Clinical trials provide scientific basis for nutrition decisions
Posted Dec. 15, 2006
Of all the education and resources that Hill's Pet Nutrition Inc. provides to veterinarians and their health care teams, the most potentially valuable for their patients are criteria for evidence-based clinical nutrition.
Conducting high-powered clinical trials is not simply Hill's approach to product development but another way the company gives back to the profession—by providing scientific evidence they believe veterinarians can depend on when arriving at informed clinical decisions.
"Strong scientific evidence drives how our nutritional products are created, and the evidence that we wrap our messages to practitioners in is, in many cases, grade 1 or grade 2, which is the strongest possible," said Dr. Mary Beth Leininger, Hill's director of professional affairs and a past president of the AVMA.
Hill's was the first pet food or animal health company to publish evidence-based medicine-related criteria for clinical nutrition, according to Dr. Phil Roudebush, director of scientific affairs at Hill's. Evidence-based clinical nutrition is an extension of evidence-based medicine, a movement to establish clinical medicine as a verifiable scientific activity.
"Evidence-based clinical nutrition is the effort to integrate medical and nutritional research with clinical practice in the most efficient manner," Dr. Roudebush said.
For veterinarians to be able to make good clinical choices among products with therapeutic claims, scientific documentation must be available. Although the Food and Drug Administration has, in most cases, relinquished its responsibility for evaluating therapeutic claims of product efficacy in pet foods, the Federal Trade Commission enforces truth-in-advertising regulations. According to FTC v. U.S. Sales Corp.,a. a nutrition company is entitled to use the term "clinically proven" when describing a product only if it has conducted a minimum of two well-controlled clinical trials in the target species, using the commercially available product.
Results of randomized, controlled clinical trials are important to incorporate in clinical decisions because they are the most reliable predictors of results that practitioners are likely to see in practice. A study published in the Sept. 15, 2006 issue of JAVMA, for example, found that feeding a specific therapeutic renal food to cats with spontaneous chronic kidney disease was superior to feeding them an adult maintenance food in minimizing uremic episodes and renal-related deaths.
One of the challenges Hill's encounters is a misperception among pet owners and some pet professionals that over-the-counter products that have marketing claims implying a health benefit are comparable to therapeutic products that have undergone extensive clinical trials. What makes this confusing is that the federal rules governing advertising and marketing messages are much more stringent for therapeutic foods, and oversight of the OTC channel is slight.
"Speaking from a practitioner's experience," Dr. Leininger said, "I know that we veterinarians always talk about the fact that we are scientists, and we make decisions based on the best available scientific evidence. Yet when practitioners are making therapeutic choices, sometimes they don't differentiate between scientific evidence and marketing hype."
The research and development that leads to a therapeutic nutrition product is painstaking and complex. For example, Hill's sponsored more than 200 clinical trials to prove the effectiveness of its therapeutic dental product. "It was the first nutritional product to receive the Seal of Acceptance from the independent Veterinary Oral Health Council," Dr. Leininger said. "Yet, many veterinarians instead recommend chew toys, mouth rinses, and biscuit treats that are neither backed by clinical studies nor validated for efficacy by the VOHC.
"Evidence for some of the therapeutic nutritional products is so strong that veterinarians are simply not doing the best for their patients if they don't at least consider them. One of the challenges that Hill's faces is that therapeutic pet foods are not a pill, and veterinarians find it easier to prescribe pills for medical management of their patients."
Converting a therapeutic formula from dry food to canned form can also be a challenge. After Hill's launched its product containing hydrolyzed protein for dogs and cats with food allergy dermatitis as a dry product, there was a call for a canned counterpart. It took two more years for the company's veterinary researchers, food scientists, and process engineers to formulate the same product in canned form.
Evidence-based clinical nutrition is just one example of Hill's commitment as it partners with practitioners to achieve the best in patient care. In addition, the company sponsors diverse continuing education sessions at the AVMA Annual Convention and other events, and holds symposia on topics such as dietary management and evidence-based therapeutic choices. Through its Web site, www.hillspet.com, and Veterinary Consultation Service, (800) 548-VETS (8387), Hill's offers clinical resources and client education materials for proper pet nutrition.
"The whole point of Hill's commitment to evidence-based clinical nutrition is that we provide products that have real scientific evidence behind it," Dr. Leininger said, "not only in their development but in the proof of their effectiveness in patients.
a. Rosden GE, Rosden PE. Chapter 35:05(4). In: The law of advertising, 2006. Vol 3. New York: M. Bender, 1973:42-43.