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Legal and Constitutional Affairs Legislation Committee

KRISHNASAMY, Professor Mei, President, Clinical Oncology Society of Australia

MELTON, Dr Lisa, Research Development Manager, MS Research Australia and MS Australia

WHITTAKER, Ms Kate, Manager, Cancer Care Policy, Cancer Council Australia


CHAIR: Welcome. These are proceedings of the parliament, so parliamentary privilege applies. If there is any reason you would like to give evidence in camera, please let us know and we can talk about that. We have received a joint submission from the Cancer Council and the Clinical Oncology Society, which we have numbered 37, and a submission from MS Research Australia and MS Australia, which we have numbered 49. If any of you want to make any alterations or amendments to those statements, that is possible now. Otherwise, I invite any or all of you to make an opening statement and then we will have some questions. Because of my inefficiency as a chairman, we are running well over time, and we do have planes to catch. Anyhow, we will try and go for close on half an hour with the three of you, and we will considerably shorten the lunchbreak to try and finish on time.

Ms Whittaker : As you have noted, our submission has been jointly submitted with the Clinical Oncology Society of Australia. Cancer Council Australia is Australia's peak national non-government cancer control organisation, and the Clinical Oncology Society, who we work really closely with, is the peak body representing health professionals from all disciplines whose work involves the care of cancer patients. This is one of many joint submissions we have done together. Those submissions are based on anything affecting cancer patients, survivors, carers and the system in which cancer care is delivered.

The submission is an overview based on the fact that managing illness induced by chemotherapy, especially in patients with advanced cancer who have responded poorly to the conventional relief options, is a significant problem for cancer patients and their doctors. That is the position we are taking today and that the majority of available evidence has been in providing relief in cancer care and the symptoms related to cancer.

We acknowledge that, given the available evidence of cannabis and cannabinoid products, they could be available to provide medical benefit to cancer patients. We support the need to conduct comprehensive research into their use in controlling the side effects of cancer and cancer treatment and to inform safe and effective routes of administration. We also acknowledge the place for potential compassionate programs underpinned by evidence.

In this submission, Cancer Council Australia and COSA focus on current scientific evidence of the implications of cannabis and cannabinoids use in practice and we address the core principles of patient access to products of high quality, safety and proven efficacy, including the conduct of research in Australia and the interaction of current legislation. We did not explore any issues of exporting, importing or the complexities of the licensing scheme.

CHAIR: Thank you very much.

Prof. Krishnasamy : It is my pleasure to be here today representing the Clinical Oncology Society of Australia as their president. As Kate just said, we are very pleased to have the opportunity to present to support some of the emerging evidence around the benefits for patients but also to have the opportunity to talk about the evidence as it stands and what the opportunities are very importantly for patients in the community to have a broader understanding of some of that evidence and where we still need to garner further evidence.

Dr Melton : MS Australia is the national peak body representing the state based MS societies which provide services to people with MS and also people with MS themselves. MS Research Australia is the largest national not-for-profit body funding MS research in Australia.

People with MS experience a range of neurological symptoms, including pain and muscle spasticity—two of those that are most relevant to the discussion that is going on here today. MS is most commonly a relapsing-remitting disease but it can become progressive at later stages, and 10 per cent of people are diagnosed with progressive disease from the outset.

There are a range of medications that can control the relapses of MS but there are no medications that can halt the progressive phase of the disease. There are also a range of medications available to treat some of the symptoms of MS such as pain and spasticity but they have varying efficacy. They do not work for everybody and some have side effects that make it intolerable for some people.

MS Australia and MS Research Australia understand and acknowledge that people with MS will investigate all options available to them to maintain their quality of life. A 2004 international survey that was conducted by an Australian group of researchers showed that around 10 per cent of people with MS believe that cannabis is a factor that can help improve their MS symptoms.

We do not endorse or recommend the use of cannabis due to the health effects associated, for example, with smoking. There is substantial evidence that cannabis can have adverse effects on thinking and memory—cognition—and this is a particular problem for people with MS as an effect as cognition is part of the range of symptoms experienced by sufferers.

The potential for harmful side effects in the absence in large part of evidence for efficacy means that this needs further research and investigation. As discussed already, we are concerned about the lack of control over dose and quality—and that was a big part of the earlier discussion with the previous witness. We totally agree that we need much more information about the content of the products that are available.

There is some evidence that medicinal cannabis can help with symptoms of pain related to MS and there is also some evidence that cannabis can assist with bladder symptoms with MS. But the strongest evidence relates to muscle spasticity in MS. The cannabis derived product, Sativex, has been shown in clinical trials to ease the muscle spasticity associated with MS and has in fact been approved by the TGA specifically for that purpose. But the current regulatory framework means it is still not available to people with MS in this country for that purpose.

There is also some evidence from animal studies that cannabis based components may protect against the neurodegeneration that underlies the progressive phase of the disease. There has been a large clinical trial in the UK conducted to investigate that. It was unable to confirm those findings completely but there was some evidence from a sub-group analysis that there may have been a population of that trial who did show some slowing of the progression of the disease. There is a real need there for more research into those components of cannabis and the different effects that they can have both in symptomatic relief and in the degeneration of the disease.

To sum all of that up, MS Research Australia and MS Australia would welcome the introduction of a regulatory framework that would allow the safe and scientific exploration of the therapeutic potential of cannabis based products and that would ensure the standardised and licensed manufacture of cannabis based products with consistent quality controlled formulations. The framework will enable those products to be made available to people with chronic illnesses such as MS once the safety and efficacy has been established through clinical trials.

CHAIR: Just to clarify, you said 'Sativex', which is, as you say, approved by the TGA but is, I understand, very expensive. Did you say that is not permitted for use in MS cases?

Dr Melton : It is for spasticity. It is not available in the country though. The company that produces the medication has not marketed in Australia because of the complexity of the regulations around it so it is not available. It was knocked back by the PBAC for listing on the PBS as well.

Senator DI NATALE: Why have they knocked it back? I am interested.

CHAIR: It has been approved by the TGA, it is legal to use it in Australia but the company has not done it?

Dr Melton : My understanding is it is not legal. Because of the state and territory regulations, it needs rescheduling on the poisons schedule in the states and territories before it can be legally available in those states and territories. I think the compexity of that is the reason the company has not yet marketed it.

Senator DI NATALE: My understanding is that the TGA can change its scheduling, which it has done, but there is another step involved; I think that is right. Are you saying the states have to change their own poisons schedule to update them to make them consistent with the TGA schedule?

Dr Melton : Yes.

Senator DI NATALE: I thought they had not introduced it because the market was too small and because it did not get PBAC approval so the cost to the patient would be in the many thousands of dollars per year.

Dr Melton : That may well be a part of it as well.

Senator DI NATALE: Okay, so perhaps they are not putting pressure on the states to update their schedule because they have got no intention of importing it.

Dr Melton : I do not know.

Senator DI NATALE: I am speculating.

Senator SINGH: In knowing that Sativex would be of benefit to MS patients in relation to the spasticity of MS sufferers, do you as an organisation lobby government or the TGA about treatments that are of benefit? In this case, Sativex is obviously one that has gone through all of the clinical trial hurdles. Do you lobby government or the necessary authorities to help promote its delivery in Australia?

Dr Melton : We made a submission to the PBAC supporting its listing on the PBS. Where medication has been shown through clinical studies to provide an option that may benefit some people with MS then we would certainly encourage it being made available affordably to people with MS so that amongst the range of options that they and their doctors have available to them, they can look at that as an option. That was the basis of our submission to the PBAC. In a similar vein, we have been making submissions to the state based inquiries that are happening in parallel with this one basically saying the same thing. Where a medication is shown to be useful it should be made available to people, and the regulations should support further research so that we can investigate what other benefits it might have for people with MS.

Senator SINGH: Cancer Council, do you do a similar thing?

Ms Whittaker : I have not in my time at Cancer Council Australia been involved in advocating for a particular drug. We draw a lot on the evidence base that is formed from the TGA reviews et cetera but I could not strongly comment on if we would or we do advocate for particular drugs.

Senator SINGH: Could you take that on notice and let the committee know?

Ms Whittaker : Yes.

Senator DI NATALE: Some of those questions around Sativex we might need to raise with the company itself. Would you have any objection if a regulator allowed the production of a preparation that had the same properties—if it were a one-to-one ratio of CBD to THC—and it were made available through a regulator where quality control was guaranteed? Would there be any issue with giving patients access to that drug?

Dr Melton : From our perspective, if it is done in a way that the evidence can be gathered as to whether it is effective—

Senator DI NATALE: I am talking specifically for MS, where it is already an approved indication.

Dr Melton : For an approved indication, yes; absolutely.

Senator DI NATALE: Whether it comes from a drug company or whether the preparation is developed in some other way outside of the traditional drug-delivery model, you would not have any concern, provided you were satisfied that quality control were in place.

Dr Melton : If quality control and the formulation, the concentration, of the components are consistent and known, yes, we would support that, given the evidence.

Senator DI NATALE: We have research trials being discussed in different states and jurisdictions. Do you see a benefit in bringing that together and being auspiced under the one national framework?

Prof. Krishnasamy : Speaking on behalf of COSA, I think there would be real benefit in having an opportunity around national oversight. Just listening to some of Mrs Haslam's experience—of the ability to have research done rigorously but in a very timely way so that we are cognisant and remain cognisant of the need to meet people's urgent needs for symptom management, where other measures have failed or other agents have failed—the benefit of having a body that brings people together where you generate larger studies and have more robust evidence in a more timely way would be beneficial.

There are obvious opportunities, in terms of engaging with a health-professional community that is obviously working with an evidence based framework. It is the ability to understand, as you mentioned earlier, who the subgroups are who have the greatest capacity to benefit quickly from some of these agents and who perhaps those people are who would benefit through better application of the knowledge and evidence that we have around current drugs, and opioids are a prime example.

We have heard some examples where the complications have less than ideal management of opioids and leave people in dire straits. It is a complicated picture but we do need to understand who those people are—who do not have the capacity to benefit from conventional drugs that are already available—so that we can meet the needs of those people quickly. A national body would be very beneficial.

Senator DI NATALE: Do you have a sense of the scale of use amongst MS patients? Have you conducted any surveys?

Dr Melton : The survey I mentioned, in 2004, asked who felt they had a benefit. It was looking at what people found benefited their MS and what people thought made their MS worse. It simply asked the question: what makes it better? What makes it worse? Ten per cent said cannabis makes it better. There was no question of, 'Who is a user of cannabis?' There is a 2009 survey that one of our research platforms conducted, a research survey which showed that about 14 per cent of Australians with MS use prescribed muscle-relaxant medications and 10 per cent use analgesics, including narcotics. That is the kind of range of people who have those symptoms with MS who feel they need medicating for those symptoms. I do not have to hand any numbers on how many people with MS, for example, in Australia use cannabis-based products.

Senator DI NATALE: How many people with MS are there in Australia?

Dr Melton : The current estimate is 23,000.

Senator DI NATALE: And back in 2004 you said that about 10 per cent of people said that cannabis made their symptoms better?

Dr Melton : Yes.

Senator DI NATALE: Obviously, you do not want to draw a conclusion from that, but it is quite possible that there are thousands of people with MS who might be using medicinal cannabis to get some improvement.

Dr Melton : It is possible. Anecdotally we know that people do use it.

Senator DI NATALE: Do either of you have any personal experience with patients coming to discuss cannabis as a therapy? What sort of advice do you give them? Do they express concerns about sourcing it? Is that something that either of you have come across?

Dr Melton : I am the research representative today, so my MS Australia colleagues would probably be able to give a slightly different answer to that. We do take regular inquiries from the public about, for example, access to Sativex or whether there is any evidence for cannabis-based products being helpful in MS. We say basically what I have said today—what we know from clinical studies. That is as much information as we are able to give them.

Prof. Krishnasamy : Certainly from a cancer perspective and speaking from a clinical rather than a COSA perspective, few people ask. I think that is because of a concern about what the reaction may be if they raise that conversation. Again, we talk to people openly about the level of evidence that we have, and we talk about the medications that are available to them. But people are understandably anxious about bringing that forward in a clinical consultation.

Senator DI NATALE: Thank you very much, that is very helpful.

CHAIR: Your written submissions have helped us, and also the other evidence we have had this morning has meant we probably do not have the same number of questions as we perhaps normally would. Can I thank all three of you for attending today, and for your submissions. We very much appreciate that; particularly your written submissions, which do contain a lot of very useful information for the committee.

Proceedings suspended from 13:02 to 13 : 44