[Editor's Note: This article is written by Vogel, who has put extensive work in evaluating LifeVantage's Canine Health. I have done some minor cosmetic edits for readability. The title is mine and my opinion after evaluating information below.
With the launch of the new pet formulation of Protandim (Canine Health), LifeVantage continues its tradition of shoddy tainted science and fraudulent marketing, established previously with the human version of Protandim. The company and its distributors are claiming that the new canine supplement has been validated through research; the alleged research in question is referred to by the company as the "Canine Health Study." It appears that the company has taken measures to misrepresent and bury the results of the study.
The so-called Canine Health Study is unpublished, so the design, data, and conclusions cannot be properly scrutinized. Additionally, the study was not an independent study but rather was initiated by LifeVantage using a dubious looking contract research lab by the name of Animal Health Consulting, LLC (run by Craig Woods, DVM). AHC’s website went defunct at the beginning of this year; and it now redirects to a placeholder page with the message: "As of January 1, 2013, we are not accepting new clients." It is suspicious to say the least that this company appears to have gone defunct at almost the exact same time that they were being cited by LifeVantage as the source of the research on the Canine Health supplement.
Aside from a press release , the only discussion by the company of the alleged Canine Health Study has been in:
- a 30-minute audio recording of a February 2013 Science Call, hosted by LifeVantage sales VP Jon McGarity, in which former CSO Darlene Walley provides details about the alleged study...
- a printed promotional document from February 2013 – dubbed The Canine Health Study White Paper — which also features Darlene Walley. LifeVantage once had that document available on their media page but the link is no longer operative (see dead link); I was however, able to find a copy on the website of Nicole Rexing, a Protandim distributor/pet cremator.
It is remarkable that the webpage for Canine Health contains no information whatsoever about any supporting research. It seems that LifeVantage is deliberately burying details of the Canine Health Study out of view of the general public.
Note that Darlene Walley became the company’s CSO in October 2012 and then abruptly resigned in early 2013. Her sudden departure was only revealed when LifeVantage President/CEO Doug Robinson was pressed for details in a May 10, 2013 earnings call.
The details provided in the company’s 2 sources on the Canine Health Study and the inconsistencies between them raise unmistakable red flags and render the associated claims and conclusions highly suspect to say the least.
The white paper claims that the Canine Health Study was carried out at 2 sites — Prescott Animal Hospital in Prescott, AZ, and Animal Health Services in Cave Creek. AZ. There is no apparent evidence that either of these clinics is equipped for or experienced in the conduct of clinical research trials. The study bears the ID number V011413F and a date of January 14th, 2013, which is presumably when the report was issued.
The research, the stated aim of which was to measure oxidative stress, was described in the white paper as a 60-day study conducted in 80 dogs (including both arthritic and healthy animals) with a mean age of 8.6 years. Four dogs dropped out before completion leaving a total of 44 dogs in the arthritic group and 32 in the healthy group (the reason for the imbalanced group sizes was not given). According to the white paper, “veterinarians and owners assessed these dogs for clinical disability outcomes and for hematological and biochemical changes”.
The white paper claims that there was a 27% reduction in Overall Disability Scores, as assessed by the owners on a 33-point scale, in dogs with bilateral hip disability that received the active product (n = 13) versus a 2% reduction in the placebo group (n = 17). Note that there are several problems with this claim. First, the number of animals doesn’t add up. If there were 44 dogs in the arthritic group and 32 in the non-arthritic group, why are they reporting data for only 30 arthritic dogs (i.e., 13 that got the product and 17 that got the placebo). In the best case-scenario, one might assume that the data presented are from a subgroup analysis of only those dogs in the arthritic group that had bilateral hip involvement. However, using a post-hoc analysis of a subgroup of arthritic dogs with bilateral involvement while arbitrarily excluding those with unilateral involvement would be an example of cherry-picking. Presumably, the product did not have an appreciable effect on disability scores when all 44 arthritic animals were included in the analysis.
Another problem with the data is that it reflects only the disability scores as determined by the dog owners. However, upfront it was stated that disability was also assessed by veterinarians. Presumably, the failure to report that data and focus only on what would be considered less reliable data from pet owners (who are less experienced in the objective disability assessment), is because the vet scores showed no appreciable effect of the product. Thus, this is again suggestive of cherry-picking and negative data suppression.
Lastly, the document claims that “technicians at Prescott Animal Hospital affirmed that they were able to identify which dogs were receiving the active product based on these abovementioned responses [i.e., energy, alertness, playfulness]”. Thus, by the company’s own admission, the study was, in effect, not adequately blinded – a major flaw.
Regarding other data parameters, the white paper claims that at day 60, catalase was increased by 36% in the active group and decreased by 11% in the placebo group, and concludes that the active product may up-regulate the oxidative capacity of the dogs. There are numerous issues with this claim. First, it appears that the overlooked a typo when claiming that the product upregulated “oxidative capacity”; presumably they meant "antioxidative capacity" — that’s a major error. Second, the stated objective was to measure oxidative stress, but catalase is not a measure of oxidative stress, it is an endogenous antioxidant enzyme and whether it is up- or down-regulated provides no definitive evidence whatsoever regarding the degree of oxidative stress in an animal. Third, the data for catalase, unlike the disability data, inexplicably did not include the number of animals per group, which is indicative of either sloppiness or whitewashing, and it is not clear whether the data were from arthritic or normal animals or both combined. Fourth, the results are presented as percentage change from baseline rather than as absolute catalase levels (far preferable), which is a common trick used to gussy up bad data. Lastly, as with the disability data, no statistical analysis was described, so it’s not even clear whether any of the reported effects are statistically significant, let alone clinically relevant.
Despite all these glaring deficiencies and red flags, the summary of the "study" in the white paper is followed up with staggeringly obtuse and baseless conclusions from a vet named Maureen McMichael, presumably a shill for the company. She states:
"LifeVantage Canine Health meets all criteria for a safe, an easily administered, product that targets multiple oxidative stress pathways in canines... I believe this continuing study currently demonstrates the importance and utility of this supplement – for improving the health and quality of life of dogs as they age."
However, the study did not report on multiple oxidative stress pathways, or safety, or health, and what little data it did include was so flawed and poorly presented as to be worse than worthless.
The second company source in which the Canine Health Study is discussed is the February 2013 Science Call audio recording, again featuring Darlene Walley, which took place just a week or so prior to the release of the Canine Health Study white paper.
The first glaring red flag comes at the 10:25 mark, where Walley says: "We measured TBARs, we measured catalase, which are the top 2 indicators in humans for oxidative stress."
Two major problems here. First, these are not the top 2 indicators in humans for oxidative stress. In fact, as mentioned above, catalase is not even a measure of oxidative stress at all (it is an antioxidant enzyme) and the TBAR test is one of the worst indicators (it is an outdated test that has been supplanted by much better methods in the past decade or so). Secondly, recall that no TBAR data were presented in the company’s white paper (PDF), which purported to summarize all of the key results of the study. That’s the smoking gun. The company never released any TBAR data.
At the 14:45 mark, Wally claims that measuring the levels of 8-isoprostane (8-IP) is a better indicator of oxidative stress and that the company sent samples from the alleged dog study to an outside lab for analysis of 8-IP. Walley states that the results were expected later that month, which would have been roughly in late February. The obvious problem with that statement is that roughly 6 months have passed since then and the 8-IP data have never been mentioned again, and the only reasonable explanation for this, as in the case with the never-released TBAR data, is that (1) the results were negative and therefore suppressed or (2) the story was an outright fabrication.
At the 16:25 mark, Walley says that the company is producing a "white paper" about the study that will be on the website "very soon"; she mentions that they are still doing statistical analysis on the data; and that the white paper will include 8-IP data. It is now late July; the white paper was released in February and contained no data on 8-IP or TBARs.
At 10:30, Walley alleges that the study measured joint mobility and cognitive function. However, the white paper reported overall disability scores (not the same as joint mobility) and mentioned nothing at all about cognitive function. Nonetheless, at 14:20, Walley claims “the results were very exciting — we saw improvements in joint health; we saw improvements in cognitive function”?
Aside from the 2 company sources discussed above, I also found 2 audio recordings on a distributor website (operated by distributors Jennifer Smith, Susan Kuhlman and Nancy Leavitt) that discuss the alleged Canine Health Study. One of the recordings (titled “Personal Testimonials Using True Science, Protandim and Canine Health”) is rife with illegal promotional claims positioning the product as a panacea (e.g., it cures cancer, heals lame animals, etc...).
The other recording features an interview with veterinarian/LifeVantage distributor Lee Seward, who was hyping the alleged Canine Health Study (comments begin at roughly the 10:30 mark). Seward contends that the study proves that the product improves disability from arthritis. At the 32:00 mark, Seward directs listeners to Youtube to watch the “Cassie” video, which purports to show a dog’s seemingly miraculous recovery from lameness after being given Protandim.
In summary, the manner in which LifeVantage and its distributors are marketing Canine Health is extremely deceptive and irresponsible. The company made initial claims about the therapeutic efficacy of the product based on a study which by all appearances was so critically flawed as to be worthless and which the company has since attempted to hide from public view. The company CSO who was involved in the misrepresentation of the study abruptly resigned shortly thereafter, while the contract research lab that was allegedly responsible for conducting the study suddenly went defunct. Subsequently, the company’s high-level distributors held teleconferences to disseminate false claims about the product curing cancer and other diseases — a morally reprehensible act and a flagrant violation of US law.
Of course, all of the deception is necessary because LifeVantage is again using a horribly overpriced but essentially inert concoction of cheap mundane ingredients to lure desperate people into participating in a crooked pyramid scheme/cult.
Originally posted 2013-08-30 15:46:48.This post involves:
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