PRACTICE MANAGEMENT
VACCINES: NEW WORLD ORDER The Inside Story

March 2004 Veterinary Forum

by Jo Birmingham

Reactions to AAHA's new canine vaccination guidelines are mixed. Practitioners have howled with fear over imagined lost revenue, impending lawsuits, and the discomfort of having to develop protocols of their own. While it's not likely that the debate will end soon, the good news is that it might bring a lot of issues to the table and thereby ultimately improve patient care.
In an effort to shed new light on some of these fears as well as discuss some of the recent developments in this new world order of vaccines, we asked veterinarians who work for some leading vaccine manufacturers to share their thoughts on the subject. Their views and advice follow. As always, we invite Forum readers to respond to this special report with comments or questions of their own.

Response to Vaccination Guidelines
While most on our panel of veterinarians voiced support for the guidelines, a few did have some points of concern. No one had made any changes to their product labels or marketing programs because of them, however.
"We aren't here to preach (the task force or practitioners) right from wrong," says Merials Dr. Zack Mills. Our job is to support veterinarians however we can and to focus our efforts on continuing to improve our products and technology."
Others panel members, however, had suggestions on how the guidelines could be improved. "I don't like the terms 'core' and 'non-core' in the guidelines," says Intervet's Dr. Sebastien Huron, a French veterinarian now based in the United States. "I prefer a medical process that looks at each animal's need, its exposure, and other factors. Then you can decide what vaccines to use."
Dr. Mike LaRosh at Fort Dodge Animal Health takes his concerns even further. He believes that the guidelines lack sufficient scientific data to support the recommendations made. "Very limited scientific information was used to establish vaccination guidelines for dogs and cats. Until more conclusive scientific evidence exists to support a universally accepted shift in vaccination protocol, Fort Dodge will continue to support the vaccination schedules approved by the USDA on our product labels."
He also contends there was limited peer-reviewed published research to support the shift from 1- to 3-year vaccination protocols and opposes the use of serologic testing to solely determine a vaccine's duration of immunity. "The AVMA Council on Biologic and Therapeutic Agents (COBTA) has reported that it is impossible to determine the immune status of an animal relative to all the infectious diseases without conducting challenge testing," he says. "COBTA also reports that serologic results do not appear to be a sensitive indicator of an immune response for some diseases or vaccines in cats and dogs. There is also virtually no standardization in the veterinary profession with regard to conducting these tests, and validated sensitivity, specificity, and confidence intervals are lacking."
Without standardization, it is difficult to determine scientifically what the measurement of antibodies or titers means, he explains. "Most of the serologic studies conducted so far have been in relatively small populations of animals that do not accurately depict a vaccine's duration of immunity," he adds.
Intervet's Dr. Michael Coyne agrees. "There's too much dependence on serology as a measure of efficacy. We feel efficacy needs to be evaluated based on challenge."
"Titer tests can only show you the humoral response in the animal," Dr. Mills explains. "They don't tell you anything about the cell-mediated response. Another issue is variability in testing results from lab to lab. I'd only use a titer test with a dog that had experienced problems with vaccine reactions in the past."
Pfizer's Dr. Ed Kanara summarizes the conundrum this way: "The only point of consensus is that it's an unresolved issue. There's not enough information out there." This was the reason Pfizer invested so heavily in its own first-of-its-kind study to look at vaccine performance over time in a real-life setting.
The Pfizer study, however, did use serologic data. "I believe that serology can be meaningful—but by no means the complete answer to every situation," Dr. Kanara explains. "We really have to talk antigen by antigen. There's a growing body of evidence that equates serologic response to protection, for some diseases. But to try to simply correlate serologic response to protection is not always possible. For example, other factors that play a role include the age of the animal, cell-mediated immune responses and how severe the challenge is— every natural challenge is not created equal."
"So, we would love to simplify this down to, 'Does this mean we can now go to 3-year vaccines?" But, we can't make that leap. It still comes back to the vet, based on client-patient relationship and the veterinarian's knowledge, as the best resource to determine the appropriate antigen choice and appropriate revaccination interval. As much as we would like to fit all that into a nice neat box, the science doesn't take us there yet," says Dr. Kanara.

Missed Opportunities
Several of our industry experts believe that the guidelines would have benefited—both from a process and data standpoint—from having vaccine company representatives on the task force, helping to establish the new guidelines.
"We fully support the new vaccination guidelines, but we would have liked to see industry representatives involved," says Dr. Coyne. In addition to tapping into industry data, he suggests industry representatives might have added a new emphasis to the guideline communications. "Perhaps they would have emphasized greater benefits to pet owners. Moving away from the one-size-fits-all approach to vaccinations is of great benefit to pet owners." Individualized medical care, he says, is better and mirrors human health care.
Avoiding Litigation
Legal experts have suggested that the disparity between new guidelines and the manufacturers' label claims raises the likelihood of litigation for practitioners who are jammed between the two.
"I agree the differences between the label claim and the guidelines could put practices at risk, but I don't see widespread litigation sweeping the country tomorrow," says Dr. Mills. "The real problem stems from practitioners not understanding the label claim in the first place. "With the exception of rabies vaccines, you are not legally bound to comply with annual booster recommendations on vaccine labels. You do have legal authority to administer vaccines with discretion, as long as you are practicing in accordance with a 'standard of care' accepted by the profession. Publication of vaccination guidelines for dogs and cats can represent this appropriate standard of care. This is one reason the USDA and Animal Health Institute are working together in changing vaccine labels. [Note that the USDA, not the manufacturer, ultimately determines the label claim.] In the future, you may not even see revaccination recommendations on the product label," Dr. Mills says.
Legal experts and Dr. Mills agree on the major defense against litigation—solid client communications. "Communication can fight off litigation and compliance issues," says Dr. Mills. "Talk to your clients. Inform them. Document that you've done so in all patient records. The most common reason litigation occurs is because of lack of communication."

The Missed Revenue Issue
On weekends, Dr. Coyne practices at an eight-doctor hospital in Bear, Delaware. He says this practice experience, as well as his work at Intervet, gives him the data he needs to rest assured that this problem isn't as big of a threat as many practitioners believe it to be.
"We've been stuck on the paradigm of dog in office, gets X vaccinations, dog out; cat in, gets Y vaccinations, cat out. Now we have to think a bit. The guidelines provide us with a huge opportunity to create additional income and further develop our practice by refocusing on total health care. We need to focus more on the physical exam and additional diagnostics during the annual visit. Not only will we prevent infectious diseases, we'll do a much better job detecting other issues earlier."
His colleague, Dr. Huron, agrees and supports the
argument with European data. He cites scenarios in the United Kingdom in which veterinarians had worried ahout lost vaccination revenues but, in time, were proven wrong.
"Keep in mind that the cost of vaccines to pet owners in Europe is much higher than in the United States," he says. "Annual visits to the veterinarian were getting very expensive." Changes in the vaccination protocols that extended the time between boosters reduced the overall costs of visits to the veterinary hospital—and clients started coming in more often. "We also saw that veterinarians were finding more health issues earlier or ones they would have missed altogether. So, the change ultimately led to increased revenue to the practice, not decreased revenue, plus better health care for the pet."
Dr. Mills feels strongly about this issue as well. "I owned two practices in the South and worked at them for 10 years. You're not going to lose money when you practice the best medicine and communicate with clients."

A Look at the Future
While these experts may differ on many aspects of the vaccination debate, they all agree: The future is
going to be exciting. The 100+ vaccines available to veterinarians today will mushroom into many, many more— offering new ways to fight diseases and maintain health in dramatically different ways from what you see today.
"We'll look at three key areas in the future of vaccines," says Dr. Kanara. "Emerging diseases, improving existing products to make them safer and more efficacious, and developing new technologies, especially to enhance the delivery of vaccines."
Dr. Coyne's crystal ball says you'll see more vaccines using DNA technology. "You'll see smaller combos— with some things taken out and others added as needs change. You'll see therapeutic vaccines, such as a cancer vaccine and antitumor vaccines. You'll see new delivery systems, such as intranasal," he says. Marker vaccines for such diseases as FIV to aid in distinguishing vaccinated cats from those that have been exposed to the virus are also on the horizon, he believes.
Regardless of how they are administered, all future vaccines share a common goal—optimal efficacy and safety. The present challenge for practitioners remains focused on sorting it all out and communicating clearly to clients. Fortunately, you don't have to do it alone.

Materials for In-Practice Use
Both Merial and Fort Dodge offer help to practitioners who want to educate themselves, their staff, and their clients about vaccines.
With so much changing so quickly in vaccinology,
unless you're in veterinary school studying the subject right now, you're probably missing some important information. "By and large, practitioners need a [knowledge] booster on vaccinology," Dr. Mills says, and his company is ready to help. Merial offers a free CD course that can be obtained online. Check it out at us.merial.com.
Merial also offers free physical examination forms, client brochures, and in-practice staff training. Two public relations campaigns—"Help Make Rabies a Thing of the Past" and "Be a Heart Guardian"—educate pet owners and encourage them to seek veterinary care for their pets.
Fort Dodge has also committed to help practitioners who are concerned about the vaccination issue. The company has created a program, called "Responsible Healthcare for Pets" (RHP) to assist veterinarians who are working to educate pet owners about vaccination issues and trying to build awareness of the importance of vaccinations. The RHP kit includes a technical guide, poster, pet owner brochure, and risk assessment form. The brochure details a list of disease threats as well as information about the safety of vaccines and the appropriate frequency of vaccinations. A risk assessment form identifies the information needed to develop an appropriate vaccination protocol for an individual pet.
It's time to look at nutrition, diagnostics, and other areas to fully enhance the health care delivered to each animal. Large practices with several DVMs on staff will likely have differences of opinion. Argue it out. Put the issues on the table, research them, and decide. Doctor-to-doctor challenges can be healthy— for the practice as well as, ultimately, the pet."