The Olympic Games in Sochi captures the world’s attention as athletes compete to bring home gold. Our industry plays a key role in helping to maintain the integrity and honor of sports and competition by remaining vigilant in our anti-doping efforts. Doping undermines the integrity of our industry’s core mission of serving patients through drug discovery and development.
The same medicines that can be used to help children with devastating genetic deficiencies and growth disorders, or to help a chemotherapy patient combat cancer, can also be abused by healthy athletes to gain an unfair advantage. Biologic products intended for use as medicines can enhance endurance, minimize recovery time, or promote muscle growth.
In 2011, BIO signed a “declaration on cooperation” with the World Anti-Doping Agency to encourage companies to voluntarily pass along early information about drugs in development that could be used to boost physical performance.
The risks associated with doping are a real and present danger. By definition, all prescription drugs carry both benefits and risks that must be carefully evaluated by regulators, patients, and their physicians. For a patient suffering from a life-threatening disease, this is a very personal and serious decision.
Yet the benefit/risk balance shifts in the context of doping. If an otherwise healthy athlete abuses a prescription drug or biologic, they assume the known risks, side effects, and potential adverse events without any potential medical benefit.
While some currently marketed medicines are at risk of doping, we know that athletes are looking to newer medicines and emerging technologies still in the laboratory to gain an unfair advantage in sport. These unapproved compounds may be alluring to would-be cheaters due to the perception that no test is yet available to help anti-doping authorities detect them.
Doping activity could even lead to unauthorized manufacturing or counterfeiting of unapproved medicines. Or it could be a motive for the theft or diversion of an investigational product which can delay clinical trials and development programs – harming patients.
BIO endorses the World Anti-Doping Agency/International Federation of Pharmaceutical Manufacturers and Associations (WADA-IFPMA) frameworkto identify medical compounds with doping potential, restrict misuse of medicines still in development, improve the flow of relevant information, and facilitate development of detection methods in the context of the fight against doping in sports.
The“2 Fields, 1 Goal”publication offers companies practical and realistic advice for identifying compounds with doping potential. The report also suggests how companies can collaborate with WADA to minimize the potential risk.
The WADA/industry partnership can help mitigate a potential risk before it becomes a problem. We know that companies need to protect key confidential commercial information and trade secrets. The suggested process does this, and does not place additional burdens on the drug development process. In the event of a doping crisis, we encourage companies and WADA to work together to manage and mitigate the issues.
Together, we can make a difference to maintain the dignity and integrity of sports by reducing the prevalence of doping and continue to develop modern medicines for patients suffering from debilitating and life-threatening diseases.