[The following is another guest post by frequent commenter and researcher, Vogel.]
I just stumbled on a research article that mentions Protandim. It was published in FASEB J (a pretty good journal) in 2009. The study used an in vitro skeletal muscle model to identify factors that might improve muscle function in Duchenne muscular dystrophy patients. A variety of drugs and supplements, including Protandim, were tested. An increase in muscle contraction (tetanic force) was used as the benchmark for potentially useful compounds. While some of the compounds tested produced a significant increase in tetanic force (e.g., glucoocorticoids, which are used currently in the treatment of DMD), Protandim not only failed to increase tetanic force, it actually decreased it, suggesting that, if anything, Protandim would have negative effects in DMD patients. This is what the study reported:
"The glucocorticoids methylprednisolone, deflazacort, and prednisone increased tetanic forces at low doses, indicating a direct muscle mechanism by which they may be benefitting DMD patients" (p. 3325)
"At high concentrations, 6 of the compounds (Protandim, Haelan 951, coenzyme Q10, alanine, losartan, and ursodeoxycholate) significantly inhibited mdx mBAM tetanic force." (p. 3326)
"...the antioxidative compounds Protandim, coenzyme Q10, and Vital Detox, as well as the membrane stabilizer poloxamer, were ineffective in increasing mdx mBAM tetanic force..." (p. 3332)
The key author of the study was Brian Tseng, who also coauthored the 2010 Protandim study in DMD mice, funded in part by LFVN [Qureshi et al. J Diet Suppl. 2010 Jun 1;7(2):159-178]
So, isn't it interesting to see how Protandim succeeds in research trials only when McCord’s name is on the paper, and fails when it's not. Isn't also interesting that LFVN never mentioned the existence of this study on their website, instead displaying only studies that they believe shows their product in the best light.
The following is a guest post from Vogel. In the interest of getting this out there as quickly as possible we'll keep it in its raw/unformatted form and make it more reader friendly soon.
I just came across a video that can rightly be called a smoking gun. The following video was posted to YouTube by LifeVantage distributor Christi Baus from Daily Life Source on October 3, 2011, accompanied by the following caption:
“A young boy with a failing heart, gets a second chance thanks to Protandim.”
[Editor's Note: The video has been taken private by Christi Baus. However, it serves the public interest to have this illegal act available for consumers to witness.]
The video, shot on the first day (April 14, 2011) of the LifeVantage Convention held at Salt Lake City’s Convention Center, opens with company president and former CEO David Brown passing a microphone to a distributor from South Dakota named Randy Antonsen, who proceeded to tell a 6-minute story about the ongoing medical treatment of his 7-year old son’s heart condition and alleges that it was Protandim that somehow miraculously cured him. The damning (i.e. illegal) portion of Antonsen’s “testimony” came at the 4 minute mark, as follows (the disjointed syntax is not a transcription error):
Antonsen: “We started him (Paul) on Protandim, and I’ll let my wife explain how I got to that, but we started him on Protandim in December of this (sic) year. Without the cardiologist knowing about it, because we researched about it and they did not know the knowledge of it, so we researched it quickly and basically uh, found out the information, started him on Protandim, went in January of this year and they gave us records of July of last year – his function was 31% — his function, and from what we can gather from our best of knowledge – he was supposed to have an appointment, hadn’t made it – best of our knowledge is that his function – we’re going to have an appointment soon, so we’re hoping it continues that way –his function went to 45 [CROWD CHEERS AND APPLAUSE] And the left side of his heart in July of last year was 51 centimeters and at his last appointment it dropped down to 41…When we were there in Iowa City, we decided — I asked the doctor; I asked the transplant doctor — I told him, I says, I says ‘can you explain him to me’. He looked me in the eye and he says ‘we have no medical explanation for him’. He, by the doctor’s explanation, he should not have been running around; he should not have been active. Matter of fact you put him in a room with perfectly healthy kids and you can’t tell the difference between him and anyone else.
More background details on Antonsen and the LifeVantage conference can be found here and here
At the very least, what we’re witnessing here is the President of the company, David Brown, giving his tacit blessing to the use of disease-cure testimonials in the training of LifeVantage distributors and the marketing of Protandim. Not only did Brown do nothing to stop this illegality from taking place (i.e. Brown aided and abetted this illegal activity), it is a fairly safe assumption that Antonsen’s illegal testimonial was pre-arranged and orchestrated by LifeVantage senior staff with prior knowledge that distributor would be violating US law.
LifeVantage can never again argue that they are not directly complicit in the use of illegal medical claims in the marketing of Protandim.
Now let’s consider some of the broader implications. LFVN is a publicly-traded company, and in their annual filings to the SEC, they have identified various risk factors that can impact the company’s business and the shareholders investment. The risk factors discussed pertain directly to the claims that Antonsen made with Brown’s oversight and blessing. The following risk factors are included in LifeVantage's 10K filing:
“Adverse publicity could also increase our product liability exposure, result in increased regulatory scrutiny and lead to the initiation of private lawsuits.”
We are subject to the risk of investigatory and enforcement action by the FTC: We will always be subject to the risk of investigatory and enforcement action by the FTC based on our advertising claims and marketing practices. The FTC routinely reviews product advertising, including websites, to identify significant questionable advertising claims and practices. The FTC has brought many actions against dietary supplement companies based upon allegations that applicable advertising claims or practices were deceptive or not substantiated. If the FTC initiates an investigation, the FTC can initiate pre-complaint discovery that may be nonpublic in nature. Any investigation may be very expensive to defend and may result in an adverse ruling or in a consent decree."
The FDA may determine that a particular dietary supplement or ingredient is adulterated or misbranded or both, and may determine that a particular claim or statement of nutritional value that we make to support the marketing of a dietary supplement is an impermissible drug claim, is not substantiated, or is an unauthorized version of a “health claim.” Any of these actions could prevent us from marketing that particular dietary supplement product, or making certain claims for that product. The FDA could also require us to remove a particular product from the market. Any future recall or removal would result in additional costs to us, including lost revenues from any product that we are required to remove from the market, which could be material. Any product recalls or removals could also lead to liability, substantial costs, and reduced growth prospects.
LifeVantage’s form 10-K filed with the SEC acknowledges directly that the use of medical claims could result in censure by the FTC and/or FDA leading to investigations and regulatory actions that substantially harm the value of the company’s stock.
Based on what we saw from the David Brown video, he is failing, as the company President, in his responsibilities to the company’s shareholders by placing the company at risk for regulatory action by the FDA and FTC.
I'd like to add that the not only is this video proof of criminal activity, but it also shows that LifeVantage Policies and Procedures are simply window-dressing for the FTC and FTC. Here's a reminder of one section of it:
"8.11.2 – Product Claims
No claims, which include personal testimonials, as to therapeutic, curative or beneficial properties of any products offered by LifeVantage may be made except those contained in official LifeVantage materials. In particular, no Independent Distributor may make any claim that LifeVantage products are useful in the cure, treatment, diagnosis, mitigation or prevention of any diseases or signs or symptoms of disease. Not only are such claims violations of LifeVantage policies, but they potentially violate federal and state laws and regulations, including the Federal Food, Drug, and Cosmetic Act and Federal Trade Commission Act."
As you can see LifeVantage only includes this clause so that they can protect themselves in the case that a LifeVantage distributors makes an illegal medical claim. They have the signed document that effectively says, "It isn't our fault that our distributors break the law. We have it in writing that we told them not to." However, at every opportunity they get, they are pushing information at distributors that leads them to believe that they can make these claims.
In addition, this article mentioned that they flew the boy to the event and surprised him on the stage. Imagine putting a boy on stage in front of hundreds of people and then surprising him. That sounds like a checklist of things NOT TO DO to a person with a heart condition. Then again, if you are LifeVantage, why do you care about the welfare of the boy, when you can use him to convince distributors that the product helps with medical conditions that it simply hasn't been shown to do.
LFVN has nowhere to hide now. No more plausible deniability or trying to blame this on low-ranking distributors. The cat is out of the bag. Illegal marketing is at the core of the marketing strategy for Protandim. This is unlikely to end well for LifeVantage.
Eagle-eyed investigator Vogel has come up with a few startling pieces of information regarding the only study of Protandim in humans. The study titled "The induction of human superoxide dismutase and catalase in vivo: a fundamentally new approach to antioxidant therapy", was done by Nelson SK, Bose SK, Grunwald GK, Myhill P, McCord JM.
Specifically, it has been discovered that the study used subjects who were company insiders. Watch this outdated spot on PBS' Health Quest:
At the 5:05 mark, Sally Nelson, a LifeVantage employee, interviews two participants in that clinical study, Steve Ossello and Reed Madison. Steve Ossello calls it "a major breakthrough and a life-changing event for [him]." What the video doesn't tell you though is that Steve Ossello and Reed Madison are top-ranked LifeVantage distributors.
Another article, Colo. Doctor Invents 'Anti-Aging' Pill from ABC7 News in Colorado says that McCord invented Protandim which is a lie - as we know. However, it also quotes another participant of the study, Leigh Severance. The article makes Leigh Severance sound like just an enthusiastic support of Protandim when it reads: "... Leigh Severance swears by this new 'anti-aging' pill. He said he'll take it until the day he dies but jokes that if the pill really works, he'll be around for a long time."
"H. Leigh Severance became a director of Lifeline Therapeutics in January 2005 as the designee of Keating Securities pursuant to Keating Securities contractual right to designate one member of our board of directors."
There's that Keating Securities again.
This filing seems to show that he certainly had a lot of stock in LifeVantage. I guess it is pretty easy to swear by something when they are paying you well and you likely get a lifetime supply of free product. ABC7 News never disclosed the relationship between Severance and LifeVantage.
Bottom-Line: LifeVantage chose at least 3 participants in the study who were clearly financially biased. If all the above information wasn't enough to establish this, all three are documented insiders with the SEC with Madison and Ossello having around 100,000 shares as of June 2005 and Severance having over a million. It is worth mentioning that these are the only three people in the study who I have the names of. For all we know, all the participants could have been company insiders like these three.
It is particularly important to note that when relying on test like TBARS diet can drastically alter the results. Is 16.5 million dollars motivation to alter a diet for a month to make the results look great? I don't know anyone who would turn down that offer.
"Jim Galloway – Galloway Enterprises: Hi, Doug. You were just talking about new products and science and everything. There were enthusiastic comments about the new Chief Science Officer when she joined the company last fall, but no mention of the fact she departed after over – only several months. What transpired, and how is the lack of a Chief Science Officer affecting the company? And what’s the job description of the Chief Science Officer and the budget for that department?
Doug Robinson: Let me try to hit all of your questions, Jim. You’re absolutely right. We made an announcement last October for a start date in November of a new Chief Science Officer. And after only five months or so, it was determined, really, by our Chief Science Officer, that she’d like to go back and pursue consulting, which is the world that she came from before she joined us. And so we honored that resignation and we parted ways."
There are at least four interesting things about this:
1. LifeVantage didn't deem the Chief Science Officer important enough to talk about until they were asked about it specifically. With the press release about her showing up, why was there no official recognition that she left?
Our Health and Abundance looks to be a repository of conflicting information. It's purpose is clearly to pitch Protandim with the tagline of "Featuring: Testimonials, Doctors, Vets and Pets for Protandim." It includes categories on the sidebar of diseases such as: Fibromyalgia, Multiple Sclerosis, Cancer, and Diabetes. However in small letters at the bottom of the page is the disclaimer, "*Products not intended to cure, treat or prevent disease*." This would seem to fall afoul of the FTC's endorsement guidelines where you can not suggest Protandim plays a role in disease and then in small letters negate the whole statement.
When you dig a little further you can see that there are a number of illegal claims on a Protandim testimonial page. There you can find Protandim distributor Don Wheat crediting Protandim helping his throat cancer and Protandim distributor Alithia Rutherford credit Protandim with helping with headaches (though the site categorizes the testimonial under Multiple Sclerosis as well as many other testimonies involving various diseases.
Michelle Skaff's own LinkedIn Page contains illegal claims about Protandim:
"Featured on ABC, NBC, PBS, and in Sanjay Gupta's book, Chasing Life, Protandim is proven to be a scientific breakthrough for our health based on it's ability to activate the powerful survival genes in our bodies that reduce aging, oxidation, inflammation and impact diseases like cancer, heart disease, diabetes and more. It has been researched by LSU, Harvard, Massachusetts General Hospital, University of Colorado and and other leading universities based on it's powerful ability to activate the survival genes within our cells, which are millions of times more powerful then what we might consume externally.. If you are serious about your health, learn about this product and science."
I bolded the parts where she illegally claims that Protandim does impact diseases. However it also worth pointing out that Harvard and MGH have not researched Protandim.
It is quite clear that Michelle Skaff is using testimonials to pitch Protandim as an aid to many, many diseases despite her own disclaimer and LifeVantage's that it isn't intended for such purposes. There's a word in the dictionary for this and it's called fraud.
According to the 8-K disclosure, the agreement will mean LifeVantage will give "twelve (12) equal monthly payments to Dr. McCord in the aggregate amount of $1,700,000." That's a lot of money, but the agreement that McCord made to get the money is perhaps more interesting:
"The Agreement contains provisions relating to, among other things, confidentiality, non-disparagement, return of company property, and a general release of claims in favor of our company."
What kind of confidentiality does LifeVantage need from McCord? It's not like Protandim has changed its formulation or that it is any kind of secret. If LifeVantage is running a strong organization that isn't a scam, why would they need to put McCord under a non-disparagement agreement?
One person close to me read this and suggested that this looks like hush money.
It was noted that in this 10-K filing with the SEC that McCord was making $10,000 a month ($120,000 a year) plus $0.50 for every bottle of Protandim sold as of June 2011 (his salary may have been updated since then). Getting $1.7 million is certainly a good amount of money compared to that base salary.
The other interesting thing in that 10-K is the termination clause:
"Termination. Either party may terminate the employment agreement without cause upon 180 days notice to the other party. If a party commits a breach of a material provision of the employment then the agreement can be terminated by the other party for cause. If the Company were to terminate the agreement for cause then Dr. McCord shall be not entitled to any further compensation after the date of termination."
Now Dan Royal is looking to pull off a new scam. A scam within a scam. How is he looking to do this? Through a LifeVantage Challenge. Let
Here's how it works. Let's see if you can spot the scam:
Go to the website: www.royalmedicalclinic.com
Fill out patient forms (below) and either fax to (702) 938-5844 or scan and email to [email protected]:
a) LFVN Nutritional Assessment;
b) Patient Information; and
c) Patient History.
Pay Administrative Fee of $100 for Nutritional Assessment or Homeopathic Consultation to Royal Medical Group (“RMG”) by credit card or PayPal, calling (702) 938-5055, faxing (702) 938-5844 or emailing: [email protected]
Get blood test for MicroNutrient Test:
a) Physician orders test from SpectraCell;
b) Test kit is shipped to participant;
c) Participant has blood drawn and sample shipped to SpectraCell;
a. Insurance patients must include insurance information and/or copy of their insurance card, along with co-pay of $160;
b. Cash patients must pay RMG $320 via credit card, PayPal, or check.
d) Physician receives and reviews test results and provides a copy to participant.
CIGNA, Medicaid, and Blue Cross/Blue Shield in TX, IL, OK, NM, SC and TN are not billable insurances and cash must be paid.
Take Protandim as prescribed by physician.
a) Participant should obtain Protandim from LFVN Distributor; but
b) If Participant does not have Distributor, he/she may purchase Protandim at: www.mylifevantage.com/royal.
Participant repeats blood test in 3-6 months or as recommended by Physician.
Did you catch it? Dan Royal collects the $100 administrative fee plus whatever commissions he gets from people buying the product in part 5b. That $100 doesn't sound like that much, does it? Well it also looks like those with insurance have to pay a $160 co-pay to Royal Medical Group and those without pay $320. If you read the summary of the his PowerPoint at LifeVantage Elite he's looking to get 1,000 people to take the test. That's $100,000 in his pocket in administrative fees, and around $160,000 in co-pays, plus the product commissions.
Who else wins in this? Well LifeVantage gets distributors to foot the bill for testing its product. If the test comes out good, they will certain trumpet it as a success. If it comes out to do nothing, it will likely never see the light of day and Dan Royal will quietly end the challenge. One thing is for sure, this test by using people who are likely distributors to begin with will be biased and subject to a very significant placebo effect.
Who is the loser in this? It is the poor victim of the scam, the distributors. It's unlikely that health insurance is going to consider one nutritional assessment a good use of their money, much less two in a 3-6 month span. They are much more likely to suggest that you buy a cheap multivitamin and kick you out of their office. So in reality, the distributor is looking at paying $640 for two tests, $100 for an administrative fee, $300 in 6 months - a total of over $1000. Why pay $1000 to prove that someone else's product works? LifeVantage should be footing the bill, not the distributors.
"Guarantees: I acknowledge that RMG has not made any promises or guarantees to me regarding my medical condition(s) and that RMG’s assessment does not constitute a physician-patient relationship."
It doesn't end there. The agreement also requires that you go through binding arbitration instead of suing for damages:
"Arbitration: I agree that any claim or dispute arising out of this Agreement shall be subject to binding arbitration pursuant to the Commercial Rules of the American Arbitration Association (AAA) and conducted by a single AAA arbitrator in Henderson, Nevada. In no event shall either party be entitled to punitive damages."
Finally the non-patient (I don't know what else to call the distributor signing this) receives all care through telephone or email.
"ROYAL MEDICAL GROUP...will perform either a telemedicine nutritional assessment or homeopathic consult via email and/or phone."
An email consultation... that seems to be what the $100 administrative fee gets you.
It seems odd to trust Dan Royal's expertise. In both documents he mentions that Protandim is prescribed by a physician. Next time you visit your doctor ask him to write a prescription for a Protandim and see what he says. Or perhaps if you find yourself at a drug store ask the pharmacists how many prescriptions for Protandim they fill each day.
In seriousness, please don't bother your doctor and pharmacists about Protandim. They are busy enough without having to deal with pranks designed to prove Dan Royal's ignorance.
"McCord, chief scientific officer for LifeVantage, the makers of Protandim (protandim.com), says one pill a day could help keep everything from cancer and Alzheimer’s disease to baldness and creaky joints away."
At first I gave LifeVantage the benefit of the doubt and figured that the journalist or the magazine misrepresented what McCord had said. However, as this website has proved time and again with illegal claims, they haven't earned any benefit of the doubt - quite the opposite. When you have examples of television stations spreading the lie that McCord invented/formulated Protandim, it's obvious that it isn't the journalist's fault.
That said, the journalists and magazine editors need to do a better of job of not publishing articles that illegal promote products. When they do, they come off as advertisements disguised as news articles.
"An Independent Distributor that provides a product experience testimonial in any medium should use care to disclose their affiliation with LifeVantage ('LifeVantage Independent Distributor'), be honest in their testimonial personal experience, and assert that they are not claiming that their experience is the typical result experienced by consumers."
On the surface this sounds pretty responsible. However, as was previously pointed out in the aforementioned article, is no typical result experienced by consumers so Independent Distributors can make no claims.
What I had missed, though, is that the Independent Distributor can't even make the claim WHILE disclosing that it is not typical. The FTC's Endorsement Guidelines read:
"Example 1: A brochure for a baldness treatment consists entirely of testimonials from satisfied customers who say that after using the product, they had amazing hair growth and their hair is as thick and strong as it was when they were teenagers. The advertiser must have competent and reliable scientific evidence that its product is effective in producing
new hair growth.
The ad will also likely communicate that the endorsers’ experiences are representative of what new users of the product can generally expect. Therefore, even if the advertiser includes a disclaimer such as, “Notice: These testimonials do not prove our product works. You should not expect to have similar results,” the ad is likely to be deceptive unless the advertiser has adequate substantiation that new users typically will experience results similar to those experienced by the testimonialists."
"In our ads we want to feature endorsements from consumers who achieved the best results with our product. Can we do that under the revised Guides?
Testimonials claiming specific results usually will be interpreted to mean that the endorser’s experience is what others can expect. Statements like “Results not typical” or “Individual results may vary” won’t change that interpretation. That leaves advertisers with two choices:
Have adequate proof to back up the claim that the results shown in the ad are typical, or
Clearly and conspicuously disclose the generally expected performance in the circumstances shown in the ad
How would this principle apply in a real ad?
The revised Guides include a lot of examples with practical advice for marketers. Suppose an ad features an endorsement from 'Mary G.' who says, 'I lost 50 pounds in 6 months with WeightAway.' This ad likely conveys that Mary G.'s experience is typical of what consumers will achieve by using the product. If consumers can’t expect to get those results, the ad likely would mislead consumers unless it makes clear what consumers can expect to lose in similar circumstances – for example, 'Most women who use WeightAway for six months lose at least 15 pounds.'"
By suggesting that Independent Distributors disclose that the results aren't typical ignores the FTC Guidelines that they either need to be able to back up the claim with adequate proof (which doesn't exist for any Protandim claim on humans) or that they disclose the general expected performance (which is no expected change for the customer of the product).
In other words, it seems every conceivable testimony for Protandim would be considered deceptive by the FTC. LifeVantage, instead of recognizing this and making distributors aware of these guidelines, hides behind the inadequate and antiquated notion of telling distributors to say, "results not typical." That's no longer sufficient according to the FTC.
[Editor's Note: The following is 99% the work of Vogel in a comment that you can read at the main Protandim Scams article. I've done a little clean up and fit the links in to flow like a traditional article on the web.]
PubMed shows that between 2003 and 2008 there were 20 research articles published in which the effect of curcumin on NRF2 was described, and in that same timeframe, many articles have been published on the activation of NRF2 by a variety of other common compounds aside from curcumin, such as green tea polyphenols (such as this one and this one.
Curcumin and green tea extract (75 mg each) are 2 of the 5 ingredients in Protandim.
McCord is also an insider shareholder of LifeVantage, owning (or having owned) a 10% share of the company, and he receives a substantial amount of money (50 cents) from every bottle of Protandim sold. Here are details on his financial interest.
One of the other authors of the 2003 article on curcumin and NRF2 published in Biochemical Journal (Balogun et al. 2003) was Jawed Alam, PhD (from the Department of Molecular Genetics at Ochsner Medical Center in New Orleans), was also an author on the 2009 LifeVantage study on Protandim and NRF2 by Velmurugan and McCord et al.
In a nutshell, that's a smoking gun. LifeVantage’s 2009 report about Protandim simulating NRF2 in vitro was totally predictable, given that the product contains curcumin and green tea extract. They merely piggybacked on a pre-existing line of research, which presumably they had to have been aware of for years (prior to the creation of Protandim). It is also presumably no mere coincidence that the genesis of the Protandim/NRF2 article took place right around the time that the company announced the hiring of David Brown (former CEO of infamous Metabolife) as their new President/CEO – i.e., LifeVantage announced Brown’s hiring in a January 2008 press release and the Protandim/NRF2 manuscript (which included only in vitro experiments, which can be performed fairly quickly) was first submitted to the journal on July 8, 2008 (according to the publication details in the article).
LifeVantage's sleight of hand trick with respect to NRF2 reminds me of how other MLM supplement companies (e.g., Monavie, Juice Plus etc.) spike their products with vitamin C and then publish worthless studies showing that the products have antioxidant effects, which in reality is attributable simply to the added vitamin C (a cheap commonplace ingredient).