The cattle industry finally has a pain reliever approved by the Food and Drug Administration! This is a pharmaceutical first and was a long time coming.
On Jan. 31, Merck Animal Health introduced Banamine Transdermal, the first and only product on-label for pain control in food animals approved by the Food and Drug administration (FDA). The pour-on product is specifically for reducing pain associated with foot rot in cattle and fever associated with bovine respiratory disease.
“It’s a non-steroidal anti-inflammatory,” explained Jen Deppe, senior counselor of MorganMyers which represents Merck, when speaking to WLJ in early February. “In human terms, it would be like taking an Advil or a Tylenol.”
The process that got the product to market was a harrowing one, however. The FDA requirements to get a new drug approved take years and countless tests and studies.
“It took a long time,” Dr. Kevin Hill, cattle technical services veterinarian with Merck, told WLJ. “It’s been over 10 years in development.”
To get a drug approved by the FDA, a pharmaceutical company must do something obvious: Prove the drug works. But how do you prove a pain reliever has worked on an animal? It’s not like you can ask them directly.
“You can,” Deppe observed with a chuckle, “but you won’t get much of an answer.”
To get the product approved by the FDA, the Merck development team had to prove it reduced pain. But to prove it reduced pain, they had to come up with a way to measure pain in a quantifiable, direct manner.
“For years they’ve been trying to come up with a good measurement,” Hill explained. “They’ve looked at cortisol … and different blood measurement factors, but they were never very successful with that.”
Cortisol is often called the “stress hormone.” It has been one focal point in research related to pain in animals because pain usually results in higher cortisol levels in the blood.
“You give an intervention to relieve pain and those stress hormones are lower. You can show that and there’s a ton of papers on that—just a ton of papers,” Dr. Temple Grandin, professor of animal science at Colorado State University, Fort Collins, told WLJ last week. There’s a problem with using stress hormones as a measuring stick for pain, however.
“Those are indirect measures of pain,” Grandin said.
Additionally, cortisol and other stress hormones are not restricted to the experience of pain. They are also released when non-pain stress is experienced, such as fear or surprise. This makes it a less than ideal measuring stick for pain.
“So, the model they were successful with was the foot rot model,” continued Hill. “They could measure the pain from foot rot by the pressure that the cow was willing to put on that foot.
“They would walk them across pressure mat like you do in the Dr. Scholl’s foot booth and that pressure mat would record how much force and the length of the stride, area of contact, and those kind of things. So now they can put a metric to that.”
Hill explained that lame cattle would be walked over the pressure mat, given the treatment, then walked over the mat again six hours later. According to Merck’s information on the research methods, all treated cattle across the two experimental groups saw at least one level of improvement on the five-point lameness scoring system after being treated.
This outcome “showed a dramatic decrease in the pain, or an increase in the amount of pressure they were willing to put on that foot,” Hill said. “So that’s what the FDA then accepted as a viable model to measure [foot rot pain].”
Both Hill and Deppe said that this first on-label product for pain relief in cattle is an important step in addressing consumers’ social consciousness concerns and ranchers’ welfare and production concerns.
“In general, for consumers, everybody has their antenna up about animal wellbeing,” said Hill.
“And I haven’t met an animal owner yet who doesn’t want their animals to feel better if they’re having any kind of disease issues.” — Kerry Halladay, WLJ editor
