Case study: A soldier suffers health problems after using Hydroxycut
Robert Tropea is a plaintiff in a planned lawsuit against maker Iovate Health Sciences Inc.
By Melissa Healy melissa.healy@latimes.com
May 25, 2009
Early this month, Robert Tropea was at his new job at the cash register of an Army PX when his former sergeant rushed in to deliver some news: Hydroxycut, the weight-loss supplement Tropea had taken for three months in 2007, had been recalled from the market. The FDA had linked the product to a string of illnesses, including liver damage, seizures, abnormal heart function and a condition called rhabdomyolysis.
Tropea says he was "completely shocked": How could an herbal supplement he took to trim down do all that? At least, he thought, it offered an explanation for the mysterious turn in his health and fortune.
A former Army radio operator stationed in Stuttgart, Germany, the 27-year-old had been medically discharged from the service just six months before. After a physical-training session with his sergeant in July 2007, Tropea's arm and shoulder muscles ached as they never had before. His urine was black. At the hospital, a blood test showed his creatine kinase levels -- a test for organ and muscle damage -- were 3,000 times the normal limit.
Doctors diagnosed rhabdomyolysis, an acute breakdown of muscle tissue that can damage the liver and kidneys and, in severe cases, cause sudden death. Because rhabdomyolysis is most often the result of crush injuries, heat stroke, alcoholism or drug use, doctors thought it was unusual to see the condition in a fit, active-duty serviceman who, according to his military records, drank alcohol very rarely, had regularly passed drug tests, and had no recent history of trauma. Fearing a potentially disastrous recurrence, Tropea's physicians have warned against physical exertion of any kind.
He used to bench press hundreds of pounds and could do push-ups with one arm. Now, says Tropea, he has trouble picking up his 3-year-old daughter and worries that he won't be able to coach her soccer team one day. His Army career -- from which he had planned to retire as an officer after completing his college degree -- is over.
Hydroxycut, Tropea believes, has left his health -- and his future -- uncertain. Tropea, who still lives in Stuttgart, is among the first wave of plaintiffs in a planned lawsuit against Iovate Health Sciences Inc., the maker of Hydroxycut.
"I thought of it as a supplement to help burn fat and increase energy -- no different than a vitamin to help me with exercise," says Tropea of the Hydroxycut Hardcore supplement he took. "I had read the label, looked at some of the ingredients. Quite a bit of it, I didn't know what it was. But they were selling it as something safe, and I took what they said and ran with it." Iovate refused to discuss Tropea's experience. "We have not seen the complaint and therefore cannot comment on it," said company spokeswoman Jamie Moss.
Like 59% of Americans polled by the Harris Poll in 2002, Tropea believed a government agency such as the FDA assured the safety of dietary supplements before they could be sold to the public. It is a belief that is only partially true.
Tropea had not even thought to inform his doctors that he had been taking Hydroxycut steadily for the three months leading up to his hospitalization, in an effort to boost his fitness level and get down to the weight limits set for active-duty soldiers. The only medication he had ever taken was Ibuprofen. And Hydroxycut, he reasoned, wasn't medication.
That's where Tropea was wrong.
"Dietary supplements are typically derived from plants and minerals, and they certainly can have effects on the body" as powerful as the effects that drugs can have, says David B. Allison, director of the University of Alabama at Birmingham's Clinical Nutrition Research Center and an expert on the safety of dietary supplements.
"This idea that dietary supplements are all natural is nice. But they're really no different than many drugs which are traditionally derived from minerals or extracts of plants or animals. And everything we do and take has side effects."
Monday, May 25, 2009
Saturday, May 2, 2009
Another Weight Loss Gimmick or Tool?
Friday, May 01, 2009
When Your Diet Needs a Band-Aid
A new "smart patch" determines caloric intake and expenditure.
By Lauren Gravitz
Weight watcher: A foam patch, like the one in this illustration, will monitor caloric intake and expenditure and send the data via Bluetooth to the user's cell phone. Credit: PhiloMetron
It could be a dieter's best friend or worst nightmare: technology that knows how much a person has just eaten, knows how many calories he has burned off, offers suggestions for improving resolve and success, and never lets him cheat. And it's all done by a small, stick-on monitor no bigger than a large Band-Aid.
The calorie monitor, which is being developed by biotech incubator PhiloMetron, uses a combination of sensors, electrodes, and accelerometers that--together with a unique algorithm--measure the number of calories eaten, the number of calories burned, and the net gain or loss over a 24-hour period. The patch sends this data via a Bluetooth wireless connection to a dieter's cell phone, where an application tracks the totals and provides support. "You missed your goal for today, but you can make it up tomorrow by taking a 15-minute walk or having a salad for dinner," it might suggest.
Caloric-intake monitoring has long been the bugaboo of dieting systems. There are devices, such as the bodybugg, that can measure energy expenditure through a combination of accelerometers, pedometers, and temperature and sweat sensors. But the intake side is much trickier to track. Currently, the most reliable way to determine caloric intake is meticulous diary keeping or having a trained professional do the calorie counting.
"What they're working on here, I would argue, is the holy grail in health and wellness," says Don Jones, vice president of business development for health and life sciences at Qualcomm, which specializes in wireless technologies. Other than the two methods mentioned above, he notes, which aren't scalable and aren't always accurate, "there are no good methods for calculating caloric intake."
PhiloMetron won't yet reveal exactly what makes its patch tick, but the company says that it consists of a single chip surrounded by numerous sensors, electrodes, and accelerometers, embedded in a foam adhesive patch. The system, which is designed to be replaced once a week, measures a variety of things (temperature, heart rate, respiratory rate, skin conductivity, possibly even the amount of fluid in the body), then throws the data into an algorithm to calculate the number of calories consumed, the number burned, and the net yield. Caloric-intake measurements are accurate only to about 500 calories--about two Snickers candy bars. But PhiloMetron CEO Darrel Drinan says that it is much more accurate in determining net gain or loss and is most useful for measuring trends over the course of a week or a month. In fact, the system only provides users with rolling 24-hour totals and no instantaneous data.
An increasing number of studies conclude that a diet's success or failure depends on simply decreasing the number of calories consumed. Be it a Mediterranean, Atkins, Weight Watchers, or South Beach diet, it's the caloric bottom line that matters.
"A repeatable trend is a more useful value than an accurate number," says Drinan. "The trend line helps you establish the pattern to your behavior." He says that the company is working with the largest device manufacturers, weight management, and pharmaceutical companies--"and none believe we need more sensitivity because of the long-term nature of the underlying problem."
PhiloMetron's prior ventures include the recently launched Corventis which sells a sensor-based patch that detects the volume of fluid in a person with congestive heart failure and notifies her when it's time to take a diuretic. PhiloMetron plans to spin off another startup company to market a calorie monitor, with a product on the market in 18 months. Drinan envisions the product being sold through health-care professionals or personal trainers, or at gyms. But the system will cost a pretty penny: somewhere between $100 and $400, sold as a kit with multiple patches included.
"There's 1.6 billion people in the world who are overweight, and approximately 600 million of them are obese, so there's consumer applications all over the place here--for everything from weight management to part of disease-management programs, to consumer applications for fitness and wellness," says Jones of Qualcomm.
Eric Topol, director of the Scripps Translational Science Institute, in San Diego, and a practicing cardiologist, is interested in the device as a way to help keep his patients on track. He says that the technology is not only possible, it's reality: "Digestion and metabolic activity affects tissue conductance, and this can be detected via appropriate sensors worn on the skin."
Topol is interested in putting together a randomized clinical trial to see if the device can help people reverse type 2 diabetes, or help prevent progression to the disease in the first place. "I'm not suggesting that this is going to cure the obesity epidemic," he says. "[But] I think it has great potential--if it works and it's validated--to make an impact in the most common public-health problems today."
When Your Diet Needs a Band-Aid
A new "smart patch" determines caloric intake and expenditure.
By Lauren Gravitz
Weight watcher: A foam patch, like the one in this illustration, will monitor caloric intake and expenditure and send the data via Bluetooth to the user's cell phone. Credit: PhiloMetron
It could be a dieter's best friend or worst nightmare: technology that knows how much a person has just eaten, knows how many calories he has burned off, offers suggestions for improving resolve and success, and never lets him cheat. And it's all done by a small, stick-on monitor no bigger than a large Band-Aid.
The calorie monitor, which is being developed by biotech incubator PhiloMetron, uses a combination of sensors, electrodes, and accelerometers that--together with a unique algorithm--measure the number of calories eaten, the number of calories burned, and the net gain or loss over a 24-hour period. The patch sends this data via a Bluetooth wireless connection to a dieter's cell phone, where an application tracks the totals and provides support. "You missed your goal for today, but you can make it up tomorrow by taking a 15-minute walk or having a salad for dinner," it might suggest.
Caloric-intake monitoring has long been the bugaboo of dieting systems. There are devices, such as the bodybugg, that can measure energy expenditure through a combination of accelerometers, pedometers, and temperature and sweat sensors. But the intake side is much trickier to track. Currently, the most reliable way to determine caloric intake is meticulous diary keeping or having a trained professional do the calorie counting.
"What they're working on here, I would argue, is the holy grail in health and wellness," says Don Jones, vice president of business development for health and life sciences at Qualcomm, which specializes in wireless technologies. Other than the two methods mentioned above, he notes, which aren't scalable and aren't always accurate, "there are no good methods for calculating caloric intake."
PhiloMetron won't yet reveal exactly what makes its patch tick, but the company says that it consists of a single chip surrounded by numerous sensors, electrodes, and accelerometers, embedded in a foam adhesive patch. The system, which is designed to be replaced once a week, measures a variety of things (temperature, heart rate, respiratory rate, skin conductivity, possibly even the amount of fluid in the body), then throws the data into an algorithm to calculate the number of calories consumed, the number burned, and the net yield. Caloric-intake measurements are accurate only to about 500 calories--about two Snickers candy bars. But PhiloMetron CEO Darrel Drinan says that it is much more accurate in determining net gain or loss and is most useful for measuring trends over the course of a week or a month. In fact, the system only provides users with rolling 24-hour totals and no instantaneous data.
An increasing number of studies conclude that a diet's success or failure depends on simply decreasing the number of calories consumed. Be it a Mediterranean, Atkins, Weight Watchers, or South Beach diet, it's the caloric bottom line that matters.
"A repeatable trend is a more useful value than an accurate number," says Drinan. "The trend line helps you establish the pattern to your behavior." He says that the company is working with the largest device manufacturers, weight management, and pharmaceutical companies--"and none believe we need more sensitivity because of the long-term nature of the underlying problem."
PhiloMetron's prior ventures include the recently launched Corventis which sells a sensor-based patch that detects the volume of fluid in a person with congestive heart failure and notifies her when it's time to take a diuretic. PhiloMetron plans to spin off another startup company to market a calorie monitor, with a product on the market in 18 months. Drinan envisions the product being sold through health-care professionals or personal trainers, or at gyms. But the system will cost a pretty penny: somewhere between $100 and $400, sold as a kit with multiple patches included.
"There's 1.6 billion people in the world who are overweight, and approximately 600 million of them are obese, so there's consumer applications all over the place here--for everything from weight management to part of disease-management programs, to consumer applications for fitness and wellness," says Jones of Qualcomm.
Eric Topol, director of the Scripps Translational Science Institute, in San Diego, and a practicing cardiologist, is interested in the device as a way to help keep his patients on track. He says that the technology is not only possible, it's reality: "Digestion and metabolic activity affects tissue conductance, and this can be detected via appropriate sensors worn on the skin."
Topol is interested in putting together a randomized clinical trial to see if the device can help people reverse type 2 diabetes, or help prevent progression to the disease in the first place. "I'm not suggesting that this is going to cure the obesity epidemic," he says. "[But] I think it has great potential--if it works and it's validated--to make an impact in the most common public-health problems today."
Friday, May 1, 2009
It Was Only A Matter of Time (and Consequences) Before The FDA Would Take Notice
FDA warns dieters: Stop Hydroxycut use immediately
By RICARDO ALONSO-ZALDIVAR, Associated Press Writer Posted May 1, 2009
WASHINGTON – Government health officials warned dieters and body builders Friday to immediately stop using Hydroxycut, a widely sold supplement linked to cases of serious liver damage and at least one death.
The Food and Drug Administration said the maker of the dietary supplement has agreed to recall 14 Hydroxycut products. Available in grocery stores and pharmacies, Hydroxycut is advertised as made from natural ingredients. At least 9 million packages were sold last year, the FDA said.
Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy living in the Southwest. The teenager died in 2007, and the death was reported to the FDA this March.
Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One received a transplant and another was placed on a list to await a new liver.
There was no immediate comment from the U.S. distributor of the diet pill, Iovate Health Sciences, headquartered near Buffalo, N.Y. Made by a Canadian company, Hydroxycut is used by people trying to shed pounds and by body builders to sharpen their muscles.
Dietary supplements aren't as tightly regulated by the government as medications. Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers. But regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems.
Katz said it has taken so long to get a handle on the Hydroxycut problem because the cases of liver damage were rare and the FDA has no authority to review supplements before they're marketed. "Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow," she said.
The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge.
Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times. A medical journal report last month raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said it could potentially damage the liver.
FDA Press Release
-------------------------
RANT:
I've been worried about this product for many years. As well as another weight loss/muscle building supplement commonly known as NO-xplode.
I've seen a few young men in the pediatric ICU with heart issues and found out they were using these products....but the cardiologist were looking at physiological/organic causes rather than inorganic vasodilator/high caffeine/unknown proprietary 'blend' of ghod knows what. These products may be created from "natural" ingredients, but they have real medicinal affects on the human body. And finally there is some active reporting (but why did the doctors WAIT a year to report the death???). It took 81 reported deaths before ephedra was banned by the FDA.
By RICARDO ALONSO-ZALDIVAR, Associated Press Writer Posted May 1, 2009
WASHINGTON – Government health officials warned dieters and body builders Friday to immediately stop using Hydroxycut, a widely sold supplement linked to cases of serious liver damage and at least one death.
The Food and Drug Administration said the maker of the dietary supplement has agreed to recall 14 Hydroxycut products. Available in grocery stores and pharmacies, Hydroxycut is advertised as made from natural ingredients. At least 9 million packages were sold last year, the FDA said.
Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy living in the Southwest. The teenager died in 2007, and the death was reported to the FDA this March.
Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One received a transplant and another was placed on a list to await a new liver.
There was no immediate comment from the U.S. distributor of the diet pill, Iovate Health Sciences, headquartered near Buffalo, N.Y. Made by a Canadian company, Hydroxycut is used by people trying to shed pounds and by body builders to sharpen their muscles.
Dietary supplements aren't as tightly regulated by the government as medications. Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers. But regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems.
Katz said it has taken so long to get a handle on the Hydroxycut problem because the cases of liver damage were rare and the FDA has no authority to review supplements before they're marketed. "Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow," she said.
The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge.
Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times. A medical journal report last month raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said it could potentially damage the liver.
FDA Press Release
-------------------------
RANT:
I've been worried about this product for many years. As well as another weight loss/muscle building supplement commonly known as NO-xplode.
I've seen a few young men in the pediatric ICU with heart issues and found out they were using these products....but the cardiologist were looking at physiological/organic causes rather than inorganic vasodilator/high caffeine/unknown proprietary 'blend' of ghod knows what. These products may be created from "natural" ingredients, but they have real medicinal affects on the human body. And finally there is some active reporting (but why did the doctors WAIT a year to report the death???). It took 81 reported deaths before ephedra was banned by the FDA.
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