1998 Flashback: Clenbuterol Use 'Simply Incompatible With Pari-Mutuel Horse Racing' - Horse Racing News | Paulick Report

1998 Flashback: Clenbuterol Use ‘Simply Incompatible With Pari-Mutuel Horse Racing’

(Editor's Note: The following commentary on clenbuterol as a performance enhancing drug was written in June 1998 by Paul Berube, who retired in 2005 after serving for 17 years as president of the Thoroughbred Racing Protective Bureau. Berube brought the article from the Standardbred Investigative Services newsletter to our attention in the wake of commentaries by Ray Paulick in the Paulick Report and Mark Casse in the Thoroughbred Daily News calling for the elimination of clenbuterol as an approved therapeutic drug in horse racing.)

It's hard not to pick up a racing publication these days without reading another headline, story, or commentary about clenbuterol, the German-made bronchodilator sold under the trade name of Ventipulmin. Despite the risk of overkill, the Standardbred Investigative Services (SIS) believes there is still room for a review of this controversial substance about which Thoroughbred Racing Protective Bureau's Information System contains 187 factual references. Hopefully the following insights and opinions will serve to set an accurate record of what clenbuterol is all about and whether its use in a race horse of any breed is wise or ethical.

The very first reference to clenbuterol in TRPB files is dated October 1980 when an official of the U.S. Food and Drug Administration announced that the substance was being used in race horses at low dosage levels and that the drug was effective in lowering air pressure on the trachea of a horse while increasing tidal volume of the lungs. In February of the following year (1981), a disreputable drug vendor sold Ventipulmin granules to a TRPB undercover agent with specific dose and administration times that, according to the vendor, were designed to enhance racing performance. This information was furnished to Dr. George Maylin at Cornell University and by September 1981 he announced that his laboratory had developed post-race testing procedures for the drug. Shortly thereafter post-race positives were reported in Standardbreds and Thoroughbreds in several jurisdictions.

Perhaps the most interesting information conveyed by Dr. Maylin in the spring of 1981 was his confirmation of the strong increase in performance he had been able to document when exercising clenbuterol dosed Standardbreds on the Cornell training track. This led him to describe clenbuterol as “the real McCoy.”

At the time clenbuterol first came on the U.S. racing scene, it was only available for use as an experimental drug by registered veterinary researchers as a prelude to FDA approval for the U.S. marketplace – approval that was denied until May 1998 when the FDA finally approved restricted equine use of a clenbuterol syrup for airway obstruction-related disease. During the 18 years that clenbuterol was not legally available in the U.S., it was approved for equine uses in Canada and Europe. This led to an underground industry of illegal importation and resale to racetrack veterinarians and trainers. TRPB files are replete with Thoroughbred cases where clenbuterol was the common link among trainers with post-race positives and vendors who sold this always in demand (but non-FDA approved) product. In one TRPB case during the summer of 1991, a Thoroughbred trainer had four horses in his barn die overnight. Administration of clenbuterol was identified as the cause of their death.

Beyond horse racing, the use of clenbuterol in food-producing livestock was (and still is) of greater concern to the U.S. Food and Drug Administration since residues of the drug in meat consumed by people has been identified as the cause of severe illness and physical reactions. When administered to steers, lambs, hogs, etc., clenbuterol acts as a growth stimulant. In recent years, testing for clenbuterol at livestock shows and state fairs has produced scandal after scandal where show champion and award winners have been found positive and disqualified. In the mid 1990s, the abuse of clenbuterol in the veal industry brought about an investigative crackdown by three federal agencies, and two Midwestern veterinarians were criminally prosecuted for trafficking in clenbuterol with food producers. Despite its very recent limited approval of clenbuterol syrup for equine use, the U.S. Food and Drug Administration still has not approved the drug for use in food-producing animals. To the contrary, that agency has added clenbuterol to its list of drugs that are prohibited from extra-label use, i.e., use other than for which approved and labeled.

Human athletes have also not been immune from the influence of clenbuterol with some athletes using it as a substitute for steroids in their bodybuilding regimen, this despite inclusion of the drug on the banned list of the International Olympic Committee. In 1972, the women's world champion sprinter and five other athletes were banned from Olympic competition after testing positive for clenbuterol.

In early 1997, intelligence information reached SIS/TRPB that a combination (cocktail) of Lasix and clenbuterol was one of the “hottest hops” being used in racing. A specific regimen of dose and administration time was also received. This information was forwarded Feb. 18, 1997, in separate but identical letters to Dr. Maylin at Cornell and Dr. Rick Sams at the Ohio State Analytical Laboratory. Exactly one year later (Feb. 18, 1998), updated letters were sent to Drs. Maylin and Sams on the details of a field trial with a Thoroughbred that had been dosed with the Lasix/clenbuterol cocktail, exercised, cooled and then sampled. The sample was forwarded to a reputable post-race laboratory with a clenbuterol screen requested. Despite the lab's use of an Elisa test (the most sensitive screen available in racing), clenbuterol was not detected. Also received in 1998 was an added twist on the race day use of clenbuterol – namely injection of a small amount directly into the trachea of the horse within an hour of race time.

In late February (1998), Dr. Maylin advised SIS/TRPB that because the clenbuterol dose levels used with Lasix were one-thirtieth below those previously used in establishing testing procedures, he was going to have to develop new protocols by extracting and concentrating the urine specimen. By mid-March, Dr. Maylin advised that he had developed his new methodology and successfully applied it. Not long afterward, the Lasix/clenbuterol cocktail received national attention in a Daily Racing Form article (April 19, 1998) authored by Matt Hegarty. Since early May, numerous clenbuterol positives in at least four states have been reported in Thoroughbred and Standardbred racers. In the midst of all this, Mr. Hegarty used the newly developed testing protocols to highlight the philosophical and operating differences between two groups of racing chemists, the FDA approved the use of clenbuterol syrup, and the debate between regulators and horsemen was again initiated on low level and supposedly no performance effect post-race positives.

As we move into the summer months of this year and beyond, the stage is set for even more controversy. From a racing standpoint, there is automatic conflict between the FDA's approval of clenbuterol syrup for the U.S. equine market and the new post-race testing standards that can now detect clenbuterol at picogram levels. Conflict is also inherent with the drug itself since it is dual acting.  Although it can be used therapeutically to treat specific physical conditions of a horse, TRPB can attest that its major use in racing has been to illegally enhance/improve racing performance.

To SIS/TRPB, the issue with clenbuterol is clear. Its use is simply incompatible with pari-mutuel horse racing. While it does have value and can be effective in treating a horse with airway obstruction or chronic pulmonary disease, a horse with these problems probably shouldn't be in training or racing in the first place. There is no solution to the sure-to-happen situation where a chemist detects clenbuterol at the picogram level and the trainer and his vet claim therapeutic use of the drug many days prior to a race. The fact is there is no way to differentiate between the use of clenbuterol a few hours before a race or many days prior. Trying to apply no-effect performance thresholds simply won't work with clenbuterol. Pari-mutuel horse racing doesn't need nor can it afford more confusion over the use of drugs in the equine athlete. Clenbuterol may be a worthwhile treatment for a sick horse on the farm but it should be kept far removed from training and pari-mutuel competition with a zero tolerance for any post-race detection.

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