The Role of Animal Health Care Products and Pharmaceuticals in Agriculture

As a key element in meeting the protein needs of growing populations, a range of significant efforts is being directed toward enhancing the health of America’s livestock.

Within the context of heightened media attention and consumer awareness about the issue of antibiotic resistance, and the U.S. government taking action to change the way in which antibiotics are used in livestock as described in the 2015 “National Action Plan for Combating Antibiotic-Resistant Bacteria,” the entire industry is adjusting to new regulations in this regard. Increased focus on animal disease prevention, technological advances, and new alternative products, combined with responsible use of antibiotics, all play a role in maintaining a healthy food supply, according to industry experts.

“Vaccines and antibiotics play a key role in prevention and treatment of disease for anyone involved in raising livestock,” said Craig Jones, D.V.M., MS, director, Cattle Professional Services at Boehringer Ingelheim Vetmedica, Inc. (BIVI). “But I think we need to keep in mind that keeping animals healthy involves a much greater, more holistic view than just vaccines or pharmaceuticals/antibiotics. We’ve got to focus on proper nutrition, genetics, housing, other basic animal care and husbandry practices. Animal health care products are a tool for helping us produce healthy animals, but by themselves, they’re not going to be nearly as effective. We have to have good animal husbandry, in addition.”

This philosophy supported the 2012 launch of the Prevention Works initiative by the BIVI cattle division. The initiative emphasizes disease prevention as a preferable way to maintain animals’ well-being, rather than just treating diseases as they arise, and to reduce the number of animals that require disease treatment. “We have a real focus around preventive medicine,” said Jones. “We believe that with good management and a well-designed vaccination protocol, many of the diseases can be prevented, or at least minimized.”

“Animal health care products are a tool for helping us produce healthy animals, but by themselves, they’re not going to be nearly as effective. We have to have good animal husbandry, in addition.” — Craig Jones, D.V.M., MS

Speaking from a cattle perspective, Jones explained that the goal is promoting those measures “early in the calf’s life, in order to enhance immunity and prepare that calf for challenges as it moves on through the production phase. In the case of the beef calf, moving from being on its mother to being weaned, or moving from the ranch to the feed lot, we want to prepare that calf for those next steps. With vaccination and good management, we can make that transition much, much smoother and improve that calf’s well-being.”

While those measures provide an excellent foundation for livestock health, vaccines and antibiotics also continue to support that effort.

“Vaccines are really a cornerstone to preventing many of the animal diseases,” Jones said. “I think we need to keep in mind that preventive medicine also helps us address many other important issues. When we prevent disease, we reduce the need for antibiotics, and at the same time, we promote animal well-being. It’s a win-win for everyone – the animal, the producer, and customers on down the line.”

Addressing the changing landscape concerning use of antibiotics, Jones said, “The livestock industry, whether we’re talking producers, veterinarians, the animal health industry, all of us recognize the consumer concerns about the use of antibiotics in food-producing animals. I think we have to keep in mind that just like people, animals get sick. We have to have antibiotics – they’re very important and necessary tools for treating disease and improving the health of that animal … When animals get sick, we need to treat them.”

Jones emphasized, “Everyone involved in the care of animals says we need to make sure we’re using them judiciously and responsibly so that they’ll continue to be efficacious, as far as antibiotics go. That means working with our veterinarians to determine a diagnosis, selecting an antibiotic that is effective for the condition to be treated, and any product that we use, using it as it’s labeled and/or prescribed.”

“When we prevent disease, we reduce the need for antibiotics, and at the same time, we promote animal well-being.” — Craig Jones, D.V.M., MS

The use of antibiotics has been the subject of recent government action. Specifically, the U.S. Food and Drug Administration (FDA) Veterinary Feed Directive (VFD) final rule aims to eliminate the use of medically important antibiotics for growth promotion and feed efficiency, and brings their remaining therapeutic uses in feed and water under licensed veterinarians’ supervision. Jones said that although BIVI doesn’t market any products that are affected by the new VFD rules, it does represent a change for producers and veterinarians.

“I believe the producers will rely on their veterinarian extensively to help them gain the necessary information, to better understand these regulations, and to help them, if needed, implement them in their operations,” he said. “They’ve got to learn what these [regulations] are and work with their veterinarian to determine how they can implement them when needed.

chickens no antibiotics

Broiler chickens graze on organic pastures and live in pens that protect them from predators, direct sunlight, and wind on Nick’s Organic Farm in Adamstown, Maryland. Some major producers have started eliminating the use of antibiotics in their chicken feed, following the lead of organic farms. Credit: USDA photo by Lance Cheung

“I think consumers should know that the livestock industry, from animal health companies to veterinarians to livestock producers, we all work hard to provide food that is healthy and safe,” Jones stressed. “Producers are committed to caring for their animals properly and treating them when needed, giving them respect and proper care, to ensure their health and well-being.”

Jones said that BIVI’s vaccine research and development efforts focus on “trying to monitor diseases and disease trends to help us better understand what challenges are out there, how they’re affecting the industry, and from there, is there a vaccine that is needed or not?” He also acknowledged challenges in developing both new vaccines and medications like antibiotics, including cost and the lengthy time required to develop new products and gain regulatory approval, as well as risk that some will not succeed.

Summarizing his message, Jones reiterated, “Vaccines are a key component of maintaining a healthy herd and antibiotics are an important tool for us when we have sick animals. We’re committed to trying to provide safe and efficacious vaccines and antibiotics to ensure that the animals that we care for are healthy, and that consumers have a safe and healthy food supply and protein source to choose from.”

Joel Harris, head of sales and marketing at Harrisvaccines, Inc., echoed some of those concepts regarding the role of vaccines in agricultural animal health. “Especially as people look toward alternatives to antibiotics, vaccines can be used as a preventive [measure],” he said. “I think that it’s an important role in mitigating disease issues that come up, but it is a tool. I think that you have to have a comprehensive strategy that includes biosecurity and animal welfare for a vaccine to really be effective.”

Harris explained that the company is unique in that it utilizes advanced molecular technology to develop and produce custom, herd-specific vaccines. A sample from an infected animal is sent to a lab where the RNA gene sequence of that specific viral strain is identified, and forwarded electronically to the Harrisvaccines production facility. With that precise genetic information, the custom vaccine is synthesized to address the specific organism in a herd. The vaccines can also contain more than one viral strain. And, this process takes as little as four weeks, a time frame Harris indicated they’re attempting to further reduce.

“Especially as people look toward alternatives to antibiotics, vaccines can be used as a preventive [measure].” — Joel Harris, Harrisvaccines

“We know that if you match the vaccine 100 percent to the strain that’s affecting the herd, you’ll have an impact on production, meaning you’ll have a positive impact on mortality rates and performance,” Harris said.

That process not only allows them to make custom vaccines for individual herds or flocks, Harris said, but to also tackle newly emerging diseases more responsively than traditional vaccine technology with the ability to rapidly develop new candidate vaccines in a period of weeks instead of months or years. For example, he said, “We were the first company to commercialize and get USDA [U.S. Department of Agriculture] approval for [a vaccine for] porcine epidemic diarrhea, which entered the U.S. in 2013 [and killed up to 8 million pigs], and the first company to get an avian influenza vaccine approved by the USDA and a subsequent stockpile order by the U.S. government. Both of these scenarios are very similar. When a new disease or a foreign animal disease comes into the U.S. and there isn’t a product on the market, we’re able to answer that need.

“I think at Harrisvaccines we’re kind of at the forefront of the newer technologies being more accepted in the animal health industry,” said Harris, adding that as they move forward and improve production, “it becomes more affordable, and we can try to address these diseases on the agricultural side that do matter and have an economic and emotional impact when something like bird flu comes in and wipes out 50 million birds.

“With a growing population and a need for more protein and having to raise more animals, there is going to be a need to protect the food supply from the next bird flu epidemic or foot and mouth disease, or something that can really put pressure on the food supply,” he said.

Looking ahead, Harris believes Harrisvaccines, which has recently been acquired by Merck Animal Health, is unique in how the company is positioned to react first when a new disease enters into the U.S. agricultural system, whether it’s in poultry, swine, or other livestock. “The paradigm shift with us is that we’re more of a responsive role, so that when an outbreak happens, we can develop candidate vaccines in as little as four weeks, [and] we can bring them to the field and start evaluating their effectiveness,” he said, “instead of what I think the standard has been for the last hundred years, which is if a foreign animal disease comes in, we kill all the animals and try to stomp it out, or we develop vaccines by guessing what’s going to happen next.”

Harris said that they’re trying to instill in the industry a shift away from that way of thinking. “I think it’s important,” he stressed. “You have to have effective vaccine tools in order to eradicate disease without killing all the animals to try to stomp it out.”

Along with an increased role of vaccines and continued use of antibiotics to treat animal diseases, Randy R. Simonson, Ph.D., former CEO and president of Grazix Animal Health, Inc., also sees an important emerging role of alternative, polyphenol-based products.

Reflecting on more than three decades in the animal health business, Simonson, a veterinary microbiologist, identifies technology as one area of “amazing” change. “Now we can do complete genetic sequencing in a day. That goes a long way in terms of diagnostics, it goes a long way in terms of developing the proper vaccine, and [it] also works on the pharmaceutical side.”

In his former position at Grazix, Simonson worked to introduce the new, polyphenol-based products, which he said are extracted from green tea and pomegranate and composed of a wide range of chemicals, to the swine market.

Lysozyme pig

Lysozyme, an antimicrobial enzyme, could replace antibiotics for promoting pig health. Credit: USDA photo

“Antibiotics are directed at a certain group of bacteria, typically the gram-negatives or the gram-positives, and vaccines are targeted at a particular bacteria or virus,” he said. “These polyphenol-based [products] seem to have a lot broader mechanism. The work I see in the scientific literature is that they’re antiviral, they’re antibacterial, they’re antiparasitic, and they’re also anti-inflammatory. The information is coming out stronger and stronger on how these work.”

Simonson added that research shows that polyphenols don’t seem to be harmful to the normal, helpful bacteria in the gut, but are detrimental to the pathogens. And they also have a positive effect on the immune system, augmenting the animal’s ability to withstand infection.

Grazix products for pigs and calves were getting “some good traction,” Simonson said, and users were seeing good results. He noted that another company, Jaguar Animal Health, is also using botanical extracts in its alternative products.

Regarding the new regulations about use of antibiotics, Simonson said, “I don’t see the use of antibiotics as far as treatment necessarily going down,” and that the industry is responding appropriately. He observed that additional record keeping and compliance could be an issue for producers, with a potential impact on cost of production.

Concerning replacement products, Simonson said, “We’re seeing more and more science come out about probiotics and prebiotics, enzymes – there’s a lot more data out there. I think that is looking very good, in addition to the antibiotic alternative such as the Grazix products I worked with.”

As vaccine use increases, one of the issues Simonson indicated concern about is the cost of developing new products that has changed so much over the years. “When I started my career, we could get a USDA-licensed vaccine, once you had the initial discovery research done, in about 24 months, at a cost of about $500,000, somewhere in that range. Today, that same vaccine will take over five years and several million dollars,” he said. “I see some impact on that side of it.”

Simonson said he sees more and more research looking at alternative products that can be used more naturally to make the animals healthier and be able to withstand stress as they are in the production system.

Regarding the industry’s future, he said, “There are definitely going to be changes, and it’s already started. I think the technologies to replace some of these products are coming. The science is very strong. We have technologies today that are just amazing.”