More Natural Nonsense and Unethical CAM Marketing

A colleague recently saw an older dog who had vomited up roundworms and was doing some coughing. He diagnosed and treated the patient appropriately, but the client later contacted him with questions about some alternative remedies that had been recommended to her by the folks at Native Remedies. The owner had the common misconception that “natural” is a word with a real and precise meaning in medicine (as opposed to a marketing term invented to take advantage of the fear of “toxic” modern life) and that using it to describe a remedy somehow guaranteed safety. The folks trying to sell her such products took full advantage of this idea in their letter to her.

They began by flattering her, “You are to be commended for researching the use of natural alternatives.” They then recommended a host of herbal and homeopathic products.

Several were claimed to be homeopathic products: Respo-K, Sinu-Rite, and KC-Defense. These contain a variety of ingredients all diluted in the usual homeopathic way. 100% safe? You bet! Why–because they’re 100% water! (Well, technically some of the ingredients are diluted less then 12C, so they could possibly contain a few molecules of the original substance, but still quite likely much less than needed to have any measurable physiologic effect). The seller did engage in a bit of deceptive advertising. They repeatedly stressed the products are “FDA registered.” Well, doesn’t this mean they are tested and approved by the FDA?

Actually, not at all. The issue of how homeopathic preparations are regulated is a complex, and fuzzy one. Homeopathic products for human use were grandfathered, without any scientific testing or validation, into the original legislation establishing the FDA and its mandate as a concession to an influential senator who was a homeopath. These products can be marketed with medical claims as long as they have been included in the Homeopathic Pharmacopeia of the Untied States, an index of such remedies maintained by an independent organization of homeopaths which sets rigorous standards for proving the safety and efficacy of water in a way totally inconsistent with the rest of medical science. The over-the-counter sale of such remedies is limited to disease that are “self-limiting” and which an average consumer should be expected to recognize and be able to treat on their own. If the homeopathic “drugs” are used for serious illnesses, they require a prescription, though for obvious reasons they seldom are so used.

With regard to the veterinary use of homeopathic “drugs,” the FDA has stated that it does not considered this activity to be covered under the same rules as the human use of these products, so veterinary homeopathy is technically a use of unapproved veterinary drugs and so illegal, though doubtless lawyers could wade through the voluminous legislation and make all sorts of arguments for and against this claim. In any case, the FDA has neither the will nor the resources to enforce any such position and has generally agreed to ignore homeopathy when used in companion animals.

All of this is simply to illustrate that “FDA registered” when applied to a homeopathic drug 1) implies no scientific testing of safety and efficacy and 2) only properly applies to human use, which was allowed in the 1930s as a political concession. Thus, the term is meaningless from the point of view of legitimizing any claims sellers of these products may make.

Because these remedies are essentially only water, and so harmless in themselves, there is not likely ever to be any interest among politicians in the controversial and thankless task of requiring them to either prove themselves scientifically or be banned. But it is clear that they should not be expected to have any benefit for real disease, nor should they be used in place of scientific medicine which has demonstrated safety and efficacy in a legitimate way.

The other two recommended products were herbal concoctions, and so have some potential to be helpful or harmful. The usual caveats apply to these remedies, namely that they are in no way regulated and all quality control is voluntary, so cases in which the label does not accurately reflect the ingredients and toxic or pharmaceutical contaminates are present are common. I have a long, and growing, list of examples of this problem.

The first nostrum reocmmended was Parasite Dr., which the sellers claim is a mixture of wormwood (Atremesia absinthinium), Cloves (Eugenia caryophyllata), Neem (Azadirachta indica), and Herb of Grace (Ruta graveolens).

Wormwood has been used medicinally and as a flavoring agent for centuries, most notoriously in the alcoholic drink absinthe. Limited in vitro studies have shown some toxicity to roundworms, however, these must always be interpreted cautiously since bleach can poison worms in a test tube too, but that doesn’t make it a safe and effective deworming agent. There is one in vivo trial in sheep conducted in India in which water and alcohol extracts of the plant had some effects on parasite egg counts, but again when one takes extracts from a plant and purifies them, one has a drug, not an herbal remedy. How much of which compounds from wormwood are in this product is completely unknown, so even if wormwood had antiparasitic properties, which is far from demonstrated, that doesn’t mean this product would. As for toxicity, one small rat study found no obvious toxic effects, however neurologic and GI symptoms have been reported from ingestion of compounds in wormwood, so the safety of this product is as much a mystery as its efficacy. No evidence concerning safety or effectiveness in dogs appears to exist.

Clove oil has also had a history of medicinal and flavoring use. The NCCAM has concluded there is insufficient evidence to support any use other than as a mild topical analgesic, and a review of traditional veterinary herbal remedies for GI and parasite problems has concluded there is insufficient evidence to justify its veterinary use. There have also been reports of an increased risk of bleeding, particularly when used concurrently with non-steroidal anti-inflammatory medications, and allergic reactions have been seen. No evidence concerning safety or efficacy in dogs specifically appears to exist.

Neem is currently quite popular among gardeners as an insect repellant, and has a history of use as an anti-parasitic. There is reasonable evidence for its topical use on animals and plants, including one study showing some flea repellent effects in dogs and cats. Extracts have been tested in several trials in sheep, and most have found little or no efficacy in reducing intestinal parasites. (1, 2, 3, 4). A review of the limited safety data available for humans and lab animals finds minimal toxicity, and the EPA has exempted some neem products from its more stringent pesticide regulations under the presumption of safety. However, no data on the safety or oral use in dogs appears to exist.

Finally Rue or Herb of Grace is primarily known in traditional herbal use as a substance used to induce abortion. There is limited data on it’s safety and efficacy, and nothing to support its use for parasites or gastrointestinal disease generally. Some pretty serious toxicity, including photosensitivity (blisters and ulcers developing with sun exposure after use of rue) and potential mutagenic and carcinogenic properties have been reported.

So the pattern is clear. Minimal or no evidence of effectiveness, limited evidence of safety or even known risks, and no assurance of any particular ingredient or dose or the absence of toxic contaminants. Yet we are supposed to rest comfortably in the confidence that because it’s “natural” it must be good regardless of whether there is any evidence either way.

The folks at Native Remedies are very tricky in their marketing of this and the other products recommended. When one searches their web site for Parasite Dr, for example, the search turns up a clear (and illegal) medical claim: 

However, when one follows the link to the actual page, they are very careful only to make allowable “structure and function” claims, such as these:

Parasite Dr. Benefits:

• Promote digestive health and balance
  Calm and soothe the digestive system
• Cleanse and detox the digestive system and improve digestive functioning
• Cleanse the blood
• Support correct balance of intestinal flora
• Act as a tonic for the entire digestive system
• Support the immune system

They even go so far as to note, “ Disclaimer: Testimonials have been edited to comply with FDA regulations. While positive results are likely, the testimonials used are general results and are not intended to represent or guarantee that anyone will achieve the same or similar results – individual results may vary.”

Unfortunately, this is merely an effort to comply with the letter of the law, and they show no restraint in making illegal and unethical claims in their e-mail to the client. The nostrum is promised to “rid your pet of unhealthy infestations of internal parrasites without the unwanted side effects sometimes associated with synthetic parasite medication…As an added bonus, Parasite Dr . also helps to cleanse the system and contains herbs with antifungal properties, thus helping to reduce systemic yeast infections which compromise health…” Clearly, the evidence supports none of these claims, and the old saw about “yeast infections” as a cause of illness is a bit of popular CAM mythology which has nothing to do with this patient’s problem.

The most disturbing and ethically offensive part of the marketing materials, however, concerns heartworm disease. This is a serious parasitic infection which is widespread in much of the United States and which is routinely fatal if acquired. There are, however, safe and effective, FDA approved and adequately tested, preventatives in common use. The native Remedies representative, however, claims their product is an effective preventative for this deadly disease, which it almost certainly is not. They also imply conventional preventatives “can undermine the liver” (which is not at all true, while they have risks like any drugs, these have nothing to do with the liver), and they then try to sell another herbal concoction, Detox Plus, to treat this. Any owner unfortunate enough to believe these lies and who lives in an area where heartworm disease is endemic is likely to see their pet die from heartworm infection if they follow this advice. That is why such claims are illegal, not some sinister conspiracy of government and the pharmaceutical industry to deny people effective natural medicines. It is only a pit that the government has not the will or resources to enforce such laws, and that pets and people must inevitably suffer for it.

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