WADA Health, Medical & Research Committee Meeting May 2001 Stockholm SWEDEN. Minutes

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WADA Health, Medical & Research Committee Meeting 27-28 May 2001 Stockholm SWEDEN Minutes 1. Meeting Commencement, Review of Agenda Members present: Arne Ljungqvist Chair Barbara Drinkwater Bengt Saltin Alain Garnier Eduardo de Rose Gary Wadler Ken Fitch Ted Friedmann Minoru Irie Christiane Ayotte Klaus Mueller Guest: Bjorn Hedman WADA Staff: Nicki Vance Apologies: Johann Koss Arne Ljungqvist welcomed the members, in particular, the new member from Japan, Professor Irie, and acknowledged the presence of Bjorn Hedman, Member of the IPC Medical Commission who had accepted an invitation to attend the meeting. 2. Approval of previous meeting minutes. Minutes approved 3. Report by Chair Arne Ljungqvist provided a general update, including reference to the meeting of the Chair of the IOC Medical Commission with the Medical Commission s of the International Federations, particularly with regard to those IFs who fund research projects. 4. a) Update on current membership, deputy chair Arne Ljungqvist reminded the Committee that Professor Minoru Irie had been confirmed at the previous Executive Committee meeting, and to complete the continental representation, he had received a CV of an African proposal. The Committee agreed to his proposal that Dr Jean-Claude Mbanye, an endocrinologist from Cameroon be invited to become a member of the working committee pending approval by the Executive Committee in Capetown. This would complete the group, although it was acknowledged that the presence of the IPC Medical Commission was appropriate and should be followed up for permanent membership.

AL proposed that Ken Fitch be nominated as the Deputy Chair, stating that it was useful to have a formal Deputy as had been shown by the previous meeting when Arne Ljungqvist had been unable to attend at short notice. b) Update on current staff Nicki Vance explained the new staff at WADA: Stacy Spletzer Education projects Sibylle Villard general administrator 5. Key work of other WADA Committees/staff a) Action arising from previous minutes - 5.1 - HES Acknowledge that while the test for HES is relatively simple it does require additional methods which may increase the cost of the tests. This highlights an issue that is currently facing the laboratories and their clients ie the ability of all labs to detect all substances, and the costs involved in being able to do this. The Committee recommended that the WADA Laboratory Subcommittee address this issue. b) Development of WADA Anti-Doping Code Update Klaus Muller, who represented Arne Ljungqvist at the meeting, provided a brief update re the first meeting of Coordinating Committee. c) Other Nicki Vance updated the Committee on a number of key projects, particularly those relating to the Committee: 1. Athlete Passport It was suggested by the Committee that any therapeutic use approval, including acceptance of medical use of beta-2 agonists could be included in an athlete passport. 2. WADA Laboratory Subcommittee Update re the establishment by the WADA Standards and Harmonisation Committee of a WADA Laboratory Subcommittee to progress the development of a WADA Laboratory Accreditation system as well as address other laboratory issues, initially concentrating on aspects of the current system that are not so well developed, such as continuous quality assessments. ACTION: The H, M & R Committee proposes that it provide a member to the WADA Laboratory subcommittee. The H, M & R Committee would like to be represented by Christiane Ayotte. Nicki Vance to advise George Walker, Chair of WADA S & H. 6. Terms of Reference ACTION: Send out with minutes of meeting. Nicki Vance to include in minutes.

7. Research Applications a) Report from Bengt Saltin WORLD ANTI-DOPING AGENCY Bengt Saltin reported that the quality of the applications was very strong. BS outlined the process of review, and sought feedback from the Committee re a number of issues which needed to be considered prior to the Ad-hoc Research Review Committee making its final recommendations. Issues to consider: Consensus of Committee Research into effect of substances vs development of methods: primary support for development of methods with acknowledgement that a few projects relating to effect of substances may be useful. Length of projects ability to fund for more than 1 year: important to be able to provide funding for more than 1 year with all necessary caveats project progress, WADA funding available etc. Also want to be able to provide long term funding but still able to fund new research in following years need to seek increased funding from WADA Board. Partial and full funding of projects: general principle to provide partial funding, also possible need for negotiation with research applicants, re offering to fund specific sections of their proposals. Should the 3 priority areas be divided into 3 equal amounts of funding: general support for this principle. Appropriateness of research involving administration of banned substances to athletes: While most of the Committee agreed that this was not appropriate it was decided that the Executive Committee should be consulted before a final decision. It was acknowledged that this may change some of the recommendations from H, M&R Committee. Need for Ethical Review of the research: agree that the Ethics Review Committee of the Ethics and Education Committee should be provided with the recommended applications and review them prior to final approval. ACTION: Bengt Saltin to meet with Don Vereen in Capetown to discuss process of Ethical review. Nicki Vance to set up meeting. Partnerships: USADA has $2 million available for research funding, and seeks coordination with WADA. ACTION: Bengt Saltin to meet with Terry Madden in Capetown send email to confirm. Nicki Vance to set up meeting. Patent rights what is the policy re patents?

ACTION: Ask the Legal Director/Committee to provide comment about the issue. Nicki Vance to follow up with Olivier Niggli b) Recommendations from the Ad-hoc Research Review Group Once the general discussion was over and prior to the specific review of the applications, the two members of the Committee who had made applications, Christiane Ayotte and Minoru Irie, left the room. Bengt Saltin explained that for Category A, Ted Friedmann had reviewed the applications without external reviewers but with some input from BS; BS had used two (2) external reviewers to assist in the review of Category B, and Klaus Muller had used six (6) external reviewers. Ken Fitch had also reviewed all applications and gave his views for each application in each category. Ted Friedmann outlined the review of the first category of applications Category A Growth Factors, and provided the rationale for either fully or partially supporting or declining the ten (10) applications. After discussion with the Committee it was determined that five (5) of the ten (10) applications should be recommended to be provided with WADA funding. Bengt Saltin outlined the review of the second category of applications Category B Oxygen carrying capacity, and provided the rationale for either fully or partially supporting or declining the nine (9) applications. After discussion with the Committee it was determined that six (6) of the nine (9) applications should be recommended to be provided with WADA funding. Klaus Muller outlined the review of the third category of applications Category C Endogenous testosterone, testosterone precursors and metabolites, 19 nor-steroids and establishment of normal urinary levels of these and related compounds, involving six reviewers and provided the rationale for either full or partial supporting or declining the 21 applications. After discussion with the Committee it was determined that nine (9) of the 21 applications should be recommended to be provided with WADA funding. It was noted that as there were two projects that involved personnel from Klaus Muller s laboratory that after reporting on the feedback from the reviewers, Klaus was not involved with the final decisions. The applications which would be recommended to the Executive Committee for approval are at Appendix A. Note these are not to be regarded as final as the Executive Committee did not agree to all recommendations. Ken Fitch asked that it be noted to thank the reviewers for a difficult job well done.

c) Recommendations to go to Executive Committee It was agreed that Bengt Saltin would represent the H, M & R Committee at the Executive Committee meeting in Capetown and he would prepare the papers and a presentation to be made to the Executive Committee, supported by Nicki Vance in the WADA office. 8. Therapeutic Use of Prohibited Substances a) Update from Subcommittee meeting on 26 May Ken Fitch The Subcommittee had developed some general principles and procedures for therapeutic use approvals. The draft paper was provided to the Committee, and the Committee asked to send any feedback to Nicki Vance or Ken Fitch. ACTION: Provide feedback on the draft paper to Ken Fitch or Nicki Vance 9. Banbury Centre Genetic workshop a) Update of preparations Ted Friedmann and Nicki Vance updated the members. Preparations are progressing well. Casey Wade had met with the Director of the Banbury Centre to understand requirements of both organisations. ACTION: Banbury requires a final list of participants as soon as possible. Nicki Vance to finalise with Ted Friedmann and Harri Syväsalmi. b) Update re Program Aim of the Workshop to bring experts in the fields of anti-doping, sports medicine and genetics together in order to discuss the matter of the possible misuse of gene therapeutic technologies for the purpose of enhancement of physical performance. Expected Outcome/Output Banbury Report: A summary of the meeting outlining definition of the problem and recommendations for moving forward. ACTION: Ted Friedmann and Gary Wadler to prepare a second draft program and forward it to WADA office. c) Next steps Preparations for Press Conference: There is already significant media interest in this issue, and while the media will not be invited to Banbury itself, WADA intends holding a press conference at a facility near by after the Workshop. It was not clear whether the Banbury Centre people would also be involved in such a press conference. ACTION: Confirm with Isabel Tornare and Mike Kontos where the press conference will be held and who is organising it.

d) General Issues Gene Doping Consider refining definition of doping to include reference to gene doping through providing a recommendation to the Ad-hoc List Committee ACTION: Gary Wadler to prepare a revised definition. Ted Friedmann and Johann Koss have prepared an article to be published soon. ACTION: Ted Friedmann to provide article to Nicki Vance to distribute the article to the Committee. 10. 2001 List of Prohibited Substances a) Update re 2001 List Arne Ljungqvist and Nicki Vance updated the Committee with regard to the current status of the List. The new IOC Executive Board approved list (approved following recommendation from WADA) will be circulated to International Federations, National Olympic Committees and National Anti-Doping Agencies through a joint letter from WADA and the IOC. The 2001 List will be valid from 1 September 2001. b) IOC MC Asthma Workshop, 13 May 2001 outcomes Ken Fitch presented the outcomes of the IOC Medical Commission asthma workshop, particularly the requirement for Olympic Games that requires athletes who want to use beta-2 agonists to be reviewed by an independent panel. The Committee approved in principle the proposals. 11. 2002 List of Prohibited Substances a) Update re meeting 12 May Arne Ljungqvist provided a report from the first List Subcommittee meeting, held 12 May 2001. The IOC has since agreed to the List Subcommittees recommendations that due to the 2001 List only becoming valid in September 2001, that this list will be valid until at least the beginning of 2003. This follows the general recommendation from the WADA List Subcommittee that the List should be valid for 2 years, with provision for amendments made where necessary at other times. The next meeting of the List Subcommittee will be in September 2001. 12. Testing of natural steroids testosterone, nortestosterone and precursors Christiane Ayotte made a presentation regarding testing of steroids etc.

13. EPO Test Update Nicki Vance outlined the discussions and outcomes from the two meetings held with six International Federations. Bengt Saltin added remarks relating to the meetings, adding some specific information relating to the FIS. Bengt Saltin supported WADA s involvement in the program working with the IFs. Christiane Ayotte suggested that for future meetings additional scientific members from this Committee should be involved, particularly from the laboratories. ACTION: Nicki Vance to follow up with Harri Syväsalmi re the possibility of inviting an additional member from the Committee to participate in the next meeting to be held on 2 July 2001 in Lausanne, and at least to ensure that Bengt Saltin is available and representatives form the Lausanne Laboratory. Issues raised: Future development of genetically produced EPO resulting in the current EPO urine test being redundant Consequently, the need for ongoing research into a blood test for EPO This style of meeting with a small group of specific IFs was seen as a constructive way to work with International Federations. Recommendation: Following the report by Nicki Vance and Bengt Saltin, the Committee supported the progress made by WADA in this area, and endorsed the test as outlined: A blood screen, including three measures haematocrit, haemoglobin and % reticulocytes followed by an EPO urine test on selected athletes. 14. Nutritional Supplements a) Update re current projects/research Christiane Ayotte presented update information regarding Nutritional Substances and functional food. [reference Consumer Reports June 2001; S Hendley, PDR for Nutritional Supplements, 2001.] The Committee asked that some of this information be prepared for the WADA Internet site.. ACTION: Christiane Ayotte agreed to prepare some materials and provide them to WADA to put on Internet Site. Nicki Vance to follow up with Isabelle Tornare.

15. IV Fluid Replacement WORLD ANTI-DOPING AGENCY a) Review of rules relating to sport weigh-in requirements Ken Fitch reminded the Committee that the original request to examine this issue had come from an Australian doctor who was concerned that he was being asked by athletes to provide IV fluid replacement after athletes had made weight for their event. As had been agreed at the previous meeting Eduardo de Rose tabled a review of the weigh-in timing and procedures relating to weight related sports. Recommendation and ACTION: The Committee agreed that Arne Ljungqvist and Nicki Vance would contact the Medical Commission Chairs of the relevant sports to discuss the interest in having a meeting with regard to this issues. 16. Forums a) Table any related forums no new forums tabled 17. Any other business Bengt Saltin expressed concern about the malpractice of the physicians involved in doping cases, such as the Finnish doping cases, and despite them being banned from sport that this did not effect their medical practice. ACTION: Bengt Saltin would follow up with the Finnish Sports minister, and Arne Ljungqvist would follow up with his colleagues, and both would report back to the Committee in September. 18. Next meeting - 23 September 2001 Banbury Centre, New York, USA [List Subcommittee 22 September 2001 Banbury Centre exact location to be advised; Banbury Genetic Workshop, 24-26 September 2001] Minutes Review process: 1. Minutes reviewed by Arne Ljungqvist feedback provided and amendments made 9/6/01 2. Minutes circulated to all members of Committee for review - 11/6/01 3. Feedback received, amendments made and final minutes circulated and posted on website 18/6/01