The Breeders’ Cup Forum: Inside the Testing Lab by Ray Paulick|08.28.201301.17.2015|1:01pm11:45am Dr. Rick Sams Richard Sams, Ph.D., is director of HFL Sport Science, a Lexington, Ky., laboratory that performs drug testing for the Kentucky Horse Racing Commission and the Virginia Racing Commission, among other jurisdictions. It is one of two North American laboratories to have received accreditation from the Racing Medication and Testing Consortium (the other being the Kenneth L. Maddy Equine Analytical Chemistry Laboratory at the University of California-Davis). Widely recognized as a leader in the field of equine drug testing, Dr. Sams previously headed the Florida Racing Laboratory at the University of Florida's College of Veterinary Medicine and before that was longtime director of the Analytical Toxicology Laboratory at the College of Veterinary Medicine at Ohio State University. HFL Sport Science is a relatively new player in the equine drug testing field. What's the brief history of the company and your involvement with HFL? HFL Sport Science, Inc. in Lexington, Kentucky was established by HFL Sport Science in Fordham, Great Britain, in 2010 to provide testing services for the Kentucky Horse Racing Commission. HFL Sport Science in Fordham has a long history of providing testing services for horse and dog racing in Great Britain having begun as the Horseracing Forensic Laboratory more than 40 years ago. The HFL laboratory in Fordham is one of the pioneering laboratories in anabolic steroid research in horses and dogs and is widely recognized for its accomplishments in these and other areas of investigation. I was approached by HFL early in 2010 to become director of the Lexington laboratory. I was director of the Florida Racing Laboratory at the University of Florida at the time but was attracted by the opportunity to establish a new laboratory in Lexington with strong ties to the Fordham laboratory, to hire highly qualified and dedicated personnel, and to implement innovative testing methods using state-of-the-art instrumentation in order to serve the testing needs of the Kentucky Horse Racing Commission as well as others. How did HFL so quickly become just one of two labs accredited with the Racing Medication and Testing Consortium? Laboratory accreditation is a priority with HFL Sport Science at the Fordham and Lexington laboratories. Both laboratories have invested substantial human and financial resources in establishing a laboratory that is able to meet all accreditation requirements. Furthermore, we take pride in fostering a laboratory culture that embraces the principles of laboratory accreditation. These principles are practiced by all of our employees every day and not just during accreditation site visits. Furthermore, we received considerable assistance and guidance from our colleagues at HFL Fordham and at our parent company LGC in preparing our accreditation application materials. What are the biggest changes in drug testing since you entered the field in 1977? Testing procedures have changed dramatically in terms of specificity and sensitivity of detection since I began working in this area in the late 1970s. I have witnessed the introduction of newer approaches to testing that are characterized by dramatically increased sensitivity and specificity as well as the use of automation and high-speed data processing and data analysis. Gas chromatography with electron capture detection and thin layer chromatography were the primary screening procedures available for my use in the Ohio laboratory from the late 1970s to the mid-1980s when the first ELISA tests specifically developed to detect drugs and related substances in urine samples from horses were introduced. Many laboratories quickly changed their testing programs to include a few to many ELISA tests in order to detect substances that were not detectable using thin layer chromatographic methods. For the past decade or so liquid chromatography with mass spectrometric detection has become the method of choice for screening test samples for regulated and prohibited drugs and the use of ELISA methods has declined steeply except in a few laboratories. The scope of coverage of prohibited and regulated substances that is possible with the use of instrumental methods of analysis cannot be duplicated by ELISA methods and is substantially less expensive per detectable substance. The specificity of instrumental methods of analysis is a distinct advantage because it is possible to learn the identity of a substance in the screening test. When I joined the Ohio laboratory in 1977 many state racing commissions allowed the use of a number of therapeutic medications on race day without restriction. The focus of testing at that time was on the detection of stimulants and depressants as well as local anesthetic drugs and others that are performance enhancing or that have the potential to endanger the horse and rider. Due to race day administration of permissive substances it was not unusual to receive urine samples that contained very large concentrations of substances such as phenylbutazone and to see evidence for the diuretic effects of furosemide in urine samples that were very dilute. Awareness of the effects of high concentrations of phenylbutazone and its metabolites on the detection of other substances and the effects of furosemide-induced diuresis on the detection of drugs in urine was recognized by racing officials in the early 1980s and rules were established by the National Association of State Racing Commissioners (NASRC, predecessor to the Association of Racing Commissioners International) in 1983 to restrict or eliminate race day medication. Much of the discussion regarding drugs in racing 30 years after these critical decisions by the NASRC still deal with the proper roles of therapeutic medication in racing. Last weekend, the New York Times published results from an anonymous survey done by the World Anti-Doping Agency, which showed that 29% of track and field athletes at the 2011 world championships and 45% of those at the Pan Am Games admitted to illegal doping. What's your reaction to that story? I was surprised that so many human athletes would admit to illegal doping and I wondered what U.S. horse trainers would report in a similar survey. I believe that most horse trainers do not consider the administration of therapeutic medications at any time to be a form of doping so the questionnaire would need to be worded correctly to differentiate the routine administration of regulated therapeutic substances from performance-altering substances. How important is the relationship between the testing lab and a racing commission, in particular its equine medical director? I believe that the relationship between the testing laboratory and the racing commission is one of the most important factors in assuring the integrity of racing. The relationship is one that must be based on mutual trust and respect. I feel that we have such a relationship with the racing commissions for which we have testing contracts and I work hard to maintain those relationships. Who's winning the war in horse racing: those who are trying to get a chemical edge or the regulators and testing labs? I don't know who is winning. I tend to be an optimist so I expect others to follow the rules of racing. Therefore, I was shocked and disgusted by the discovery of relatively widespread use of dermorphin by a number of trainers for no purpose other than to affect the outcome of the race with complete disregard for the health and safety of the horse and jockey and the integrity of the sport. I am particularly disgusted by the person or persons who made dermorphin available to horse racing. What is the difference in testing of out-of-competition samples vs. post-race samples? Out-of-competition testing in Kentucky is targeted for just those substances identified in the out-of-competition testing rules and does not include therapeutic substances or many Class 1 and Class 2 substances. Out-of-competition testing has been focused on detecting the use of blood doping substances such as EPO and related substances that can produce an effect that persists after the drug is no longer detectable. How do you think drug testing can become more effective under the current regulatory structure? 1. Institute uniform rules across all racing jurisdictions; 2. Specify what each laboratory is required to be able to do and to fund it adequately so that it can meet those specifications; 3. Require RMTC accreditation of each laboratory; 4. Provide research findings to laboratories to develop new methods of detection and to detect new substances; 5. Improve intelligence and surveillance in order to detect drug use; 6. Increase the use of out-of-competition testing and the use of nontraditional samples to increase our knowledge of the substances that are being used to affect performance; 7. Make better use of equine medical directors and require each commission to obtain the services of an equine medical director. The term “super test” was created about a decade ago. When we hear that term, what does it mean? The “super test” is a term used to describe an expanded menu of tests and is typically used to describe tests performed on samples collected from horses in graded stakes races. The term was introduced in the late 1990s when laboratories relied primarily on ELISA tests to screen samples for prohibited and regulated substances. Most laboratory budgets did not allow a laboratory to purchase all commercially available ELISA kits so most were forced to select certain tests from the available tests to test samples. The number of tests that they performed on each sample was dictated largely by budget and the test menu was varied over time to provide expanded coverage of prohibited and regulated substances. The “super test” then was a test that utilized an expanded menu of ELISA tests compared to the menu used to test routine samples. For those few laboratories that still use ELISA tests as their primary means of detecting substances in test samples test rotation is used to provide expanded coverage. These laboratories may use an expanded menu of tests or a “super test” to test certain samples or samples from stakes races. For HFL Sport Science the term “super test” is not applicable because all samples received by the laboratory are tested by a comprehensive menu of instrumental based methods designed to detect the broadest range of prohibited and regulated substances that goes beyond what can be achieved by the use of an expanded menu of ELISA tests. All samples are subjected to the same intense scrutiny whether they were collected from the Kentucky Derby or an isolated county fair. Another term often used is “zero tolerance.” What is its meaning to someone in drug testing? For each substance there is a concentration below which the substance can no longer be detected by that method. That concentration of substance is defined as the limit of detection of the method for that substance. If we change the method to a more sensitive one, the limit of detection for that substance will be lower in the more sensitive test. Limits of detection are not values that we set but they are values that are determined by the physicochemical properties of the substances that we want to detect and by the methods that we chose to use. “Zero tolerance” then refers to a policy under which a substance will be reported if the laboratory detects it. In other words it is the limit of detection of the method for each substance that determines the lowest concentration of the substance that will be reported. One of the consequences of the use of a “zero tolerance” policy is that the concentration at which a substance will be reported will differ from one laboratory to another and within the same laboratory from time to time as new methods with different sensitivities are introduced. A “zero tolerance” policy is based solely on the analytical methodology and not on the pharmacology of the drug. For those substances such as dermorphin and etorphine that should never be present in a horse at any concentration, a “zero tolerance” policy is appropriate and the introduction of new methods with lower limits of detection without notice is proper. On the other hand, the use of a “zero tolerance” policy for therapeutic substances is not appropriate because it contributes substantially to differences between racing jurisdictions and makes compliance with rules more difficult particularly if methodology is changed without notice to veterinarians. What are the biggest challenges you face in the drug-testing field, and how do you deal with them? One of the biggest threats is the introduction of protein based drugs such as human recombinant erythropoietin and peptide drugs such as dermorphin because these substances are larger than most of the drugs that our methods are designed to detect and therefore present analytical challenges that are sometimes difficult to overcome. There are many peptides that have the potential to affect the horse. Because peptides are readily synthesized, it is possible for unscrupulous persons to obtain them with little effort. It will require concerted efforts of those involved in racing combined with appropriate penalties to deter the use of these substances. The excessive use of therapeutic substances with thresholds threatens to overwhelm laboratories in some racing jurisdictions because the effort required to confirm a phenylbutazone or flunixin overage is comparable to the effort required to confirm the presence of dermorphin in a blood or urine sample. Consequently, laboratory resources are being severely stretched to meet these needs and to report findings in a timely manner. The ARCI's new penalty guidelines for multiple medication violations may be of assistance if it acts as a deterrent to repeated medication violations. Several racing commissions provided substantial amounts of research funding to racing laboratories in the 1980s and 1990s but most of these sources of funding have been lost. Those research funds were essential for developing new methods and for identifying new substances with the potential to affect performance. Identification of new sources of research finding is essential if we are to continue to detect newer substances. Federal legislation currently before Congress would put the United States Anti-Doping Agency (USADA) in a powerful oversight role. How would that effect a lab such as HFL? The United States Anti-Doping Agency has a long history in drug testing in amateur and professional sports in the United States but no experience at all in testing samples from race horses. Although most, if not all, of the drugs that are prohibited in human athletic competition are prohibited in horse racing, the converse is not true. Large numbers of drugs that are prohibited in horse racing are permitted in human athletic competition without any restriction or are permitted with a medical use exemption. Therefore, personnel at USADA would need to become knowledgeable about the regulatory paradigm in horse racing. USADA employs a number of highly trained and experienced scientists and other professionals who are aware of these differences and who would quickly understand the consequences to and challenges of testing for larger numbers of substances than is the norm for human drug testing. If it is determined that USADA will have an oversight role for race horse testing in the U.S., we at HFL look forward to working with them and assisting in any way that we can. If you could change four things about the horse racing industry as it relates to drug testing, what would those changes be? 1. Adopt uniform drug and medication policies and rules across all racing jurisdictions in the US; 2. Adopt uniform performance standards for all race horse testing laboratories in the US; 3. Allocate adequate budgets to carry out race horse testing as it is mandated by the rules and to perform the fundamental research that is required to implement validated methods to detect new substances; 4. Encourage collaborative efforts by all persons involved in horse racing to bring an end to the excessive use of drugs and medication in horses entered to race.