Chevrolet Impala (via Wikimedia Commons)
[Swivelchair note: This post was originally published 01.08.08, and this is an update 03.10.08 in view of the renewed interest in weight loss meds, see here, and here, for example]. The JP Morgan Health Care conference is coming up, where biotechs present their research and business developments.
I’m sure a lot of weight loss meds will be presented. I’ve worked in this area for quite a while, and there seems to be a serious disconnect between data (I mean, facts) and feelings (like, what’s right and wrong). This may be a truthiness situation.
For years, I’ve sat in conference rooms and listened to expert endocrinologists say the same thing: Fat deposition — obesity or fat tissue distribution on the body — is predominantly hereditary. There is a behavioral component — which, last I checked, resulted in plus or minus 10% or so change. But for the most part, if your parents were giraffes, that’s what you’ll be. If they were hippos, that’s what you’ll be.
To me, the gold standard — well, ok, maybe the 10K gold standard — well, ok, the Home Shopping Network gold standard — for weight loss meds is Phen-fen. Now, I posted on this here, and here explaining what I mean by that.
In the 10+ years since Phen-fen was banned, science as marched on, and we figured out what serotonin receptor subunits – subunits are on the heart — so now we know how to avoid them. (Explained before). Lorcaserin was screened for that in drug development. Sort of a yawner in terms of science, imo. (This is from the website and is my interpretation).
So, lorcaserin is a totally new chemical entity — like Phen-fen without the scatter-shot serotonin receptor approach — it pretty much avoids heart serotonin receptors, and is selective for the serotonin receptor subunit-subunit within the brain. OK, mode of action pretty much figured out. [Swivelchair addendum 03.10.08: The 5-HT2C specificity was previously discussed here and the chemical structure is presented in Smith et al. cited below]
Is this totally the perfect drug? No. It probably acts a lot like Phen-fen, which had some additional side effects (like, potential dry mouth, dizziness, insomnia). But if you’re taking this stuff every six months or so to keep off 20 lbs, you’ll suffer that kind of thing (I’m guessing).[Swivelchair note 03.10.08: I'm totally guessing that this will be a diphasic dosing regime -- people will dose to lose weight, and then take only as a maintenance dose to keep the weight off as needed. Again, nothing anyone else has said indicates this, but that's how I would self dose if I were taking it.].
Like I said, it’s a Chevy, not a Maybach. A Maybach, your fat would melt in about a week, you could eat whatever you want and your calories would turn to muscle and bone and energy, and not fat, and you’d look 15 years younger and you’d be smarter and richer and better looking and more popular.
[Swivelchair note 03.10.08: The following I think is interesting in terms of the biopharma business -- this drug is a safe version of one previously on the market that was a runaway best-seller. If negative reputation of the "primitive phen-fen" can be overcome by launching "targeted, accurate and safe son-of-phen-fen" then you pretty much can forecast the market size. I don't know, but those must have been interesting meetings in the board room. ]
From an industry perspective, this is the perfect storm: you have the market data already. You know how big the market is.
You already know market acceptability. Maybe the trouble is, “Hey, there’s the Phen-fen taint — no one will prescribe this stuff because they don’t want to be sued.” Don’t know, but plenty of other product-liability second generation products did just fine. IUD’s come to mind. [Swivelchaire note 03.10.08: And Celgene's thalidomide compositions]. Plus, obviously the eat-less-exercise-more gig is a miserable failure. What doc wouldn’t lurve to be a hero when their patients start losing weight?
You already know safety and efficacy — if the heart receptor binding is eliminated. You know pretty much about any other side effects. Efficacy should be the same as Phen-fen, which sold like gangbusters. (The phase III’s aren’t complete, and I have no idea what the data look like or how it will be crunched).
And, you know mode of action, pretty much — that’s better than 90% of the drugs out there that work, but we have no idea why.
And, you have virtually no competition in probably the largest therapeutic area ever (but who knows what’s coming up on the heels of lorcaserin.) [Swivelchaire note 03.10.08: To me, when I compare this to, say, leptin or other injectables, it's a no-brainer. First, the placebo vs. drug data will be much cleaner, because I think the placebo effect of an injectable is much bigger and longer lasting than that of a pill. (I have no data for that, just a hunch). So injectables may have fewer side effects (especially if they're natural proteins), but who cares if you can't tell if they're effective. Plus, who is going to want a daily injection? No one. OK, maybe diabetic people already on insulin. Which leads me to a conspiracy theory: are all those drug makers in the diabetes market conspiring to make the FDA hurdles so high that perfectly usable weight loss drugs can't get approval? I mean, having everyone lose weigh all of a sudden really makes those marketing types go back to their forecasts and re -do the NPV's of the diabetes pipeline, probably].
And the market is growing (to make a lame, offensive, double entendre).
I think this is a case where the FDA should lower trial requirements and speed up approval.
The FDA instead has lots of resources devoted to “eat less exercise more.” Duh. Do they really think people didn’t know that?
Or is this a case of truthiness — they feel that obesity is a moral failing or failing of self-control so that a drug is cheating.
[Swivelchair addendum 03.10.08: It looks like public sentiment is coming around that weight loss meds aren't just "cheating", check out the public comments on the Newsweek articles referenced above. (see here, and here)]
Full disclosure, I invest, long mostly, in a variety of biotech companies that have anti-obesity meds in the pipeline, including the one that makes lorcaserin. With the market as it is, I’m getting wiped out — so if this blog raises the stock price of anything (which it shouldn’t or else something is seriously wrong with our markets), good.
More full disclosure — I have no inside information whatsoever, and am only going on what is in the publicly-available databases or business news, etc. Nothing here should be interpreted as any kind of recommendation to take any kind of health roll-of-the-dice or money-roll-of-the-dice with anything I’m writing here. Frankly, I’m just paranoid that someone will come back and say, “Swivelchair caused me to take this poisonous medicine! Sue!” or whatever. Nope, of course you are a grown up and have free will and can make your own decisions about your money or your body.
Smith, B.M., Smith, J.M., Tsai, J.H., Schultz, J.A., Gilson, C.A., Estrada, S.A., Chen, R.R., Park, D.M., Prieto, E.B., Gallardo, C.S., Sengupta, D., Dosa, P.I., Covel, J.A., Ren, A., Webb, R.R., Beeley, N.R., Martin, M., Morgan, M., Espitia, S., Saldana, H.R., Bjenning, C., Whelan, K.T., Grottick, A.J., Menzaghi, F., Thomsen, W.J. (2008). Discovery and Structure−Activity Relationship of (1R)-8-Chloro-2,3,4,5-tetrahydro-1-methyl-1H-3-benzazepine (Lorcaserin), a Selective Serotonin 5-HT2C Receptor Agonist for the Treatment of Obesity. Journal of Medicinal Chemistry, 51(2), 305-313. DOI: 10.1021/jm0709034
The patient takes how much for how long twice a year to keep 20lbs off? The side-effects only last while the meds are being taken? Does taking it four times a year, say make any difference? I’m not asking for myself, you understand, but I have this friend.
Heh, . . gee, why does do my jeans shrink after Christmas every year? . . .
Yikes, what I meant was that it would probably be dosed daily until you reach a target weight, and then stop the meds — and go on a maintenance dose every six months or so to keep the weight off. I’m guessing. Unless there was some kind of warning against it, I would probably self-dose this way, just because there probably will be the Phen-fen type side effects (dry mouth, etc., except not the heart valve side effects).
I am actually going to the Dr in 2 weeks to pre-screen for a clinical trial of this medication. I know the trial will last for 1 yr. I guess I will find out more about it then.
I go to this screening in a week. Can someone who has been taking it email me and tell me about how it makes them feel or the result. Tammy davisandtammy@aol.com
Texas – where’s the trial? The Pennington in LA?
Tammy – I don’t think the company has posted the final results of the clinical trials, but see the interim results so far:
http://www.arenapharm.com/wt/page/lho.html
Here’s a copy of the company conference call and analysts questions (from Seeking Alpha):
http://seekingalpha.com/article/67893-arena-pharmaceuticals-q4-2007-earnings-call-transcript?source=side_bar_transcripts
Good luck — And thank you both for participating in clinical trials.
FDA -CDER: Get with it. No drug is perfect, but at least get some weight loss med out there with a the side effects in the label if need be. You already have the warnings on obesity: fat causes all sorts of things. So do you consider the benefit only weight loss or the avoidance of the consequences of obesity? What about using that as an end point?
Take the budget from the “eat less, exercise more” department and throw it at CDER’s group, hire more people, and get moving on this therapeutic area.
Hello…I am participating in this trial as well in Connecticut. I have been on the meds for 2 weeks and side effects have not been bad. The next day after the first dose I had an awful headache so I took Tylenol and it went away. Other than that I had had dry mouth and a little lightheadedness. Not too bad. I have also lost 5 pounds in two weeks. It seems to be helping.
Thank you for your comment Jennifer. Congrats on the 5 lbs in 2 weeks (!)
Thanks again for commenting, and thanks for participating in a clinical trial, that is very generous of you.
I have taken my 3rd dose this morning (yesterday the AM dose was monitored at pennington). By now I’m 90% sure I’m on the placebo because of virtually no detectable side effects and it surely hasn’t curbed my appetite or cravings. Getting motivated to lose weight is tough, and I’ve been only feeling slightly motivated and answered the questionaire honestly. I’d kind of hoped I’d be on the ‘real’ drug to help with this lack of motivation. In 2005 (for 9 months)I took a 75mg of Effexor from depression when I lost a grandmother to cancer. I lost 30 lbs without trying (on effexor), because if I wasn’t hungry I didn’t care to eat. If my fiance wanted to go to wafflehouse at 9pm, I’d go with him to keep him company, but had 0 temptation and would drink a water or diet soda. (that side effect surprised both of us) It was easy to eat with health in mind. I remember how my brain felt different during that time and hoped for simular results with this trial. However I’ve decided prior to this that the dietician support and accountablity would be worth the effort and plan to continue even though I could be on a double dose of placebo. I’d like to connect with others on previous or current trials of lorcaserin. Thanks! leigh2anne@yahoo.com
Thanks LA — your Effexor experience brings into high relief the organic basis for eating motivation — I mean, self control and exercise play a role of course — but if a molecule can change your behavior so dramatically, why isn’t more work being done on that?
Sorry you haven’t had any effect, whether or not you are on placebo. My first thought — assuming you are on placebo — is that the data should look great for this trial, because of little placebo effect. Biostatisticians love no confounding placebo effects.
Thanks for your quick response Swivelchair. With your expertise on such things, is it possible that it may take more than 3 days (possible 10mg twice a day) to ‘feel’ anything? I asked the head of the study about the % of people on full placebos, and was told 44%. That’s pretty high. (1200 on placebo, 1200 on 10mg, and 800? on 20mg… or so). At the end of the 3rd day I’m 100% thinking I am on the placebo. But then I am comparing it to the 75mg of Effexor (though it did not kick in immediately).
My understanding is that this drug works on the hypothalmus part of the brain and creates feelings of satiety. diet pills don’t work for me since I don’t like the anxious feeling they create. Some of the effects from taking Effexor have stayed with me, such as being less shy in social situations… or as I tend to think that it gave me an opportunity to exercise a weak muscle in that department, and the positive social effects have stayed on. The satiety aspect of effexor did diminish over time, probably after 6 months (of 9 months). I do appreciate being part of the study even though I keep feeling I’m in the placebo group and also your comments and insight. Any thoughts?
Hi LA -
Probably the best source of information is going to be your clinical trial site managers (and docs) so please make sure you ask them as many questions as you have. They may not be able to answer all of them, but they can tell you what they don’t know.
I don’t know anything special about this drug or this clinical trial beyond what’s published, but years ago I heard a story about a person in another clinical trial for a different weight loss med. This person wrote to the company (who made the drug) thanking them profusely because of all the weight loss. Turns out the person was in the placebo group. Point: you just never know for sure until the data is unblinded.
Thanks again LA for being in the clinical trial. You don’t have to do this — and you may not see any benefit yourself. So it really is generous of you to participate.
Talked to the Dr here in Sacramento. Got an appt on the 17th for screening. Read a lot today on this. Looking forward to being part of the study. Just foud out my BMI is 44. It was 37 2 yrs ago. Ugggggg!
Chef Russ, hope you get some weight loss, but you could get placebo.
Is it ethical at this point to do a placebo controlled? This should really be a cross over study at this point.
Having just listened to Morgan Stanley webcast (5/2/08), it seems like they should just put everyone on drug at this point — the valvulopathy and hypertension (the phen fen problems) would have been apparent by now, and the mode of action is known (5HT2c specific, not found on heart).
No one is going to see any really out there signal with these numbers. You need thousands and thousands to see if there is any kind of weird sub population one-off type result. At this point — where most pts have been 17-18 mos — why not put everyone on drug?
Sorry Chef Russ — I mean, here you are, watching your BMI going up, and we know that the drug causes weight loss which could rapidly prevent any harm from your rapid weight gain — I mean, at least preventing further weight gain.
Good luck to you and I hope your BMI can be reduced.
Im on day two of the trial… Im having some symptoms such as lightheadedness, dry mouth, headache, and a dizziness after the evening dose. Has anyone had any good results since starting??
Thanks for the comment eaa — I think the company said these were common side effects, that usually go away, but of course make sure you talk to the docs.
I think that the FDA needs to rethink the approval path with this one:
An extra year with obesity is very harmful — get this drug out with perhaps a “conditional” approval requiring post-market surveillance. As I said above, with 12-18 or more months of phIII data, with these numbers, no one is going to see any rare side effects.
Any unacceptable side effects would have been seen already — particularly since the mode of action is (a) known; and (b) fen-phen had something like 18 million scripts written — so any non-cardiac side effects would for sure have been uncovered and litigated along with the valvulopathy. Are you kidding? The litigation forensics on fen-phen were probably better than the FDA review to begin with. Maybe hire the Plaintiff’s experts to work at the FDA.
I thought I heard the company say (on the MS presentation) that most people on drug lost over 5% of body weight, and that no cardiac or psychiatric side effects have been observed at all. Even in placebo. (I could be wrong about that one). This is in thousands of pts after at least a year, maybe year and a half.
So why does the FDA want all this extra pre-approval data? Because they don’t see obesity as an exigent circumstance requiring immediate intervention? Because they see obesity as a moral failing and behavioral? The “truthiness” argument? Because they don’t think that irreversibly turning diabetic is that big a deal? Because they don’t think that an extra year or two of obesity-related costs in the health care budget is a problem?
Is the FDA protecting the last few years of lipitor? (My guess is that with weight loss there will be a lower need for anti-cholesterol meds).
Is the FDA playing to the diabetes drug industry?
Not that I’m trying to drum up conspiracy theories or anything.
I am supposed to go tomorrow morning, 5/19, for initial bloodwork for the study in Arizona and i’m having second thoughts. I lost 35 pounds on my own, gained back 10, and just feel stuck. What are your thoughts? I’m just not a drug person AT ALL. I hate to even take ibuprofen and won’t take tylenol.
Thanks for your comments alisa — Wow,losing 35 lbs on your own, that’s great.
You know, I can’t say about your situation. I do think that obesity, at some level, is an organic thing — there is an adiposity set point, and it’s different for different people. Plus, within the same person, it can change. It’s common to be heavier at 40 than you were 18. Why? Obviously your “metabolism” slows down, but why is that? Is it a character flaw? No, of course not.
Probably, obesity will be treated as a chronic condition, and drugs will be a part of it. If you’re not a drug person, good for you if you can lose significant amounts of weight on your own. But I don’t think there’s anything shameful at all in taking a med to lose weight/prevent weight gain.
One interesting thing an anesthesiologist just told me – it’s not unusual for smokers to not get nauseated with general anesthetic. This is because smokers have reduced serotonin receptors in the gut. People take up smoking to stay slim. So that’s actually a form of medication for weight loss (or preventing weight gain).
I have been in the study for 10 weeks now. I am 100% sure I am not on the placebo, because I took a decongestant “DM” without knowing it would interact with the medication and got serotonin poisoning (google that if want a scare!) I don’t blame the drug at all though, because I was told to call before taking anything over the counter so I’m just an idiot. I DEFINITELY know better now!! FYI – I have lost 21 pounds (10% of my body weight) in 10 weeks so I couldn’t be happier. I’m excited for the next 42 weeks because I wouldn’t mind being able to wear a single digit size by next summer!
Thanks for the comment Marsha. In clinical trials you can’t live your life normally. I mean, normally, if you have a runny nose, you’d take a decongestant and not think much about. Not so if you’re in a study. So thank you for being in study, even though you didn’t know whether you’d get any benefit.
With your weight loss, I just don’t think the placebo effect with a pill is this great. With an injection, maybe.
From what I’ve seen of the data, it looks like there is a continuous, more or less linear, weight loss. So for all 42 weeks, let’s assume you’ll lose 2 lbs a week. (This could be a faulty premise if the drug just stops working, and you plateau at a particular weight, or start to regain weight. )
Let me do the math:
Marsha’s original weight (if 21 lbs is 10%) = 210
Marsha’s current weight: 210-21 = 189 lbs
Marsh’s weight at week 42 if 2 lbs a week for 42 weeks = 210 – 84 = 126 lbs
WOW.
On the adverse reaction with the OTC decongestant: Glad you are better . Serotonin syndrome apparently has been an issue for some time with the SSRI’s and even the decongestants should put the specific warning on the label as well as the SSRI’s. That’s the trouble with OTC drugs, there’s no gatekeeper, like the pharmacist, for drug interactions. It would be great if lorcaserin were OTC, since Alli(r) is, but that may require quite a bit more political backlash than the FDA is willing to put up with.
I had my echocardiogram done last week and go tomorrow for my first dosing. I’ll report my progress here, if you don’t mind. I’d love to find a forum where people in the study can get together and chat.
Thank you for your comment alisa. It’s great that you are participating in this clinical trial, very generous. You may get placebo, or drug — and it is a commitment for you, not knowing if you’ll even really benefit yourself.
The more I think about it, I’m surprised that there even is a placebo group in this clinical trial. I mean, which is more harmful, excess weight or this 5-HT2c agonist which is selective for brain receptors, not heart receptors?
The other thing is that there would be a huge reduction in diabetes with the introduction of a safe and efficacious weight loss med. To me, that would go a long way toward reducing the national health care bill. So, FDA, what gives?
One more thing alisa – As far as a forum, this post gets a pretty constant number of hits from people searching “lorcaserin” on Google — so there are probably others in the trials who are reading this.
But I really don’t know if there are any other weight loss forums having IM, chat, etc. which you can use (this blog doesn’t have that functionality).
So if anyone knows of any, you can past the link in the comments, and I’ll re-post as a blog entry optimized for Google, to send clinical trial participants to that site.
I started my first two doses today and I’m pretty sure I have the drug. I am less hungry, feel fuller with meals, and have a headache and am having dizziness. I’m eager to see if this continues or if I’ve somehow conjured up these symptoms to make myself believe i got Lorcaserin vs. the placebo.
The nutritionist said she’s confident I’ll meet my goal of 150 pounds with no problems at all, drug or no drug, as long as I keep up my activity level (training for a 5k, plus strength training) and keep my calorie intake limited to about 1500 daily. Weight today was 198.2
Thanks for the blow by blow description alisa.
Good luck with the 5K – plus, during the summer it’s hotter.
I wonder if the drug works better during the summer or with people who exercise because the heat tends to make the squalene in the brain more liquid and the receptors are less likely to be clogged up? (My totally speculative hypothesis of brain thermoregulation relating to weight loss).
Still headache this morning and dizziness as well. I had one bowl of weight control oatmeal and tried to eat an apple with it and was only able to eat 2 wedges. Amazing. I mean, most of the time I can exercise self control and stop eating when I should, but here I wanted to eat a healthy fruit and I couldn’t. I’ll fit it in at another time today.
Thanks alisa -
swivel, can you email me please
Devin my e mail is: swivelchair@neurologicalcorrelates.com if you would like to contact me == thanks
So I have been on the drug for a complete 7 days and I’ve lost 2.5 pounds. My appetite is much less, sometimes so low it makes me a little apprehensive about continuing for a whole year. I have been able most days to eat 1500 calories, which is what the nutritionist gave me. There were a few days last week where I only got in around 1300.
Now, I am exercising almost every day. I have started eating more fruits and vegetables, though not as many as I should be! I just stocked the house yesterday with lots of fruit and carrots, so I’ll have food to grab and eat that’s healthy vs. eating something that’s boxed and in my pantry.
I’ll update here every few weeks, or you can check out my blog where I post about my weight and the drug as well.
I typed my blog in wrong.
http://www.extrapounds.com/blog/littlealisa/index.php
that should hopefully work
Thanks alisa — I should note that the people who post on this are unknown to me, in fact, I have no idea if they’re really on the trial or not (no disrespect meant to anyone) — so if anyone is going to invest or go on the trial or make any other major decisions based on these posts, obviously I’m not recommending that.
And I just checked alisa’s web page, and it’s great — so you go alisa, and good luck.
I’d like to know if Alisa’s sex drive and ability to climax has been obliterated yet, because this is a very common and disturbing side effect of many SSRI’s. And the bigger problem is even if you stop taking them, your sex drive and ability to climax can take YEARS to come back. That’s a nasty side effect in order to lose, what, 10 pounds more than if you just dieted without using any drugs ?
I’m afraid lorcaserin is going to have some surprise damaging effect just like fenfluramine did. So they’ve made sure that the drug doesn’t cause valve damage or PPH, what if it destroys a part of the brain or some other vital organ ???
Diet drugs are insane. First of all, the extra fat that most people are hauling around does not create the kinds of health problems people have been brainwashed into thinking they do, so people are not taking diet drugs to correct a serious medical condition. It’s all about appearance and the horrendous pressure in our society, especially on women, to be thin. Remember fen-phen, women who were only 30 pounds overweight, who wanted to look better for a wedding or reunion or wanted to look better in a bikini during a summer vacation were KILLED because they took a drug instead of simply eating less, eating better, and exercising more. I will not be surprised at all if the same thing happens to the people who take lorcaserin.
It’s also very important to remember that losing weight isn’t just about achieving a goal weight, it’s about MAINTAINING that weight too. Is the drug company intending to advise people to take the drug forever ? If not, anyone who has lost weight using it will need to learn new habits after they have stopped using the drug. Gastric bypass surgery has the same problem, look at Carnie Wilson, she’s gained back half of the weight she lost because she didn’t learn to eat to maintain a lower weight.
The problem with fen-phen is that most people have forgotten about it, or those that do remember it have only a vague memory and don’t remember just how damaging it was. I recommend that all people thinking about taking a diet drug read Alicia Mundy’s book “Dispensing With The Truth”. You will wonder why Wyeth is still in business, and you will wonder if the FDA exists to protect consumers or protect the drug companies’ profits.
And now I will offer my diet advice: settle on a realistic weight that is a balance of physical comfort and desire to eat, figure out how many calories you require to maintain that weight, develop a diet that is as nutritious as possible while including your favorite foods (eat them in smaller amounts if they are calorie-dense), get at least 30 minutes of exercise each day, get plenty of sleep, drink sufficient water (you don’t need to overdrink, it will just make you pee more), and try to be happy and enjoy life and enjoy the miracle that is your body regardless of your weight. Forget drugs, they are a bandaid, they can wreck your health, and they are not a real solution.
Oh my god, I just visited Alisa’s blog and this is what she wrote on July 15: “As I’ve told you-all lately, I just don’t feel the drug is working, so the not eating is all me. I’m serious. I still get light-headed and dizzy sometimes but otherwise, I don’t feel as full as quick as I used to.”
THE DRUG IS NOT WORKING !!!!! She’s only been on it for, what, 6 weeks ? And it’s already not working for her after losing 10 pounds ? She admits her dieting is now all her own effort, she’s not getting any help from the drug !
Sorry to keep posting, but I was looking for info about 5-HT2c receptors which lorcaserin allegedly binds to. I found this:
“Autoradiographic studies, using a variety of ligands have provided a detailed map of the distribution of 5-HT2C binding sites in rat and many other species. In addition to the very high levels detected in the choroid plexus, 5-HT2C binding sites are widely distributed and present in the cortex (olfactory nucleus, pyriform, cingulate and retrosplenial), limbic system (nucleus accumbens, hippocampus, amygdala) and the basal ganglia (caudate nucleus, substantia nigra). The presence of 5-HT2C binding sites in the pyriform cortex and substantia nigra is relevant to findings of 5-HT2C receptor-mediated electrophysiological responses in these regions.”
I am disturbed by two things.
First, it is apparently known that there are lots of 5-HT2C receptors throughout the body (“widely distributed”). And surely they are not all known yet. When lorcaserin is approved, we will no doubt have millions of people taking this drug, and the drug will have an effect on, presumably, many if not all of the 5-HT2C receptors in the body. There might be clinical trials going on now, the drug doesn’t appear to be living up to its promise but for now we’re not hearing any reports of people dying. But what if damaging effects are not measurable short-term ? Remember, many fen-Phen users used the drug combo for just a few months, but YEARS after discontinuing use they developed valve and lung problems. What if the lorcaserin users find out in 5 or 10 years that they have some debilitating or fatal disease of a major organ ? It will be too late then, and all of the people in the pipeline who had taken the drug before the first group of people experienced problems will be doomed.
The other thing that disturbs me is that even though the 5-HT2C receptors appear to be fairly well known, the clinical trial administrators appear to be focusing only on heart functioning. Are they checking any other organs ? Are they monitoring the patients’ cognitive functioning ? Are they simply trying to prove that lorcaserin is not just another fenfluramine and the focus on heart health is merely a PR tactic ?
I actually feel sorry for the trial participants right now. They are guinea pigs in the most disturbing kind of experiment. The drug companies know that there are bazillions of dollars to be made from weight loss drugs, so they are eager to produce them. But they are marketing the drugs to people who do not have a legitimate health need requiring a drug ! Only the most grossly obese people, a very small percentage of the population here in the US, are experiencing serious health problems due to their weight. The rest of the overweight and obese people are not. We’re being told that fat is deadly, but the facts PROVE that this is simply not true. The scare stories start with the people who profit from selling us drugs, weight loss plans, diet foods, and exercise equipment, and they are for the sole purpose of bullying us into believing that fat is dangerous.
Unfortunately, most people believe the lies, and many of them will use this drug with its yet unknown consequences.
I pray that if there are any dangerous effects from this drug that they appear quickly and nobody (drug company or FDA or unscrupulous doctors) attempt to cover them up, the way they did when fen-Phen started killing and maiming.
Alisa says at first “the drug is working great”, so much that she “is worried she wont be able to force herself to consume enough calories”.
A few weeks later when shes lost over 10 lbs, she wants to claim that “its all her”.
The drug is known to cause you to feel full. No one is trying to sell drugs that dont work or are unsafe. Obesity is a huge problem in the USA. Nearly everyone is fat, and its because of overeating.
I’m not claiming anything. I don’t feel full like I used to. I could continue to eat and eat at breakfast, lunch, or dinner. I do not have the feeling of fullness I had in the beginning.
I had no appetite in the beginning. I couldn’t eat even if I wanted to. I felt stuffed. Now I do not have that feeling. I have to measure my food and stick to what’s on my plate and not double-dip or eat my daughter’s leftovers. This is my will-power kicking in.
Don’t take quotes from my blog out of context. I am describing my feelings and feeling that it is me doing the work here and not the drug. I will continue in the study because I made the commitment for one year and IF anyone at the research company wishes to ask me about any of this, I will be happy to tell them. I’m not trying to hide anything.
Not everyone can follow the insane diet you follow Devin and have a glass of orange juice only as a breakfast, if my memory serves me correctly from a contact from you.
I would guess most people wish to eat their meals and not drink them.
By the way I am down to 183.6 this morning and started out at 200. So I have lost 16.4 pounds in 2 months. I didn’t start taking the drug until 6/5 and between 5/19 and 6/5 I had lost 3 pounds on my own with just cutting back a few calories.
Hello everyone –
“Devin” and “Sandra” (“Devinsandra”) cut it out. I’m not sure what your financial interest is — short, long, trying to get patients for a clinical trial for some other company, whatever.
If you have actual data from similar drugs then by all means post. But these theatrics serve no useful purpose here. If you can’t play nicely, I’m going to delete your comments. >:-(
Let me say this about that: I’m pro short sellers — shorts are the natural predators to company insiders who puff up the stock too much.
But this relates to real humans who are receiving an experimental therapy to treat a medical condition. To try to spook the stock is one thing — but talking about “maiming” could hurt patients who may really benefit.
“Devinsandra,” give it a rest.
Apologies to all for not catching this sooner, (I’ll be updating this blog soon — ), but please know that this post gets lots of hits on the key word “lorcaserin”. (That and “parle a ma main”, sigh.) So it will attract paid shills. My policy is not to delete anything but spam (or haters), but I may have to change that.
Again, for anyone enrolled in any clinical trials, the best source of information is going to be the MD investigator on behalf of the clinical trial sponsor — go directly to that person if you have any questions.
(Again, for the record, sadly, I’m long various stocks for biopharmas who are in the clinic with weight loss meds).
I have been in one of the arena lorcaserin clinical trails for over one year. I can hardly wait for it to be over, I have lost 6 lbs. I was told to not alter my diet drastically but to eat sensibly and make better food choices and to ex cerise moderately 3 to 5 times a week. I have had great weeks of excerising and then I began to be very injury prone with weeks off , plantar factitious, tendinitises in my foot/leg, common sprain ankle, shoulder injury, etc. I then began swimming 3 days a week and have been doing that for the last 8 months, still not much weight lost, For the first 15 months no pop and no ice cream and chocolate only once a week for a treat. I do eat a lot more spinach and broccoli that I use to and rally enjoy them , always plain nuts no salt and not roasted. Red meat about 3 times a month. So I have learned some new things, I hope I am on the placebo because if this was the real drug and I had this disappointing results, I would feel like a total failure. I have developed some nerve problems in my leg , they thought first maybe diabetic neuropathy but my blood sugars are fine so on to more testing and I hope it is not from this either, at the study they say it is not related, but my D. wants me to quit , but I said I would finish so I am going to then I am looking to se if something like medifast or nutrisystem would be a good jump start to losing weight because this has been very, very disappointing.
Thanks for the comments dissapointed1 –
For one, thank you for participating in clinical trials, and by no means should you or anyone who participates in a clinical trial ever consider themselves failures — I think it’s great — and make no mistake, it’s not for everyone. So thanks for sticking it out, even if the results aren’t what is expected.
To everyone: The people who post their results are unknown to me, so before deciding to participate in any clinical trial or make any decisions based on posts here, please rely on official company comments or scientific publications.
Perhaps a minor rant: Doctors who conduct clinical trials who also consult for investors need to watch out for confidentiality to their sponsors, as well as insider trading violations. Personally, I think that any doctor who is also a consultant for anyone who stands to make money from the results of the clinical trial has a huge conflict of interest, and should disclose that not only to the patients, but to the medical journals and their employer. [Rant over].
What they don’t tell you is the possibility of serotonin discontinuation syndrome when you discontinue the drug, so be careful of this.
I decided to stop the study due to adverse effects and the discontinuation syndrome kicked in pretty bad within a day or so off the drug. I had near fainting episodes, severe dizziness, nausea. Thank god it only lasted a week.
So Arena unblinded me and found out I was on the drug twice a day and are going to pay for my ER visit due to the above effects.
Hello everyone – Please know that I have no way of determining if the statements posted by others are true – or not.
Hello , I have been in arenas study for 22 months . I believe the first year I was on the meds. I lost 20 lbs (I weighed 160 ) my blood pressure went down ,my cholesterol went down all my levels are great now.I have fibro and CFS and really felt great last year . At the end of the first year I believe I went off the meds and did have some side effects for about a week . This year I have gained back about 5 lbs but I am still trying to take it off , I have gained most of it in the last 3 months when I stopped exercising as much . I cannot wait for this med. to come out (and also to see if I really was on it ) I feel it has been a great thing for me . we shall see
Thanks for the comment Shawn. 20 lbs in 22 months is about a pound a month — and at least you didn’t gain any weight.
Fibro and CFS have got to cause metabolic havoc – so glad you found that the drug helped (if you were in the drug arm) .
This is really interesting — I wonder if the caloric restriction alone shuts down cellular metabolism enough to stop the disease progression? (I lost track of the CFS research, but I thought there was an Epstein Barr connection somewhere. . . ). An appetite suppressant would surely cause caloric restriction (I mean, if you don’t eat), and caloric restriction is being studied for all sorts of life-prolonging effects.
I meant to respond to Alisa on the serotonin syndrome issue. I hope she’s ok. A quick PUBMED search on “serotonin syndrome” turns up mostly ER visits from people being weaned off opioids with meds.
Also, here’s an abstract on no serotonin syndrome in 1174 patients, even if it is anecdotal evidence from Oklahoma (“Anecdotal from Oklahoma” sounds like a Merle Haggard song. . . but I’m drifting off topic)
“The use of sympathomimetic appetite suppressants and serotonin-selective reuptake inhibitors (SSRIs) has been questioned due to anecdotal reports of serotonin syndrome. This survey of bariatric physicians using these medications in clinical practice did not find any cases of serotonin syndrome among 1174 patients. The monitored use of the combination of these medicines by trained practitioners is justifiable.”
Rader, WA et al., “Clinical experience using appetite suppressants and SSRIs,”J Okla State Med Assoc. 2008 Aug;101(8):180-1.
Please know that I have deleted some of the comments on request.
I thought I had posted a message a few days ago, I guess not.
No, I’m not working for any competing interests. I’m just an expert in dieting and anti-drug for most cases of overweight and obesity. The problem with drugs is that they are short term solutions, and they really aren’t that effective. What do the people do when they stop taking the drug ? And is being overweight worse, or is the drug worse ?
I’m tempted to buy stock in Arena when this drug is approved. I’ll probably make a mint. Unfortunately I’ll be profiting from the disappointment of others (disappointment when the hopeful realize that this latest drug isn’t the miracle they expected it to be), but if I don’t do it, someone else will.
Nope, “Sandra”, didn’t delete anything from you yet.
Welcome to those from Yahoo Finance message boards — please know that nothing, absolutely nothing said on any of these posts or comments is intended to pass along any rumors or can be relied upon for any investment or medical decisions.
Hi Swivelchair,
first of all how do you know, that lot of poster or reader here are from yahoo finance message board (especially Arena,vvus and orex board) ?
I think the term “follow the money” is the best way to describe it
anyway, thank you for your effort setting up this blog.
and, yes I also posted at yahoo under the same name above…
by the way, I found it funny reading “sandra” posts…
she basically said she is the “expert” on dieting and also anti drug… that would made her a “santa”…
but at the same time she also mention about her “interest” in making money buying ARNA stocks ???
as I said above, always follow the money
and everybody here (including an expert in diet) also want to make “extra” money
LOL
ps: I am here to make money too… on my investment (which I could potentially lost too if Lorcaserin fail)
Thank you
Hi Biotech Maven –
Thank you for your comment.
You asked how I know if visitors are from yahoo finance. With a hosted website, you can get any number of analytics — including which show who is referring your traffic.
But, I have no idea who is for real and who is not — with this post or with any other post on this blog. “Sandra” has a lot to say, and, let the public opinion fall where it may — Absolutely the only legit information is from the company or the FDA (or other regulatory authority).
The posts here are my opinion only. I own stock, sadly, in a bunch of biotech companies, and am not ahead in any of them. I have no idea if this company — even if the drug is a success — will have any effect on the stock price of anything. That’s way too complicated (patents, M&A, etc.). Who knows.
But, for the record, here’s my vote for Arena, assuming the FDA gets its act together and can approve the drug:
1. No deal with anyone . Launch the drug. (Assuming the drug is licensed and it is marginally effective). Don’t even hire a sales force — partner with Jenny Craig or Weight Watchers or even 24 hour fitness or whatever. This has to go retail level (with store-front docs) because the docs make more money treating obesity than causing weight loss.
2. Branding, branding branding. It’s a lifestyle, not a drug. Defeat stigma. Plus, I’m assuming patents only go so far. Have add-on line extensions and extensive branding (to keep out competition, I’m assuming patents only go so far). Add some branded products like “the lorcaserin milkshake” or whatever to help patients with portion control.Also nutritionist counseling and other product/services mix. Include psychological counseling (now that insurance pays for it). People would pay retail for that.
3. Put a sustained release in the clinic. Once a day.
Crass commercial? You bet. Watch how much our healthcare budget is reduced once we keep people from strokes or diabetes or dialysis. Just like quitting smoking.