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Protandim

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Protandimis a herbaldietary supplementmarketed with unsupported claims that it can treat a number of medical conditions. The product is apatented[1]mix of five herbal ingredients and sold by LifeVantage Corporation (formerly LifeLine Therapeutics, Lifeline Nutraceuticals, and Yaak River Resources, Inc), aUtah-basedmulti-level marketingcompany.[2]The manufacturers of Protandim make no claims that it can prevent or cure any medical conditions.[3]In 2017, LifeVantage was issued awarning letterby theU.S. Food and Drug Administration(FDA) regarding illegal advertising claims on the company's websites suggesting that Protandim can help to cure various ailments, including cancer and diabetes.[4][5][6]

History

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In 2003, Lifeline Therapeutics, a privately held Denver-basednutraceuticallicensing and marketing company, entered into an agreement with Massachusetts biotechnology company CereMedix for the rights to market CMX-1152, an experimentalpeptide-basedcompound,under the brand name "Protandim" (also sometimes referred to at that time as "Rholen," "Rejuven8r" and "ependymin" ).[7][8][9][10][11][12]CereMedix was a ten percent owner of Lifeline and members of the CereMedix management board served on Lifeline's board of directors. CMX-1152 was claimed to upregulate the production of the endogenous antioxidant enzymessuperoxide dismutase,catalase,andglutathione peroxidase,and to offset the aging process.[11]

CMX-1152 was due to be marketed as anover the counteranti-agingpill in June 2004 after completing human clinical trials. However, plans to market the CMX-1152 version of Protandim fell through and in April 2004 Lifeline Therapeutics announced that it would instead be marketing a different (non-peptide)dietary supplementunder the name "Protandim CF" (to distinguish it from the peptide version initially developed by Cermedix). The new version of Protandim, a combination of five commonherbalingredients includingturmericandgreen teawas invented following "months of extensive research and development" by Lifeline employees Paul Myhill and William Driscoll (a former oil company executive), who together hold the patent on the product,[1]and it was launched in February 2005. Myhill and Driscoll resigned from the company later that year.[12][13][14][15]

Like CMX-1152, the herbal mixture known as Protandim that supplanted it was marketed by Lifeline as an "anti-aging" supplement that increases the body's antioxidant defenses by upregulating superoxide dismutase, catalase, and glutathione peroxidase. According to the company, the product was initially sold through retail channels such asGNC;[16]however, in 2009, after several consecutive years of multimillion-dollar losses, the company, which by then was doing business under the name LifeVantage, stopped marketing it through retailers and switched to multi-level marketing, selling it instead through a network of commissioned independent distributors. According to LifeVantage, the move from retail to multi-level marketing was prompted by the January 2008 hiring of David W. Brown, (formerly CEO and president ofMetabolife) as the company's CEO and president.[17][18]

Beginning in 2005, Protandim was produced under a manufacturing agreement withThe Chemins Companyof Colorado Springs, Colorado.[19]In July 2008, LifeVantage entered into a new manufacturing agreement with Cornerstone Research & Development to produce Protandim, and with Wasatch Product Development to produce a Protandim-based skin cream (TrueScience).[20]

In 2006, biochemistJoe M. McCordjoined the LifeVantage board of directors as the company's director of science.[21]McCord, who is listed by theU.S. Securities and Exchange Commissionas a LifeVantageinsider shareholder,[22]served as a spokesperson for Protandim and was responsible for distributor training and product research.[22]Under the terms of his 2011 employment agreement, McCord received $529,994 in direct compensation as well as a 50-cent commission on every bottle of Protandim sold.[23][24]McCord served as LifeVantage's Chief Scientific Officer from June 2011 until September 2012, and then became a member of its science advisory board. LifeVantage announced McCord's retirement in June 2013.[25][26]Under the terms of the separation agreement, McCord was to receive a payment of $1.7million from the company.[26]

In January 2014, McCord was replaced by Shawn Talbott (developer ofCortiSlim),[27]who served as the company's chief science officer[28]until being relieved of his duties in June 2015[29]and replaced in August 2015 by Natalie Chevreau, who was hired as the company's senior vice president of research and development and is credited with the invention of the company's TruScience skin care product.[30]

Product invention

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As recently as July 21, 2011, LifeVantage credited McCord as the creator of Protandim on its website.[31]At a 2011 conference for LifeVantage distributors, McCord stated, "I was presented with a list of 41 potential ingredients for a product they wanted to call Protandim, and I went through the list and penciled out, rapidly, about 36 of those ingredients," leaving the 5 ingredients in the current formulation of Protandim.[32]In March 2009, former LifeLine Therapeutics executive, Paul Myhill stated, "We initially decided to hide that fact [that Myhill derived the core composition for Protandim] for marketing purposes and instead rely on the impeccable background of Dr. McCord."[33]In April, 2005, Myhill produced a signed letter from McCord in which McCord stated, "I do not honestly feel that I have made contributions to the intellectual property, up to this point, that would qualify me as an inventor...I must congratulate you and Paul for having framed the concept of Protandim so close to its final embodiment, prior to the beginnings of our association."[34]

Composition

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Protandim consists mainly of a blend of five herbal ingredients (amounts per caplet listed in parentheses):[35]

  • Milk thistle(Silybum marianum) extract (70–80% Silymarin) (225 mg)
  • Bacopa(Bacopa monnieri) extract (45% bacosides) (150 mg)
  • Ashwagandha(Withania somnifera) powder (150 mg)
  • Green tea(Camellia sinensis) extract (98% polyphenols, 45% EGCG) (75 mg)
  • Turmeric(Curcuma longa) extract (95% curcumin) (75 mg)

Effectiveness

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Marketing claims that Protadim can prevent or treatcancerare unproven and have been deemedfraudulentby the FDA.[36]Research into use as a treatment foramyotrophic lateral sclerosisis of poor quality, casting doubt on its usefulness for drawing any conclusions about efficacy.[37]

In 2011,Harriet A. Hallwrote forScience-Based Medicinethat "we simply don't know enough at this point to recommend Protandim for treatment or prevention of any disease, for anti-aging, for making people feel healthier or more energetic, or for anything else".[38]

Side effects

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According to the manufacturer, Protandim can cause allergic responses, gastrointestinal disturbances (stomach ache, diarrhea, vomiting), headache, and a rash on the hands and feet.[39][40]

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Protandim voluntary recall

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In December 2012, LifeVantage issued a voluntary recall of select lots (ten lots in total comprising 247,896 bottles) of Protandim due to potential health risks arising from the possible inclusion of small metal fragments in the final product.[41][42]In February 2013, the company announced that it was extending the recall to include additional lots of the product, estimating the total cost of the recall at $5.9 million.[43]

FDA Warning for illegal marketing

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On April 17, 2017, LifeVantage was issued awarning letterby the U.S. Food and Drug Administration (FDA) regarding illegal advertising claims on the company's websites suggesting that Protandim can play a role in helping to cure various ailments, including cancer and diabetes. The claims were deemed to be in violation of Section 201(g)(1)(B) of theFederal Food, Drug, and Cosmetic Act[21 U.S.C. § 321(g)(1)(B)].[4][5][6]

Other

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In 2009, LifeVantage was sued by Utah-based Zrii LLC, a marketer of nutritional fruit drinks endorsed byDeepak Chopra,based on allegations that LifeVantage had conspired with former Zrii executives to "ruin the company" and take it over “on the cheap” following a "mass exodus". The case was closed in December 2009 following LifeVantage's settlement payment of $400,000 to Zrii.[44]

On October 14, 2011, Burke Hedges, a former LifeVantage distributor (hired for his background as a speaker and trainer) filed a lawsuit with the Utah District Court against LifeVantage and its executives, seeking $3million in punitive damages over allegations of wrongful termination and tortious interference.[45]

In September 2016, a class action lawsuit was filed against LifeVantage in Utah alleging that the company and its executive Darren Jensen and Mark Jaggi made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, the case alleged that the defendants made false and/or misleading statements and/or failed to disclose that: (i) LifeVantage lacked effective internal financial controls; (ii) as a result, the Company had improperly accounted for sales in certain international markets, along with associated revenue and income tax accruals; and (iii) as a result of the foregoing, LifeVantage's public statements were materially false and misleading at all relevant times.[46][47]The case was dismissed in June 2017.[48][49]

In January 2018, a class action lawsuit was filed against LifeVantage in Connecticut alleging that the company and its chief executive officer Darren Jensen, chief sales officer Justin Rose, and chief marketing officer Ryan Goodwin were operating an illegalpyramid schemein violation of theRICO Act,federal securities laws, and the Connecticut Unfair Trade Practices Act.[50]

Promotional sponsorship

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Major League SoccerteamReal Salt Lakeannounced on October 29, 2013, that it had partnered with LifeVantage for a long-term, multimillion-dollar jersey-front sponsorship. The partnership was set to formally go into effect on January 1, 2014, with the LifeVantage logo appearing on the Real Salt Lake jersey starting in the next season.[51]In July 2015, Real Salt Lake ownerDell Loy Hansenwas reported by theU.S. Securities and Exchange Commissionto have bought a 5.1 percent ownership stake in LifeVantage.[5]

See also

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References

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  1. ^abUS 7241461,Myhill, Paul R. & Driscoll, William J., "Composition for alleviating inflammation and oxidative stress in a mammal.", issued 10 July 2007
  2. ^LifeVantage Corporation"FAQs – LifeVantage".Retrieved4 July2014.
  3. ^Hall H(9 May 2017)."Protandim Update: New Studies and an FDA Warning Letter".Science-Based Medicine.
  4. ^abKamrani, Christopher (April 26, 2017)."Real Salt Lake: RSL jersey sponsor LifeVantage in hot water with FDA over supplement's treatment claims".Salt Lake Tribune.RetrievedApril 26,2017.
  5. ^abcMontgomery, Matt (April 26, 2017)."FDA warns RSL kit sponsor LifeVantage over cancer treatment claims".SB Nation.RetrievedApril 27,2017.
  6. ^ab"2017 – Lifevantage Corp 4/17/17".www.fda.gov.Retrieved2017-04-25.
  7. ^"Lifeline Nutraceuticals, CereMedix sign agreement".Nutraceuticals World.December 1, 2003. Archived fromthe originalon April 13, 2016.Retrieved2012-08-19.
  8. ^"The Uncertain Antiaging Pill (press release)".Betterhumans.December 1, 2004. Archived fromthe originalon January 25, 2005.Retrieved2012-08-19.
  9. ^Alison McCook (February 2006)."Your Money for Your Life".The Scientist.20(3): 33.
  10. ^Bailey, Patrick."The Uncertain Antiaging Pill".Betterhumans.Archived from the original on December 4, 2004.Retrieved2004-11-29.{{cite news}}:CS1 maint: unfit URL (link)
  11. ^ab"Scientist returns to build long-life pill plant".The Scotsman.November 17, 2003.Retrieved2012-08-20.
  12. ^abAustin, Marsha (December 8, 2003)."Denver Businessmen Gamble on Selling Fountain of Youth in Pill Form".Denver Post.Archived fromthe originalon June 10, 2013.Retrieved2012-08-20.
  13. ^"Some days it's just hard to believe".Footnoted.November 17, 2005.Retrieved2012-08-19.
  14. ^"Lifeline Therapeutics CEO resigns".Denver Business Journal.July 5, 2005.Retrieved2012-08-20.
  15. ^"Paul R. Myhill. RE: Resignation from the Board of Directors and Executive Committee of Lifeline Therapeutics, Inc (Form 8-K)".United States Securities and Exchange Commission.November 11, 2005.Retrieved2012-08-20.
  16. ^"Protandim to be Available at General Nutrition Center (GNC) Stores".Lifeline Therapeutics press release.July 20, 2005.Retrieved2012-08-19.
  17. ^"LifeVantage Corporation Appoints Industry Veteran David Brown as President & CEO (LFVN press release)".Reuters.January 14, 2008. Archived fromthe originalon June 9, 2013.Retrieved2012-08-24.
  18. ^"The LifeVantage Story".LifeVantage, Inc. Archived fromthe originalon 2011-11-12.Retrieved2012-08-24.David Brown, President of LifeVantage Network, recognized Protandim's potential.
  19. ^"LIFEVANTAGE CORP, Form 10KSB/A, Filing Date Jan 26, 2006".secdatabase.com.RetrievedMay 15,2018.
  20. ^"LIFEVANTAGE CORP, Form 10-K, Annual Report, Filing Date Sep 28, 2011"(PDF).secdatabase.com.RetrievedMay 15,2018.
  21. ^"Dr. Joe M. Mccord Joins Lifeline Therapeutics, Inc. Board of Directors. | Business News and Press Releases from AllBusiness.com".Archived fromthe originalon 2011-08-24.Retrieved2014-09-22.
  22. ^ab"MCCORD JOE M ALL SEC FILINGS - SEC Watch".Archived fromthe originalon 2011-03-04.Retrieved2011-02-16.
  23. ^"LifeVantage Corp 10-K 2011".sec.edgar-online.com.RetrievedSeptember 5,2015.
  24. ^"Employment agreement with Dr. Joe McCord".U.S. Securities and Exchange Commission.April 1, 2011.Retrieved2014-09-21.
  25. ^"Dr. Joe McCord, LifeVantage Corporation's First Chief Science Officer, Retires from Company Nasdaq:LFVN".Archived fromthe originalon 2015-02-21.Retrieved2014-09-22.
  26. ^ab"Form 8-K for LifeVantage Corp".Yahoo.com.June 25, 2013.Retrieved10 November2013.
  27. ^"Three Cortislim Defendants to Give up $4.5 Million in Cash and Other Assets".Federal Trade Commission.September 21, 2005.RetrievedJuly 14,2016.
  28. ^"LifeVantage Corporation Appoints Shawn Talbott Ph.D. as New Global Chief Science Officer".LifeVantage, Inc. January 7, 2014.RetrievedJuly 14,2016.
  29. ^Shawn M. Talbott (July 13, 2015)."My New Gig?".Shawn M. Talbott Personal Blog.RetrievedJuly 14,2016.
  30. ^"Patent WO 2015164504 A1: Topical compositions and methods for reducing oxidative stress".October 29, 2015.RetrievedJuly 14,2016.
  31. ^"Scientific Breakthrough. [Filed 21 July 2011]".Archived from the original on 21 July 2011.{{cite web}}:CS1 maint: bot: original URL status unknown (link)
  32. ^"The History of Free Radical Biology, Dr. Joe McCord [Filed 17 August 2011]".Archived fromthe originalon 2013-09-27.Retrieved2012-08-13.
  33. ^"Inside Protandim: The Paul Myhill Interview [Filed 09 March 2009]".Retrieved2012-08-13.
  34. ^"McCord Rejects Credit for Inventing Protandim [Filed 29 March 2005]".Joe McCord.Retrieved2012-08-13.
  35. ^Velmurugan, Kalpana; Alam, Jawed; McCord, Joe M.; Pugazhenthi, Subbiah (2009). "Synergistic induction of heme oxygenase-1 by the components of the antioxidant supplement Protandim".Free Radical Biology and Medicine.46(3): 430–40.doi:10.1016/j.freeradbiomed.2008.10.050.PMID19056485.
  36. ^"Illegal Cancer Treatments: FDA Warning – Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure".FDA. 25 April 2017. Archived fromthe originalon 24 April 2018.
  37. ^ALSUntangled Group (2015)."ALSUntangled No. 31: Protandim".Amyotroph Lateral Scler Frontotemporal Degener(Review).17(1–2): 154–6.doi:10.3109/21678421.2015.1088707.PMID26414415.S2CID207664215.
  38. ^Hall, Harriet (11 October 2011)."Pursued by Protandim Proselytizers".Science-Based Medicine.Retrieved12 November2011.
  39. ^"FAQ".protandim.com.[third-party source needed]
  40. ^Hall, Harriet (December 5, 2017)."I Was Wrong about Protandim".Science Based Medicine.RetrievedJune 26,2018.
  41. ^"LifeVantage Corporation Announces Voluntary Recall and Replacement of Select Lots of Protandim® Dietary Supplement Due to Potential Health Risk"(Press release). 5 December 2012.Retrieved7 December2012.
  42. ^"Enforcement Report – Week of January 16, 2013".U.S. Food and Drug Administration.Retrieved10 August2013.
  43. ^"LIFEVANTAGE CORP, Form 8-K, Current Report, Filing Date Feb 13, 2013".secdatabase.com.RetrievedMay 15,2018.
  44. ^Harvey, Tom (2009-12-23)."Supplement company Zrii settles suits against rebellious ex-managers: LifeVantage pays $400,000 in dispute stemming from failed takeover attempt".Salt Lake Tribune.Retrieved6 November2011.
  45. ^Burke Hedges V. Lifevantage Corporation,United States District Court for the District of Utah: Civil No. 110918424, October 14, 2011
  46. ^Rosen Law Firm (September 16, 2016)."Rosen Law Firm Announces Filing of Securities Class Action Lawsuit Against LifeVantage Corporation – LFVN".RetrievedApril 27,2018.
  47. ^"Zhang v LifeVantage et al: Case 2:16-cv-00965-BCW"(PDF).September 15, 2018.RetrievedApril 27,2018.
  48. ^"LifeVantage Announces Dismissal of Class Action Lawsuit".Lifevantage. October 10, 2017.RetrievedApril 27,2018.
  49. ^"Zhang v Lifevantage et al: Memorandum decision and order granting defendants' motion to dismiss".June 15, 2017.RetrievedApril 27,2018.
  50. ^"Sommers Schwartz, P.C. Announces the Filing of a Securities Class Action Claims Against LifeVantage Corp. and Certain of its Executives".Business Wire.February 19, 2018.RetrievedApril 27,2018.
  51. ^"Real Salt Lake unveils new long-term jersey-front partnership with LifeVantage".RealSaltLake.com. October 29, 2013.RetrievedApril 27,2017.
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