Confidentiality in Research Called Necessary

An official with the Racing Medication and Testing Consortium said confidentiality agreements used when the organization considers research to set thresholds and withdrawal times for medications are necessary because of scientific factors and involvement by other racing jurisdictions.

The issue came to light during the recent National Horsemen's Benevolent and Protective Association summer convention, at which a forum on the bronchodilator clenbuterol was held. Dr. Steven Barker, chemist for the Louisiana State Racing Commission, questioned the use of confidentiality agreements; he suggested the industry should know the science behind a given policy.

Dr. Thomas Tobin, a scientist at the University of Kentucky Gluck Equine Research Center and a National HBPA medication adviser, was on the RMTC Scientific Advisory Committee but opted not to sign a confidentiality agreement. The RMTC had decided those who didn't sign the agreement would be removed from the committee.

The National HBPA, Thoroughbred Horsemen's Association, and Thoroughbred Owners of California all have seats on the RMTC board of directors.

In a July 19 letter and follow-up conversation July 22, RMTC executive director Dr. Dionne Benson said members of the Scientific Advisory Committee were asked to sign confidentiality agreements for two reasons: Researchers are often to required to have their information published, and the publishers don't want the studies released beforehand; and because other countries often don't make research public.

"The RMTC has entered into confidential relationships with other racing jurisdictions in North America, Europe, and Asia that perform drug administration research on horses," Benson said. "In most other jurisdictions, the results of their research are not made available to the public and are only available to those who are willing to enter into a confidentiality agreement that restricts dissemination of the data and results.

"In order to obtain this information and not repeat costly research, the RMTC has entered into confidentiality agreements with other jurisdictions. As a result of the RMTC confidentiality agreements, members of the (Scientific Advisory Committee) have access to data and results that would otherwise not be available, and can review the data and make recommendations to the (RMTC) board."

Benson said if that wasn't the case, some of the 24 substances on the most recent controlled therapeutic medication list would be prohibited.

The RMTC said it costs about $60,000 to develop threshold and withdrawal times for one therapeutic drug. If an organization requests that substances be added to the controlled list, they are required to pay part of the cost.

The National HBPA, during its convention, said it believes there could be up to 10 more medications worthy of the list, depending on feedback from veterinarians. Benson said the 24 therapeutic drugs on the list were determined by a task force under the Association of Racing Commissioners International, which is responsible for model rules.

Benson said the task force was broad-based with regulatory vets, chemists, regulators, practicing vets, and others. The National HBPA had at least one representative, she said.

The proposed model rule on multiple violation penalties relies on the threshold levels and withdrawal times for the 24 therapeutic medications. The RCI will consider the model rule during meetings July 30-31 in Saratoga Springs, N.Y.

During the National HBPA convention, Barker said he and others are uncomfortable with the RMTC position on confidential research. He said "variability" in the level of clenbuterol in a sample can vary from day to dayand that could be the case for other drugs on the therapeutic medication list.

"How much of this is based on science, and how much is based on something else?" Barker said.

A summary of a study conducted by the University of California-Davis on detection, pharmacokinetics, and cardiac effects following administration of clenbuterol to exercised horses was released in mid-June. The summary appears on the RMTC website.

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