Yourlawyer.com (Ephedra News) http://www.yourlawyer.com/topics/overview/ephedra Sat, 21 Nov 2009 00:42:58 -0800 pixel-app en Studies show diet pills still pose risks http://www.yourlawyer.com/articles/read/11482 Mon, 13 Mar 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11482
Although the drugs were widely effective at suppressing appetite, patients began to complain of rapid heartbeats and unpredictable mood swings. Doctors also began to notice patients’ blood pressure elevating to dangerous levels.

Since that time, there have been hundreds of prescription weight loss drugs introduced to the public and hundreds of recalls due to dangerous side effects. Many of these drugs, although containing different ingredients, have been associated with the same health risks, including high blood pressure, severe heart damage, kidney damage and stroke.

In the mid-1990s, there was an explosion of all-natural, over-the-counter, weight loss pills. With people feeling safe in the terms used to describe these pills, the over-the-counter diet pill sales peaked for several years. Studies done on many of these pills have shown they too can cause serious health problems regardless of being natural.

Then, in 2004, the FDA banned ephedra, which is an all-natural substance used in many popular weight loss pills. The ban was issued after 155 people died while on the supplement. Many diet pill manufactures are now looking for new suppressants and have turned to citrus aurantium.

Citrus aurantium, also known as bitter orange, is believed to have similar effects as ephedra and is now one of the most widely used dietary supplements. Citrus aurantium contains a compound called synephrine that, like ephedra, stimulates the central nervous system and may boost metabolism.

Manufacturers claim citrus aurantium safely boosts energy while suppressing appetite and increasing metabolic rate and caloric expenditure. However, Dr. Christine Haller, a clinical pharmacologist at the University of California Medical Center in San Francisco, questioned the safety of the substance in two supplements, Advantra Z and Xenadrine EFX, in a 2005 study.

For the study, Dr. Haller and colleagues examined participants randomly given Advantra Z, Xenadrine EFX, or a placebo on three separate occasions. They measured participants’ short-term cardiovascular responses and found compared with the placebo condition, Xenadrine EFX boosted blood pressure up to 10 points, while Advantra Z did not appear to affect blood pressure.

Both products elevated heart rates for as long as six hours after taking the supplement. Dr. Haller says the fact that Advantra Z contains only bitter orange extract as its active ingredient suggests it alone does not raise blood pressure; rather, the mixture of bitter orange extract, caffeine and various herbs contained in Xenadrine EFX is what affects blood pressure.]]> Herbal Supplements May Cause Dangerous Side Effects During Plastic Surgery http://www.yourlawyer.com/articles/read/11355 Thu, 16 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11355
While natural herbal supplements are touted as offering a wide range of health benefits, they may not be "harmless" during plastic surgery when dangerous side-effects may occur, according to the study.

The situation is made even more problematic by the fact that approximately 55% of plastic surgery patients take supplements but often do not tell their surgeons.

According to study co-author and ASPS member, Dr. James Bradley of the University of California, Los Angeles: "When patients are asked about the medications they are taking, many do not mention medicinal herbs because they assume that they are safe. What many unsuspecting patients don't know is that the natural herbs they are taking may cause serious complications during and after surgery."

The 55% of plastic surgery patients who used herbal supplements took at least two different ones at least one daily. The most popular supplements were found to be  chondroitin (18%), ephedra (18%), echinacea (14%) and glucosamine (10%).

While all of these supplements are claimed to have beneficial effects, they may cause serious problems in the operating room. For example, chondroitin is often used to treat osteoarthritis. Chondroitin, however, may cause bleeding complications during surgery, particularly when used in combination with prescription blood-thinning medications.

Ephedra is already a substance that has been blamed for all types of health problems. Thus, while it may help people to lose weight loss, increase energy and treat respiratory conditions such as asthma and bronchitis, it has also been linked to increased blood pressure, heart rate and metabolic rate, heart attacks, heart arrhythmia, stroke and even death.

Echinacea is commonly used to prevent and treat viral, bacterial and fungal infections, as well as chronic wounds, ulcers and arthritis. However, it can trigger immunosuppression, resulting in slow wound healing and infection.

Glucosamine, often paired with chondroitin, is made of chemical elements that mimic human insulin, and may trigger hypoglycemia during surgery.

Thus, according to Dr. Bradley, patients “should tell doctors about all of the medications they are taking – natural or prescribed. Only then can we safely suggest the appropriate discontinuation period, which can range from 24 hours to one month. Taking this precaution is essential to a safe surgery and smooth recovery."]]> Health Canada advises consumers not to use Kaizen Ephedrine HCL tablets for weight loss http://www.yourlawyer.com/articles/read/11119 Wed, 28 Dec 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11119
Kaizen Ephedrine HCL tablets contain ephedrine hydrochloride, which is authorized by Health Canada only for use as a nasal decongestant in over-the-counter cold products. When used in combination with caffeine and other stimulants, ephedrine hydrochloride has caused reported adverse events ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and stroke.

Kaizen Ephedrine HCL tablets are distributed by The Winning Combination Inc. to retail stores. The tablets are packaged in bottles containing either 28 tablets or 50 tablets, with a purple and grey label. The Drug Identification Number (DIN) for this product is 02236722.

The Winning Combination Inc. has cooperated with Health Canada to remove claims from their website pertaining to "body fat reduction or a preworkout energy boost." The company has also taken action to discontinue pamphlets that list the product as one of their weight loss products. It should be noted that this product can still be taken for its approved use as an oral nasal decongestant for short periods of time.

Health Canada advises all individuals who may have used Kaizen Ephedrine HCL tablets or any other products containing ephedrine for weight loss or increased energy purposes to immediately stop taking it and consult their health care practitioner if they have experienced any adverse effects.

Several health advisories have been issued by Health Canada warning Canadians not to use products containing ephedrine/ephedra, in combination with caffeine and other stimulants, for purposes of weight loss, body building or increased energy. No specific adverse reactions have been reported for Kaizen Ephedrine HCL tablets at this time.

Consumers and health care professionals may report any adverse reaction suspected as being associated with ephedrine/ephedra-containing products by contacting Health Canada toll-free by telephone (866) 234-2345 or fax (866) 678-6789.

Consumers who see other products advertising ephedrine for weight loss claims can call Health Canada's toll-free line at 1-800-267-9675.
]]> Experts Warn that Bitter Orange May Be as Dangerous as Ephedra http://www.yourlawyer.com/articles/read/10810 Wed, 12 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10810
A new study from the University of California, San Francisco has shown, that in similar doses, bitter orange alone is not as potent as ephedra. In the 10 experimental subjects who tried it, bitter orange increased the heart rates, but not as much and not for as long as ephedra, said Dr. Christine Haller, an assistant professor of medicine who led the study.

The drug may have some dangerous effects, however. The same study reports that when bitter orange peel is combined with caffeine, as it is in many diet pills promoted as “ephedra free,” it can raise the heart rate and the blood pressure as it did in the 10 healthy subjects who were between 19 and 42.

The researchers had not expected to see a significant increase in blood pressure in a study with only 10 people and, thus, regarded the finding as “amazing.”

In the study, participants were given the ephedra-free supplements Advantra Z, which contains bitter orange alone, and Xenadrine EFX, which at the time of the study contained bitter orange along with vitamins and minerals and caffeine equal to two large cups of coffee. (Cytodyne, the company that makes Xenadrine EFX, no longer uses bitter orange.)

Although the Advantra Z had 15.6 milligrams of synephrine (the main active ingredient in bitter orange) and the Xenadrine EFX 2.75, only the Xenadrine EFX raised blood pressure.

According to researchers, the increase could not be caused entirely by the caffeine, because although caffeine can boost systolic blood pressure (when the heart beats), it does not affect diastolic blood pressure (when the heart is at rest).The Xenadrine EFX increased both.

Whether the blood pressure problems caused by pills are triggered by the caffeine, the bitter orange or a combination of the two, experts agree that taking the pills is probably not worth the health risk.

The F.D.A. does not require manufacturers of dietary supplements to prove that the products are safe and effective before they are sold. Adam Myers, a professor of physiology and biophysics at Georgetown University Medical Center in Washington, who recently reviewed the research on the supplement, said "There are no clinical studies that show it's an effective weight loss agent."  

Dr. Jonathan Waitman, a specialist in internal medicine and clinical nutrition at the Comprehensive Weight Control Program at NewYork-Presbyterian/Weill Cornell Hospital, said the study illustrated the risks involved with over-the-counter diet pills.

"My take-home point would be that you don't know what you're getting when you take one of these supplements," Dr. Waitman said. "There's no way for the consumer to use caution other than not to buy these at all."
]]> Study Suggests Ephedra-Free Supplements May Not Be Risk-Free http://www.yourlawyer.com/articles/read/10645 Sun, 11 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10645
The findings are published in this month’s issue of the American Journal of Medicine.

Both of the weight loss products tested contain Citrus aurantium, or bitter orange extract, a substance that is rapidly replacing ephedra in dietary supplements since its ban by the FDA last year due to concerns about severe health effects of the herbal supplement.

(Although a federal judge lifted the ban, ephedra has gradually been phased out by many supplement manufacturers concerned with potential civil liability for injuries and deaths blamed on the supplement.)

In the first clinical study of the effects of these newly formulated dietary supplements, researchers monitored blood pressure, heart rate, moods, and emotions of 10 healthy adults.

Single doses of both Xenadrine EFX and Advantra Z caused increased heart rate among those tested. Xenadrine EFX also increased blood pressure and alertness. Neither product showed a serious effect on mood.

Researchers found that while Advantra Z contains only bitter orange, one dose of Xenadrine EFX has many other ingredients, including as much caffeine as found in 3 cups of coffee.

They concluded that the increased blood pressure Xenadrine EFX caused did not come from the caffeine alone, but was probably due to the combination of other ingredients of the supplement.

According to Christine Haller, MD, UCSF assistant professor of medicine and lead author of the paper: "These findings indicate that ephedra-free dietary supplements could have some of the same adverse health effects associated with previously available ephedra products, such as Metabolife 356 and Ripped Fuel."

Until longer-term studies of these weight loss supplements are conducted, doctors should alert patients to the potential dangers of ephedra-free dietary supplements and should monitor blood pressure in people who choose to use them.]]> EPHEDRA DEATH CASE SETTLED FOR ALMOST $1 MILLION BY NUTRAQUEST INC. AND FOUR OTHER COMPANIES http://www.yourlawyer.com/articles/read/10210 Tue, 12 Jul 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10210
Bechler was working out in extremely hot weather with heavy clothing in an attempt to lose weight. He also had a number of risk factors which should have discouraged him from using the product. A medical examiner found ephedra contributed to the deadly heatstroke where Bechler’s body temperature soared to 108 degrees.  

Bechler’s wife instituted a $600 million dollar lawsuit against the product manufacturer Nutraquest Inc. (formerly known as Cytodyne Technologies), which filed for bankruptcy in October 2003. Several lawsuits against the company are in mediation discussions.

Now, according to Newsday.com, a settlement has been announced wherein Nutraquest, its owner, and three related companies have agreed to pay almost $1 million and refrain from making unsubstantiated claims in their advertising.

Nutraquest states that it stopped selling ephedra-based products in 2003 because they were no longer profitable. Although the company claims 10 clinical studies have proven their products are safe and effective when used as directed, it settled the case “to avoid the uncertainty and cost of litigation.”

Ephedra is a stimulant containing ephedrine, an herbal “remedy” often used for weight loss, increased energy, and to relieve the symptoms associated with asthma, congestion, hay fever and allergies, and the common cold. (Ephedrine-containing products may list any of the following ingredients on their labels: ma huang, Chinese Ephedra, ma huang extract, Ephedra, Ephedra Sinica, Ephedra extract, Ephedra herb powder, Sida Cordifolia, or epitonin.)

Ephedra is a shrub-like plant that is found in desert regions in central Asia and other parts of the world. The main active ingredients in ephedra are the alkaloids ephedrine and pseudoephedrine.

Ephedra, which is or has been used in a wide array of products, has been accused of causing adverse reactions including heart attack, stroke, tachycardia, paranoid psychosis, depression, convulsions, coma, fever, vomiting, neuropathy (nerve damage), myopathy (muscle injury), palpitations (rapid heart rate), hypertension (elevated blood pressure), memory loss, insomnia, nervousness, tremors, seizures, respiratory depression, and even death.

While most of the products containing ephedra include only the recommended or otherwise permissible amounts of the supplement, some of the products, such as those designed for weight-loss and body building, often contain unsafe amounts of the substance, are used in unsafe concentrations, are used under conditions which greatly increase the risk of injury, or are taken by people who have one or more risk factors which made the use of Ephedra extremely dangerous.

The likelihood of suffering serious health problems increases as the exposure to ephedra-containing products increases. However, even short-term use at increased levels, or under adverse conditions, or by those with known risk factors, may prove to be even more dangerous. Sudden “jolts” of ephedra in high dosages may result in heart attack, stroke, seizure, or death.

As a result of the efforts of Health Canada to stop the improper use of ephedra, the sale of Ephedra products was banned completely in Canada in January 2002.

In October 2002, the FDA announced that it was stopping imports of “Yellow Jackets,” an herbal amphetamine product which contains ephedra among other stimulants.

This action was likely a response to the death of a teenager who died after taking Yellow Jackets. The FDA claimed that there did not seem to be any legitimate use for this product and that it was being marketed to consumers as an alternative to cocaine and other “street drugs”.

In February 2003, the Department of Health and Human Services (HHS), working in conjunction with the FDA, announced that they were finally going to take action to protect Americans from potentially serious risks associated with products containing ephedra. HHS and the FDA stated that they would make information concerning the health risks associated with Ephedra more readily available to the public in order to support new restrictions on Ephedra-containing products.

In addition, they demanded that new warning labels, which accurately explain the risks associated with ephedra use, appear on any products which continue to be marketed. They also sought to eliminate false or misleading advertising associated with the substance (as in the case of Yellow Jackets and energy-boosting products which promise enhanced athletic performance).

The results of a RAND Corporation study were perhaps responsible for this change in FDA and HHS policy as these results illustrated just how harmful ephedra can be when used both properly and improperly.

The results of the study listed about 16,000 adverse side effect reports including two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases. The report also concluded that while ephedra-products make up less than one percent of all dietary supplements sales, these products account for 64% of adverse events associated with dietary supplements.

As a result of these findings, the FDA sent warning letters to more than two dozen firms marketing dietary supplements that contain ephedrine. The FDA also proposed a new warning label which illustrates the serious health risks associated with ephedra and the heightened risk of these health conditions when the supplement is taken in unsafe dosages, with strenuous exercise, and with other stimulants such as caffeine.

Notwithstanding efforts to restrict the sale of ephedra-based products and to prohibit unsubstantiated advertising claims, young people and athletes often risk serious injury or death by taking unsafe amounts of the supplement without proper medical monitoring.

As discussed above, on February 17, 2003, Steve Belcher died of multiple organ failure secondary to severe heatstroke while using an ephedra based weight loss product in an inappropriate way and probably in unsafe amounts.
 On November 21, 2002, Johnny Perry, a 30-year-old strongman (6’5” and 375 pounds) died shortly after finishing among the top qualifiers in the World’s Strongest Man competition. Perry, who also used steroids, was known to “get wired” before a competition by taking 5 or 6 capsules of Ephedra.

In May of 2003, following the death of a 16-year-old boy in Illinois who ingested Ephedra in order to help him make the football team, a nationwide class action lawsuit against Metabolife and other manufacturers of Ephedra-containing products was commenced. As a result of this lawsuit, Illinois completely banned the sale of Ephedra.

Many sports organizations such as the NCAA, the NFL, and the International Olympic Committee have already banned Ephedra while others are considering similar bans.

In addition, General Nutrition Centers (GNC) announced that it will no longer sell Ephedra-containing products due to the overwhelming reports of adverse health events. Many of the manufacturers of products which had included Ephedra or one of its derivatives or associated compounds have reformulated their products to exclude those substances. Their advertising campaigns clearly announce their products are now "Ephedra free.”

Although Ephedra was finally banned by the FDA in April 2004, the ban was lifted by a federal judge.
]]> Ruling Stokes Ephedra Controversy; FDA Ban In Question http://www.yourlawyer.com/articles/read/9650 Mon, 25 Apr 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9650
The April 13 ruling by Judge Tena Campbell of the U.S. District Court in Utah threatens the FDA's ability to enforce its year-old ephedra prohibition nationally and raises questions about the strength of its regulatory authority over dietary supplements. These products currently fall under food guidelines and are not subject to the same premarket restrictions as prescription drugs.

The decision "puts America's patients back in harm's way and will no doubt cause confusion," said AMA Trustee Ronald M. Davis, MD.

In response to the ruling, some federal lawmakers and physicians called for a legislative remedy that would toughen the agency's power to stop the sale of products known to have damaging effects on their users.

The decision underscores the need to revisit how supplements are regulated, said Gary Wadler, MD, an internist and sports medicine specialist in Manhasset, N.Y., and a former trustee with the American College of Sports Medicine. "It's an issue of premarket safety assurances vs. postmarket surveillance," he said.

Supplements are governed by the Dietary Supplement Health and Education Act of 1994, under which the products are assumed to be safe until proven harmful by the FDA. Thus, it is the agency's duty to determine a safe dosage level for the product, Campbell ruled. But the FDA did not sufficiently prove that ephedra was unsafe for consumers in low doses, she concluded.

In her decision, Campbell ordered the FDA to revisit its rules regarding ephedra and prohibited the agency from taking action against Nutraceutical Corp., the Park City, Utah-based company that filed the lawsuit at the heart of the case. The company's challenge of the ban was specific to the sale of "a dietary supplement containing 10 mg or less of ephedrine alkaloids per daily dose."

It remains unclear how the judge's ruling will affect the distribution and manufacturing of ephedra products in the short term. Jonathan Emord, an attorney based in Reston, Va., who represents Nutraceutical, said the decision strikes down the entire FDA ban. But FDA spokeswoman Kimberly Rawlings said the agency plans to look at the judge's decision literally.

"From the FDA's perspective, the order remains in effect for higher doses," Rawlings said. The agency is evaluating its options, including an appeal, she added.

Health food chains General Nutrition Centers, based in Pittsburgh, and Wild Oats Markets, based in Boulder, Colo., said they had removed all ephedra products from their shelves before the FDA ban and had no immediate plans to change their stance. But ephedra-containing products were available for sale on various Internet sites soon after the decision.

"Unnecessary deaths"

Physicians said dosage levels are irrelevant when talking about the return to market of a supplement that has been linked to stroke, heart attack and death in extreme cases and has generated more than 18,000 consumer complaints.

Renewed sales "would mean the unnecessary deaths of children and adults," said Eric Small, MD, a pediatric sports medicine specialist in New York and chair of the American Academy of Pediatrics' Committee on Sports Medicine and Fitness.

"There are a lot of young athletes who take supplements to quickly lose weight," Dr. Small said. "If they want to make a certain weight in a sport, like wrestling, they may resort to taking something like this."

The AMA's Dr. Davis said, "Findings from independent researchers and the government support the scientific basis for a ban on ephedra."

But the judge ruled that the FDA had overstepped its bounds.

"Simply stated, to declare all [ephedrine-alkaloid dietary supplements] adulterated, as it has done, the FDA must prove that any dose amount, no matter how small, presents a significant or unreasonable risk of illness or injury," she wrote.

Nutraceutical filed the lawsuit to challenge the FDA's regulatory practices, not its specific action with ephedra, company President Bruce Hough said. The company does not have immediate plans to renew sales of its whole-herb ephedra product.
Supplements an odd fit for regulation

Even with dosage instructions, however, ephedra products could still be misused, doctors said.

The American Academy of Pediatrics recently published a new policy statement condemning performance-enhancing substances, and it includes dietary supplements in that category. Very little information is available on the safety and efficacy of these products in children and adolescents, according to the policy statement.

Because of the way dietary supplements are regulated, however, there doesn't need to be much data available before a product like ephedra reaches the market. While prescription and over-the-counter drugs undergo a rigorous process to prove safety and efficacy before gaining FDA approval, supplements are monitored based on complaints from consumers and health professionals once they're already available.

The regulatory framework is challenging because dietary supplements are neither foods nor drugs, said Adriane Fugh-Berman, MD, an associate professor in Georgetown University Medical Center's Depts. of Physiology and Biophysics. Herbs are not patentable, so it would not be profitable for manufacturers of dietary supplements to undergo clinical trials, only to have another company copy its formula, she said.

On the other hand, many supplements have pharmacologically active ingredients, rendering them an odd fit in the food category, she said.

"It makes sense to have them regulated separately," Dr. Fugh-Berman said. But the dietary supplement law "is problematic because it's very confusing to consumers and very difficult for the FDA to regulate."

It often takes a long record of adverse events to put any sort of regulatory action in motion, including some high-profile cases. The ephedra issue took center stage in 2003 when it was cited as a factor in the death of Baltimore Orioles pitcher Steve Bechler. Major League Baseball later banned the substance, joining the National Football League and the International Olympic Committee.

"How soon we tend to forget," Dr. Wadler said.]]> 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. ]]> Ephedra At Fault In Suit http://www.yourlawyer.com/articles/read/8450 Fri, 27 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8450
The case represents a rare instance of a retailer being found liable for selling a product containing ephedra.

Ephedrine supplements were widely used for weight loss and bodybuilding, but have been linked to more than 150 deaths, including that of Baltimore Orioles pitcher Steve Bechler.

The Food and Drug Administration banned all dietary supplements containing ephedrine alkaloids on April 12.

Hagen, who lives in Santa Margarita, suffered a stroke on Feb. 11, 2002, hours after taking the thermogenic weight management pill Dymetadrine Xtreme, which he purchased at Fox Nutrition in Los Angeles.

As a result of the stroke, Hagen now needs a wheelchair or a walker to get around, and he has trouble speaking because his vocal chords continually spasm, among other lingering health problems.

Fox Nutrition ended up becoming a defendant in the case as a result of California liability law, which states everyone along a chain of commerce becomes a defendant in a product liability suit.

Golden, Colo.-based manufacturer AST Sports Science went bankrupt and the courts dismissed the case against a Northridge-based distributor, DMA Industries, said an attorney who represented Fox Nutrition.

While the FDA ban on ephedra products had not yet been instituted at the time Hagen was taking the diet supplement, jurors decided the vitamin discount seller was partially responsible.

The 2-week-long trial ended Wednesday. Jurors initially returned a $6.9 million award, but then reduced it by 40 percent, citing that Hagen had also been using a prescription drug at the same time he took the ephedra-laced pill.

The jury also did not award damages to Hagen's wife, who had sought compensation for loss of consortium and other emotional hardship.]]> Mother Says Ephedra Caused Son's Death http://www.yourlawyer.com/articles/read/8220 Thu, 08 Jul 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8220
But Lee, 21, died in the back seat of his mother's car while traveling to his Oklahoma City home after taking a recommended dosage of an ephedra-based product.

In a lawsuit filed Thursday in Oklahoma County District Court, attorneys for Lee's mother claim Stacker 2, an ephedra-based diet supplement, caused the cardiac dysrhythmia that killed Lee.

Ephedra, an herbal stimulant, was banned by the federal Food and Drug Administration in April. It was once widely used for weight loss and bodybuilding.

The stimulant, paired with other herbs, acts like amphetamine in the body, speeding up the heart rate and constricting blood vessels. Ephedra has been linked to 155 deaths, including Steve Bechler, a pitching prospect for the Baltimore Orioles.

The lawsuit seeks damages on behalf of Lee's mother, Camille, as well as damages to cover the lawsuit and Lee's burial expenses.

Lee began taking Stacker 2 in October 2002 while stationed at Fort Gordon in Augusta, Ga. He died in June 2003 shortly after being transferred to Tinker Air Force Base in Oklahoma City.

The lawsuit names New Jersey-based NVE Pharmaceuticals, which makes the dietary supplement, as a defendant. Pittsburg-based General Nutrition Corp., which operates GNC stores where Lee purchased the supplement while living in Georgia, is also named as a defendant.

The Smoke Shop, an Oklahoma City tobacco store, where Lee purchased Stacker 2 while in Oklahoma, is also named in the suit.

Terry Gaffney, a representative for NVE, said the company was unaware of the lawsuit and refused to comment until company officials had seen the legal filings.

NVE still sells Stacker products, but they are now ephedra free, Gaffney said.]]> Herbal Supplements Can Damage Kidneys, Liver http://www.yourlawyer.com/articles/read/8221 Sun, 04 Jul 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8221
According to doctors at UT Southwestern Medical Center at Dallas, substances such as bitter orange, germander, jin bu huan and usnic acid ingredients in weight-loss products have been associated with kidney and liver problems.

A number of herbal preparations have been implicated in causing liver damage, some even leading to the need for a liver transplant or to death, says Dr. William Lee, professor of internal medicine and an expert in digestive and liver diseases. Herbal products are not under any specific supervision by the Food and Drug Administration, so there is no quality control, no proof of efficacy and no tests of safety.

The ban on ephedra, which had been linked to more than 150 deaths and dozens of heart attacks and strokes, was the governments first for a dietary supplement. New manufacturing and labeling regulations for dietary supplements are expected later this year, according to the FDA.

The herbal industry is largely satisfying a need for self-remedies for patients who are unwilling to seek conventional medical attention or are wary of doctors, says Dr. Lee. Most supplements are indeed harmless and only injure the pocketbook. Many people, however, take these compounds in any amount, never limiting themselves to what is advised regarding dosing. ]]> 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.]]> Utah Couple Sues Companies Over Ephedra-Based Dietary Supplement http://www.yourlawyer.com/articles/read/8111 Wed, 26 May 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8111
Scott Walker and Angie Walker filed the lawsuit Monday against Connecticut-based Unique Nutrition Corporation and Sportika Domestic Corporation. It also names Utah-based Supplement Warehouse and two Unique Nutrition officers as defendants.

The couple claim Scott Walker, 33, suffered a stroke and a seizure March 31 after using an ephedra and caffeine dietary supplement made by Unique Nutrition, packaged by Sportika and sold by Supplement Warehouse.

The Walkers have asked for unspecified monetary damages for Scott Walker's bad health following the stroke.

An FDA ban on ephedra in dietary supplements took effect April 12.]]> State Checks Stores For Ephedra http://www.yourlawyer.com/articles/read/8051 Wed, 19 May 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8051
Ephedrine supplements were widely used for weight loss and bodybuilding, but have been linked to 155 deaths, including that of Baltimore Orioles pitcher Steve Bechler.

The Food and Drug Administration banned all dietary supplements containing ephedrine alkaloids on April 12.

Any store still selling products containing ephedra will face sanctions, state Consumer Protection Commissioner Edwin R. Rodriguez said Tuesday.

"Based on complaints and our investigations, we know that some ephedra-containing supplements are still on the market in Connecticut," Rodriguez said.

After years of fighting manufacturers over the risks, the FDA announced in December that it was banning the sale of the amphetamine-like herb - the first such ban of a dietary supplement.

"There is clearly a risk to public health and safety linked to the use of this product," Rodriguez said. ]]> FDA Ephedra Ban To Start http://www.yourlawyer.com/articles/read/7906 Thu, 15 Apr 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/7906
U.S. District Judge Joel Pisano refused to grant two supplement makers a restraining order that would have prevented the Food and Drug Administration (FDA) from banning dietary products containing Ephedra.

State College pharmacies and nutrition stores have stopped selling Ephedra during the past year.

Ephedra, commonly used for bodybuilding, was popular for its weight-loss side effects. It was linked to 155 deaths and dozens more heart attacks and strokes in the United States.

Kevin Smith, clinical supervisor at the Mount Nittany Medical Center, said effects of Ephedra depend on an individual's medical history. Some people who use it have no side effects, he said. "It may not happen on 60 percent of the people, and then 10 percent can die. We just don't know," Smith said.

Patrick Fitzgerald, General Nutrition Center (GNC) spokesman, said GNC made the decision to discontinue dietary supplements containing Ephedra early in 2003, and by the end of June, all Ephedra-related products were taken off the shelves from all GNC stores. "It was really dictated by the overall business climate," he said. "There was an increasing consumer demand for Ephedra-free products."

Officials from NVE Pharmaceuticals Inc., which manufactured Stacker 2, said there is lack of proof to demonstrate Ephedra-related dangers.

The FDA maintains that the great number of scientific studies and reports is sufficient proof for the herb's stimulant-like effects.

Tom Miller, pharmacist at CVS Pharmacy, 116 W. College Ave., said CVS took dietary supplements containing Ephedra off the shelves about a year ago. "There were a lot of adverse effects, and then there was the pitcher from the Baltimore Orioles death. It's always been known that it could cause problems, but it took something as tragic as that to make it noticeable to the public," Miller said.

Baltimore Orioles pitcher Steve Bechler's Ephedra-related death on Feb. 17, 2003, caused a decrease in Ephedra sales and urged three states New York, Illinois and California to prohibit the stimulant on their own.

Research shows that the herb can speed up heart rate and constrict blood vessels, even in apparently healthy people. The greatest danger is for those suffering with heart disease and high blood pressure or those who engage in strenuous exercise.

Smith considered the nationwide ban a positive change because of the number of people with problems relating to Ephedra. "It can cause enough problems by not being completely controlled and on who gets it. It was either being banned completely or having very stringent guidelines to control it."

There are other herbs that can be used for dietary supplements that have no side effects, Smith said.

Dietary supplements are not as strictly regulated as medication, which has to be proved safe and effective before introducing it for sale. Federal law allows dietary supplements to be sold without having any such proof. To discontinue a dietary supplement, the law requires the FDA to show that it poses a significant health threat.

"Actual information about [Ephedra] should be published rather than having it banned. What people put into their bodies is their choice," Paige Richardson (junior-communications) said.

The FDA has been fighting manufacturers of dietary supplements containing Ephedra for a year, and in December 2003, it decided to ban the herb.

"I think it was wonderful that the [FDA] is starting to regulate drugs that are non-prescriptive. They're sold at nutritional centers for health, and they're probably the worst things you could take," Amanda Goldstein (junior-history and French) said.]]> Ephedra Ban Takes Effect Nationwide http://www.yourlawyer.com/articles/read/7902 Tue, 13 Apr 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/7902
Ephedra, once hugely popular for weight loss and bodybuilding, has been linked to 155 deaths, including that of Baltimore Orioles pitcher Steve Bechler a year ago.

U.S. District Judge Joel Pisano refused to grant a temporary restraining order that would have prevented the Food and Drug Administration from banning the products.

After years of fighting manufacturers over the risks, the FDA announced in December that it was banning the sale of the amphetamine-like herb the first such ban of a dietary supplement.

"These products pose unacceptable health risks, and any consumers who are still using them should stop immediately," Health and Human Services Secretary Tommy G. Thompson said.

NVE Pharmaceuticals of Newton, manufacturer of the diet supplement Stacker 2, had hoped to head off the ban, arguing its product is safe if used as directed. It was joined by a second company, the National Institute for Clinical Weight Loss, manufacturer of a product called Thermalean.

The judge said the manufacturers did not meet several legal requirements, including proving that they are likely to win the case and that they would suffer irreparable harm if the ban took effect.

Pisano's ruling means the ban will be in effect at least until NVE's lawsuit can be heard. No trial date has been set.

Ephedra sales already had plummeted because of publicity about the risks, especially after Bechler's death a year ago. Three states New York, Illinois and California prohibited the stimulant on their own.

"Ephedra has killed more than 100 individuals and injured thousands of others," said Bruce Silverglade, legal director of the Washington based Center for Science in the Public Interest. "The only problem is, it took the FDA almost 10 years to ban the substance."

Unlike medications, which must be proven safe and effective before they ae allowed to be sold, federal law allows dietary supplements to be marketed without any such proof. To curb a supplement, the FDA must show it poses a significant health threat.

NVE maintains that the FDA failed to prove such a threat if the supplement is taken correctly, and was swayed by the outcry over ephedra deaths.

"The FDA chose to ignore valid science that showed that there wasn't a problem," said Walter Timpone, a lawyer for NVE. "In 1999, (there were) 104 deaths as a result of aspirin ingestion. Are we going to ban aspirin now?"

Andrew Clark, a Justice Department lawyer arguing the case for the FDA, said the ban is based on sound science.

Research shows ephedra can speed heart rate and constrict blood vessels even in seemingly healthy people, and is particularly risky for those who have heart disease or high blood pressure or engage in strenuous exercise.

"We think it's a rule that can save lives," Clark said.

The ban does not affect decongestants and other medicines containing ephedrine, a synthetic version of ephedra. Drugs containing ephedrine and a chemical cousin called pseudoephedrine are regulated and approved by the FDA and are safe, said agency spokesman Lawrence Bachorik. ]]> Plymouth Couple Sues Maker of Diet Pill http://www.yourlawyer.com/articles/read/7871 Wed, 31 Mar 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7871
David and Patricia Hintz, who live on Third Road, filed a federal lawsuit last week. They claim the weight-loss pills he took caused a blood vessel to burst, resulting in a hemorrhagic stroke on the right side of his brain.

The product, TrimSpa, contained ephedrine or ephedra, which the defendants should have known can cause serious harm, including strokes, or death to users, the suit says.

The U.S. Food and Drug Administration took final action in February to ban the sale of dietary supplements containing ephedra because of health risks.

David Hintz, 49, was hospitalized for several weeks after the stroke, the suit says, and his life activities have been severely restricted since then.

In a Tribune story published in early January, Hintz said numbness, pain and swelling in his legs ended his 19-year career as a sheet metal worker.

Defendants are Goen Technologies Corp., Nutramerica Corp. and TrimSpa, a division of Goen. All are based in New Jersey and were involved in the manufacture, marketing and distribution of TrimSpa, the suit says.

A TrimSpa spokesman said Tuesday the complaint has not been served and he could not comment on it.

The company makes and sells a new ephedra-free product and, of local interest, is a sponsor of NASCAR driver David Stremme of South Bend.

According to the suit, David Hintz began taking TrimSpa at the recommended dosage of one tablet three times a day in early January 2003. He suffered a stroke about a month later.

Since then, he has experienced severe physical pain and mental anguish, suffered permanent injuries, and incurred substantial hospital and medical bills and lost wages, the suit says.

The defendants, the suit adds, assured the product was safe for weight-loss treatment when they knew or should have known the dangerous health risks associated with its use.

The suit seeks compensatory damages and costs.]]> Ephedra Ban Approaching http://www.yourlawyer.com/articles/read/7864 Tue, 30 Mar 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7864
And some nutrition stores are seeing the effects of an FDA ban first hand.

Ephedra is an ingredient that the Food and Drug Administration says isn't worth the risk to the public health.

The Food and Drug Administration finalized the ban on the sale of Ephedra last February.

And as of April 12th it will be illegal to sell any dietary supplements containing Ephedrine.

This comes after the FDA issued a consumer alert warning the public about the risks and side effects associated with Ephedra.

And local nutrition stores are already seeing their customers react to the ban.

Paul Estrada, ATP Nutrition Center, says, "A lot of people are very upset. A lot of us even here at the stores have written to our congress persons and people like that to try and maybe persuade them otherwise and stuff like that. But a lot of people are upset. Some people are I guess happy about it, but I think mainly because they're unaware of what the Ephedra can really help them out with."

Paul says that when April 12th rolls around his store will probably have to send any remaining fat burners with Ephedra back to the manufacturer.]]> Bill to Ban Ephedra Sales In Indiana Heads to The Senate http://www.yourlawyer.com/articles/read/7556 Mon, 09 Feb 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7556
The chemical ephedra has been blamed for more than 155 deaths, including that of Steve Bechler, pitcher for the Baltimore Orioles.

On Dec. 30, 2003, the FDA said it would seek to ban the sale of products containing ephedra. Republican state Senator Ronnie Alting has introduced a bill that would ban the sale of ephedra in Indiana. The bill passed through the Senate Health and Provider Committee unanimously and passed debate by the full Senate last Wednesday.

Ephedra is a common ingredient in many diet pills. However, a recent report released by RAND, a government think-tank, found only minimal evidence that supports the health benefits associated with ephedra.

Ephedra is often referred to as "legal speed," and Nancy Maylath, director of the Student Wellness Office, said that's an accurate description.

"It acts on the same pathways and it acts very similarly to speed and methamphetamines," she said. Ephedra is also in the family of chemicals that are the active ingredients in methamphetamines.

Susan White, director of the Purdue pharmacy, said ephedra is a stimulant similar to epinephrine, a chemical associated with the "fight-or-flight" syndrome. When people take ephedra, their blood vessels dilate, their heart rate increases and their metabolism speeds up. White said pharmacists have been uncomfortable with ephedra for years.

"It should have been taken off the market years ago," she said. "People don't use it as they're supposed to."

People should not take ephedra if they have a pre-existing heart condition or if they are pregnant. White said many people aren't aware of the possible dangers associated with taking ephedra on a regular basis.

Rueben Schuff, senior in the Schools of Engineering, said he takes ephedra to help him study.

"It's a more focused kind of energy," he said. "I only take it when I'm tired and don't have time to sleep."

Schuff also says that the ban would be unnecessary if people used ephedra safely.

"I think people need to take responsibility for themselves and not rely on the government," he said.

Illinois and Ohio have already banned the sale of ephedra. The NFL, NCAA and NBA have all banned the use of ephedra.

Schuff said he will buy a few bottles of ephedra pills if it looks like the bill will pass.

The General Nutrition Center hasn't stocked ephedra since June 2003, said Chris T., the manager of the GNC store in the Tippecanoe Mall. The company removed ephedra in response to the proposed bill that would ban the sale of it. The company has also instituted a card-checking system to prevent the sale of vitamins, diet pills and hormones to minors.

"GNC has always been a leader when it comes to providing our customers with the right product," Chris T. said.]]> FDA Set to Finalize Ephedra Ban http://www.yourlawyer.com/articles/read/7547 Fri, 06 Feb 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7547
It will mark the government's first-ever ban on a dietary supplement. Ephedra has been linked to 155 deaths and dozens of heart attacks and strokes.

In December, the Food and Drug Administration warned consumers to stop using ephedra immediately, saying it was working to ban sales by early this year.

A regulation formally setting that ban in motion will be published "very soon," possibly by Friday, Associate Commissioner Peter Pitts said Thursday.

Sixty days after that publication, all sales must cease.

Ephedra once was hugely popular for weight loss and body building. But it can cause life-threatening side effects even in seemingly healthy people who take the recommended doses, because the amphetamine-like stimulant speeds heart rate and constricts blood vessels. It is particularly risky for anyone with heart disease or high blood pressure or people engaging in strenuous exercise.

Sales already have plummeted because of publicity about the herb's dangers, and three states New York, Illinois and California have passed their own bans. But after FDA's December announcement, sales spiked briefly as some ephedra believers stocked up.

Unlike pharmaceuticals, federal law allows dietary supplements to sell without first providing proof of safety. That law requires the FDA to prove harm before it can force a supplement off the market, a hurdle the agency says is very steep.

The FDA isn't waiting for the formal ban to stop sales of some products that contain ephedra.

On Thursday, the FDA seized supplements from a Massachusetts-based Internet seller, Musclemaster.com, saying the Web site illegally claimed that the products enhanced athletic performance. The products seized included more than 800 bottles of Betatrim, Thermbuterol and Stacker 2. ]]> 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.]]> FDA Plans Closer Look at Diet Supplements http://www.yourlawyer.com/articles/read/7457 Wed, 21 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7457
The agency will issue new guidelines on the manufacture and labeling of herbal diet supplements later this year, CNN quotes McClellan as saying Tuesday during a speech in Mississippi.

He said the FDA will investigate three common ingredients in particular that have been associated with kidney and liver problems: bitter orange, aristolochic acid and usnic acid, CNN reports.

Unlike prescription and over-the-counter drugs, diet supplements do not have to be proven safe before they are marketed. But the FDA does have the authority to investigate and remove from store shelves any supplement it deems a threat to public health.

The pending ban on ephedra, an amphetamine-like herb, was announced Dec. 30. Weight-loss supplements containing the substance have been linked to more than 100 cardiac-related deaths, including that of Baltimore Orioles pitcher Steve Bechler last year.]]> FDA Plans To Expand Inquiry; Diet Aids Targeted http://www.yourlawyer.com/articles/read/7458 Wed, 21 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7458
McClellan, speaking at the University of Mississippi School of Pharmacy, named three ingredients in weight-loss products that are already being tracked: bitter orange, aristolochic acid and a lichen derivative called usnic acid.

The FDA announced last month that it plans to prohibit sales of ephedra, which has been promoted for weight loss, enhanced sports performance and increased energy. The stimulant has been linked to about 16,000 adverse reactions, including strokes, heart attacks and irregular heartbeats. The FDA said as many as 155 deaths also have been linked to ephedra. The ban should go into effect this spring; if it stands up to expected court challenges, it could provide a model for similar bans.

Bitter orange has been used as a replacement for ephedra in weight-loss products. Aristolochic acid, from the plant aristolochia, also has been included in weight-loss preparations. It is a potential carcinogen and has been associated with permanent kidney damage. Usnic acid is a component of Lipokinetix, a dietary supplement that has been associated with serious liver toxicity.

December's ephedra announcement was the first time FDA has moved against a supplement since a 1994 law was passed that holds supplements to a different standard than new drugs, which must go through large-scale safety and effectiveness studies. The law says the FDA can move to block sales of a supplement only if it can prove they ''present an unreasonable risk to health.''

But by later this year, ''the public will not be faced with 'buyer beware' any longer,'' McClellan said Tuesday.

In his speech at the University of Mississippi, McClellan said the agency plans to issue a rule that will lay out a framework for determining whether a dietary supplement presents such a risk. A senior FDA spokesman said the announcement might come as early as next week.

McClellan called for more partnerships with universities and researchers to create the science that will allow the FDA ''to take more effective steps to make sure that dietary supplements that people take are safe and have benefits that outweigh their risks.''

John Hathcock of the Council for Responsible Nutrition, a supplement industry group, says he is impressed with the steps McClellan is taking. ''It's also important to recognize that this is the first time ever that they are attempting to ban a dietary supplement, which says to us that dietary supplements are abundantly safe.'' ]]> 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. ]]> MLB Looking To Ban Ephedra http://www.yourlawyer.com/articles/read/7436 Wed, 14 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7436
On Dec. 30, the U.S. Food and Drug Administration announced that it intended to ban any dietary supplements including the substance ephedrine, pending a final ruling. In the alert, the FDA advised consumers to immediately stop buying and using products including ephedrine. Upon publication of a final ruling, the ban of those products becomes effective in 60 days.

"We're having ongoing discussions with the union," said Rob Manfred, MLB's vice president of labor relations and human resources, during a break in owners meetings here Wednesday. "Because ephedra is not a steroid, it doesn't automatically become banned. But we're moving toward an agreement."

Gene Orza, an associate counsel for the union who works closely with MLB on the joint drug program, couldn't be reached to comment.

MLB banned the use of ephedra at the minor-league level last spring after the death of Baltimore Orioles pitcher Steve Bechler. An autopsy report revealed that a substance including ephedrine was found in Bechler's body and was a contributing factor to the death.

Ephedra, also called Ma huang, is a naturally occurring substance derived from plants. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug, the FDA said in its alert. In recent years ephedra products have been extensively promoted to aid weight loss, enhance sports performance, and increase energy. Bechler came into Orioles camp last February overweight and was trying to work himself back into shape so he could secure a position on the team.

This season, all players on the 40-man rosters of MLB teams, will be subject to two random tests for 28 "Schedule III" anabolic androgenic steroids banned by the FDA. For the first time, MLB players testing positive for those drugs will go into treatment and then risk fines and suspensions for repeated use. Recreational drugs and over-the-counter nutritional substances are not included in the MLB program.

The testing program, though, is much wider in the minor leagues for players who are not on their team's 40-man roster. For those players, alcohol, recreational drugs and over-the-counter nutritional substances are included.

MLB and the union added the steroid-based tetrahydrogestrinone, commonly known as THG, to the list of testable substances after the FDA banned it last year. Only steroid-based drugs banned by the FDA are automatically added to MLB's list of tested substances.

Survey testing for all Major Leaguers on the 40-man roster began this past season and when 5 percent of the players tested positive, the program was formalized for 2004. The program was collectively bargained in 2002 as part of the Basic Agreement, which is in force through the 2006 season. ]]> 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. ]]> Ephedra: Young Stroke Victim Sues For $2.5 Million http://www.yourlawyer.com/articles/read/7380 Tue, 13 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7380 Damon Violette filed the suit against the maker and marketer of a dietary and body building supplement that includes the substance.

The 35-year-old says he had a stroke in 2002 after taking the supplement for about a month.

His suit accuses Metabolife International and the Chemins Company of ignoring health problems.

The lawsuit also names Bally Total Fitness. That's where Violette bought the body-building supplement that includes ephedra.

Spokespeople for each company declined to comment because they hadn't seen a copy of it.

Ephedra has been linked to 155 deaths, including that of Steve Bechler, a Baltimore Orioles pitcher and Oregon native. ]]> FDA Issues Ephedra Alert http://www.yourlawyer.com/articles/read/7359 Fri, 09 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7359
Food and Drug Administration officials have issued a consumer alert on the safety of dietary supplements containing ephedra that calls for consumers to immediately stop buying and using ephedra products.

Besides issuing an alert, FDA officials are notifying manufacturers that they intend to publish a final rule stating dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of these products as soon as it becomes effective, 60 days after publication.

"FDA will publish a final rule as soon as possible that will formalize its conclusions that dietary supplements containing ephedrine alkaloids present unreasonable risks to those who take them for any reason," said Tommy G. Thompson, health and human services secretary.

"[The action] puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now," said Thompson.

"We are taking action today to notify Americans about the unreasonable risk of ephedra as currently marketed in dietary supplements," said Dr. Mark B. McClellan, FDA commissioner. "Our action is based on diligent and thorough work by the agency as required by the challenging legal standard in the dietary supplement law.

"We worked hard to obtain and review all the available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra's safety and effectiveness, adverse event reports, and reviews by independent experts," said McClellan.

In February, a jury in Austin, Texas, determined that ephedra use was at least 50-percent to blame for the death of 24-year-old Charles Bryant Scurlock II, of Round Rock, Texas. Scurlock collapsed and later died after a two-mile run for an Army National Guard physical fitness test in 1999. The jury awarded $1 million to the plaintiffs.

In September 2002, the Air Force surgeon general issued a revised policy covering dietary supplements containing ephedra that strongly discouraged the use of such supplements and highlighted associated risk factors.

In November 2002, the Air Force's surgeon general issued a notice to airmen on the potential risks associated with dietary supplements containing ephedra following the death of a young airman. These medical notices are released by the AFMS clinical quality management division to disseminate lessons learned from medical incident investigations and other pertinent events. ]]> Diet Drug Missing From Most Local Shelves http://www.yourlawyer.com/articles/read/7338 Thu, 08 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7338
Ephedra, an herbal supplement that gained popularity as an energy booster and quick weight-loss aid, was pulled from local shelves months before the U.S. Food and Drug Administration announced it as a potential health risk last week.

Because of paperwork requirements, the earliest the FDA could enforce the ban is in March.

"It's not that it's off the market yet," said Daphne Davis, a pharmacist at Rite Aid off U.S. 1. in Fredericksburg. "But Rite Aid and other chains decided to take it out of their stores for safety and liability reasons."

According to the FDA, ephedra can cause an increase in blood pressure and has been linked to 155 deaths and many heart attacks and strokes in the United States.

Concerns about its safety became an issue last February when ephedra contributed to the death of 23-year-old Baltimore Orioles pitcher Steve Bechler.

Local retailers said few, if any, customers have requested ephedra since it has been in the news.

GNC, which has more than 5,000 health food stores across the country, banned products containing ephedra in June.

Wal-Mart Spokeswoman Danette Thompson said customers seem to prefer ephedra-free products, so they removed ephedra from their stores in May.

Pharmacist Doug Harris at the CVS near Mary Washington Hospital said his company returned all of their ephedra merchandise to the manufacturer months ago after bad publicity began to surface about the diet drug.

"People that were using it were kind of panicking," Harris said.

Other local retailers won't have any ephedra to return.

"We never had it in any of our products," said Bertha Romagnoli, owner of Shaklee Product Distributors in Fredericksburg. "It causes heart problems, complications, seizures, and that's not something I want to sell to my customers."

Carl Braun, owner of Highlander Health and Fitness in downtown Fredericksburg, said the common problem with diet pills like ephedra is abuse.

"People want a quick fix and take 20 times the amount that they should," Braun said. "I'm very pleased that they banned it."

Former body builder Joan Sharperson Hailstalk, 40, of Spotsylvania said retailers made a good decision by stopping the sale of ephedra.

"Stores may end up with a loss in profit, but it's much better than a lawsuit," Hailstalk said.

Although ephedra and ephedra-containing products aren't easily available locally, they can still be bought online.

Ephedra is sometimes disguised on labels of weight-loss or body building products by other names, such as Ma Huang or Desert Herb. It used to be found in popular diet supplements like Metabolife, Herbal Fen-Phen, Stacker and Xenadrine RFA.]]> Students File Suit At 11th Hour http://www.yourlawyer.com/articles/read/7340 Thu, 08 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7340
The lawsuits were filed in Contra Costa Superior Court Dec. 30, just a day before a federal law, granting a one-year window for victims to sue over sexual abuse occurring in the past, expired.

The cases, filed on behalf of "John Doe 36" and "John Doe 43," came less than a month after another former De La Salle student sued the priest once in charge of a St. Helena religious retreat for allegedly molesting him.

The two newest suits do not name the former De La Salle priests accused of the sexual abuse.

In instances when the statute of limitations is about to expire, the law grants an additional 60-day period for investigation, Simons said.

Both the attorney representing the Christian Brothers Order and De La Salle's administration were taken by surprise by the lawsuits.

"This is the first we've seen of both of these," said attorney Paul Gaspari. "We intend to do our due diligence and investigate the claims."

De La Salle President Bruce Shoup said he was not familiar with any of the allegations.

"I can't speak to things going back 30 years," Shoup said. "I don't know that we have anybody who was here that many years ago who would have a recollection of anything improper going on."

Shoup noted that the current administration of De La Salle has a "no tolerance" policy toward sexual abuse.

"In the last 10 years or longer, we have had a hard and fast sexual molestation and sexual harassment policy," Shoup said. "All the staff go through that (on an annual basis).

"We have continued to assure parents that this is a safe and healthy place for boys."

De La Salle's campus has some co-educational classes with nearby Carondelet High School.

The most recent batch of cases point to past abuse that allegedly occurred in the Archdiocese of San Francisco, the Diocese of Oakland as well as two defunct seminary high schools in Santa Cruz and Santa Barbara.

The John Doe 43 lawsuit claims that during 1981 and 1982, a former high school student was molested by a priest who worked as a teacher and counselor at De La Salle.

The John Doe 36 case alleges that during 1975 and 1976, a student was sexually abused by two men: another priest and a lay instructor.

The attorney said one of the two priests had been criminally investigated at some point in the past.

"In both cases, many years ago, the order was appraised of the conduct," he said.

"It's a personal decision," he said. "There are a lot of issues of shame and embarrassment." ]]> Man Blames Stroke on Ephedra Use http://www.yourlawyer.com/articles/read/7360 Thu, 08 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7360
But 37-year-old Michael Smith of Villa Rica said he wishes the FDA had taken such a strong stance years ago before he suffered a stroke.

In 2000, Smith took a dietary supplement containing ephedra called Thermadrene to help shed a few pounds.

He'd been using it for about six weeks without any trouble. Smith said he never had any concerns about how ephedra might affect his health.

"Never, because I had never heard any bad stories about ephedra," Smith said. "I really didn't know that much about what it was. I just knew that it made the weight come off pretty easily."

He said his opinion of ephedra changed dramatically one day when he was rushed to the emergency room after taking two tablets.

"I started feeling side effects like a loss of feeling in my left side, nausea, severe headache, stuff like that," Smith said.

His doctors quickly realized that Smith had suffered a stroke, but they had no idea at first what triggered it.

"There was nothing that was known to him or his family that would cause a stroke," said one of Smith's attorneys. "There was nothing in his medical history, so they were searching for a cause."

The doctors later wrote about Smith's case in a medical journal, concluding that his stroke was "a consequence of his use of a product containing ephedra."

They called for "better government controls" and "more adequate warnings" about the risks on product labels.

"If he had been aware that this drug could cause a stroke, he would have never taken it," said the attorney who represents Smith in a lawsuit against the companies that made, distributed and sold Thermadrene with ephedra.

"There are a lot of innocent people that have been harmed from the use of this product," she said.

In fact, according to the FDA, ephedra has been linked to 155 deaths and 16-thousand cases of adverse reactions, including stroke.

Now seven years after it first tried to regulate the substance, the government is warning consumers they should stop using ephedra. A ban could be in place by march.

In reacting to the FDA's decision, Smith said he felt "a great sense of relief that nobody else may have to go through this as I have."

"I wouldn't wish this on my worst enemy," he said.

Smith spent two months in the hospital after his stroke and has gone through extensive rehabilitation since then.

He still has trouble walking, talking and writing from time to time.

A spokeswoman for one of the defendants in Smith's lawsuit, General Nutrition Companies, Inc., said GNC does not comment on any pending litigation.]]> NASCAR Bans Ephedra http://www.yourlawyer.com/articles/read/7328 Tue, 06 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7328
On Dec. 30, federal officials announced it was moving to ban dietary supplements containing ephedra because of continued health concerns about the product.

The announcement marked the first time U.S. officials have blocked the sale of an over-the-counter nutritional supplement. Unlike drugs, dietary supplements do not have to be proven safe before going on the market, but federal authorities can act to take them off the shelves if they are shown to be unsafe.

Early this year, a regulation will go into affect making it illegal to sell products containing ephedra.

Last season, NASCAR advised its participants in all of its series to seek guidance from their personal physician before taking any supplemental product labeled as containing ephedra/ephedrine.

Ephedra, which is extracted from an Asian plant, was already banned in college sports, the Olympics, the NFL and minor league baseball.

Supplement manufacturer Stacker 2 sponsors the NASCAR Busch Series car of Kenny Wallace. ]]> Ex-UH Athlete Backs Ephedra Ban http://www.yourlawyer.com/articles/read/7329 Mon, 05 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7329
Takemoto says she is glad that the supplement will soon be banned.

Takemoto, a standout in her studies as well as on the soccer field, said she took ephedra on the advice of another player. She said ephedra did give her a lot of energy, so much that she couldn't relax for hours after the game.

She said the herbal supplement appeals to athletes who don't feel like they're going to perform as well as usual, especially on the road. "You're so tired," she said. "You don't get enough sleep. You don't eat much."

The federal government last week announced a ban on the sale of the popular diet supplement ephedra, also known as ma huang, that is expected to take effect as early as March after the federal rules are formally adopted.

The move came after the sudden death last spring of Baltimore Orioles pitcher Steve Bechler, who had been taking ephedra. The supplement also has been linked to heart attacks and strokes, because it speeds heart rate and stresses the system, federal officials said.

For people who buy the herbal supplement in the Islands, it's harder to find the products on the shelf at major stores, health-food stores and specialty retailers.

Takemoto, 22, said she didn't think the quick boost of energy was worth the revved-up feeling that stayed with her. "I didn't want to be dependent on it," she said.

In 2002, Takemoto received academic All-America honors from the National Soccer Coaches Association of America. She is finishing school with a major in Hawaiian studies and history, coaching junior varsity boys soccer at Punahou School and working as a caregiver.

The Mo'ili'ili resident said she knew one woman who took ephedra for weight loss and had such a severe reaction that she was hospitalized. "I'm glad that they're banning it," she said.

The Food and Drug Administration is notifying consumers and 62 manufacturers that it will soon be illegal to sell ephedra, a move that is expected to face challenge from those who sell the supplement, which charted sales last year of more than $300 million.

Costco stopped selling diet supplements that contain ephedra nationwide about a year ago, said Charles Burnett, senior vice president for Costco's pharmacy division. Burnett said the Washington-based chain had carried a Metabolife diet product that contained the drug, but discontinued that version because of the growing controversy.

"We wanted to be on the more-than-safe side," Burnett said. "We don't want to carry anything that would cause anybody harm."

Huckleberry Farms health-food stores in Nu'uanu did carry some products containing ephedra earlier but stopped as fewer distributors handled the supplement because of the controversy.

Manager Sharonne Pascua said customers still ask for ephedra now and then, but the company stopped stocking the items after the supplement was linked to health problems.

Pascua said people looking to buy ephedra usually want it for weight loss. Despite that lucrative dieter market, Pascua said many health-food companies want to steer clear of such an item, even before a ban takes effect. "The health food industry realized that herbs if used improperly can be detrimental to your health," she said.

Pascua said at her store the staff encourages customers to do research on supplements before they take anything.

And they encourage common sense among consumers. When it comes to weight loss,"there are no miracles," Pascua said. "You and I both know that diet and exercise are the only way to bring your weight down and keep it off."

At Down to Earth, an employee was pulling any remaining products that contain ephedra off the shelves, but the company would not comment.

Kokua Market vitamin buyer Karen Murray said the health-food store hasn't carried ephedra products for at least 18 months.

"There's too much controversy over it," Murray said. "You don't want people getting hurt using it wrongly."

In May, the national General Nutrition Centers chain also stopped selling products with ephedra.

At Mits' Basic Foods in Kaka'ako, owner Mits Kawashima said he's been easing out of the sale of products that contain ephedra for months.

Kawashima knows that at least one regular customer will be disappointed by the news that ephedra is being phased out in anticipation of the ban. Kawashima said he had been ordering ephedra for an experienced canoe paddler who has taken the supplement regularly for the energy boost. "It does help him with his paddling," Kawashima said.]]> FDA Bans Herbal Stimulant http://www.yourlawyer.com/articles/read/7330 Mon, 05 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7330
The FDA plans to officially ban, and has given manufacturers 60 days to recall, ephedra-based dietary supplements linked to thousands of health complications, including the death of Baltimore Orioles pitcher Steve Belcher last February.

Once a popular supplement among serious dieters and athletes, ephedra can increase a person's risk of heart attack, stroke and other ailments - even if taken in moderate doses, medical experts say.

FDA commissioner Mark McClellan made last week's announcement alongside Health and Human Services Secretary Tommy Thompson, who reported more than 16,000 "adverse incidents" in a government study involving ephedra-related dietary products.

"Today's actions tells consumers that the time to stop using these products is now," said Thompson, who estimates there are about 62 companies making and selling dietary supplements with ephedra.

Sales already have plummeted because of publicity about the herb's dangers. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.

The herbal remedy, which was originally extracted from a Chinese shrub called ma huang, is traditionally used to treat bronchial ailments. In recent years, companies have harnessed ephedra's stimulative effects in dietary and performance-enhancing products.

Ephedra will be the first additive banned under 1994's Dietary Supplement Health and Education Act, which forces federal regulators to clearly prove a public risk before triggering a product ban. The act differs greatly from the rules governing pharmaceutical makers, who must prove a drug's efficacy and safety before winning FDA approval to sell it.

Local sellers of herbal remedies distanced themselves from the dietary products in question, saying ephedra's risks have been known for years. At Debra's Natural Gourmet in Concord, a ban on ephedra-based dietary and performance-enhancing products has been in effect since the store's opening in 1989.

"We're certainly familiar with it," said Debra Stark, owner of the holistic shop. "We made the decision not to carry it in any dietary supplements anything to jazz you up."

A spokesman at Whole Foods Market, which operates six stores in MetroWest, offered similar sentiments, adding that the grocery chain stopped selling ephedra-based dietary products well before yesterday's news.

However, he said Whole Foods, like most pharmacies, carries some decongestants and bronchial dilators made with ephedra. The government's ban does not include decongestants or bronchial medications.

"Is the problem with ma huang or ephedra? Not really. It's the people marketing it and using it. They're not reading the directions," said Gary Kracoff, owner of Johnson Drug in Waltham. "Medicinally, it does have its place."

Peguy Caddeus, manager of the Vitamin Shoppe in Framingham, stopped carrying ephedra-based dietary supplements last spring after Belcher's collapse on the baseball diamond.

"Ever since that, we stopped. Everybody stopped," he said.

With all of the negative publicity, Caddeus said shoppers would be hard pressed to find the products anywhere in MetroWest, let alone Massachusetts. Three states: Illinois, New York and California have already banned the sale of ephedra-based diet products.

Most retail chains have quit selling ephedra-containing products, and only a handful of major ephedra producers still are in business to supply Internet sellers. Even market leader Metabolife International suspended ephedra sales last month, citing ambiguities in state laws.

"It's a dead product, and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

Ephedra makers insisted their products are safe if used correctly, but so far aren't saying if they'll sue to block the ban.]]> FDA Orders Sales Ban On Ephedra http://www.yourlawyer.com/articles/read/7331 Wed, 31 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7331
Ephedra, linked to heart ailments, is simply too risky to be used,'' said Tommy Thompson, secretary of health and human services. He advised people to stop using it immediately.

Consumer groups lauded the ban but said it should have occurred long ago. Companies that make or sell ephedra products maintained they were safe, and Thompson said he expected a lawsuit in an attempt to block the ban.

In the Kansas City area, most nutrition stores and weight-loss centers contacted Tuesday said use of ephedra had dropped sharply in the last year or two because of reported risks.

Ephedra is promoted by manufacturers as good for weight control, building muscles and increasing energy. But its chemicals also can affect heart rate and increase blood pressure, studies show.

The FDA sent letters to 62 manufacturers Tuesday urging them to stop dispensing ephedra, even though the sales ban will not take effect for 60 days after publication in the Federal Register to allow time for congressional review.

We have long been urging the FDA to take decisive action because it's been a product creating negative publicity that has washed over the whole diet supplement industry, said Judy Blatman of the Council for Responsible Nutrition, which represents 80 dietary product makers. It has hurt consumer confidence.

Public Citizen, a consumer advocacy group, petitioned the FDA to ban ephedra more than two years ago because of a reported 81 ephedra-linked deaths, a number that has since almost doubled. The ban is far too late, the group said.

This is an inexcusable dereliction of responsibility by an agency that has acted more like an ephedra sales extension agency than the public-health agency it is supposed to be, said Sidney Wolfe, director of the Public Citizen Health Research Group.

A leading manufacturer of ephedra products, in a statement issued Tuesday, said the supplement was safe, though the company said it should not be used by minors or by athletes trying to improve performance.

Millions of consumers throughout the United States have used ephedra dietary supplements as safe, inexpensive and effective means by which to support weight loss, said Jan Strode, spokeswoman for Metabolife International Inc.

Strode said the company would carefully consider its options regarding the ban when the final rules are published in the Federal Register. The San Diego company suspended sales of ephedra last month pending clarification of a California ban on the supplement, Strode said.

The owner of a store in Overland Park that sells 30 to 50 bottles of ephedra products monthly was displeased with the ruling but said it won't put him out of business.

If you're going to take a product like that, you have to do it responsibly, said Russell Wood of Fit 4 Less. This is just the government telling you what's best for you.

The FDA has been concerned about ephedra for some time, and last February it ordered warning labels to be placed on products that contain it. The order came 11 days after Baltimore Orioles pitcher Steve Bechler died of heat stroke that a medical examiner linked in part to his use of ephedra.

A lot of times when people are desperate and want to lose weight, they are looking for quick fixes,'' said Kristi Widmar, public relations manager for the Weight Watchers International Inc. regional office in Kansas City. It's kind of an eye-opener for them to realize, Boy, this isn't as safe as I thought. If the federal government doesn't believe in it, maybe I shouldn't either.'

Not many stores carry ephedra in the Kansas City area, according to interviews with store owners.

There is just too much negative media out there, and we don't like to associate ourselves with that, said Paul Bennett, of Harvest Moon Natural Foods in Olathe.

Bennett said ephedra products once made up 5 percent to 10 percent of all supplement sales and that a lot of customers were upset when he no longer carried them.

The Nutrition Business Journal has reported that ephedra product sales of about $1.4 billion last year could drop to $300 million to $500 million this year. Ephedra is banned in three states Illinois, California and New York.

They're almost impossible to get, said Larry Maples, owner of the Muscle Matrix store in Olathe. Ephedra is tempting to athletes but is banned by the National Collegiate Athletic Association, National Football League and minor league baseball. It is not banned in Major League Baseball, the National Hockey League or National Basketball Association.

High school coaches have tried to keep athletes from using ephedra. Four years ago, Olathe East High School suspended 15 athletes for using Ripped Fuel, which contains ephedra.

I believe it is a dangerous substance, Olathe East varsity football coach Jeff Meyers said. I'm glad it's being outlawed.]]> U.S. Bans Ephedra, Drug Linked to Deaths http://www.yourlawyer.com/articles/read/7307 Tue, 30 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7307
It was the government's first-ever ban on a dietary supplement, one that comes eight years after the Food and Drug Administration first began receiving reports that ephedra could be dangerous.

"The time to stop taking these products is now," Health and Human Services Secretary Tommy Thompson said. "They are simply too risky to be used."

Ephedra once was hugely popular for weight loss and body building. But it can cause life-threatening side effects even in seemingly healthy people who use the recommended doses, because the amphetamine-like stimulant speeds heart rate and constricts blood vessels. It is particularly risky for anyone with heart disease or high blood pressure or people engaging in strenuous exercise.

The ban isn't immediate because federal rules require paperwork steps that mean the earliest it could take effect would be March. But the FDA wrote 62 current and former makers and sellers on Tuesday that, "we intend to shut you down," said Commissioner Mark McClellan.

"There are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk," McClellan said. "Any responsible manufacturer and retailer should stop selling these products as soon as possible."

Thompson said he was announcing the upcoming ban now so that people making New Year's resolutions to lose weight won't be tempted to try ephedra.

"Ephedra raises your blood pressure and stresses your system," McClellan added. "There are far better, safer ways to get in shape."

The FDA put manufacturers on notice that it will be watching what ingredients replace ephedra in weight-loss products. But while the ban sets an important legal precedent for supplement regulation, no other crackdowns are imminent, McClellan said.

Critics called the ephedra ban long overdue.

Sales already have plummeted because of publicity about the herb's dangers, which peaked after the ephedra-related death of Baltimore Orioles pitcher Steve Bechler last February. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.

Three states: New York, Illinois and California have passed their own bans. Most retail chains have quit selling ephedra-containing products, and only a handful of major ephedra producers still are in business to supply Internet sellers. Even market leader Metabolife International suspended ephedra sales last month, citing ambiguities in state laws.

"It's a dead product, and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

Wolfe petitioned the government for a ban in 2001, when the agency had reports of 81 deaths. That number now is 155; also, FDA has reports of more than 16,000 health complaints from ephedra users.

"It was unfortunately only with the tragic death of a high-profile athlete that this started to get the attention that was due," added Dr. Mark Estes of the New England Medical Center in Boston, who called FDA unresponsive to years of physician complaints.

Others welcomed FDA's crackdown.

"It won't bring Steve back, but it will help and protect other people," said Pat Bechler, the baseball player's mother. Her husband Ernie recently urged Congress to pass a ban, saying, "Please don't let my son die in vain."

Added the American Heart Association "Being thin is not worth risking your life by using questionable products."

The FDA said it couldn't act any sooner because of a controversial federal law that lets dietary supplements sell over the counter without any requirements that they prove safe first. To curb supplement sales, FDA must prove a clear danger to public health something Thompson called "a tremendous burden of proof" that Congress should rethink.

In March, the FDA proposed putting tough new warning labels on ephedra and said it was building a case for a ban. In the ensuing months, FDA scoured all the available science and more than 10,000 public comments about ephedra to carefully build a case that could withstand court challenge.

"We are laying the strongest possible foundation to not only take the product off the market, but to keep it off," McClellan said.

Ephedra makers insisted their products are safe if used correctly, but so far aren't saying if they'll sue to block the ban.

"Millions of consumers throughout the United States have used ephedra dietary supplements as a safe, inexpensive and effective means by which to support weight loss," San Diego-based Metabolife said.

"Cold medicine kills more people a year than ephedra does," charged Robert MacKenzie, owner of MaxOutBody.com, an Internet supplement seller that has sold $300,000 worth of ephedra since July. He said he is looking for ephedra-free alternatives to sell once the ban begins.

But ephedra, also called ma huang, has divided the supplement industry, and the leading Council for Responsible Nutrition had no plans to oppose the ban.

"We think the reputable players have found so much controversy and difficulty in this marketplace that they've decided to get out of it," said CRN's John Hathcock. "We recognize the controversy is a cloud over our whole industry."

The final regulation outlining the ephedra ban will be formally released in a few weeks, and take effect 60 days later. ]]> FDA Takes Strong Action Against Ephedra http://www.yourlawyer.com/articles/read/7310 Tue, 30 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7310
Although 4 individual states have already banned, or partially banned the sale of ephedra, Tuesday's announcement marks a new role for the FDA: It's the first time U.S. officials have attempted to block the sale of an over-the-counter nutritional supplement a move some in Washington had been working on for years.

FDA Commissioner Mark McClellan calls the move the "result of a long hard road."

The road has been long not only for government officials, but also for families who've lost loved ones, including that of Baltimore Orioles pitcher Steve Bechler, who's heat stroke death last February was attributed to the use of ephedra by medical examiners.

Last July, Bechler's mother gave emotional testimony before the House Energy and Commerce Committee, urging the government to ban ephedra on behalf of her son and others who had died while taking the supplement.

"He was 23 years old, married for two months with a child on the way. Now he has a daughter that will never know how great her daddy was. How many Steve Bechlers or Sean Riggins have to die to prove that these are not safe?," she said in her testimony.

Sean Riggins' father also testified after, he says, his 16-year-old son took ephedra to enhance his athletic abilities.

"September 3rd of last year, Sean had a heart attack and died in our home. The cause: ephedra," Riggins' father told the congressional committee.

According to the FDA, some 155 deaths can be attributed to ephedra.

The Department of Health and Human Services says ephedra, an herbal supplement, poses several health dangers, including heart attacks, strokes, seizures, and death.

But some ephedra marketing companies disagree with this assessment.

The FDA notified 62 companies that market products containing ephedra of the planned ban, including the San Diego-based Metabolife, the most widely sold supplement. Metabolife, which also sells ephedra-free products, said it "respectfully disagrees" with the FDA decision and will "carefully consider its options."

"If it was dangerous and had been shown it was dangerous, it would have already been taken off the market," said Richard Kreider of the Ephedra Education Council.

Some organizations have already banned the use of ephedra products, including the NCAA, the International Olympic Committee and the NFL. Following Steve Bechler's death, the FDA had proposed having warning labels put on the front of ephedra products. Even the American Medical Association and other medical groups called for a ban of the supplement.

But it was still legal to buy and sell. So why the unprecedented move to ban it?

Dietary supplements aren't regulated like drugs; they don't have to get prior approval from the FDA.

"The law requires us to go through a very, much of a scientific finding. When a pharmaceutical company wants to put a drug on the market, they have to prove its efficacy and safety, but nutrition and food supplement drugs don't have to go through that process," explained Secretary Thompson.

Tuesday's ruling came after months of scientific analysis by the FDA, who said they studied over 16,000 adverse incidents reports. The law is now in the final administrative process and is expected to be completed in a few weeks, after which, stores would have 60 days to remove ephedra products from their shelves. ]]> 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. ]]> U.S. To Ban Sale Of Ephedra http://www.yourlawyer.com/articles/read/7312 Tue, 30 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7312
"The time to stop taking this product is now," Health and Human Services Secretary Tommy Thompson said in announcing the government's first-ever ban on a dietary supplement. "They are just too risky to use." The ban was based on extensive scientific study involving more than 16,000 reports of adverse health effects from products containing ephedra, officials said. It will formally take effect 60 days after a federal rule is formally published in a few weeks.

Thompson said he was announcing the ban now so Americans emerging from the holiday season with New Year's plans to lose weight won't be tempted to use the dietary supplement. "I don't want people turning to ephedra thinking they could lose weight," he said.

Roughly 155 deaths have been blamed on the amphetamine-like stimulant, including the heat stroke of Baltimore Orioles baseball player Steve Bechler earlier this year. Ephedra is linked to heart attacks and strokes, even when used by outwardly healthy people at recommended doses, because it speeds heart rate and constricts blood vessels.

Canada issued a recall order almost two years ago for ephedra products that make claims of weight loss or increased energy.

However, the January 2002 recall allows ephedra containing products in traditional medicines provided they have no caffeine and contain less then eight milligrams of ephedrine, a chemical derivative of ephedra per dose, to a maximum of 32 milligrams a day.

Much smaller amounts are permitted in a wide range of over-the-counter products such as nasal decongestants and cough medicines.

Mark McClellan, chief of the U.S. Food and Drug Administration, said his agency is notifying consumers and 62 manufacturers that it will publish a rule making it illegal to sell and use ephedra.

But he called on both to stop the sale and use of ephedra immediately.

"By alerting the public right now we're sending a strong and clear signal that dietary supplements containing ephedrine alkaloids should come off the shelves," McLellan said.

"You all know there are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk. Any responsible manufacturer and retailer should stop selling these products as soon as possible," he said.

McClellan said the FDA reviewed major studies of ephedra and publicly issued findings about the herb. He said the publication received thousands of comments and expressions of support for taking the product off the market.

"Ephedra raises your blood pressure and stresses your system," McClellan said. "There are far better, safer ways, to get in shape."

Critics called the federal crackdown too late. U.S. sales already have plummeted because of publicity about the deaths.

Ernie Bechler, father of the baseball player who died, said he was awakened by a phone call around 6 a.m. local time with word of the decision.

"It's the only thing that could make my wife and I be happy," he said. "Nothing else could have done what this is doing. I mean to get this off the market and to save other peoples' lives is just amazing to us."

Ernie Bechler testified in Congress, urging a ban. "That's the last thing I said: 'Please don't let my son die in vain.' "

At the news conference, McClellan said FDA has spent months "scouring all of the adverse effects reports." The decision was not based on adverse effects alone, he said, but also on clinical studies and expert opinion and review.

"It is the totality of the evidence" that was used to make the decision, he said.

McClellan said the FDA was prepared to defend the action in court. "We are laying the strongest possible foundation to not only take the product off the market, but to keep it off," he said.

Three states: New York, Illinois and California have passed their own ephedra bans. Its use has been banned in professional football, college athletics and minor-league baseball, and several retail chains, including supplement giant General Nutrition Centers, recently quit selling it, too.

"It's a dead product and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, which petitioned the government for a ban in 2001.

Wolfe urged remaining manufacturers to recall all ephedra-containing products still on store shelves. For any future ephedra-linked injuries, "there's going to be hell to pay in terms of increased liability on the part of the companies that are allowing it to be sold," he said.

The supplement industry's Council for Responsible Nutrition said it didn't oppose a ban, noting that very few companies still make the stimulant, and its members who once did no longer do so.

Remaining ephedra manufacturers didn't immediately comment Tuesday, but have insisted that studies prove their products 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," Metabolife International chief executive Russell Schreck said over the summer. "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'." ]]> Bechler's Parents: Ephedra Ban Will Save Lives http://www.yourlawyer.com/articles/read/7314 Tue, 30 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7314
The Baltimore Orioles pitcher's heatstroke in February was linked to the herbal weight-loss supplement, which also has been blamed for more than 150 other deaths.

"In one aspect, I feel that it's not enough, because it won't bring Steve back," Bechler's mother, Pat, said in a telephone interview from Medford, Ore.

"But it will help and protect other people."

While the NFL, NCAA and International Olympic Committee already banned ephedra, major league baseball did not.

Baseball commissioner Bud Selig and Gene Orza, associate general counsel of the Major League Baseball Players Association, did not immediately return phone calls Tuesday.

Mike Flanagan, the Orioles' vice president for baseball operations, said Tuesday's announcement "is one the Orioles' organization has pushed for" since Bechler's death.

"The Orioles sincerely hope that people heed this message, and that the government continues to take any and all steps to stop the manufacture and sale of products with ephedra," Flanagan said.

Steve Bechler, 23, died during spring training in Fort Lauderdale, Fla. The medical examiner said ephedra contributed to heatstroke.

In July, Bechler's parents testified before Congress in support of a ban. His father, Ernie, said Tuesday that one of the last things he told lawmakers was: "Please don't let my son die in vain."

A dietary supplement firm being sued over Bechler's death has said it believes the Baltimore Orioles are liable and wants the team to pay any damages stemming from a lawsuit filed by the player's widow.

Nutraquest Inc. of Wall Township, N.J., formerly known as Cytodyne Technologies Inc., claimed in U.S. District Court in Miami that the tragedy "could have been avoided" if the team had acted properly.

Richard H. Catalina Jr., an attorney for the company, declined to comment specifically on the Bush administration's ephedra ban.

"It has been our position all along that the product Xenadrine RFA was safe if taken as directed by healthy individuals," Catalina said.

Steve Bechler's widow, Kiley, has filed a $600 million wrongful death lawsuit against the company. ]]> Statewide Ephedra Ban Signed Into Law http://www.yourlawyer.com/articles/read/7020 Wed, 12 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7020
Storekeepers who now sell the product face a fine of up to $500, according to the new law, which does not cover over-the-counter medicines containing ephedra, which fall under the watch of the Federal Drug Administration.

"There is a lot of evidence that people are using ephedra to their detriment in many cases," said Kristine Smith, spokeswoman for the New York State Department of Health. "Many people, since it is an herb, a natural product, think it is good for you, but rather we have seen it associated with many serious illnesses and even death when used in conjunction with physical activity," Smith said.

Smith said the state's timing on this issue was based on the fact there were many studies and peer-reviewed articles published on the dangers of combining ephedra for weight loss and use in physical activities. "It was the weight of the evidence," Smith said. "There have been a number of studies recently on ephedra and many peer-reviewed articles published on ephedra when it is used for weight loss in conjunction with athletic performance."

Smith said that although New York State realizes banning products such as ephedra is typically the federal government's job and that "the Federal Drug Administration is considering banning it, the governor felt now was the right time to ban it."

The sponsor of the bill, New York State Senator Charles Fuschillo Jr. (R- Freeport), said he started his own personal research on the subject after reading about the death of Baltimore Orioles pitcher Steve Bechler last year, who died after taking ephedra during Spring Training and also pointed to two Suffolk County residents who died after taking the herb during the last two years as impetus for his interest. After researching the product, he said he found there were more than 100 deaths reported related to the use of ephedra.

"It was just horrific," Fuschillo said. "It wasn't regulated, there was no recommended use or dosage, and people thought it was a muscle building and weight loss pill." Out of all the complaints lodged with government agencies against all natural herb products, Fuschillo said 61% were complaints about ephedra. "When you look at a product that is unregulated and causing death, it is time to do something about it," he said.

Fuschillo, chairman of the State Senate Consumer Protection Committee, introduced the legislation last spring and held a public hearing on the idea.

Suffolk County Executive Robert Gaffney signed the bill banning ephedra sales in Suffolk County this past February. The bill, introduced by Legislator Jon Cooper (D-Huntington), followed an earlier Suffolk County ban on the sale of the product to minors. The bill was introduced, Cooper said at the time, because he had become concerned about the death of a 20-year-old ephedra user, the son of a constituent.

"I am happy it will help set a national trend," Cooper said of the state ban. "This is something that ultimately had to be done at the federal level. My hope is that as states move to ban it, it will put pressure on the federal government to ban it."]]> Lawmakers Ask FDA To Ban Ephedra http://www.yourlawyer.com/articles/read/6955 Fri, 07 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6955
"Ephedra isn't snake oil it's snake venom," said Rep. Jim Greenwood, R-Pa., who chaired hearings on the supplement last summer in the wake of the death of a 23-year-old Baltimore Orioles pitcher who had been taking ephedra.

The FDA is considering a nationwide ephedra ban, similar to ones in New York, California and Illinois. But while U.S. Health and Human Services Secretary Tommy Thompson remains concerned about the supplement, "we are going as far as we can right now within the context of the law," said HHS spokesman Bill Pierce.]]> Lawmakers Target Ephedra http://www.yourlawyer.com/articles/read/6958 Thu, 06 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6958
"Ephedra isn't snake oil it's snake venom," said Rep. Jim Greenwood (R., Pa.), who chaired hearings on the supplement last summer in the wake of the death of a 23-year-old Baltimore Orioles pitcher who had been taking ephedra.

"Snake oil is something that you take that doesn't do you any good," said Rep. Greenwood. "Snake venom and ephedra is snake venom kills. This product is not only of no value for weight loss, [it has got] no value for anything that is connected with good health. And it is extremely dangerous."

The FDA is considering a nationwide ephedra ban, similar to ones in New York, California and Illinois. But while Health and Human Services Secretary Tommy Thompson remains concerned about the supplement, "we are going as far as we can right now within the context of the law," said spokesman Bill Pierce.

A 1994 law left dietary supplements largely unregulated. The statute requires the FDA to prove that a dietary supplement is harmful rather than having the manufacturer prove that it is safe, as with drugs. The agency is currently collecting that legal and scientific evidence.

Since the law only applies to natural dietary supplements, the FDA already has yanked manufactured, or synthetic, ephedra from retail shelves, noted Mr. Pierce.

Ephedra is used to lose weight and boost athletic performance. The Ephedra Education Council, an industry-funded group, has said the supplement is safe when used correctly. The group also said there is no clinical study that shows the supplement causes harm.

But Sen. Dick Durbin (D., Ill.), said the supplement has been linked to at least 155 deaths and 16,500 heart attacks, strokes and seizures.

"Nothing's been done by Sec. Thompson," charged Sen. Durbin. "These are lethal products that are killing unsuspecting Americans, and it should be taken off the shelves immediately."

Also calling for the ban were California Democratic Reps. Susan Davis and Henry Waxman and Rep. Greg Walden (R., Ore.). ]]> Still Lots of Danger In Ephedra-Free Products http://www.yourlawyer.com/articles/read/6960 Wed, 05 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6960
Shaking. Sweating. A ridiculous boost of energy that had this former aerobics instructor running her class into the ground.

Susan Schillingberg, who took an Ephedra-free supplement, said "I can't do this cuz I was teaching like 2 to 3 classes a day and he said here drink this, and I drank it, and they were like 'Susan what is wrong with you???"

What was wrong? She'd taken a dietary supplement packed with Guarana, a natural plant substance. But the Ephedra-free boost didn't feel that way.

Schillingberg said, "no difference to me... It was like drinking a gallon of coffee."

Her side-effects were very much like those caused by Ephedra. Ephedra-free weight-loss products contain stimulants which can cause rapid heartbeat, sweats, even strokes and heart attacks, just like Ephedra.

Tom Sterrett, a former Ephedra user, said "I was sweating, shaking couldn't sleep."

Ephedra's been linked to 800 injuries, including 50 deaths. One of those, Major League Baseball player Steve Bechler, sparked Congress to look into the dangers and prompted the Food and Drug Administration to require a warning label on all products containing Ephedra. Major nutrition stores have pulled it off the shelves.

As a result, more and more people are turning to different supplements to shed those extra pounds, but they're finding out. Ephedra-free doesn't always mean danger-free."

Dr. Dino Delaportes of Washington County Hospital said, "what patients need to understand is these products usually have large amounts of caffeine"

Some of the ingredients to watch out for??? Bitter Orange, Guarana, Ma Huang, Sida Cordifolia, Citrus Aurantium, Kola Nut, Synephryne, and Green Tea Extract. Another danger: these products aren't regulated by the FDA.

Nutritionist Lisa McCoy said, "we really don't know how these active ingredients work together and also how they interact with other medications, even something like an allergy medication."]]> New York Becomes 2nd State to Ban Ephedra http://www.yourlawyer.com/articles/read/6868 Tue, 04 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6868
Gov. George Pataki on Monday signed the new law, which calls for fines of up to $500 for each sale of the supplement. Ephedra's prescription sales are not affected by the law, WCBS Radio reports.

Illinois has already banned the substance, which is used to lose weight and enhance athletic performance. Hawaii, Massachusetts, Nebraska and New Jersey are considering similar bans.

Manufacturers say ephedra is safe when used correctly.

Ephedra use has been tied to numerous deaths, according to the U.S. Food and Drug Administration. In February, Baltimore Orioles pitcher Steve Bechler died of heatstroke during spring training. The medical examiner said ephedra contributed to his heatstroke. Bechler was 23
]]> N.Y. Bans Ephedra As Supplement http://www.yourlawyer.com/articles/read/6869 Tue, 04 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6869
The law, signed by Gov. George Pataki, includes a fine of up to $500 for each sale of the supplement and takes effect immediately. Ephedra's prescription sales are not affected.

Manufacturers of ephedra are facing lawsuits and a possible ban by the Food and Drug Administration. Illinois and several New York counties already ban the substance. In May, Florida joined New Jersey and California in banning ephedra sales to minors.

Ephedra is used to lose weight and boost athletic performance and has been linked to several deaths, according to the FDA. The Ephedra Education Council, an industry-funded group, says the supplement is safe when used correctly.

Bechler, 23, died of heatstroke in February during spring training. The medical examiner said ephedra contributed to his heatstroke.]]> Pataki Signs Ephedra Ban http://www.yourlawyer.com/articles/read/6870 Mon, 03 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6870
The public signing was attended by Baltimore Orioles vice president Mike Flanagan, who was present in February when Orioles pitcher Steve Bechler collapsed and later died from ephedra-induced heatstroke.

The governor actually had signed the ban into law on Aug. 19 and the ban took effect on Oct. 19.

Dietary supplements containing ephedra are now prohibited, and a $500 fine is to be levied for each violation against anybody who knowingly violates the ban.

Exceptions allow ephedra to be included in nonprescription drugs which are regulated by the federal Food and Drug Administration and for the sale of ma huang by practitioners of traditional Chinese medicine and acupuncture. Ma haung, the herb ephedra is derived from, is an important element in these practices.

The principle active ingredient in ephedra is ephedrine. When it is chemically synthesized ephedrine is regulated as a drug.

Research has shown that severe side effects, including death, can occur with ephedra use, especially when combined with strenuous physical activity, or taken with another stimulant, such as caffeine.

A recent Rand Corp. study concluded that ephedra is associated with higher risks of side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, tremors and insomnia, the governor's office said. ]]> Ephedra Xenadrine Heart Attack Stroke Side Effects Lawyer http://www.yourlawyer.com/topics/overview/ephedra Mon, 03 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/ephedra DOWNLOAD OUR EPHEDRA INFORMATION PACKAGE

Injured by Ephedra?

Ephedra is a plant consisting of six ephedrine alkaloids and has been linked with serious side effects including:
  • Stroke
  • Heart attack
  • Palpitations
  • Hypertension
  • Coma
  • Tachycardia
  • Respiratory depression
  • Death
Ephedra, derived from an Asiatic shrub, contains ephedrine, a stimulant that acts on the central nervous system to relax bronchial tubes. A synthetic form of ephedrine is used in bronchodilators and over-the-counter medications like Sudafed and Actifed, which fall under the FDA's watch.  Before being banned, Ephedra was used in over the counter weight loss supplements, asthma remedies, cold and allergy remedies, and sports energy drinks.  According to a study commissioned by the Food and Drug Administration (FDA), Ephedra can seriously harm or kill somebody who uses it who is unaware of the associated hazards.

On December 31, 2003 Government officials announced plans to ban dietary supplements containing Ephedra due to continued health concerns about the product, and warned consumers not to take products containing the stimulant.  The government has determined that products containing Ephedra "present an unreasonable risk of illness or injury," said Food and Drug Administration Commissioner Mark McClellan.  On February 6, 2004 the Government finalized its ban of Ephedra.

Unlike drugs, dietary supplements do not have to be proven safe before going on the market, but federal authorities can act to take them off the shelves if they are shown to be unsafe. The FDA also issued a consumer alert warning the public to immediately stop buying and using Ephedra. The government issued a regulation making it illegal to sell products containing Ephedra. 

The Annals of Internal Medicine reported that, although products with Ephedra make up less than 1% of dietary supplement sales, it has accounted for 64%of the serious side effects that have been reported to the Centers for Disease Control and Prevention in association with dietary supplements. A second study published in the journal Neurology found that the rate of strokes among Ephedra users was higher than in nonusers. The supplement users in the study took more than 32 milligrams a day; some Ephedra labels recommend almost 100 milligrams daily.

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