A couple of “news” articles, which were essentially truncated but often verbatim reprints of a company press release, appeared today about a clinical trial looking at a mysterious new veterinary product with grand but vague claims. Naturally, this caught my attention. 🙂
The Chemaphor company announced “it has completed its first clinical trial to evaluate the efficacy of an oral Oximunol supplement in promoting overall health and well-being of companion canines.” The only details of this trial were that it was a “blinded, randomized clinical trial involving forty six dogs recruited from the public. The animals were randomly assigned to receive either the Oximunol supplement (0.5 mg/kg body weight) or a placebo once daily over a period of six months. The Oximunol supplement’s potential benefit to canine wellness was assessed by analyzing owner responses to standardized questions regarding the health status of their pets before and after the supplement period” The press release claims, “A full report of the study is being prepared for submission for publication in a peer-reviewed journal.”
So what is Oximunol? It is described as “a proprietary mixture containing compounds found naturally in the plant world in minute amounts as oxidized derivatives of carotenoids. The supplement is obtained via the spontaneous, full oxidation of beta-carotene.”
There are a number of red flags here right from the start. Announcing the results of a “clinical trial,” especially one conducted in house by a company trying to launch a new product, in a press release prior to publication in a legitimate journal is a marketing ploy that is rarely consistent with good science. And while it is impossible to judge the merits of the study without having it properly vetted and published, I am skeptical of a trial that starts with the hypothesis of the treatment “promoting overall health and well-being” and that reports as, presumably, its best and most newsworthy findings “improvement in coat quality and reduction of shedding[and]….a tendency to increased enjoyment of walks” as judges by subjective owner assessment. Vague and lofty goals of health promotion and vague, subjective measures of success do not inspire confidence in the reliable scientific evidence for a treatment.
The company web site indicates they are producing and preparing to market a couple products derived from oxidation of beta carotene, and they make a number of claims about these molecules:
“OxBC is a premium product embodying the untapped potential of the many non-vitamin A carotenoid oxidation compounds we believe are the true agents responsible for the various non-vitamin A activities of carotenoids.”
“OxBC possesses a wide range of biological properties that are exerted non-toxically. These include:
1. Inhibition of proliferation of cancerous cells grown in vitro (5-30 micromolar concentration);
2. Effective inhibition of growth of experimental tumours implanted in mice, (10-30 mg/kg body weight injected intraperitoneally, dose frequency every 1-3 days);
3. Promotion of cellular differentiation in vitro (concentrations roughly same as for item 1);
4. Non toxic bioactivity, in vitro and in vivo (e.g., mice, multiple injections; 150 mg OxBC/kg body weight);
5. Enhancement of intercellular gap junctional communication in vitro;
6. Induction of Phase 2 enzymes in vitro (shown for at least one component) implies cancer chemoprevention activity;
7. Promotion of growth and feed conversion in food production animals.”
OCL-1 is Chemaphors’ primary cancer drug candidate for the following reasons:
• Non-toxic inhibition of growth in mice of tumours derived from human cell lines
• Wide therapeutic range of activity
• Available orally
• Rapid tissue distribution and penetration predicted by low molecular weight (<150 Da) and fat-soluble nature
• Antimetastatic activity
• Chemopreventive anticancer activity
• Novel – although a carotenoid oxidation product, it is virtually an unknown compound
• No known reports of biological activity of any kind prior to Chemaphor’s studies
• Unusual chemical structure with potential to elaborate into a distinct chemical class with a spectrum of biological activities
• Non-classical, non-toxic mechanism of anti-tumour action, e.g. enhanced gap junction intercellular communication
• Low manufacturing cost based on simplicity of chemical structure.”
No references are cited to support any of these claims. A quick PubMed search finds some references to in vitro studies of some similar compounds, but no clinical trial evidence of significant benefit in humans, and no studies of non-retinoid carotenoids at all in dogs. This is not to say the molecules couldn’t have beneficial effects as cancer preventatives or therapeutics or in some other application, only that the company is following the all too common and unfortunate path of building hype and marketing products without adequate evidence of safety and efficacy. As I have discussed before, this is a tried and true strategy for supplement manufacturers, trying to take preliminary hints of utility for a product and use them to support sales before definitive evidence can disprove them. It may make economic sense, but it is scientifically and ethically indefensible.
And the promotional materials for Chemaphor make it very clear that the goal is to draw investors and their dollars. They are refreshingly open about the economic aspects of their agenda.
” Chemaphor is developing a set of major, business opportunities centred on the rich, non-pharmaceutical potential of the OxBC product….In comparison to drug development, each opportunity offers shorter product commercialization times by requiring much less development work and being subject to less restrictive and smaller regulatory hurdles. Yet each business activity addresses global market biotechnology segments with major, multi-million dollar revenues.”
“ Target market areas:
• Non-antibiotic feed additives for improving growth and feed conversion efficiency in production animals (e.g. poultry and swine)
• Nutraceuticals for companion animals
• Veterinary applications
• Skin care
Intended applications of products:
• Improving growth and feed conversion in swine and poultry
• General promotion and maintenance of good health in farm animals, dogs, horses and cats (companion animal nutraceuticals; feed additives)
• Control of diseases of aging (e.g., cancer) in companion animals (pet nutraceuticals)
• Anti-aging protection of skin, including protection against skin cancer (skin care and cosmetics, e.g., after exposure to sun)
• Amelioration of pre-existing skin conditions or prevention of recurrence of treated conditions (skin care and cosmetics)
• Maintaining healthy skin by providing broad, multi-level protection against various conditions (skin care and cosmetics)”
“In the area of pet nutraceuticals, Chemaphor’s goal is to obtain entry into this rapidly growing, lucrative market with OxBC as a health-maintenance, chronic disease protecting product. The companion animal market is attractive because there is an unmet need for the type of product OxBC represents, the market is large, and it is the fastest growing segment of the animal health market, at over 6% per year. This market also poses lower regulatory hurdles to entry.”
There is, of course, insufficient information to say with certainty whether or not this company’s products have any real medical value, but these promotional materials are a classic example of what I’ve come to call Big CAM. Contrary to the mythology promoted by CAM advocates, in which small providers make available free or cheap health care miracles despite the oppressive forces of “industrial medicine” to keep our pets sick for our own monetary well-being, the reality is that CAM products represent a lucrative market and CAM manufacturers, distributers, and providers are just as interested in making a living as anyone else. The classic Big CAM features of this marketing material are:
1. Aggressively touting the benefits of a product well before adequate evidence exists to support the claims made.
2. Vague and lofty claims of treatment for a wide range of conditions, from cancer to aging skin.
3. A clear interest in taking advantage of the inadequate regulatory oversight for “dietary supplements” and other products that can avoid FDA or USDA requirements for proof of safety and efficacy.
These features justify some serious skepticism about the company’s claims. Before profiting from the belief the company is actively seeking to create, that it’s products offer health benefits to companion animals, the company ought to be obliged, by ethics if not laws, to prove that the product is truly beneficial. I hold out little hope that the regulatory agencies will enforce such an obligation, and I await with interest further indications of whether or not the company will voluntarily do the right thing and refrain from profiting from its products until it can convincingly demonstrate they are helpful and safe.