Metabolife 356
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Metabolife International, Inc. was a
multi-level marketing Multi-level marketing (MLM), also called network marketing or pyramid selling, is a controversial marketing strategy for the sale of products or services in which the revenue of the MLM company is derived from a non-salaried workforce selling th ...
company based in
San Diego, California San Diego ( , ; ) is a city on the Pacific Ocean coast of Southern California located immediately adjacent to the Mexico–United States border. With a 2020 population of 1,386,932, it is the eighth most populous city in the United Stat ...
which manufactured dietary supplements. Metabolife's best-selling product, an
ephedra Ephedra may refer to: * Ephedra (medicine), a medicinal preparation from the plant ''Ephedra sinica'' * ''Ephedra'' (plant), genus of gymnosperm shrubs See also * Ephedrine Ephedrine is a central nervous system (CNS) stimulant that is of ...
supplement called ''Metabolife 356'', once generated hundreds of millions of dollars in annual sales. However, Metabolife 356 and other ephedra-containing supplements were linked to thousands of
serious adverse event A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose #Results in death #Is life-threatening #Requires inpatient hospitalization or causes prolongation of existing hospitalization #Result ...
s, including deaths, which caused the
U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) to ban the sale of ephedra-containing dietary supplements in 2004. 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."


History

Metabolife was founded in the early 1990s by Michael Ellis, a former
police officer A police officer (also called a policeman and, less commonly, a policewoman) is a warranted law employee of a police force. In most countries, "police officer" is a generic term not specifying a particular rank. In some, the use of the ...
on
probation Probation in criminal law is a period of supervision over an offender, ordered by the court often in lieu of incarceration. In some jurisdictions, the term ''probation'' applies only to community sentences (alternatives to incarceration), such ...
for charges relating to his involvement with a methamphetamine lab. 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. 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). Metabolife 356, an ephedra supplement manufactured by Chemins, was initially marketed by Metabolife as a
bodybuilding supplement 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 ...
, 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; at their peak, sales of Metabolife 356 were in the hundreds of millions of dollars annually. At one point, Metabolife offered the Russian government $15 million to paint its logo on an
International Space Station The International Space Station (ISS) is the largest modular space station currently in low Earth orbit. It is a multinational collaborative project involving five participating space agencies: NASA (United States), Roscosmos (Russia), JAXA ( ...
rocket and incorporate Metabolife's ephedra supplement into the diet of its
cosmonaut An astronaut (from the Ancient Greek (), meaning 'star', and (), meaning 'sailor') is a person trained, equipped, and deployed by a human spaceflight program to serve as a commander or crew member aboard a spacecraft. Although generally r ...
s.


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. These included reports of
psychosis Psychosis is a condition of the mind that results in difficulties determining what is real and what is not real. Symptoms may include delusions and hallucinations, among other features. Additional symptoms are incoherent speech and behavior ...
,
heart attack A myocardial infarction (MI), commonly known as a heart attack, occurs when blood flow decreases or stops to the coronary artery of the heart, causing damage to the heart muscle. The most common symptom is chest pain or discomfort which ma ...
, stroke, and
diabetic ketoacidosis Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of diabetes mellitus. Signs and symptoms may include vomiting, abdominal pain, deep gasping breathing, increased urination, weakness, confusion and occasionally loss of ...
. A clinical trial conducted to address safety concerns found that Metabolife 356 increased blood pressure and induced mild
cardiac arrhythmia Arrhythmias, also known as cardiac arrhythmias, heart arrhythmias, or dysrhythmias, are irregularities in the heartbeat, including when it is too fast or too slow. A resting heart rate that is too fast – above 100 beats per minute in adults ...
s; the trial concluded that there were serious safety concerns associated with the use of Metabolife. Metabolife took an active role in
lobbying In politics, lobbying, persuasion or interest representation is the act of lawfully attempting to influence the actions, policies, or decisions of government officials, most often legislators or members of regulatory agencies. Lobbying, which ...
against regulation of ephedra, forming an advocacy group called the Dietary Supplement Safety and Science Coalition and contributing heavily to
Congressmen A Member of Congress (MOC) is a person who has been appointed or elected and inducted into an official body called a congress, typically to represent a particular constituency in a legislature. The term member of parliament (MP) is an equivalen ...
Brian Bilbray Brian Phillip Bilbray (born January 28, 1951) is an American Republican politician who represented parts of San Diego County in the U.S. House of Representatives from 1995 to 2001 and again from 2006 to 2013. Bilbray was Chairman of the House ...
( R- Calif.) and
Dan Burton Danny Lee Burton (born June 21, 1938) is an American politician. Burton is the former U.S. Representative for , and previously the , serving from 1983 until 2013. He is a member of the Republican Party and was part of the Tea Party Caucus. Ea ...
( R- Ind.), among other politicians. 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 The financing of electoral campaigns in the United States happens at the federal, state, and local levels by contributions from individuals, corporations, political action committees, and sometimes the government. Campaign spending has risen ...
to both political parties, and almost $3 million to
lobbyists In politics, lobbying, persuasion or interest representation is the act of lawfully attempting to influence the actions, policies, or decisions of government officials, most often legislators or members of regulatory agencies. Lobbying, whi ...
. At the state level, Metabolife contributed $10,000 to then-Governor of Texas
George W. Bush George Walker Bush (born July 6, 1946) is an American politician who served as the 43rd president of the United States from 2001 to 2009. A member of the Republican Party, Bush family, and son of the 41st president George H. W. Bush, he ...
, who intervened to stop regulation which would have banned
over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...
sales of ephedra. Bush subsequently returned the $10,000 after Ellis' and Blevins' methamphetamine convictions were publicized in the media. Other recipients of Metabolife contributions included then-Governor of California Joseph Graham 'Gray' Davis, Jr., who was given $175,000.


Legal issues

Metabolife was investigated by the Internal Revenue Service and the
Department of Justice A justice ministry, ministry of justice, or department of justice is a ministry or other government agency in charge of the administration of justice. The ministry or department is often headed by a minister of justice (minister for justice in a ...
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. 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 Probation in criminal law is a period of supervision over an offender, ordered by the court often in lieu of incarceration. In some jurisdictions, the term ''probation'' applies only to community sentences (alternatives to incarceration), such ...
. 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. 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. 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. In July 2002, criminal investigators of the Internal Revenue Service raided Compton's office, seizing documents and computer data, 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. Some of the politicians associated with Metabolife also encountered legal difficulties; Texas state legislators
Jeff Wentworth Earl Jeffrey Wentworth (born November 20, 1940), is a Republican former member of the Texas Senate from San Antonio. He represented District 25 in the upper legislative chamber from January 1997 to January 2013. In addition, from 1993 to 1997, h ...
and Rick Green were accused of illegal lobbying on behalf of the company. 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. 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. In response to falling sales, and facing more than $1 billion in
personal injury Personal injury is a legal term for an injury to the body, mind or emotions, as opposed to an injury to property. In common law jurisdictions the term is most commonly used to refer to a type of tort lawsuit in which the person bringing the suit (t ...
legal claims related to Metabolife 356, Metabolife filed for Chapter 11 bankruptcy in 2005. 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. Metabolife's non-ephedra assets were acquired by Ideasphere Inc., a New York-based dietary-supplement manufacturer, for $12 million in 2007. In 2008, Michael Ellis authored a memoir entitled ''The Metabolife Story: The Rape of Cinderella'', with a testimonial by the former
FBI The Federal Bureau of Investigation (FBI) is the domestic intelligence and security service of the United States and its principal federal law enforcement agency. Operating under the jurisdiction of the United States Department of Justice, t ...
special agent who arrested Ellis in 1989 for producing and distributing methamphetamine.


References


External links


Metabolife home page

Metabolife 356 Associated With Increased Cardiac Risk
Peggy Peck, ''Medscape'' * {{Multi-level marketing Companies based in California Companies established in 1995 Corporate scandals Health law in the United States Dietary supplements Defunct multi-level marketing companies