Yourlawyer.com (Metabolife News) http://www.yourlawyer.com/topics/overview/metabolife Fri, 20 Nov 2009 23:18:44 -0800 pixel-app en Metabolife Seeks Single Big Settlement http://www.yourlawyer.com/articles/read/9161 Wed, 05 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9161
The privately held San Diego company, citing a "litigation onslaught" that threatens to financially bury it, has asked a federal judge in New York to approve the proposed multimillion-dollar class-action settlement.

If the plan is approved, consumers represented in about 300 personal injury lawsuits in federal and state courts could each receive up to $1.05 million although they could also opt out and pursue separate court cases. The settlement would also cover future claims by injured consumers who have not filed lawsuits.

Once the nation's leading seller of ephedra diet aids, Metabolife has seen its reputation and revenue founder in the wake of lawsuits and federal investigations. Last year, the company and its former chief executive, Michael Ellis, were indicted for allegedly lying to the Food and Drug Administration about the safety of its flagship product, Metabolife 356.

The pill, which was used by bodybuilders for increasing stamina and dieters for shedding pounds, reaped hundreds of millions of dollars after its 1995 launch. But Metabolife 356, a combination of caffeine and the herbal stimulant ephedra, has also been linked to strokes, heart attacks and, in some cases, death.

Last year, the FDA banned all dietary supplements containing ephedra.

In a court filing, Metabolife downplayed the merits of the personal injury lawsuits but called the proposed settlement a business necessity.

The company compared the dosage of caffeine in two Metabolife 356 caplets to the amount in a single serving of Ben and Jerry's Nonfat Coffee Fudge Frozen Yogurt. It compared the amount of ephedra to the quantity of ephedrine, the active ingredient in ephedra, found in over-the-counter asthma medicines.

"While Metabolife is confident it can expose the deficiencies of (the) cases, the cost of doing so in the hundreds of claims currently pending throughout the country threatens the very existence of Metabolife," the company said in court documents filed in U.S. District Court in New York.

Many medical experts argue that it is not the separate ingredients in Metabolife 356 that pose a health risk but the combination. Ephedra stimulates the nervous system, elevating blood pressure and increasing the heart rate. When mixed with caffeine and other herbal stimulants, the effect can be dangerously magnified.

A single Metabolife 356 pill can change electrical pulses that control the heart, increasing a person's risk threefold of developing a potentially fatal, irregular heart beat, according to a study published last year in the Journal of the American Medical Association.

Such evidence has proved persuasive with some juries. In June, Metabolife was ordered to pay $7.4 million to a Texas woman who suffered a stroke after taking Metabolife 356. Earlier, a jury in Alabama awarded $4.1 million in damages to four people who suffered injuries after taking the diet pill.

About 170 lawsuits filed against Metabolife in federal court have been consolidated in New York under a multidistrict litigation program. Another 130 lawsuits are pending in state courts, including 91 California cases transferred to a San Diego court.

As part of the proposed settlement, Metabolife is seeking a stay on the litigation pending in state courts, including one lawsuit set for trial in San Diego in March.

Metabolife has resolved more than 400 claims since it was first hit with personal injury lawsuits in 1999. Much of that cost was borne by the company's insurance carriers, but now Metabolife is on the financial hook for many of the unsettled lawsuits, according to court documents.

The company said it had traditional insurance through March 2001, but about 200 lawsuits claim injuries after that date. In those cases, Metabolife has had to pay most of the cost of defending itself and could be responsible for paying jury awards if it loses.

As of Dec. 1, Metabolife had spent about $20 million in legal fees and costs defending the lawsuits. Meanwhile, sales of the company's products have plummeted. In 2003, revenue had fallen to less than $90 million and the company had an operating loss of $20 million, according to court documents.

Metabolife had more than $350 million in revenue and a profit of $24 million in 1999, the company said in the court filing.

Jan Strode, a spokeswoman for Metabolife, said the settlement is an "efficient" way to resolve the litigation.

"Metabolife has made the sound business decision, in light of the cost of defending many baseless lawsuits, to resolve its ephedra litigation via a class-action settlement," Strode said.

It does not propose an amount to settle claims; instead it would use a formula to resolve them according to severity. Factors such as a consumer's age or pre-existing health problems would reduce payouts.

The most a consumer could receive under the settlement would be $1.05 million, according to Arnold Levin, a Philadelphia lawyer who negotiated the proposed settlement on behalf of consumer plaintiffs.

Levin acknowledged Metabolife's claim that its financial resources could be exhausted by litigation if the settlement is not approved, posing a risk of the company going under and consumer litigants getting nothing.

"Metabolife is not Wyeth. They're not Pfizer or Johnson & Johnson, so there is that problem," Levin said. "But I think the figures are fair and equitable anyway, even if the company was not in some dire straits, as they say they are."

A New York judge will hold a preliminary hearing on issues associated with the proposed settlement next month, though a decision on whether to approve it is not likely to come before March, according to Levin.

While a settlement could ease some of Metabolife's legal and financial woes, the company and its owners still face serious legal problems.

Federal prosecutors accuse Metabolife and Ellis of covering up Metabolife 356's alleged safety problems, which consumers complained about to the company as early as 1997.

Yet Metabolife told regulators in 1998 that the company had never received any notice from a consumer of a serious health problem because of Metabolife 356, and repeated the claim in 1999.

It wasn't until 2002, under pressure from the FDA and the Justice Department, that Metabolife turned over about 13,000 consumer health complaints to federal regulators.

In a separate probe, the Internal Revenue Service is investigating allegations of tax evasion by Ellis and Metabolife's other owners, Michael Blevins and William Robert Bradley.]]> The Dark History Behind Metabolife http://www.yourlawyer.com/articles/read/8666 Mon, 18 Oct 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8666
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 users heart rate zoomed to 300 beats a minute. Anothers 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.

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

Those papers reveal new details about Metabolifes 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, Metabolifes 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.

Case history

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.

Thornburgs 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 shed give anything for the chance to talk to Ellis, an ex-cop.

"What police officer," she said, "wouldnt know that the same ingredient in crystal meth or speed wouldnt 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.

Legalized drug dealing

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.

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 laws biggest oversights.

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.

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. ]]> Stroke Victim Sues Herbalife http://www.yourlawyer.com/articles/read/8377 Fri, 13 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8377
Robert A. Smith said he took an Herbalife product with ephedra and then had a blood vessel burst in his brain, resulting in a stroke in May 2002, according to the complaint filed in state Supreme Court last month.

The lawsuit does not say how long Smith took the product, what he was doing at the time of the stroke, and it does not specify Smith's age. Smith has since moved to Florida and could not be reached for comment.

Smith is represented by a New Jersey lawyer who is also a liaison to similar lawsuits against Herbalife filed in New York City. Records show there are about a half-dozen lawsuits filed against Herbalife in U.S. District Court in Manhattan.

Ephedra is a naturally occurring substance derived from plants. But its principal active ingredient, ephedrine, is regulated as a drug when chemically synthesized, according to the FDA. Ephedra was most often placed in dietary supplements and marketed as a way to lose weight and increase energy.

In April, the Food and Drug Administration banned ephedra-based products because their use was linked to more than 150 deaths since 1994. The ban forced more than 60 companies to stop adding ephedra to their supplements.

Last month, a grand jury indicted a different company, Metabolife, and its founder for telling the FDA it had never received complaints about serious side effects. In fact, Metabolife later revealed it had received about 13,000 complaints about ephedra.

Smith is asking for an unspecified amount of damages to pay for his medical expenses, suffering and requests an award for additional damages in an amount sufficiently large to be an example to others and to deter (Herbalife) and others from engaging in similar conduct, according to the lawsuit.]]> Jury Awards $7.4 Million In Ephedra Lawsuit http://www.yourlawyer.com/articles/read/8178 Thu, 24 Jun 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8178
The jury found Wednesday that San Diego-based marketer Metabolife International acted maliciously when it falsely told state and federal regulators that its Metabolife supplement had no adverse effects and that the company had comprehensive safety monitoring procedures.

Rhea McAllister was awarded $2.4 million in actual damages and $5 million in punitive damages.

Ephedra was once widely used for weight loss and bodybuilding, with industry groups claiming at least 12 million users. The amphetamine-like stimulant, which speeds the heart rate and constricts blood vessels, has now been linked to 155 deaths, including that of Baltimore Orioles pitching prospect Steve Bechler, and the federal government banned it in April.]]> Houston Woman Sues Maker Of Metabolife http://www.yourlawyer.com/articles/read/8159 Tue, 15 Jun 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8159
Rhea McCallister said she was taking the supplement when she suffered a stroke. She believes the drug contributed to her ill condition.

The 34-year-old woman claimed she became so sick after only a few weeks of taking the product that she couldn't stand up.

"I actually had to hold onto the table, and I actually had fallen a couple of times in the house," said McCallister.

Metabolife contained Ephedra, which the government banned after finding evidence linking it to heart attacks, strokes and even death.

Other Metabolife users have successfully sued the makers for millions.

Neither side would talk to the media since it could result in a mistrial. The trial is expected to last for a week.

Metabolife executives have already taken the Fifth Amendment in depositions and during congressional investigations on Capitol Hill.]]> Shawnee Heart Patient Sues Ephedra Supplement Maker http://www.yourlawyer.com/articles/read/7506 Thu, 29 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7506
Gerald Portillo, along with his wife, Josephine, filed the lawsuit Tuesday in U.S. District Court at Kansas City, Kan., naming Metabolife International Inc. and The Chemins Co. Inc. as defendants.

In the suit, Portillo says he suffered a heart attack on Feb. 2, 2002, after taking a recommended dosage of Metabolife 356, which contains ephedra. He was taken to Lawrence Memorial Hospital, then to University of Kansas Hospital in Kansas City, Kan., for surgery.

The lawsuit contends the defendants knew or should have known about the dangers of ephedra.

"Defendants continued to market its ephedra containing dietary supplement to (Portillo) and consumers when there were safer alternative methods and treatments," said the lawsuit.

A Metabolife representative said the company did not discuss pending litigation; a Chemins Co. representative did not return a call for comment.

The federal Food and Drug Administration in December issued a statement warning consumers to stop using or buying dietary supplements containing ephedra, a natural substance derived from plants. While ephedra was promoted as speeding up a user's metabolism and aiding weight loss, critics said it also caused heart problems and the substance was blamed for the death of Baltimore Orioles pitcher Steve Belcher in February 2003.

Portillo's lawsuit is the second against Metabolife in Kansas; the first was filed by a Shawnee County man in August.]]> Drugs Triggering Heart Problems http://www.yourlawyer.com/articles/read/7448 Tue, 20 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7448
Dr. Michael White with the University of Connecticut's School of Pharmacy wanted to find out what effect, if any, one Ephedra containing product has on the heart. His findings are reported in the latest issue of the Journal of the American Medical Association.

Dr. White said, "In this study over 53-percent of patients, when they took Metabolife 356, had an increase in their QTC interval over 30 milliseconds. That has been defined by the FDA and by the European equivalent of the FDA, as a possible risk of an arrhythmia."

The QTC interval is a measure of the time intervals that occur during the electrical impulses that generate the heart beat. An increase in QTC intervals could spell trouble for the heart.

"What it does, in effect, is it alters the electrical impulses in the heart. And by doing that, it increases the chances you could have one of these heart rhythm disturbances. And if you have one it could be very serious, it could lead to unconsciousness or even death," explained Dr. White.

Heather Sue was one of the 15 volunteers in the study. She alternated taking the dietary supplement and a sugar pill; doctors took her blood pressure and EKG regularly.

Heather Sue said, "I knew that Metabolife was a diet supplement and that a lot of people take it, I didn't know what kind of health risks would be involved. That is one of the reasons I agreed to be part of the study, just to see what the results would show."

Drug study

A recent study found that Ephedra, along with other herbal ingredients, may trigger heart problems.

The results showed there is a possible risk to the heart. That concerns Dr. White, but he isn't 100-percent sure Ephedra is the culprit.

When asked what his advice to a patient would be who wanted to take a product with Ephedra, Dr. White said, "I would have to recommend against people taking those products, until more information is known."]]> Commentary: Ephedra: One Down, More To Go http://www.yourlawyer.com/articles/read/7430 Wed, 14 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7430
In the face of growing concern, the $4 billion herbal supplement industry has been flooding the shelves of health-food stores with ephedra-free products that purport to boost athletic performance and weight loss.

Trouble is, says Woosley, "it is very likely that the substitutes for ephedra are going to be just as toxic." And without a change in the law, it would take many years for the FDA to amass enough evidence to take each one of them off the market if problems arise, just as with ephedra.

Paranoid much? Get smart about different kinds of attacks, plus keeping yourself safe and nine famous hacks.

Ephedra was banned because the active ingredient in ephedra supplements, ephedrine, causes blood pressure and heart rate to rise. Chemically similar to amphetamines, or "speed," ephedrine is used in products that have been linked to heart attacks, strokes, and deaths. Those effects are even more pronounced when combined with caffeine, yet many so-called natural dietary supplements that include ephedrine also contain the stimulant. That's one reason why over-the-counter drugs, regulated separately by the FDA, cannot combine the two.

The new products, such as Diet Fuel Ephedra Free from Twinlab Corp., Metabolife International Inc.'s Ultra, and Cytodone Technologies' Xenadrine EFX, typically substitute an herb called bitter orange. But bitter orange contains synephrine, a chemical kissing cousin of ephedrine that produces some of the same effects. Already, there are reports of adverse reactions to the new ephedra-free products, says pharmaceutical sciences professor Bill J. Gurley at the University of Arkansas. The ephedra ban is "like putting your finger in the dike when the river is overflowing," says Dr. Marvin M. Lipman, chief medical adviser for Consumers Union.

Industry representatives concede that bitter orange can raise blood pressure and heart rates, yet insist it is safe. "We have reviewed all available publications," says Metabolife spokesperson Jan Strode. "None indicate any significant side effects in normal individuals." Twinlab and Cytodyne did not return calls.

NO DATA, NO ACTION. How did we get into this mess? Blame Congress for a 1994 dietary supplement law. Makers don't have to show that a product works or that it's safe. They don't even have to report problems to the FDA, as drugmakers must. To order a product off the market, the agency must prove that it poses "imminent harm" a standard met only by a sudden, dramatic rise in injuries or deaths or "unreasonable risk." To make its case, the FDA must rely largely on doctors' or consumers' voluntary reports. But under 1% of problems are reported, and those reports are often vague.

That's why it took years for the FDA to build its case against ephedra. It had been trying to regulate the products since the mid-1990s, only to be undercut by Congress and the courts for lacking sufficient evidence. Now, the FDA has reports of more than 16,000 adverse events, including at least 155 deaths. And lab results show that ephedra can cause heartbeat changes associated with higher risk of heart attacks. Even so, there's no guarantee that the agency will win an expected court challenge, though a loss might ultimately give it more authority. "If the judge says we don't have enough evidence, it's pretty clear the FDA is out of the game and Congress has to change the law," says one top official.

With the potential threat of harm from ephedra-free products, leaving the law unchanged is too great a risk. But unless the FDA can argue that the synephrine in bitter orange is chemically close enough to ephedrine to be covered by the coming ban, the agency will find it tough to restrict. "A lot of people will die waiting to get it off the market," Woolsey says. If that happens, the ephedra ban would be little more than a hollow victory. ]]> Ephedra Found To Change Heart Rhythm http://www.yourlawyer.com/articles/read/7437 Wed, 14 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7437
The small study underscores concerns that led the Food and Drug Administration last month to announce plans to ban products that contain the herbal stimulant ephedra, including the popular diet pill made by San Diego's Metabolife International.

The ephedra ban is expected to take effect 60 days after the FDA publishes a final regulation, which is expected in coming days.

In the JAMA study, researchers tested 15 healthy volunteers to determine the effect of ephedra. When given the nation's leading ephedra diet pill, Metabolife 356, 53 percent of those tested had a noticeable change in their heart rhythm, called QT interval.

Prolonged QT intervals are linked with heart arrhythmias, and the FDA has either banned or refused to approve several drugs that stretched QT intervals past 13 milliseconds, said C. Michael White, the study's lead author and an associate professor at the University of Connecticut School of Pharmacy.

In comparison, White said Metabolife 356 increased the QT interval by 24 milliseconds, similar to medicines such as Seldane, a prescription allergy drug taken off the market in 1997 because of reports of fatal cardiac arrhythmias.

Metabolife said in a written statement yesterday that its products are safe and effective when used as directed. The company suspended sales of its ephedra products in November but continues to market an ephedra-free pill.

"Today's article seems to be nothing more than a case of researchers making questionable data leaps to jump on the anti-ephedra bandwagon," Metabolife said.

Last year, the Rand Corp. reviewed several clinical studies on ephedra, many sponsored by the ephedra industry. The Santa Monica think-tank concluded that the available scientific evidence suggested a link between ephedra products and serious side effects, but said the quantity and quality of the research fell short of scientific proof.

There have been about 16,000 consumer complaints and 155 deaths linked to patients who took ephedra supplements, White said.

White said his study was modeled on the single-dose safety studies required by the FDA for prescription drugs. He said such studies, which are relatively inexpensive and of short duration, should be done on herbal supplements to provide initial safety information.

"There are herbals touted as doing this or that, but if they increase the QT interval and blood pressure, that is probably information that patients should know," said White.

White said his research group will soon launch another safety study to test Metabolife's ephedra-free diet pill, with results expected in November.

Some consumer advocates and medical experts warn that the new generation of ephedra-free diet pills offered by supplement companies have not been properly tested for safety or benefit, and could pose problems similar to ephedra.

Under federal law, supplement companies are not required to test their products before they market them or to report suspected incidents of deaths or side-effects to government regulators. ]]> FDA Seeks Ban On Dietary Supplement Ephedra http://www.yourlawyer.com/articles/read/7311 Tue, 30 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7311
Health and Human Services Secretary Tommy Thompson says the ruling comes after at least 16,000 reports of adverse effects related to ephedra. Figures show ephedra accounts for seven percent of dietary supplement sales, and had about $1.4 billion in sales last year.

But ephedra has had problems. In 1997 the FDA proposed warning labels on ephedra and dosage limits, but the proposal was later withdrawn. In 2001, the NFL banned ephedra.

In early 2003, the FDA once again proposed warning labels after ephedra use was linked to the death of Baltimore Orioles pitcher Steve Bechler.

Then Tuesday, in an unprecedented move, the FDA announces a ban of ephedra.

Manufacturers insist ephedra is safe when used correctly, which is the operative phrase here. They say problems happen when people use the drug incorrectly, wrongly thinking if one pill helps them lose weight or run faster, two pills would work even better.

In a statement one company, Metabolife, said theFDA's science actually supports the safety of ephedra. Metabolife says it will decide whether to challenge the ban, after it becomes final.

Ephedra speeds up the body's metabolism and has been linked to heart problems, strokes, seizures, psychiatric problems and about a hundred deaths. The FDA found it to be a significant and unreasonable threat, which is what it takes for the government to ban a dietary supplement.

John Honnigford, MD says, "I think it's a bold move by the FDA, and one that I applaud them for. They generally do not venture into the world of these non-prescription medications which are closer to food products, these herbal supplements. They're not regulated by the FDA, and I think it was a very bold venture for them to limit this medication."

The FDA says a final rule banning all products containing ephedra, will come in 60 days.

But Secretary Thompson says the time to stop using ephedra is now. ]]> FDA Considering Banning Diet Supplement Ephedra http://www.yourlawyer.com/articles/read/6355 Fri, 25 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6355
The FDA in February ordered labels to be put on products with ephedra warning of the possibility of heart attacks, strokes or death. The move came two weeks after the death of 23-year-old Baltimore Orioles pitcher Steve Bechler, who was taking a supplement containing ephedra.

Under pointed questioning from House members, FDA Commissioner Mark McClellan said Thursday the agency is looking at taking stiffer action.

"A ban on ephedra use is in the range of options we are considering," he said.

A 1994 law left dietary supplements largely unregulated. The statute requires the FDA to prove a dietary supplement is harmful rather than having the manufacturer prove it is safe, as with drugs.

McClellan said the agency has new evidence, including studies on the herb and health complaints submitted to companies that use it in their products, that may support a ban under the law.

On Wednesday, Health and Human Services Secretary Tommy Thompson said makers of dietary supplements should have to tell the FDA about potential side effects, as do drug-makers. He urged Congress to revise the 1994 law.

During two days of hearings, lawmakers heard from scientists, health officials, the parents of two people who died after taking ephedra, representatives of pro sports leagues and players, and officials from companies that make products with ephedra.

The head of the major league baseball players' union told lawmakers Thursday that the sport should not ban dietary supplements containing ephedra unless the government does.

"The position of the players' association has long been that players should not be prohibited from using any substances that the United States government has effectively determined are not unsafe for consumption by other American consumers," said Eugene Orza, associate general counsel of the Major League Baseball Players Association.

The issue is particularly relevant to baseball because of Bechler's death, after which commissioner Bud Selig banned players with minor league contracts from taking ephedra.

After the hearing Thursday, Selig issued a statement urging Congress to regulate ephedra and to re-examine the 1994 law. "The proper venue for the regulation of these dangerous supplements is in Congress," he said.

Other sports leagues do ban ephedra and test players to make sure they are not using the product. They include the NFL and MLS, both of which sent representatives to Thursday's hearing.

Orza said that a ban on ephedra would violate players' privacy rights, since they would be subject to random drug testing.

But several lawmakers criticized the union's stance, saying baseball could act long before Congress does.

"It's going to take a long time to legislate this. It always does," said Rep. Cliff Stearns, R-Fla., chairman of the commerce subcommittee. "You in the private sector have the opportunity to act much, much more quickly than that. I don't know why you're not rushing to get rid of it."

The head of a trade group representing makers of dietary supplements questioned the need for the hearings.

"A wealth of scientific information, expert testimony and consumer input already exists, including reports commissioned by the FDA itself, that the agency can use to determine once and for all whether ephedra presents a hazard to public health," said David R. Seckman, executive director of the National Nutritional Foods Association.

"Whatever the FDA's ultimate decision on ephedra, we urge the agency to utilize its powers for a swift regulatory resolution that will put this debate to rest and make hearings such as these unnecessary."

On Wednesday, three past or present Metabolife International officials took the Fifth Amendment and declined to testify. The San Diego-based company makes supplements that include ephedra.

The Justice Department is investigating whether the company lied about ephedra's safety. The president of the company in 1998 told the FDA the firm never received any consumer complaints of serious side effects, but later turned over more than 14,000 records of calls from ephedra consumers with concerns about health-related issues. ]]> House Panel Hears Testimony on Ephedra http://www.yourlawyer.com/articles/read/6337 Thu, 24 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6337
Congress should rewrite a law that rolled back dietary-supplement regulations and require manufacturers to acknowledge potential side effects, Health and Human Services Secretary Tommy Thompson said Wednesday.

Thompson's comments came as the House Energy and Commerce oversight subcommittee opened two days of hearings on the supplements, with a particular focus on ephedra, often promoted as a weight-loss product. Ephedra has been linked to as many as 100 deaths.

Ernie and Pat Bechler, the parents of Baltimore Orioles pitcher Steve Bechler, were among those who testified. Their son died during spring training last February. He had been trying to lose weight, and toxicology tests after his death showed ephedra in his system.

Kevin Riggins, whose 16-year-old son, Sean, died of a heart attack after taking ephedra, also testified.

"How many Steve Bechlers or Sean Rigginses have to die to prove that these are not safe?" Mrs. Bechler said, sitting behind a framed picture of her son in his Orioles uniform, her voice cracking. "We need to get this off the market. We need to help our children."

Executives of several companies that make ephedra-based products say that studies have proven that they are safe when used properly.

"Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products," said Russell Schreck, chief executive officer of San Diego-based nutritional supplement-maker Metabolife International. "We make it quite clear on our label that the ephedra products are not to be sold or used by minors and that customers with certain pre-existing medical conditions should 'consult a physician before product use.' "

But several scientists said that it was impossible to prove whether ephedra was safe because studies screen out participants who have health problems the people most likely to be hurt by the product.

The General Accounting Office, Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.

Marcia Crosse, the GAO's acting director of health care-public health and science issues, said the health problems reported to Metabolife included heart attacks, strokes and seizures. Five deaths also were reported.

Crosse said the problems reported to Metabolife "are consistent with the types of adverse events reported to FDA and with the documented physiological effects of ephedra." The records of calls to Metabolife, she said, "contain reports of serious adverse effects in consumers who were young and among those who used the product within the recommended guidelines."

Crosse also noted the Food and Drug Administration has received more reports of problems from ephedra than from any other supplement.

A 1994 law left dietary supplements largely unregulated. The FDA has said the statute prevents it from banning such products.

Thompson said makers of dietary supplements should have to tell the FDA about potential side effects, just as drug makers do. He urged Congress to revise the 1994 law.

"FDA is somewhat hampered," Thompson said. "We are unable to really do as effective a job as possible."

A subcommittee member, Rep. Greg Walden, R-Ore., has co-sponsored legislation to amend the law.

"I don't think that the FDA is properly equipped to quickly deal with an issue of this magnitude," Walden said. "While somebody does a study to figure out if something is safe or not, we let people get injured before we decide to act. The burden of proof should be on the manufacturer, not the consumers who suffer stroke, heart attacks and death, all of which is associated with these ephedra-based products."

Rep. Henry Waxman, D-Calif., a member of the subcommittee, said he favors changing the law.

"They claim they don't have sufficient legal authority," Waxman said of the FDA. "That may be an excuse, and I don't want them to have the excuse."]]> Congress Investigates Ephedra http://www.yourlawyer.com/articles/read/6338 Thu, 24 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6338
The Bush administration joined the call. Health and Human Services Secretary Tommy G. Thompson said the Food and Drug Administration is "somewhat hampered" by a 1994 law that leaves dietary supplements largely unregulated.

Speaking at the first of two days of hearings on the dietary supplement ephedra, House Energy and Commerce Committee Chairman W.J. "Billy" Tauzin, R-La., said, "If [manufacturers] don't clean up their act, I can promise you we will." Ephedra has millions of users, especially among young people seeking to lose weight or build muscle.

The committee is scheduled to hear today from FDA Commissioner Mark B. McClellan, who in a July 14 internal memo said his agency is pursuing "significant new enforcement actions."

The FDA earlier this year called for stronger warning labels on products containing ephedra, and McClellan is expected to amplify on his plans during his testimony.

Several committee members criticized the FDA Wednesday, saying it has not been aggressive enough in protecting consumers from the side effects of ephedra, which range from nausea to strokes to death.

But others, reflecting Thompson's view, said the 1994 law makes it difficult for the FDA to remove dietary supplements from the market, even if they are considered dangerous. "At best, the FDA has a dull set of instruments to work with," said Rep. Greg Walden, R-Ore.

Rep. John D. Dingell, D-Pa., found many to blame. "I believe that because of a combination of weak statutory language, clever uncovering of legal loopholes and shoddy enforcement, the law cannot adequately protect the public from these modern-day patent medicine peddlers," Dingell said.

Despite a barrage of criticism, ephedra manufacturers defended their product. "The overwhelming scientific evidence is that ephedra is safe and effective when used as directed," said Robert Occhifinto, president of NVE Pharmaceuticals in New Jersey.

Ernie and Pat Bechler of Medford, Ore., sharply disagreed. Their 23-year-old son Steve died earlier this year at the Baltimore Orioles spring training camp. Belcher's death, which has been linked to ephedra, sparked the congressional inquiry.

Wiping tears from her eyes, Pat Belcher told the committee, "They lied to our son about this product being safe."

"They took our pride and joy from us and his wife and baby," Pat Belcher continued. "We need to get this off the market."

Rep. James Greenwood, R-Pa., who presided over Wednesday's hearing, assured the Belchers, "We would not bring you here unless we intended to take this very seriously."

Robert Hermann, vice president of Metabolife International of California, one of the nation's largest ephedra manufacturers, said his company does not oppose "reasonable regulation" of dietary supplements. But he added, "We ask only that it be granted in the rigors of clinical evidence, rather than the hearsay of anecdotal reports."

Three other current or former

At least two experts said that some studies ephedra manufacturers have used are not grounded in sound science.

"However, on close examination, serious questions have been raised about the conduct and results of these studies," Greenwood said. "For example, certain e-mails we've uncovered appear to indicate that one ephedra manufacturer was trying to influence the work of one of its researchers to make the study more marketable."

Marcia Crosse, acting director for public health issues at the General Accounting Office, the investigative arm of Congress, told the committee that FDA records indicate the agency has received 15 times more complaints about ephedra than any other dietary supplement.

"While it is difficult to establish with certainty that a particular adverse event has been caused by ephedra," Crosse said, the FDA has concluded that supplements containing ephedra "pose a significant public health threat." ]]> Newton Firm Never Tested Supplements, Exec Says http://www.yourlawyer.com/articles/read/6341 Thu, 24 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6341
Robert Occhifinto, president of NVE Pharmaceuticals in Newton, testified yesterday the company had not used medical professionals in the formulation of supplements containing the controversial herb ephedra. He also acknowledged serving sentences for two criminal offenses once for money laundering and another time for his dealings involving the illegal drug hashish.

NVE, meanwhile, is under investigation by the Food and Drug Administration for adding a prescription male potency substance to an over-the-counter dietary supplement, he said.

The executive appeared under oath before a House Energy and Commerce subcommittee investigating health risks associated with ephedra. The insights into the operations of the Sussex County company and its president come amid increasing scrutiny of the largely unregulated world of dietary supplements.

The subcommittee heard a defense of ephedra products from the founder of Cytodyne Technologies of Manasquan, now known as Nutraquest, and from executives of Metabolife International of California. Three former Metabolife officials refused to testify, invoking their Fifth Amendment right against self-incrimination.

Derived from the Chinese herb Ma Huang, ephedra is an adrenaline-like stimulant that affects the heart and central nervous system. Supplements containing ephedra have been marketed as weight-loss aids, energy boosters and sports performance enhancers claims some experts question.

The FDA has warned ephedra- based products pose "significant and unreasonable" health risks, including heart attacks, strokes and death, and the agency is examining ways to impose new restrictions on the supplements.

An ephedra-based diet pill made by Cytodyne was named by officials as a factor in the death of a Baltimore Orioles pitcher in February. The state of New Jersey has sued Cytodyne for making false claims regarding the supplement and a successor that does not contain ephedra. Cytodyne said yesterday the death of Steve Bechler had nothing to do with ephedra.

In 1994 Congress largely deregulated the dietary supplement industry, making it difficult for the FDA to pull products off the market. A number of companies have been charged with making misleading claims and dozens of personal injury lawsuits have been filed against supplement makers.

One of those lawsuits was filed by the parents of Sean Riggins, a 16-year-old high school athlete from Lincoln, Ill., who died of a heart attack while using Yellow Jacket, an ephedra supplement made by NVE Pharmaceuticals.

The company denies responsibility for the teen's death and is contesting the lawsuit. But Riggins' father, Kevin Riggins, told the House panel yesterday that ephedra products "are a poison that killed my son."

"The majority of companies in my opinion are illegitimate companies no more than drug pushers, because they are marketing a deadly substance and they don't care."

Occhifinto, in his prepared testimony, said: "I strongly believe in the safety and effectiveness of NVE's products. The overwhelming scientific evidence is that ephedra is safe and effective when used as directed."

The New Jersey executive also maintained the safety record of ephedra is "comparable and in some cases better than that of many over-the-counter pharmaceutical products."

But in a questionnaire he filled out for the subcommittee, Occhifinto was asked whether his company conducted studies on any NVE product including more than 80 containing ephedra. He answered "no."

Occhifinto, a high school graduate, was asked during the hearing whether he ever hired a medical professional or pharmacologist to formulate his products. He said he had not. Even though he lacks education or training, he said he was responsible for deciding the composition of scores of dietary supplements.

Rep. James Greenwood (R-Pa.), chairman of the subcommittee, expressed outrage at the testimony. He noted that after Riggins died and NVE pulled one ephedra product off the market, Occhifinto "changed the formulation of the product by increasing the amount of ephedrine and changing the name, without consulting any scientific or health experts."]]> House Panel Threatens To Subpoena Metabolife Execs http://www.yourlawyer.com/articles/read/6273 Thu, 10 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6273
House Energy and Commerce Committee Chairman Billy Tauzin, R-La., signed the subpoenas for the testimony or appearance of Metabolife founder and co-owner Michael Ellis; board member and former chief executive David Brown; and Daniel Rodriguez, described by the committee as "a nurse who oversees Metabolife's call complaint office," said committee spokesman Ken Johnson.

"The subpoenas will be issued as soon as possible," Johnson said. "They have been uncooperative with our investigators and unwilling to testify publicly. That certainly raises some serious questions in our minds."

Metabolife spokeswoman Jan Strode said "senior officials," including new Chief Executive Officer Russell Schreck, would testify at an Energy and Commerce subcommittee hearing on ephedra scheduled for July 23.

"The company has cooperated with the committee and looks forward to presenting its views to the Congress," Strode said in a written statement. "Metabolife will continue to make appropriate company officials available for congressional testimony."

But Johnson said: "No one from the company has agreed to testify. Everyone else we've asked has, but no one from Metabolife, which has forced us to take a hard line."

Metabolife, which makes the popular ephedra-containing dietary supplement Metabolife 356, is one of several companies that have come under scrutiny by the committee. It is investigating ephedra following numerous deaths and thousands of health complaints linked to the largely unregulated substance.

The committee has also sought documents and testimony from representatives of professional sports leagues, citing the death earlier this year of Baltimore Orioles pitcher Steve Bechler. Ephedra, which is marketed as an energy booster and diet aid, was a contributing factor to Bechler's heatstroke, according to a Florida medical examiner.

The subcommittee plans to examine use of ephedra in the sports world at a July 24 hearing.

Rep. James C. Greenwood, R-Pa., who chairs the subcommittee on oversight and investigations, sent letters to 13 individuals earlier this month asking them to confirm that they would appear voluntarily to testify and answer questions about ephedra.

Ellis, Brown and Rodriguez "have sent written responses through their respective counsels declining the invitation to testify at the July 23 hearing at this time," said Rep. Greg Walden, R-Ore., who made the motion to authorize the subpoenas. The motion passed unanimously.

Johnson said the committee has gathered thousands of ephedra-related documents from supplement makers, sports leagues and the Food and Drug Administration.

Under significant pressure to act after Bechler's death, the FDA in February proposed stronger warning labels for ephedra products and said it would consider other regulatory steps, including an outright sales ban.

The House committee also launched its investigation in February.

"Clearly we're concerned about the growing number of deaths across America linked to ephedra usage," Johnson said.

The FDA claims that efforts to regulate ephedra have been hampered by a 1994 law that subjects herbal dietary supplements to far less federal scrutiny than pharmaceuticals. But critics say there is more than enough evidence to support a ban on ephedra and that federal officials have failed to act because of the industry's political clout, fueled by campaign contributions.

The industry counters that its products are safe if used as directed.

Metabolife spokeswoman Strode said the company would "present a compelling case in favor of dietary supplements and their use before Congress."

"Metabolife supports consumer choice based on strong, science-based labels about the appropriate use of its products," she said. "Metabolife has consistently supported regulatory measures to bar the inappropriate marketing of ephedra products, including prohibitions on sale of products to minors or for inappropriate purposes." ]]> Blagojevich Takes Care of Ephedra http://www.yourlawyer.com/articles/read/6016 Thu, 29 May 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6016
Both houses of the Illinois legislature unanimously supported the ban of the dietary supplement, which has been linked to over 100 deaths.

Have you ever taken a product containing ephedrine? This nutritional supplement can be quiet tempting, as it claims to safely help you lose weight and/or improve athletic performance.

Ephedra use has surged in the last decade, primarily because of the Dietary Supplement Health and Education Act (DSHEA) of 1994, which allows supplements to be sold as foods, not drugs.

These days, ephedra is being blamed for countless heart attacks, strokes, and over 100 deaths, including that of Baltimore Orioles pitcher Steve Bechler. Bechler's death has been associated with Xenadrine RFA-1, an over the counter diet supplement. Last year, six plaintiffs were awarded $4 million in damages in a verdict against leading ephedra manufacturer Metabolife. Clearly, the Food and Drug Administration (FDA) has fallen under great pressure to ban this herb and better educate the public on its potential health risks. To arm yourself, read the following information on the effects of ephedra.

You may be wondering what ephedra is. It refers to several related species of herbs that grow in the desert. The prime ingredient is an alkaloid called ephedrine. When ephedrine is chemically synthesized, it turns into pseudephedrine, which is a less potent decongestant found in many over the counter cold/allergy medications that is regulated as a drug.

You are probably curious about how the herb works. Ephedra works like a stimulant in that it stimulates the thyroid gland (that regulates metabolism), elevates blood pressure, constricts blood vessels, raises heart rate and body temperature, and suppresses appetite. One recent study also found it to cause heart palpitations, tremors, insomnia, upper gastrointestinal effects, and psychotic episodes, especially when combined with other stimulants.

In a lot of ways, ephedra imitates the effects of exercise in relation to heat production. It causes the heart to work harder. This spelled out disaster for Steve Bechler, who had a history of heart/liver problems, especially when he further intensified the stress to his body by working out in a rubber suit in the hot Florida sun.

As stated earlier, ephedra use has soared in recent years. While the International Olympic Committee, the NCAA and the NFL have banned it, the herb seems to be commonplace among athletes at all levels, both professional and amateur, from high-school age to college on up. Popularity of ephedra is in part due to the immense marketing efforts that promise weight loss and performance enhancement. Everyone is quick to jump on a product that is going to make losing weight easier or give him or her a competitive edge.

But does it work? Makers of the product are quick to cite studies of people who lose more weight while using it than those who don't. As with most stimulants, the boost in metabolism can lead to an increased caloric burn that results in weight loss. Improved performance claims however, are much weaker, with results demonstrating that athletes only improve their perception of their performance, not the actual results.

More importantly, is it safe? That depends on a number of factors including the amount of ephedra in the supplement, dosage, combinations of other supplements, and your personal health. Persons suffering from heart disease, hypertension, and thyroid disease should never take products containing ephedra. Interestingly, most government officials and scientists agree that it is dangerous enough to be regulated like a drug. Because of the DSHEA ruling, supplements don't have to meet standards for purity, content, and labeling and be proven safe before being introduced to the general public like drugs do.

Consider the fact that recent data from poison control centers revealed that 64 percent of all the negative events from herbal products in the U.S. resulted from ephedra, even though they represent less than 1 percent of sales. Adverse effects may be greatly underestimated because unlike drug manufacturers, supplement makers aren't required to report these occurrences to the FDA.

What's frightening is that kids often think that if a little bit is good for losing weight or improving performance, then more will be better. This, coupled with the fact that it's not being tested for makes it all the more appealing.

When it comes to losing weight and gaining that competitive edge, there's no magic pill. Good old-fashioned hard work and commitment still seems to be the safest, most successful way to go.]]> Metabolife, Rexall Are Sued Over Supplement Ephedra http://www.yourlawyer.com/articles/read/5932 Wed, 14 May 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5932
While individuals have sued makers of the diet-loss supplement, attorney Kenneth B. Moll said the suit filed today in federal court in Chicago is the first that seeks to represent all U.S. consumers injured by ephedra. Moll said the proposed class- action lawsuit may attract millions of plaintiffs and cost defendants hundreds of millions of dollars.

Demand for ephedra, which some athletes use to boost energy and enhance performance, is falling after the compound was linked to the February death of 23-year-old Baltimore Orioles pitcher Steve Bechler. The U.S. Health and Human Services Department has said it wants to add restrictions on ephedra and possibly ban it.

"We think it's time to pull it from the market," said Moll, who is working on the case with other lawyers. "It's time to get this off the shelves."

The suit asks that a judge recall ephedra-based products, force companies to stop making and selling them and require that the public be informed of ephedra-related complications. Moll also is seeking compensation for alleged victims, a fund for medical monitoring and reimbursement for consumers who bought the supplement.

Illnesses Claimed

The suit was filed on behalf of Jacquelyn Castillo, Greg Van Buren and Jayne A. Burleson. Castillo, of Texas, had a seizure as result of taking ephedra dietary products, the suit said. Van Buren, also of Texas, suffered heart complications and Burleson, of Indiana, experienced heart palpitations and anxiety, the suit said.

Twinlab Corp.'s Twin Laboratories is among the defendants named in the suit in addition to San Diego-based Metabolife and Boca Raton, Florida-based Rexall, a subsidiary of the Dutch company Royal Numico NV.

Metabolife spokeswoman Jan Strode and Rexall spokeswoman Carol Walters said the companies don't comment on pending litigation. Bill Rizzardi, a spokesman for Hauppauge, New York- based Twinlab, didn't immediately return phone calls seeking comment.

Twinlab said in a 2002 regulatory filing that it would stop selling ephedra-based products on March 31.

General Nutrition Cos., the largest U.S. chain of vitamin stores and another Numico subsidiary, announced May 2 that it won't sell products containing ephedra. GNC said demand for ephedra products, which accounted for 40 percent of fourth-quarter revenue, has fallen. Sales of the product are no longer significant, the company said.

Ancient Chinese Medication

Ephedra, also known as Ma Huang, has been used in medicines in China for more than 5,000 years. Ephedrine, an extract of the shrub-like plant, can cause elevated blood pressure, rapid heart beat, vomiting and other side-effects when used improperly, GNC said on its Web site.

The U.S. Food and Drug Association said in March it would require makers of dietary supplements to list all ingredients, after an increase in reports of deaths and illness linked to the products.

Major League Baseball told athletes to avoid using the stimulant after Bechler died of heatstroke. The National Football League and National Collegiate Athletic Association have banned use of ephedra, as has Suffolk County, New York.

The suit filed in Chicago said products such as Metabolife, MetaboLift, Hydroxycut, Herbalife, Herbalite, Stackers, Ripped Fuel and Extreme Ripped Force should be banned.

Other defendants include American Bodybuilding, WH Holdings Ltd.'s Herbalife International Inc., Trimspa, Next Proteins Inc., Syntrax Innovations Inc., PDK Labs Inc., Bioplex Nutrition Inc., Mega Pro International, Natural Balance, MuscleTech, Cytodyne Technologies, NVE Pharmaceuticals and EAS.]]> Metabolife Linked To 92 Serious Complaints http://www.yourlawyer.com/articles/read/5739 Thu, 01 May 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5739
But congressional investigators stressed that the existence of thousands of consumer complaints about the San Diego company's popular ephedra product, Metabolife 356, doesn't prove the herbal stimulant caused the health problems.

In a review of 14,684 complaints turned over by Metabolife to the Justice Department, GAO investigators found reports of five deaths, 18 heart attacks, 26 strokes, and 43 seizures. Other problems included significant elevation in blood pressure, abnormal heart rhythm and loss of consciousness.

The GAO, the investigative arm of Congress, noted that the "inherent" limitations of such complaints, combined with Metabolife's "incomplete" record-keeping, made it difficult to determine cause and effect.

The Food and Drug Administration, which in March announced a proposal to put warning labels on ephedra products, said consumer complaints, known as adverse events, can establish cause when supported by evidence such as medical documents.

"Today's report does nothing to change FDA's heightened concern that dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury," the agency said yesterday.

As with previous studies of Metabolife's consumer complaints, the GAO report took aim at the company's record-keeping. While consumer complaints aren't sufficient on their own to establish that a product causes a problem, GAO investigators said they "signal potential health problems that deserve investigation."

Metabolife's records, however, were "difficult to understand, and consumer information was not consistently recorded," the GAO report said. In some cases, the evidence for a report of an adverse event was limited to a single word on the record, and most call records did not contain complete information about potentially relevant items.

Though the report does not paint a flattering picture of Metabolife's handling or investigation of consumer health complaints, the company yesterday said it is "pleased" that the GAO said it couldn't establish that any of the adverse events were caused by Metabolife 356.

"Metabolife reaffirms its position that the 20 years of clinical studies support that ephedrine-containing products such as Metabolife 356 are safe and effective when used as directed," the company said in a written statement.

Congressman Dan Burton, R-Ind., who requested the GAO report, said the findings show that the government needs to set up a tracking system for consumer complaints of any dietary supplement.

He also construed the GAO report as proof that ephedra products are safe a conclusion the report does not reach.

Burton, a longtime supporter of the dietary supplement industry, has received generous campaign contributions from companies that make ephedra products, including $13,000 from Metabolife; its founder, Michael Ellis; and Ellis' wife, Monica.

"Individual consumers can assume, according to the findings of this report, that when used properly, according to the product label recommendations, and under the supervision of their physician, dietary supplements containing ephedra are safe for consumer usage," Burton said.

Ephedra critics, who have called on the FDA to ban ephedra products, said Burton's remarks indicate a "complete disconnect" from reality.

"Burton is saying there may or may not have been a crime committed because no one was there to see it happen," said Joe Shoemaker, a spokesman for Sen. Richard Durbin, D-Ill., who has introduced legislation that would require companies to prove their ephedra products are safe before selling them. "We're saying there are 15,000 clues here that something went seriously wrong."

Dr. Sidney Wolfe, a spokesman for Public Citizen, a Washington, D.C., consumer watchdog group that has also called for a ban on ephedra, said Burton should "spend as much energy trying to understand what is going on as he does trying to protect Metabolife and the rest of the ephedra industry.

"Ephedra is not safe, and the GAO report doesn't say it is safe," Wolfe said. "The main thing that comes out of this report is that Metabolife never tried to follow up on complaints of serious problems, which is why there isn't more information about them." ]]> Athletes Sue Over Ephedra http://www.yourlawyer.com/articles/read/5553 Thu, 10 Apr 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5553
The lawsuit by Jahn Bernard Smith is one of 15 filed Wednesday by a group of Houston attorneys.

In December 2001, at age 22, Smith suffered a heart attack, kidney failure and liver damage, and doctors could not understand why.

"They asked me if I took cocaine," said Smith, who also played at the University of Texas. "I've never taken any kind of drugs, not even alcohol."

Smith didn't suspect the herbal stimulant ephedra might have been a factor until the death of Baltimore Orioles pitcher Steve Bechler in February. Last month, a Florida coroner said Bechler's use of ephedra helped cause his fatal heatstroke.

That eventually led Smith to file a lawsuit in Montgomery County against dietary supplement maker Twin Laboratories Inc.

On Wednesday, state court lawsuits were filed in Montgomery, Tarrant, Dallas, Van Zandt, Hidalgo, Jefferson, Palo Pinto and Titus counties, as well as in Bernalillo County, N.M., and Los Angeles. The Houston lawyers previously have filed one lawsuit each in state court in Houston and federal court in Georgia.

"This is a bad product that has hurt a lot of people," said Tommy Fibich, whose law firm filed the lawsuits.

Some of the lawsuits were filed by people claiming ephedra-related injuries and others by family members of ephedra users who died from strokes, heart attacks or other medical problems.

Young athletes like Smith used ephedra as an energy boost to enhance workouts. Others used ephedra in weight-loss products like Metabolife, also included in the lawsuits.

The lawsuits are requesting unspecified monetary damages, Fibich said.

A corporate spokesman for Hauppage, N.Y.-based Twin Laboratories said he could not comment on Smith's lawsuit because he hadn't seen it, but added that the product in question Ripped Fuel was "safe and effective when taken according to instructions."

The lawsuits also targeted San Diego-based Metabolife International; Century City, Calif.-based Herbalife International; Cytodyne Technologies Inc.; and Zoetermeer, Netherlands-based Royal Numico NV, which faces lawsuits both as a maker of products under the Rexall Sundown brand and as a retailer at General Nutrition Center stores. Wal-Mart and a number of smaller retailers also are named in several suits.

During a news conference Wednesday, attorneys played videotaped depositions of Metabolife Vice President Robert Herrmann and founder Michael Ellis.

Herrmann, who said he had taken his company's products without consulting a physician, was asked to read the warning label on a bottle of Metabolife 356.

"I can't see it. I cannot read this small a font," Herrmann said, later explaining his laser eye surgery made it difficult to read small, all-capital letters. Using reading glasses provided by Fibich, Herrmann managed to read the instructions, which included a warning not to use the products without first consulting a doctor.

Ellis refused to answer questions based on his "privilege against self-incrimination."

Many makers of ephedrine-based diet aids have switched to non-ephedrine formulas in recent months as debate over the substance, which is not regulated by the Food and Drug Administration, has intensified. Twin Laboratories' Chief Executive Ross Blechman said last November that the company's change in formulas was a "sound business decision in the current climate of escalating insurance costs, and regulatory uncertainties."

Last week, the American Heart Association joined several consumer groups in calling for a ban on all ephedra-based supplements. ]]> Supplements Making Inroads In High Schools http://www.yourlawyer.com/articles/read/3732 Tue, 17 Dec 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3732
At 5 feet 6 inches and 210 pounds, Seeberger, 17, is a fireplug. He's a senior at Columbia High School, where he's a running back and linebacker. He bears little resemblance to the once somewhat pudgy 160-pounder who hardly looked suited for football as a freshman.

Seeberger is not unlike scores of teens across the country who are building better bodies by entering the world of sports nutritional supplements. It's a $1.6 billion-a-year industry that sells products that can be harmful, even deadly.

One million American youths between the ages of 12 and 17 are estimated to have used nutritional supplements, according to a survey conducted last year by the Blue Cross and Blue Shield Association's Healthy Competition Foundation. The survey found that 96 percent of the youths who used supplements were aware of the associated health risks.

Supporters tout nutritional supplements as safe and effective when used properly, even though the long-term effects aren't known. Sales of one popular supplement, creatine have grown by 730 percent since 1995.

Nutritional supplements include everything from protein shakes and bars to products that contain harder-edged substances such as androstenedione and ephedra.

"It's not just the athletes," said Ron Annis, Columbia High's trainer. "The ones walking around the halls take [supplements] for self-esteem and body image."

No FDA regulation

Nutritional supplements are not regulated by the Food and Drug Administration and are available to anyone at nutrition stores, supermarkets, drug stores and on the Internet.

Supplements can vary widely in purity and in the amount of active ingredients they contain. Moreover, manufacturers can make health claims that aren't supported by studies proving the products safe or effective.

If anabolic steroids are the biggest danger in a young athlete's development, then supplements are the red alert.

FDA spokeswoman Monica Revelle said supplements can pose dangerous health risks if taken by someone with a pre-existing condition such as heart disease.

"Our general advice to all consumers is that they consult with their healthcare professional before taking any nutritional supplements," Revelle said.

Despite being in a school weight lifting program that discourages the use of supplements, Seeberger said he said he likes using them and hasn't been hurt by them.

"The program helps, but I'm into lifting so much, it makes me feel a lot better when I do that stuff," Seeberger said of supplements. "I mean, you could be driving and get killed by a drunk driver. It's not a factor to me. I've had no ill effects from it."

For Seeberger, the decision to use supplements was simple: He wanted to get bigger. He started lifting in the ninth grade and gained 55 pounds by the beginning of this school year. His favorite supplement is Cell-Tech, a creatine powder that claims to help build muscle. It comes in one-gallon vats that last about a month and sell for $63.

Seeberger mixes a couple of spoonfuls with water and drinks the concoction before he hits the weight room.

"I've used powder, the pills, the liquids. It gets me fired up," said Seeberger, who wants to play college football.

Creatine is a substance Mark McGwire and fellow power-hitters Barry Bonds and Sammy Sosa have acknowledged using. It is a naturally occurring amino acid taken in concentrated form, and is reputed to briefly increase strength and power.

Associations concerned

The New York State Public High School Athletic Association has no written policy on the use of nutritional supplements, but in the past five years the subject has been included in its annual chemical health program for coaches. Previously, the program was limited to tobacco, alcohol and illegal drugs.

The National Federation of State High School Associations does not ban supplements, but acknowledged last month the "continued widespread use" of them and reiterated its 1998 stance against the improper use of the products. The organization said physicians should be consulted first and that "coaches and school staff should not recommend or supply any supplement product to student-athletes."

Walter Eaton, assistant director of the New York State Public High School Athletic Association, agreed supplements are a national issue.

"To what extent it is being used we can't be certain, but we know it's a problem and do fear the worst," Eaton said.

Androstenedione, commonly known as "andro," gained national prominence in 1998 when the Cardinals' McGwire acknowledged using the over-the-counter substance when he hit a then-major league record 70 home runs.

Andro, which many athletes believe increases the body's production of muscle-building hormones such as testosterone and human growth hormone, is sold under brand names like 3-Andro Xtreme, Andro-Gen, Andro-Stack and Animal Stak.

Considered a precursor to steroids, which are illegal in the United States unless prescribed by a physician, andro is banned by the International Olympic Committee, the National Football League and the National Collegiate Athletic Association.

Deadly consequences

Ephedra, meanwhile, can be deadly. Two years ago, an analysis in the New England Journal of Medicine attributed at least 54 deaths to the substance since the mid-1990s.

The FDA leaves the policing of supplements up to manufacturers, and has received 1,400 ephedra-related complaints since 1984. The NFL, NCAA and IOC also have banned ephedra.

Wes Siegner, a lawyer for the Ephedra Education Council in Washington, D.C., said manufacturers would support laws prohibiting the sale of ephedra to minors and would welcome an independent government study into its safety.

Siegner said that though no negative effects have shown up in studies conducted by manufacturers involving hundreds of ephedra users, consumer groups doubt the validity of such research.

Ephedra, a Chinese herb, is a stimulant that supporters claim boosts energy, although it is marketed mainly for weight loss.

"Our studies show there are no problems if it is taken as directed for overweight problems by otherwise healthy adults," Siegner said. "Minors shouldn't be taking it or making decisions about losing weight without the supervision of their doctor and their parents."

A watershed moment for the supplement industry, which has a powerful lobby in Washington, came in 1994 when Congress passed the Dietary Supplement Health and Education Act. The law differentiated nutritional supplements from food and drugs.

While the law set rules about what can be said about supplements in promotional materials and established standards for labeling, it meant the products could not be regulated by the FDA.

"Nutritional supplements can make all the claims they want with no backing of scientific studies," said Dr. Bruce Dick, an orthopedic surgeon and specialist in sports medicine at Albany Medical Center.

Dick has a blunt warning about ephedra in particular.

"It kills people," he said. "It has an association with cardiac problems."]]> More Than 30 Army Deaths Attributed To Ephedra http://www.yourlawyer.com/articles/read/3734 Fri, 06 Dec 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3734
Soldiers were taking ephedra on their own as an "all-natural" way to get an edge in their physical training. But military doctors became alarmed when a rash of healthy young men some in their early 20's began dropping dead, all of them using ephedra products.

Not waiting for a ruling from the FDA, who has been debating ephedra's safety for years, Army leaders have taken action to remove all ephedra products from their bases.

What is Ephedra?

Ephedra is a readily available and legal herbal supplement. And because it is classified as an "herb" it is perceived to be innocuous and doesn't fall under the much tighter scrutiny by the FDA that synthetic drugs do.

Although its risks are highly debated, ephedra is a proven energy booster and fat burner. It is found in over-the-counter diet pills and bodybuilding drinks or mixes, and many of your younger male members at your fitness center may be using it as you read this.

It also known as "ephedrine" and "ma huang", it acts as a stimulant that raises the bodys core temperature and cause irregular heartbeat, insomnia and elevated blood pressure. Furthermore, its energy-boosting effects can dangerously mask signs of fatigue and dehydration.

U.S. Air Force Has Similar Problem

The Army incident follows closely on the heals of the Air Force Surgeon General last month issuing a "Notice to Airmen" on the potential risks associated with any dietary supplements that contain ephedra. This motion was precipitated by the death of a young Air Force member.

"What we know is that this young man took dietary supplements, including ephedra," said Royal Air Force Wing Commander, Dr. Victor Wallace, "Although there was insufficient evidence to be causal, the changes seen in this young man's cardiovascular system can be associated with ephedra use."

In response, the Air Force Services Agency issued a memorandum which called for services activities to remove all ephedra related supplements from Air Force operations.

Response from the Ephedra Industry

The ephedra industry says nobody's proven what caused the military deaths, and its own scientific studies show ephedra is entirely safe.

Industry spokesman Wes Siegner does say soldiers in rigorous training programs may want to avoid ephedra but insists it should be available to others on base who need it.

"Maybe there are some people on military bases who should not be taking these products," Siegner says. "We'd be happy to try figure that out with the military and educate those people."

Death of Athletes Also Attributed to Ephedra

Our young servicemen are not the only ones affected by ephedra; it has made its way into the sports locker rooms for year.

On September 3, 2002, 16-year old Sean Riggins died of heart failure. He was a Lincoln Illinois Community High School sophomore athlete who purportedly took "Yellow Jacket", an ephedra-caffeine compound that experts blame for his death. His parents have subsequently launched a campaign to ban the herbal supplement.

Further studies have shown that more than 70 percent of college athletes and up to 50 percent of high school athletes have taken some type of performance enhancing supplement. Despite the fact that both the National College Athletic Association and more recently, the NFL, have banned ephedrine supplements, it is still extensively used.

The NFL ban came after the tragic death of Minnesota Vikings offensive lineman Korey Stringer, who succumbed to heat stroke during pre-season camp. While autopsy results did not find any evidence of ephedra in his body, supplements containing ephedra were found in his locker.

Today, at least 20 states and the National Football League are among those who have banned or restricted use of ephedrine products. ]]> Suit Over Metabolife Successful http://www.yourlawyer.com/articles/read/3735 Wed, 04 Dec 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3735
Thornburg had to endure a series of major health problems directly associated with her use of Metabolife 356.

I started taking it in January of 1999, said Thornburg, a Fayetteville resident. At the time you couldnt buy it locally, so I bought it at Brookwood Mall (in Birmingham), and then they started selling it on the Internet and it was a lot cheaper that way.

Thornburg said she took Metabolife, an appetite suppressant, for approximately six months when she started having health problems.

In July of 1999 I developed pancreatitis, which is not typical for someone like me, Thornburg said. And I told the doctor I was taking an herbal diet pill, but I didnt think it would have anything to do with me being sick.

She was treated for the pancreatitis, but the problems persisted. In October 1999, Thornburg had to have gall stones removed, another illness that seemed to perplex her and her doctor.

I just kept getting sicker, but I kept taking the Metabolife, she said.

But in January 2000, while Thornburg was in Montgomery on a business trip, she said she began having severe headaches.

I felt like I was about to pass out, she said. And that night after my husband fell asleep, I passed out in the hotel room.

Thornburg said she was able to crawl to the bathroom, but was unsure as to what was happening to her.

I just sat in the bathroom and cried. My headache was so bad I thought I was about to die.

She said she managed to get back into her bed, but spent the evening in pain as she clutched a Bible against her chest.

I just prayed and asked God to get me through it, she said.

She attempted to follow through with her business engagement the following day, but as her condition worsened, she found herself in her husbands car racing home to see her doctor.

My husband was dragging me in to Dr. (Ghayas) Habashs office, she said. And he looked at me and said, Oh my God, youre having a stroke.

Thornburg was hospitalized after the stroke, and had to return to the hospital several more times in the next few months.

I had to learn to walk, talk, feed myself, Thornburg said. She said none of the tests performed on her after her stroke were able to produce any results pointing toward a reason behind her stroke.

She said a friend of hers saw a commercial about the effects of Metabolife, so she brought a bottle of the drug to her neurologist, Dr. Hisham Hakim.

Hakim said he noticed that Metabolife 356 contained a form of ephedra alkaloid called ma huang.

Who would know it was unhealthy? Hakim said. Its supposedly natural and safe, so no one is going to think it could be harmful.

Thornburg began working toward filing her lawsuit several months later, secure in the thought that the use of Metabolife has caused her problems.

She said the defense in the court case tried to create the perception that she was at fault.

But they proved without a shadow of a doubt that this product had never been tested, Thornburg said.

Thornburg and three other plaintiffs with varying health problems related to their use of Metabolife received a favorable verdict for their efforts.

The four plaintiffs were awarded $4.6 million, but Thornburg said the money does not make up for what she has endured over the past three years.

I dont think anything can make up for what happened to all of us, Thornburg said. My losses are much worse than what we received from the trial.

A federal jury in Birmingham found Metabolife 356 was "unreasonably dangerous" under the state's manufacturer liability laws.

The decision was made after reviewing testimony by expert witnesses and thousands of consumer complaints that Metabolife recently turned over to federal regulators.

During the two-week trial, Metabolife's founder and co-owner, Michael Ellis, refused to give a deposition or answer questions posed by the plaintiffs' attorneys, asserting his Fifth Amendment right.

The suit was the first to be heard pertaining to the drug, but Hakim, who served as the expert medical witness in the trial, said he knows that more cases will follow.

This was the first successful suit, he said, but there will be more.

Metabolife faces more than 100 personal injury cases in state and federal court.

The company is also the subject of criminal investigations by the Justice Department and the Internal Revenue Service.

Investigators for the Justice Department are seeking to determine whether Ellis lied to the Food and Drug Administration about the existence of consumer complaints alleging serious side effects caused by the diet pills.

In August, the same day the Justice Department investigation became public, Metabolife turned over 14,700 reports by people who said they experienced health problems from the Metabolife products.

Following the lawsuit in Birmingham, the company said it was turning over an additional 1,480 customer complaints that had been missed earlier because of a computer glitch.

Metabolife has been linked to three deaths, 20 heart attacks and 24 strokes nationwide. ]]> Worth The Weight? http://www.yourlawyer.com/articles/read/3736 Wed, 04 Dec 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3736
This well-known path to weight loss is through weight loss supplements containing the old Chinese herb, ephedra. What sets these supplements apart from the rest is the fact that the drug is labeled "all natural." When compared to other drugs, a consumer might think that the supplement is safe to take because it is "all natural". Not everyone has or wants to take the time to research the diet drug or supplement they plan to take, which aids in the problem of ephedra. The root of the problem lies in the history of the ingredient.

According to the Web site, www.ephedra.net, ephedra and pseudoephedrine both come from the plant Ma Huang. Ephedra has been used by the Chinese to treat asthma and reduce upper respiratory infections for more than 5,000 years. The pseudoephedrine is a chemical isomer that is similar to ephedra and is used mainly as a decongestant. In addition to treating asthma, ephedra is used to lose weight due to its thermogenic effect.

"Ephedra has the ability to open up the adrenergic receptor switches.... thereby increasing the metabolic rate and calorie consumption," the Web site explains. The burning of fat and the increased metabolic rate leads to the notion of thermogenic effects. With all this in mind, the supplements have become commonplace in gyms across the nation.

"I work at the gym (Bally's), and everyone takes it, even the old people," Eddie Garcia, a senior electronic engineering major said.

A few workout supplements that are commonly used are Hydroxycut, Xenadrine, and Stackers I & II. More and more supplements debut on different fitness Web sites like Bodybuilding.com or in fitness magazines like Men's Health and Self. These ads promise the promotion of muscle and the loss of fat, using pictures of people who have taken the drug. However, the ad doesn't include the most important information about the product.

The difference in using ephedra for asthma by the Chinese and the use for weight loss in the United States is the amount taken on a daily basis. Because of the dangerous effects the drug has on some users, the Food and Drug Administration had to get involved to regulate the amount that should be consumed in order to protect consumers.

Cristin Maradino explains the severity of the issue in her article, "Ephedra falls under FDA jurisdiction" in the September 1997 issue of Vegetarian Times.

"Although the Dietary Supplements Health and Education Act of 1994 prohibits the FDA from regulating dietary supplements...if one poses a 'significant or unreasonable risk of illness or injury' the FDA is within its authority to implement regulation," Maradino said.

After hearing how dangerous the drug is considered by the DSHE and the FDA, a person might wonder why the drug is still being used.

Depending on the person in question, the thought of the consequences might be blurred due to the fact they don't know anyone that has had problems with ephedra. But they exist.

Joshua Lintz, a junior public policy major, had problems when he took the supplement, Xenadrine, and regrets taking it in the first place.

"Today's society is so concerned with image that they close their ears to it (the dangers of the drug),"Lintz said.

Lintz hopes now, the dangers will be heard. He felt so strongly about the drug, he offered to share his story with the students of SMU.

Last July, Lintz was in track and preparing for cross-country when he wanted to shed 5 to 8 pounds. He had heard of the great results of Xenadrine and decided to take it for two months. He lost the pounds he wanted, but noticed he started getting flashes in temperature in addition to heart palpitations. Because he had already had his physical and was found to be in great health, he consulted the medical trainer and learned that it was due to the ephedra he was taking. It was then that he learned, personally, that it could happen to anyone.

Garcia had to see a cardiologist due to the use of the drug. Lintz and Garcia's symptoms coincided with the side effects listed on the FDA Web site. Although these are just two instances of the drug effecting people, there are many more.

On the FDA Web site, www.fda.gov.com, a list is featured with different supplements that have dangerous side effects. Ephedra was found to have possible health hazards that range from high blood pressure, irregular heart beat, nerve damage, injury, insomnia, tremors, headaches, seizures, heart attack, stroke and death. These are not the only side effects, but these are some the FDA wanted to make known.

Even though the most favored path to weight loss, lower consumption of fat and carbs combined with a steady workout a couple of times a week, sounds like a broken record, it really does work. There are many other weight loss paths that work for some people and not for others, just make sure to do the research to be fully aware of any side effects.

With this in mind, SMU students will now be aware of how dangerous supplements containing ephedra can be. Because the drug has the same effects as caffeine, maybe the supplement will be substituted for a latte or two. ]]> Suit Blames Las Vegas Man's Death On Bodybuilding Supplement http://www.yourlawyer.com/articles/read/3737 Sat, 30 Nov 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3737
In their Clark County District Court lawsuit filed last week, the wife and daughter of Eric Ashment are seeking damages from Hauppauge, N.Y.-based Twinlab Corp. on multiple claims, including product liability, negligence and misrepresentation.

A lawyer for the family blamed Ashment's death on use of an ephedrine-containing nutritional supplement known as"Ripped Fuel."

"There is no other health reason for him to have a heart attack at this age,"attorney Robert Murdock told the Las Vegas Review-Journal.

A message left on an answering machine at Twinlab's corporate communications department was not immediately returned Saturday.

Last month, Twinlab announced it would discontinue selling ephedra-containing supplements effective March 31, 2003 and focus instead on non-ephedra products.

Twinlab has launched a line of clinically tested, ephedra-free products under its leading national brands, including Ripped Fuel.

Ephedra is an herbal stimulant that has been banned by the National Football League.

Ashment, who worked as a butcher at a grocery store, began a new exercise regimen earlier this year.

"He was starting a weight-lifting program, trying to build body mass,"Murdock said.

Ashment consumed Ripped Fuel in the days and weeks before his death and bought it over the counter at a variety of Las Vegas-area stores, the lawyer said.

Ashment was not abusing the product, and an autopsy determined the cause of death was heart failure, he added.

"I hope the lawsuit accomplishes just compensation for my clients, but it also should serve to help take this product off the market,"Murdock said.

The Ephedra Education Council, a group funded by supplement makers, insists that ephedra dietary supplements are safe and effective for weight loss when used as directed.

But doctors claim ephedra is responsible for as many as 100 deaths since the mid-1990s. Ephedra remains available in about 200 supplements used for weight loss, building muscle and boosting energy.]]> Lincoln Family Pushes For Ban On Ephedra http://www.yourlawyer.com/articles/read/3738 Sat, 30 Nov 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3738
Kevin and Debbie Riggins of Lincoln are lobbying lawmakers, planning a nonprofit foundation and contemplating a civil lawsuit. They petitioned the Lincoln City Council this week to ban sales of ephedra supplements.

"We're plugging away, a day at a time," said Kevin Riggins of Lincoln, father of a 16-year-old boy who died Sept. 3 of heart failure. The Lincoln Community High School sophomore athlete took Yellow Jacket, an ephedra-caffeine compound that experts blame in his death.

Thanksgiving difficult

"Thanksgiving was rough," Kevin Riggins said, recalling how his only child used to sneak dill pickles from the kitchen while dinner was cooking. The Rigginses' extended family gathered for Thanksgiving, but it wasn't the same.

"There is a hole in this family that never can be filled," Kevin Riggins said. "Everything we're doing now, we're doing because we don't want this to ever happen again."

The Rigginses now fill much of their time with efforts to tighten regulations on ephedra. They are working with a lawyer to start the Sean Riggins Foundation, a nonprofit organization to educate young people about the dangers of both legal and illegal substances, Kevin Riggins said.

Kevin Riggins has met with State Sens. Larry Bomke, R-Springfield, and Bill Brady, R-Bloomington, and state Rep. Dan Brady, R-Bloomington, to press his case for tightening the Illinois Controlled Substances Act. The law regulates how ephedrine compounds are marketed. But it does not apply to supplements of ephedra, the Asian herb from which the stimulant ephedrine is derived.

"What we can do within the confines of the law, we need to get done," Kevin Riggins said.

The Rigginses have talked with a lawyer about filing a lawsuit, but they haven't filed yet, Kevin Riggins said.

Meanwhile, Sean's schoolmates still drop by the Riggins home. They come at all hours to sit and talk.

"They're always welcome; we really enjoy it," Kevin Riggins said. "They're helping us, and we're helping them get through it too."]]> AF Surgeon General Issues NOTAM On Ephedra Risks http://www.yourlawyer.com/articles/read/3739 Fri, 29 Nov 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3739
NOTAMs are released by the Clinical Quality Management Division of the Air Force Medical Operations Agency to disseminate lessons learned from medical incident investigations and other pertinent events.

"What we know is that this young man took dietary supplements, including ephedra," said Royal Air Force Wing Commander (Dr.) Victor Wallace, of the Aerospace Medicine Division at the Air Force Medical Operations Agency. "Although there was insufficient evidence to be causal, the changes seen in this young man's cardiovascular system can be associated with ephedra use."

"The purpose of the NOTAM is to ensure that Air Force personnel and their attending medical staff remain alert to the risks and can provide appropriate advice and education," said Wallace, an RAF exchange officer.

The Air Force Surgeon General issued a revised policy covering dietary supplements containing ephedra on Sept. 5, 2002, that strongly discouraged the use of such supplements and highlighted associated risk factors.

The revised AFSG policy was followed by a memorandum from the Air Force Services Agency, which called for services activities to remove such supplements from their resale inventories.

"Since ephedra and its alkaloids have several different names, products should be evaluated by [major command] and base-level dietitians to ensure all items known to include this herb/ingredient are identified and removed from your operations," the services memo read.

In late August, the Army and Air Force Exchange Service also removed the products from its inventories.

According to a statement issued from AAFES headquarters in Dallas: "Due to health and safety concerns, AAFES has replaced all 'performance enhancing' dietary supplements that contain ephedra with ephedra-free products. All products with ephedra have been removed from AAFES' stores, along with those operated by AAFES concessionaires. Signs have been posted to encourage customers to carefully read the labels of all dietary supplements to help them make informed choices."

Air Force Surgeon General officials have repeatedly "strongly advised" people to contact their physicians or health care providers before taking dietary supplements containing Ma Huang, ephedra or ephedra alkaloids.

"Consultation is especially necessary if an individual has pre-existing medical problems, is taking other medications or exercises vigorously as part of (his or her) occupation or fitness program," Wallace said.

Such supplements, which include so-called energy boosters, over-the-counter diet pills and bodybuilding drinks or mixes, may pose health and occupational risks even for those not taking other prescribed drugs, Wallace said.

Today, at least 20 states and the National Football League are among those who have banned or restricted use of ephedrine products. ]]> Diet Pill Distributor Sued for Alleged Scheme http://www.yourlawyer.com/articles/read/3733 Sun, 17 Nov 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3733
But while discussions about health risks associated with ephedra products continue, one of the leading opponents of the ban, Collins County, Texas, -based Wellness International Network Ltd., distributor of the supplement BioLean, is fighting a different sort of battle.

Wellness is trying to deflect a lawsuit brought by former associates who allege that the company is no more than a pyramid scheme that bilked them out of hundreds of thousands of dollars.

In Suffolk, operators of Wagner Associates, an arm of Wellness International, have spearheaded the effort to vote down the ephedra ban, which is sponsored by Legis. Jon Cooper (D-Lloyd Harbor). The principals, Bob and April Wagner, declined to comment on the Texas case.

In state civil court papers filed in eastern Texas' Texarkana District, an attorney for a half a dozen plaintiffs involved in distributing BioLean called Wellness International "an artfully disguised pyramid scheme, which has managed to succeed primarily because most unsuspecting victims are too embarrassed or broke to pursue [president Ralph] Oats and his company."

Wellness International communications director Shannon Camp said in a statement that the company's "policy is not to comment on pending litigation," although in the past when "disgruntled distributors have initiated suit, Wellness has successfully defended its program."

She added that "the issues raised in the East Texas litigation have nothing to do with the proposed legislation on ephedra in Suffolk County."

Court papers tell the story of plaintiff Ginny Murphy, whose husband, Tom, faced financial ruin after entering into the BioLean business and committed suicide, $250,000 in debt.

After responding to an ad, Tom Murphy had attended a multilevel marketing course in Dallas, and later pulled his wife into the mix. The couple sent Wellness a check for $200,000, and a senior Wellness distributor told Tom that he would make his money back in three months.

Over the next two years, Murphy's efforts to recruit other distributors were unsuccessful and he was asked to make increasingly large payouts to the company.

"He had been doing this for two or three years and he had not been successful," said Nick Oliva, 49, a friend of the Murphys from Henderson, Nevada and a former BioLean distributor. "The man talked to everyone. Murph was looking for credibility."

After years of little success, Murphy, a former craps dealer in Las Vegas, put some money into stocks, hoping that a good return would lead him out of debt, Oliva recalled in an interview.

On March 30, 2001, the stock plummeted. The next day, Murphy called his wife and left a message saying "No matter what happens I love you very much." Later that day, Murphy put a handgun to his head and ended his life, according to the lawsuit.

Wellness launched a countersuit which sought to recoup lawyers' fees and cited the fact that all distributors must sign an agreement before embarking on their BioLean careers.

The agreement states: "I have read the [Wellness International] rules and regulations and... certify that neither the company or my sponsor have made any claims of guaranteed earnings." ]]> Metabolife Ephedra Heart Attack Stroke Side Effects Lawyer http://www.yourlawyer.com/topics/overview/metabolife Sun, 17 Nov 2002 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/metabolife DOWNLOAD OUR Metabolife INFORMATION PACKAGE

Injured by Metabolife?

Metabolife, which contains Ephedra (active ingredient: ephedrine), has been linked to serious side effects including seizures, heart attacks, and death. Metabolife is a dietary supplement used to control appetite and facilitate weight loss.  Ephedra is the main ingredient in Metabolife and has been linked to serious side effects including death. Ephedra is derived from an Asiatic shrub and contains ephedrine, a stimulant that acts on the central nervous system to relax bronchial tubes.

On August 15, 2002, the Justice Department announced that it started a criminal investigation into whether Metabolife lied about the safety of the controversial dietary supplement. A few hours after news of the federal investigation on Metabolife was made public, Metabolife announced it would finally give the FDA the 13,000 complaints it received since 1997. Of those complaints, 80 of them involved deaths, seizures, heart attacks, or other serious events. The number that Metabolife provided caused even more concern than was initially thought, according to Dr. Lester Crawford of the FDA.

If you or a loved one took Metabolife and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>