Metabolife
Encyclopedia
Metabolife International, Inc., is an multi-level marketing
company based in San Diego, California
which manufactures dietary supplements. Metabolife's best-selling product, an ephedra-based
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
s, including deaths. These deaths caused the U.S. Food and Drug Administration (FDA) to ban the sale of ephedra-containing dietary supplements in 2004.
Subsequently, Metabolife's founder 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."
on probation
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 (who went on to serve as CEO/President of LifeVantage
in 2008).
Metabolife's ephedra supplement was initially marketed 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 advertize 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
rocket and incorporate Metabolife's ephedra supplement into the diet of its cosmonauts.
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
, heart attack
, stroke
, and diabetic ketoacidosis
. A clinical trial conducted to address safety concerns found that Metabolife 365 increased blood pressure
and induced mild cardiac arrhythmias; the trial concluded that there were serious safety concerns associated with the use of Metabolife.
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. 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. 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. Other recipients of Metabolife contributions included then-Governor of California Gray Davis
, who was given $175,000.
Metabolife was also investigated by the Internal Revenue Service
and the Department of Justice
for income tax evasion; ultimately, the company pled guilty to filing fraudulent tax returns and was sentenced to pay a criminal fine of $600,000. Metabolife owner William Bradley also pled guilty to evading millions of dollars in taxes and was sentenced to 6 months in federal prison
and 2 years of probation
. 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.
In response to falling sales, and facing more than $1 billion in personal injury
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
special agent who arrested Ellis in 1989 for producing and distributing methamphetamine.
Multi-level marketing
Multi-level marketing is a marketing strategy in which the sales force is compensated not only for sales they personally generate, but also for the sales of others they recruit, creating a downline of distributors and a hierarchy of multiple levels of compensation...
company based in San Diego, California
San Diego, California
San Diego is the eighth-largest city in the United States and second-largest city in California. The city is located on the coast of the Pacific Ocean in Southern California, immediately adjacent to the Mexican border. The birthplace of California, San Diego is known for its mild year-round...
which manufactures dietary supplements. Metabolife's best-selling product, an ephedra-based
Ephedra
Ephedra refers to the plant Ephedra sinica. E. sinica, known in Chinese as ma huang , has been used in traditional Chinese medicine for 5,000 years for the treatment of asthma and hay fever, as well as for the common cold...
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
Serious adverse event
A serious adverse event in human drug trials are defined as any untowardmedical occurrence that at any dose#results in death,#is life-threatening#requires inpatient hospitalization or prolongation of existing hospitalization...
s, including deaths. These deaths caused the U.S. Food and Drug Administration (FDA) to ban the sale of ephedra-containing dietary supplements in 2004.
Subsequently, Metabolife's founder 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 officerPolice officer
A police officer is a warranted employee of a police force...
on probation
Probation
Probation literally means testing of behaviour or abilities. In a legal sense, an offender on probation is ordered to follow certain conditions set forth by the court, often under the supervision of a probation officer...
for charges relating to his involvement with a methamphetamine
Methamphetamine
Methamphetamine is a psychostimulant of the phenethylamine and amphetamine class of psychoactive drugs...
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 (who went on to serve as CEO/President of LifeVantage
Protandim
Protandim is a patented dietary supplement marketed by LifeVantage Corporation , a Utah-based multilevel marketing company...
in 2008).
Metabolife's ephedra supplement was initially marketed as a bodybuilding
Bodybuilding
Bodybuilding is a form of body modification involving intensive muscle hypertrophy. An individual who engages in this activity is referred to as a bodybuilder. In competitive and professional bodybuilding, bodybuilders display their physiques to a panel of judges, who assign points based on their...
supplement, but in 1995 was rebranded as an aid for dieting
Dieting
Dieting is the practice of eating food in a regulated fashion to achieve or maintain a controlled weight. In most cases dieting is used in combination with physical exercise to lose weight in those who are overweight or obese. Some athletes, however, follow a diet to gain weight...
. The product became highly successful due to a marketing plan that enlisted customers to advertize 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
Russia
Russia or , officially known as both Russia and the Russian Federation , is a country in northern Eurasia. It is a federal semi-presidential republic, comprising 83 federal subjects...
$15 million to paint its logo on an International Space Station
International Space Station
The International Space Station is a habitable, artificial satellite in low Earth orbit. The ISS follows the Salyut, Almaz, Cosmos, Skylab, and Mir space stations, as the 11th space station launched, not including the Genesis I and II prototypes...
rocket and incorporate Metabolife's ephedra supplement into the diet of its cosmonauts.
Regulation and lobbying
In the late 1990s, the U.S. FDAFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
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
Psychosis means abnormal condition of the mind, and is a generic psychiatric term for a mental state often described as involving a "loss of contact with reality"...
, heart attack
Myocardial infarction
Myocardial infarction or acute myocardial infarction , commonly known as a heart attack, results from the interruption of blood supply to a part of the heart, causing heart cells to die...
, stroke
Stroke
A stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage...
, and diabetic ketoacidosis
Diabetic ketoacidosis
Diabetic ketoacidosis is a potentially life-threatening complication in patients with diabetes mellitus. It happens predominantly in those with type 1 diabetes, but it can occur in those with type 2 diabetes under certain circumstances...
. A clinical trial conducted to address safety concerns found that Metabolife 365 increased blood pressure
Blood pressure
Blood pressure is the pressure exerted by circulating blood upon the walls of blood vessels, and is one of the principal vital signs. When used without further specification, "blood pressure" usually refers to the arterial pressure of the systemic circulation. During each heartbeat, BP varies...
and induced mild cardiac arrhythmias; the trial concluded that there were serious safety concerns associated with the use of Metabolife.
Metabolife took an active role in lobbying
Lobbying
Lobbying is the act of attempting to influence decisions made by officials in the government, most often legislators or members of regulatory agencies. Lobbying is done by various people or groups, from private-sector individuals or corporations, fellow legislators or government officials, or...
against regulation of ephedra, forming an advocacy group called the Dietary Supplement Safety and Science Coalition and contributing heavily to Congressmen Brian Bilbray
Brian Bilbray
Brian Phillip Bilbray is the U.S. Representative for , serving since 2006, and previously for the 49th district from 1995 to 2001. He is a member of the Republican Party. Bilbray is Chairman of the House Immigration Reform Caucus and a member of the influential...
(R
Republican Party (United States)
The Republican Party is one of the two major contemporary political parties in the United States, along with the Democratic Party. Founded by anti-slavery expansion activists in 1854, it is often called the GOP . The party's platform generally reflects American conservatism in the U.S...
-Calif.
California
California is a state located on the West Coast of the United States. It is by far the most populous U.S. state, and the third-largest by land area...
) and Dan Burton
Dan Burton
Danny "Dan" Lee Burton is the U.S. Representative for , and previously the , serving since 1983. He is a member of the Republican Party....
(R
Republican Party (United States)
The Republican Party is one of the two major contemporary political parties in the United States, along with the Democratic Party. Founded by anti-slavery expansion activists in 1854, it is often called the GOP . The party's platform generally reflects American conservatism in the U.S...
-Ind.
Indiana
Indiana is a US state, admitted to the United States as the 19th on December 11, 1816. It is located in the Midwestern United States and Great Lakes Region. With 6,483,802 residents, the state is ranked 15th in population and 16th in population density. Indiana is ranked 38th in land area and is...
), 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 to both political parties, and almost $3 million to lobbyists. At the state level, Metabolife contributed $10,000 to then-Governor of Texas George W. Bush
George W. Bush
George Walker Bush is an American politician who served as the 43rd President of the United States, from 2001 to 2009. Before that, he was the 46th Governor of Texas, having served from 1995 to 2000....
, who intervened to stop regulation which would have banned over-the-counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
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 Gray Davis
Gray Davis
Joseph Graham "Gray" Davis, Jr. is an American Democratic politician who served as California's 37th Governor from 1999 until being recalled in 2003...
, who was given $175,000.
Legal issues
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.Metabolife was also investigated by the Internal Revenue Service
Internal Revenue Service
The Internal Revenue Service is the revenue service of the United States federal government. The agency is a bureau of the Department of the Treasury, and is under the immediate direction of the Commissioner of Internal Revenue...
and the Department of Justice
United States Department of Justice
The United States Department of Justice , is the United States federal executive department responsible for the enforcement of the law and administration of justice, equivalent to the justice or interior ministries of other countries.The Department is led by the Attorney General, who is nominated...
for income tax evasion; ultimately, the company pled guilty to filing fraudulent tax returns and was sentenced to pay a criminal fine of $600,000. Metabolife owner William Bradley also pled guilty to evading millions of dollars in taxes and was sentenced to 6 months in federal prison
Federal prison
Federal prisons are run by national governments in countries where subdivisions of the country also operate prisons.In the United States federal prisons are operated by the Federal Bureau of Prisons. In Canada the Correctional Service of Canada operates federal prisons. Prison sentences in these...
and 2 years of probation
Probation
Probation literally means testing of behaviour or abilities. In a legal sense, an offender on probation is ordered to follow certain conditions set forth by the court, often under the supervision of a probation officer...
. Some of the politicians associated with Metabolife also encountered legal difficulties; Texas state legislators Jeff Wentworth
Jeff Wentworth
Earl Jeffrey "Jeff" Wentworth is a Republican member of the Texas Senate since 1993. He succeeded Republican Cyndi Taylor Krier , who instead became the Bexar County judge...
and Rick Green were accused of illegal lobbying on behalf of the company.
In response to falling sales, and facing more than $1 billion in personal injury
Personal injury
Personal injury is a legal term for an injury to the body, mind or emotions, as opposed to an injury to property. The term is most commonly used to refer to a type of tort lawsuit alleging that the plaintiff's injury has been caused by the negligence of another, but also arises in defamation...
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
Federal Bureau of Investigation
The Federal Bureau of Investigation is an agency of the United States Department of Justice that serves as both a federal criminal investigative body and an internal intelligence agency . The FBI has investigative jurisdiction over violations of more than 200 categories of federal crime...
special agent who arrested Ellis in 1989 for producing and distributing methamphetamine.
External links
- Metabolife home page
- Adverse Event Reports from Metabolife: A report prepared for the United States House Committee on Oversight and Government Reform
- Metabolife 356 Associated With Increased Cardiac Risk Peggy Peck Medscape medical news