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Stem Cell Treatments: A quick guide for medical practitioners and FAQ: a resource for patients submission

ID: 
11
This submission reflects the views of
Organisation Name: 
Dept of Industry, Innovation, Sci, Research & Tertiary Educ
Please identify the best term to describe the Organisation: 
Government Department – Federal
Personal Details
Questions
1. Is the document in the appropriate format? If not, how could the document be better formatted?: 

The Department considers the draft Stem Cell Treatments – a quick guide for medical practitioners (‘medical practitioner guide’) and Frequently Asked Questions – A Resource for patients (FAQ) (‘patient resource’) documents, to be well-formatted, well-structured and easy to understand. The documents contain important information about stem cell treatments and the Department therefore encourages the NHMRC to disseminate the documents in both electronic and hardcopy forms to reach a much wider audience.

The Department also suggests including the exact address of websites linked in both the medical practitioner guide and the patient resource document. For example, in the patient resource document under 4. What evidence should I look for when researching stem cell treatments online?, where the hyperlinked entry The Australian New Zealand Clinical Trials Registry (ANZCTR) is included, the full address could be included in brackets directly after this text (www.anzctr.org.au). 

2. Is the language appropriate for the target audience (i.e. medical practitioner for the quick guide on stem cell treatments and patient for the FAQ resource)?: 

The language used in the draft documents is considered appropriate for their target audiences.  In particular, the Department notes that the ‘patient resource’ document presents helpful information about ‘stem cells’ and their use in Australia.  Further the patient checklist is a useful means of encouraging patients to inform themselves prior to having a more detailed discussion with their medical practitioner.

In a similar way, the ‘medical practitioner guide’ not only provides practitioners with information needed to inform patients of stem cell treatments in Australia but more importantly, provides advice about why patients should be cautious about unproven treatments. Australia has a reputation as a country with a strong regulatory framework for ensuring that its health and medical sector is effective.  It is therefore vital that information is available to the public about these strengths and their importance to minimise the likelihood of individuals seeking alternative and unproven treatments being offered in Australia or overseas.

3. Does the document contain relevant information? If not, which sections do you consider to be irrelevant?: 

Outlining the distinction between ‘standard practice’ and ‘unproven/experimental’ stem cell treatments is especially valuable in informing patient decision-making and the Department commends the NHMRC for this approach.  However the Department believes that it would also be useful to consider the reasons behind the decision that individuals make when considering ‘unproven/experimental’ treatments and to reflect these in the said documents. It can contribute to relevant studies on the subject.  For example, from 2012-2014 through an Australian Research Council (ARC) Discovery Grant, Monash University in collaboration with Stem Cells Australia and the Centre for Biomedicine and Society (Brunel University, London) will be undertaking a study titled “High hopes, high risk? A sociological study of stem cell tourism”[1].   The study will involve interviews with patients, carers and other stakeholders in the field of stem cell treatments, analysis of media and policy documents, field work at clinics that offer such treatments and a policy research workshop.  The aim of the study is to better understand the socio-dynamics of stem cell tourism particularly those factors that shape Australians’ views and expectations of overseas stem cell treatments.  The study follows the 2010 pilot study “Hopeful Journeys: Experiences of Stem Cell Treatments Offered Outside Australia” which was funded under the Department’s National Enabling Technologies Strategy.

Therefore while both draft documents contain relevant information regarding key issues facing potential stem cell patients and their physicians, the Department suggests that the NHMRC keep abreast of developments with the abovementioned study and consider updating the current documents to further inform and increase awareness in the general public. 


4. Does the document exclude any important information that would be useful to medical practitioners or patients?: 

The Department suggests that a similar title to the medical practitioner guide be adopted for the patient resource document, as patients may not initially be aware of the topic of the document when first looking at the resource.

The Department suggests that both documents include information about the Therapeutic Goods Administration’s Regulatory Framework for biologicals (http://www.tga.gov.au/industry/biologicals-framework.htm ), which will improve regulation of human tissues and cellular therapies. The Framework includes the Australian Regulatory Guidelines for Biologicals (ARGB), which provides information for manufacturers, sponsors, health professionals and the general public on the legal arrangements for the supply and use of biologicals within Australia (http://www.tga.gov.au/industry/biologicals-argb.htm). Inclusion of this information in the document would provide both patients and their physicians with additional sources of information with which to assess advertised stem cell treatments.

Concerning the draft Frequently Asked Questions – A Resource for patients (FAQ) document, with regard to “4. What evidence should I look for when researching stem cell treatments online?,  the Department suggests that mention of the International Society for Stem Cell research – Patient Handbook on Stem Cell Therapies could also be made in this section, as well as where it is currently mentioned under 5. How can I seek further information?”. This Handbook also includes information on what patients can look for when considering a stem cell treatment and what to be cautious about if they are considering a stem cell treatment (http://www.isscr.org/PatientHandbook.htm, english language version page 6).

The Department also suggests that the list of links under “4. What evidence should I look for when researching stem cell treatments online?”,  in the patients guide, and under the “Quick Tips for medical practitioners” section in the medical practitioner guide, be updated to include the Australian Clinical Trials Website, http://www.australianclinicaltrials.gov.au/, which was launched on 11 October 2012. The website provides patients, patient’s families, and health service providers with access to information about clinical trials in Australia.

5. How could this information best be disseminated to patients and medical practitioners?: 

The Department encourages the dissemination of this information to patients and medical practitioners using as many methods as feasible. These methods may include, but should not be limited to, publication on the NHMRC website; circulation of electronic and hardcopy versions to patient support and advocacy groups; and provision of documents at medical conferences and events attended by General Practitioners (GPs) and industry conferences. The Department also suggests that the NHMRC may like to investigate the possibility of a media release being issued to announce the release of the documents.

The Department will provide a link on its website to these documents as well as work closely with the NHMRC to determine its role in assisting with their wider dissemination. The Department also suggests that a link to these documents could be included on the newly launched Australian Clinical Trials Website, http://www.australianclinicaltrials.gov.au/.

The Department also suggests that the NHMRC provide hard copies of the documents to GP surgeries or hospitals.

6. How could general practitioners best access this information (i.e. an appropriate website)?: 

The Department suggests that the draft documents be promoted in relevant industry publications such as the Medical Journal of Australia and Australian Doctor, with information about the articles appearing both in printed journals and on the journal’s websites.

The Department also suggests that the NHMRC consider sponsoring an event, workshop or booth at a national General Practitioner conference to raise awareness of the documents and invite further public debate on any issues surrounding stem cell treatments especially those that are considered to be unproven or experimental in their nature.

Specific Comments
Specific Comments: 
General Comments
Comments: 

7.    Are there any other questions or comments you have?

Stem cells are a promising area of research and their potential to transform the treatment of various diseases is slowly being realised.  It is therefore important to ensure that the public and medical profession have access to accurate information about the status and safety of stem cell treatments when making critical decisions about their health.

We are unaware of another overseas government body or organisation utilising this approach to raise awareness of stem cell treatments and the Department is supportive of the NHMRC’s decision to conduct a public consultation on these documents.

Executive Summary

The Department of Industry, Innovation, Science, Research and Tertiary Education (the Department) commends the National Health and Medical Research Council (NHMRC) for its production of the draft Stem Cell Treatments – a quick guide for medical practitioners and Frequently Asked Questions – A Resource for patients (FAQ) documents. The Department supports the wide dissemination of these documents, and supports the decision of the NHMRC to produce two separate documents representing the different information needs of medical practitioners and patients.

About the Department of Industry, Innovation, Science, Research and Tertiary Education

The Department of Industry, Innovation, Science, Research and Tertiary Education works with stakeholders to help shape the future economy, through discovery, skills and innovation. The department, and the wider portfolio, are working to accelerate productivity growth and secure Australia’s prosperity in a competitive global economy.

Recognising that collaboration, education and a strong science and research base are keys to success, the department brings together business, research bodies, the tertiary education sectors—vocational education and training (VET) and higher education, government and the broader community to discover, embrace and drive new ways of achieving economic and social benefits and deliver those benefits to Australia.

The department is focussed on promoting technological, social and environmental innovation and shaping businesses, industries and the workforce to turn these opportunities into action.

Page reviewed: 7 February, 2014