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PEOPLE Top 5 are the most-viewed stories on the site over the past three days, updated every 60 minutes
- July 01, 2002
- Vol. 58
- No. 1
A Deadly Diet Aid?
Hyped as a Weight-Loss Miracle, Ephedra Is Banned by the NFL, Targeted by the FDA, Suspected in Dozens of Deaths—and Easily Available at a Drugstore Near You
In private, Richard Gregory, 35, had a special way of addressing his wife, Shannon, 32. "My name for her was Sexy Slim," says Gregory, an Air Force master sergeant. But like so many other women worried about their weight, Shannon, who at 6 ft. fluctuated between 150 and 170 lbs., had trouble accepting compliments about her looks. Gregory recalls, "She'd say, 'Yeah, right. Sexy Fat.' "
While working as a doctor's secretary and raising the couple's children Shameka, 15, Latasha, 10, and Nigel, 7, Shannon watched what she ate and exercised regularly. In the spring of 2001, according to her husband, with summer fashions and a family reunion on her mind, Shannon began taking a diet aid called Xenadrine RFA-1 that she had heard about on a TV infomercial. "We heard all of the good about it," says Gregory, who would later learn the pills contained an amphetamine-like herbal stimulant known as ephedra that speeds the heart and suppresses appetite, "not the bad."
On April 4, 2001, just as Gregory was about to leave his home in Newport News, Va., to meet his wife at a high school running track, someone called to say that Shannon had collapsed while jogging. About 45 minutes later, in the hospital emergency room, with Gregory standing by helplessly, doctors pronounced Shannon dead of cardiac arrest. "I hugged her and told her goodbye," he recalls, sobbing. "It was so hard to believe."
According to her autopsy, Shannon "appeared to be a healthy woman" with no heart, cardiovascular or lung problems. Tests conducted later revealed no traces of cocaine, amphetamines or opiates in her blood. What she did have in her system were levels of ephedra and three closely related chemicals that were "consistent with those found in others who had serious health problems after ephedra-product use," says Bill J. Gurley, a University of Arkansas pharmacology professor who evaluated the test results.
Last November, alleging that his wife's death was "a direct and proximate result" of taking Xenadrine, Richard Gregory became one of some 100 people who have sued ephedra-products makers in the past two years. (An attorney for Xenadrine's manufacturer, Cytodyne Technologies, says Shannon's death was related to other factors and his product played no role.) The mounting legal claims, coupled with disturbing medical reports linking the popular compound to deaths and serious maladies, have raised red flags in the U.S. and elsewhere about ephedra. "They are the most dangerous of all the dietary supplements being sold," says Dr. Sidney Wolfe, director of Public Citizen Health Research Group, a Washington, D.C., consumer watchdog organization that petitioned the Food and Drug Administration to stop the production and sale of ephedra products. On June 14 the Health and Human Services department announced an expanded scientific evaluation of ephedra scheduled to begin this fall; in the meantime the agency urges consumers who experience chest pains to stop taking ephedra.
Used in China for thousands of years to treat asthma, herbal ephedra (also called ma huang, after the spindly shrub from which it is derived) is an active ingredient in more than 200 diet aids and energy boosters that often contain caffeine and other chemicals to boost effectiveness. Sold in pill, liquid and powder form at drug and health food stores, they carry names like Ripped Fuel and Metabolife. A synthetic chemical twin of the substance (called ephedrine) is used in a small number of over-the-counter asthma medications that are closely monitored by the FDA. Unlike the version created by drug companies, the herbal form isn't regulated. And because they successfully lobbied Congress in 1994 to be exempted from most FDA rules, herbal product makers aren't obligated to test their goods before selling them nor to report health problems resulting from their use.
Despite ephedra's unknowns, many weight-conscious women, professional athletes and regular-guy bodybuilders still swear by it. Last year sales to some 9 million customers pushed total revenues to $1.1 billion. Home-maker Karen Ruiz from San Clemente, Calif., says she started taking ephedra-containing diet pills in 1996 based on claims in a newspaper ad. "It said the product was made of all-natural herbs, and that sounded good to a tired mom like me," says Ruiz, 34, who has two children, James, 8, and Justine, 6, with husband Donald, 42, an electronics distributor. After just five days she began to experience severe delusions and paranoia that landed her on a psychiatric ward. (She settled a legal claim against the manufacturer for an undisclosed amount.)
Reports of drastic side effects have led many to conclude that ephedra, although herbal, is neither healthy nor harmless—especially when combined with caffeine. "The caffeine, the ephedra and so on are synergistic," says Gurley. "For the wrong person at the wrong time, it's problematic." After reviewing 135 reports of serious reactions to the compound, including irregular heart rhythms, strokes, seizures—and 10 deaths—Dr. Ray Woosley, vice president of health sciences at the University of Arizona, says, "It's clearly killing people." The government of Canada warned its citizens last summer to avoid ephedra. And following the deaths of some high school and college athletes suspected of using ephedra, the NFL joined the NCAA and the International Olympic Committee in banning it.
To help the FDA assess the stimulant's safety, the government has hired the Rand Corporation, a research group, to examine more than 1,300 medical emergencies reportedly related to ephedra since 1993. "We have the authority to remove unsafe products," says Christine Lewis Taylor, the FDA's point woman on diet supplements, whose office collected the reports, "but first we have to prove they are unsafe."
All of which has the dietary-supplement industry scrambling. Wes Siegner, legal counsel for the Ephedra Education Council, a lobbying group representing six leading makers and marketers, cites several research reports showing that the products are safe and effective when used according to the label and dismisses medical studies suggesting a link between the compound and medical problems as either flawed or inconclusive. Siegner also contends that with millions of people using ephedra each year it's inevitable that some will have heart attacks or strokes for reasons unrelated to the supplement.
Furthermore, countless ephedra users, such as Jeannie Dodge, insist that it works. A homemaker with three children from Victorville, Calif., Dodge, 36, says she has lost 150 lbs. in two years through a combination of gym workouts, daily five-mile walks and ephedra. "I feel like I'm just starting my life now," she says. Indeed, Dodge was so pleased with her results that in 2000 she appeared in a TV ad for Metabolife 356.
Todd Weger of Arlington, Texas, tells a much different story. A decorated former U.S. Army paratrooper in top physical condition, he says he almost died after taking an ephedra-spiked supplement named Ultimate Orange. "My friends at the gym said it gave them extra energy on days when they were feeling slow," says Weger, now 33.
On Dec. 29, 1998, as he was making pancakes for his son Austin, Weger downed a glass of ephedra powder mixed with water before heading out to the gym. Later, while running on a treadmill, Weger says he felt a sensation "like a pinprick in my brain" and fell to the floor. Weger was rushed to Arlington Memorial Hospital, where Dr. Kevin Connor told him he had suffered a stroke. "He said that the Ultimate Orange was the only thing that could have caused it," recalls Weger.
Later that night he had a second, more serious stroke. Fighting to relieve the swelling in Weger's head and save his life, surgeons eventually removed almost half of his brain tissue. "They were saying, 'We don't know if he's going to make it,' " recalls Weger's father, Mike, 53, a private investigator.
By all accounts Weger's recovery has been miraculous. After three years of physical therapy, he can walk, talk and perform many functions that were impossible immediately after the strokes, and he has regained the ability to do simple math in his head. "People said I wouldn't be able to live on my own or feed myself, but it just made me work harder," says Weger, who sued Next Proteins, the makers of Ultimate Orange, and received a $4 million out-of-court settlement in 2001. Next Proteins president David Jenkins declined to discuss Weger's case, except to say that his company no longer makes Ultimate Orange.
Meanwhile, other cases are moving toward trial. Vincent Livsey, a taciturn corn and soybean farmer from Marshall, Mo., becomes visibly upset when he describes how he collapsed with a heart seizure while playing racquetball after he took Metabolife 356 in 1999. "My life just spun out of control," recalls Livsey, who says his heart stopped beating for more than five minutes, causing extensive brain damage, before he was revived by EMS workers. Dr. Dan Pierce, the cardiologist who treated him, subsequently discovered that Livsey had a clogged artery but argues that the blend of stimulants in the Metabolife pills acted in a way that dangerously overstressed his heart. Adding ephedra, caffeine and strenuous exercise made Livsey more susceptible, Pierce said in a sworn deposition: "It's like adding fuel to the fire."
Livsey is suing Metabolife International Inc. of San Diego for negligence in a case scheduled to begin in the fall. During pretrial hearings, Metabolife relied on statements from Dr. Steven Karch, a cardiac pathologist, who says there is no evidence that herbal ephedra causes cardiac arrest in individuals with underlying coronary artery disease. Moreover, the Ephedra Education Council's Siegner cites a recent industry-sponsored study in which researchers at New York City's St. Luke's-Roosevelt Hospital Center and Beth Israel Deaconess Medical Center in Boston found no significant side effects among 87 overweight men and women who were given ephedra and caffeine (or a placebo) for six months.
Meanwhile, in Sanford, Fla., former school secretary Brenda Propps is slated to go to court against Starlight International, the maker of NaturalTRIM ephedra-based diet pills. Propps, 53, alleges that she suffered a debilitating stroke after taking the pills in 1998. "I take care of her every personal need," says her husband, Mike, 56, a former medical supply salesman who quit his job to give his wife the 24-hour care she now requires. (David Cohen, Starlight's National Science Counsel, says, "There is not any way that NaturalTRIM could have caused this stroke.")
As concern among health experts grows, it's getting harder to argue against closer scrutiny of ephedra. Dr. N.A. Mark Estes III, coauthor of a study published in the journal Mayo Clinic Proceedings this past January, notes that dieters with no evidence of cardiovascular disease have experienced serious health problems after taking ephedra at the dosages indicated on the bottle. "It raises the possibility that even normal, healthy people can be at risk," says Estes, who advocates comprehensive testing of the chemical.
Of course for Richard Gregory and his three children, it's too late for more testing. Shattered by his wife's death, Gregory moved his family to Greenville, Ala., where as high schoolers he and Shannon first met and where she's buried. "Shannon got the job done," he says. "Housewife, working wife—she was always get-up-and-go. I knew I was blessed." Now he must raise his children without her. "You do your best with what you have," Gregory says as he watches them play football on the lawn outside his house. "Life is a gift."
Patrick Rogers
Giovanna Breu in Marshall, Steve Ellman in Greenville, Melody Simmons in Manassas, Gail Cameron Wescott in Orlando, Diane Herbst in New York City, Frances Dinkelspiel in Oakland, John Hannah and Jill Movshin Singer in Los Angeles and Ellise Pierce in Dallas
While working as a doctor's secretary and raising the couple's children Shameka, 15, Latasha, 10, and Nigel, 7, Shannon watched what she ate and exercised regularly. In the spring of 2001, according to her husband, with summer fashions and a family reunion on her mind, Shannon began taking a diet aid called Xenadrine RFA-1 that she had heard about on a TV infomercial. "We heard all of the good about it," says Gregory, who would later learn the pills contained an amphetamine-like herbal stimulant known as ephedra that speeds the heart and suppresses appetite, "not the bad."
On April 4, 2001, just as Gregory was about to leave his home in Newport News, Va., to meet his wife at a high school running track, someone called to say that Shannon had collapsed while jogging. About 45 minutes later, in the hospital emergency room, with Gregory standing by helplessly, doctors pronounced Shannon dead of cardiac arrest. "I hugged her and told her goodbye," he recalls, sobbing. "It was so hard to believe."
According to her autopsy, Shannon "appeared to be a healthy woman" with no heart, cardiovascular or lung problems. Tests conducted later revealed no traces of cocaine, amphetamines or opiates in her blood. What she did have in her system were levels of ephedra and three closely related chemicals that were "consistent with those found in others who had serious health problems after ephedra-product use," says Bill J. Gurley, a University of Arkansas pharmacology professor who evaluated the test results.
Last November, alleging that his wife's death was "a direct and proximate result" of taking Xenadrine, Richard Gregory became one of some 100 people who have sued ephedra-products makers in the past two years. (An attorney for Xenadrine's manufacturer, Cytodyne Technologies, says Shannon's death was related to other factors and his product played no role.) The mounting legal claims, coupled with disturbing medical reports linking the popular compound to deaths and serious maladies, have raised red flags in the U.S. and elsewhere about ephedra. "They are the most dangerous of all the dietary supplements being sold," says Dr. Sidney Wolfe, director of Public Citizen Health Research Group, a Washington, D.C., consumer watchdog organization that petitioned the Food and Drug Administration to stop the production and sale of ephedra products. On June 14 the Health and Human Services department announced an expanded scientific evaluation of ephedra scheduled to begin this fall; in the meantime the agency urges consumers who experience chest pains to stop taking ephedra.
Used in China for thousands of years to treat asthma, herbal ephedra (also called ma huang, after the spindly shrub from which it is derived) is an active ingredient in more than 200 diet aids and energy boosters that often contain caffeine and other chemicals to boost effectiveness. Sold in pill, liquid and powder form at drug and health food stores, they carry names like Ripped Fuel and Metabolife. A synthetic chemical twin of the substance (called ephedrine) is used in a small number of over-the-counter asthma medications that are closely monitored by the FDA. Unlike the version created by drug companies, the herbal form isn't regulated. And because they successfully lobbied Congress in 1994 to be exempted from most FDA rules, herbal product makers aren't obligated to test their goods before selling them nor to report health problems resulting from their use.
Despite ephedra's unknowns, many weight-conscious women, professional athletes and regular-guy bodybuilders still swear by it. Last year sales to some 9 million customers pushed total revenues to $1.1 billion. Home-maker Karen Ruiz from San Clemente, Calif., says she started taking ephedra-containing diet pills in 1996 based on claims in a newspaper ad. "It said the product was made of all-natural herbs, and that sounded good to a tired mom like me," says Ruiz, 34, who has two children, James, 8, and Justine, 6, with husband Donald, 42, an electronics distributor. After just five days she began to experience severe delusions and paranoia that landed her on a psychiatric ward. (She settled a legal claim against the manufacturer for an undisclosed amount.)
Reports of drastic side effects have led many to conclude that ephedra, although herbal, is neither healthy nor harmless—especially when combined with caffeine. "The caffeine, the ephedra and so on are synergistic," says Gurley. "For the wrong person at the wrong time, it's problematic." After reviewing 135 reports of serious reactions to the compound, including irregular heart rhythms, strokes, seizures—and 10 deaths—Dr. Ray Woosley, vice president of health sciences at the University of Arizona, says, "It's clearly killing people." The government of Canada warned its citizens last summer to avoid ephedra. And following the deaths of some high school and college athletes suspected of using ephedra, the NFL joined the NCAA and the International Olympic Committee in banning it.
To help the FDA assess the stimulant's safety, the government has hired the Rand Corporation, a research group, to examine more than 1,300 medical emergencies reportedly related to ephedra since 1993. "We have the authority to remove unsafe products," says Christine Lewis Taylor, the FDA's point woman on diet supplements, whose office collected the reports, "but first we have to prove they are unsafe."
All of which has the dietary-supplement industry scrambling. Wes Siegner, legal counsel for the Ephedra Education Council, a lobbying group representing six leading makers and marketers, cites several research reports showing that the products are safe and effective when used according to the label and dismisses medical studies suggesting a link between the compound and medical problems as either flawed or inconclusive. Siegner also contends that with millions of people using ephedra each year it's inevitable that some will have heart attacks or strokes for reasons unrelated to the supplement.
Furthermore, countless ephedra users, such as Jeannie Dodge, insist that it works. A homemaker with three children from Victorville, Calif., Dodge, 36, says she has lost 150 lbs. in two years through a combination of gym workouts, daily five-mile walks and ephedra. "I feel like I'm just starting my life now," she says. Indeed, Dodge was so pleased with her results that in 2000 she appeared in a TV ad for Metabolife 356.
Todd Weger of Arlington, Texas, tells a much different story. A decorated former U.S. Army paratrooper in top physical condition, he says he almost died after taking an ephedra-spiked supplement named Ultimate Orange. "My friends at the gym said it gave them extra energy on days when they were feeling slow," says Weger, now 33.
On Dec. 29, 1998, as he was making pancakes for his son Austin, Weger downed a glass of ephedra powder mixed with water before heading out to the gym. Later, while running on a treadmill, Weger says he felt a sensation "like a pinprick in my brain" and fell to the floor. Weger was rushed to Arlington Memorial Hospital, where Dr. Kevin Connor told him he had suffered a stroke. "He said that the Ultimate Orange was the only thing that could have caused it," recalls Weger.
Later that night he had a second, more serious stroke. Fighting to relieve the swelling in Weger's head and save his life, surgeons eventually removed almost half of his brain tissue. "They were saying, 'We don't know if he's going to make it,' " recalls Weger's father, Mike, 53, a private investigator.
By all accounts Weger's recovery has been miraculous. After three years of physical therapy, he can walk, talk and perform many functions that were impossible immediately after the strokes, and he has regained the ability to do simple math in his head. "People said I wouldn't be able to live on my own or feed myself, but it just made me work harder," says Weger, who sued Next Proteins, the makers of Ultimate Orange, and received a $4 million out-of-court settlement in 2001. Next Proteins president David Jenkins declined to discuss Weger's case, except to say that his company no longer makes Ultimate Orange.
Meanwhile, other cases are moving toward trial. Vincent Livsey, a taciturn corn and soybean farmer from Marshall, Mo., becomes visibly upset when he describes how he collapsed with a heart seizure while playing racquetball after he took Metabolife 356 in 1999. "My life just spun out of control," recalls Livsey, who says his heart stopped beating for more than five minutes, causing extensive brain damage, before he was revived by EMS workers. Dr. Dan Pierce, the cardiologist who treated him, subsequently discovered that Livsey had a clogged artery but argues that the blend of stimulants in the Metabolife pills acted in a way that dangerously overstressed his heart. Adding ephedra, caffeine and strenuous exercise made Livsey more susceptible, Pierce said in a sworn deposition: "It's like adding fuel to the fire."
Livsey is suing Metabolife International Inc. of San Diego for negligence in a case scheduled to begin in the fall. During pretrial hearings, Metabolife relied on statements from Dr. Steven Karch, a cardiac pathologist, who says there is no evidence that herbal ephedra causes cardiac arrest in individuals with underlying coronary artery disease. Moreover, the Ephedra Education Council's Siegner cites a recent industry-sponsored study in which researchers at New York City's St. Luke's-Roosevelt Hospital Center and Beth Israel Deaconess Medical Center in Boston found no significant side effects among 87 overweight men and women who were given ephedra and caffeine (or a placebo) for six months.
Meanwhile, in Sanford, Fla., former school secretary Brenda Propps is slated to go to court against Starlight International, the maker of NaturalTRIM ephedra-based diet pills. Propps, 53, alleges that she suffered a debilitating stroke after taking the pills in 1998. "I take care of her every personal need," says her husband, Mike, 56, a former medical supply salesman who quit his job to give his wife the 24-hour care she now requires. (David Cohen, Starlight's National Science Counsel, says, "There is not any way that NaturalTRIM could have caused this stroke.")
As concern among health experts grows, it's getting harder to argue against closer scrutiny of ephedra. Dr. N.A. Mark Estes III, coauthor of a study published in the journal Mayo Clinic Proceedings this past January, notes that dieters with no evidence of cardiovascular disease have experienced serious health problems after taking ephedra at the dosages indicated on the bottle. "It raises the possibility that even normal, healthy people can be at risk," says Estes, who advocates comprehensive testing of the chemical.
Of course for Richard Gregory and his three children, it's too late for more testing. Shattered by his wife's death, Gregory moved his family to Greenville, Ala., where as high schoolers he and Shannon first met and where she's buried. "Shannon got the job done," he says. "Housewife, working wife—she was always get-up-and-go. I knew I was blessed." Now he must raise his children without her. "You do your best with what you have," Gregory says as he watches them play football on the lawn outside his house. "Life is a gift."
Patrick Rogers
Giovanna Breu in Marshall, Steve Ellman in Greenville, Melody Simmons in Manassas, Gail Cameron Wescott in Orlando, Diane Herbst in New York City, Frances Dinkelspiel in Oakland, John Hannah and Jill Movshin Singer in Los Angeles and Ellise Pierce in Dallas
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