The faux science journal Integrative Veterinary Care has recently been pushing a supplement called Vivamune on their Facebook page, so I thought I’d investigate and see what the product was about. It turned out to be an interesting look into the business side of the supplement market.
Vivamune, currently marketed by a company called Avivagen, turns out to be a repackaging of Oximunol, a supplement marketed by a company call Chemaphor (of which Avivagen is a subsidiary). I wrote about Oximunol/Vivamune way back in 2010, and at the time the product was a nice example of marketing outstripping science in the supplement arena. Sadly, the changes in name, ownership, and marketing strategy that have occurred since, and even the scant additional research published in the intervening 5 years, have not changed the basic fact that this product relies on taking a tiny bit of promising but limited science and using it to cash in on the hopes and fears of pet owners.
What is Vivamune/Oximunol?
The core idea behind this supplement is a number of chemicals collectively identified as OxC-beta by the company. These are produced by oxidation of beta-carotene, the pigment that gives carrots their characteristic color and which is a precursor of Vitamin A. The theory, which is perfectly plausible, is that these compounds have biological effects which might enhance the function of the immune system and influence inflammation. However, as usual the statements made by the company in its marketing are much more exciting and dramatic than this humble hypothesis.
Vibrant health made simple
Revolutionary immune supporting active ingredient
Many beneficial health effects
Promotes normal mobility, and relieves occasional stiffness especially in older pets
Soothes skin-related issues associated with seasonal allergies
In pets, OxC-beta supports overall vitality and energy, mobility and joint function, as well as a healthy skin, coat and gut.
Results observed in food animals include healthier growth, better utilization of feed and decreased morbidity. In food animals, it is intended that use of OxC-beta avoids the feeding of antibiotics.
The claims made are pretty vague, as required both by supplement regulations which allow only “support” claims rather than specific treatment claims and also, as we will see, by the lack of specific evidence to support more specific claims. Nevertheless, the implication of wide-ranging and dramatic health benefits is clear. All the usual marketing buzzwords can be found as well, including “holistic,” “natural,” “organic,” and so on. The company does appear, however, to have abandoned some of the language used in marketing Oximunol which suggested their product might have a role in preventing or treating cancer.
Though the company is still marketing to pet owners, the emphasis appears to be on the potentially much more lucrative livestock market, and ultimately the human supplement market. The goal is apparently to market OxC-beta as a growth promoter in food animals, to replace the use of antibiotics for this purpose, which is being limited and in some cases banned by regulatory authorities due to concerns about antibiotic-resistance.
“In OxC-beta, we have discovered a natural alternative technology to antibiotics that we’re now targeting to improve productivity in livestock,” president and CEO, Cameron Groome, says… “We can quickly turn on enough OxC-beta production to generate tens of millions of dollars of revenue,” Mr. Groome suggests. “What we need to do is complete the sales cycle with those companies that can become multimillion dollar customers. That’s what we’re doing now…”
Does It Work?
The Vivamune/Oximunol marketing emphasizes the scientific credentials of the company’s leaders and the scientific basis for their product and claims:
Scientifically formulated
Rigorously researched and developed in Canada by a dedicated team of chemists, biochemists and veterinary immunologists
We have already had three peer-reviewed scientific papers published in leading journals on its chemistry and biology
The reality is a bit less impressive.
My original article on Oximunol was prompted by a press release suggesting an in-house “clinical trial” had been conducted on the product and that “A full report of the study is being prepared for submission for publication in a peer-reviewed journal.” I have not been able to find any evidence that this study has been published beyond the company’s own marketing statements in the intervening five years.
There are a number of published studies referred to on various Avivagen web pages and in other press releases. One paper in PLOS One presents some in vitro and lab mouse data indicating OxC-beta has some physiologic effects. Another study published in the American Journal of Veterinary Research found evidence for some effects of OxC-beta on white blood cells in vitro and in the lungs of Holstein calves. A study in poultry presented at a conference in Korea suggested some protective effects against a bacterial infection of the intestines, and another unpublished Korean study in pigs suggested OxC-beta might have growth promoting properties. The company has announced additional livestock studies in Asia, where it appears to be focusing its marketing efforts.
This research certainly suggests the chemicals in OxC-beta have measurable effects, and that some of these effects might be useful in preventing disease or promoting health. But as usual, the research is preliminary and very limited, and it does not justify widespread use of this supplement, especially in pets. There are still no clinical studies showing any benefits of any kind for dogs and cats, and only the most preliminary studies showing any benefits in food animals that might justify widespread use or effectively replace antibiotics as growth promoters in feed. The exuberance of the advertising has more to do with marketing and profits than with science.
Is It Safe?
As I often have to remind people, the absence of strong evidence for benefits from a medical therapy also means an absence of strong evidence for safety. The use of marketing terms like “natural” and “organic” are not reliable indicators of whether or not a product is safe. And while the chemicals in OxC-beta are derived from a food which, in itself, is safe to eat in reasonable amounts (though you can turn your skin yellow from eating too many carrots) that doesn’t mean the supplement is automatically safe.
Vitamins and other “natural” substances found in foods can cause serious harm if taken in quantities larger than normally found in food. The makers of OxC-beta specifically market the supplement on the basis that it contains far more of the chemicals they are interested in that one could get from a normal diet: “ While the process of carotenoid oxidation occurs naturally in the plant world (and to at least some extent in animals), the products of that oxidation reaction are present in such minuscule amounts that it would be physically impossible to get the full benefit just by increasing vegetable consumption.” The possibility of some risk cannot be ruled out except with appropriate research.
Avivagen claims to have run safety studies on dogs at ten times the recommended dose, but these do not appear to have been published or submitted for any regulatory review. The studies that have been published in other species do not report any significant side effects, but these are limited studies on small numbers of animals, which we all know from the experience of the pharmaceutical industry do not always guarantee safety in the much larger and more diverse general population, and most are funded or run by the company marketing the supplement.
Bottom Line
The idea that oxidation products of beta-carotene might have beneficial health effects is certainly plausible, and there is some preliminary data to support this. However, this product has been marketed as all-purpose tonic for pets for at least five years under two different names, and the manufacturer has yet to provide any reasonable published evidence of meaningful benefits in dogs and cats. And while there is slightly more evidence to suggest usefulness in some food animals, even this is not robust enough to justify widespread use.
The company repeatedly claims to be committed to a science-based approach and yet clearly acts in ways that have more to do with economic goals than scientific priorities. This is yet another example of the fact, which many users of dietary supplements fail to understand, that companies in the supplement business are no less motivated by profit and no more committed to the welfare of patients than pharmaceutical companies. The fact that they deal in largely unregulated substances they may label “natural” does not make their products safer nor their motives any purer than those of the conventional pharmaceutical business.
I’m struck by the sentence (last paragraph): “This is yet another example of the fact, which many users of dietary supplements fail to understand, that companies in the supplement business are no less motivated by profit and no more committed to the welfare of patients than pharmaceutical companies.” This has face validity. Basic economics says that companies exist for profit, not for customer welfare. But I’m a little surprised to see the implicit tarring of the pharmaceutical companies in this statement. I guess the take home message should be that supplements need to be held to the same standards of evidence as drugs . . . not that the companies producing supplements are evil. Capitalism requires regulation, lest quacks and frauds prevail.
Personally, I’d also like to see some anti price-gouging measures taken along with requirements to prove safety and efficacy. In my observation, pet meds are priced at what the market will bear, which according to economic theory is to be expected where producers are few and there is little or no direct competition. In the cases where I have bought the active ingredients for dog medicines in non-pet formulations (ivermectin, pyrantel pamoate, spinosad, pyretheroids), the fraction of price/quantity of active ingredient is many many times higher for the pet formulations than for the agricultural or meat-industry prices. I would guess that the active ingredients in rimadyl or cartrophen is more than a tiny fraction of their market prices. The welfare of pets would be better if the price of medicines more closely reflected the cost of production . .. and less money was spent on advertizing, marketing, and profit taking.
Companion animal drugs are one of the most profitable parts of the pharmaceutical industry. eg. http://pharmaceuticalcommerce.com/brand_communications?articleid=26854 . I suspect that is because a large number of people will pay extraordinary prices to prevent suffering in pets; and legislators been less inclined to regulate pet pharmaceuticals than human pharmaceuticals. See, eg., http://www.indystar.com/story/news/investigations/2014/12/18/drug-companies-loosen-purse-strings-to-woo-vets/20492301/
p.s. I also think that the excessively high prices charged for pet medicines play a major role in consumers turning their attention to alternative medicines and natural products.
What is fair and right to charge for medical products and services is always a difficult and controversial question, and I don’t have an answer for it. I will say that users of CAM rarely site cost as a major factor, but rather ideas about “safe and natural,” “lack of success with conventional therapies,” and ideological beliefs, so I am not sure how much a roll cost plays in this choice. Also, if one makes up a supplement and starts selling it without having to go through a rigorous process of testing to prove it is safe and effective, of course this will be less expensive than fully testing the product. The costs of research and licensing for pharmaceuticals are enormous, and as I’ve pointed out elsewhere, Big Pharma puts a much higher proportion of revenue back into research than does Big Supplement, so one could argue that the up-front price of the meds is justified because it represents the cost of protecting the public against unsafe and ineffective medications. Still, not an easy or simple issue.
I definitely agree that
1. Corporations are organized around shareholder value and profit primarily. That isn’t to say that the individuals in pharmaceutical and supplement companies don’t care about producing products that are safe and effective and that help patients, because I am certain nearly all of them do. However, the way our economic system is structured, corporations must be about making money first and foremost or they cease to exist. This is a philosophical and economic issue that there’s no point in debating here since it’s outside the purview of the blog, but it does mean that mechanisms have to be in place to protect the public from being harmed when profit is placed above public good.
2. Regulation has been a very effective means of accomplishing this in the pharmaceutical industry. The FDA is often unjustly and inaccurately maligned despite the fact that we nearly all take for granted most of our food and medicine is safe and effective, and we can only do so because of the efforts of this agency. One of the major reasons supplement companies get away with peddling products that either are unproven or blatantly ineffective and unsafe is that an anti-government and anti-regulatory ideology has prevented appropriate regulation of these companies. They are no better nor worse in their motives than the pharma industry, but they are virtually unsupervised, and history has shown us that leads to worthless and harmful medicines.
3. As for pricing of medications, this is a complex issue. Obviously, when a product is FDA regulated and must produce meaningful evidence to justify licensing, the cost of production is far greater than the cost of the raw ingredients and manufacturing process, and it is spread out over many years. Producing a licensed pharmaceutical means years of research, hundreds of discarded products that fail at each level of scrutiny, and enormous regulatory burdens, and this has to be recuperated and a profit made during the lifetime of patent exclusivity or the company (which we agree exists to generate profit more than general welfare) ceases to be successful.
To a lesser extent, the same is true for veterinary practices, which must endure costs of running their own pharmacies and must be profitable to continue to exist. So while I don’t doubt there are plenty of examples of truly excessive charging for some medical products and services, I also think most people don’t really realize what the true costs behind the production and distribution of safe and effective medicines are under the economic system we have.
Interestingly, cost is a much bigger factor in veterinary client choices than in human medicine, for several reasons. And the costs of very similar products and services are much less in veterinary medicine than in human medicine, despite the relative lack of regulation. Pets get less effective care than they could if money were not a limiting factor, but they also get good care much more cheaply than human patients because customers simply can’t and won’t pay what human patients and the insurance system will for human medical care. I’m not saying this is good or bad, but simply how things are. People complain a lot about the cost of veterinary care because they have to pay for it directly, rather than paying a co-pay for a service they receive that their insurance company pays far more for than they realize. And yet vets do a far greater variety of things than MDs for nearly equivalent educational debt and far lower salaries. Just something to consider.