Metabolife

Last updated

Metabolife International, Inc. was a multi-level marketing company based in San Diego, California which manufactured dietary supplements. Metabolife's best-selling product, an ephedra supplement called Metabolife 356, once generated hundreds of millions of dollars in annual sales. [1] However, Metabolife 356 and other ephedra-containing supplements were linked to thousands of serious adverse events, including deaths, which caused the U.S. Food and Drug Administration (FDA) to ban the sale of ephedra-containing dietary supplements in 2004.

Contents

Subsequently, Metabolife's founder Michael Ellis was convicted of lying to the FDA and concealing evidence of ephedra's dangers, and the company and its owner were both convicted of income tax evasion. A congressional investigation found that Metabolife had received thousands of reports of serious adverse events, many occurring in young and otherwise healthy people, and that Metabolife concealed the reports and acted with "indifference to the health of consumers." [2]

History

Metabolife was founded in the early 1990s by Michael Ellis, a former police officer on probation for charges relating to his involvement with a methamphetamine lab. [3] [4] Ellis and a boyhood friend, Michael Blevins, were arrested in 1989 for producing and distributing methamphetamine. Both Ellis and Blevins cooperated with federal authorities in return for lighter sentences. Following Blevins' release from prison, the two formed Metabolife to market ephedra, an herbal supplement containing compounds chemically related to methamphetamine. [4] Ellis served as the company's CEO until September 2000, when he was succeeded by David Brown (Brown went on to serve as president and CEO of LifeVantage in 2008). [5]

Metabolife 356, an ephedra supplement manufactured by Chemins, [6] [7] was initially marketed by Metabolife as a bodybuilding supplement, but in 1995 was rebranded as an aid for dieting. The product became highly successful due to a marketing plan that enlisted customers to advertise and sell the supplement; [3] at their peak, sales of Metabolife 356 were in the hundreds of millions of dollars annually. [1] At one point, Metabolife offered the Russian government $15 million to paint its logo on an International Space Station rocket and incorporate Metabolife's ephedra supplement into the diet of its cosmonauts. [8]

Regulation and lobbying

In the late 1990s, the U.S. FDA considered regulating ephedra more strictly, in response to reports of adverse reactions and more than 100 deaths linked to the supplement. [9] These included reports of psychosis, [10] [11] heart attack, [12] stroke, [13] and diabetic ketoacidosis. [14] A clinical trial conducted to address safety concerns found that Metabolife 356 increased blood pressure and induced mild cardiac arrhythmias; the trial concluded that there were serious safety concerns associated with the use of Metabolife. [15]

Metabolife took an active role in lobbying against regulation of ephedra, forming an advocacy group called the Dietary Supplement Safety and Science Coalition and contributing heavily to Congressmen Brian Bilbray (R-Calif.) and Dan Burton (R-Ind.), among other politicians. [3] Bilbray subsequently criticized the FDA's treatment of Metabolife and its efforts to regulate ephedra. During this period in the late 1990s, Metabolife contributed $1.6 million in soft money to both political parties, and almost $3 million to lobbyists. [4] At the state level, Metabolife contributed $10,000 to then-Governor of Texas George W. Bush, who intervened to stop regulation which would have banned over-the-counter sales of ephedra. Bush subsequently returned the $10,000 after Ellis' and Blevins' methamphetamine convictions were publicized in the media. [4] Other recipients of Metabolife contributions included then-Governor of California Joseph Graham 'Gray' Davis, Jr., who was given $175,000. [4]

Metabolife was investigated by the Internal Revenue Service and the Department of Justice for income tax evasion; ultimately, the company pleaded guilty to filing fraudulent tax returns and was sentenced to pay a criminal fine of $600,000. [16] Metabolife owner William Bradley also pleaded guilty to evading millions of dollars in taxes and was sentenced to 6 months in federal prison and 2 years of probation. [16] [17]

According to federal prosecutors in the case against Metabolife and its executives, the company's certified public accountant, Michael Compton, knew about and helped conceal Metabolife's illegal activities. [18] Compton had admitted falsifying tax returns for company executives and was complicit in the company's failure to account for $93.7 million in income on its income tax returns from 1996 through 1999. [18] [19] [20] [21] Compton had assisted the company in setting up secret offshore bank accounts and trusts in the Cayman Islands and was aware that Bradley, Ellis, and Blevins each had over $1 million in unreported cash concealed in safes within their homes. [20] In July 2002, criminal investigators of the Internal Revenue Service raided Compton's office, seizing documents and computer data, [20] and in November 2003, 10 days after a warrant against Metabolife and its principals was unsealed in U.S. District Court, Compton died from a self-inflicted gunshot wound to the head. [20]

Some of the politicians associated with Metabolife also encountered legal difficulties; Texas state legislators Jeff Wentworth and Rick Green were accused of illegal lobbying on behalf of the company. [4]

Following the FDA's ban of ephedra, Michael Ellis was indicted on eight counts of making false statements to the FDA in an effort to obstruct regulation of ephedra. [22] [23] Ellis ultimately pled guilty to a single count of lying to the FDA about the adverse effects of Metabolife 356. He was sentenced to 6 months in federal prison and a $20,000 fine. [24]

In response to falling sales, and facing more than $1 billion in personal injury legal claims related to Metabolife 356, [25] Metabolife filed for Chapter 11 bankruptcy in 2005. [1] The company's furnishings and property, including a large collection of artwork, were liquidated in late 2006 to compensate creditors and settle outstanding personal-injury claims. [26]

Metabolife's non-ephedra assets were acquired by Ideasphere Inc., a New York-based dietary-supplement manufacturer, for $12 million in 2007. [24] In 2008, Michael Ellis authored a memoir entitled The Metabolife Story: The Rape of Cinderella, with a testimonial by the former FBI special agent who arrested Ellis in 1989 for producing and distributing methamphetamine.

Related Research Articles

Dietary supplement Product that provides additional source of nutrients

A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.

Ephedrine Medication and stimulant

Ephedrine is a medication and stimulant. It is often used to prevent low blood pressure during anesthesia. It has also been used for asthma, narcolepsy, and obesity but is not the preferred treatment. It is of unclear benefit in nasal congestion. It can be taken by mouth or by injection into a muscle, vein, or just under the skin. Onset with intravenous use is fast, while injection into a muscle can take 20 minutes, and by mouth can take an hour for effect. When given by injection it lasts about an hour and when taken by mouth it can last up to four hours.

Ephedra (medicine) Medicinal preparation from the plant Ephedra sinica

Ephedra is a medicinal preparation from the plant Ephedra sinica. Several additional species belonging to the genus Ephedra have traditionally been used for a variety of medicinal purposes, and are a possible candidate for the soma plant of Indo-Iranian religion. It has been used in traditional Chinese medicine, in which it is referred to as Ma Huang, for more than 2,000 years. Native Americans and Mormon pioneers drank a tea brewed from other Ephedra species, called "Mormon tea" and "Indian tea".

Bitter orange Hybrid citrus plant

Bitter orange, Seville orange, bigarade orange, or marmalade orange is the citrus tree Citrus × aurantium and its fruit. It is native to Southeast Asia and has been spread by humans to many parts of the world. It is probably a cross between the pomelo, Citrus maxima, and the mandarin orange, Citrus reticulata.

Herbal medicine Study and use of supposed medicinal properties of plants

Herbal medicine is the study of pharmacognosy and the use of medicinal plants, which are a basis of traditional medicine. There is limited scientific evidence for the safety and efficacy of plants used in 21st century herbalism, which generally does not provide standards for purity or dosage. The scope of herbal medicine commonly includes fungal and bee products, as well as minerals, shells and certain animal parts. Herbal medicine is also called phytomedicine or phytotherapy.

Valdecoxib Nonsteroidal anti-inflammatory drug

Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor. It was patented in 1995.

Anti-obesity medication Class of pharmacological agents

Anti-obesity medication or weight loss medications are pharmacological agents that reduce or control weight. These medications alter one of the fundamental processes of the human body, weight regulation, by altering either appetite, or absorption of calories. The main treatment modalities for overweight and obese individuals remain dieting and physical exercise.

An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not a complication. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment. Adverse effects can also be caused by placebo treatments . Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. Adverse effects of medical treatment resulted in 142,000 deaths in 2013 up from 94,000 deaths in 1990 globally.

TrimSpa was a dietary supplement designed for weight loss, marketed by the company Goen Technologies and headed by Alexander Szynalski. The ephedra-based supplement was marketed by TrimSpa to help "stave off hunger", until ephedra was banned from the United States. TrimSpa's parent company, Goen Technologies, filed for bankruptcy protection in May 2008.

The ECA stack is a drug combination used in weight loss and as a stimulant. ECA is an initialism for ephedrine, caffeine, and aspirin, with variants of it including the EC stack, which removes the aspirin for those who can not tolerate it. Dietary supplements based on or including elements of ECA were popular through the 1990s and early 2000s, but the marketing of ephedra- or ephedrine-containing stimulant combinations for weight loss and bodybuilding is now restricted or illegal in the United States, Canada and Netherlands due to reports of heart attack, stroke, and death associated with these supplements.

Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding, weightlifting, mixed martial arts, and athletics for the purpose of facilitating an increase in lean body mass. Bodybuilding supplements may contain ingredients that are advertised to increase a person's muscle, body weight, athletic performance, and decrease a person's percent body fat for desired muscle definition. Among the most widely used are high protein drinks, pre-workout blends, branched-chain amino acids (BCAA), glutamine, arginine, essential fatty acids, creatine, HMB, whey protein, ZMA, and weight loss products. Supplements are sold either as single ingredient preparations or in the form of "stacks" – proprietary blends of various supplements marketed as offering synergistic advantages.

Vinpocetine

Vinpocetine is a synthetic derivative of the vinca alkaloid vincamine. Vincamine is extracted from either the seeds of Voacanga africana or the leaves of Vinca minor.

Twinlab Consolidated Corporation is an American company which manufactures and markets vitamins, minerals, and bodybuilding supplements. Twinlab is based in Boca Raton, Florida.

Hydroxycut is a brand of dietary supplements that is marketed as a weight loss aid. Hydroxycut was originally developed and manufactured by MuscleTech Research and Development; MuscleTech was sold to Iovate Health Sciences in 2003–2004 and declared bankruptcy in 2005; Iovate continues to use MuscleTech as a brand to market Hydroxycut.

Carlon Colker American physician (born 1965)

Carlon M. Colker is an American physician, whose practice specialties include internal medicine, integrative medicine, medical nutrition and applied nutritional science, sports medicine, human performance, injury rehabilitation, and longevity medicine. Colker has also been referred to in the media as a former champion bodybuilder, powerlifter, and MMA fighter and coach. Colker is a familiar television personality and medical correspondent on Fox News Channel's Fox & Friends. Dr. Colker has appeared on such shows as ESPN Outside the Lines, NBC's Health Segment, Court TV, Bloomberg, and ABC's World News Tonight, offering his expert opinion and advice to millions of American households. Colker is also a contributing editor and regular columnist in the health and fitness lay press for such popular publications as Muscle and Fitness, Muscular Development, Flex,and Ironman magazines. He is the founder of Peak Wellness, Inc., a private practice and consulting company in Greenwich, Connecticut, and was the chief medical officer and executive vice president for the dietary supplement company Atlas Therapeutics. Colker is an industry consultant and clinical researcher. As a published clinical researcher authoring a number of journal publications, Colker is also credited with numerous lay-press articles and books.He has served as board member, product developer, and/or spokesman for other companies including Microsoft, GNC, Health Sciences, LifeVantage, Atlas Therapeutics, ITV Ventures, Cytodyne Technologies, Muscletech Research and Development, Metabolife International Vital Basics, FairwayMarkets, R Baby Foundation.

Metropolitan Correctional Center, San Diego

The Metropolitan Correctional Center, San Diego is a United States federal administrative detention facility in California which holds male and female prisoners of all security levels. It is operated by the Federal Bureau of Prisons, a division of the United States Department of Justice.

Edward F. Blizzard is a pharmaceutical injury attorney and a founding partner of Blizzard, McCarthy & Nabers, LLC based in Houston, Texas.

The Chemins Company is a dietary supplement manufacturer based in Colorado Springs, Colorado. The company, founded in 1974 by James Cameron, became embroiled in a series of criminal investigations in 1994 after a woman died and more than 100 other people became ill after taking one of the company’s products marketed under the brand name Nature's Nutrition Formula One. The adverse events were later linked to the product having been tainted with ephedrine. A three-year federal investigation, which revealed that the company had doctored records, misled FDA investigators, and purposely hindered inspections, led to Cameron being sentenced to 21 months in prison and him and the company being fined $4.7 million. The company also paid out $750,000 to settle a class action lawsuit alleging that the company's protein powder supplements contained approximately half the protein content and twice the carbohydrate content listed on the label.

Dietary Supplement Health and Education Act of 1994 1994 statute of United States Federal legislation

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.

Pre-workout is a generic term for a range of bodybuilding supplement products used by athletes and weightlifters to enhance athletic performance. It is taken to increase endurance, energy, and focus during a workout. Pre-workout supplements contain a variety of ingredients such as caffeine and creatine, ranging by product. It can be taken in a variety of forms including capsules and powder. The first pre-workout entered the market in 1982, and since then they have grown in popularity. Some pre-workouts contain ingredients linked to adverse effects. Although these products are not banned, the Food and Drug Administration (FDA) warns consumers to be cautious when consuming pre-workout.

References

  1. 1 2 3 Allen, Mike (2005-10-17). "Metabolife Continues Its Search for Buyer". San Diego Business Journal. Archived from the original on 2007-09-27. Retrieved 2007-04-11.
  2. ↑ "Adverse Event Reports from Metabolife" (PDF). United States House Committee on Oversight and Government Reform. October 2002. Archived from the original (PDF) on 2014-12-23. Retrieved 2013-03-29.
  3. 1 2 3 Brownlee, Shannon (2000-06-07). "Swallowing Ephedra". Salon.com . Retrieved 2008-10-07.
  4. 1 2 3 4 5 6 Crabtree, Penni (2003-07-20). "Little Pill, Big Trouble". San Diego Union-Tribune . Retrieved 2008-10-07.
  5. ↑ "Executive profile: David Brown". BusinessWeek .
  6. ↑ Gonzalez, Steve (November 30, 2004). "Metabolife and Walgreen's hit up for $450k". The Madison / St. Clair Record . Archived from the original on October 15, 2013. Retrieved 2012-08-22.
  7. ↑ Bortnick, Barry (April 22, 2000). "Diet drug maker faces wrongful death lawsuits -- maker of Metabolife 356 is targeted". The Gazette . Archived from the original on November 5, 2013. Retrieved 2012-08-23.
  8. ↑ Hurley, Dan (2006). Natural Causes . New York: Broadway Books. ISBN   978-0-7679-2042-1.
  9. ↑ Wolfe SM (April 2003). "Medicine. Ephedra--scientific evidence versus money/politics". Science. 300 (5618): 437. doi:10.1126/science.1081910. PMID   12702860. S2CID   152994880.
  10. ↑ Verduin ML, Labbate LA (2002). "Psychosis and delirium following metabolife use". Psychopharmacology Bulletin. 36 (3): 42–5. PMID   12473963.
  11. ↑ Walton R, Manos GH (July 2003). "Psychosis related to ephedra-containing herbal supplement use". Southern Medical Journal. 96 (7): 718–20. doi:10.1097/01.SMJ.0000054913.04507.68. PMID   12940331. S2CID   7720854.
  12. ↑ Enders JM, Dobesh PP, Ellison JN (December 2003). "Acute myocardial infarction induced by ephedrine alkaloids". Pharmacotherapy. 23 (12): 1645–51. doi:10.1592/phco.23.15.1645.31959. PMID   14695044.
  13. ↑ Chen C, Biller J, Willing SJ, Lopez AM (January 2004). "Ischemic stroke after using over the counter products containing ephedra". Journal of the Neurological Sciences. 217 (1): 55–60. doi:10.1016/j.jns.2003.08.012. PMID   14675610. S2CID   24777680.
  14. ↑ Case CC, Maldonado M (November 2002). "Diabetic ketoacidosis associated with Metabolife: a report of two cases". Diabetes, Obesity & Metabolism. 4 (6): 402–6. doi:10.1046/j.1463-1326.2002.00235.x. PMID   12406039.
  15. ↑ McBride BF, Karapanos AK, Krudysz A, Kluger J, Coleman CI, White CM (January 2004). "Electrocardiographic and hemodynamic effects of a multicomponent dietary supplement containing ephedra and caffeine: a randomized controlled trial". JAMA: The Journal of the American Medical Association. 291 (2): 216–21. doi: 10.1001/jama.291.2.216 . PMID   14722148.
  16. 1 2 "Metabolife and owner William Bradley Plead Guilty to Tax Charges" (PDF). United States Department of Justice. 2005-10-05. Archived from the original (PDF) on 2008-10-12. Retrieved 2008-11-24.
  17. ↑ Potter, Matt (2006-10-05). "Breaking Stories: Case Closed". SanDiegoReader.com. Retrieved 2008-04-11.
  18. 1 2 Crabtree, Penni (December 2, 2003). "Kickbacks also paid, affidavit alleges". San Diego Union-Tribune . Retrieved February 26, 2015.
  19. ↑ Hettena, Seth (October 17, 2004). "Metabolife: its rise and fall". Seattle Times . Retrieved February 26, 2015.
  20. 1 2 3 4 Bauder, Don (November 26, 2003). "A Metabolife Death". San Diego Reader . Retrieved February 26, 2015.
  21. ↑ Vardi, Nathan (April 19, 2004). "Poison Pills". Forbes . Retrieved February 26, 2015.
  22. ↑ "Criminal investigation sought for diet supplement seller". USA Today . 2002-08-15. Retrieved 2007-04-11.
  23. ↑ Washburn, David (2005-08-06). "Metabolife will plead guilty, end tax probe". San Diego Union-Tribune . Retrieved 2007-04-11.
  24. 1 2 "Metabolife Founder Gets 6-Month Prison Sentence". Law360.
  25. ↑ Crabtree, Penni (2002-06-02). "Ex-Metabolife Hopes to Settle Ephedra Claims". San Diego Union-Tribune . Retrieved 2007-04-11.
  26. ↑ Bell, Diane (2006-11-30). "Metabolife's Artwork Goes on the Block Today". San Diego Union-Tribune. Retrieved 2007-06-22.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.