Prescription Drug to Aid Weight Loss Wins F.D.A. Backing By ANDREW POLLACK Published: June 27, 2012 67 Comments Facebook Twitter Google+ Email Share Print Reprints
The first new prescription diet pill in 13 years won approval from the Food and Drug Administration on Wednesday, providing a new option for the roughly one-third of American adults considered obese.
Readers’ Comments Share your thoughts. Post a Comment » Read All Comments (67) » Now the question is whether people will use it. Despite a seemingly huge market, diet drugs have not sold well in the past, in part because people tend to use them for only a short time.
The new drug, developed by Arena Pharmaceuticals of San Diego, has been known as lorcaserin and will be sold under the name Belviq by Eisai Inc., the American branch of the Japanese pharmaceutical company.
Before Belviq’s approval, only one anti-obesity medicine had been approved for long-term use — Roche’s Xenical, which reached the market in 1999 and is rarely used because of modest weight loss and unpleasant effects on the digestive system.
The history of diet pills has been marked by many safety problems and product withdrawals, which has made the F.D.A. reluctant to approve new drugs. Belviq itself was turned down by the agency in 2010, but Arena came back with new data that assuaged the agency’s safety concerns.
Some patient advocates and doctors who treat obesity say there is a need for new medicines to help to plug a “treatment gap” between diet and exercise, which do not work for many people, and the more radical option of bariatric surgery. They say obesity itself is a serious disease that causes other health problems like diabetes and heart disease.
In announcing the approval of Belviq, the F.D.A. suggested that it ascribed to that point of view. “Obesity threatens the overall well being of patients and is a major public health concern,” Dr. Janet Woodcock, director of the drug evaluation center at the F.D.A., said in a statement.
Belviq is the first drug to reach the market for Arena, which was founded in 1997. Its stock price has more than quadrupled in the last two months, with much of the gain coming after an advisory committee to the F.D.A. recommended approval of Belviq by a vote of 18 to 4 on May 10. On Wednesday, the stock rose 29 percent to $11.39.
Arena said it was not clear yet when the drug would be available to patients and what it would cost. Because the F.D.A. deemed that there was some potential for the drug to be abused, the Drug Enforcement Administration must now decide what controls to place on prescribers, a process that Arena said could take four to six months.
Belviq provides only modest weight loss. In the two main clinical trials, those who took the drug lost an average of 5.8 percent of their weight after a year, while those using a placebo lost 2.5 percent. However, some 23 percent of the patients using Belviq lost at least 10 percent of their body weight.
Taken twice a day, Belviq activates a receptor in the brain, called serotonin 2C, in a way that controls eating and makes people feel full.
The main safety concern is that Belviq works somewhat like fenfluramine, a drug that was part of the popular fen-phen combination but was withdrawn from the market in 1997 because it damaged heart valves. The F.D.A. said Wednesday that it was satisfied that Belviq was unlikely to cause such problems.
The agency is not requiring patients taking Belviq to be monitored for valve damage. However, it recommends that people stop taking the drug if they do not lose 5 percent of their weight in 12 weeks, because they are not likely to benefit and should not be exposed to the risks. (About 40 percent of patients taking the drug in clinical trials achieved that much weight loss in 12 weeks.)
Arena committed to conducting six studies after the drug reached the market, including one to determine whether the drug increased the risk of heart attacks and strokes.
Some advocates hailed the approval. “The F.D.A. seemed so scared of another fen-phen recall that they had like a psychological hurdle to approve any new drug,” said Morgan Downey, editor of the Downey Obesity Report. “I think they maybe now have gotten beyond that.”
The F.D.A. could approve a second obesity drug, Vivus’s Qnexa, next month.
But Public Citizen, the consumer group, called the approval a “reckless” action and predicted Belviq would eventually have to be taken off the market for safety reasons.
The next hurdle for Arena and Eisai will be selling the drug. This would seem easy given the tens of millions of obese and overweight people. Some analysts are projecting annual Belviq sales will exceed $1 billion.
But no other obesity drug has done that well. Only a small percentage of obese people use such drugs now.
While that is partly because there are few good choices, another issue is that insurers have been reluctant to pay for such drugs. Medicare Part D, which pays for drugs for seniors, explicitly excludes obesity drugs, along with drugs for erectile dysfunction and hair growth. Only 10 state Medicaid programs clearly pay for weight-loss drugs, according to a 2010 study by researchers from George Washington University.
Another issue is that patients tend to stop using the drug, in part because they are dissatisfied with the weight loss. The 5.8 percent average weight loss in the clinical trials of Belviq means that a person weighing 220 pounds, the average weight at the start of the trial, would still weigh 207 pounds a year later.
Even in the clinical trials, in which people tend to take drugs more faithfully than in real life, more than 40 percent of patients stopped taking Belviq before the year was out.
Dr. Ed J. Hendricks, an obesity specialist in Sacramento, said that he and other doctors might try prescribing Belviq in combination with phentermine, to essentially reconstitute the once popular fen-phen combination. “Once that word gets out that it works the same way, you are going to have a huge demand,” said Dr. Hendricks, who was on the advisory committee that voted in favor of approving Belviq.
Perhaps to discourage this, the label of Belviq states that the drug has not been tested for use with other weight-loss agents.
Post by lyssbobiss, Command, B613 on Jun 27, 2012 20:55:36 GMT -5
Did they happen to mention why so many people quit taking the drug within a year? That's interesting. If you are so desperate to lose weight that you are willing to be in a drug trial (and I have BTDT and bought the t-shirt), it surprises me that you'd quit unless there were unfortunate side effects (anal leakage?).
"This prick is asking for someone here to bring him to task Somebody give me some dirt on this vacuous mass so we can at last unmask him I'll pull the trigger on it, someone load the gun and cock it While we were all watching, he got Washington in his pocket."
Did they happen to mention why so many people quit taking the drug within a year? That's interesting. If you are so desperate to lose weight that you are willing to be in a drug trial (and I have BTDT and bought the t-shirt), it surprises me that you'd quit unless there were unfortunate side effects (anal leakage?).
They said it's because people experience such minor weight loss that they apparently don't think it's worth it to keep taking it.
Post by LoveTrains on Jun 27, 2012 23:03:50 GMT -5
I was actually part of a 2 year clinical trial for lorcaserin (the same drug mentioned in the article) out of the weight center at mass general in Boston from 2007 - 2009. Part of the trial required me to have an ultrasound of my heart every six months to check for heart valve damage.
It was a double blind study so not sure if I was on placebo or drug, but I really didn't lose weight during the 2 year trial. I was taking the medicine 2x a day, an hour before bfast and an hour before dinner. I did not feel any less hungry or more full, but again, I might not have been taking the actual drug.
Post by LoveTrains on Jun 27, 2012 23:08:01 GMT -5
This drug is supposed to affect your brain and has nothing to do with your GI system. I certainly did not have any thing even remotely close to anal leakage nor was that a possible listed side effect. I did have to come in once a month to get weighed & measured (hips & waist). They also said I couldn't be pregnant in study. I also had to take monthly questionnaires about mental state. They tested blood pressure monthly and also quarterly took blood to run tests.
I'm not sure what to think about this. Yes, not everyone gets great results after diet and exercise. But isn't that typically due to other conditions (i.e. thyroid) for which there already are medications? Though I suppose for people who have unexplained conditions causing weight loss troubles, Belviq may be what's needed.
As an obese person who has had been able to unsuccessfully maintain weight loss, this just doesn't sound worth it.
Risking heart damage for 10-20lbs just isn't good enough. Now if I had any medical issues (diabetes for example), it might be worth trying--I'm not even sure most hospitals would participate because of disproportionate risk or harm vs potential benefit of the drug.
And to pp, it is standard to strongly discourage pregnancy during clinical trials. I don't know that most companies every bother to study safety in pregnant women.
As an obese person who has had been able to unsuccessfully maintain weight loss, this just doesn't sound worth it.
Risking heart damage for 10-20lbs just isn't good enough. Now if I had any medical issues (diabetes for example), it might be worth trying--I'm not even sure most hospitals would participate because of disproportionate risk or harm vs potential benefit of the drug.
And to pp, it is standard to strongly discourage pregnancy during clinical trials. I don't know that most companies every bother to study safety in pregnant women.
Lurker here. I'm a statistician trained to design / execute clinical trials.
No, it is unethical to randomize a pregnant woman to any arm of a clinical trial simply because of the unborn child in question. I doubt you will find any IRB that would allow something like that. Of course there are trials relating to pregnancy, but that seems to be interventions during delivery or drugs we've already established are safe during pregnancy.
Also if this is being marketed as an anti-obese drug... I agree with the poster I've quoted. I don't think that losing 5-10% of my weight in a year is worth either taking or paying for the drug. However, I am not a health professional so I don't know what's ideal in that arena. As a statistician, I'd like to see the study to see how strong the association between drug and weight loss is, as well as the study design (specifically the population they targeted).
Anyhow, I will go back into lurking - just question clinical trial results when you see them!
I have mixed feelings about this drug. I don't think the trials have shown enough positive results to justify the possibilities of serious side effects. I took Meridia and it was awesome for about 3 months. For the first time in my life, I wasn't hungry all the time and I lost weight. They it just stopped working. From what I have read, this drug does the same thing -- it stops working over time.
I don't think I'd ever take a weight loss drug, even my lazy ass would probably rather exercise. Too many risks from a medication when (for ME) I could just exercise and eat better. But for some Im sure this drug shows great promise.
I don't think I'd ever take a weight loss drug, even my lazy ass would probably rather exercise. Too many risks from a medication when (for ME) I could just exercise and eat better. But for some Im sure this drug shows great promise.
Also two pugs please stay!
For a lot of people it's not a choice between taking a drug (or getting surgery) or "just eating better and exercising." If diet/exercise worked for everyone, there would be little need for weight loss drugs. I tried every diet in the world and have always exercised regularly and until weight loss surgery, I was ALWAYS so freaking hungry that I couldn't stick to a diet more than a few days at a time. After WLS, I eat less than 1400 calories a day (because I can't physically eat more) and exercise regularly. I lost 100 pounds, but I am still not thin and probably never will be.
There is so much more to weight loss that "just eating better and exercising."
Does this one make your ass leak at inconvenient times?
No, I already said I was part of the clinical trials for this drug and that it doesn't have anything to do with your GI system.
I will say that when i first started the clinical trial for this drug that I did lose weight in the first 2-3 months. Then I just stayed the same weight for the remaining 1.75 years of the trial.
The trial also included meeting with a dietician once a month and getting guidance on diet and exercise. We were supposed to be journaling our food, eating no more than 1500 calories/day, and exercising along with the drug.
I don't think I'd ever take a weight loss drug, even my lazy ass would probably rather exercise. Too many risks from a medication when (for ME) I could just exercise and eat better. But for some Im sure this drug shows great promise.
Yes, but I don't think this drug (or any other weight loss drugs) are meant for people who want shortcuts to weight loss, i.e. able people who refuse to exercise. I would hope this drug or others that may work in the future could help people for whom exercise and a healthy diet isn't working for some reason. Like the article mentioned, it does stink that if diet/exercise don't work and doctors can't explain to you why, then the other option is major surgery that may or may not even work either. Whether Belviq works for people or not, I'm glad strides are being made to give people options.
Does this one make your ass leak at inconvenient times?
No, I already said I was part of the clinical trials for this drug and that it doesn't have anything to do with your GI system.
I will say that when i first started the clinical trial for this drug that I did lose weight in the first 2-3 months. Then I just stayed the same weight for the remaining 1.75 years of the trial.
The trial also included meeting with a dietician once a month and getting guidance on diet and exercise. We were supposed to be journaling our food, eating no more than 1500 calories/day, and exercising along with the drug.
Did you follow these guidelines? And still didn't lose any weight after the first couple months?
Several of my physician professors have said that a 10% weight loss can have pretty significant positive outcomes on health such as lowering systolic blood pressure by 10 mmHg, helping people to not become insulin dependent, etc. I don't have time to look for any specific data and I'm not sure if this statistic only holds true up to a certain weight, but I do think a 10% weight loss can be very helpful for some people. Now whether it's worth it to take a drug to get there if that drug has side effects, well that's another question/debate.
This is valid; I was only thinking about the goal of losing weight, not the other benefits that come from losing weight. And yes - it should be evaluated that if the drug reduces weight by 5-10% AND decreases SBP (or whatever benefit you're going for), is it worth the other side effects?
I am always super skeptical of new drugs. Just because the first cohort of participants were followed for 2 years doesn't imply that we really know the long-term effects (or benefits) of this drug. It really makes me sad when these things are published and the general population is all OMG YES YES YES SIGN ME UP when there are so many things that need to be considered at the same time.
No, I already said I was part of the clinical trials for this drug and that it doesn't have anything to do with your GI system.
I will say that when i first started the clinical trial for this drug that I did lose weight in the first 2-3 months. Then I just stayed the same weight for the remaining 1.75 years of the trial.
The trial also included meeting with a dietician once a month and getting guidance on diet and exercise. We were supposed to be journaling our food, eating no more than 1500 calories/day, and exercising along with the drug.
Did you follow these guidelines? And still didn't lose any weight after the first couple months?
Nope I got tired of following the guidelines, and as someone stated above, this drug did nothing to address my disordered eating.
But let's not turn this thread into how I'm the captain of #teamfatass. I'm on a good weight loss streak right now.
LoveTrains - if you don't mind me asking - how did you get involved with the clinical trial?
I am sure I saw an ad for it. I used to be on an email list where I get emails about clinical trials for all kinds of drugs in the Boston area. I think I must have signed up originally for the email list through an ad on CraigsList or something when I was right out of college and kind of poor.
It was when I lived in Boston. I also received monetary compensation for participating. I can't remember exactly how much now - but I think in the range of $800ish but it was paid out over two years. I didn't even get any payments until after the first year was completed. And they would also pay for parking or T-fare to get to the appt.
I don't think I'd ever take a weight loss drug, even my lazy ass would probably rather exercise. Too many risks from a medication when (for ME) I could just exercise and eat better. But for some Im sure this drug shows great promise.
Also two pugs please stay!
For a lot of people it's not a choice between taking a drug (or getting surgery) or "just eating better and exercising." If diet/exercise worked for everyone, there would be little need for weight loss drugs. I tried every diet in the world and have always exercised regularly and until weight loss surgery, I was ALWAYS so freaking hungry that I couldn't stick to a diet more than a few days at a time. After WLS, I eat less than 1400 calories a day (because I can't physically eat more) and exercise regularly. I lost 100 pounds, but I am still not thin and probably never will be.
There is so much more to weight loss that "just eating better and exercising."
I agree with you - not sure you understood what I said - I wouldn't take it but I won't deny the potential it could have fr many. I'm fortunate enough that diet and exercise usually do the trick for me. I know not everyone has that experience.
Does this one make your ass leak at inconvenient times?
No, I already said I was part of the clinical trials for this drug and that it doesn't have anything to do with your GI system.
I will say that when i first started the clinical trial for this drug that I did lose weight in the first 2-3 months. Then I just stayed the same weight for the remaining 1.75 years of the trial.
The trial also included meeting with a dietician once a month and getting guidance on diet and exercise. We were supposed to be journaling our food, eating no more than 1500 calories/day, and exercising along with the drug.
Ooooh you just answered one of the questions I had about the design. I wondered if they had you guys do diet/exercise along with the intervention or if it was intervention only. That's *really* interesting that it was calorie restriction / exercise AND the drug, and people still only lost 5-10% of their weight. Do you know if you had to be within certain weight limits to enroll in the trial?
And I also agree with others that it's not always diet and exercise that help weight. I've struggled with weight my entire life, and was limiting calories and exercising pre-pregnancy. I dropped about 20 lb. in 5 months, but then got pregnant. But ultimately, the amount I had lost with my calorie restriction and exercise... I should have lost more than that. I was restricting myself to where I should lose 2 lb./week, not 1 lb./week. I don't know that I'd ever turn to a pill... mostly because I've been scarred by the coverage on Alli and ass leakage.
Someone asked about the FDA making something like fen-phen and making it safer. That will never happen.
There certainly would have been weight limits to any trial (I actually work with clinical trials as well)
Annoyingly my previous comment was switched around--the sentence about hospitals not wanting to participate did refer to pregnant women and would assume IRBs would be opposed (though left out specifics as I doubt anyone outside of industry knows what IRBs are.)
Twopugs, I am not going to quote because it is getting big, but yes, I am sure that one had to be within certain weight limits. My BMI was between 35-39 when I was in the trial. They did all of the measurements in Kilograms and centimeters.
Also keep in mind that I did this study at just one study site. I am sure that there were multiple sites around the country, right? Whenever I would go for a visit, it was just me there and a nurse/study coordinator who would take all the measurements. I saw the residents every so often who would do some sort of neural tests like touch your finger to your nose, walk in a straight line, etc.
Also, after one year we did a "re-randomization" or something like that.
Twopugs, I am not going to quote because it is getting big, but yes, I am sure that one had to be within certain weight limits. My BMI was between 35-39 when I was in the trial. They did all of the measurements in Kilograms and centimeters.
Also keep in mind that I did this study at just one study site. I am sure that there were multiple sites around the country, right? Whenever I would go for a visit, it was just me there and a nurse/study coordinator who would take all the measurements. I saw the residents every so often who would do some sort of neural tests like touch your finger to your nose, walk in a straight line, etc.
Also, after one year we did a "re-randomization" or something like that.
Depending on the size/design of the trial, there was probably more than one site. Doesn't necessarily have to be around the country.
I was also trying to avoid asking about your weight directly. My thought process: if the population's more in the obese range, they had more to lose. If the population was more in the normal range, they wouldn't have had as much to lose. The 5-10% has different meanings for different weight groups.
Thanks for answering my questions! I'm going to see if I can find the original publication of the research (if it has been published yet).
kcpokergal - yes, I knew there had to be weight limits defined in the inclusion/exclusion criteria, I was just trying to figure out what populations were included. Nice to see another clinical trials person!
Why cant the fda take something like phen phen, make it safer and sell that?
Well, the phen portion of phen-fen is still available. I've had success with it, but it needs to be prescribed and is not intended for long term use.
Also, FDA doesn't develop/manufacture/market drugs. Another drug company could do something with phen, and FDA could review/approve it, but FDA wouldn't actually create the drug.