Industry questions AAHA vaccine guidelines; minor changes made
Cleveland-Just months after the release of the new canine vaccine guidelines, the American Animal Hospital Association (AAHA) has agreed to make two minor revisions and continues to stand behind its recommendations despite some criticism from practitioners and industry.
At the center of the criticism is why AAHA used unpublished studies to develop the guidelines and why the entire report is not being made readily available to veterinarians.
Dr. John Albers, AAHA executive director, says he has been contacted by some manufacturers regarding the guidelines and has agreed to make "minor" changes.
"We actually have been very pleased that there hasn't been any significant fallout or uproar over this," Albers says. "Our feedback that we have gotten is that (the guidelines) have been very well received."
AAHA has agreed to remove two editorial comments from Table 1 of the document regarding Bordetella bronchiseptica and Borrelia burgdorferi, Albers says.
However, industry leaders claim there are still questions pertaining to the document, and it has created confusion among practitioners on implementing the guidelines. Critics charge that AAHA is not doing enough to support its recommendations.
"Veterinarians are confused about what these guidelines mean, and what they represent," says Craig Wallace, director of companion animal business for Fort Dodge Animal Health. "I think there is a lot more that needs to be done before veterinarians understand what the intent of these were, and I don't think the guidelines were clearly communicated."
Dr. Janine Pepin, owner of Tender Loving Care Animal Hospital in Medina, Ohio, already felt some uncertainty about the new guidelines and is now waiting to see what the modifications are before she adopts the protocols in her own practice.
"I definitely have more questions than answers right now and to hear there might be some changes to the new guidelines will make me wait a little longer," she says. "I need to feel I can trust these recommendations before I implement them because the transition can be bumpy with clients."
As a general practitioner, Pepin says she walks a fine line with her clients when recommending changes in the health care of their pets.
"It's difficult to implement changes in your recommendations, especially when it comes to new drugs and vaccines," she says. "You can't constantly keep making changes and expect your clients to accept them. It can undermine their confidence in you."
As manufacturers started digging into the specific recommendations, some company leaders believe they have uncovered some problems with the document.
Biocor and Fort Dodge approached AAHA officials about proposed changes to Table 1 of the document, because they felt some information was incorrect, Albers says.
Specifically, Fort Dodge officials were concerned about the reference made in the section pertaining to Borrelia burgdorferi vaccination that states:
"Most authoritative papers recommend the rLyme borreliosis vaccine over the killed bacterin for reasons of safety (believed to be associated with fewer adverse reactions)."
Fort Dodge officials say the information was incorrect and contacted AAHA.
Albers says those editorial comments were made during the development process. When it was brought to the attention of AAHA leaders, they decided it should be removed.
Similar revisions were made in the same table regarding Bordetella bronchiseptica. The changes helped clear up inconsistencies between the executive summary and the tables that accompany the document, Albers says.
"The changes made are not like we are now recommending annual vaccinations instead of every three years," he says. "It wasn't a huge change like that."
Adam Yankowsky, director of sales and marketing for Biocor Animal Health, says Biocor contacted AAHA because it felt some of the comments made about the vaccines for Bordetella bronchiseptica were based more on opinion than fact.
"We wanted to make sure AAHA's recommendations were based on the most recent science as possible," he says.
Biocor scientists were able to provide AAHA with additional scientific data that led to the correction, Zankowsky says.
Zack Mills, DVM, executive of director of veterinary professional services for Merial Ltd., agrees that some editing changes need to be made to the guidelines.
"I just think there was some poor choice of words in parts of the document that could have been edited if manufacturers could have reviewed the guidelines beforehand and made their recommendations," he says. "It's not to say they had to accept all of them but at least we could have made our comments known."
Leaders from both Fort Dodge and Merial agree that some changes could have been avoided if industry was allowed to play more of a role in developing the guidelines.
Mills commends AAHA's effort to address a very controversial issue and develop recommendations based on the available data.
"It's a good first attempt, and it has opened discussions on the issue," he says. "But, it also makes it easy for everyone to armchair quarterback now that the document has been released."
"We did not try to have every single company represented at the table," Albers says.
A member of the Animal Health Institute did provide some advice but did not serve as an industry representative, Albers adds.
During The North American Veterinary Conference in January, AAHA hosted an informational meeting for all the canine vaccine manufacturers to update them on the new guideline recommendations.
"As a result of that, some of them did write and make comments," Albers says.
Some changes came before the guidelines were published while others currently are being considered, Albers says.
"A lot of the companies didn't have any input at all," he says. "Many were more interested in how we were going to distribute the information and when it was going to be released so their sales forces could be prepared for it. They were very appreciative of the opportunity to get a heads-up."
But that might not have been enough for companies that plan to bring other issues to the forefront.
Although AAHA provided vaccine manufacturers with a preview of the new guidelines, some industry officials hoped they could have been more involved in the process, Yankowsky says.
"I don't expect them to run everything by us. They have to do what they want to do, but when it affects manufacturing we hopefully would have some input because we're also held to the guidelines of the USDA," he says.
Fort Dodge is currently gathering information to present to the task force regarding the guidelines, Wallace says.
Although Albers says AAHA has an open door policy and will listen to any comments or concerns from industry officials or from the profession, it's unlikely any more revisions will be made to the guidelines at this time.
Dr. Michael Paul, chairman of the AAHA canine vaccine task force, echoed those comments by saying that industry had time to make its comments and the purpose of the document was to give practitioners guidelines that were not heavily influenced by industry.
"This was not intended to be an industry document," Paul says. "It was intended to be a guideline for practitioners."
Mills expects some changes will be made to the AAHA canine vaccine guidelines because he considers the report a working document.
"These guidelines are fluid and hopefully will continue to have changes," he says. "(AAHA) and veterinarians have to expect these changes, and they should be willing to discuss them."
As new vaccines enter the market, the guidelines will have to be altered to reflect new technology and how the profession will effectively incorporate them into practice, Mills says.
"I think the message we're trying to convey to industry is if you have information that we are not aware of please send it to us," Albers says. "We're not saying we believe this document is the final word."
Pfizer Animal Health was unaware of changes being made to the guidelines and declined comment. At press time, Intervet and Schering Plough Animal Health had not returned telephone calls seeking comment.
Access to the facts
But perhaps the biggest question raising eyebrows from veterinarians and some industry leaders is why the AAHA task force used unpublished data from Ronald Schultz, Ph.D., dipl. ACVIM and a task force member, to develop the guidelines.
Since 1978, Schultz, a professor at the University of Wisconsin School of Veterinary Medicine, has conducted a variety of studies directly related to the efficacy and duration of immunity of vaccines. Some of his work includes experimental control studies where 19 dogs of various breeds were vaccinated once for parvovirus, adenovirus and distemper and then were challenged with the viruses beginning at seven years following inoculation. Some dogs in that study were challenged as far out as 11 years after vaccination.
"The reason we picked seven is because we didn't have very many animals at eight, nine or 11 (years). Although the protection was very good there, the majority of animals were in the seven-year range," he says.
Another study Schultz conducted examined the duration of immunity for 82 Beagles ranging in age from 13 months to 10 years of age and challenged with the viruses again at different year intervals.
Five years ago the veterinary teaching hospital at the University of Wisconsin moved to a three-year protocol for administering core vaccines. Since the transition, Schultz has been tracking more than 500 canine patients at the veterinary teaching hospital by collecting their blood for serum testing when they come in for annual wellness exams. This allows Schultz to track dogs at different yearly intervals post vaccination to measure the duration of immunity of the vaccines.
"We also have owners who have decided they don't even want to vaccinate at three years," Schultz says, which goes against the teaching hospital's recommendations.
Despite this in-depth research, Schultz has never published detailed reports on his studies. However, he has released brief summaries on some of the studies, but they are not widely known in the veterinary profession. Schultz says he hopes to publish complete reports on his studies some time this summer.
Pepin thinks it's critical for Schultz's information to be published.
"We need to be able to read the opinions of all the scientists and experts in immunology and see all the data to fully understand their opinions before we make our own decisions," she says. "Otherwise we're not going to have the confidence to institute the guidelines or develop our own. Even though AAHA is there and is an excellent credible source to guide us, we're still going to want to have access to all that information. "
Why three-year intervals?
Some veterinarians also question why the task force chose three years as the benchmark for administering vaccines.
"That's another embarrassing question. It's completely arbitrary. It's just completely arbitrary," says Richard Ford, DVM, MS, dipl. ACVIM and member of the AAHA Canine Vaccine Task Force. "I will say there is no science behind the three-year recommendation, and that's completely true with the cat."
Ford says the decision to recommend a three-year cycle for vaccines was a compromise.
"We picked a compatible medium, and it corroborates and corresponds with what was recommended for the cat too," he says. "We have some level of consistency, but there's nothing magical about three years at all.
"There are not a lot of studies to support the three-year duration of immunity that are clinically-controlled, challenge studies which are done under good laboratory conditions," Ford says.
Conducting such studies is very difficult to accomplish because of the time and cost that must go into them, he says. To perform a challenge study, the dogs are put in very isolated conditions for several years and are exposed to a variety a viruses.
Schultz agrees with Ford adding that he picked the three-year interval because he thought practitioners would be more likely to accept it.
"I thought if the veterinarian understood that if a killed rabies vaccine could work for three years that they could surely understand that a modified-live distemper, adeno or parvo (vaccine) could work for three years, minimum," he says. "Modified-live vaccines have a much longer duration of immunity than killed vaccines."
However, Schultz admits some vaccines still need to be administered annually to dogs if there is truly a risk of the animal getting the disease. He uses kennel cough and the leptospira vaccines as examples. He says dogs that live in endemic areas for these diseases may need to receive vaccines on an annual basis or perhaps even more frequently in the case of leptospira. However, he advises practitioners to consider all the pros and cons before making their decisions.
AAHA has published two documents pertaining to the 2003 AAHA Canine Vaccine Guidelines and Recommendations. An executive summary was published in the March/April issue of the Journal of the American Animal Hospital Association and the April/May issue of Trends magazine. AAHA's Web site (www.aahanet.org) provides a complete report of the guidelines, but it is only available to AAHA members. The complete report includes additional sections pertaining to immunology, duration of immunity, serological testing, vaccine production, adverse-event reporting and legal implications of biological use. The full report also addresses how vaccinations serve as a component of comprehensive individualized care.
Restricting this material only to AAHA members makes it difficult for practitioners to develop their own opinions and protocols because they are unable to review the data.
"I would think that practicing veterinarians would want to look at all the information that is available and then decide what is most appropriate for their practice, for the pets in their practice and the environment those pets are in," Wallace says.
"We're proponents of laying all the information out there and having veterinarians make the decisions based on most current information," he says.
Pepin says she is reluctant to make changes until she has reviews all the material.
"I find this very frustrating because I don't think I should have to be an AAHA member to have access to even part of that data let alone the full report," Pepin says. "That's where the ambiguity lies. I want to do the right thing. The time has come, and I realize there are going to be economic issues because of these changes, but there has to be support to make that transition."
AAHA currently is working with the American Veterinary Medical Association to also make the entire report available to its members, Albers says.
Lack of education
Ford along with some industry officials say they talk daily with practitioners who are still trying to decipher the new guidelines and how to implement them.
"The bottom line here is what are we going to do with these guidelines? Why were these guidelines written, and how do I use them?" Ford says. "These are the questions I keep hearing veterinarians ask."
During the last few months, Ford has been traveling the country speaking on the topic of vaccines for Merial and he says he keeps hearing this central theme from practitioners.
"They are consistently skeptical of using (the guidelines) because they don't know how," he says. "There is no definition on how to implement the guidelines, so we're stuck with that, and I think it has been confusing for practitioners."
Ford is in the process of developing a Web site on vaccines and plans to include examples of how to implement vaccine protocols from birth to life using rotating schedules. The Web site should be up and running later this summer. (Next month, DVM Newsmagazine will focus on vaccines through a special magazine supplement which will also be posted on its Web site.)
"What we have done very well in our profession is to educate clients that vaccines are to be given every year. The need for shots is what brings people into the veterinarian at the very beginning," Ford says. "So given that, nobody on either the cat or the dog task forces has recommended we do anything but annual vaccinations. Nobody is saying just vaccinate every three years. Just don't vaccinate for everything every year."
Ford says practitioners can develop a rotating schedule that allows them to incorporate vaccines annually.
Mills says AAHA has a responsibility to educate both veterinarians and the public on the new guidelines.
"We're spending a lot to educate the veterinarian, not to have Merial make more money on vaccines," he says. "I think that's where AAHA missed the boat."
Mills also would like to see AAHA develop a public education campaign that explains why the new guidelines were developed and how it impacts dogs and their owners.
"They need to help get rid of the idea that vets are just vaccinating for money," Mills says. "That's not the reason why they are vaccinating. (Vaccines) work very, very well in controlling disease and to keep pets healthy and happy."
AAHA has no specific plans to offer veterinarians any resources to implement the guidelines or to address the public's questions, Albers says.
Paul says the new guidelines should not come as a big surprise to the veterinary profession because the topic has been talked about for years.
"AAHA has been publishing and giving presentations for the last four or five years to let people know these changes were coming and to get prepared for them," he says. "Unfortunately, too many people in the profession did not want to hear what we were telling them and didn't realize the impact the (changes) would have. They were looking at it but not wanting to hear it."
AAHA reiterates that the guidelines were designed to help practitioners develop their own protocols and that this area of medicine will continue to evolve.
"There's new knowledge all the time so there's nothing cast in stone," Albers says.