Does it Work? - New Drug - now THIS sounds interesting!!

Now everyone knows I'm a COMPLETE skeptic, but ya know I'll be watching how THIS develops:

One pill attacks smoking, obesity

SOUNDS ALMOST TOO GOOD TO BE TRUE

By Marilynn Marchione
Associated Press


NEW ORLEANS - An experimental pill that offers the fairy-tale promise of helping people lose weight and quit smoking has gathered even more stardust.

The biggest test yet of the drug found that it helped people not only drop pounds but also keep them off for two years -- longer than any other diet drug has been able to achieve. Cholesterol and other health measures improved, too.

The impressive results from a study of 3,040 obese people were presented at a medical conference Tuesday, capping months of anticipation about the new drug, Acomplia, made by the French pharmaceutical firm Sanofi-Aventis.

Doctors called the research exciting and the company, which funded the study, thinks the drug could have blockbuster potential similar to cholesterol-lowering statin drugs.

In a study of obese people throughout the United States and Canada, those given the higher of two doses of the drug lost more than 5 percent of their initial body weight, and a third of them lost more than 10 percent.

"They achieved and maintained a weight loss of 19 pounds as compared to 5.1 pounds in the placebo group,'' said Dr. F. Xavier Pi-Sunyer of Columbia University in New York, who led the research and presented results at the American Heart Association conference.

Those who quit taking the pill in the second year of the study regained most of what they had lost, suggesting that people might have to take the drug indefinitely to maintain a lower weight.

About two-thirds of U.S. adults are overweight or obese, raising their risk of everything from cancer and cardiovascular disease to sore joints and snoring. About a fourth of U.S. adults smoke, which brings many of the same health woes.

It has been difficult to develop effective treatments for either problem. Diet drugs in particular have a checkered history, most notably the withdrawal from the market in 1997 of the popular "fen-phen'' drug combination after users developed heart valve problems.

Drugs now on the market either are designed for short-term use or have distasteful side effects like bowel problems that make many shy away from them.

Acomplia's maker thinks it will avoid those problems by attacking obesity in a novel way, and plans to seek federal approval for it next year.

It is the first diet drug aimed at blocking the "pleasure center'' of the brain and interfering with the cycle of craving and satisfaction that drives many compulsive behaviors and addictions. This same circuitry is activated when people smoke marijuana.

Wait and see...note that the article does say the drug would have to be taken indefinitely - kind of like a birth control pill. IF IT IS SAFE AND EFFECTIVE, shoot - I wouldn't mind taking a pill every day to help lose and maintain a healthy weight! Of course, that doesn't mean I wouldn't be watching my nutrition and exercise...

I saw that on the news yesterday!! I'm curious to hear more about it once it is actually out on the market.

Well, think logically about that, if you are taking the pill to help lose weight, odds are your subconcious is going to kick in and you are going to be doing things you wouldn't normally do to:

A: Make the process go even faster

and

B: Keep the weight off.

Kind of like when you get something new and kind of expensive, you coddle it for a while so it won't get broken without even realizing it. Many people do this, it's normal. Odds are while you're taking the drug, you're lifestyle would change to the point that if you went off the pill and gained a few pounds, it wouldn't matter, because with your new lifestyle you'd lose them again anyway. The reason they gained weight after going off the pill was probably because this was a controlled study, and they told the participants not to do anything out of the ordinary (AKA: eat differently or exercise more than they were doing).

Well, think logically about that, if you are taking the pill to help lose weight, odds are your subconcious is going to kick in and you are going to be doing things you wouldn't normally do to:

A: Make the process go even faster

and

B: Keep the weight off.

Kind of like when you get something new and kind of expensive, you coddle it for a while so it won't get broken without even realizing it. Many people do this, it's normal. Odds are while you're taking the drug, you're lifestyle would change to the point that if you went off the pill and gained a few pounds, it wouldn't matter, because with your new lifestyle you'd lose them again anyway. The reason they gained weight after going off the pill was probably because this was a controlled study, and they told the participants not to do anything out of the ordinary (AKA: eat differently or exercise more than they were doing).

Guess we'll see what transpires. From what I've read, there has been EXTENSIVE testing and study on this drug already (I'd think that the pharmeceutical companies are being extremely cautious after the Redux/Phen-Fen debacle of the 1990's). I've found a report of one of the studies - this is the 2-year North American study of the drug, known as Acomplia.

Note that the people that gained weight after going off the pill in the second year were on a placebo - they didn't know that they were off the pill. Additionally, all participants were on a reduced-calorie diet throughout the study.

The RIO-North America Study

This North American multi-center, double-blind, placebo-controlled study enrolled 3,040 overweight or obese patients -- approximately 80 percent of them women -- from 72 medical centers in the United States and Canada.

Patients were randomized to receive for one year either a low daily, fixed dose of 5 mg of Acomplia, a higher dose of 20 mg of Acomplia, or a placebo.

After the first year, patients on either dose of Acomplia were rerandomized to receive either the same dose of Acomplia or a placebo for a second year.

Throughout the study, calorie intakes were reduced by 600 calories per day.

The primary objective of the trial was to assess weight loss over one year, and then to determine the ability of Acomplia to prevent regaining weight during a second year of treatment.

Secondary objectives included an assessment of improvement in risk factors associated with abdominal obesity (dyslipidemia), and glucose metabolism and metabolic syndrome.

Patients on the higher dose of Acomplia were far more successful in losing weight and maintaining weight loss than patients on the lower dose or in the placebo control group.

Some 62.5 percent of patients treated for the full two years with the higher dose of Acomplia lost more than 5 percent of their body weight compared to 36.7 percent of those on the low dose of Acomplia and 33.2 percent of patients in the control group.

Moreover, 32.8 percent of patients treated for the full two years with the higher dose of Acomplia lost more than 10 percent of their body weight compared to 20 percent of patients on the low dose of Acomplia and 16.4 percent of patients in the control group.

The researchers also reported that patients treated for two years with the higher dose of Acomplia reduced their waist circumference by an average of 3.1 inches compared to 1.9 inches for those on the low dose of Acomplia and 1.5 inches for patients in the control group.

The researchers also reported that those treated with the higher dose of Acomplia increased their HDL cholesterol (good cholesterol) by 24.5 percent compared to 15.6 percent for those on the low dose of Acomplia and 13.8 percent for those in the control group.

At the same time, patients treated with the higher dose of Acomplia for two years lowered their triglycerides by 9.9 percent, compared to 5.6 percent for patients on the low dose of Acomplia and 1.6 percent for those in the control group.

For those patients with metabolic syndrome at the outset of the study, approximately one third of those taking the higher dose of Acomplia for the full study period no longer had this problem at the end of the two years.

Diabetic patients were not included in the study, but researchers reported that patients on the higher Acomplia dose significantly improved their insulin sensitivity compared to those on the lower dose of Acomplia and on the placebo.

"The effect of rimonabant on HDL-cholesterol, triglycerides, fasting insulin and insulin sensitivity appeared to be twice that which would be expected from the degree of weight-loss achieved," the researchers reported.

The researchers also reported that side-effect and safety results derived from the trial were also encouraging.

"Side effects were mainly minor and short-lived," the researchers reported. They said 12.8 percent of patients taking the higher dose of Acomplia dropped out of the trial during the first year as a result of adverse events, compared to 9.4 percent taking the lower Acomplia dose and 7.2 percent of those in the control group.

They reported that the drop-out rate for those who continued treatment for a second year was 6.0 percent for those taking the higher dose of Acomplia, compared to 8.3 percent for those taking the lower dose and 6.7 percent for those in the control group.

"No differences were noted in the three groups with regards to scores measured by the Hospital Anxiety Depression scale," the researchers reported. And they said that in this trial and in two preceding studies, Acomplia was also shown to produce no significant EKG or heart rate changes.

"The results from this study data are consistent with the findings from two previous large-scale studies on rimonabant -- RIO-Lipids and RIO-Europe -- communicated earlier this year and add to the ever-growing body of evidence supporting the drug's efficacy and tolerability profile," the researchers concluded.

Dr. Xavier Pi-Sunyer, Chief of the Division of Endocrinology at Saint Luke's - Roosevelt Hospital Cente in New York and lead researcher on the study, added:

"The two-year results of the RIO-North America trial confirm that rimonabant is an innovative and promising tool for the long-term management of weight and associated cardiovascular risk factors in abdominally obese patients.

"There was no evidence that this drug in two years had something we have to worry about in regard to safety," he added.

As much as I think some day there will be a miracle pill, it makes you wonder. Look at all of these drugs and what they do to people. I love listening to these commercials and wondering why people even bother. Eye drops for dry eyes that can cause temporary blindness and burning. A feminine product that can cause dementia and heart attack. Heck, just look at what the research is saying high fructose corn syrup does to us. (Maybe I should cut back on the splenda!)

I guess my point is even though it takes a lot of work, I'd rather watch what I eat and exercise than take a pill which will lower heath risks of being overweight only to cause a side effect of paralysis or something.

I guess my point is even though it takes a lot of work, I'd rather watch what I eat and exercise than take a pill which will lower heath risks of being overweight only to cause a side effect of paralysis or something.

I've read quite a bit now about Acomplia, and the way it works is NOT to 'lower health risks of being overweight' - what it's supposed to do is reduce or eliminate CRAVINGS for food - that dreaded HEAD HUNGER which is, IMO, the main reason 'diets don't work' for so many, and the bottom-line reason for our obesity epidemic. Many, many, MANY times in the past, I've eaten - or overeaten - not because I was hungry, but because the food was there and I was/am addicted to the taste. Of course, if this drug (as well as the promising-sounding Hoodia plant - see the sticky thread in this forum) works like it's supposed to, its function is NOT to 'melt off fat' or 'burn fat' - you STILL need to do the work of eating right and exercising, making those healthy, permanent lifestyle changes...however, taking a SAFE and EFFECTIVE drug to reduce/eliminate cravings for food (or smoking, or drug/alcohol abuse) would help tremendously. :yes: I wholeheartedly believe that sugar and fat are as addicting as tobacco, alcohol or drugs, and YUP - if there was a safe and effective pill available to help with those cravings that can be taken on a long-term basis, I would most definitely ask my doctor about it, because even though it's been 15 years since I was obese, those cravings can really do a number on me...

The spectre of Phen-Fen is always in the background...IMO, as previously stated, I believe that the pharmecutical industry learnt a valuable (and costly) lesson from that experience and will be VERY careful about both short-term and long-term safety.

But I already take a BCP and a multivitamin every day anyway. I know quite a few people on daily meds - HRT, blood pressure, heart meds, etc. To be able to take a daily medication to allieviate those killer cravings...I wouldn't have a problem with that whatsoever, as long as it's SAFE AND EFFECTIVE. We'll see what happens...

This is all very interesting. I have read very little about this drug but it does show some promises. I am so afraid of medications now I doubt I would take it. I took Celebrex and now you read all this terrible stuff about it. And the weight gain was terrible. Who knew? It would be so nice to have a pill to take but realistically I'm sticking to my calorie counting. :^:

I think the best thing to do it stay away from drugs to loss weight. I took phen-fen when i was 15 years old. By the time i was 17 teen i started passing out. My heart was damaged and know ever six months i have to have my heart checked to make sure theres no bleeding. I still pass out time to time. Dr. still try to give me diet pills but i want take any to scared.

Hi there. Just thought I'd drop a note on this subject. My best friend was/is actually doing the testing for this drug. She works for Sanofi in Pennsylvania. From what she says and has seen, it works. It should become available in or around May 2005. They've had extremely successful results with this drug and are very excited to be offering it soon. If I hear more from her, I'll post again and give an update. All I know is that I'll be buying some stocks in Sanofi soon. Lol. :lol:

Hi there. Just thought I'd drop a note on this subject. My best friend was/is actually doing the testing for this drug. She works for Sanofi in Pennsylvania. From what she says and has seen, it works. It should become available in or around May 2005. They've had extremely successful results with this drug and are very excited to be offering it soon. If I hear more from her, I'll post again and give an update. All I know is that I'll be buying some stocks in Sanofi soon. Lol. :lol:

That's interesting!

However...3 months sounds a bit soon for a prescription drug to be put on the market. The most recent information I could find says that Sanofi is still doing clinical trials on the drug - doesn't look like it's even gotten to the FDA yet. And with the recent news regarding other prescription drugs such as Vioxx and in the past with Redux and fenfluramine, I'm sure that the FDA will be very, VERY careful in reviewing Acomplia.

Perhaps you meant 2006?

I don't believe in miracle pills, no matter how promising or extensively studied. IMO, sooner or later, a whole lot of even the most established and respected drugs runs into a snag and they find out that people are dying from them (does Vioxx ring a bell? :) )

It's been my recent experience that you can pretty much eliminate a good deal (not all) of food cravings by, er, just not eating the offending food for awhile (in my case, sugar and white flour).

Many people stop smoking without any pills at all.

Many people lose weight without any pills at all.

Dunno. I just don't believe in pie in the sky ... seems like it'd be simplest to just stop smoking and just eat less and move more.

That may be true - and if you look at many of my previous posts, you'll know that I'm one of the all-time biggest skeptics as well as a fervent advocate for 'eat less/move more' (after all, that's how I lost AND how I've kept off 115 pounds over the past 15+ years). However...I think that there IS a definite need for a truly SAFE and EFFECTIVE (emphasis on SAFE) pharmeceutical weight loss aid for a variety of reasons - just off the top of my head:

* The HUGE increase in weight loss surgeries - which is supposed to be utilized as a last resort after everything else (regular diet and exercise) has failed, to me is a PRIME reason to be looking for other medical alternatives. Often it is not covered by insurance (and more and more carriers or employers are declining to cover the surgery) and it's a fairly risky procedure, with a very high price tag. IMO having a viable pharmecutical alternative to WLS would definitely be a plus.

* I remember back in the 1970's & 80's there were TONS of 'miracle hair restorer' products on the market...maybe as many or MORE than there were 'miracle weight loss' products. Then in 1988, Rogaine became the first pharmaceutical ever approved by the US Food and Drug Administration as being safe and effective for hair growth (followed in 1998 by Propecia) and the VAST majority of those 'miracle hair cures' went POOF. I can easily see that happening in the event that a truly safe and effective weight loss medication (I would rather not use the term "Magic pill") is found. If Acomplia turns out to be 'what the doctor ordered'...IMO that would be a fatal, or near-fatal, blow to many of the weight loss snake-oil hucksters out there.

(BTW I can't resist adding that when I typed the bit about hair loss, I couldn't help but visualize that Seinfeld episode where George orders the stinky hair growth potion from China... :lol: )

And if it helps smokers quit - there's ANOTHER bonus. :)

Of course bottom line it comes down to 'calories in calories out'/'eat less move more' - but there are MANY people who need help - I suppose, like WLS, you would call it a 'tool'.

I work in a large med. school where the Pharm. Reps. round constantly. The next time I see the Sanofi-Aventis rep. I'll ask her for some info. on approval. marketing dates. This may become popular from a cardiovascular point of view. Since Sanofi bought out Aventis I haven't seen too many of the old pharmaceutical reps, they usually shift things around.

what caught my eye was the line about "reduction in weight circumference" (I'll beg for samples of the drug if that is true!)

In my area, on one of the local cable stations, one of the bariatric surgeons actually has an infomercial......

We've all seen what can happen to a drug touted as the miracle answer, whether it's for weightloss, arthritis, diabetes, etc. Researchers find something that truly does work, but they can't know the safety record until millions of people have volunteered to be guinea pigs for them.

All drugs are poison, in some form or another. Each of us reacts differently to the poison--some of us would take Vioxx today if we could get our hands on it, because it did NOT cause us health problems. But it was deadly for others, and we only found out too late.

I'd love to think that modern medicine could come up with an appetite suppressant that wouldn't have side effects. But when this drug comes out, I will not be among its first users, no matter how tempted I am. I will wait at least a year to see if it's truly safe. Even then, I always opt for the lowest possible dosage of any drug, because one year of public testing isn't always enough.

New Article on Acomplia.

Experimental Diet Pill Keeping Pounds Off

By MARILYNN MARCHIONE

ORLANDO, Fla. (AP) - A second study confirms that an experimental diet pill can help people lose weight and keep it off for up to two years, setting the stage for its maker to seek approval to sell it in the United States.

The drug, rimonabant, which the French company Sanofi-Aventis hopes to sell under the brand name Acomplia, trimmed nearly 16 pounds on average from people taking the optimal dose for two years, compared with 5.5 pounds for those who took dummy pills, doctors reported Tuesday at a cardiology conference.

``The majority of the weight that was lost at one year is still maintained after two years. There is only a slight increase over that second year,'' said Dr. Luc Van Gaal of University Hospital in Antwerp, Belgium, who led the company-funded study involving 1,507 severely obese people in Europe.

About two-thirds of American adults are overweight or obese; in European countries, one-third to half are. Diet drugs sold now are only for short-term use or have unpleasant side effects that make it tough to stay on them.


Acomplia works in an entirely different way, by blocking a ``pleasure center'' in the brain, leading people to eat less and acting directly on fat cells to prevent weight gain. Company studies suggest it also might help people quit smoking.


In a North American study of 3,040 obese people reported last fall, those given the higher of two doses of the drug lost about 19 pounds and kept it off for up to two years, compared with only 5 pounds for those given fake pills.


In the new study, those on the higher dose regained some weight in the second year but fared far better than those on placebo. Waistlines in the drug group were 3.4 inches smaller after one year and 3 inches after two.


The proportion of people with metabolic syndrome - a collection of unhealthy conditions such as high blood sugar and blood pressure and low amounts of ``good'' cholesterol - went from 42 percent at the start of the study to 21 percent at two years for those on the higher dose of the drug.


Dr. Sidney C. Smith, a former American Heart Association president and cardiology chief at the University of North Carolina, said this was especially important, since 47 million Americans have metabolic syndrome.


However, the drug has side effects: 13.7 percent on the optimal dose reported nausea compared with 5.5 percent taking dummy pills, though researchers said it tended to be mild and short-lived. Rates of dizziness and diarrhea were almost twice as common on the drug.


About 19 percent on the higher dose dropped out of the study because a problem occurred, but so did 13 percent in the placebo group. Depression was the reason for discontinuing for 2.8 percent on the higher dose of the drug and 1.6 percent in the placebo group.


Dr. Julius Gaardin, a cardiologist at Wayne State University who had no ties to the study or the company, called it and similar ones on the drug ``truly landmark studies in the field of obesity.''


He said ``the safety profile was quite good'' and obesity is such a serious problem that there ought to be higher tolerability of side effects than for drugs for other conditions.


Company officials say they are on track to seek Food and Drug Administration approval within a few months.


Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, said health officials would welcome an effective obesity drug if it proved safe.


``The important message is that we want men and women to focus on heart-healthy behaviors, modifications in lifestyles that promote health,'' she said.


Smith said the drug could give people ``a wonderful jump start,'' but that for long-term success, ``there have got to be some improved behavioral and diet changes going on beyond taking a pill.''

We've all seen what can happen to a drug touted as the miracle answer, whether it's for weightloss, arthritis, diabetes, etc. Researchers find something that truly does work, but they can't know the safety record until millions of people have volunteered to be guinea pigs for them.

All drugs are poison, in some form or another. Each of us reacts differently to the poison--some of us would take Vioxx today if we could get our hands on it, because it did NOT cause us health problems. But it was deadly for others, and we only found out too late.

I'd love to think that modern medicine could come up with an appetite suppressant that wouldn't have side effects. But when this drug comes out, I will not be among its first users, no matter how tempted I am. I will wait at least a year to see if it's truly safe. Even then, I always opt for the lowest possible dosage of any drug, because one year of public testing isn't always enough.

Well, since it is estimated that 1,000 people die each year from aspirin, I guess you *could* be right in saying "all drugs are poison". BUT on the other hand...what about lives that were prolonged or SAVED due to modern medicine? Saying "All drugs are poison" is throwing the baby out with the bathwater - really no different than saying "all carbs are bad" or whatever.

As far as studies go - Acomplia has already undergone two 2-year studies - in North America and Europe - and the results (as Michelle posted) look very promising indeed.

And as far as the comparison to Vioxx and other drugs that have been withdrawn from the market - I would presume that this would cause Sanofi to be even MORE diligent in ensuring that Acomplia, or any other new drug, is tested as rigorously as possible prior to its submission for FDA approval.

Incidentally...for those of you who wish to keep track of what's happening with Acomplia - there is a website called The Acomplia Report (http://www.acompliareport.com/) (produced by MedicalWeek - not by Sanofi) which has been tracking the progress of the drug and is regularly updated. ;)

Well, since it is estimated that 1,000 people die each year from aspirin, I guess you *could* be right in saying "all drugs are poison". BUT on the other hand...what about lives that were prolonged or SAVED due to modern medicine? Saying "All drugs are poison" is throwing the baby out with the bathwater - really no different than saying "all carbs are bad" or whatever.

I wholeheartedly agree with that MrsJim. I know a lot of people raised a fuss when vioxx was taken off the market, I for one was one of the people it helped and I have no ill side-effects from it. Same goes for weightloss prescriptions, a lot of people don't agree with it being used especially because it causes harm to SOME people.

As many of you know I have taken Meridia for a number of months now and have no side effects whatsoever.

Anyway on to my point, I think that to some degree the prescription drug companies are responsible for doing more than adequate research to alert us as to who can or cannot take specific drugs. There are drugs that help many people but in some instances it can kill another person.

So to kind of sum it up, what works for one may not work for another. As MrsJim said look at all the deaths from aspirin but it's still sitting on the shelf, should we yank that too? I'm willing to bet that every drug OTC or RX on the market today has caused the death of some person somewhere. Not every situation is the same and sometimes there isn't going to be a common link that we can associate, but that is where our duty as consumers comes in. Amidst all the rhetoric and fallacy and small print there are answers, and when people decided (along with their doctors) to take these medications they also agreed that they read and understand the package inserts.

I of course am not a medical or scientific professional so this is all my opinion. But I do know that everytime a doctor prescribes a med for me it is my right to decline to take it.

Hi Michelle:\

I've heard that Merck? will be bringing Vioxx back on market....but I don't know details, I either read it somewhere or heard a blurb on the news that was playing in the background noise. I would think it would be a slightly different configuration (safer)

for general information:

I ran into the pharmaceutical rep. today.....asked her about Acomplia....she believes it should be on the market in the first quarter of 2006. Also told me that the majority of patients in the clinical trials were women.

Ohhh thanks for the information marble!! I'm hoping I'm at goal by that time so I won't get to try it but I am anxious to hear about the results of other people who are going to take it once it's released.

(isn't Marbleflys the most ridicules on-screen name....my daughter was in junior high at the time i registered in 1999 and I listened to her......).

I was plaguing the rep. with questions about Acomplia.....(we've known each other for almost 6-7 years when i worked in another dept. that used her products). When i was speaking about my stubborn mid-section, she told me how most of the study patients were women who were more successful.

MrsJim..You are right. More and more insurance companies are refusing to cover the cost of surgery because they feel that it is up to us to take control over what goes in our mouth and do all we can to prevent the the surgery from taking place.

I know a lady whose husband works with mine. The surgery nearly killed her last year. YOu always hear about the ones who had a successful recovery, you do not hear about the ones who died or almost died from the surgery.

I am on xenical right now. It is a slow process but I am losing. Maybe not as fast as someone on the other drugs but still a loss. Will I take this drug if it comes out? I don't know. Perhaps not right off the bat but maybe later.

I think they will eventually come up with a drug that will fight obesity. I just don't know when.

I wholeheartedly agree with that MrsJim. I know a lot of people raised a fuss when vioxx was taken off the market, I for one was one of the people it helped and I have no ill side-effects from it. Same goes for weightloss prescriptions, a lot of people don't agree with it being used especially because it causes harm to SOME people.



I was on redux about three months when it was taken off. It was helping me but look at what it was doing to others.

I wish people would not try and condemn those of us who do take the pills. We all have to do this our own way, whichever way works best for us. :)

I wish people would not try and condemn those of us who do take the pills. We all have to do this our own way, whichever way works best for us. :)

Speaking for myself, as I said previously...one of the bonuses IMO of Acomplia - IF it actually works in practice and IF it is approved by the FDA - would be its anticipated effect on the big scam market - you know, all those 'diet pills' that are sold online or in the backs of magazines or in infomercials and are asked about here SO often at Buyer Beware - the vast majority are a total waste of money and/or are VASTLY overpriced for what little they actually DO.

If there's a safe and effective pill that doctors (and I'm not talking about those weight-loss-clinic type of doctors, I'm referring to your PCP) feel comfortable prescribing to their patients on a regular basis (my own PCP will NOT prescribe diet pills except as an ABSOLUTE last resort at this point), then I predict and HOPE that the pill scam marketers will fade away. It really angers me to see how they keep taking innocent people for a ride...and I want that to STOP.

I also agree that there is no miracle cure, but they are not claiming that this pill is a cure. If you read the articles, the patients in the studies reduced their daily caloric intake by 600 calories. They aren't claiming that if you take the pill and don't make any other lifestyle changes that you will magically lose weight. Since the premise of this pill is that is helps to control cravings and such, health benefits probably occured because those on the pill were more likely to reach for fruit or vegetables or other healthy snacks and meals rather than chocolate, ice cream, greasy pizza, or any of the other things we eat that are bad for us, yet we submit to the cravings.

I guess what I'm getting at is that, no, there is no magical pill to make us all skinny, but this isn't claiming to do that anyway. I'll probably never take it simply because I don't like taking pills (I have to pretty much be on my death bed to pop a Tylenol or Sudafed).

As for FDA approval, you would think that they need to study these things more thoroughly because of what has happened in the past, but look at artificial sweeteners. How many huge issues did we have in the past with artificial sweeteners causing problems, and yet Splenda is out there, FDA-approved, and is now being found to cause health problems for some people? As much as I would like to believe that the FDA is there for our protection, I more-realistically believe that they are moving things more quickly through than they should due to corporate pressures to expedite revenues.
I wasn't a science major or a medical student or anything like that. I was a Business student, so feel free to take this expression of my opinions with a grain of salt :)

Jill - I think you're exactly right about Acomplia - it's not being purported as a magic pill - just a possible aid. Ultimately it is up to the individual to adopt and maintain healthy permanent lifestyle changes to lose and keep weight off! :)

I don't know if I should even go into the artificial sweetener debate. Splenda, asparatame and saccharin have been studied and researched for years (saccharin has actually been around for well over 100 years and has a great safety record!) and I personally believe they are safe and can be used with no problems for the vast majority of the general public. Of course there is always going to be a segment of the population who will have an adverse reaction to Splenda or asparatame, just as there are people who have adverse reactions to MSG, dairy products, wheat, peanuts, etc. I know that you've probably seen the anti-sweetener websites (one even run by the Sugar Institute - can't take the competition I guess!) but it is important to realize that the organizations behind them very much have their own agendas at play.

You can go to pubmed.com and browse through the published, peer-reviewed studies on pretty much anything...here's one abstract for example (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15367404)...

Ann Oncol. 2004 Oct;15(10):1460-5.

Artificial sweeteners--do they bear a carcinogenic risk?

Weihrauch MR, Diehl V.

Department of Internal Medicine I of the University of Cologne, Cologne, Germany. martin.weihrauch@uni-koeln.de

Artificial sweeteners are added to a wide variety of food, drinks, drugs and hygiene products. Since their introduction, the mass media have reported about potential cancer risks, which has contributed to undermine the public's sense of security. It can be assumed that every citizen of Western countries uses artificial sweeteners, knowingly or not. A cancer-inducing activity of one of these substances would mean a health risk to an entire population. We performed several PubMed searches of the National Library of Medicine for articles in English about artificial sweeteners. These articles included 'first generation' sweeteners such as saccharin, cyclamate and aspartame, as well as 'new generation' sweeteners such as acesulfame-K, sucralose, alitame and neotame. Epidemiological studies in humans did not find the bladder cancer-inducing effects of saccharin and cyclamate that had been reported from animal studies in rats. Despite some rather unscientific assumptions, there is no evidence that aspartame is carcinogenic. Case-control studies showed an elevated relative risk of 1.3 for heavy artificial sweetener use (no specific substances specified) of >1.7 g/day. For new generation sweeteners, it is too early to establish any epidemiological evidence about possible carcinogenic risks. As many artificial sweeteners are combined in today's products, the carcinogenic risk of a single substance is difficult to assess. However, according to the current literature, the possible risk of artificial sweeteners to induce cancer seems to be negligible.


and some more studies can be found here (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=15367404)...

IMO - the bottom line for any kind of drug or food or whatever comes up to this - if you don't want to use it, then you don't have to...it's a personal choice. Personally I would say that the people going after artificial sweeteners should shift their efforts towards tobacco, trans fats, and high-fructose corn syrup instead - they're FAR more harmful to the general population!

I hope its a big winner..I bought stock in the company when I read all the positive reports on it.

Slim do you know of a site to go buy stock??

Slim do you know of a site to go buy stock??

Not Slim, but...the stock is traded on the NYSE. (NYSE listing code is SNY)

Their investor relations page is here ==> http://www.sanofi-synthelabo.us/index.html

You could probably buy the stock from etrade.com (this is NOT an endorsement - I've never done business with them myself) or any broker or firm licensed/registered with the SEC.

http://www.sec.gov/investor/brokers.htm

I saw a presentation about rimonabant (Acompli) at the ICRS conference last year. My husband researches similar drugs but not for a pharmaceutical company, he's in acedemics. It seems that the drug really is safe and really does make you lose weight but the bad news is that it will probably only work while you 're taking it, so after you stop, you'll gain the weight back. Also there is serious speculation that one if the reasons it works is because it makes you nauseous and therefore you don't eat. It had a hogh drop out weight at the higher dose because of this. This didn't happen at the lower dose but it did cause weight loss either. The good news is that it has open the door for other cannabinoid researched to work on other drugs that work on the same principles and that work is very promising. I really think that it will be this line of research that will create a drug that will help.

yep... pop a pill and... woooolaaaaaa a size 2...:)

Wand...we have an account with fidelitymagellen so we buy stocks there. Its gone up $5 per share since we bought it. I had this feeling about RetinA years ago but never bought it and it went nuts..hope this product prooves to be a safe and effective method for weight loss.

Here's an article from the LA Times that was published June 1st...

Still no "Magic Bullet" weight loss drug (http://www.azcentral.com/news/articles/0601nomiracle-ON.html)

Snippets from the above article pertaining to Acomplia:

A drug that would make weight loss easier is one of the most prized, but elusive, goals in medicine. And numerous pharmaceutical companies are working on diet drugs that could reach the market during the next decade. One company, Sanofi-Aventis, recently applied to the Food and Drug Administration for approval of a drug called Acomplia, which, if approved, would become the first new prescription obesity drug in six years.

But one thing is becoming painfully clear to researchers and drug companies: Previous efforts to produce a blockbuster diet drug have fizzled, and there is still no miracle remedy in sight. Recent studies of Acomplia (also known as rimonabant, its generic name) show that the drug, while potentially helpful, will not benefit everyone, and it will not produce substantial weight loss in most people.

Instead, Acomplia's role more likely would be as one of a number of diet drugs that not only aid weight loss but also address the medical consequences of obesity, such as diabetes and heart disease, say researchers. It's likely that a combination, or cocktail, of obesity drugs will ultimately prove most beneficial.

and

As an obesity treatment, Acomplia may be best suited for people who are not only overweight but also have metabolic syndrome. Metabolic syndrome is a collection of symptoms, including high blood pressure, high cholesterol, large waist circumference, obesity and insulin resistance, that can lead to diabetes and heart disease without treatment.

A study published in April in the Lancet, a medical journal, showed that 67 percent of people taking 20 milligrams of Acomplia achieved an overall weight loss of 5 percent after one year, and 39 percent of the participants achieved a 10 percent weight loss.

Acomplia also produced an average reduction of 1.6 inches in waist circumference and led to improvements in cholesterol levels (including HDL, or "good" cholesterol) and insulin resistance...

Overall, half of the patients with metabolic syndrome no longer had the condition after taking Acomplia for two years...

But the drug has been found to have some significant side effects that could lower the odds of FDA approval. About 19 percent of the patients dropped out of the study due to depression, vomiting and nausea. Because of the possibility of a psychiatric side effect -- and because Acomplia is the first medication to act on the cannabinoid system in the brain -- the FDA may proceed with extra caution.

(this is a really interesting article BTW!)

Well, think logically about that, if you are taking the pill to help lose weight, odds are your subconcious is going to kick in and you are going to be doing things you wouldn't normally do to:

A: Make the process go even faster

and

B: Keep the weight off.

Kind of like when you get something new and kind of expensive, you coddle it for a while so it won't get broken without even realizing it. Many people do this, it's normal. Odds are while you're taking the drug, you're lifestyle would change to the point that if you went off the pill and gained a few pounds, it wouldn't matter, because with your new lifestyle you'd lose them again anyway. The reason they gained weight after going off the pill was probably because this was a controlled study, and they told the participants not to do anything out of the ordinary (AKA: eat differently or exercise more than they were doing).

Fair enough. But that is why they compare it to a placebo, to factor out the effects of the subconscious mind on weight loss. Those who got accomplia got the results of placebo plus a chemical, those on placebo just got the results of their subconscious.

I think this drug is overhyped. 5% of bodyweight in a year is not a major change, for a 200 pound man that is one pound a month of weight loss. The anti-smoking effects and the fact that this will help smokers quit (since weight gain is one of the reasons given as to why people don't want to quit smoking) are far more important in my view.

Looks like FDA approval is coming closer...

Drug firms eye fat profits from new obesity pills (http://today.reuters.com/business/newsArticle.aspx?type=ousiv&storyID=2006-01-16T051007Z_01_L12648932_RTRIDST_0_BUSINESSPRO-OBESITY-DC.XML)

Plus two more down the pipeline. Interesting!

Looks like FDA approval is coming closer...

Drug firms eye fat profits from new obesity pills (http://today.reuters.com/business/newsArticle.aspx?type=ousiv&storyID=2006-01-16T051007Z_01_L12648932_RTRIDST_0_BUSINESSPRO-OBESITY-DC.XML)

Plus two more down the pipeline. Interesting!

Great....something to come on the market, everyone will sing the praises of the "wonderdrug", after a while, some will start to have problems, lawsuits will fly around, people will point the finger and lay blame, and then it will be pulled off the market. Blah blah blah....same old story over and over again and people don't learn. It's sad. There will never be a "safe" drug to treat obesity. It's just not worth the risk.

I wonder if this is wellbutrin/zyban remarketed?

I say that because, last time I was on wellbutrin I heard it was going to be remarkted as a weight loss drug and a stop smoking pill, mainly because they realized it was one of the very few anti depressants that didnt seem to cause weight gain..

If it is wellbutrin remarketed I wont be able to take it, I had a horrible..and I do mean HORRIBLE reaction to wellbutrin..but that is just my total personal body chemistry thing..

but I was just curious if this was wellbutrin remarketed..

I think it'd be great if a safe drug came out that really, really helped in the fight against obesity and focused on the whole impact of obesity and metabolic syndrome on the patients, as well as addressing the depression factor.

Somehow I just doubt it and think educating people on ways to reduce all the negative consequences and risk factors of obesity is where the research dollars should be going.

In the time it's taken for a number of obesity pills to go through all this development rigmarole, only to be found as less exciting than promised, many overweight people have dieted and exercised their way out of the category of needing medication for the purpose.

Sorry, but as someone said up thread, it is sad that people are going to get their hopes up again when the answer is, in many cases of obesity, so simple.

It would be nice but I thought I finally read some bad stuff on it only a few weeks ago. I think people had gotten of it for whatever reason or something of that nature.

I have been waiting for this pill to become available for over 2 years now so it would help me stop smoking, 8 months ago I gave up waiting and quit all by myself. Now I have 20 lbs. to lose because I quit, but I figure if I quit smoking by myself, I can lose this weight by myself.

The upside to doing it alone, all that money you can save to buy new clothes when you do lose the weight. Do we really need to make these people richer off us?

And it says they lost 5 to 10 percent of their body weight... Let's face it; for those with serious weight problems that is a drop in the bucket!

Hi all! There is actually an article on the new diet drugs coming on the market in the May/June WW magazine. W/ Accomplia it says that it does work by reducing cravings but the side effects could be nausea, dizziness, diarrhea, and depression. It goes on later to say that in addition to aiding weight loss this drug also can improve some of the risk factors w/ cronary heart disease! I am a pharmacy tech so I know that all drugs have side effects but that heart disease thing scares me!

They are also coming out w/ an OTC form of Xenical called Alli. This one has side effects like gastrointestinal distress like gas, fecal incontinence and oily discharge...ew! Just thought that I'd share since I saw this article!

Sounds lovely LOL. Thanks for the educational message!

So I had not yet heard of Accomplia until my doctor mentioned it the other day. In spite of my best efforts, exercising regularly and following South Beach Diet, I am not losing weight. The good news is that I feel better, my blood pressure was 114/58 (the best it's ever been) and the doctor said my blood work was excellent, so it is working, even if the stupid scale isn't reflecting it yet.

My doctor encouraged me to keep doing what I am doing, and also mentioned that Accomplia is expected to be avaialablee here in the US in the next 3 months. He explained how it works and encouraged me to do my own research, but thinks it is very promising. He is not the type of doctor to just "put you on a pill", and the practice in general intergrates eastern and western medicine, so I put a lot of stock in his opinion. So I am off to do more research.

IrishCowGirl, I am confused, isn't improving coronary risk factors a "good" thing. Did I misread that?

BTW- I have to agree with some of the other members, there are a lot of people on really high horses. What's right for one person is not right for another. Plus not everyone is looking for a magic pill, a lot of people are working very hard doing the "right" things and want to consider a possible option to add on to the diet and exercise. Personally I am not big on medication in general, but they do have their place, and this one I might consider.

I was very surprised to read some of the posts here-everything I've read on this forum before has been extremely anti diet pill. I'm not-I have taken pills in the past that did work for me, and have been shushed and scolded for posts expressing that opinion. The mere mention of a pill has seemed to bring down nothing short of hellfire and damnation from some of the long-timers here!
I am open minded to anything that would help in the quest to lose weight, and I'm well aware of the fact that snake-oil abounds on the market, and that prescriptions can carry with them some severe side effects. This new stuff, Accomplia, doesn't seem worth the while, though. The amount of weight loss it proclaims isn't really even a drop in the bucket-nothing you couldn't do fairly easily on your own, especially considering that you have to keep taking it indefinitely. You can lose a pound a month by parking further from the store when you shop, taking some stairs occasionally, etc, without changing your eating habits at all. If I'm going to go through the expense and risk of a diet pill, it has to be one with more potential or a better track record. If I can take a pill that lets me lose 40 or 50 pounds in a few months, then even with possible side effects, the health benefits of not being overweight may outweigh the risks of the meds. I can't, however, see myself taking that risk or expense for the 19 pounds lost and maintained in 2 years that was quoted by the study.

I believe the reason probably seems anti diet pill is because, as far as I know, there is no diet pill that is proven to help someone lose weight and sustain that weight loss without the continued use of that diet pill. Diet pills are also notorious for bad side effects. If you ask someone who has lost 20, 30, 40 or more lbs and maintained it for over a year, how many of them will attribute diet pills to their loss? I think that is one reason that the national weigh control registry is interesting because it documents people who have lost weight, sustained that weight loss and how they did it. Although everyone is different, the basics are the same, increase exercise, decrease portions as well as fat and sugar. The maintainers forum on this site is also useful for the same reason because you can see how people have lost weight and maintained that weight loss.

Accomplia does seem to be different in that I believe the studies suggest that weight loss may be maintained even a year after the pill has been stopped. Do the benefits outweigh the risks? That is something that an individual would have to decide.

Some people choosed to lose weight by calorie counting, some do Atkins or low-carb, some do weight watchers, and so on. No matter how you do it, even if it would be with this new pill, if you don't keep up a healthy lifestyle when you go off plan or off meds, you WILL gain it back. There is no way around it, and there's nothing in this pill or any other that will prevent that from happening. Permanent changes are necessary to maintain-and the fault doesn't lie with the plan or the pill.
My problems with weight have been from having children. This is my 3rd and hopefully last time to have to lose a large amount of weight. I can't speak for anyone but myself, but I have used diet pills to lose weight, and didn't have to keep taking them, and didn't gain the weight back (atleast not until I got pregnant again, which is what put me here now).
I have lost over 50 pounds before, and maintained it with yoga and sensible eating for several years. Twice. No diet pill is or should be a crutch that enables us to get or stay thin without working for it. It would be a scientific impossibility for a pill to MAKE you gain weight back once you stop taking it, or to prevent it either, for that matter. The fact that this study (which by the way was funded by the manufacturer) makes that claim would make me be just as skeptical about this drug as all the relacores or cortislims out there. This pill is said to work by controlling cravings-which is exactly what the prescriptions already on the market today do. This isn't big news, or even a new development. It's what ALL diet pills do.
You're right-diet pills do have side effects. But so do tylenol, prozac, birth control, and viagra-every product over the counter or prescription has SOME unwanted or even deadly side effect with SOMEONE, so why do we bother? Because there are also ill effects caused by whatever reason people take these medications-the pain, depression, untimely pregnancy, or impotence. In the case of diet pills, it's overweight.....by weighing more than we should we are putting ourselves at more risk for heart disease/attack, stroke, respiratory and circulation problems, and even some forms of cancer.
There are prescriptions available today that have been proven safe and effective to help with weight loss, and have been in use for years-proven through use, not just some study funded by an unbiased manufacturer. If they weren't safe or effective, the FDA would not not allow them to be prescribed and marketed-they ban drugs of all kinds regularly for those very reasons. Doctors wouldn't prescribe them. Just like any other med, every pill doesn't work for everyone.

Anyone ever taken an antidepressant? There isn't one out there that works for everyone, or that doesn't have a mile long list of precautions/side effects/withdrawals, and overweight is just as serious of a health issue as depression-but no one is out there vehemently protesting the sale and use of zoloft......taking any form of birth control puts you more at risk for heart attack, using tampons can cause toxic shock syndrome-people have died because of both, MANY more than because of diet pills, but there are literally millions of people in the world using them every day, and not thinking twice about it.

I started Acomplia in October last year. First week I got some weird side effects, being dizziness and a strange sensation when going to sleep - very hard to explain that one to be honest, but it is a bit scary. I rode them out and yep, it did curb my cravings very much for the first month and I lost a stone. But this is certainly not an appetite surpressant at all. Not honestly sure what it is!

Several months later, nothing - not a single thing. I was back to eating as I was before and the crave curbing effect had worn off, as had all the side effects. I've now stopped taking them because they were just a waste of time.

One side effect that is evidence is anxiety - you don't handle stress well when you start Acomplia so if you have anxiety avoid this pill.

To be honest though, I would not hang your hopes on it. I think it is great if you want to give up smoking - I know many on the Acomplia forums who have done just that but not lost a pound.

I still have several packs left - not quite sure what to do with them. Bin them probably and stick with the old fashioned way and WW.

Caroline :)

Sounds like it would only help people who have compulsive eating disorders or those who binge. The yo-yo factor is disturbing. This drug looks like it will not be much better than a fad diet. If you go off it, you gain the weight right back.

I, for one, would not want to take a pill for the rest of my life for anything. My parents are both on a heavy number of medications due to heart disease, high blood pressure, bad circulation, kidney problems, diabetes and other complications from obesity. Whereas it's hard enough for me to remember to take my vitamins each day.

No thanks, Accomplia.