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Does LifeVantage’s “Cure-All” Protandim Patent break the Law?

It has come to my attention from Dr. Harriett Hall's article on Protandim (via Protandim Watch) that LifeVantage second patent application may break the FDA's law. The part that I'm looking at is the following quote on page 28 of the patent application:

"The compositions of the present invention are useful to prevent or treat the following disorders and diseases: memory loss; Parkinson’s disease; aging; toxin-induced hepatotoxicity, inflammation; liver cirrhosis; chronic hepatitis; and diabetes due to cirrhosis; indigestion; fatigue; stress; cough; infertility; tissue inflammation; cancer; anxiety disorders; panic attacks; rheumatism; pain; manic depression; alcoholic paranoia; schizophrenia; fever; insomnia; infertility; aging; skin inflammations and disorders; alcoholism; anemia; carbuncles; convalescence; emaciation; HIV; AIDS; immune system problems; lumbago; multiple sclerosis; muscle energy loss; paralysis; swollen glands; ulcers; breathing difficulties; inflammation; psoriasis; cancer (e.g.; prostate cancer, lung cancer and breast cancer); pain; cardiovascular disease (e.g.; arteriosclerosis and atherosclerosis); ischemia/reperfusion injury; anxiety; attention deficit disorder; leprosy; arthritis (e.g., psoriatic arthritis; ankylosing spondylitis; and rheumatoid arthritis); hemorrhoids; tuberculosis; high blood pressure; congestive heart failure; venous insufficiency (pooling of blood in the veins; usually in the legs); sore throat; hepatitis; syphilis; stomach ulcers; epilepsy; diarrhea; asthma; burns; piles; sunburn; wrinkles; headache; insect bites; cuts; ulcers; sores; herpes; jaundice; bursitis; canker sores; sore gums; poison ivy; gastritis; high cholesterol; heart disease; bacterial infection; viral infection; acne; aging; immune disorders; dental caries; periodontitis; halitosis; dandruff; cardiovascular disease (e.g., hypertension; thrombosis; arteriosclerosis); migraine headaches; diabetes; elevated blood glucose; diseases of the alimentary canal and respiratory system; age-related physical and mental deterioration (e.g., Alzheimer’s Disease and age-related dementia); cardiovascular disease; cerebral vascular insufficiency and impaired cerebral performance; congestive symptoms of premenstrual syndrome; allergies; age-related vision loss; depression; Raynaud’s disease; peripheral vascular disease; intermittent claudication; vertigo; equilibrium disorder; prevention of altitude sickness; tinnitus (ringing in the ear); liver fibrosis; macular degeneration; asthma; graft rejection; and immune disorders that induce toxic shock; bronchpulmonary disease as cystic fibrosis; chronic bronchitis; gastritis; heart attack; angina pectoris; chronic obstructive pulmonary disease; kidney damage during coronary angiography; Unverricht-Lundborg disease; pseudoporphyria; pneumonia; and paracetamol hepatotoxicity."

This immediately reminds me of the quote from the FTC warning about scams that I referenced here: Protandim, Miracle Claims, Scientific Breakthroughs, and the FTC:

"Miracle products claim to cure serious conditions — often conditions that science has no cure for, like arthritis, diabetes, Alzheimer’s disease, multiple sclerosis, cancer, and HIV-AIDS. Some products even claim to be a ‘cure-all’ for several diseases and a host of symptoms. Often, the ads claim the products come with money-back guarantees. Unfortunately, these products, devices, and treatments often are unproven and useless, making promises they can’t fulfill."

It appears that every single one of the conditions that the FTC warns about is in the list. Even more interesting is that several conditions such as cancer, gastritis, cardiovascular disease, asthma, infertility, and diabetes are listed more than once. The patent lists "aging" three times (Fountain of Youth, anyone?).

It is interesting to read "The compositions of the present invention are useful to prevent or treat the following disorders and diseases:" and then find on LifeVantage's own FAQ: "Protandim is not intended to diagnose, treat, cure, or prevent any disease." Clearly LifeVantage is confused about the intentions of its own product. One has to ask the question why should consumers have any trust in LifeVantage or Protandim when the company clearly doesn't know what their own product is intended to do?

Where does this patent perhaps break the law? Well section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) says that drug is defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals." From the words in the patent, LifeVantage views Protandim to fit the FDA's definition of being a "drug."

However, for such claims to be made, the product itself must be approved by the FDA through a process called the New Drug Application (NDA). To the best of my knowledge (and any doubters feel free to prove otherwise), LifeVantage has NOT filed with the FDA to classify Protandim as drug.

It seems one could view this patent application as violating the FDA's laws regarding dietary supplements (which is what Protandim is classified as).

Originally posted 2011-06-18 21:22:03.

This post involves:

FDA, Protandim and FTC

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16 Responses to “Does LifeVantage’s “Cure-All” Protandim Patent break the Law?”
  1. Vogel Says:

    This is a very interesting question. I think the answer is no, but ultimately yes.

    The patent was essentially a composition patent, into which Myhill inserted a variety of potential medical uses. It’s not unusual for a medical use patent to be filed for novel compounds in the event that they might someday be found to be useful for such applications — although Myhill’s list of potential medical uses contain everything but the kitchen sink and is utterly ridiculous).

    The claims in a medical use patent probably would not be considered advertising as long as they are not used for advertising. However, in the case of the people selling Protandim, the patent is being used as advertising — prospective customers are being referred to go look at the patent. In that case, the patent would be considered an extension of the product labeling, and in that event, the claims in the patent would constitute illegal advertising.

    Ultimately, I have no doubts whatsoever that this was a premeditated strategy from the get-go — i.e., to use the patent as a vehicle for disseminating far fetched and misleading disease claims so that the patent itself could be used to by distributors to illegally advertising the product.

    This is the exact same strategy that the company used when they initiated the used research studies. Distributors point to a worthless unreliable study in mouse cells and then use that to support illegal claims about Protandim’s use as a disease treatment.

  2. Protandim Scams Says:

    I agree Vogel.

    I think it was worth showing that kitchen sink nature of the patent, especially as it included the same items multiple times. The other thing that I wanted to highlight is that people selling Protandim have been using the patents as advertising, so it would be admissible in any kind of legal case.

  3. Joe H Says:

    “The compositions of the present invention are useful to prevent or treat…” Key word is “useful”. Aside from that I the product is in the midst of a diabetes study at one of the major Ohio universities. Can’t remember which but Ohio State comes to mind. I believe the results are due fairly soon..

  4. Protandim Scams Says:

    Actually, the word “useful” isn’t a key word there. The most important part of that is that word, “useful”, is that it seems to be presumptuous, wishful thinking on the part of LifeVantage. If it were truthful, they would have FDA approval to claim that it prevents or treats those conditions.

    The Ohio study didn’t seem to be a clinical trial involving people, which is the important thing to note with this article and this patent. For more see: The Lack of Protandim Clinical Trials

  5. Curt Says:

    Hi Protandim Scam,

    Interesting blog. Yet I’m not sure what your true agenda is. I hope you are an advocate for good, solid science discovering natural elements, and the unique combination of them in assisting the body’s ability to successfully heal itself.

    The way I read your posts here, you seem to think the word “useful” means “cure,” which it simply doesn’t. Water is “useful” in treating dehydration but doesn’t treat or cure it, and nutrition is “useful” in treating, not treating or curing malnutrition. The body does that when given the necessary “tools” and optimal environment to operate and go through its healing process. Would you agree? Would you agree that Dr. McCord is no slouch? That he is a respected expert who has impeccable credentials in his field of study and research? What is your background to say otherwise?

    From what I’m learning from reading the clinical studies of inflammation at the cellular level, free radical damage; Protandim, has been proven in a number of careful studies (with many more disease specific on the way) to reduce the body’s oxidative stress by providing the body the necessary “tools” assisting it to turn on (a growing number of) positive genes that in turn trigger the body’s ability of manufacturing Superoxide Dismutase and Catalase at levels thought improbable. Are we on the same page here?

    Protandim is proven to be an important NRF2 synergizer. (This, I hope, you understand and see is a significant discovery) This is the body’s natural production of anti-oxidants, which fight free radicals that ravage and damage the body at the cellular level. This action creates cell inflammation.

    Comprehensive studies report it’s inflammation (heat) at the cellular level where many diseases get their start. Just like a river starts with particles in the atmosphere, producing droplets to fall as rain (inflammation), that gathers, grows, and builds up to form a tiny steam (sick, heated cell) and flows into a river (disease). Thus the comprehensive list of diseases listed in LifeVantage’s patents but with no claims are being made.

    Finally, your harsh use of the word “Scam” in regards to Protandim could come back to effect your reputation if/when you are indeed wrong. You are in a sense disputing/opposing the growing number of credible people, universities, and studies being published at PubMed.gov I’ve always beeen amazed by the many people who throughout history in being so certain in their opinion only to be proven wrong, have that D’oh! label attached forever to their names. I guess only time will tell which list you and I are added to. I’m going with the growing evidence and experts. Perhaps with further understanding, in time, you will too.

    Your reply and civil exchange of ideas and debate are most welcomed. I wish you well.

  6. protandimscams Says:

    Thanks for the comment Curt,

    I’m not sure what you are getting with your comment about my “true agenda.” The agenda is to provide truthful, unbiased, information for people looking into buying Protandim.

    The reason I tied “cure” and “useful” is that the English language hasn’t quite adopted the phrase “useful-all” like it has “cure-all.” Also the FTC warning about products of this nature (useful to all, or cure-all) is “cure-all.” It isn’t meant to be taken that literally. Protandim’s “useful-to-all” claim in their patent filing would still fall in the frauds and scams definition of the FTC that I quoted.

    A number of dictionaries say that “cure” means “a means of healing or restoring to health; remedy”, so I would say that water cures dehydration and nutrition does cure malnutrition… it is a remedy for these conditions.

    Curt said,

    “The body does that (cures dehydration/malnutrition) when given the necessary ‘tools’ and optimal environment to operate and go through its healing process. Would you agree?”

    This seems like you are using the quackery of the body heals itself. I would say that the body needs fluid/nutrition to work efficiently and without it, it fails. My car needs gas/oil to work efficiently and without it, it fails. When I add gas to a car without gas or change the oil, I don’t say that I gave the car the tools to go through its healing process. In both cases, we simply resolved a known deficiency.

    Curt said,

    “Would you agree that Dr. McCord is no slouch? That he is a respected expert who has impeccable credentials in his field of study and research? What is your background to say otherwise?”

    This is known as an Appeal to Accomplishment logical fallacy. McCord was hired by LifeVantage because he was respected member of the community. It is important to understand that he’s a celebrity endorser of Protandim in the same way that Michael Jordan is a celebrity endorser of a line of Nike shoes. There’s more detail on that in this article: Dr. Joe McCord’s Role at LifeVantage. Further more we have LifeVantage and Dr. Joe McCord Lied about the Creation of Protandim as well as McCord lying again about inventing Protandim after being caught the first time.

    McCord is paid millions of dollars by LifeVantage and was caught lying about inventing Protandim twice. That hardly seems like someone with impeccable credentials. However, you don’t need to take my word for it. There are unbiased doctors with credentials speaking out against the research. Here are a few articles: Dr. Harriet Hall on LifeVantage Protandim, the Protandim Escapades, and Dr. Harriet Hall on LifeVantage Protandim Again.

    Curt said,

    “From what I’m learning from reading the clinical studies of inflammation at the cellular level, free radical damage; Protandim, has been proven in a number of careful studies (with many more disease specific on the way) to reduce the body’s oxidative stress by providing the body the necessary ‘tools’ assisting it to turn on (a growing number of) positive genes that in turn trigger the body’s ability of manufacturing Superoxide Dismutase and Catalase at levels thought improbable. Are we on the same page here?”

    Actually, as Harriet Hall pointed out in one of the articles above (you may have to click through to her article), Protandim has not be proven in any legit studies to help the body in any way. That’s kind of the point here. There are a lot of studies, but they end up not proving anything. The ones that don’t work for LifeVantage aren’t published on the company’s website. Your use of ‘tools’ here is similar to the water and dehydration example above, but I hope you are smart enough to see the difference. The body doesn’t have a Protandim deficiency that is causing a medical condition like in the case of a dehydration and water. Are we on the same page here?

    “Protandim is proven to be an important NRF2 synergizer. (This, I hope, you understand and see is a significant discovery) This is the body’s natural production of anti-oxidants, which fight free radicals that ravage and damage the body at the cellular level. This action creates cell inflammation.”

    Actually Protandim isn’t proven in any way. It isn’t proven to be important. It isn’t proven to be an NRF2 synergizer. I hope you understand that there’s no significant discovery here. It’s why no scientists are looking into it without LifeVantage’s push of science is for marketing reasons. If there was such a great discovery here, industry insiders would be buying up the stock and it would be a billion-dollar company. If you are familiar with LifeVantage history something like this happened in June 2005 when the company got on ABC Primetime. In the 6 years since, it has dropped off. It is only getting more interest lately, because corporate profits are up due to LifeVantage’s ability to convince the multi-level marketing community that it is a worthwhile business opportunity.

    You went into a big analogy of inflamation and rivers, but LifeVantage doesn’t have the FDA approval to say that Protandim is useful for helping with a number of diseases. If LifeVantage wishes to make these claims, they are welcome to get FDA approval. Tellingly, LifeVantage hasn’t filed anything with the FDA (that I’m aware of) that they intend to ever prove Protandim works for any of conditions mentioned in the patent. This is a very simple procedure and one that any product claiming to be useful for any medical condition does. No one has answered the question, why hasn’t LifeVantage does this? It would make them billions of dollars. (The answer is that they know Protandim doesn’t work, and that they don’t need to prove it as long as uninformed consumers buy it.)

    Curt said,

    “Finally, your harsh use of the word ‘Scam’ in regards to Protandim could come back to effect your reputation if/when you are indeed wrong. You are in a sense disputing/opposing the growing number of credible people, universities, and studies being published at PubMed.gov I’ve always beeen amazed by the many people who throughout history in being so certain in their opinion only to be proven wrong, have that D’oh! label attached forever to their names. I guess only time will tell which list you and I are added to. I’m going with the growing evidence and experts. Perhaps with further understanding, in time, you will too.”

    Sorry, but scam is the appropriate word for a confidence trick. You are under the erroneous assumption that there are credible people, universities, and studies supporting Protandim. There is only LifeVantage and its marketing. There are no universities supporting Protandim. You can’t find one press release from a university saying they are in support of Protandim. Friends and/or colleagues of McCord affiliated with universities may be doing studies on Protandim as a favor, but universities are not supporting Protandim.

    You seem to have a misunderstanding of how articles are published on PubMed.gov. Please read that link and learn about how the process works. Understand that Joe McCord was in on the board of a journal with a number of published studies, meaning that he can rubber stamp approval for such articles.

    Perhaps when you read how McCord has lied about Protandim multiple times and that “growing evidence” is simply LifeVantage marketing, you’ll realize that you are part of the D’Oh group.

  7. Helpful Advice Says:

    Protandimscams,

    You seem extremely angry and condescending in your comments as they are littered with underlying aggression.

    You should strongly consider taking Protandim for about 6 months and see if it helps you. You would make for an interesting case study.

  8. protandimscams Says:

    Helpful Advice,

    Good people get upset when others are being scammed like in the case of Protandim. Any anger you see is from recognizing that LifeVantage’s dangerous marketing has corrupted another individual’s ability to apply critical thinking skills.

    Your quote is another example of someone whose critical thinking skills are impacted by LifeVantage. If you understood placebo effect, you’d know that it wouldn’t make an interesting case study at all.

  9. Mary Says:

    What a terrible thing to happen to an awesome scientific discovery. To have someone try to destroy it because of “legal” wording. No wonder this world can’t find no, can’t share there awesome discoveries! I take it and “I SEE the results of “MY” body changing and performing better for “me” “I” see results with my Family members also! no clinical study just pure seeing is believing!

  10. protandimscams Says:

    Mary,

    There’s an easy way to share awesome discoveries when they truly are awesome discoveries. It’s called creating clinical trials and proving to the FDA that the discovery is awesome. Every company that thinks it has an awesome discovery does this and then that discovery is validated and shared.

    LifeVantage chooses not to validate their “awesome discovery” and instead lie about the product.

    Please look into the placebo effect and understand that “seeing is believing” is quite often an optical illusion. That’s why we need to carefully measure the benefit in large scale placebo controlled studies.

  11. Nita Says:

    I think if people used the energy that is expended in criticism, for good, the world would be lightyears a head on may levels. Political posturing never improved one persons healthspan. I encourage a trip to the dialysis clinic or hospice care ward and see if you can find a way to search for answers for hopeless people. YOU can be so right and people are never impacted in a positive way by what you say and do. YOu are either part of the answer or part of the problem. Hint placebo effect doesn’t work on animals. Why did my 15 year old dog recover after one week of use the little yellow (plant)pill? We were about to put him down. I guess you have more questions than answer. Time honors all facts. You would be interested in what the university of Minnesota DNA lab is studying! Do something constructive with your curiosity.

  12. protandimscams Says:

    Criticism of those who commit fraud on the American public does a lot of good. If people saved their money from this and applied it towards reputable organizations that are actually willing to do clinical trials to show that the product works, we’d have much more progress.

    I’ve shown conclusively that LifeVantage has a chance through clinical trials to show that they are part of the solution, but they have refused to. All logic would dictate that if their product worked, they’d show it. It would help many, many more people and the company would make a lot more money by being able to reach a wide audience. The only logical reason why they’d refuse to do the clinical trials is that they know that the product doesn’t work and they don’t want to jeopardize their current business of selling false hope.

    These were all the claims that MonaVie was making years ago about their super juice. Not just them, but Xango, Xowii, Zrii, Nopalea and just about any other MLM health product out there. Time doesn’t honor those facts, because there’s no one willing to do the clinical studies on these products. Everyone with half a brain can see the connection between these products and realize that they all don’t treat, prevent, or cure the myriad of health conditions claimed.

    No placebo effect in dogs. From this article:

    “A recent double-blind veterinary study involved arthritic dogs randomly assigned to either a treatment or a placebo group. Their response to treatment was objectively assessed by force-plate analysis, which precisely measures the use of individual limbs while a dog is in motion. The result? Fifty-six percent of placebo-treated dogs had an objectively measured, significant, positive response.”

    I would be interested in what the University of Minnesota’s DNA lab is studying. Maybe you can send me a link from their official website and show how it would be relevant to the discussion. I hope LifeVantage isn’t making the same false claims from imaginary doctors at the University of Minnesota as they have in the past.

    Next time you leave a comment, you might want to clarify that you are LifeVantage distributor. It adds important context with the financial bias to your view.

  13. -Joede Says:

    I want to think this site for the Info.

    I admit that I am a simple person and don’t understand all the medical talk specific to clinical trials. What I can share with you is that I have been taking protandin for only 5 weeks. I am on a fixed income and $50 for a supplement is something I really considered before investing in. I wasn’t a supplement type person but I trusted in a friend enough to see if it could help because I take over 10 different RX pills a day to control high blood pressure, heart disease, diabetes, focus problems and numerous other things. The last time I went to the heart Dr we spent the most time talking about my energy level and lack of sex appetite. I promise a week later I went to my family Dr with the same complaint. My heart Dr wouldn’t prescribe a sex enhancer due to blood pressure issues. Our family doctor recommended cuddling. Maybe the B12 she put me on helped my energy, if so marginal.

    Now the facts. Within 10 days Protandim gave be a more than an adequate sex drive. You ask how do I know and the answer is that I am a simple man. My mobility has increased, my focus and memory is returning, my joints feel much better and I have to watch my diabetes low blood sugar much closer. The only way I have changed my lifestyle is take 1 prontandim daily with what I have been taking for the last 5-10 years.

    I’m in no way endorsing protandim but as I talk to people who took the $50 and tried it all have benefited by it. Again I am a simple person, I have better things to do with my time than having an intellectual conversation on proving something doesn’t work or scammers based on Info I have to rely on that someone is feeding me not being aware of their agenda as well being as it may be,

    I do honestly know this. Maybe the 10 plus Rx pills may keep me alive but the protandim gives me a quality of life I haven’t realized in the last 10 years. I don’t know what it’s doing to my T cells and all that scientific mumbo jumbo but I don’t care. The 1 thing I do care about is that it works for by wife and I and all the other people I know that have tried it. I sure don’t guarantee the same results for anyone reading this. I only represent the people I know who benefit from it. To protect myself I guess you could have side affects or it doesn’t do anything for you. For my wife, for me and a handful of friends I have recently met I want to say it’s worth the financial budgeting it causes us.

  14. protandimscams Says:

    This article explains it in detail: http://www.aitse.org/no-your-mlm-doesnt-work/

  15. Vogel Says:

    Joede said:

    “I admit that I am a simple person…”

    “…I am a simple man…”

    “…Again I am a simple person…”

    “I have better things to do with my time than having an intellectual conversation…”

    “I don’t know what it’s doing to my T cells and all that scientific mumbo jumbo but I don’t care. The 1 thing I do care about is that it works for by wife and I and all the other people I know that have tried it.”

    We get it! You’re simple and don’t want to be bogged down with the tedium of such mundane things as details, logic, explanations, commonsense, and basically using your F-ing brain for its intended purpose. It’s disturbing to see someone being so damn proud to be a simpleton (and so reckless with their T cells). You’re a serious contender for a Darwin Award.

  16. Vogel Says:

    Joedde said: “Within 10 days Protandim gave be a more than an adequate sex drive….My mobility has increased, my focus and memory is returning, my joints feel much better and I have to watch my diabetes low blood sugar much closer…Protandim gives me a quality of life I haven’t realized in the last 10 years…The 1 thing I do care about is that it works for by wife and I and all the other people I know that have tried…It’s worth the financial budgeting it causes us.”

    Joedde said: “I’m in no way endorsing protandim”

    Huh??? First off, yes, you clearly are endorsing Protandim — with gusto, I might add — so you come across like a confused idiot when you say that you’re “in no way endorsing” Protandim.

    Secondly, Protandim obviously did not do any of the things you claimed that it did — it did not affect your mobility, memory, joints, or diabetes; and it sure as F didn’t give you a boner.

    Smarten up and abandon this reprehensible effort to illegally market your worthless product. Thanks in advance. You can go back to snuggling now limpy.

 

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