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Legal and Constitutional Affairs Legislation Committee - 31/03/2015 - Regulator of Medicinal Cannabis Bill 2014

CALLAGHAN, Ms Liz, Chief Executive Officer, Palliative Care Australia

CHYE, Associate Professor Richard, Board Member, Palliative Care Australia

HANSEN, Ms Linda, Executive Officer, Palliative Care New South Wales

HUNTIR, Mr Alex, Manager, Volunteer Support Services, Palliative Care New South Wales

Evidence from Ms Callaghan taken via teleconference—

[16:11]

CHAIR: Welcome. Thank you very much for your time. We do have a submission from you which we have numbered as submission No. 23. This is a hearing of parliament, so parliamentary privilege applies. If there is anything you particularly wanted to say in camera, you should mention that to us. I will ask all or any of you to make an opening statement, and then there will be some questions from the committee. Who would be the right one to call to start?

Ms Callaghan : I will. Palliative Care Australia is a national body established by the membership of eight state and territory palliative care organisations and the Australian and New Zealand Society of Palliative Medicine. Together, Palliative Care Australia members network to foster, influence and promote local and national endeavours to realise the vision of quality care at the end of life for all.

Palliative Care Australia supports the intent of the Regulator of Medicinal Cannabis Bill 2014. We believe elements of the bill set in place appropriate mechanisms to establish a scheme that enables safe access to medical cannabis for people who require it. Adopting the use of cannabis for medicinal purposes requires a strong regulatory and approvals process that involves research and building the medicinal cannabis evidence base. PCA, the member organisations and individuals endorsing our submission call for further research and evidence on the use and benefits of medicinal cannabis and derivatives. It calls for the bill to provide details on key prescribing issues including adverse effects and the provision of product information. We call for the bill to provide details on the evidence that will be required by the regulator for approved products. We ask to ensure that the regulator ensures prescribers in Australia become familiar with the evidence based indications for using cannabis and the therapeutic regime appropriate for particular individuals and their symptoms. We ask that the regulator considers in the first instance that only purified oral preparations of known potency are made available and we ask that palliative care expertise remain in the suggested composition of the board of the regulator and that a role for the regulator be established to register medications used in different states and territories to enable these medications to be transported or used across jurisdictions. We ask that the regulator consider guidelines for the use of medicinal cannabis that have been developed by medical bodies, including in countries where mechanisms for the use of medical cannabis have been introduced.

Gathered here today is a group of people who represent the special population of individuals with terminal illness. Palliative Care Australia affirms patient choice as a central principle of palliative care, and clinical experience in this area also affirms individual patient difference. In other words, in practical terms, there is rarely one universally applicable approach to symptom management. Having medicinal cannabis available following rigorous evaluation would expand the tool kit available to physicians in the management of symptoms for their patients.

I would like to introduce to you today Associate Professor Richard Chye, who is the network director of Palliative Care in Eastern Sydney, covering the University of New South Wales Teaching Hospitals at St Vincent's and Prince of Wales hospitals and their community services since 1998. Richard Chye chairs and participates in several New South Wales Ministry of Health committees and ministerial task forces to enhance the interdisciplinary provision of palliative care and pain management across the state. He also advises on subacute activity based funding issues and has developed palliative care across the different disciplines. He is currently working with several national health institutions such as Cancer Australia, the Independent Hospital Pricing Authority, Palliative Care Australia and Catholic Health Australia. Professor Chye is also a board member of Palliative Care Australia. I would like to add that the associate professor is a named investigator of the New South Wales submission to this inquiry. Associate Professor Chye would be delighted to speak with you about the research aspects of medicinal cannabis, as he is currently involved in the multicentre trial. He is also able to answer questions you may have about long-term use as well as delivery of palliative care.

I would also like to introduce Ms Linda Hansen. Linda is the executive officer of Palliative Care New South Wales and is ready to answer any queries you may have in relation to palliative care and the different approaches in the submission from Palliative Care Australia and our member organisation.

Finally, Mr Alex Huntir is the manager of volunteer support services at Palliative Care New South Wales. Mr Huntir is able to speak in support of why we support the proposed regulator approach over the TGA.

Finally, I would like to sincerely apologise for my inability to be present with you today. Unfortunately, circumstances beyond my control are at play. I would like to thank you. I know it is very difficult to have someone on the phone. I will hand it over to you.

CHAIR: Thank you very much and thank you for making yourself available in these circumstances. You are obviously well represented by people in front of us. Do any of you three want to make an opening statement or any comment?

Prof. Chye : I think Ms Callaghan has said everything. We are here to help you understand our position perhaps in more clarity.

CHAIR: Right. We did have someone at yesterday's hearing in Canberra from one palliative group.

Prof. Chye : It was probably from the Australian and New Zealand Society of Palliative Medicine, of which I have to say I am also a member as well.

Senator DI NATALE: Their submission expressed a few more reservations than your submission.

Prof. Chye : Yes.

CHAIR: One of their concerns, as I recall, was the long-term impact that the THC drug can have on people, which they were concerned about. In palliative care, what would be the maximum time you would be dealing with someone? Does that mean we should be cautious about the long-term bad effects, if I can say that as a layman, of the THC?

Prof. Chye : I think the first thing is that I do not know what the long-term side effects are in our palliative care population because it has never been researched. It has never been looked at, so I do not know. In my practice, five per cent of patients referred to me and to my service are still alive at 12 months time, and a smaller number are obviously alive at up to even three to five years, so there are patients who are around and receiving palliative care in addition to their anticancer treatments or other treatments for quite some time. So, whilst it is a small percentage of our patients, it is still a sizable number if put all together. Therefore, knowing what side effects, whether short term or long term, will then become an important need to understand if I were to explain to my patients about whatever medication I am about to prescribe—and also its long-term effects as well. I do that on a daily basis for every medication that I am trying to convince my patients to take. The patients have to understand what the side effects are, short term or long term, and I also have to have confidence that the drug will do what it is supposed to do.

CHAIR: She certainly will not mind me mentioning her name, but we had some evidence this morning from Mrs Lucy Haslam, who has apparently been in the media with her son, who died recently from cancer. She was indicating that the raw cannabis had some benefits for nausea and, pain and, I think she said, bowel problems.

Senator DI NATALE: Yes. The opiates caused constipation, and that did not.

CHAIR: Yes. She of course is a lay person. She has no idea what it was that worked, but something worked. Are you familiar with those sorts of results? Would they be at all useful for people in palliative care?

Prof. Chye : The answer is yes, I think it is, but I do not know how well these medications work. It does work for pain, but I understand the research suggests it is no better than Panadeine Forte. So, yes, it does help pain, but if pain becomes worse or requires a medication that is stronger than Panadeine Forte then perhaps it does not have a place. But I do not know that without the research. We believe it does help in chemotherapy related nausea and vomiting. I think it worked in a 40-year-old, but I do not know whether it is safe to prescribe in a 90-year-old who is having chemotherapy, for example. That research is not there at this point in time. We think it helps patients whose appetite is poor, but then again I do not know the side effects, what dose I should be using and how long I should use it before saying it does not work, and those are the things that I want to know as a clinician, as a researcher and perhaps as a possible prescriber later on. I want to know those issues, those questions before I can confidently say yes it works or it does not work.

CHAIR: Okay. Thank you for that.

Prof. Chye : I am putting a submission together with my colleagues to be able to test whether it is a pharmaceutical medication or even raw cannabis leaf to see whether it helps patients in the setting of patients with a very poor appetite from cancer. We are actively putting together a paper to be submitted to the New South Wales government. It is one of their trials that we are doing. I have to say I was also part of the New South Wales health expert committee on medicinal cannabis advising them as to which way they should be going as well. We recognise trials in palliative care are not easy to do. They require a long period of time but also require the trials we have done to be done in many different hospitals right across Australia. Therefore, I see this regulator as a body to be able to allow medications such as raw cannabis leaf, for example, to be transported across borders so that it can be standardised for research purposes. I see this as a regulator who will be able to say, 'This is how much THC or CBD this drug has,' and we are able to test it appropriately. That is where I see this regulator and its role to be important.

Senator DI NATALE: Carrying on from that, it is the ability to standardise treatment protocols and so on. Given we have different states expressing an interest in doing this work, do you seen having that national coordination, that overarching framework, progressing the evidence base?

Prof. Chye : Yes, I certainly do. As I said, we have run trials in palliative care that took three to four years across up to 10 centres across Australia—in South Australia, Victoria, New South Wales and Queensland. One hospital or one state cannot do it alone because of the nature of trying to recruit patients who are already very frail in our population. We need to be able to do it across Australia.

Senator DI NATALE: Yes. I want to come to the key thing in your submission, which is something we wrestled with in the drafting of the bill, and that is the issue of how much detail you include in the legislation versus how much you actually allow through regulation or the rules. The reason for making that distinction is: what we introduce through legislation, an act of parliament, is fixed and much more difficult to change. We are not able to vary those parameters easily. Creating the framework through legislation but then allowing the rules to be developed by the regulator and having those introduced through regulation or specific rules that do not require an act of parliament to change them was what we opted for because this is an area that is changing. You have identified in your submission all of the areas that need to be included in the rules. The question is: should they be in the rules and regulations or in the bill? We have opted for the former—we are opting for the rules and the regulations rather than legislation to allow that flexibility, to allow emerging evidence to determine whether we potentially change, expand or limit some of the areas we are looking at. Does that make sense given your concerns expressed in the submission about the lack of detail in the bill itself? Do you have anything to say in response to that?

Ms Hansen : Yes, I think that makes perfect sense.

Senator DI NATALE: Would that sort of assuage your concerns to some degree?

Ms Hansen : Yes, it would.

Senator DI NATALE: Even though they would not specifically be spelt out in law, we would absolutely expect all those questions to be answered through the regulator.

Prof. Chye : I trust that whatever body is created—and I am sure you would have a role in deciding who is on the regulator—will have eminent and trustworthy people on it, who will make the right decisions based on your framework. This is changing all the time. I agree with you that legislation cannot be easily changed but regulations can be. It is such a changing field that the regulator I suspect will be much more responsive to those changes than the legislation could ever be.

Ms Callaghan : I agree.

Senator DI NATALE: Good. I am glad to hear that because I would not want you to think we have not considered those questions; it is just where they will sit.

Prof. Chye : I think the framework is important.

Senator O'SULLIVAN: I really have only one question. Did I understand in evidence earlier today that, in the area of aged care and palliative care, Israel had been doing work in this area? Are you familiar with what is happening in Israel?

Prof. Chye : No, I am not aware.

Senator O'SULLIVAN: There was a suggestion—Senator Di Natale, was it 20,000 patients?

Senator DI NATALE: Yes, correct.

Senator O'SULLIVAN: Who were in a trial arrangement over there with the use of this. It is not something you are necessarily following?

Prof. Chye : No. I am not aware. My colleagues?

Mr Huntir : No.

Ms Hansen : No.

Senator O'SULLIVAN: I am going to show my ignorance in relation to palliative care. My street-level entry knowledge of it is that, when someone is in palliative care, there is a likelihood that there is not a great expectation of a long period of life.

Prof. Chye : That is true.

Senator O'SULLIVAN: Would it be fair to say, in that space, that the long-term effects or side effects—putting aside side effects that might exacerbate their circumstances—the longer term effects that seem to be associated with constant use of cannabis might not be as serious consideration as they might be in using this for pain relief for juveniles?

Prof. Chye : I would agree that, if it is used in a patient whose prognosis is limited, then, yes, the chances of these patients developing long-term effects are minimal, because these patients do not live for very long. Whilst I say that five per cent, or one in 20, of my patients live for a year or more, about 50 per cent do not survive past three or four months. So, yes, the majority of patients do not live as long and therefore probably do not develop the long-term side effects of prolonged cannabis use. What is more important for me to know, given the short period of time—for example, I do know what to tell people patients if I am starting an opioid, for whatever reason it is, and I can tell patients: 'This is what will happen. There is a chance that you will get constipated or nausea. This will dull your thinking for two or three days before you resurface again.' I do not know those facts for medicinal cannabis. That is where the research and being able to allow my research team or my research colleagues to access the medications or raw material will help answer that.

Senator O'SULLIVAN: One of the things that I have struggled with all day is this reference to medicinal cannabis as opposed to cannabis. I thought it should be the other way round—that it is cannabis for medicinal purposes. It would seem to me that there is a lot known about the effects of the consumption of cannabis. It has been the subject of many studies over decades in terms of its effects. I am going to revert to my own anecdotal experiences as a retired detective from the drug squad, having worked undercover and having been very much up close and personal with users, including chronic users. The anecdotal evidence that they used to report was often a sense of wellbeing, an increased appetite and a range of things that, it would seem to me, were consistent in most of the reports. With others, it did affect and alter personality. If they had a fractured personality, it did tend to exacerbate it. Put that aside for a second. Just on the basis of people reporting this sense of wellbeing and sort of taking the edge off life, in certain circumstances for someone who is in palliative care, where pain is a big issue or anxiety—I imagine you could not be in palliative care without having anxiety—if there exists a body of evidence to suggest that this can dampen or take the edge off that, would that in and of itself, in your view—notwithstanding that I agree we need to go through the trials and be very careful—with the evidence that exists now that those can be two outcomes, would that persuade you to consider its application for those purposes alone?

Prof. Chye : The answer is yes. If the evidence suggests that it helps patients' wellbeing, then I am happy to prescribe it for that indication—of improving wellbeing. The answer is, as you say, anecdotal, in lots of people who use it.

Going back one step, we use antidepressants, for example, to try and help patients' mood. There was a study in Australia using cancer patients where an antidepressant, sertraline, was used to try and improve a patient's 'wellbeing'—to try and make them happier whilst they are going through cancer treatments. And we were very hopeful that that would help, but that trial was stopped early because they found that patients who were on the antidepressant died earlier than those who did not take antidepressants. So whilst there was a lot of hope on our part—we felt that this antidepressant must make patients better; feel better—when it was properly trialled, it turned out to be incorrect. And that changed the way medical oncologists treated patients who were sad—that antidepressants were not the right drug. As I said, there was lots of anecdotal evidence that this medication, sertraline, helped, but when it was put to the proper test, it did not show that it was effective and, in fact, it was detrimental. And I think that is where the research in this setting—of using cannabis for medicinal use, for example—needs to be carefully researched as well, to tell us once and for all, aside from anecdotal stories, that it does improve wellbeing, that it does work and—if I am to prescribe cannabis for medicinal use—that I am confident that x number percentage will improve with its use. What I do not know at the moment is what that percentage is, and how to warn my patients what they are likely to get, or not likely to get, as problems from its use.

Senator O'SULLIVAN: I have one final question: we have heard in evidence today and also, I think, from all of our personal experiences—to the extent that we have them in this space—we have learnt that possibly as many as hundreds of thousands of Australians who are suffering from—I do not quite know what the medical term is—a biological condition such as cancer, epilepsy and the like, are accessing this drug currently. And in doing so, they are exposing not just the patient but others to possible prosecution. We have heard evidence of parents, and we have had some evidence today from a parent whose husband was a police officer, who took—he bought into that process and helped his son, in that case. There are two evils sitting here in front of us with respect to that issue: about the period that these trials will take and then, more importantly, the development of consistent quality delivery of whatever the outcome is in the development of a pharmaceutical product.

This is a moral question I am asking you, but doctors are exposed to this every day with their patients: do you have a view about us trying to take some measures, or introduce some measures in the interim, which at least prevent these people being exposed to criminal prosecutions? There is not a lot of evidence that that is happening, but I think that is by the good grace or at the discretion of law enforcement officers and other front-line practitioners.

Mr Huntir : Do you mean, is there a step before the bill?

Senator O'SULLIVAN: No; look, I know it is probably outside any of your realms of expertise, but it is a big question for us.

Prof. Chye : I do have an answer. It is a big question. I think my colleagues from the college of physicians talked about not being sure about its use and where its place is, and about orphan drugs. I use orphan drugs all the time because there are a lots of medications that I am not sure whether they work or not. But we use them because we have some evidence anecdotally that they work. There is a system through the Pharmaceutical Benefits Scheme called the SAS, or Special Access Scheme, whereby I am able to access medications that we think work for some of our patients. We used to use cyclizine, which is an antihistamine, that is used for nausea in my population. It is one of those orphan drugs. We gain access to that using authority through the Special Access Scheme. It is a very well-used scheme for a whole range of medications where the indication may not be as clear-cut.

That is something that your regulator may wish to consider, because then it helps patients get access to the drug early even though the use may not be as clear-cut. It also then tells us who is using it and not using it, and may also be a safeguard for those procuring the medication. Whilst the medications or the cannabis may be of uncertain origin with an unclear constitution, if it was done through the regulator where you know this particular product has a percentage of CHB or THC and is licensed that way, then that may be a way for the regulator to think about using it. There is a scheme and that is run through the Pharmaceutical Benefits Scheme, as I said. The Special Access Scheme—scheme A and scheme B—is not only used for drugs. It is also used for chemotherapy and things like that. I hope that answers your question.

Senator O'SULLIVAN: It does, Professor Chye. You have been a very impressive witness.

CHAIR: Professor, something you indicated seems counterintuitive to me. Now, I am not a medical practitioner, but you were saying that using antidepressants made people happier but shortened their life?

Prof. Chye : No. This was a study where this antidepressant was used in patients with cancer who were sad but not necessarily depressed. They thought by using this antidepressant that these patients who were sad would feel a bit happier. But in fact it showed there was a detrimental effect on survival of these patients.

CHAIR: But did it make them happier?

Prof. Chye : I cannot tell you whether it did.

CHAIR: If your lifespan is three or four weeks and you can have three weeks happy or four weeks sad, perhaps you would say you will take the three weeks happy.

Prof. Chye : My suspicion—and I cannot remember the paper—is that I do not think it made them any happier. The drug sertraline, an antidepressant, is used specifically for patients who are depressed to get them out of that depression. Patients who were sad as a result of their diagnosis are not necessarily depressed. Therefore, the drug may not have any depression for it to work upon. Therefore, trying to make them feel happier, I suspect, was not achieved.

Senator O'SULLIVAN: It might make you happier even if you are just at that baseline?

Prof. Chye : Yes. The patients who have told me they have used it—and I questioned very carefully: did it help your pain? Did it help your nausea?—after very close questioning, the answers that came back were that it helped them forget that they had difficulties. I tell them I am happy for them to 'use it' on that basis. Do not expect it to improve your pain. Do not expect it to improve your nausea. Only use it for the effect of making you feel a bit happier, but do not expect it to improve your pain. Still use the medications that I have prescribed for pain.' It does not replace the morphine if it is severe pain or the other nausea medications. It does not replace that.

Senator O'SULLIVAN: But equally it would not prevent you from administering these other streams of drugs that might deal with that.

Prof. Chye : No, it certainly does not. I think, more importantly, if I am able to have a patient tell me that they are using it then I am aware of interactions that might happen much more confidently. If patients do not tell me they are using cannabis and I prescribe a drug that has effects on memory or effects on mood, I can actually make things worse if I do not know that they are on cannabis.

Senator O'SULLIVAN: Would you agree at the moment, until we tidy this up, more often than not a greater percentage of patients who are trialling this unlawful solution will not share that with you?

Prof. Chye : I think that if it were out in the open then they would be more likely to share that with me. If I know exactly what they are taking—Chinese herbal medications or any other herbal medications; St John's wart is an important example—it helps me understand how the medications I am prescribing may interact with those medications and what to warn the patients about. That I think is still paramount in my ability to look after patients.

Senator O'SULLIVAN: We just need to bring Solomon back and all will be well.

CHAIR: Professor, Ms Hansen and Mr Huntir—you two at the end have had a fairly easy go—thank you all very much for coming along today. We very much appreciate the evidence you have given. It has been very helpful to the committee and the deliberations we have. Thanks very much.

Prof. Chye : Thank you very much for the opportunity.

Committee adjourned at 16:47