual hospitals could negotiate with drugs companies about the conduct of drugs trials. That was the practice until recently. Then the EU passed a directive governing clinical trials.

The Government legislated for this and, as a result, a clinical trial which has received the go-ahead from an ethics committee in one place may legally proceed in a hospital which has an entirely different ethos. This places the Mater and other Catholic hospitals in a difficult position.

According to Tallaght hospital, its charter allows provision of all services which are lawful within the State. So if a clinical trial which is legal but unethical is given the go-ahead in Tallaght, what can a Catholic hospital do? It can grant or refuse permission for the trial to go ahead within its own walls. But it cannot negotiate with the drugs company to present and conduct the trial in an ethical way.

The Government has placed Catholic hospitals in an impossible position - pitting their distinctive ethos against their need to conduct clinical trials for the benefit of present and future patients.

The worst of it is that the Government was well warned. The Catholic Bishops Bioethics Commission foresaw the problem and raised the issue with the then Minister for Health, Micheál Martin, 18 months ago. It seems he failed to act.

Despite the prejudiced commentary of last week, this controversy is not of the Church’s making. It is down to pushy pharmaceutical companies and philistine politicians. And some pompous physicians have been no help at all.