Ergogenics

  [Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance." (Wilmore and Costill)

  Nieuwsbrief over doping, supplementen, voeding en training

  Nutraquest/problemen       AST/problemen       Efedra terug?       Efedra terug    

Metabolife

Al na één keer slikken begint mix van cafeïne en efedrine het hart te slopen (Ergogenics, 20-1-2004)

Hoofdkwartier Metabolife staat te koop (SAN DIEGO UNION-TRIBUNE, August 17, 2004)

Metabolife werd steeds rijker, klanten werden alsmaar zieker (AP, 10-16-04)

Metabolife betaalde politici (AP, 10-16-04)


2 0 - 0 1 - 2 0 0 4

Al na één keer slikken begint mix van cafeïne en efedrine het hart te slopen

Metabolife 356, de best verkopende stacker van het supplementenconcern Metabolife, begint al enkele ogenlikken na inname de hartspier aan te tasten. Dat schrijven onderzoekers van de University of Connecticut in de Journal of the American Medical Association. Het inmiddels verboden supplement ontregelt de aansturing van de hartspier.

De onderzoekers deden proeven met 15 gezonde vrijwilligers, zowel mannen als vrouwen. Hun gemiddelde leeftijd was 27 jaar. Ze kregen de ene keer het supplement, de andere keer - na een 'uitspoeltijd' van een week - een placebo. 1, 3 en 5 uur na inname onderzochten de Amerikanen hun proefpersonen.

Ze keken daarbij onder meer naar de bloeddruk. De systolische bloeddruk, de bloeddruk op het moment dat het hart slaat, begon in die vijf uur al te stijgen en liep gemiddeld op tot 123.5 millimeter kwikdruk. Bij de placebogroep kwam de bloeddruk niet hoger dan 118.93 millimeter kwikdruk.

Belangrijker vonden de onderzoekers wat er gebeurde met het corrected QT interval of QTc. Dat is een maat voor de tijd tussen twee verschillende electrische prikkels die het hart krijgt om samen te trekken. De meeste proefpersonen hadden een toename van de QTc met dertig milliseconden of meer.

Wetenschappers die de veiligheid van medicijnen onderzoeken beschouwen zo'n toename als een alarmsignaal. Het betekent dat een medicijn op termijn hartritmestoornissen kan veroorzaken.

De Amerikanen durven niet te zeggen of het de efedra is die het effect veroorzaakt. De proefpersonen slikten één dosis van de stacker en kregen zo twaalf milligram efedra en veertig milligram cafeïne binnen. In het preparaat bevinden zich nog nog meer stoffen behalve cafeïne en efedrine.


Ingredients/cap

Vitamin E (6 i.u.)
Magnesium (as Magnesium Chelate) (75 mg)
Zinc (as Zinc Chelate) (5 mg)
Chromium (as Chromium Picolinate) (75 mcg)

Proprietary Blend (728 mg)
Guarana Extract (seed)
Ephedra (Ma Huang) extract (aerial part)
Bee Pollen
Eleuthero (root)
Ginger (root)
Lecithin
Damiana (leaf)
Sarsaparilla (root)
Goldenseal (whole plant)
Nettles (leaf)
Gotu Kola (aerial part)
Spirulina
Royal Jelly

Other Ingredients: Dicalcium phosphate, maltodextrin, protein hydrolysafe, caffeine, citric acid, silica, stearic acid, croscarmellose sodium, modified cellulose, magnesium stearate, dextrin, aspartic acid, dextrose, sodium carbxymethlcellulose, sodium citrate.


Metabolife is het niet eens met de studie. David Cohen, adviseur van het bedrijf, zegt dat het onderzoek niet klopt. ,,Wij hebben al eens eerder naar de QTc gekeken. En toen vonden we niets.''

1. McBride BF, Karapanos AK, Krudysz A, Kluger J, Coleman CI, White CM. Electrocardiographic and hemodynamic effects of a multicomponent dietary supplement containing ephedra and caffeine: a randomized controlled trial. JAMA. 2004 Jan 14; 291(2): 216-21. [PubMed]
2. Herbal weight loss supplement appears to impact heart on first dose. NutraIngredients.com, 14-1-2004. [Link]
3. Herbal diet drug 'is heart risk'. BBC News, 13-1-2004. [Link]

Metabolife headquarters available for $12 million

By Penni Crabtree
SAN DIEGO UNION-TRIBUNE
August 17, 2004

Beleaguered Metabolife International has put its San Diego headquarters up for sale.

The three-story, 36,000-square-foot office building at 5643 Copley Drive is listed for $12 million.

The move by the San Diego dietary supplement company to unload its headquarters comes at a time when both Metabolife and its founders face criminal investigations, scores of lawsuits and an uncertain financial future.

Last month, Metabolife and one of its owners, Michael Ellis, were indicted by a grand jury for allegedly lying to federal drug regulators about the safety of the company's now-banned ephedra diet pill.

Another Metabolife owner, Michael Blevins, awaits trial in federal court on charges of illegal possession of firearms and conspiracy to illegally obtain them.

Metabolife also is the subject of a criminal investigation by the Internal Revenue Service, and faces numerous personal injury lawsuits filed by consumers who allege they were harmed by the company's former ephedra product, Metabolife 356.

Jan Strode, a spokeswoman for Metabolife, said: "Metabolife is not going out of business. Management has simply decided to move to another building."

Strode said the company is in the process of looking for another building, but she declined to say where. She would not say how many people Metabolife employs.

Local real estate experts familiar with the Metabolife building said the premium price – which translates into about $332 per square foot – appeared to be above the going rate in the surrounding area.

Matt Root, a partner with The Shidler Group, a national commercial real estate investment group, said the top end of commercial real estate in Kearny Mesa runs about $275 per square foot, with an occasional pricey exception.

Earlier this month, Manchester Plaza, a five-story office building on Waxie Way, sold for $32.7 million, or $295 per square foot. The Metabolife office building features a three-story open atrium, a reflecting pool, a two-story reception lobby, vaulted ceilings, a fitness center and a truck dock.

"The Metabolife building was built as a corporate headquarters," Root said. "A lot of guys build monuments to themselves and that is what this is, lots of glass and space with fountains running in and around it.

"Typically, companies like an efficient use of space," Root said. "Will someone pay $332 per square foot? I'd say no way in heck."

San Diego property records list the Copley Drive property as owned variously by Metabolife International and Area 52, a limited liability corporation that lists Ellis and Blevins as partners. Last year, the property's worth was assessed at $7.7 million, according to county records.

[Link]

Health complaints disregarded as pill firm execs grew rich, prosecutors say

By SETH HETTENA
AP
10-16-04

SAN DIEGO -- Once busted in a raid on a methamphetamine lab, Michael Ellis went legitimate by selling pills designed to boost energy and burn fat. His legal business soon made him a millionaire many times over.

But his company, Metabolife International Inc., had a problem: Its customers were winding up in emergency rooms across the country.

Health complaints flooded headquarters. One user's heart rate zoomed to 300 beats a minute. Another's pulse stopped for 16 minutes. One 25-year-old woman suffered a seizure after a week on Ellis' wonder pill.

If this became public, Ellis allegedly told one employee who handed him a written complaint in the late 1990s, federal regulators would "stomp bloody holes in my chest.''

So, prosecutors say, Ellis wadded up the complaint and tossed it in the trash.

Now, Ellis and Metabolife are accused of covering up a health crisis that escalated as the company became a diet supplement leader.

Charges against Ellis stem from a 1998 letter to federal regulators in which he claimed no customer had registered even a single health complaint about Metabolife 356, his signature product. It was a claim the company repeated a year later.

In fact, according to prosecutors, the company was receiving a cascade of complaints -- some 14,000 from 1997 to 2002. Among them: 18 heart attacks, 26 strokes, 43 seizures and five deaths. Others may never have complained.

Ellis, 51, and Metabolife -- now a shadow of its former self, no longer selling Metabolife 356 but remaining in the supplement business -- call the charges "utterly baseless'' and a "hypertechnical violation'' concocted by taking statements out of context.

A judge recently dismissed six of eight counts on the original grand jury indictment, including obstruction of justice charges. Remaining charges accuse the company and Ellis of lying to the U.S. Food and Drug Administration.

Attorneys for Metabolife and Ellis declined to speak with The Associated Press and declined to make Ellis available for comment. "We will wait and see what the outcome is and let the system do its job,'' said company spokeswoman Jan Strode.

The U.S. attorney's office in San Diego said it could not comment beyond what it had disclosed in court papers.

Those papers reveal new details about Metabolife's woes.

A high school friend whom Ellis made a Metabolife board member is facing federal gun charges. An affidavit briefly unsealed in the gun case showed Ellis and others are under investigation for allegedly hiding millions in overseas tax havens and personal safes.

Last November, shortly after the documents were unsealed, Metabolife's outside accountant, Michael Compton, committed suicide. In a document presented to the federal judge hearing the Metabolife case, prosecutors said Compton had admitted falsifying tax returns for company executives, including Ellis.

Connie Thornburg thought Metabolife 356 was a miracle.

The 48-year-old mother of two from Childersburg, Ala., began her regimen in 1999 and dropped 65 pounds fast.

"That summer, when I was on the beach in Florida with my grandchildren, I thought I was the Queen of Sheba,'' Thornburg said.

The strokes began the following year. She suffered four and was hospitalized 11 times before a doctor told her what was in her diet supplements.

The main ingredients in Metabolife 356 were ephedra and caffeine, a combination that had been discovered in Denmark a quarter-century ago.

Ephedra is the herbal form of the stimulant ephedrine, an ingredient in cold medicines that raises heart rates, suppresses appetites and staves off sleep. Ephedrine also is a key ingredient in the street drug methamphetamine.

Earlier this year, the Bush administration banned sales of ephedra after linking it to 155 deaths. Perhaps the most famous victim was 23-year-old Baltimore Orioles pitcher Steve Bechler, who died trying to shed pounds during spring training last year.

Thornburg's case was the first of scores of Metabolife lawsuits to reach trial in 2002. An Alabama jury found Metabolife 356 was unreasonably dangerous, but jurors also found that the plaintiffs had failed to follow directions. The company is appealing the $4.1 million verdict.

Thornburg says she'd give anything for the chance to talk to Ellis, an ex-cop.

"What police officer,'' she said, "wouldn't know that the same ingredient in crystal meth or speed wouldn't harm people?''

According to the company Web site, Ellis discovered the formula for Metabolife 356 in 1989 while searching for something that would give his father energy to fight terminal cancer.

It was also the year Ellis and Michael Blevins, the longtime buddy he would later make a Metabolife co-owner, were indicted in what the Drug Enforcement Administration called the biggest single roundup of methamphetamine manufacturers in U.S. history.

Blevins had bought chemicals and lab materials from a supply house that was part of a massive undercover drug sting. Federal agents raided the home Ellis rented in Rancho Santa Fe, an exclusive San Diego suburb, and found a clandestine methamphetamine laboratory. A forensic chemist determined that more than 50 pounds of methamphetamine had been made in the house.

Facing prison time on the methamphetamine charges, Ellis cut a deal. He became an undercover FBI informant and testified before a federal jury in 1990 about meeting a major marijuana dealer.

In testimony before the jury, he revealed that he left his job as a police officer in the working class San Diego suburb of National City after he was subpoenaed in an investigation of the sale of illegal automatic weapons.

For his efforts as an informant, Ellis received probation.

Ellis drove Blevins to a prison in the Mojave Desert where he was sentenced to serve more than five years. Blevins wrote a federal judge that, in parting, Ellis promised to build a business for the both of them.

When Blevins was transferred to a San Diego halfway house in 1995, a job was waiting at the recently founded Metabolife.

"With hard work and dedication we are going to build something we can all be proud of,'' Blevins wrote the judge.

Metabolife got its start less than a year after Congress deregulated the dietary supplements industry in 1994.

The law, sponsored by Sen. Orrin Hatch, R-Utah, who dabbled in the vitamin business as a young man, treated dietary supplements as food instead of drugs. Dietary supplement makers no longer had to show their products were safe. The burden was on the federal government to show a product was unsafe.

Under the law, Metabolife had no duty to report even the deaths of its customers.

Congress had created "a legalized form of drug dealing,'' said Dr. Peter Lurie of the watchdog group Public Citizen, which successfully petitioned the government in 2001 to pull Metabolife 356 and similar pills.

There is widespread agreement that ephedra has been one of the law's biggest oversights.

Earlier this year, Hatch called the health problems linked to the key ingredient of Metabolife 356 "extremely troubling'' and said the Food and Drug Administration took "too long'' to respond. FDA representatives declined comment for this story.

Metabolife sold more ephedra than anyone else. By 1999, the company boasted that Americans were gobbling 225,000 of its pills an hour.

Revenues at the privately held company had soared to more than $360 million in four years.

The company had so much cash that in 1999, Ellis offered to pay the Russian government $15 million to put Metabolife's logo on an International Space Station rocket. He suggested cosmonauts make Metabolife part of their in-space diet, according to a letter obtained by the AP.

Between 1999 and 2001, Ellis and two other company owners were paid a total of $146 million, Metabolife's vice president of finance testified in a deposition.

Documents show Ellis, the son of a Lebanese immigrant who ran men's clothing stores, enjoyed his personal fortune. He paid cash for his $2.2 million mansion in Rancho Santa Fe and a 200-acre mountain cattle ranch. Foundations set up for Metabolife and Ellis distributed more than $6.75 million to charities.

All along, some of Metabolife's customers were falling ill.

In 1998, when Ellis wrote the FDA that that Metabolife had received no serious health complaints, the company already had heard from nine consumers of Metabolife 356 who had to be hospitalized, prosecutors say in court papers.

When a company lawyer repeated the claim to the FDA the following year, Metabolife had heard from 12 more seriously ill customers, according to company records cited by prosecutors.

A review by the U.S. House Committee on Government Reform of the 14,000 health complaints Metabolife handed over concluded the company showed an "indifference to the health of consumers.''

Nearly a decade after they created the loophole that allowed Metabolife to flourish, federal lawmakers last year subpoenaed Ellis and demanded to know whether he "put sales above safety.'' Ellis took the Fifth Amendment, declining to reply.

Answers may emerge in San Diego federal court. Former employees are cooperating with the investigation.

Ellis understood how company documentation might one day become evidence.

He was unhappy when the company's newly hired medical director started tracking complaints on a computer. Ellis viewed it as "an admission of guilt,'' according to prosecutors.

"Help us,'' one man wrote after doctors said Metabolife 356 was responsible for his wife's grand mal seizure. "Her experience could occur again.''

Washington lobbying firm drawn into probe of Metabolife

By SETH HETTENA
AP
10-16-04

SAN DIEGO -- When federal regulators started to scrutinize the safety record of dietary supplements sold by Metabolife International Inc., the company turned to the influential Washington lobbying and law shop of Patton Boggs LLP.

The two firms first hooked up while Metabolife was still building a dieting empire -- and kept their ties as federal prosecutors mounted their case.

For years, Patton Boggs earned millions helping project reassurances to Congress and its customers that Metabolife products were safe. Patton Boggs attorneys helped prepare carefully worded responses to regulators. Between 2001 and this year, Metabolife paid Patton Boggs $1.8 million to lobby Congress, according to PoliticalMoneyLine, a lobbying data clearinghouse.

Michael Ellis, oprichter van Metabolife

One former and four current Patton Boggs attorneys were subpoenaed by a federal grand jury in San Diego, court documents say. Prosecutors allege company founder Michael Ellis lied about Metabolife's safety record in a 1998 letter to the U.S. Food and Drug Administration, which documents say Patton Boggs attorneys helped draft.

A Patton Boggs spokesman, Brian Hale, declined comment. Attorneys at the firm who worked for Metabolife did not return messages left seeking comment.

Earlier this year, the Bush administration banned the sale of ephedra, which was used in some Metabolife products, after the FDA linked the stimulant to 155 deaths.

Metabolife was once far more welcome in the halls of power.

Former California Gov. Gray Davis vetoed an ephedra warning label bill in 2000 after collecting $150,000 from Metabolife. The administration of then-Texas Gov. George W. Bush dropped a plan to ban ephedra-based products after Metabolife spent as much as $1.3 million to plead its case in Austin, according to a review of state records by Texans for Public Justice, a nonpartisan watchdog group.

Metabolife also invested in Congress -- $1.7 million in federal soft money donations to both political parties from 1999 to 2002, according to the Center for Responsive Politics.

In mid 2002, Patton Boggs lobbyist Lanny Davis wrote a senator whose subcommittee was investigating Metabolife that the company had received only 78 "unproven, anecdotal allegations'' of strokes, heart attacks, seizures and deaths. Davis also testified at a hearing chaired by Sen. Dick Durbin, D-Ill.

About a week after the hearing, the company turned over thousands of health complaints amassed from 1997 to 2002. Among them, according to federal auditors: 18 heart attacks, 26 strokes, 43 seizures and five deaths.

Davis, once a crisis manager in the Clinton White House, did not return messages left seeking comment.

As prosecutors pursued a case against Metabolife, the company instructed its lawyers to assert attorney-client privilege and refuse to testify, according to court documents.

But U.S. District Judge Irma Gonzalez ordered the attorneys to testify, ruling she had "reasonable cause to believe that Ellis and Metabolife used their attorneys to knowingly and willfully make false statements to the FDA about Metabolife 356.''

Metabolife appealed and in May, a panel of federal judges ruled that the attorneys had to testify. Federal prosecutors won't disclose whether that has happened.

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