The World Anti-doping Authority (WADA) wants pharmaceutical manufacturers to identify drug candidates in their pipelines that could be used to cheat in sport.
WADA issued the request in a guide published just days before the start of the 2012 Olympics to coincide with the launch of “2 Fields 1 Goal,” an anti-doping accord with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the global Biotechnology Industry Organization (BIO).
In the document – called ‘Points to Consider’ – WADA tells manufacturers how to identify drugs with the potential for abuse in sport and sets out how such information can be shared with the agency in a secure and confidential way.
The identification advice ranges from the assessment of a drug candidate’s structure and mechanism of action – to check for similarity with products already used by cheats – to the measurement of performance enhancement effects observed in preclinical development and clinical trials.
WADA also provides some advice on how candidate compounds deemed to have abuse potential can continue to be developed in a way that minimizes the risk.
“Once a genuine doping risk has been identified in agreement with WADA, it may be useful to set up within the company a dedicated subteam of the product team for each compound with an identified doping risk potential. This group would be responsible for sharing information and materials with WADA.”
In addition the ‘Points to Consider’ booklet contains measures designed to minimize misuse of compounds during clinical trials.
2 Fields 1 Goal
WADA has worked with the drug industry for several years, primarily by asking individual companies to share information on compounds that could be used by sports cheats and to help it develop testing methods capable of identifying them.
The collaborative approach has already produced positive results according to WADA communications director Julie MASSE who told in-Pharmatechnologist.com that: “Just one example is that of CERA, the EPO drug developed by Roche.
“Our ability to detect CERA, a drug perceived by some doping athletes to be undetectable, was the result of a four-year collaboration with Roche to ensure that we had a detection method to find abusers as soon as the drug became available for good and proper medical care.”
Following on from this WADA signed a joint declaration with the IFPMA that encouraged member companies share more information. BIO joined the collaboration in 2011.
The latest step in this tripartite effort - the 2 Fields 1 Goal Campaign that was launched on July 23 - is focused on candidate compounds rather than approved medicines, which are more popular among drugs cheats according to the IFPMA.
“While some approved medicines have abuse potential, their attractiveness for doping is diminished by the fact that these products are well known and detection methods are available. However, medicinal compounds in pre-clinical or clinical development or that have been discontinued may be less well known.”
This relative lack of knowledge may mean it takes longer for anti-doping organisations to become aware of such compounds, enables cheats to use them for longer than they would do if testing procedures were developed.
Eduardo Pisani, IFPMA Director General. "Doping is a public health issue and undermines the integrity of scientific innovation and competitive sports.
“We are pleased to provide support that will help companies determine if they have products in their pipelines that could be abused by athletes, even before they come to market."