asked the Minister for Health if, arising from the death of a man during an experiment at a private research clinic in Dublin yesterday, he will request the clinic involved to suspend all such tests until an investigation can be conducted into their operations; and the steps he is taking to ensure that the lives of the poor and unemployed who are normally used for these tests are not being endangered?
Private Notice Questions. - Clinical Trials Death.
As I understand both questions are being taken together, will Deputy Enright please read his question?
asked the Minister for Health if he has taken steps to ensure that all testing of a drug code named 3791 have been stopped in view of the death of a person at the Institute of Clinical Pharmacology adjoining St. James Hospital, Dublin, yesterday; if the Minister is aware of the drugs or the effect of same currently in use for experiments at this clinic; the system of monitoring the work of this clinic that is undertaken by his Department; and the grants, if any, paid to clinics for the carrying out of these experiments?
I do not consider it appropriate to request this clinic to suspend all clinical trials. The trials undertaken there are undertaken in accordance with guidelines which have been agreed between the National Drugs Advisory Board and the medical profession.
I have been informed by the National Drugs Advisory Board that they had considered and agreed to the conduct of studies with the particular drug which was administered. I am also informed that there were at the time four patients undergoing trials with the drug and that the other three patients did not show any significant effects. Reports on the outcome of all such clinical trials are sent to the National Drugs Advisory Board and therefore are available to me. No grants are paid by my Department for carrying out these experiments.
I would like to take this opportunity to convey to the relatives of the person concerned my sincere sympathy on this tragic occurrence.
Would the Minister indicate what procedure his Department have to ensure that the guidelines established between the Drugs Advisory Board and the clinic concerned, or any of these clinics, are abided by and could he indicate whether he is satisfied that the guidelines are adequate given the tragic death of this young man?
The guidelines which have been agreed by the National Drugs Advisory Board operate on a voluntary basis at present. The guidelines make it clear that it is important on moral and ethical grounds that the volunteer, be he a normal subject or a patient, understands clearly the purpose of the trial, the procedures to the used and the expected effects, and that he agrees to his participation. The explanations are required to be given in the presence of a disinterested witness and it has to be made clear to the subject that the drug may not benefit him personally.
On what basis and how regularly are checks carried out by the Department or the National Drugs Advisory Board? What system is there to screen and monitor what is going on? Could the Minister of State give us a little more detail?
Might I extend a welcome to all the young people in the Gallery and say how glad we are to see them? We have a rule that we must have silence. Even a whisper from many people can cause noise down here. Will they please remember that?
It is the policy of the National Drugs Advisory Board that investigators undertaking clinical trials in this country should submit the relevant details of the trials and test drugs for consideration by the appropriate ethical committee.
This clinic and presumably other clinics are private groups of people testing these drugs for a profit. Does the Minister of State consider it is appropriate that private clinics of this nature should be using human guinea pigs for the purpose of these trials? The guidelines set down are voluntary and do not appear to be statutorily controlled.
There is no question of people being used as guinea pigs in these trials. It is on a voluntary basis. Guidelines are laid down, as I have already stated.
It sounds very like a guinea pig operation.
There could be voluntary guinea pigs.
The spokesman from National Drugs Advisory Board said that this is the first major casualty to occur in this clinic. Have there been any other casualties of a lesser nature than the one which occurred yesterday? I understand grants are paid by an authority to this clinic. Can the Minister tell me the amount of the grants being paid by an authority such as the IDA to multinationals to carry out such experiments?
I did not get the first part of the question.
The spokesman said this was the first major casualty. Have there been other casualties and, if so, how many? Has the Minister this information and, if not, could he obtain it for us?
I have no information in relation to the first part of the question. We will have it checked. A grant was paid by the IDA in 1980 for research and development work on hormonal drugs. My information is that the company is seeking further grants for the manufacture programme for drugs. The proposal has not yet been formally considered by the Government.
Are any of these clinics licensed or is there any form of licensing for them? What monitoring is done by the Department of Health on the operations of these clinics, apart from the guidelines for the use of guinea pigs, because that is what they are? What standards are being implemented by these clinics and have the Department any say in the standards which are implemented?
The National Drugs Advisory Board are the people in question and this clinic is answerable to them.
For what?
For the work they carry out and so forth.
Other than the guidelines for the person participating, what guidelines are there to ensure that these clinics are operated correctly and that they are not bringing in people and trying out drugs on an ad hoc basis on anyone they choose?
The Deputy is inclined to suggest——
I am not suggesting anything. I am asking a question.
The Deputy is inclined to insinuate——
I am not insinuating anything.
——that there was something sinister about this death. I want to make it clear to Deputy De Rossa that people take part in these tests on a voluntary basis. They have to be normal, healthy people before they are allowed to take part.
That does not answer the question.
Who decides whether a person is normal?
Are there many more of these clinics around the country and, if so, how many and where are they located? I should like to know whether this is the only clinic carrying out such experiments.
Everybody who goes to a doctor or a dentist goes voluntarily.
I have not got the information the Deputy is seeking.