Post by Enchantress on Dec 6, 2004 7:59:30 GMT -5
‘Miracle’ diet drug stirs calls for caution
By GINA KOLATA
The New York Times
To people who have struggled for a lifetime to lose weight, the new drug called rimonabant sounds like a dream come true.
It will make a person uninterested in fattening foods, they have heard from news reports and word of mouth. Weight will just melt away, and fat accumulating around the waist and abdomen will be the first to go.
And, by the way, those who take it will end up with higher levels of HDL, the good cholesterol. If they smoke, they will find it easier to quit. If they are heavy drinkers, they will no longer crave alcohol.
“Holy cow, does it also grow hair?” asked Dr. Catherine DeAngelis, editor of The Journal of the American Medical Association.
At obesity treatment centers, nearly every patient asks for rimonabant — or Acomplia, as it will be called if its maker, Sanofi-Aventis, gets approval to market it in the United States.
But many medical researchers say not so fast. While rimonabant might be intriguing, these experts say, the mythology in the making is hardly justified by what is known so far.
There are no published studies from clinical trials to justify any of the claims for what some patients are already calling a miracle drug. The data that the company has presented indicate that rimonabant is about as effective for weight loss in obese people as two other drugs already on the market — sibutramine (sold under the brand name Meridia) and xenical (sold as Orlistat).
Nor are there any clinical tests to indicate how or whether it would work in people who are only moderately overweight.
Rimonabant has not been approved for sale in the United States or anywhere else. Sanofi-Aventis has not yet submitted its application for marketing to the Food and Drug Administration. The company says it plans to apply early next year.
All that adds up to a problem, says Dr. Madelyn Fernstrom, who directs the weight-management center at the University of Pittsburgh Medical Center.
“It’s disturbing, in my view, the amount of attention this compound is getting,” Fernstrom said. “I’m underwhelmed by the results so far.”<br>
Rimonabant blocks a protein in brain cells that allows cannabis, the active ingredient in marijuana, to work. It also blocks the body’s own versions of cannabis, the so-called endocannabinoids. Marijuana is supposed to increase appetite. So a drug that blocks cannabis, it seems logical, should suppress appetite.
Obese people have more receptors for endocannabinoids than thin people, said Dr. F. Xavier Pi-Sunyer, a professor of medicine at Columbia University and the principal investigator of a large rimonabant study in the United States and Canada. The drug does not completely block these receptors, Pi-Sunyer said.
The idea of blocking these receptors worked in animals.
Rimonabant, said Dr. Jeffrey Friedman, an obesity researcher at Rockefeller University, “is the first in what I think will be a wave of rational therapies” that attack what has recently been learned about how eating is controlled. But with rimonabant, he said, “the issue is, what’s the safety and efficacy?”<br>
www.thestate.com/mld/thestat...on/10342885.htm
By GINA KOLATA
The New York Times
To people who have struggled for a lifetime to lose weight, the new drug called rimonabant sounds like a dream come true.
It will make a person uninterested in fattening foods, they have heard from news reports and word of mouth. Weight will just melt away, and fat accumulating around the waist and abdomen will be the first to go.
And, by the way, those who take it will end up with higher levels of HDL, the good cholesterol. If they smoke, they will find it easier to quit. If they are heavy drinkers, they will no longer crave alcohol.
“Holy cow, does it also grow hair?” asked Dr. Catherine DeAngelis, editor of The Journal of the American Medical Association.
At obesity treatment centers, nearly every patient asks for rimonabant — or Acomplia, as it will be called if its maker, Sanofi-Aventis, gets approval to market it in the United States.
But many medical researchers say not so fast. While rimonabant might be intriguing, these experts say, the mythology in the making is hardly justified by what is known so far.
There are no published studies from clinical trials to justify any of the claims for what some patients are already calling a miracle drug. The data that the company has presented indicate that rimonabant is about as effective for weight loss in obese people as two other drugs already on the market — sibutramine (sold under the brand name Meridia) and xenical (sold as Orlistat).
Nor are there any clinical tests to indicate how or whether it would work in people who are only moderately overweight.
Rimonabant has not been approved for sale in the United States or anywhere else. Sanofi-Aventis has not yet submitted its application for marketing to the Food and Drug Administration. The company says it plans to apply early next year.
All that adds up to a problem, says Dr. Madelyn Fernstrom, who directs the weight-management center at the University of Pittsburgh Medical Center.
“It’s disturbing, in my view, the amount of attention this compound is getting,” Fernstrom said. “I’m underwhelmed by the results so far.”<br>
Rimonabant blocks a protein in brain cells that allows cannabis, the active ingredient in marijuana, to work. It also blocks the body’s own versions of cannabis, the so-called endocannabinoids. Marijuana is supposed to increase appetite. So a drug that blocks cannabis, it seems logical, should suppress appetite.
Obese people have more receptors for endocannabinoids than thin people, said Dr. F. Xavier Pi-Sunyer, a professor of medicine at Columbia University and the principal investigator of a large rimonabant study in the United States and Canada. The drug does not completely block these receptors, Pi-Sunyer said.
The idea of blocking these receptors worked in animals.
Rimonabant, said Dr. Jeffrey Friedman, an obesity researcher at Rockefeller University, “is the first in what I think will be a wave of rational therapies” that attack what has recently been learned about how eating is controlled. But with rimonabant, he said, “the issue is, what’s the safety and efficacy?”<br>
www.thestate.com/mld/thestat...on/10342885.htm