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Suits question science on diet supplementsDate: 23.06.2003
Posted by: Anabolic Info Team France
When a California judge handed down a $12.5 million false-advertising judgment against the maker of an ephedra-based weight-loss pill late last month, he also issued what amounted to a bill of reproach against the science of dietary supplements.
.
The company, Cytodyne Technologies, maker of the supplement implicated in the death of a Baltimore Orioles pitcher, had not just exaggerated the findings of clinical trials it commissioned, Judge Ronald Styn of Superior Court said in ruling on a class-action suit. It had also cajoled some researchers into fudging results in published scientific articles.
.
The evidence, Styn said, had left him no alternative but to conclude that the researchers had set out to create a study that "justified the money being spent" by Cytodyne and would ensure that they received further work from the company.
.
The Cytodyne case is part of a swelling tide of litigation that is raising serious questions about how makers of ephedra and other dietary supplements use - and often misuse - the promise of scientific proof to market products.
.
In the past eight months, three leading manufacturers of weight-loss pills have been hit with false-advertising verdicts in the millions of dollars. A fourth has been rebuked by a federal judge for hiding evidence. The Missouri attorney general and a group of district attorneys in California have also brought false-advertising suits against manufacturers, and Congress has demanded Cytodyne's research records.
.
Under pressure in the courts and from regulators, some manufacturers, including Cytodyne, have refashioned some weight-loss products without the herbal stimulant. Last week, legislative leaders in Albany agreed to make New York the second state to ban ephedra, after Illinois, and the federal government is considering a ban.
.
But experts say a switch in ingredients does not alter the industry's reliance on questionable science. They say they are concerned because there is so little rigorous research on the ephedra substitutes, primarily synephrine.
.
Supplement makers are not obliged to do research.
.
A 1994 law exempts them from having to prove that their products are harmless and effective. But the $18 billion-a-year supplement industry has embraced research because, when carefully aimed, it can be worth money.
.
Precisely because the industry is not regulated, its research is sometimes not strictly scientific, experts say.
.
"There will be 250 to 300 clinical trials on nutraceuticals this year," said Anthony Almada, a consultant and founder of EAS Inc., the biggest sports nutrition company, who advocates scientific research on products but criticizes the way supplement makers do it. "The rigor applied in these studies on the average is somewhat notably less than that of a drug study," he said.
.
Often relying on as few as a dozen subjects, these studies are scaled-down versions of the double-blind, placebo-controlled clinical trials required before drugs may be approved.
.
An industry spokesman, Steven Dentali, vice president for science and technical affairs at the American Herbal Products Association, said that "whenever there's a desired outcome, you've got the potential for bias." But he said supplement science is no worse than that done for pharmaceuticals.
.
The Food and Drug Administration has collected reports linking ephedra to more than 100 deaths. But most of the studies done have been too small and too limited to assess the danger. A Rand Corp. analysis combining results of the many small studies found legitimate evidence that ephedra worked for weight loss in the short term but could produce many cardiac side effects.
.
Documents from the lawsuits, including e-mail and experiment records, provide an inside look at how the demands of marketing have sometimes compromised those of science. They show how companies and researchers suppressed negative data; removed product names from abstracts when the conclusions showed no positive effects; changed statistical methods to see if results improved, and left out subjects who complained of troublesome side effects. The New York Times When a California judge handed down a $12.5 million false-advertising judgment against the maker of an ephedra-based weight-loss pill late last month, he also issued what amounted to a bill of reproach against the science of dietary supplements.
.
The company, Cytodyne Technologies, maker of the supplement implicated in the death of a Baltimore Orioles pitcher, had not just exaggerated the findings of clinical trials it commissioned, Judge Ronald Styn of Superior Court said in ruling on a class-action suit. It had also cajoled some researchers into fudging results in published scientific articles.
.
The evidence, Styn said, had left him no alternative but to conclude that the researchers had set out to create a study that "justified the money being spent" by Cytodyne and would ensure that they received further work from the company.
.
The Cytodyne case is part of a swelling tide of litigation that is raising serious questions about how makers of ephedra and other dietary supplements use - and often misuse - the promise of scientific proof to market products.
.
In the past eight months, three leading manufacturers of weight-loss pills have been hit with false-advertising verdicts in the millions of dollars. A fourth has been rebuked by a federal judge for hiding evidence. The Missouri attorney general and a group of district attorneys in California have also brought false-advertising suits against manufacturers, and Congress has demanded Cytodyne's research records.
.
Under pressure in the courts and from regulators, some manufacturers, including Cytodyne, have refashioned some weight-loss products without the herbal stimulant. Last week, legislative leaders in Albany agreed to make New York the second state to ban ephedra, after Illinois, and the federal government is considering a ban.
.
But experts say a switch in ingredients does not alter the industry's reliance on questionable science. They say they are concerned because there is so little rigorous research on the ephedra substitutes, primarily synephrine.
.
Supplement makers are not obliged to do research.
.
A 1994 law exempts them from having to prove that their products are harmless and effective. But the $18 billion-a-year supplement industry has embraced research because, when carefully aimed, it can be worth money.
.
Precisely because the industry is not regulated, its research is sometimes not strictly scientific, experts say.
.
"There will be 250 to 300 clinical trials on nutraceuticals this year," said Anthony Almada, a consultant and founder of EAS Inc., the biggest sports nutrition company, who advocates scientific research on products but criticizes the way supplement makers do it. "The rigor applied in these studies on the average is somewhat notably less than that of a drug study," he said.
.
Often relying on as few as a dozen subjects, these studies are scaled-down versions of the double-blind, placebo-controlled clinical trials required before drugs may be approved.
.
An industry spokesman, Steven Dentali, vice president for science and technical affairs at the American Herbal Products Association, said that "whenever there's a desired outcome, you've got the potential for bias." But he said supplement science is no worse than that done for pharmaceuticals.
.
The Food and Drug Administration has collected reports linking ephedra to more than 100 deaths. But most of the studies done have been too small and too limited to assess the danger. A Rand Corp. analysis combining results of the many small studies found legitimate evidence that ephedra worked for weight loss in the short term but could produce many cardiac side effects.
.
Documents from the lawsuits, including e-mail and experiment records, provide an inside look at how the demands of marketing have sometimes compromised those of science. They show how companies and researchers suppressed negative data; removed product names from abstracts when the conclusions showed no positive effects; changed statistical methods to see if results improved, and left out subjects who complained of troublesome side effects. The New York Times When a California judge handed down a $12.5 million false-advertising judgment against the maker of an ephedra-based weight-loss pill late last month, he also issued what amounted to a bill of reproach against the science of dietary supplements.
.
The company, Cytodyne Technologies, maker of the supplement implicated in the death of a Baltimore Orioles pitcher, had not just exaggerated the findings of clinical trials it commissioned, Judge Ronald Styn of Superior Court said in ruling on a class-action suit. It had also cajoled some researchers into fudging results in published scientific articles.
.
The evidence, Styn said, had left him no alternative but to conclude that the researchers had set out to create a study that "justified the money being spent" by Cytodyne and would ensure that they received further work from the company.
.
The Cytodyne case is part of a swelling tide of litigation that is raising serious questions about how makers of ephedra and other dietary supplements use - and often misuse - the promise of scientific proof to market products.
.
In the past eight months, three leading manufacturers of weight-loss pills have been hit with false-advertising verdicts in the millions of dollars. A fourth has been rebuked by a federal judge for hiding evidence. The Missouri attorney general and a group of district attorneys in California have also brought false-advertising suits against manufacturers, and Congress has demanded Cytodyne's research records.
.
Under pressure in the courts and from regulators, some manufacturers, including Cytodyne, have refashioned some weight-loss products without the herbal stimulant. Last week, legislative leaders in Albany agreed to make New York the second state to ban ephedra, after Illinois, and the federal government is considering a ban.
.
But experts say a switch in ingredients does not alter the industry's reliance on questionable science. They say they are concerned because there is so little rigorous research on the ephedra substitutes, primarily synephrine.
.
Supplement makers are not obliged to do research.
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