From: “Weight-Loss Trial Final Report: 52 Pounds of Fat Melted Away”
By Ed Susman, Contributing Writer, MedPage Today, Published: February 06, 2009
Swivelchair note: Thank you Dr. Sussman, very generous of you to both be in the clinical trial and enlighten us as to what your thoughts are. Good luck and you look terrific!
FDA and insurance reimbursement wonks: Weight loss meds can really improve quality of life, and aren’t just a cosmetic or lifestyle drug. Get the safe and efficacious drugs through the clinic and let’s get reimbursement.
Let’s not get too excited here. Sussman admits “I still don’t know if I was getting the active drug or a placebo”.
People who voluntarily participate in weight loss related clinical trials are highly motivated and, I would say, highly susceptible to the placebo effect.
Wait a minute – the impulsive, hedonistic, can’t-park the-car- in- the- garage-because- you’ll- be- tempted “Sandra” is telling moi to “not get too excited here”? ;P
So, I’m going to get way too excited:
Let’s see, 52 weeks = 52 lbs = 1 lb/week . Placebo? (This is probably a faulty premise because I think he said he lost weight more rapidly in the first few weeks, so it’s not a constant 1 lb/week).
I wonder what the drug was? Sounds like an appetite suppressant, maybe one of the 5-HT2c antagonists.
I think this video was significant on a number of levels:
First, this demonstrates, in real life, that anti-obesity meds aren’t just “lifestyle” meds. Dr. Sussman was able to ameliorate other conditions, reduce his diabetes meds, and improve his overall health. You can see the real world effect of losing a pound a week for 52 weeks. Really extraordinary.
On another level, patient video is probably a game changer for biopharma. From the biopharma point of view, this must be a little unsettling to not be in control of when your data is released, even anecdotal. Dr. Sussman and the other medical journalists are the elite of the elite. (Thank you again for putting this up, and arranging for the other journalists to ask questions, that was terrific).
My guess is that most patients perhaps won’t be as responsible. Who knows, what if you get trial subjects on YouTube totally misstating the situation?
Actually, sponsors should go all in and partner with the Health Channel or MTV for a reality TV show “Celebrity Anti-obesity Med Clinical Trial”. Sort of like “Celebrity Rehab”.
Having personally participated in a double blind clinical trial, I can say that clinical trials are wonderful things to get treatment for conditions that are currently have no treatments or very poor/outdated treatments. However, it is very maddening to NOT KNOW if you are in the experimental group or the placebo group. No one knows, actually.
Uncertainty about whether or not you actually are receiving medication can soon progress into illogical thoughts like “my results are not contingent upon if I am getting medication”. Yea, it does matter. Perhaps when the experiment deals with weight loss the placebo effect is more relevant. Most of weight loss involves consciously NOT doing things, like eating starchy sugary foods… and in the short term the placebo effect can sufficiently alter ones priorities so that they withstand hunger and food craving.
But ultimately the placebo effect really doesn’t matter that much, it is usually small and it is short lived and that is the difference between placebo and active drug.
When I stopped my clinical trial, I naively thought that the wonderful almost miraculous changes in me would persist on… guess what? I gained 8 pounds in 2 months because of that attitude.
When I saw the researchers for my 3 month follow up, they told me it takes a month for the drug to fully leave the system… and, that is about the time when I started feeling horrible and depressed and tired and hungry again. The first month off the drug I still felt okayish, but it was all down hill after that.
The reason I gained so much is because of two reasons. The first is that I was so used to how I felt on the drug that it became my new normal and I stopped doing a lot of things I used to do before taking the drug (like not eating when hungry and forcing myself to move even if tired). The second reason is that I had deluded myself into believing that the changes were not from the drug and so I was not vigilant enough after they withdrew it. If I had been firmly and logically prepared for the effects of not having the drug I would not have gained that weight, because I never would have allowed myself to get “used” to eating to fullness and “used” to having energy.
I guess my point is… um, the placebo effect is real, yea of course. But most of the time I think that we assume that the way we feel, things we do, they are just “a matter of perspective” when this is not at all correct.
People who receive placebo usually do receive useful things like support and education and resources… why is it assumed that the placebo is responsible for improvement outcomes, when it is probably all those things?
If there is no gap between placebo and drug, I think the drug probably sucks. If the placebo group is able to make significant improvements without the drug, this suggests drugs are not necessary to treat the condition being studied.
Hey ITW, I hope clinical trial sponsors read your post – you were on an injectable, no? Injectables have an even bigger placebo effect than oral delivery for weight loss meds.
I’ve seen drugs equaling placebo safety and efficacy, and that to me isn’t a deal killer. That means the drug is safe at least, phase I. Could be the dosing assuming the preclinical data shows efficacy.
But your bigger point is about treating obesity as a chronic condition because the med re-set your body to a new normal. That has more implications that I think people realize.
Yep it was an injectible, but I know in my case I was definitely in the experimental group because I started having menstrual cycles (which promptly stopped after the drug was withdrawn).
The drug was not for weight loss, it was for hypothalamic amenorrhea. The drug is actually used for women who are more likely to be too thin and food restricted. The drug is recombiant human leptin (a natural protein like insulin, women with hypothalamic amenorrhea do not make enough leptin and this contributes significantly or exclusively to why we develop amenorrhea).
Unless the placebo effect was so strong that it actually made my body start having reproductive menstrual cycles, it definitely wasn’t placebo. This is significant considering I had not had a cycle in 4 years prior to that.
Oh yes, I intimately understand how obesity is a real disease and a chronic condition. My body does not work normally even though my weight is “normal”. When measured in the screening process of the study my leptin level was about the level one might expect of someone with active anorexia nervosa (<2).
So much of obesity research focuses on appetite control, weight loss in the acute phase of treatment… no one gets that this is physically real and appetite is usually reactive to numerous other physical abnormalities. People don’t get fat because they eat more, they eat more because they’re getting fat, and they’re getting fat because there is something really abnormal about how their body works.
ITW, do you know (and of course I don’t mean to pry) if your leptin deficiency is genetic?
Swivelchair I have considered perhaps I have genetic leptin deficiency. Considering that my leptin was so pitifully low even though I eat a decentish amount of food and was not underweight, this might suggest that I don’t make leptin normally.
I have decided this is not likely for me, because when I was overweight I had very high LH levels (12). It is impossible to have high LH levels if you are leptin deficient as leptin deficiency will turn off gonadotropin releasing hormone which in turn will shut down LH level.
This suggests my innate leptin system functions “normally”, but something is suppressing leptin production in the present. Considering I have lost 160 pounds, I think this is the most likely cause of hypoleptinemia. My research seems to support this. Even modest weight loss in obese people will cause hypoleptinemia. It’s unfortunate researchers are so focused on this mythical “leptin resistance”, researchers are so preoccupied with beneficial effects of reducing leptin in the obese that no one is realizing hypoleptinemia after weight loss is a major reason for weight loss recidivism. In studies decreases in leptin correlate with more effective weight loss, so the thought process is so single minded that “lowering leptin is good in obese people”… very few people are considering that this drop in leptin may ironically precipitate weight regain!
ITW, thank you for taking the time to explain to us.
Years ago it was considered that leptin may not be a weight loss molecule, but rather a weight loss maintenance molecule — because, just as you point out, if leptin is made in fat cells, once you lose the fat cells, you get leptin deficient, and that re-boots the appetite cycle.
The unified field theory with leptin, fertility, circadian rhythms and hibernation and diurnal length and ambient temperature has yet to be connected. There were lots of studies with hibernating animals and leptin levels and fertility (and perhaps there is an imbalance similar to “hibernation” with low leptin, low fertility and high fat, low metabolic rate).
Welcome Investor Village readers!
I’ve been following this one for a while. Please click here for all my lorcaserin posts linked in one place:
http://neurologicalcorrelates.com/wordpress/2009/03/21/lorcaserin-reviews-reviewed/
Just now responding to your comment, swivelchair. Wondering how you feel about Sussman’s 52 pound loss now that Arena has published their data and we know that the average for the lorcaserin group was only 18 pounds.
52 pounds in a year, for a man, is not at all surprising. 1 pound a week is quite easy to achieve. 3 years ago I took off 35 pounds in 6 months without any drug assist. I did it the old fashioned way, portion control, improved quality of food, and more exercise.
We still don’t know if Sussman actually took lorcaserin, do we ? If he’s a responsible doctor acting as a journalist of sorts, he should disclose this important fact.
Btw, who is this Ed Sussman? How do we know he’s legit? Swivelchair, you referred to him as “Dr”. What kind of doctor is he? An MD? Why can I find no info about him on the ‘net?
It’s Mr. Susman, sorry, he’s a medical writer. He was on a lorcaserin trial, but not the one reported, because he has diabetes. Here are his progressive videos as he was in the trial via YouTube. (Thank you Mr. Susman).
Well, what if he’s Mr. Sussman, the sociopath? My point being, we have no idea who this person is and no way of verifying that what he has written or said is actually true. What if he works for Arena?
How do you know I’m really Swivelchair? Maybe I’m Swivelchair’s evil twin.
At least you (and your twin) aren’t attributing your 52 pound weight loss to a drug when you don’t even know if (either of) you actually took the drug.
I reread Sussman’s medpage submission. His only disclosure appears to be this single brief phrase, “I’m still blinded to my therapy”, imbedded among all of the glowing remarks about lorcaserin’s promise. What I find most interesting are the investors in the fora who spot the disclosure….. but then go on to assume that Sussman was in the active group simply because he lost weight, even though they know that placebo subjects also lose weight. What kind of logical fallacy is that? Petitio principii?
Is Sussman the Jeff Gannon/James Guckert of pharmaceutical journalism?
So. . . you believe Mr. Sussman is misleading because other people used his reports to mislead. Petitio principii backatcha.
Swivelchair note: This is a post I had taken down, but I’m putting back up because it illustrates the techniques used to discredit people.
I’m not saying Sussman IS misleading people, so sorry, no petitio principii here.
But it’s obvious I’m leaning toward disbelief. I’m probably at 75% right now. You do agree, don’t you, that it’s POSSIBLE Sussman is a shill?
Why did MedPageToday, a web site which claims to report “breaking medical news”, publish TWO editorials written by a clinical trial participant who isn’t a physician or other medical professional?
Why would the editors allow Sussman’s contributions to contain so much information about lorcaserin, thus implying that his weight loss is attributable to the drug, when Sussman admits he doesn’t even know if he took the drug?
Why did the MedPage Today staff have an “informal meeting” with Sussman? Why was he interviewed? Why did they videotape the interview and then make it available on YouTube? Is this really breaking news, that an obese person with health problems experienced some improvement in those problems after losing weight?
If Sussman is some sort of medical news reporter, why is his web presence limited to just this one topic? Where is his story “from a diabetes meeting in Paris”?
You don’t find this at all odd? I do.
Maybe it’s just me. Maybe this is how MedPageToday operates, they get random editorials from people, meet with them, videotape interviews and put them on YouTube, and then allow the contributors to submit subsequent editorials. About drugs that will soon be up for FDA approval.
http://www.medpagetoday.com/PrimaryCare/Obesity/12772
http://www.medpagetoday.com/PrimaryCare/Obesity/13506
Just need to add one more comment before I’m gone …
I discovered that I was misspelling Susman’s name. I was then able to find lots of stuff about him on the ‘net, so at least I know he’s an established writer on medical issues. In 2007 he was listed as a MedPage Today “staff writer”, which explains why they gave him so much time and editorial space. He now has a writing business.
Do you know that Wyeth paid ghostwriters to write flattering reports about fenfluramine to be published in medical journals? $20k per article. One even made it into the New England Journal of Medicine. This is why I don’t trust. Medical ghostwriting is a lucrative business.
Interesting find … Susman appeared on the Today show to discuss his participation in the lorcaserin trial. Why would a clinical trial participant go on the Today show? Especially one who doesn’t even know if he was taking lorcaserin or placebo. Don’t you find this odd? I do.
He used to be a medical reporter for the National Enquirer. (snicker) OK, NOW I’m done. Promise. This is too funny.
Sandra, I’m leaving your comments up. I have not checked your facts, and have no idea if you are making this up or not.
Readers: this behavior is right out of the Rove playbook where one wants to discredit someone who is otherwise credible. When you can’t argue with the facts, you go for an ad hominem attack. Actually, this is a textbook example, and a good way to educate people about sociopathic behavior. I have to say, the sociopaths I know are far more smooth, and would only imply a base motive, with just a mere whiff, of ad hominem attack in the air. This is not to say “Sandra’s” comment is valid in the least, just to critique the quality of the smear itself.
Sandra, are you a shill?
Actually, I too am a medical writer and I know Ed. He’s been in the business a long time and has doubtless written for many outlets, high- and low-brow alike. That said, he is well respected and his work, and his perspective are sound.
As for the trial, his belief in his being on the active drug comes from having tried alternative weightloss methods many times before, all to no avail.
I found the most interesting comment to be Ed’s observation that if a trial of this sort does not have a reported significant placebo effect – there’s something wrong with the reporting.
Thanks Neil, I appreciate your comments. Mine only go so far.
What I found remarkable is that Mr. Susman is on our radar at all. From a drug company point of view, what are you going to do when your subjects all are on Youtube? So Mr. Susman is a pioneer in the field of drug trial transparency. You can see from this blog that there is a need for accurate information from trial subjects — I have no idea if the folks who post here are for real or not.
I’m assuming “Sandra” had some financial interest in this whole thing, although what that interest is, who knows. What really bugs me are sites like Sermo where MD’s talk about clinical trials directly to the investment community. Then Bloomberg charges zillions of dollars for access to these message board posts. Where do you want to start with the conflicts on that one? I simply don’t believe that MD’s don’t place a bet, then post information, and watch the bet pan out. Not to mention the confidentiality aspects on behalf of the company. So Mr. Susman is leveling out the playing field for all investors in that regard.
The better way is for the drug companies to put up their own blog and have subjects sign in with their trial ID. Let the chips fall where they may. Mr. Susman has demonstrated that if the drug co’s don’t do this, the trial subjects will.
In fact, I gotta go buy some domain names.
Practicing yoga isn’t just for physically fit people anymore. Plus size yoga allows everyone, no matter what their size is, to enjoy the benefits yoga provides
Wow!!! It sometimes pays off to Google oneself! I didn’t realize I was such a topic of discussion. Just for this blog, I will update my condition.
My current weight this morning (Sept. 27, 2010) was 245 pounfs, about 48 pounds less than by top weight of 293. I am far from svelte. I have not been on lorcaserin or placebo (I still have no idea which) since February 2009..so the majority of the weight loss has been maintained for more than 18 months — mainly due, I suppose, to the dietary/nutritional suggestions that were part of the clinical trial. I am still taking two diabetes medications.
Regarding my background: I began my journalism career as a sports writer when I was 15 years old and my byline has appeared regularly since then for the past 50 years, in probably more than 1,000 different publications. I enjoy my 18-year tenure at the National Enquirer where some of the reports may be worthy of skepticism and others (Hart, Edwards, Woods, etc.) have had considerable impact on the nation. That aside, I have ben a freelance medical writer since 1995 for multiple pulbications including United Press International, Onvology Times, MedPage Today, Doctors Guide and many, many others. I enc ourage you to visit by health news website Medical Front Page (www.medicalfront-page.com).
If you want to discuss this with me directly, you can e-mail me at edwardsusman@cs.com.
Oh, for the record, I am not a shill for Arena. I was disappointed by the FDA panel’s decision. I hope the main body overrides that vote.
E.S., many thanks for your reply here! We wish you all the best in improving your health . Geez – it must be weird for you to see your name connected with this, especially when you are used to being the writer, rather than the news. We think you look great, svelte or no, and if you’ve been able to maintain, reduce your other symptoms/meds, so much the better. Your story should be moving to anyone, and especially those who claims that behavioral mod alone is sufficient. (We’re perhaps leaping to conclusion that you were on the drug arm, not placebo).
Thank you for posting a brief bio (“Sandra’s” smears notwithstanding). And — thank you thank you thank you for breaking the Edwards story. (Shudder to think about what might have happened if you/NE didn’t report it). NE, for all you can say about it, is not beholden to corporate interests, and goes where main stream media dares not go. (Same with Rolling Stone – interestingly enough).
ON corporate interests: I don’t know if any of the Arena Pharmacutical investor-activists have contacted you (see here, here and here), but the endocrine advisory committee has really caused an uproar. National Enquirer + Med reporter = Is there a story there?
BTW, we checked Amazon, but we didn’t find a book about your Nat Enq experiences– we figure you have a book in there somewhere — so we have picked the title: “Monkey business: My life on the Washington Beat for National Enquirer.”
Thanks for your comments. My work at the NE ended long before the Edwards fiasco, although I did some work onthe Gary Hart story and a lot of digging into the O.J. case.
I have not been contacted by any Arena people regarding any testimonial work. I was disappointed that the trial did not have an extension arm or some mechanism to continue people either on some sore of open-label use. I still have not seen any results yet from my triam “BLOON-DM” but I keep looking for it.
ES, thank you for your public remarks here — yes, it would have been great to continue on open label and also cross over for the placebo group to start on drug.
Note to the readers who are interested in lorcaserin:
Ed kindly notes that he is not posting here at Arena’s request (n.b., I sheepishly note that I have no idea who anyone is, as readers know), and this blog is not related at all to Arena, to lorcaserin or to anyone involved in promoting or trashing the stock or drug or competitor drug, the FDA or anything. Nothing here is investment advice, or advice about anything in anyone’s life in any way at all, disclaimer, disclaimer, no reps, warranties, you all are responsible for your own use of this info. (Yes, paranoid anonymous blogger here).
I am not very comfortable with using drugs to lose weight. I prefer normal methods.
L: define normal.