Merck Makes Statement Regarding Zilmax *UPDATED*

Cattle feed additive Zilmax has been pulled by its New Jersey-based drugmaker Merck Animal Health as of Friday, AUgust 16th. In a statement, they said:

At Merck Animal Health, the health and well-being of animals is our first and foremost priority. We also take very seriously our commitment to providing safe, effective products that are developed based on comprehensive research, rigorous testing and sound science. We believe in the science that supports Zilmax and are confident in its safety and performance. Reinforcing this science and data-based approach, Merck Animal Health has announced it has strengthened its commitment to its Five-Step Approach to Ensuring Responsible Beef.

As previously announced, Merck Animal Health, in conjunction with independent experts, will conduct a scientific audit, which will monitor the process of feeding of Zilmax, and will follow identified cattle from the feedyard to the packing plant to determine potential causes of lameness and other mobility issues during feeding, transportation, offloading and staging at the processing facility. We also will do a thorough review of potential compounding factors—such as nutrition, transportation and receiving facilities.

In support of our customers and to ensure effective implementation of our five-step plan, Merck Animal Health has made the decision to temporarily suspend sales of Zilmax in the United States and Canada. This will allow sufficient time for the establishment of valid study protocols, identification of feeders and packers to participate in the audit, and creation of a third-party team to oversee this process and validate its results.

“We remain confident in the safety of the product, based on our own extensive research and that of regulators and academic institutions, and are committed to the well-being of the animals that receive it,” says KJ Varma, BVSc, Ph.D., Diplomate ACVCP, Senior Vice President Global R&D, Merck Animal Health. “This important step demonstrates our commitment to providing our industry partners with data that will reaffirm confidence in Zilmax. We sincerely regret that this situation creates business challenges for our customers but it is critical to ensure that this process is conducted appropriately and with rigorous scientific measures. After the five-step plan is completed, the results will be shared publicly.”

In addition, we are also accelerating the development of our Merck Animal Health Advisory Board, which will bring together industry experts, producers, academics and company leadership to promote an open dialogue on animal well-being and help shape and strengthen the company’s animal health and well-being program in the future.

Zilmax sales in the United States and Canada were $159 million in 2012. Visit the Zilmax Information Center at http://www.merck-animal-health.com/zilmaxinfocenter.aspx for more details and updates on Zilmax.

At Merck Animal Health, we constantly evaluate our processes and procedures across the entire company to ensure that we maintain the best science-based practices and procedures for not only the welfare of our animals but our business as a whole. We are proud of our animal well-being policies, as well as our role in providing quality products that meet the needs of a diverse consumer base around the world.

We remember that Tyson Foods sent out a letter to cattle feeders saying that as of September 6th, it will not accept cattle fed the beta agonist growth promotant Zilmax.

Zilmax (zilpaterol hydrochloride) is an FDA-approved supplement for beef cattle that increases gain and feed efficiency in the production of beef. It is marketed by Merck.

In its letter, Tyson said that there have been recent instances of cattle delivered for processing that have difficulty walking or are unable to move. The letter goes on to say, “We do not know the specific cause of these problems, but some animal health experts have suggested that the use of the feed supplement Zilmax, also known as zilpaterol, is one possible cause. Our evaluation of these problems is ongoing, but as an interim measure we plan to suspend our purchases of cattle that have been fed Zilmax.

“This is not a food safety issue,” the letter continued. “It is about animal well-being and ensuring proper treatment of the livestock we depend on to operate.”

The letter went on to say that the suspension would remain in effect “until further notice”.

National Cattlemen’s Beef Association CEO Forrest Roberts provided the following statement to Brownfield on that Wednesday evening:

“Cattlemen and women believe in the right of farmers and ranchers to responsibly use FDA-approved technologies. We also believe in Tyson’s right to make individual company decisions that they feel are in the best interest of their business. We do not have all the details regarding the animal welfare concerns cited by Tyson in the letter to their cattle suppliers. However, we take every report of animal welfare issues very seriously.

“We have expended significant resources to address questions about the use of beta-agonists relative to animal welfare concerns. We convened experts across the beef supply chain who have conducted extensive research on beta-agonists and engaged cattle feeding and animal health experts who have many years of experience using these products. We will continue these efforts until we have solid answers to these questions. In the meantime, we believe these products can be used responsibly when managed properly.”

Merck made the following statement immediately following Tyson's letter:

Animal well-being is a priority for Merck Animal Health.

The facts are clear. The benefits and safety of Zilmax® (zilpaterol) are well documented. Zilmax has a 30+ year history of research and development and rigorous testing. Worldwide regulatory agencies have reviewed extensive data on Zilmax and have concluded that use of Zilmax according to the label is safe in cattle. It is important to understand these data included rigorous animal health safety and well-being studies - conducted by University experts - that found the behavior and movement of cattle fed Zilmax is normal.

We are surprised by Tyson’s letter. We are confident that, based on all of the available data on Zilmax, the experience reported by Tyson is not attributable to Zilmax. Indeed, Tyson itself points to the fact that there are other possible causes and that it does not know the specific cause of the issues it recently experienced. We will continue to work with Tyson to help it identify those other causes. Again, we are confident that the totality of our data does not support Zilmax as being the cause of these experiences, and we remain confident in the safety of the product.

Zilmax has a withdrawal period 3 days prior to harvest. Not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves. For complete safety information, refer to product label and Zilmax website.

For more information on Zilmax and how the proposed changes may affect cattle producers, stayed tuned to AM 730 KWOA.

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