Erythropoiesis-Stimulating Agents / Steve Elliot. - Chapter 4; p. 55-74

Published in:

Hematopoietic Growth Factors in Oncology. - Boston, MA, Springer. - (Cancer Treatment and Research book series (CTAR); volume 157)

• DOI: 10.1007/978-1-4419-7073-2_4
• Print ISBN 978-1-4419-7072-5
• Online ISBN 978-1-4419-7073-2

Abstract

Erythropoiesis is the process whereby erythroid progenitor cells differentiate and divide, resulting in increased numbers of red blood cells (RBCs). RBCs contain hemoglobin, the main oxygen carrying component in blood. The large number of RBCs found in blood is required to support the prodigious consumption of oxygen by tissues as they undergo oxygen-dependent processes. Erythropoietin is a hormone that when it binds and activates Epo receptors resident on the surface of cells results in stimulation of erythropoiesis. Successful cloning of the EPO gene allowed for the first time production of recombinant human erythropoietin and other erythropoiesis stimulating agents (ESAs), which are used to treat anemia in patients. In this chapter, the control of Epo levels and erythropoiesis, the various forms of ESAs used commercially, and their physical and biological properties are discussed.

Selling androgenic anabolic steroids by the pound : identification and analysis of popular websites on the Internet
/ F.G. Cordaro, S. Lombardo, M. Cosentino. - (Scandinavian Journal of Medicine & Science in Sports 21 (2011) 6 (December); p. 247-259)

• PMID: 21210860
• DOI: 10.1111/j.1600-0838.2010.01263.x

Abstract

Internet websites offering androgenic anabolic steroids (AAS) were identified and available products were examined. Keywords for the website search were: "anabolic steroids," "anabolic steroids buy," "anabolic steroid purchase." The first 10 websites offering AAS in the first 10 pages of results were considered. At least two AAS-containing products per website were selected. Thirty AAS-selling websites were identified, mainly located in the United States (46.7%) and Europe (30%). Most websites sold other anabolic/ergogenic products (clenbuterol, 76.7%; GH/IGF, 60.0%; thyroid hormones, 46.7%; erythropoietin, 30.0%; insulin, 20.0%) or products for AAS-related adverse effects (mainly: estrogen antagonists, 63.3%; products for erectile dysfunction, 56.7%; 5α-reductase inhibitors, 33.3%; anti-acne products, 33.3%). AAS were sold as medicines (69.6%) or as dietary supplements (30.4%). AAS in medicines were mainly: nandronole (20.4%), methandrostenolone (18.4%), and testosterone (12.2%). Dietary supplements contained mainly DHEA and included several fake compounds. Manufacturers were declared for 97.9% of medicines and 66.7% of dietary supplements; however, several manufacturers were not found on the Internet. Described benefits were usually few adverse effects and no estrogenicity. Toxicity was seldom reported and presented as mild. Recommended doses were two-fourfold higher than current medical recommendations. In conclusion, misleading information and deceiving practices were common findings on AAS-selling websites, indicating their deleterious potential for public health.

Mr. Johnny Pilay is an Ecuadorean Athlete competing in the Men’s Freestyle 63 kg event at the Singapore 2010 1st Youth Olympic Games.

On 8 September 2010 the International Olympic Committee (IOC) has reported an anti-doping rule violation against the Athlete after his sample tested positive for the prohibited substance furosemide.
After notification the Athlete waived his right to be heard for IOC Disciplinary Commission and didn’t file a statement in his defence.

On 17 September 2010, the Anti-Doping Commission of the NOC of Ecuador held a hearing in the presence of the Athlete and concluded that the athlete be sanctioned with a two year suspension.

After reviewing the file and the information at hand, the IOC Disciplinary Commission unanimously concluded that the Athlete had committed an anti-doping rule violation pursuant to Article 2.1 of the World Anti-Doping Code (the “Code”) and Articles 2 and 13 of the Rules in that there was the presence of the prohibited substance Furosemide in his body.

Therefore on 15 October 2010 the IOC Disciplinary Commission decides:
1.) The Athlete, Johnny Pilay, Ecuador, Wrestling is disqualified from the Men’s Freestyle 63 kg event at the 2010 Youth Olympic Games, where he placed 5th.
2.) The Athlete shall have his participation certificate in the 1st Youth Olympic Games withdrawn.
3.) The International Federation of Associated Wrestling Styles is requested to modify the results of the above mentioned event accordingly and to consider any further action within its own competence, not only with respect to the Athlete, but, also, with respect to the Athlete’s entourage.
4.) The NOC of Ecuador is ordered to return to the IOC, as soon as possible, the participation certificate awarded to the Athlete in relation to the 1st Youth Olympic Games.
5.) This decision shall enter into force immediately.

Mr Nurbek Hakkulov is an Uzbek Athlete competing in the Men’s Greco-Roman 50 kg event at the Singapore 2010 1st Youth Olympic Games.

On 8 September 2010 the International Olympic Committee (IOC) has reported an anti-doping rule violation against the Athlete after his sample tested positive for the prohibited substance furosemide.
After notification the Athlete waived his right to be heard for IOC Disciplinary Commission and didn’t file a statement in his defence.

After reviewing the file and the information at hand, the Disciplinary Commission unanimously concluded that the Athlete had committed an anti-doping rule violation pursuant to Article 2.1 of the World Anti-Doping Code (the “Code”) and Articles 2 and 13 of the Rules in that there was the presence of the prohibited substance Furosemide in his body.

Therefore on 15 October 2010 the IOC Disciplinary Commission decides:
1.) The Athlete, Nurbek Hakkulov, Uzbekistan, Wrestling is disqualified from the Men’s Greco-Roman 50kg event at the 2010 Youth Olympic Games, where he placed second.
2.) The Athlete shall have his medal, his diploma and his participation certificate in the above-noted event withdrawn.
3.) The International Federation of Associated Wrestling Styles is requested to modify the results of the above-mentioned event accordingly and to consider any further action within its own competence, not only with respect to the Athlete, but also with respect to the Athlete’s entourage.
4.) The NOC of Uzbekistan is ordered to return to the IOC, as soon as possible, the medal, the diploma and the participation certificate awarded to the Athlete in relation to the abovementioned event.
5.) This decision shall enter into force immediately.

Mr. Van Cong Le is a Vietnamese Athlete in the sport of IPC Powerlifting. He competed at the 2010 IPC Powerlifting World Championships in Kuala Lumpur, Malaysia where he proved a sample for doping control.

In September 2010 the International Paralympic Committee (IPC) has reported an anti-doping rule violation against the Athlete after his sample tested positive for the prohibited substances prednisone and prednisolone. After notification a provisional suspension was ordered.

The Athlete submitted that he waived his right to be heard for the Anti-Doping Committee. He accepted the provisional suspension and the result of the test sample analysis.
Hereafter the IPC Anti-Doping Committee recommends to the IPC Governing Body to impose a 2 year period of ineligibility on the Athlete, starting on the date of the sample collection, i.e. on 25 July 2010.

On 15 October 2010 the IPC Governing Board accepted the recommendation of the IPC Anti-Doping Committee.

This case involves Respondent's first anti-doping violation. Respondent does not challenge the Positive Analytical Findings. He alleges that he ingested the Prohibited Substance by accident. Mr. Merritt had three positive tests on October 28, 2009, December 8, 2009 and January 16, 2010 for the same prohibited substance DHEA. Pregnenolone was also found in his samples. Those tests are treated as one violation under anti-doping rules. For reasons related to USADA's legitimate and reasonable investigation, he was not informed of his positive tests until March 22, 2010.
Respondent requests that the Panel rule on the issue of whether International Olympic Committee's ("IOC") Executive Board's unpublished Memorandum relating to IOC Rule 45 of the Olympic Charter ("The Unpublished Memo") conforms to the mandatory provisions of the Code. Under The Unpublished Memo, if this Panel imposes over a six-month period of ineligibility The Unpublished Memo precludes an athlete from competing in the next Olympic Games. The Unpublished Memo imposes this penalty even if the athlete's period of ineligibility has expired by the time of these Olympic Games.

Decision and award:
- Twenty-one month period of ineligibility commencing October 28, 2009 and ending on July 27, 2011.
- During his period of ineligibility Mr. Merritt is prohibited from participating in and having access to the training facilities of the United States Olympic Committee Training Centers or other programs and activities of the USOC.
-After his period of ineligibility has ended on July 27, 2011, Mr. Merritt is eligible to compete in the competitions of all Signatories to the Code including the USOC, IAAF and IOC, if the reason for his exclusion would be related to this anti-doping rule violation.

The administrative fees and expenses of the American Arbitration Association and the compensation and expenses of the arbitrators shall by borne entirely by USADA and USOC.

AUSTRALIAN SPORTS ANTI-DOPING AUTHORITY 2009:10 ANNUAL REPORT
© Commonwealth of Australia
ISSN 1833-8976

Table of contents
Letter of transmittal iii
Guide to this report iv
Purpose iv
Structure iv
Access iv
Organisational overview 1
Message from the CEO 2
Building awareness 2
Assisting sporting organisations 3
Detection 4
Enforcement 4
Governance 5
The year ahead 5
About ASADA 7
Legislative basis 7
Role and functions 7
Goals 8
Amendments to legislation 8
Australia’s new anti-doping framework 9
ASADA members 11
Anti-Doping Rule Violation Committee 12
Highlights of 2009–10 14
Outlook for next year 15
Report on performance 17
Outcome and program structure 18
Outcome and program change 18
Program 1.1 – Deterrence, detection and enforcement 20
Deliverables 20
Key performance indicators 23
Building awareness 25
Education 28
Partnerships 29
Assisting sporting organisations 32
Sports forums 32
Liaison with national sporting bodies 33
International engagement 34
Other international engagements 36
Detection 37
National testing program 37
Pure Performance programs 38
User-pays tests 38
The Tank 39
Accreditation of Doping Control Officers and Chaperones 40
Athlete whereabouts 41
Enforcement 43
Management and accountability 47
Corporate governance 48
Corporate and operational planning 48
Organisational structure and Senior Executive arrangements 49
Governance committees 50
Audit Committee 50
Occupational Health and Safety Committee 51
Workplace Consultative Committee 51
Senior Management Group 51
Risk management 52
Operational and financial risks 52
Business Continuity Management 53
Fraud risk 53
Information Technology risks 53
Ethical standards 54
Social justice and equity impacts 54
Internal audits 54
Record keeping 55
Quality management 55
Customer Service Charter 56
External scrutiny 57
Significant developments 57
Decisions and reports 57
Management of human resources 58
Workforce planning 58
Attraction and retention 59
Employment agreements 59
Section 24(1) determinations 60
Non-salary benefits 60
Performance Management System 60
Peer recognition 60
Staff consultation 61
Learning and development 61
Workplace diversity 63
Commonwealth Disability Strategy 63
Occupational health and safety 63
Financial information 65
Summary of financial performance 2009–10 66
Grant programs 66
Asset management 67
Purchasing 67
Engagement of consultants and contractors 68
Consultants 68
Competitive tendering and contracting 69
Auditor-General access 69
Exempt contracts 69
Financial statements 71
Anti-Doping Rule Violation Panel 117
Overview 118
ADRVP members 119
Resources 121
Australian Sports Drug Medical Advisory Committee 123
Overview 124
Therapeutic approvals for prohibited substances 124
ASDMAC members 125
Achievements 127
Resources 128
Freedom of information procedures and ASDMAC contact details 128
External scrutiny – judicial decisions and appeals 129
Federal Court of Australia 129
WADA appeals 129
Appendixes 131
Appendix A: Doping control statistics 1999–00 to 2009–10 132
Appendix B: Publicly announced anti-doping rule violations 2009–10 133
Appendix C: International anti-doping and doping control 136
Appendix D: Powers of the Minister to give directions to ASADA and the CEO 137
Appendix E: ASADA and CEO functions, powers and delegations 138
Appendix F: Staffing statistics at 30 June 2010 141
Appendix G: Occupational health and safety 143
Appendix H: Advertising and market research 144
Appendix I: Ecologically sustainable development and environmental performance 145
Principles of the legislation 145
Measures taken to minimise environmental impact 145
Appendix J: Freedom of information 146
Organisation and functions of ASADA 146
Decision-making powers 146
Authorised freedom of information decision makers 146
Arrangements for consulting external bodies or people 146
Categories of documents 147
ASADA ANNUAL REPORT 2009:10
Facilities for the public to obtain physical access to ASADA documents 148
Departmental manuals 148
Freedom of information procedures and ASADA contact details 148
Appendix K: Australian Sports Drug Medical Advisory Committee – functions 149
Appendix L: Australian Sports Drug Medical Advisory Committee – Therapeutic Use
Exemptions granted 151
Appendix M: Anti-Doping Rule Violation Panel – functions 155
Appendix N: Expenses and resources for Outcome 1 156
Appendix O: ASADA Resource Statement 2009–10 157
Abbreviations and glossary 159
Abbreviations 160
Glossary 161
Indexes 165
Compliance index 166
Alphabetical index 170
Tables
Table 1: ASADA members’ details at 31 December 2009 11
Table 2: ASADA members’ attendance at ADRV Committee meetings, July – December 2009 13
Table 3: Program 1.1 qualitative deliverables 20
Table 4: Program 1.1 quantitative deliverables 22
Table 5: Program 1.1 qualitative key performance indicators 23
Table 6: Program 1.1 quantitative key performance indicators 24
Table 7: Check Your Substances visitors and searches 27
Table 8: ASADA hotline calls 27
Table 9: Education activities undertaken during 2009–10 29
Table 10: Anti-doping tests conducted by ASADA in 2009–10 39
Table 11: Doping control facts and figures 2009–10 40
Table 12: Substances involved in anti-doping matters 2009–10 43
Table 13: Breakdown of anti-doping rule violations 2009–10 44
Table 14: Expenditure on new and existing consultancy contracts 2009–10 68
Table 15: Consultancy services let during 2009–10 of $10 000 or more 68
Table 16: Interim ADRVP – 1 January 2010 to 31 March 2010 120
Table 17: ADRVP – 1 April 2010 to 30 June 2010 120
Table 18: ADRVP expenses 2009–10 121
Table 19: ASDMAC members 125
Table 20: ASDMAC expenses 2009–10 128
Table 21: ASDMAC freedom of information statistics 129
Table 22: Doping control statistics 132
Table 23: Publicly announced anti-doping rule violations 133
Table 24: Entries on Register of Findings 2008–09 where the outcomes were to be advised 135
Table of CONTENTS ASADA ANNUAL REPORT 2009:10
Table 25: Government-to-government arrangements 136
Table 26: Full-time and part-time staff at 30 June 2010 141
Table 27: Staff by classification groups and location at 30 June 2010 141
Table 28: SES staff at 30 June 2010 141
Table 29: Staff in equal employment opportunity groups at 30 June 2010 142
Table 30: Salary ranges of employees 142
Table 31: Number of staff in the collective agreement or Section 24(1) determinations 142
Table 32: Advertising and market research 144
Table 33: ASADA freedom of information statistics 148
Table 34: Therapeutic Use Exemption applications 2009–10 151
Table 35: Substances and methods approved for therapeutic use 2009–10 154
Table 36: Expenses and resources for Outcome 1 156
Table 37: ASADA Resource Statement 157
Figures
Figure 1: Australia’s new anti-doping framework 10
Figure 2: Outcome and program structure 2009–10 18
Figure 3: Outcome and program transition 19
Figure 4: Number of athletes and support personnel recording anti-doping rule violations 45
Figure 5: Organisational structure at 30 June 2010

In September 2010 the Fédération Internationale de Volleyball (FIVB), the International Volleyball Federation, has reported an anti-doping rule violation against the Korean Athlete So-Jin Lee after her sample tested positive for the prohibited substance formoterol. After notification the Athlete filed a statement with medical documentation in her defence.

The Athlete submitted she suffered from asthma and other allergic conditions since 2008 and therefore used the prescribed medication Symbicort (formoterol and budesonide).
The Athlete stated that the WADA TUE rules for asthma was on the process of revision and that a system of retroactive TUE was available in case of an Adverse Analytical Finding. Also for the competition they had no team medical doctor present and she didn’t mention her medication on the Doping Control Form due to her limited understanding of the English language.

The FIVB Panel concludes that the Athlete acted negligently without intention to enhance her sport performance due to her asthma. Considering the principle of proportionality the FIVB Anti-Doping Hearing Panel decides on 14 October 2010 to impose a 9 month period of ineligibility on the Athlete, starting on the date of the Decision.

Facts
The French Ski Federation (Fédération Française de Ski, FFS) charges respondent M84 with a violation of the Anti-Doping Rules. During a ski event on March 7, 2010, the respondent provided a sample for doping test purposes. The sample showed the presence of a metabolite of cocaine. Cocaine is a prohibited substance on the World Anti-Doping Agency (WADA) prohibited list.

History
The respondent had bought coca tea in a supermarket in Peru, this tea he consumed had caused the positive test. He has stamps in his passport as prove for his visit there. He argues that the levels measured are not enough to enhance sport performance. However an athlete has to be cautious what he uses, in this case it is seen as negligence on his side because the ingredient of the tea is written on the product.

Decision
1. The sanction is period of ineligibility of one year in which the respondent can't take part in competition or manifestations organized or authorized by the FFS.
2. All the results obtained at the ski event on March 7, 2010, are cancelled. Medals, points and prizes are withdrawn.
3. The decision will start on the date of notification.
4. The decision will be published and sent to the parties involved.

Facts
The French Federation of Workers and Amateurs in sports (Fédération Sportive et Gymnique du Travail (FSGT)) charges respondent M58 for a violation of the Anti-Doping Rules. During a cycling contest on January 31, 2010, a sample was taken for doping test purposes. The analysis showed the presence of prednisone and prednisolone. Prednisone and prednisolone are prohibited substances according the World Anti-Doping Agency (WADA) prohibited list and are regarded as specified substances.

History
The respondent used medication for asthmatic bronchitis, this medication was the cause for the positive test. There is medical proof for his condition. However there is no statement of his physician and the concentrations measured are to high for medical reasons. The alleged therapeutic justification can not be accepted. Also not giving the name of the medication he used shows negligence.

Decision
1. The sanction is a period of ineligibility of nine months in which respondent can't take part in competition or manifestations organized or authorized by French sport federations.
2. The period of ineligibility will be reduced by the time already served under the decision (3 months of ineligibility), dated May 4, 2010, by the disciplinary committee of the FSGT.
3. The present decision will start on the date of notification.
4. The decision will be published and sent to the parties involved.