Pharmacological aids to Performance: challenges of the prohibited list
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1 Pharmacological aids to Performance: challenges of the prohibited list JA Pascual, PhD IMIM- Hospital del Mar Medical Research Institute, Barcelona Chair, IPC Anti-Doping Committee
2 Index 1.- Doping: Treating vs Eating 2.- Drugs and more: The Prohibited List 3.- Enforcement: Testing Analytical approach TDSSAs 4.- Food: Supplements 5.- Regulations: Athlete Support Personnel 2/39
3 1. Doping: Treating vs Eating Anti-doping rules, like competition rules, are sport rules governing the conditions under which sport is played (World Anti-doping Code 2015). What do these AD rules say?: Doping is prohibited! What is Doping? Conceptual Definition use pharmacological aids to improve performance : The Prohibited List Published by WADA every year Announced every 1 st October Coming into force 1 st January 3/39
4 1. Doping: Treating vs Eating Structure of the Prohibited List Substances and Methods Prohibited at all times S0. Non-Approved Substances S1. Anabolic Agents S2. Peptide Hormones, Growth Factors, Related Substances and mimetics S3. Beta-2 Agonists S4. Hormone and Metabolic Modulators S5. Diuretics and Masking Agents M1. Manipulation of Blood and Blood Components M2. Chemical and Physical Manipulation M3. Gene Doping Substances Prohibited In Competition S6. Stimulants S7. Narcotics S8. Cannabinoids S9. Glucocorticoids Substances Prohibited in Particular Sports P1. Alcohol P2. Beta-Blockers 4/39
5 1. Doping: Treating vs Eating What if an Athlete needs treatment with a Prohibited Substance? Always ask for a Therapeutic Use Exemption (TUE). Denied Approved Athlete can take medication TUE Committee Review Sent to ADO Prohibited 5/39
6 1. Doping: Treating vs Eating Why Treating vs Eating? We are what we eat (ingest or be exposed to) What is the definition of food? Are nutritional supplements drugs or food? Does a proper diet covers all nutritional needs of an athlete? Is there anything unethical in using nutritional supplements containing substances [drugs?] that cannot be considered food? Let s start by TREATING 6/39
7 2. Drugs and more: The Prohibited List Structure of the Prohibited List Substances and Methods Prohibited at all times S0. Non-Approved Substances S1. Anabolic Agents S2. Peptide Hormones, Growth Factors, Related Substances and mimetics S3. Beta-2 Agonists S4. Hormone and Metabolic Modulators S5. Diuretics and Masking Agents M1. Manipulation of Blood and Blood Components M2. Chemical and Physical Manipulation M3. Gene Doping Substances Prohibited In Competition S6. Stimulants S7. Narcotics S8. Cannabinoids S9. Glucocorticoids Substances Prohibited in Particular Sports P1. Alcohol P2. Beta-Blockers 7/39
8 2. Drugs and more: The Prohibited List Structure of the Prohibited List Substances and Methods Prohibited at all times S0. Non-Approved Substances S1. Anabolic Agents S2. Peptide Hormones, Growth Factors, Related Substances and mimetics S3. Beta-2 Agonists S4. Hormone and Metabolic Modulators S5. Diuretics and Masking Agents M1. Manipulation of Blood and Blood Components M2. Chemical and Physical Manipulation M3. Gene Doping Substances Prohibited In Competition S6. Stimulants S7. Narcotics S8. Cannabinoids S9. Glucocorticoids Substances Prohibited in Particular Sports P1. Alcohol P2. Beta-Blockers 8/39
9 2. Drugs and more: The Prohibited List Structure of the Prohibited List S0. Non-Approved Substances Governmental regulatory health authority? Stringent Regulatory Authorities (SRAs) as defined by the WHO. 9/39
10 2. Drugs and more: The Prohibited List Structure of the Prohibited List Substances and Methods Prohibited at all times S0. Non-Approved Substances S1. Anabolic Agents S2. Peptide Hormones, Growth Factors, Related Substances and mimetics S3. Beta-2 Agonists S4. Hormone and Metabolic Modulators S5. Diuretics and Masking Agents M1. Manipulation of Blood and Blood Components M2. Chemical and Physical Manipulation M3. Gene Doping Substances Prohibited In Competition S6. Stimulants S7. Narcotics S8. Cannabinoids S9. Glucocorticoids Substances Prohibited in Particular Sports P1. Alcohol P2. Beta-Blockers 10/39
11 2. Drugs and more: The Prohibited List Structure of the Prohibited List S2. Peptide Hormones, Growth Factors, Related Substances and mimetics S2.1 Erythropoietin-Receptor Agonists S2.1.1 Erythropoiesis-Stimulating Agents (ESAs) EPO and analogues (epoetins, darbepoetin, pegserpoetin, EPO-Fc) EPO mimetic peptides (EMPs) (peginesatide, CNTO 530, ) S2.1.2 Non-erythropoietic EPO-receptor Agonists (ARA-290, Asialo-EPO, Carbamylated EPO) S2.2 Hypoxia-Inducible Factor (HIF) stabilizers (e.g. cobalt, FG-4592) and activators (e.g. Xe, Ar) 11/39
12 2. Drugs and more: The Prohibited List Structure of the Prohibited List S2. Peptide Hormones, Growth Factors, Related Substances and mimetics S2.3 Chorionic Gonadotrophin (CG) Lutenizing Hormone (LH) and their releasing factors in males (buserelin, gonadorelin). S2.4 Corticotrophins and their releasing factors (corticorelin). 12/39
13 2. Drugs and more: The Prohibited List Structure of the Prohibited List S2. Peptide Hormones, Growth Factors, Related Substances and mimetics S2.5 Growth Hormone (GH) releasing factors and its analogues (e.g. GHRH, CJC-1295, sermorelin, tesamorelin) Growth Hormone secretagogues (GHS) Ghrelin and mimetics (anamorelin, ipamorelin) GH-releasing peptides (GHRPs) (e.g. alexamorelin, GHRP-6, hexamorelin, pralmorelin, ) Additional prohibited growth Factors FGFs, HGFs, IGF-1, MGFs, PDGF, VEGF and any other growth factor affecting muscle, tendon or ligament. 13/39
14 2. Drugs and more: The Prohibited List Structure of the Prohibited List Substances and Methods Prohibited at all times S0. Non-Approved Substances S1. Anabolic Agents S2. Peptide Hormones, Growth Factors, Related Substances and mimetics S3. Beta-2 Agonists S4. Hormone and Metabolic Modulators S5. Diuretics and Masking Agents M1. Manipulation of Blood and Blood Components M2. Chemical and Physical Manipulation M3. Gene Doping Substances Prohibited In Competition S6. Stimulants S7. Narcotics S8. Cannabinoids S9. Glucocorticoids Substances Prohibited in Particular Sports P1. Alcohol P2. Beta-Blockers 14/39
15 2. Drugs and more: The Prohibited List Structure of the Prohibited List S4. Hormones and metabolic modulators S4.1 Aromatase inhibitors (6-oxo, aminogluthetimide, androstatrienedione,testolactone anastrozole, letrozole, exemestane, formestane) S4.2 Selective estrogen receptor modulators (SERMs) (raloxifene, tamoxifen, toremifene) S4.3 Other anti-estrogenic substances (clomiphene, cyclofenil, fulvestgrant) S4.4 Agents modifying myostatin function(s) (myostatin inhibitors) 15/39
16 2. Drugs and more: The Prohibited List Structure of the Prohibited List S4. Hormones and metabolic modulators S4.5 Metabolic modulators S4.5.1 Activators of AMPK (AICAR) and PPARδ agonists (GW 1516) S4.5.2 Insulins and insulin-mimetics S4.5.3 Meldonium S4.5.4 Trimetazidine 16/39
17 3. Enforcement: Testing Chemical structure of compounds NH 2 CH 3 HO HO H OH O H O N CH 3 H O Amphetamine HO Morphine 9 THC Testosterone PM: 135 Da PM: 285 Da PM: 314 Da PM: 288 Da OH H O N O OCH 2 CH 2 N(CH 3 ) 2 HO HO N C 2 H 5 CH 3 CH 2 C C Salbutamol PM: 239 Da NH 2 Aminogluthetimide PM: 232 Da Tamoxifene PM: 371 Da 17/39
18 3. Enforcement: Testing Chemical structure of compounds H 2 N S O O COOH NH Cl O O N S O COOH HO F H H O OH OH Furosemide Probenecid O Betamethasone PM: 331 Da PM: 285 Da PM: 393 Da O N OH OH H Alcohol PM: 46 Da Propranolol PM: 259 Da 18/39
19 3. Enforcement: Testing Chemical structure of compounds Erythropoietin (EPO) PM: ~ 30,500 Da Growth Hormone (hgh) PM: ~ 22,000 Da Insuline PM: 5,806 Da 19/39
20 3. Enforcement: Testing Analytical Approaches General purpose methods: GC/MS n, LC/MS n injector detector Volatile compounds (gas chromatography) carrier gas oven column Non-volatile compounds (liquid chromatography) mobile phase pump injector column detector 20/39
21 3. Enforcement: Testing Analytical Approaches Singular methods: IEF, SAR-PAGE, Immunoassays, Flow cytometry, etc. EPO and analogues IEF SAR-PAGE 21/39
22 3. Enforcement: Testing Analytical Approaches Singular methods: IEF, SAR-PAGE, IMMUNOASSAYS, etc. Growth Hormone 22 kda 20 kda HRP HRP GH anti-22kda-gh GH anti-20kda-gh 22/39
23 3. Enforcement: Testing Selection of additional tests to perform 23/39
24 3. Enforcement: Testing WADA s Technical Document on Sport Specific Analysis (TDSSA) 24/39
25 3. Enforcement: Testing WADA s Technical Document on Sport Specific Analysis (TDSSA) 25/39
26 1. Doping: Treating vs Eating Why Treating vs Eating? We are what we eat (ingest or be exposed to) What is the definition of food? Are nutritional supplements drugs or food? Does a proper diet covers all nutritional needs of an athlete? Is there anything unethical in using nutritional supplements containing substances [drugs?] that cannot be considered food? 26/39
27 4. Food: Supplements Are nutritional supplements needed? Are nutritional supplements performance enhancing? Are nutritional supplements safe? Caffeine Creatine Ribose Bicarbonate / citrate Theophyline β-hydroxy-β-methyl-butirate (HMB) Glycerol Chromium picolinate Glutamine Carnitine Antioxidants Proteins and aminoacids Colostrum Rodhiola Rosea Vitamins Etc 27/39
28 4. Food: Supplements Many athletes have produced adverse analytical findings (AAFs) attributed to the use of nutritional supplements. - They may be not-properly labeled they may contain substances not mentioned or miss-spelled in the label. (e.g. natural extracts, synonims, etc.) - They may get contaminated during the manufacturing process residual contaminations may escape the GMP but be detected as doping. - They may contan drugs added intentionally e.g. green tea containing diuretics, protein shakes containing anabolic steorids, etc. 28/39
29 4. Food: Supplements 29/39
30 4. Food: Supplements 30/39
31 4. Food: Supplements 31/39
32 5. Regulations: Athlete Support Personnel What is Doping? Conceptual Definition use pharmacological aids to improve performance : The Prohibited List Legal Definition (Art. 1 of The Code): the occurrence of one or more anti-doping rule violations set forth in Art. 2 Article 2: 2.1 presence of a prohibited substance (AAF) 2.2 use or attempted use 2.3 evading, refusing or failing to submit to a test 2.4 whereabouts failure 2.5 tampering or attempted tampering 2.6 possession 2.7 trafficking or attempted trafficking 2.8 administration or attempted admin. 2.9 complicity 2.10 prohibited association 32/39
33 5. Regulations: Athlete Support Personnel What is Doping? Conceptual Definition use pharmacological aids to improve performance : The Prohibited List Legal Definition (Art. 1 of The Code): the occurrence of one or more anti-doping rule violations set forth in Art. 2 Article 2: 2.1 presence of a prohibited substance (AAF) 2.2 use or attempted use 2.3 evading, refusing or failing to submit to a test 2.4 whereabouts failure 2.5 tampering or attempted tampering 2.6 possession 2.7 trafficking or attempted trafficking 2.8 administration or attempted admin. 2.9 complicity 2.10 prohibited association 33/39
34 5. Regulations: Athlete Support Personnel What is Doping? Conceptual Definition use pharmacological aids to improve performance : The Prohibited List Legal Definition (Art. 1 of The Code): the occurrence of one or more anti-doping rule violations set forth in Art. 2 Article 2: 2.1 presence of a prohibited substance (AAF) 2.2 use or attempted use 2.3 evading, refusing or failing to submit to a test 2.4 whereabouts failure 2.5 tampering or attempted tampering 2.6 possession 2.7 trafficking or attempted trafficking 2.8 administration or attempted admin. 2.9 complicity 2.10 prohibited association 34/39
35 5. Regulations: Athlete Support Personnel What is Doping? Conceptual Definition use pharmacological aids to improve performance : The Prohibited List Legal Definition (Art. 1 of The Code): the occurrence of one or more anti-doping rule violations set forth in Art. 2 Article 2: 2.1 presence of a prohibited substance (AAF) 2.2 use or attempted use 2.3 evading, refusing or failing to submit to a test 2.4 whereabouts failure 2.5 tampering or attempted tampering 2.6 possession 2.7 trafficking or attempted trafficking 2.8 administration or attempted admin. 2.9 complicity 2.10 prohibited association 35/39
36 5. Regulations: Athlete Support Personnel 36/39
37 5. Regulations: Athlete Support Personnel Consequences of Doping Sanctions (ineligibility periods) the occurrence of one or more anti-doping rule violations set forth in Art. 2 Article 2: 2.1 presence of a prohibited substance (AAF) 2.2 use or attempted use 2.3 evading, refusing or failing to submit to a test 2.4 whereabouts failure 2.5 tampering or attempted tampering 2.6 possession 2.7 trafficking or attempted trafficking 2.8 administration or attempted admin. 2.9 complicity 2.10 prohibited association 37/39
38 5. Regulations Consequences of Doping Sanctions (ineligibility periods) the occurrence of one or more anti-doping rule violations set forth in Art. 2 Article 2: 2.1 presence of a prohibited substance (AAF) 2.2 use or attempted use 2.3 evading, refusing or failing to submit to a test 2.4 whereabouts failure 2.5 tampering or attempted tampering 2.6 possession 2.7 trafficking or attempted trafficking 2.8 administration or attempted admin. 2.9 complicity 2.10 prohibited association 38/39
39 Thank you! 39/39
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