VETERINARY BOTANICAL MEDICINE: COMMON QUESTIONS AND FACT SHEETS
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Is Veterinary Botanical Medicine is supported by a basis of scientific knowledge and practice that is acceptable to the profession?
We believe that our Petition appropriately states the current state of play of the science that underpins veterinary botanical medicine. We specifically excluded preclinical studies and phytochemical studies from the petition. The profession has responded to the first petition overall positively and we suggest that the submission of journal article examples; a review of published journal articles in mainstream veterinary journals pertaining to veterinary botanical medicines; as hundreds of abstracts, again in recognized veterinary journals- is a substantial basis for recognizing the potential of veterinary botanical medicine. The volume of publications is comparable with other Colleges forming in their infancy. We expect the volume to increase with support for the College’s recognition and one of the reasons we advocate for the formation of this Specialty.
The ACVBM acknowledges the concerns regarding the scientific basis of veterinary botanical medicine. The comment has been made that the published scientific and clinical data supporting the overall safety and benefits of many plant medicines, could be dismissed as questionable - having methodological bias and thus being of inferior quality to trials conducted on conventional drugs. It is important to note that the journal articles and abstracts presented in the petition were derived from mainstream veterinary journals.
At the same time, we agree that published research needs to be critiqued. A quantitative assessment of the reporting of herbal medicine research outlined suggestions for improvements recognizing publication bias and incomplete reporting of outcomes (1). However, to be fair, this is also the case for clinical trials generally. In veterinary medicine for example - a review of 97 clinical trials uncovered a need for more high-quality studies (2). And more recently a cross sectional study of veterinary randomized controlled trials of pharmaceutical interventions funded by different sources suggested that findings may be affected by the source of the funding and that some RCT’s provide a weak evidence base and targeted strategies are needed to improve the quality of veterinary RTCs to ensure there is reliable evidence on which to base clinical decisions (3). So this is an issue common to both herbal and veterinary research. However, to reiterate, the studies provided in the petition are from mainstream veterinary journals.
We do not believe we have over stated the science. We started by saying there are there are over 143,000 published journal articles on plant extracts of which there are over 7000 Systematic Reviews or reviews. Further, over the last 15 years there has been an increasing publication of research on plant extracts in animals, with more than 10,000 studies published from 2010 to 2014 alone. This demonstrates the emerging and substantial research being undertaken on plants in medicine. Animal models are an important source of information on toxicology, safety and phytochemistry. Veterinary Botanical Medicine draws on such resources to inform rational phytotherapy. However, we discussed in some detail specific examples of research in various species and cited over 70 veterinary and allied journals that have published studies on botanical medicines in the petition.
We believe there is a strong and rational basis for veterinary botanical medicine as a distinct and scientifically based discipline. It is true that preclinical research doesn’t always translate into a treatment benefit once evaluated in people or animals. But there are substantial studies now in people using double blinded RCT studies, with more than 3500 conducted to date. We agree there are too few in veterinary medicine comparatively, but just because that research isn’t available, does not mean there isn’t a rational basis nor scientific research that can be drawn upon for clinical decision making in supporting evidence-based medicine.
1. Naumann K1. A Quantitative Assessment of the Reporting Quality of Herbal Medicine Research: The Road to Improvement. J Altern Complement Med. 2017 Sep 15.
2. Brown DC1. Control of selection bias in parallel-group controlled clinical trials in dogs and cats: 97 trials (20002005). J Am Vet Med Assoc. 2006 Sep 15;229(6):990-3.
3. Wareham KJ1, Hyde RM1, Grindlay D2, Brennan ML1, Dean RS3.Sample size and number of outcome measures of veterinary randomized controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study. BMC Vet Res. 2017 Oct 4;13(1):295.
Is there a lack of regulation and scientific evidence which could negatively impact public safety and not result in improved veterinary medical services to the public?
The legitimate concerns of correspondents to the petition highlight the very reason why there should be an ACVBM. Until there is appropriate regulation, practitioners are much better placed to evaluate the safety of a product than the general public is. There are ways and means of establishing quality and reliability of botanical medicines. We emphasize the importance of the veterinary profession supporting animal health with botanical medicine rather than the general public seeking advice and products via the internet or non-veterinarians.
Were veterinarians in a position of having absolutely no knowledge of herbal medicine, the absence of a veterinary botanical medicine college that could provide safe answers to the public might be excusable; but now that veterinarians have discovered botanical medicines that safeguard animal well-being while responsibly filling a demonstrated public need, we strongly suggest the veterinary profession has an obligation to provide such a college, where the needs of the public and their animals can be prioritized.
Safety of patients is paramount. There is a comment on the interaction of herbs with anesthetics and analgesics - we know there are interactions with all drugs. This is exactly the area that the ACVBM can advise upon, as having knowledge and experience in utilizing botanical medicines with drugs means risks can be mitigated and potential side effects from drugs alleviated.
While the AMA does not recognize a similar specialty, this should not be a reason to suggest that the ACVBM has less rigor and less care than human medicine. We are in a unique situation as veterinarians being trained across species and having the ability to evaluate and critique information and applicability to medicine. Conventional veterinary medicine frequently requires us to consider the use drugs off label and where no research has been conducted. A cautious approach has been taken by the ACVBM, and there is a cumulative several hundred years of experience in the group to be able to guide safe use. Most practitioners of botanical medicine use consistent, quality products where issues around safety have been evaluated. It is the pet or stock owner that goes unguided to the internet , and even the veterinarians who send a client to the health food store to buy a herb that puts the patient at potential risk.
The ACVBM can help guide policy and regulation and advise on appropriate use of botanical medicines based on product quality, efficacy and safety. Currently members of the ACVBM have been involved in product development, research and regulation, and with the College accepted by the Profession, this will give more strength to the profession's involvement in ensuring animal safety from an informed perspective.
Finally, under this concern, there is a comment that there doesn’t appear to be a core charter of diplomates with the expertise to guide this group. We have purposefully excluded having Charter Diplomates. However, we have eight Diplomates on our organizing committee that will work with the rest of the committee towards the development of new evidence based knowledge. One Diplomate is already involved in a multicenter clinical trial of a botanical formula through specialty practices.
A number of the organizing committee members will present their credentials and undertake the first examination proposed for 2018, should the College be approved. This will help us to determine the pass rate for the examination and to build our Diplomate base as has been done with other RVOs establishing themselves in the first instance.
What is the Quality of products upon which ACVBM will be based?
a. As a result of DSHEA (1994), human herbal products are minimally regulated (GRAS criteria). Animal “dietary supplements” do not fall under DSHEA but are minimally regulated. How will confidence in these products be addressed in the implementation of patient care provided by ACVBM diplomates? What role does ACVBM envision it will have in addressing the lack of regulation and thus quality of products used and/or promoted by its diplomates?
One of the advantages of having a program to educate veterinarians in herbal medicine is to provide them with the knowledge of the regulatory frameworks for the companies they want to work with and a set of questions to ask to qualify the quality of their products. A well-constructed education program can help veterinarians develop their own Vendor Qualification Questionnaire which should contain questions such as:
• Under which regulatory category is your product labeled for distribution?
• Is your company compliant with all applicable regulations?
• Is your company registered with the FDA? If not, why not?
• Do you/does your manufacturer have a Quality Control System?
• How do you handle: Testing Raw Material Identity; Heavy Metals; Micro Activity; Pesticides Policy
• Has your company been inspected by the FDA? When?
• Are you a member of any Trade Associations?
• How long have you been in business?
• Is your company recording Adverse Events that occur with Animals?
With respect to Dietary Supplements, which under the US regulatory system is a term that applies only to Dietary Supplements for humans, it is important to note that they are not just regulated by Dietary Supplement Health and Education Act of 1994. There are also regulatory requirements for Facility Registration under the Bioterrorism Act of 2002. And the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding requirements for adverse event reporting and record keeping for dietary supplements and non-prescription drugs marketed without an approved application. It is the combination of these three Acts and their attendant regulations that give the FDA the ability to identify companies who they regulate, through inspection to correct any regulatory issues and identify any problem products in the industry. This is relevant for veterinarians sourcing high quality herbs from human herb suppliers.
The regulations developed for compliance with the Dietary Supplement Health and Education Act of 1994 are not minimal. There are certain requirements for products in the market prior to 1994. These regulations are quite strict and center on the confirmation of raw material identity, elimination of any adulterants or contaminants and consistency in manufacturing. A documented Quality Control System with specifications and master manufacturing procedures, personnel training, equipment and facility cleanliness, recording of customer complaints and adverse events are required. Regulations for label claims that must be filed with the FDA within 30 days of making such claims, limit the scope of what can be said about the product to how it affects the structure and function of a body. Such claims require research backup to be kept on file. Any product introduced for sale in the market after 1994 must submit a New Dietary Ingredient Application for approval by the FDA which must include the documented history of use or other evidence of safety. In addition, there are several trade associations that add Trade Recommendations, which must be complied with to maintain a membership.
Products labeled for animal use are under a completely different regulatory framework. They are either regulated as drugs by the FDA or as Foods which must comply with federal and state laws, guidance for such compliance can be found in documents provided by AAFCO (the Association of American Feed Control Officials). The National Animal Supplements Council (NASC) trade organization provides its members with an audited, self-regulatory framework that includes a Documented Quality Control System, definition of claims to mirror those allowed with human dietary supplements, adverse event reporting and recommends animal drug registration with the FDA.
Currently all imported products or ingredients being sold in quantity to veterinarians are subject to intense FDA scrutiny – much more than is applied to products manufactured in the USA from USA ingredients. Products are screened for contaminants, and labels reviewed for misleading claims and disallowed ingredients, on an ongoing basis. Companies manufacturing within the US have the option to join the NASC. Membership entails an audit process and requires demonstration of compliance with Good Manufacturing Processes (GMP) practices (similar to the pharmaceutical industry). An example is the use of mass spectrophotometry and thin layer chromatography to demonstrate appropriate levels of active ingredients as one part of the process. Reputable companies often fully disclose details of their own quality assurance programs on their websites and are thus easily identified as useful resources by college members.
It should be noted that many pet food companies that veterinarians rely upon receive no more regulation from the FDA than what is detailed above. Additionally, efficacy of therapy is not determined by the FDA, but is determined post-market based on treatment outcomes. When a product or approach is consistently rewarding for similar cases, this is directly suggestive of product consistency across batches, and by extension suggests a high level of quality control for that manufacturer. Naturally it is these more reliable products and methods that will form the core of any education imparted to college members, however as a College we do not advocate any specific brands or products in order to remain impartial.
The ACVBM and its Diplomates will play a role in encouraging veterinarians using herbs to ask the important questions, to report adverse events and to work with companies to improve quality where it matters to safety in particular, and also work with industry such as NASC to improve regulation. Having a College and Diplomates will raise the profile of botanical medicine, and improve safety by giving the public and veterinarians a source for referral and advice other than Dr Google and the thousands of websites selling uncontrolled herbs.
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The ACVBM is not affiliated with the Veterinary Botanical Medicine Association (VBMA).