Neurological Correlates

85 responses so far ↓

• 1 DrSteve // Jan 8, 2008 at 12:53 am

  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.

• 2 swivelchair // Jan 8, 2008 at 9:33 am

  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).

• 3 Texas // Mar 12, 2008 at 3:40 pm

  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.

• 4 Tammy // Mar 12, 2008 at 3:56 pm

  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

• 5 swivelchair // Mar 13, 2008 at 9:17 am

  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.

• 6 Jennifer // Mar 13, 2008 at 1:54 pm

  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.

• 7 swivelchair // Mar 13, 2008 at 3:31 pm

  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.

• 8 LA // Mar 26, 2008 at 9:51 am

  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

• 9 swivelchair // Mar 26, 2008 at 2:33 pm

  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.

• 10 LA // Mar 27, 2008 at 8:28 pm

  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?

• 11 swivelchair // Mar 28, 2008 at 9:29 pm

  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.

• 12 Chef Russ // Apr 16, 2008 at 3:58 pm

  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!

• 13 Swivelchair // May 2, 2008 at 2:39 pm

  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.

• 14 eaa // May 14, 2008 at 2:28 pm

  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??

• 15 swivelchair // May 14, 2008 at 5:44 pm

  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.

• 16 alisa // May 18, 2008 at 10:00 pm

  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.

• 17 swivelchair // May 19, 2008 at 5:59 pm

  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).

• 18 Marsha // Jun 2, 2008 at 10:10 am

  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!

• 19 swivelchair // Jun 2, 2008 at 1:07 pm

  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.

• 20 alisa // Jun 4, 2008 at 9:35 pm

  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.

• 21 swivelchair // Jun 5, 2008 at 1:33 pm

  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.

• 22 alisa // Jun 5, 2008 at 9:50 pm

  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

• 23 swivelchair // Jun 5, 2008 at 10:39 pm

  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).

• 24 alisa // Jun 6, 2008 at 4:52 pm

  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.

• 25 swivelchair // Jun 6, 2008 at 5:22 pm

  Thanks alisa -

• 26 devin // Jun 10, 2008 at 5:00 pm

  swivel, can you email me please

• 27 swivelchair // Jun 10, 2008 at 11:13 pm

  Devin my e mail is: swivelchair@neurologicalcorrelates.com if you would like to contact me == thanks

• 28 alisa // Jun 13, 2008 at 9:09 am

  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.

• 29 alisa // Jun 13, 2008 at 9:12 am

  I typed my blog in wrong.
  http://www.extrapounds.com/blog/littlealisa/index.php

  that should hopefully work

• 30 swivelchair // Jun 16, 2008 at 5:56 pm

  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.

• 31 swivelchair // Jun 16, 2008 at 5:58 pm

  And I just checked alisa’s web page, and it’s great — so you go alisa, and good luck.

• 32 Sandra // Jul 16, 2008 at 8:08 pm

  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.

• 33 Sandra // Jul 16, 2008 at 8:17 pm

  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 !

• 34 Sandra // Jul 17, 2008 at 11:07 am

  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.

• 35 devin // Jul 19, 2008 at 9:15 am

  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.

• 36 alisa // Jul 21, 2008 at 1:59 pm

  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.

• 37 alisa // Jul 21, 2008 at 2:01 pm

  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.

• 38 swivelchair // Jul 27, 2008 at 9:22 pm

  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).

• 39 dissapointed1 // Sep 8, 2008 at 8:44 pm

  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.

• 40 swivelchair // Sep 9, 2008 at 10:21 am

  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].

• 41 alisa // Sep 15, 2008 at 8:06 am

  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.

• 42 swivelchair // Sep 15, 2008 at 10:08 pm

  Hello everyone – Please know that I have no way of determining if the statements posted by others are true – or not.

• 43 Shawn // Oct 1, 2008 at 6:05 am

  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

• 44 swivelchair // Oct 8, 2008 at 10:47 pm

  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.

• 45 swivelchair // Oct 8, 2008 at 11:00 pm

  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.

• 46 swivelchair // Oct 10, 2008 at 2:26 pm

  Please know that I have deleted some of the comments on request.

• 47 Sandra // Oct 10, 2008 at 4:43 pm

  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.

• 48 swivelchair // Oct 11, 2008 at 12:07 pm

  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.

• 49 biotechs_maven // Oct 13, 2008 at 1:12 am

  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

• 50 swivelchair // Oct 13, 2008 at 10:33 am

  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.

• 51 Itsme // Oct 27, 2008 at 1:23 am

  Swivel,

  Above you said:
  “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….”

  I have read some stuff that indicates that smoking actually has somewhat of a selective MAOI effect. It is selective in that it doesn’t cause you to be tyramine sensitive, but it does otherwise provide some MAOI effect. Seriously, if you ignore the bad effects of smoking (which are hugely worse than the benefits) and only look at the benefits of smoking, it looks pretty good. It cuts your appetite, it causes you to lose weight, it perks you up, etc. But I digress.

  Anyway, I thinkthe MAOI effect is what is likely responsible for the anti-nausea effect of smoking, although I have not researched it.

  At the start of her rant, I thought Sandra was just one of those “Being overweight is just because you don’t stop eating” kind of rants given by thin people who find it easy to control what they eat and therefore believe that everyone should find it equally easy. Reading further into her post, I agree that something is up. She is either a shill or a loon. She seems to know a lot, yet she is intentionally distorting. Her first point about the sexual side effects is a perfect example. Things that work on 5HT2 actually have sexually positive side effects. I’m not sure which of the 5HT2 subtypes cause that, so I have no idea if that is a side effect here with lorcaserin or not.

  I know that you have access to the logs, and perhaps you saw that Sandra and Devin posted from the same IP address. If not, I think you have misunderstood what Devin was trying to say.

  I think he was saying that the medication is working, that at first Alisa recognized that it was working, but now believes that she is losing the weight through her own efforts.

  I think it’s his last sentence that makes his message hard to get. He says:
  “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 don’t think that he is suggesting here that overeating is a moral failure, I think he is saying that if you eat less you will lose weight, and that he is saying it because he thinks that Alisa thinks that it’s her own efforts causing her to lose weight. He seems overall to be a supporter of Lorcaserin and not a supporter of Alisa. I see nothing in his post that is so strong that would even hint that he is a shill.

  Again, you have access to the logs, so maybe you can see that they posted from the same address. Otherwise, I really do feel that you have misunderstood what Devin said.

  And just in case you are wondering, I am not Devin, or anyone else who has posted on this entry. In fact, as far as I know, I’ve never posted anywhere on your blog before.

• 52 swivelchair // Oct 27, 2008 at 4:49 pm

  Thanks for the comment Itsme. (Is your cousin ItsIts, the ice cream?)

  The smoking/weight loss effect I don’t think has been seriously studied. Smoking steadies the nerves and cuts the appetite. Is it druggable?

  As to the comments by others, here’s the usual disclaimer: don’t anyone believe anything here, go to the official sources for official information.

  I’ll put up a privacy policy, but seriously, I get back-room e mails from people, that may color my remarks out here in public. The comments are what they are, and everyone can form their own opinions.

  As to the smoking and serotonin, I agree — except for the hideous artifactual side effects, could tobacco be “druggable”? I’ve got some PubMed research in other tabs pulled up in my browser now, and it’s pretty interesting.

• 53 Sandra // Nov 5, 2008 at 2:04 pm

  I am not “Devin”, and I have no idea who Devin is. There seems to be a lot of paranoia here!

  I have been overweight all of my life, since grade 2. Not excessively though, about 20-40 pounds, depending on what else was going on in my life. But even though I wasn’t excessively overweight I suffered a great deal because of it. So many other people made me feel like I was the biggest loser in the world just because I had some extra fat on me, my intelligence, talents, or other positive characteristics didn’t matter. All that mattered was that I wasn’t thin. It took me many many years to get over it.

  I could have easily been one of the poor victims of the Phen-Fen fiasco. I wanted very badly to lose weight at that time, but despite my liberal attitude about recreational drugs, I was completely anti-drug when it came to weight loss, because I understood from all of my dieting experience that losing weight is easy, keeping it off is difficult, and keeping it off requires a total change of habits and mindset. A drug cannot help there.

  So fortunately for me I didn’t get caught up in the Phen-Fen mess. I wonder if any of the rest of you really know what happened with those drugs. You should read Alicia Mundy’s “Dispensing With The Truth”. You will read about Wyeth deliberately misreporting serious adverse effects of fenfluramine, how they dressed up their sales force in lab coats so they would look scientific and hosted drug sales shows at women’s gyms all over the US. There were plenty of docs who were writing hundreds of prescriptions per week, “prescription mills”. So much more, please read the book. It will give you much insight into the potential pitfalls of loracaserin. If you care.

  Who benefits from these drugs? The patients ? I think not. The drug companies, absolutely. This must be made clear. If you are trying to justify lorcaserin as a legitimate weight loss drug, well good luck. A person can lose just as much weight without the drug. When people stop taking lorcaserin or any other drug, they regain the weight. So what good is it for ? Mix in potential side effects, loss of sexual appetite, dizziness, what about more serious effects like we saw with fen … primary pulmonary hypertension (incurable and fatal), valvulopathy (usually requiring valve replacement) … to lose some weight? How can we do this to people?

  If you are looking at lorcaserin as an vehicle for making money, by investing in Arena, then you probably made a good choice. Most people don’t know the story behind fen and have their heads in the sand when it comes to what works for weight loss, so they’ll happily jump on this latest drug bandwagon. Arena will make a mint, and so will its investors.

  I have mixed feelings about investing in a drug that I think is at best a waste of consumers’ money and at worst damaging. But if I don’t do it, others will. Why should I be so altruistic?

  I’m hardly a “loon”. I think I know so much more than any of you. It’s a complex situation.

  Honestly, read Mundy’s book. You will be enlightened. And no, I’m not Alicia Mundy !

• 54 Sandra // Nov 5, 2008 at 2:18 pm

  Regarding smoking and weight loss … it’s no secret that many many women smoke to keep their weight down. In fact I would bet that the vast majority of thin women over 30 are smokers. I don’t know that it actually suppresses the appetite, I think the smokers consciously light up a cig in order to avoid eating. I do the same thing with coffee.

  I think we’d all agree that cigarette smoking is far worse for you than some extra fat. The CDC found that overweight is actually GOOD for you:

  “Being overweight (BMI of 25-29.9) was not associated with excess mortality. The study found that 87,000 fewer deaths than expected were associated with being overweight.”

  http://www.cdc.gov/od/oc/media/pressrel/fs050419.htm

  Analysis of existing data has shown that even mild obesity does not have a significant health impact. But look at the weight loss drug ads. I can hardly wait for lorcaserin to be approved so I can see the justification for it. The ads always blast misinformation that overweight and obesity are necessarily killers. Because if they aren’t, there would hardly be a reason to take a prescription drug, right? You should have an actual problem first, you know. It’s unethical to treat healthy people with serious prescription drugs.

• 55 swivelchair // Nov 6, 2008 at 1:04 pm

  Sandra, I disagree with just about every conclusion you draw from your facts (and I haven’t checked out your facts). But, in the spirit of reaching across, metaphorically, from the “no meds for weight loss” aisle to the “yes meds for weight loss” aisle, your comments are duly noted.

  Message from a paranoid blogger (moi): I have no idea who Sandra is, and of course don’t make any material decisions about money or health based on any blog including this one.

  I have a new post up about obesity — a theory that environmental arsenic affects thyroid-mediated gene regulation, and possibly contributes to obesity. It’s a stretch, but here’s the link:

  http://neurologicalcorrelates.com/wordpress/2008/11/06/does-environmental-arsenic-contamination-cause-obesity-by-disrupting-thyroid-hormone-mediated-gene-regulation/

• 56 Sandra // Nov 6, 2008 at 5:00 pm

  Nobody should be paranoid about me. I’m just a regular person from a connections perspective. But I am not regular from a knowledge perspective. I am highly suspicious of prescription drugs, all of them, and weight loss drugs in particular. You should see my rants about anti-depressants and drugs for the so-called ADD and ADHD. They all fall under the category of “the drug doesn’t solve the fundamental problem”.

  I would love obesity to be caused by something environmental, but I honestly believe there is a much simpler explanation: massive quantities of easily available high-calorie foods + incessant slick advertisement of these foods.

  We don’t see obesity in populations until they start having wide access to junky high-calorie foods. It appears that high-fat high-calorie foods are worse than high-sugar high-calorie foods.

  My overweight was caused by getting addicted to “convenience” foods, mostly sugary crap, in the mid-1960′s when I was a young kid. There were very very few overweight kids then, I guess my family was one of the first to purchase junk food. Fortunately I’m the only one who had a problem with it.

  If the problem were environmental, I would have expected to see more overweight kids. It’s not like I lived next to an arsenic factory. I lived in the same neighborhood as my skinny friends.

  The problem is that we overweight people eat too much and at some point we get physiologically hooked food, or hooked on certain types of foods. My drug of choice is anything with sugar. Scientists and doctors say you can’t get addicted to food. Well, the junk is many times not so much food, you know? Like what part of a twinkie is “food” ? Just because I can eat it, doesn’t make it food.

  Also an argument against the environmental explanation: I don’t have a problem losing weight, at least not physiologically. When I don’t eat, or don’t eat so much, I lose weight. The problem is the cravings. I am driven to eat.

  By the way, I want to correct a statement I made in a prior post. I think I know more about overweight, obesity, and weight loss drugs than anyone else posting here, except you. You clearly know a lot, not sure if you’ve ever been overweight or obese though, so I don’t know if you understand just how bad the cravings get.

  I see that rimonabant (Acomplia) is toast. It was determined that the side effects outweighed the weight loss benefit. Sanofis didn’t even complete Phase III trials. Looking at Phase II data, people on the highest dose (20mg) lost an average of 14 pounds in a year. In a year! That’s pretty bad. And as it is with other drugs, the weight was regained when the people stopped taking it.

• 57 swivelchair // Nov 6, 2008 at 6:51 pm

  Sandra thank you again, your views are nothing if not consistent.

• 58 swivelchair // Dec 31, 2008 at 9:28 pm

  Hey Arena Pharmaceuticals Board of Directors – handing out golden parachutes for change in control? Making it public New Years’ Eve? C’mon.

  You know the deal: if the company is sold the exec. suite gets taken care of. 2 years health bennies, lotsa cash, couple years salary, full vesting of options. Better deal than if the company stays independent.

  So, if I’m in the executive suite, and I’m say, in my 60′s, and this is my last hurrah, and I get paid a big wad of cash if I go away and play golf, or, I could stick around, and actually work and have the possibility of getting less money (if salaries are rolled back to pre-bubble levels). . . hmmm. . . work less, get more. . . or work more, get less. . .

  Even in the event of death of executive (heaven forbid, I mean no one wishes that) but really, how about life insurance for the family, instead of shareholder money? Or, are the death vesting options on top of life insurance? How nice for the family, and how magnanimous of the BOD to donate shareholder money for this. How ’bout the BOD pays out of pocket their own money?

  Oh, the comp consultant paperwork covers the diligence. Isn’t there that comp consultant who advises other companies for the same BOD members?

  Or, same comp consultant for both the target and the acquirer? Sweeten the pot to encourage the buy out?

  I’m guessing, I have no idea if there even would be a buy out, but hey, this is a 12/31 filing for a golden parachute change of control agreement.

  The dilution to pay for the clinicals by shelf registrations, OK, I get that. Selling out convertibles to raise cash, OK I get that.

  This is optics — to be clear — not that anyone is doing anything illegal, or even violating the fiduciary standards they are held to. I have no idea. But, a New Year’s eve filing for a nice, juicy golden parachute/change in control agreement?

  So, let’s review: Nice golden parachute agreements filed New Year’s Eve in era where P/E multiples are compressing and company has no profits is basically cash value. Unknown if comp. consultant is a tool by potential acquiring company to sweeten the pot so execs agree to lower share price for buy out.

  Color me cynical. BOD, same ol’ La Jolla shenanigans? I was so hopeful things would change down there.

  http://www.sec.gov/Archives/edgar/data/1080709/000110465908079122/a08-31127_1ex10d2.htm

• 59 Sandra (a.k.a., "not Devin") // Jan 7, 2009 at 3:24 pm

  Look, they updated the agreement to comply with the law. >:-) At least *primarily*.

  ===================

  “On December 30, 2008, we amended and restated the Termination Protection Agreements, originally effective on December 20, 2002, and the Severance Benefit Plan, originally effective on January 20, 2006, primarily to bring them into compliance with Section 409A of the Internal Revenue Code of 1986, as amended, and the regulations and other guidance promulgated thereunder (“Section 409A”). The executive officers that are a party to a Termination Protection Agreement include Jack Lief, Dominic P. Behan, Ph.D., Robert E. Hoffman and Steven W. Spector, and the participants under the Severance Benefit Plan are such executive officers and William R. Shanahan, Jr., M.D.

  The amendments to the Termination Protection Agreements, which require a change in control to trigger benefits, include (1) delaying cash payment until the earlier of (i) the first business day that is six months following the employee’s termination or (ii) following the employee’s termination, the employee’s death; (2) modifying the good reason definition relating to the relocation of the employee’s principal office or place of business required to trigger the benefits; (3) adding a waiver and release as a condition to receiving severance benefits; and (4) adding Section 409A compliance provisions.

  The amendments to the Severance Benefit Plan include (1) delaying cash payment until the earlier of (i) the first business day that is six months following the employee’s termination or (ii) following the employee’s termination, the employee’s death; (2) modifying the good reason definition relating to the relocation of the employee’s principal office or place of business required to trigger the benefits; (3) adding a deadline for turning in the waiver and release that is required as a condition to receiving severance benefits; and
  (4) modifying the Section 409A compliance provisions.

  The foregoing description of the amendments to the Severance Benefit Plan and the Termination Protection Agreements is qualified in its entirety by reference to the Amended and Restated Severance Benefit Plan attached hereto as Exhibit 10.1 and the form of the Amended and Restated Termination Protection Agreement attached hereto as Exhibit 10.2, both of which are incorporated herein by reference.”

  ======

  This agreement affects 5 of the 7 execs.

  Lief is the Chairman, President, and CEO
  Behan is a VP and Chief Scientific Officer
  Hoffman is a VP and Chief Financial Officer
  Spector is a VP and General Counsel
  Shanahan is a VP and Chief Medical Officer

  Judging purely by their photos on the Arena web site, only Lief appears to be old enough to wish to retire.

  http://www.arenapharm.com/wt/page/officers.html

• 60 Zade // Jan 12, 2009 at 2:36 pm

  This weekmarks the end of my 2 year participation in the Arena Lorcaserin study. I have lost about 90 lbs., can actually exercise (though I still don’t like to exercise but at least exercising no longer causes me to be so uncomfortable) and I can look in the mirror without flinching. I have not really had any side effects from the drug and would like to stay on it for a longer time. Of particular note was the fact that I cannot stand to eat chocolate or fried foods. They both make me nauseated. Quite a change from the dark chocolate gobbling junkie I was prior to the program.
  I don’t enjoy the weigh-ins even though for the most part the numbers have gotten smaller. At mid-study I was assigned a new “advisor” who was a bit of a dick and so I complained the the supervisor, noting that after 12 months I KNEW what I had to do and if I TOLD the advisor that I was bloated (salty food was the culprit) he had to at least pretend to believe me. I guess the supervisor intervened (particularly when at the next weigh in I was 5 pounds lighter) and the adviosr became, at my request, a cheerleader as opposed to the whistle-blowing coach.
  I’m so glad I got into the study, though a great deal of determination went along with it. I’m concerned about what the near future will bring. I am in the habit of exercising and understand the need to control what I eat but for the last 2 years food has been an afterthought, something I did because I needed to eat to keep going.
  Will being off the drug change all that??

• 61 Millie // Jan 13, 2009 at 8:59 pm

  Congratulations Zade – one of my coworkers, who actually directed me to the study, has just completed his second year. He’s pretty sure he was on the pill for the first year, lost 40 pounds with no particular effort, but has regained the whole thing after the second year, which he’s sure is the placebo.

  I’m just completing my first week in the study, and haven’t even weighed in yet, but as a diabetic, I’m thrilled to say my blood sugar’s nearly down to normal from sky high a week ago. I definitely find my appetite’s greatly reduced and I have to structure my eating to ensure I don’t forget meals. Someone mentioned the mental/emotional side of the equation – I don’t know what other people have encountered but my screening contained quite a few questions regarding my state of depression (on a 0 to 10 scale, I had 0 – i.e. not at all depressed). Apparently the drug has been known to cause depression. The study I’m in is 50/50 between placebo and 10 mg. of Lorcaserin twice a day.

  Swivel – thank you so much for this blogspot – it’s been really interesting reading the take of others on this drug.

• 62 swivelchair // Jan 14, 2009 at 4:13 pm

  Hello everyone. Sorry for being delinquent in not responding sooner.

  Sandra, Sandra, Sandra (said Bradybunch-esque style), why the New Year’s Eve filing? I still think the product is good (from public information,etc., imo). But, seriously. Trying to slide in a goody-laden exec. golden parachute agreement on New Year’s Eve is about par for the course for that whole La Jolla bio crowd (if you know what I mean and I think you do). (And you know who you are. . .) It’s like 10x tackier than a Friday close of business before a 3 day weekend filing. C’mon. At least the company could’ve filed in paper, like Google, to throw a log in the road against being found out immediately. http://www.sec.gov/Archives/edgar/data/1288776/999999999708048909/9999999997-08-048909-index.htm

  Moving on.

  Zade and Millie, as always, I have to hedge here, and say I have no idea if you are for real (sorry). Anyway, assuming you both are truly enrolled, thank you for being in a clinical trial. It really does amaze me when people — even if paid — volunteer.

  Zade, the data showed that stopping drug was correlated with weight gain , so I would think that appetite increase would similarly be correlated. Have you asked your investigator/company sponsor? The only valid information comes directly from the sponsor or the docs (or maybe the FDA), to be sure, and usually clinical trial sponsors are pretty good about answering questions.

  In what way was your first advisor a “dick”? I’m just curious. You’d think that the sponsor would be treating the enrolled subjects like royalty, to prevent drop outs (which could screw up the data).

  Millie, after a week, I wonder if the appetite suppression is a placebo effect. Interesting.

  I wonder about the 2x a day dosing (as well as potential additional compositions for co-dosing to increase efficacy). Is there a placebo effect 2 x with each placebo dose? Or one big placebo effect for the entire day? (Not that you’re on placebo, this is just a general question).

  And you’re welcome for this blog posting, but, the credit goes to you. I was originally interested in the pharma-biz end of this drug — and clinical trial subjects (presumably) began posting. Interesting lesson for commercial sponsors of clinical trials. To be faculty-lounge-ish, one may academically query if gag clauses in informed consent enrollment agreements are restraints against speech violating the First Amendment?

  (Actually, one “subject” requested that I remove her posts, so the previous comments are a bit confusing, as they respond to her posts).

  Arena Pharmaceuticals: Why not put up your own blog for this? I’m a random blogger. Wouldn’t it be better if enrollees in your clinical trials could post comments that your experts could address? (Anyone: if there is a sponsor blog, let me know and I’ll post the link).

  Thanks for the comments everyone.

• 63 Millie // Jan 17, 2009 at 2:32 am

  Hi Swivel,
  Obviously I can protest to the heavens that I’m real, but while I’m assigned a PIN by Arena, I don’t know if there’s any way it can generate any kind of confirmation that it’s legitimate!

  As for doubling the placebo effect, I don’t know. I also don’t know if the effect, real or imagined, is sustained, or only within the prescribed hour or so after taking the pill. I’ve forgotten to take the pill twice so far (taking it as soon as I remembered, but after eating), and I still found my appetite to be far less than it was, so I think it has to be at least partly suggestion (by the way, I was a heavy smoker who quit cold after one hypnotic session 20 years ago, so I know I’m VERY suggestible).

  As for volunteering, I’m grateful to have the opportunity and it’s not all about the $740 I’m being paid over the course of a year…the screening alone included close to a thousand bucks worth of medical tests that I’d never have had done otherwise. Knowing that my heart and lungs are in excellent shape for my age (I’m at the outer range of the study parameters – I turned 65 as I was starting it) is a comforting thought. It’s also doing something else I’d hoped would happen – it’s making me monitor myself much more closely than I had been. Between journaling all food intake and monitoring my blood glucose levels, placebo or drug, I’m feeling in control again. Empowerment is a very good thing.

• 64 Millie // Jan 17, 2009 at 2:37 am

  Oops, sorry, I should have mentioned this before – maybe it’s my aging memory, but I don’t recall any gag clause in my consent agreement. I have to root around for my copy and double check it, but I think that would stick in my mind.

  As for it’s first amendment implications, I don’t think that would fly – it would be voluntary consent, and if I felt it was a problem I’d have the choice not to agree and opt out of the clinical trial.

• 65 swivelchair // Jan 18, 2009 at 1:20 am

  Hi Millie, again, apologies if you are for real — I hope you understand the need for disclaimers here. . .

  That seriously is pretty amazing that you were able to quit smoking after one hypnotherapy session.
  Interesting that you still weren’t hungry even though you missed doses 2x — different days? I guess there’s a 1x day dose that also shows weight loss. Perhaps lack of appetite for missing a single dose on the 2x a day is just a matter of degree — similar to if you were on the 1x a day dose. Or could be your super-suggestibility and maybe they hypnotized you when you weren’t looking. . . ;P

  Hey Millie, if you’re 65+, and commenting on a blog, more power to you. Of course, as a blogger my view is that blogging is in the public interest (even if some days are better than others. . . ) and so thank you for exercising your First Amendment Rights and commenting here. And good for you if being in the trial gets you more empowered in your own health care.

  First Amendment or no, you all know the drill — I have no idea if anything anyone posts here is for real, so don’t make any health or financial decisions based on this blog. . .

• 66 swivelchair // Feb 5, 2009 at 4:18 pm

  Welcome Stock Gumshoe readers —

  Well. . . sort of welcome. Please know that nothing on this blog should be taken as any kind of investment advice or medical advice.

  I have no way of knowing who is for real and who is not, including those who say they are participating in clinical trials.

  Absolutely nothing, and I mean nothing, is meant to pass along any facts not so stated by an official source of information like the drug sponsor or the FDA. The rest is my opinion. (If there is any inaccurate information, please let me know. . . ). I am very concerned when investment advice is given based on some comments posted here. Seriously, I’m in a bind whether to take down the comments (because I don’t know whether they’re for real) or leave them up (because taking them down may itself be construed as some sort of message).

  Sorry being paranoid, but you know how it is. Swivelchair

• 67 Sandra // Feb 13, 2009 at 5:00 pm

  How does Zade know that he/she was taking lorcaserin ? It’s a double-blind study.

  Pharmaceutical companies design placebos to mimic some of the real drugs’ side effects. So just because a person lost their appetite or felt some other effect doesn’t mean they were taking the drug.

• 68 Aaron // Feb 15, 2009 at 2:23 pm

  Sandra, you can’t design a placebo to mimic side effects. That’s the fallacy of double blind clinical trials when distinct effects are expected. Don’t see them and you know you’re on placebo. Perhaps that changes a persons attitude or lead them to drop out of the study.

• 69 swivelchair // Feb 15, 2009 at 7:50 pm

  Aaron, I don’t know if distinct effects were originally expected given the novel dosing, even if the mode of action was very well characterized. I mean, lorcaserin at 20 mg/bid could have been as efficacious as sugar pills.

  I think the safety was expected, e.g., no cardio receptor binding.

  Normally, where there is an existing standard of care, you can’t run a placebo controlled trial at all.
  It would be unethical to deny people in need of treatment. I guess you could argue that the real pepsi-challenge should have been sibutramine non-inferiority.

  But I just don’t think the FDA sees obesity as anything more than a lifestyle choice, despite all data to the contrary. Like depression used to be.

  Here’s my question: Why is the FDA so slow on the uptake on this?

  Isn’t there a real life reporter who can do some digging on this one? Are diabetes med pharmas lobbying to put off having a decent weight loss med on the market?

• 70 Sandra // Feb 15, 2009 at 8:57 pm

  They’re only testing for heart problems. What if this drug has some action on a part of the brain, or lungs, or some other important organ? I worry about that.

  Placebos are most definitely designed to mimic side effects of the active drug. The term is “active placebo”, you can find lots of info on the ‘net.

  Interesting point about the ethics of giving an obese trial participant a placebo instead of the active drug. This makes the pharmaceutical companies hypcrites, because on one hand they all claim that obesity is this dangerous problem that must be mitigated (always forcefully presented in their literature), but on the other hand they are willfully withholding what ought to be “necessary” medication.

  I’m wondering why the groceries stores are filled with so much junk food. I wish someone could do a study to figure out what percentage of “food” in a grocery store is actually reasonably nutritious. I saw an interesting program on TV, maybe an Independent Lens episode ?, that showed a young girl in LA who has to take 2 buses to get to a decent grocery store that offers fresh fruits and veggies and good meats because the few stores in her neighborhood have nothing but crap, and the neighborhood is also infested with fast “food” joints. I think the girl’s round trip just for transportation, not including actual shopping, was like 2 hours. And then we wonder why people are fat. Heck, I walk to work and pass 3 Dunkin Donuts and several other shops that have nothing but sugary sh*t in them, some with signs outside advertising their confections. People probably want to think I have no willpower when in fact my willpower is tremendous, I’m an addict and yet every day I make it to and from work walking through this minefield.

• 71 biotechs_maven // Feb 28, 2009 at 1:08 pm

  First of all, I got a fully disclosure, that I am ARNA’s shareholder and so my post can be considered BIAS and not neutral,
  but I’ll let the reader judge on that

  Sandra,
  you obviously do not understand FDA trial design in general and specifically on Lorcaserin trial.

  The Placebo here is not active placebo.
  and you said that the placebo was design to mimic the side effect of the drug, but
  how do you know about the side effect of the drug before you done large scale clinical trial ?

  The Placebo in Lorcaserin trial is made to look exactly like the real drug.(in shape and color).But of course it is just an inert substance that do not have any effect at all,
  because if the placebo had some efficacy or some side effect, then
  they would not be able to get the result in controllable manner, and will never able to get Statistically significant result…

  Regarding the effect on brain or lungs or some other important organ,
  if Lorcaserin shown any adverse event on those organ, I am sure the doctor would be able to pick it up, especially with more then 7000 patients in the Two Large Phase 3 trial… An abnormal Brain, Lungs function would be easy to monitor if they occur
  so the fact that they do not occur, means Lorcaserin is safe to those Vital Organ

  and ARNA trial, specifically check on the heart valve, because this is where “Fen” failed,
  and Lorcaserin target same receptor as Fen did, but 100 times more selective and avoid targeting the other receptor that cause Heart Valve problem like the one from Fen.
  of course the focus on Heart Valve is important here…

  Why do you say the pharma is hypocrite?
  if they give all the patients the active drug, then they would not be able to compare and prove that their drug is good in EFFICACY and SAFETY.
  That is why they need some patients to take placebo.
  and it is required by The FDA, the Law and I am sure all the Medical Doctor in this world would PREFER any drug trial to have placebo for comparison purpose.

  There are some trial namely antibiotics trial that do not require Placebo, but
  what they did is using the known and approved antibiotics in place of Placebo, and compare their efficacy with the new drug in the trial.This is called Non Inferiority Trial using Active Comparator (but not placebo).

• 72 swivelchair // Feb 28, 2009 at 2:14 pm

  Thank you BTM for your comment and excuse my having to put up a disclaimer that I haven’t fact checked your remark. (Sorry).

  “Sandra,” response?

  Question if you know: will lorcaserin be used off-label with amphetamines? Any phen-lorc trials in the works?

• 73 test subject // Mar 11, 2009 at 5:44 pm

  I took Lorcaserin in a study (20, 40, and 60mg doses) in Canada. It has some initial good effects, but the overall dose is NO GOOD. MAJOR headaches, headaches on all levels, and also it feels just horrible in your system.

  AVOID this drug at all costs. More immune bodies may enjoy this drug. BUT, it is a different feeling – seems like a different drug – at different doses!

  either the 20 or 40 was great! (its a double blind study) but the others were AHHHHHH horrible!

• 74 swivelchair // Mar 11, 2009 at 10:11 pm

  Test subject,

  Come clean here. No 40 mg or 60 mg lorcaserin trials exist. What’s up?

  Readers: if test subject doesn’t respond, I’m taking down this post because it is facially incredible.

• 75 Biotechs_Maven // Mar 24, 2009 at 3:20 am

  Hi Swivelchair,

  Sorry took a while for me to respond back,
  but so far there are no Phen-Lorc trial in the works.
  Still, I think there could be this kind of trial in the future, of course after Lorcaserin is approved by FDA.

  Best regards,
  Biotechs_Maven

• 76 swivelchair // Mar 24, 2009 at 10:14 am

  Thanks for the update Biotechs Maven.

• 77 Biotechs_Maven // Mar 24, 2009 at 5:16 pm

  Hi Swivelchair,

  I just sent you an e-mail…
  I click the link on the e-mail on this webpage.
  Hope it is your correct e-mail

  Thanks,
  Best regards,
  Biotechs_Maven

• 78 swivelchair // Mar 24, 2009 at 8:01 pm

  Got it, thank you.

• 79 Sandra // Apr 2, 2009 at 1:02 pm

  biotechs_maven, how can you be sure that the lorcaserin trial placebo was totally inactive? Pharmaceutical companies often tailor placebos to mimic side effects of the active drug, presumably to make it more difficult for the placebo group to determine that they received the placebo. Do you have specific knowledge about the lorcaserin trial? Or were you making a generic comment? If the latter, do a search on “active placebo”.

  I am also suspicious of test subject’s post.

  I can’t imagine combining phen with anything. Have you ever taken that stuff? It’s old school speed and *very* clunky. Nasty side effects. Headaches, increased BP and heart rate, insomnia, constipation. I think the appetite reduction comes more from feeling weird and drugged-up than from a true direct action on any appetite drivers. Probably have a much better time and lose more weight using MDMA. It’s time to retire phen.

• 80 On My Own // Apr 6, 2009 at 5:57 am

  I completed the 2 year BLOOM study and lost 45 pounds (22% of initial weight). I went from barely being able to walk a mile to now running 25+ miles a week. My suspicion that I was on placebo was confirmed when Arena had to unblind me POST-study because of heart valve changes. Fortunately for lorcaserin, I was NOT on the active drug. It’s refreshing to know I lost the weight on my own with the encouragement of the study center staff who I found to be great motivators.

• 81 swivelchair // Apr 6, 2009 at 7:03 am

  Thank you On My Own for your comments.(Sorry but I have to include the disclaimer that I don’t know who here is for real and who isn’t.)
  Question: Why were you suspicious that you were on placebo?
  Let’s do your math:
  Initial weight = 223 or so
  Final weight = 223-45 = 178 Final weight
  45 lbs = 22% of initial weight / 22.25 lbs = 10%
  Hopefully you can keep the weight off on your own once the study ends and you may not have access to motivators at the study center.

• 82 Sandra // Apr 8, 2009 at 2:11 pm

  Hey swivelchair, notice that OMO says that BLOOM was a 2 year study. So back to that other thread where you and someone else said BLOOM was 1 year … why the discrepancy? Why would BLOOM be a 2-year study and yet Arena is publishing 1 year weight loss results?

• 83 swivelchair // Apr 8, 2009 at 4:51 pm

  Here’s the link to clinical trials.gov BLOOM, and here’s the explanation:

  Further study details as provided by Arena Pharmaceuticals:
  Primary Outcome Measures:
  * Year 1: Proportion (%) of patients achieving > or = 5% weight reduction at the end of the first year of treatment (Week 52) [ Designated as safety issue: No ]
  * Year 2: Proportion of patients maintaining > or = 5% weight reduction at the end of Year 2 (Week 104) [ Designated as safety issue: No ]
  Secondary Outcome Measures:
  * Change in body weight at the end of Year 1 [ Designated as safety issue: No ]
  * Additional body weight change during Year 2 [ Designated as safety issue: No ]
  * Change in waist and hip measurements [ Designated as safety issue: No ]
  * Change in cardiovascular risk factors [ Designated as safety issue: No ]
  * Change in use of concomitant medications for comorbidities (i.e., hypertension, dyslipidemia) [ Designated as safety issue: No ]
  * Change in Quality of Life measures [ Designated as safety issue: No ]
  Enrollment: 3182
  Study Start Date: September 2006
  Estimated Study Completion Date: March 2009
  Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

• 84 connie // Sep 20, 2009 at 1:00 pm

  I was on the one year Study and lost 32 Ibs from starting weight of 250. I took two 10 milligram tablets a day and lost an average of 2- 3 lbs per month with no side effects. Excellent product and I will recommend to anyone once FDA approved. In fact I intend on taking it again when it comes out to assist with the rest of the weight that I still wish to lose.

• 85 swivelchair // Sep 20, 2009 at 7:03 pm

  Connie, are you unblinded? Do you know if you were on drug or placebo?

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