Pharmaceuticals
Cheap, Deadly And Uncontrolled
Matthew Herper, 04.15.05, 11:30 AM ET
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Poison Pills
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§Matthew Herper
• The Biggest Cancer Drug Ever?
• The Most Expensive Diseases
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AMGN 59.95§+ 0.28
BMY 25.95§+ 0.13
MRK 34.80§+ 0.02
NUTR 15.70§- 0.11
PFE 27.71§+ 0.26
4/15/05 4:04:00 PM ET
§
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NEW YORK - A federal judge in Utah has struck down part of a U.S. Food and Drug Administration decision that banned the dietary supplement ephedra from the market. Two doctors, in interviews, said that they thought the decision exposes patients to unnecessary risk.
The case was brought by Nutraceutical (nasdaq: NUTR - news - people ), a Park City, Utah-based company. In a prepared statement, company President Bruce Hough said that the decision was about protecting the public's access to safe dietary supplements, which, under the law, are treated as food, not drugs. That means that to pull them from the market, the FDA must prove that the drug is not safe. The court decided that the FDA may have proved that for higher doses of ephedra, as high as 100 milligrams, but not for the lower doses of 10 milligrams.
To some prominent doctors, that means that the law itself is dangerous. Prediman K. Shah, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, called the decision "terrible."
"It's a dangerous drug that can be abused," Shah says. "It has serious cardiovascular risks, and I don't see any reason why they should even have it on the market as an unregulated supplement. It is a stimulant. Just like cocaine triggers heart attacks or strokes, so can ephedra."
Steven Nissen, a cardiologist at the Cleveland Clinic, says he worries that the case meant the FDA would not have the power to regulate what he sees as a large group of potentially dangerous drugs.
"The problem is that the law is designed to allow companies with dangerous products to sell them until somebody can absolutely prove that they're harmful," Nissen says. "How are these drugs any different than prescription drugs? These drugs don't have to show benefit, and they have to be proven harmful. How does that make any sense?"
Doctors like Nissen and Shah believe that whenever possible, patients should be treated with medicines that have been proven to be both safe and effective. Such large studies can drive the cost of developing new medicines to hundreds of millions of dollars. But without them, doctors have little idea whether or not a drug is safe or effective. Drug firms like Amgen (nasdaq: AMGN - news - people ) and Bristol-Myers Squibb (nyse: BMY - news - people ) have to meet this bar.
In the past 12 months, side effects emerged for a widely used class of painkillers called Cox-2 inhibitors. The medicines, including Merck's (nyse: MRK - news - people ) Vioxx and Pfizer's (nyse: PFE - news - people ) Bextra, were found to increase the risk of heart attack and stroke in large clinical trials that tested them against sugar pills. The discussion that emerged also led to new warnings on over-the-counter pain pills like Aleve and Advil that had been in use for years. But these risks emerged only because all of the drugs were tested in big clinical trials.
Dietary supplements are not tested in this way, even though they many contain what doctors see as active drugs (see: "Poison Pills"). Red yeast rice, several doctors have said, contains the same active ingredient as the cholesterol-lowering drug Mevacor. Earlier this year, the FDA rejected an application by Merck to sell Mevacor over-the-counter.
Michael McGuffin, president of the American Herbal Products Association, says that he continued to believe that dietary supplements should be classified as foods--and that there is no need for clinical studies to test such supplements.
"We don't believe that's rational," McGuffin says. "We don't believe the evidence of hundreds of years of use has no relevance to our knowledge. I do not believe we have to start over with all of the herbs that have been using for hundreds of years."
Representatives of Nutraceutical could not be immediately reached.
Video: Doctors Worried About Dietary Supplement
Want to track news by this author or about this industry? Forbes Attaché makes it easy. Click here.
Cheap, Deadly And Uncontrolled
Matthew Herper, 04.15.05, 11:30 AM ET
pic
Costly Calories
Supplemental Income
Poison Pills
By This Author
§Matthew Herper
• The Biggest Cancer Drug Ever?
• The Most Expensive Diseases
• The Drug To Watch
More Headlines
Related Quotes
AMGN 59.95§+ 0.28
BMY 25.95§+ 0.13
MRK 34.80§+ 0.02
NUTR 15.70§- 0.11
PFE 27.71§+ 0.26
4/15/05 4:04:00 PM ET
§
Most Popular Stories
What Kills Billionaires
Apple's Disappointing IPod Unit Demand
PayPal's Growing Pains
The Drug To Watch
Lilly: Zyprexa And Beyond
Better Sex Diet
More From Forbes.com Video Network
§
NEW YORK - A federal judge in Utah has struck down part of a U.S. Food and Drug Administration decision that banned the dietary supplement ephedra from the market. Two doctors, in interviews, said that they thought the decision exposes patients to unnecessary risk.
The case was brought by Nutraceutical (nasdaq: NUTR - news - people ), a Park City, Utah-based company. In a prepared statement, company President Bruce Hough said that the decision was about protecting the public's access to safe dietary supplements, which, under the law, are treated as food, not drugs. That means that to pull them from the market, the FDA must prove that the drug is not safe. The court decided that the FDA may have proved that for higher doses of ephedra, as high as 100 milligrams, but not for the lower doses of 10 milligrams.
To some prominent doctors, that means that the law itself is dangerous. Prediman K. Shah, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, called the decision "terrible."
"It's a dangerous drug that can be abused," Shah says. "It has serious cardiovascular risks, and I don't see any reason why they should even have it on the market as an unregulated supplement. It is a stimulant. Just like cocaine triggers heart attacks or strokes, so can ephedra."
Steven Nissen, a cardiologist at the Cleveland Clinic, says he worries that the case meant the FDA would not have the power to regulate what he sees as a large group of potentially dangerous drugs.
"The problem is that the law is designed to allow companies with dangerous products to sell them until somebody can absolutely prove that they're harmful," Nissen says. "How are these drugs any different than prescription drugs? These drugs don't have to show benefit, and they have to be proven harmful. How does that make any sense?"
Doctors like Nissen and Shah believe that whenever possible, patients should be treated with medicines that have been proven to be both safe and effective. Such large studies can drive the cost of developing new medicines to hundreds of millions of dollars. But without them, doctors have little idea whether or not a drug is safe or effective. Drug firms like Amgen (nasdaq: AMGN - news - people ) and Bristol-Myers Squibb (nyse: BMY - news - people ) have to meet this bar.
In the past 12 months, side effects emerged for a widely used class of painkillers called Cox-2 inhibitors. The medicines, including Merck's (nyse: MRK - news - people ) Vioxx and Pfizer's (nyse: PFE - news - people ) Bextra, were found to increase the risk of heart attack and stroke in large clinical trials that tested them against sugar pills. The discussion that emerged also led to new warnings on over-the-counter pain pills like Aleve and Advil that had been in use for years. But these risks emerged only because all of the drugs were tested in big clinical trials.
Dietary supplements are not tested in this way, even though they many contain what doctors see as active drugs (see: "Poison Pills"). Red yeast rice, several doctors have said, contains the same active ingredient as the cholesterol-lowering drug Mevacor. Earlier this year, the FDA rejected an application by Merck to sell Mevacor over-the-counter.
Michael McGuffin, president of the American Herbal Products Association, says that he continued to believe that dietary supplements should be classified as foods--and that there is no need for clinical studies to test such supplements.
"We don't believe that's rational," McGuffin says. "We don't believe the evidence of hundreds of years of use has no relevance to our knowledge. I do not believe we have to start over with all of the herbs that have been using for hundreds of years."
Representatives of Nutraceutical could not be immediately reached.
Video: Doctors Worried About Dietary Supplement
Want to track news by this author or about this industry? Forbes Attaché makes it easy. Click here.