The following is another collection of questions asked by Senator Joyce and sudsequent responses during the Senate Inquiry.

Senator JOYCE—Something pricked my curiosity the other day. We have had a presentation by the AMA saying there are no problems with the course of this treatment, the course of this drug to stop a life—that is, mifepristone and misoprostol—but the makers of misoprostol have come out and said that they have an issue with it. Do you want to discuss why the makers of misoprostol, the prostaglandin, feel that they have a problem with the use of their drug as an abortifacient, I suppose—is that what it is?

Dr Bayly—The proven effective regimens about which we are talking for medical abortion include the use of mifepristone together with a prostaglandin. In many cases, but not all, that prostaglandin is misoprostol. All of the time when we are talking about mifepristone there is another drug to be used with it, so those safe and effective regimens about which the international evidence exists also include the use of a prostaglandin. Those international regulatory authorities which have evaluated and approved mifepristone for medical abortion have approved its use in conjunction with a prostaglandin, and that has often, but not always, been misoprostol. It is very likely that an application for evaluation of mifepristone by the TGA would include misoprostol as part of that treatment regimen.

In fact, what happened in the United States in relation to misoprostol is that after it was approved with mifepristone for medical abortion the FDA, the Food and Drug Administration, the regulatory authority in the United States, required a change to the warning and product information accompanying misoprostol to indicate that it could be used in pregnancy in appropriate circumstances. The warning in relation to pregnancy for misoprostol relates to its use in the treatment of gastric ulcers, and the fact that it can cause uterine contractions is an unwanted side effect. However, when it is used for its prostaglandin effects in order to cause uterine contractions in medical abortion or in some other uses—for example, the induction of labour—the uterine contractions are a wanted effect.

The company itself has not chosen to sponsor research for this reason, and in fact it has not needed to because others have taken the responsibility for undertaking that clinical research. But there is in fact extensive clinical research and international published medical evidence supporting its use in this context.

Senator JOYCE—Undertaken by other people but not by the drug company that actually makes the drug misoprostol?

Dr Bayly—That is right, yes.

Senator JOYCE—Just for the record: it has been a bit surprising that, of all your learned colleagues who have come before this inquiry before, none of them seem to have raised the problems with misoprostol. You cannot hazard a guess as to why, being so across the medical issues, they have not brought up the fact that the drug company that makes the prostaglandin, the abortifacient, actually does not recommend its use for the process?

Dr Bayly—I do not see that as a problem. The evidence has been considered by all those regulatory bodies which have approved regimens including mifepristone and misoprostol. All of the regimens we are talking about include either misoprostol or another prostaglandin, so the misoprostol—

Senator JOYCE—Another prostaglandin such as what?

Dr Bayly—Gemeprost.

Senator JOYCE—I will go on to another thing. Professor Oats, I just want to get this absolutely clear. In the time frame for RU486 and the time frame of surgical abortion, you categorically say that that they have the same complication rate—that is, in the first eight weeks or whatever of using RU486 compared to the first eight weeks of surgical abortion, they are the same. Are you going to put that on the record?

Prof. Oats—Yes, the rates are comparable.

Senator JOYCE—What do you mean by ‘comparable’?

Prof. Oats—They are equivalent.

Senator JOYCE—They are the same?

Prof. Oats—They are within the same statistical range.

Senator JOYCE—So anybody who gave evidence that they are not the same would be telling an untruth?

Prof. Oats—I think there is always interpretation of the available scientific literature, but—

Senator JOYCE—So is it up to contention or is it not?

Prof. Oats—I do not personally believe it is contentious, and that has certainly been the experience of many learned societies that have examined this evidence.

Senator JOYCE—What study do you base that on?
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Prof. Oats—On published literature.

Senator JOYCE—Such as?

Dr Bayly—I think there is a very great deal of published literature. I am wondering if you have questions about any particular issues.

Senator JOYCE—I am really asking about evidence that has been given to this inquiry before that states that in the time frame of the first eight weeks RU486 has 10 times the complication rate compared to surgical abortions. As such, if that is the case, there will definitely be women walking around who will die because they use RU486 and who would have been alive had they had a surgical abortion.

Dr Bayly—I am not sure whether you were here when we discussed that particular issue, which I think related to mortality rates, earlier on. Would you like me to address that again in relation to the American paper?

Senator JOYCE—Could you just give a brief precis of it?

Dr Bayly—Yes.

Senator BARNETT—It is Dr Greene’s paper. You can refer to him by name; that is fine.

Dr Bayly—Sure. It is an interpretation of statistics which is about very rare events in very large populations. The author himself does not conclude that there is a difference in mortality rates. He talks about a framework for comparing them and he makes the comment that there is a small number of rare events without a clear pathophysiologic link to the method of termination and that regulators should keep this rare complication in perspective. So to suggest that there is a tenfold mortality difference is simply not substantiated in the literature. As far as the other question, about women walking around who would die if they had a medical abortion, is concerned, I think if they did not have a medical abortion they would be seeking a surgical abortion and similar numbers would die.

Senator JOYCE—Similar?

Dr Bayly—Similar numbers, yes. If they were refused access to abortion, they would be likely to be resorting to unsafe abortion and more of them would die.

Senator JOYCE—Surgical abortion as opposed to using RU486. You are saying that there is the same safety in RU486 as there is in surgical abortion. You are willing to go on the record and say that.

Dr Bayly—On the basis of c