Healing through farm or pharma?

Various grasses are known to be safe for pets. For other herbs, the jury is still out. Bigstock Perhaps you have heard a speaker at a conference claiming to have cured cancer with herbs. Maybe you wondered, “Could this be true?” Once convinced, you’re eager to learn which herbs worked, how to obtain them, and best ways to dose. You may, in fact, become so excited about “going natural” you envision bottles of botanicals side by side with pharmaceuticals in your clinic, establishing a “best of both worlds” motif. Alas, how do you know herbs actually do cure cancer, or anything else? Did the speaker publish their findings, and are the results repeatable? How do risks of medicinal herbs compare to those of FDA-approved medications? Who oversees quality control? Could the plant extracts interfere with or augment the pharmacologic activity of co-administered medications? At this point, your curiosity brings you to seek counsel from “alternative medicine experts” in one or more online veterinary networks. You hope to hear regulatory authorities enforce standards ensuring manufacturers sell supplements only after showing evidence their products are safe and effective. What you actually hear might be, “Ask the company” (unsatisfying), or “Gee, I haven’t seen any issues” (not reassuring). Here’s the thing: If evidence exists, you should be able to find it yourself, in medical databases such as PubMed. If a company or its representatives tout a product for a various condition, ask for evidence that backs their claims in a rigorously controlled clinical trial. If insufficient research exists for a particular herb or herbal mixture, then how can you confidently prescribe it for patients? If an animal experiences an untoward outcome and a client complains to the veterinary board, who does the agency contact? You. Without scientific evidence available to defend your approach, claiming to be “certified” in a field such as Chinese herbal medicine may fall flat without facts to back up what you learned to do. Where’s the package insert? I need prescribing information Research on botanical medicines, for both humans and non-humans, lags far behind that for pharmaceuticals. Most definitely, for substances such as cannabidiol (CBD) and related cannabis compounds, knowledge is expanding rapidly. Yet, we still have much to uncover. A recent report on rapidly progressive cutaneous and mucosal ulceration in a dog brought to light yet another reason to remain vigilant when recommending any remedy—natural or synthetic.1 For instance, CBD-related rashes have been reported in a number of human patients, even in light of its presumed safety and tolerability.2 Ideally, botanical remedies would come with package inserts (PIs)3 like we see for drugs. However, they do not. Why? The research does not exist to substantiate those guidelines. PIs for pharmaceuticals list the following:4 Prescribing information Comprising warnings and precautions Indications and usage Dosage and administration Dosing forms and strengths Contraindications Adverse reactions Drug interactions Advice for use in specific populations Ingredients Mechanisms of action Pharmacodynamics Pharmacokinetics Nonclinical toxicology Clinical studies References Storage and handling Patient counseling information There is also the issue of quality control, or lack thereof. Did the manufacturer institute measures to prevent contamination during processing? How would we know if the producer added undisclosed pharmaceuticals to give botanicals a “boost?” Also, what type of testing and by whom assures the contents of each batch consistently correspond with what appears on the label? Nevertheless, herbs for animals have become a big business. Up to a third of dogs and cats and over three-quarters of horses receive an animal supplement or nutraceutical, many of which include plants and/or their derivatives.5 Thus, it behooves veterinarians to acquire factual knowledge on the fundamental pharmacologic characteristics and concerns regarding these substances. Unfortunately, most veterinary schools and post-graduate education programs offer little to no rigorous instruction on botanical pharmacology. Over the years, numerous programs have developed to educate veterinary practitioners about herbal remedies. Many promote Traditional Chinese Veterinary Medicine (TCVM), i.e. a “divergent” alternative to modern medical methodologies. Some TCVM courses may advocate diagnosing internal medical conditions based on the appearance of a patient’s tongue or the “feel” of one or more arterial pulses. These fraught diagnostic techniques then, supposedly, inform the practitioner about which Chinese mixture will alleviate the patient’s Yin, Yang, or Chi imbalance. Ultimately, the TCVM herbalist, even when “certified,” too often defaults to herbal prescriptions resting on unsubstantiated claims that purportedly stem from “ethnobotanical traditions of combining multiple herbs in a formula believed to have medicinal qualities.”6 Beliefs, however, do not substitute for science. Many lines of Chinese veterinary herbs have secret quantities and/or ingredients, along with potentially dangerous or endangered contents. Any number of non-plant ingredients appear in Chinese “herbal” recipes, including seahorse, rhinoceros horn, silkworms, scorpions, and talc, to name just a few. Chinese rhubarb (the root is shown above) is one of many herbs that may prove to do more harm than good. Courtesy Dr. Narda Robinson According to the NIH National Center for Complementary and Integrative Health, “Chinese herbal products have been studied for many medical problems, including stroke, heart disease, mental disorders, and respiratory diseases (such as bronchitis and the common cold), and a national survey showed about one in five Americans use them. Given many studies have been of poor quality, no firm conclusions can be made about their effectiveness.”7 Furthermore, states the NIH website, “Some Chinese herbal products have been contaminated with toxic compounds, heavy metals, pesticides, and microorganisms and may have serious side effects. Manufacturing errors, in which one herb is mistakenly replaced with another, also have resulted in serious complications… [Certain] Chinese herbal products have been found to be contaminated with undeclared plant or animal material; drugs (such as the blood-thinner warfarin and the nonsteroidal anti-inflammatory agent diclofenac); heavy metals (such as arsenic, lead, and cadmium); pesticides or compounds called sulfites, which could cause asthma or severe allergic reactions; or incorrect herbs, some of which have caused organ damage.” For decades, researchers have expressed concerns about the inadequacy of public health protection when it comes to herbal medicines. Yes, little has been done. Why? Politics and inertia. ‘Dereliction of Duty’ by the FDA The U.S. Food and Drug Administration (FDA) “plays an essential role in ensuring the safety of vitamins, minerals, botanicals, probiotics, amino acids, and glandular extracts sold as dietary supplements in the United States. While the FDA does not assess the safety of supplements prior to market, the agency is tasked with identifying and removing adulterated and hazardous supplements from the marketplace.”8 Adulterants typically take one of two forms: 1) Economic adulteration, in which the manufacturer substitutes a less-expensive ingredient for the more expensive version that appears on the label; and 2) Pharmaceutical adulteration, wherein the company adds an undisclosed pharmaceutical to a botanical product to make it more effective. Even for human supplements, the FDA’s response has been characterized by one author as a “dereliction of duty,” 8 plagued by inertia, inaction, and unenforced voluntary recalls. The problem worsens for herbal animal supplements; these products undergo even less regulatory oversight. In a 2020 paper published in Nutrition Today, Carrie J. Finno, DVM, PhD, Dipl., ACVIM, from the Department of Population Health and Reproduction at the University of California at Davis School of Veterinary Medicine, states, “The term ‘dietary supplement’ is defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994, as a product taken by mouth in humans that contains a ‘dietary ingredient’ intended to supplement the diet. The ‘dietary ingredient’ can include vitamins, minerals, herbs or other botanicals, amino acids and substances such as enzymes, organ tissues, and metabolites.”9 She adds, “Therefore, the term ‘dietary supplement’ should only be applied to products intended for human use. By contrast, products termed human ‘nutraceuticals’ were defined in 1989 as a ‘food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease.’ There is, however, no regulatory definition through FDA for nutraceuticals.” The FDA Center for Veterinary Medicine (CVM) bears responsibility for regulation of any product that claims to cure, treat, prevent, or mitigate disease. That product, according to Finno, “[S]hould be considered a ‘new animal drug.’” As such, untested and unapproved supplements could be considered “adulterated” and “unapproved” new animal drugs. As an example, three companies in the United States, which includes a Chinese herb manufacturer, have been listed for years on the “Import Alert 68-19” page of the FDA, allowing products entering the company to be detained, “without physical examination of unapproved finished new animal drugs.”10 The “reason for alert,” the FDA states, is “New animal drugs may not be legally marketed in the United States in the absence of an approved new animal drug application (NADA), abbreviated new animal drug application (ANADA), conditional approval, or an index listing, under sections 512, 571, and 572 of the FD&C Act.” Thus, while the FDA put these three companies on their “Red List,” this has not appeared to significantly deter some manufacturers from selling similar products. Doesn’t the NASC seal mean it’s safe?’ ‘What happens if an herbal product I prescribe injures my patient?’ The “NASC” seal, provided by the National Animal Supplement Council (NASC), indicates the manufacturer met the standards of the “Quality Seal” program (https://www.nasc.cc/nasc-seal/). This nonprofit industry group does not, notably, assess the effectiveness or safety of products that bear the NASC seal. NASC also “does not require companies to perform efficacy studies on their products or verify that scientific research data are available proving product efficacy. Additionally, there is no incentive for companies to have their products tested without mandated oversight.”11 In the case of herbal prescribing, the saying, “Caveat emptor” (“buyer beware”) becomes “Caveat veterinarian.” Finno puts it this way: “[V]eterinarians are advised by their governing body to be cognizant of content, efficacy, and safety of these products. With the paucity of well-controlled systematic reviews…this is a daunting task. Perhaps more concerning is that a veterinarian is legally liable if he or she recommends a pet supplement or nutraceutical products that leads to adverse effects.” Several notable examples highlight the toxic and other adverse health effects noted even in commonly prescribed herbal medicines.12 As Ekor indicates, “The general perception that herbal remedies or drugs are very safe and devoid of adverse effects is not only untrue, but also misleading. Herbs have been shown to be capable of producing a wide range of undesirable or adverse reactions, some of which are capable of causing serious injuries, life-threatening conditions, and even death.” Many mixtures, taken for a short period of time, might escape notice insofar as adverse effects. Given over months or years, though, damage to organs may begin to accrue. Even when research on herbs exists, few studies examine untoward consequences of chronic administration. Ekor provides this example: “A number of Chinese herbal medicines and other herbal medicines from different parts of the world have…been implicated in cases of poisoning. Many of them have been shown to contain toxic compounds which are capable of reacting with cellular macromolecules including DNA, causing cellular toxicity, and/or genotoxicity.”13 Overdoses of aconite may be deadly. Courtesy Dr. Narda Robinson A false sense of security runs rampant Da Huang, also known as Chinese rhubarb, appears commonly in TCVM mixtures for animals with liver disease or cancer.14, 15 Largely due to its anthraquinones, rhubarb provides anti-inflammatory, anti-tumor, and cardiovascular protective effects.16 These active components also confer hepatoprotection by inhibiting hepatic oxidation and oxidative stress. Other key components help to slow the progression of liver fibrosis and cirrhosis. Proponents of Chinese rhubarb fail to note, or perhaps do not themselves realize, rhubarb may also induce liver injury. In fact, “The relationships between hepatoprotection and hepatotoxicity of rhubarb remain unclear and complicated.”17 The shift from liver-helpful to liver-harmful possibly depends on dosing. No proven-safe dosing guidelines exist, even for humans, and several additional factors appear to determine whether rhubarb helps or harms the liver.18 “Cancer patients should note the potential hepatotoxic effects of TCM herbs and should not assume the absence of side effects of TCM herbs.”19 Questions about dosing, safety, quality, and effectiveness plague nearly every veterinary herbal product sold. Some plant compounds, such as CBD, while not completely innocuous, may indeed outperform even medications in some cases. For others, such as the Chinese herbs strychnine and aconite, found in formulae for dogs with intervertebral disk disease, overdoses may turn deadly. Dr. Narda G. Robinson is a graduate from Harvard/Radcliffe (AB), the Texas College of Osteopathic Medicine (DO), and Colorado State University College of Veterinary Medicine and Biomedical Sciences (DVM, MS). She served on the faculty of the CSU-CVMBS for 20 years and headed the Center for Comparative and Integrative Pain Medicine. She is vice-chair of the American Board of Medical Acupuncture, the board-certifying organization for physician acupuncturists, and is a Fellow of the American Academy of Medical Acupuncture. Dr. Robinson is the CEO and president of CuraCore MED and CuraCore VET, which educate human and veterinary practitioners in science-based integrative medicine and rehabilitation/physical medicine approaches. Her website is CuraCore.org. Opinions do not necessarily reflect those of Veterinary Practice News or VPN Plus+.

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Healing through farm or pharma?

A look at herbs for animals and the big unknowns

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