2.7 Performance and image enhancing drugs
Part A - Interim decisions on matters referred to an expert advisory committee
2. Scheduling proposals referred to the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS#16)
2.7 Performance and image enhancing drugs
Scheduling proposal
The medicines scheduling delegate has referred the following scheduling proposal for consideration by the Advisory Committee on Medicines Scheduling (ACMS):
- To create new Schedule 4 and Appendix D, Item 5 entries for Thymosin Beta 4 and TB-500 to control the manner in which they are advertised, sold and accessed without legitimate purpose.
Substance summary
The applicant has provided the following information regarding Performance and image enhancing drugs:
Thymosin Beta 4 and TB-500
Thymosin Beta 4 (Thymosin β4) is a growth factor affecting muscle, tendon or ligament, vascularisation and regenerative capacity. Thymosin Beta 4 is a 43 amino acid peptide - the molecular structure is shown in the diagram below where each letter indicates one of the 20 different amino acids.
TB-500 is a short peptide analogue of Thymosin Beta 4. TB-500 is presumed by design to have the same properties as Thymosin Beta 4.
These substances are currently used illicitly to enhance sporting performance and more broadly across the community often for body building and image enhancement purposes. The substances are banned by the World Anti-Doping Agency (WADA Prohibited List, 2015) for use by athletes, both in and out of competition.
Fibroblast Growth Factors
Fibroblast Growth Factors (FGFs) are a family of growth factors involved in angiogenesis, wound healing, embryonic development and various endocrine signalling pathways. FGFs also have a role in the processes of proliferation and differentiation of wide variety of cells and tissues (Thisse & Thisse, 2005; Turner & Grose, 2010).
Scheduling status
Thymosin Beta 4, Tb-500 and Fibroblast Growth Factors are currently not listed in the schedules or appendices in the Standard for uniform scheduling of medicines and poisons (SUSMP).
Scheduling history
Advisory Committee on Medicines Scheduling: November 2015
Delegate's decision: March 2015
The ACMS considered a proposal to include new entries in Schedule 4 and Appendix D for a number of performance and image enhancing drugs. The ACMS recommended, and the delegate confirmed, that the following substances should be included in Schedule 4 and in Appendix D, Item 5 [Poisons for which possession without authority is illegal (e.g. possession other than in accordance with a legal prescription)]:
- growth hormone releasing hormones (GHRHS)
- growth hormone secretagogues (GHSS)
- growth hormone releasing peptides (GHRPS)
The ACMS recommended similarly for new individual substance entries for:
- CJC-1295 (CAS No. 863288-34-0)
- ipamorelin
- pralmorelin (growth hormone releasing peptide-2) (GHRP-2)
- growth hormone releasing peptide-6 (GHRP-6)
- hexarelin
- Aod-9604 (CAS No. 221231-10-3).
Pre-meeting public submissions
No public submissions were received.
ACMS advice to the delegate
The ACMS recommended that:
- Thymosin Beta 4, TB-500 and Fibroblast Growth Factors are included in Schedule 4 and in Appendix D, Item 5.
- Thymosin Beta 4, TB-500 and Fibroblast Growth Factors are listed in Appendix D, Part 5.
The ACMS recommended an implementation date of 1 June 2016.
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; e) the potential for abuse of a substance; and f) any other matters that the Secretary considers necessary to protect public health.
The reasons for the recommendation comprised the following:
- There is limited research regarding the harms and possible therapeutic benefits of these substances.
- No form of Thymosin Beta 4 is yet approved for human therapeutic use anywhere in the world.
- The medications are considered experimental in humans, with potential side effects including carcinogenicity and cardiovascular problems.
- The substances are used as a performance or image enhancing agent.
- Toxicity is unknown due to the experimental nature of the medications.
- Misuse/abuse of Fibroblast Growth Factors have the potential to cause adverse health effects like cancer, cardiovascular problems & endocrinological health outcomes.
- The products have not been approved for use in Australia, and as such this section is unregulated.
- There is potential for abuse given that the substances are used as a performance or image enhancing agent.
Delegates' considerations
The delegate considered the following in regards to this proposal:
- Scheduling proposal;
- Public submissions received;
- ACMS advice;
- Section 52E of the Therapeutic Goods Act 1989;
- Scheduling factors22;
- Other relevant information.
Delegate's interim decision
The delegate's interim decision is to include Thymosin Beta 4, TB-500 and Fibroblast Growth Factors in Schedule 4 and Appendix D item as per the below proposed wording for the schedule entries.
The proposed implementation date is 1 June 2016.
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; e) the potential for abuse of a substance; and f) any other matters that the Secretary considers necessary to protect public health.
The reasons for the recommendation comprised the following:
- There is limited research regarding the harms and possible therapeutic benefits of these substances.
- No form of thymosin beta-4 is yet approved for human therapeutic use anywhere in the world.
- The medications are considered experimental in humans, with potential side effects including carcinogenicity and cardiovascular problems.
- Used as a performance or image enhancing agent.
- Unknown due to the experimental nature of the medications.
- Misuse / abuse of Fibroblast Growth Factors have potential to cause adverse health effects like cancer, cardiovascular problems and endocrinological health outcomes.
Schedule entry
Schedule 4 - New entries
Thymosin Beta 4 (Thymosin β4)
TB-500
Fibroblast Growth Factors