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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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September 14, 2010

Lorcaserin in Trouble

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Posted by Derek

The FDA committee that will be looking over Arena's lorcaserin for weight loss has released its briefing information, and there were some nasty surprises therein. A memo states that the drug did not satisfy the mean efficacy requirements that the FDA has laid down for obesity therapies, and satisfied the categorical efficacy one "by a slim margin".

Well, that was known. I said as much back in May of last year, and didn't the Arena fans ever give me an earful about it. What wasn't apparent was the two-year rodent tox. The briefing document raises questions about the number of malignancies that showed up in these rats, and that's not good. The safety profile of any drug in this area has to be very clean, especially if the efficacy is borderline.

As for the big worry about any serotinergic compound in this area, 5-HT2b heart valve trouble, the briefing document isn't too reassuring there, either. The FDA staffers note that the company didn't run a positive control in the animal models, and didn't look at proliferative markers during the human clinical trials. They conclude that "the FDA has not definitively concluded that lorcaserin is devoid of valvulopathy-related cardiac effects in animals".

Frankly, I think that the tox/efficacy combination is likely to sink the drug's approval chances. There are other problems, but this is the big one. The market seems to be agreeing - Arena's stock is getting hammered today. I look forward to hearing from the various people who were after my hide about this.

Comments (39) + TrackBacks (0) | Category: Diabetes and Obesity | Regulatory Affairs


COMMENTS

1. daen on September 14, 2010 3:38 PM writes...

the drug did not satisfy the mean efficacy requirements ... for obesity therapies, and satisfied the categorical efficacy one "by a slim margin".

I like the no-doubt unintentional irony in that statement regarding a weight-loss drug.

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2. laura_aviani@hotmail.com on September 14, 2010 4:36 PM writes...

i am an oil owner in America and i am ignored by my goverment as they steal my oil or allow bp and cheveron owed by bush to firewall the native nation from there funds. Feinburg said there would be a 2 day turn around on emergency funs on claims for bp now that has been turned into 2 to 6 months i guess so they can collect that 20billion in intrest. My Dad has 4th stage cancer and Feinburg is stone walling his request. Now is the time to stand up and stop this abuse on the elders. If you can help call 5413150111 ask for Laura.

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3. David Formerly Known as a Chemist on September 14, 2010 5:01 PM writes...

A good investment strategy is to short all biotechs with clinical candidates for Alzheimer's disease or obesity. AD is just too complicated, and no one yet truly understands the underlying pathology. Obesity seems related to the same brain areas governing satisfaction and pleasure, which tends to lead to lots of odd side effects when trying to drug these receptors. Obesity isn't life threatening, and can be "cured" without swallowing chemicals (well, actually, simply by "not swallowing" as much as one has become accustomed to), and thus the safety bar should be very high indeed. It's difficult to justify tolerating ANY significant adverse effects to simply drop a few percent of body mass. Join a gym and skip the biscuit.

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4. BioBrit on September 14, 2010 5:22 PM writes...

@David Former.

Obesity is very life threatening, it kills, it kills slowly, and it makes severe impacts upon those suffering from it for years beforehand. To suggest otherwise is just arrogant and foolish.

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5. Anonymous on September 14, 2010 7:15 PM writes...

@David

"[obesity] can be "cured" without swallowing chemicals...Join a gym and skip the biscuit."

that's completely wrong too. it's like the last 20 years of obesity research never happened.

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6. Chucko on September 14, 2010 7:37 PM writes...

Actually, many weight loss drugs do have some efficacy but the question with the fda seems to be justifying the weight loss against side effects. The cannabinoid antagonist worked (rimonabant?) but the CNS side effects were apparently significant enough to prevent approval and trigger the withdrawal in Europe. Weak stimulants work, fat blockers work (orlistat?), etc.

My libertarian instincts make me unhappy when the fda makes findings on what might be thought of as lifestyle drugs. Granted there is a fine line and nobody wants grossly unsafe drugs but if I do not like being fat and rimonabant works well for me, I think I should be able to take it. The majority of folks taking it lose weight and the majority do not suffer adverse CNS effects. Why shouldn't I get to make that call? Its an easy thing to judge...if I am taking it and don't like the way I am feeling then I stop taking it. I realize that this is a gross simplification and taken to extremes, I wouldn't attempt. Lifestyle- type should have more discretion with regard to risk, not everything should be subjected to a health, benefit-risk equation and I tend to put most weight loss drugs somewhat in that category (I know there are health issues as well). Now if we are talking about giving a drug strictly for a person's health, than the benefit risk calculation is critical because that is the whole point.

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7. glinkst on September 14, 2010 11:59 PM writes...

Derek:
Thank you for initiating this topic as it is certainly of much interest. I had that most of the approval risks for Lorqess were known, but this rat carcinigenicity data is a new one for me. Does anyone know if this was disclosed publicly for the first time? It sounds like ARNA has explanations for why it is not a concern but no real evidence to support it.
G

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8. In other news... on September 15, 2010 8:12 AM writes...


Sanofi to shutter PA R&D site, cut 400 jobs

http://www.fiercepharma.com/story/sanofi-shutter-pa-r-d-site-cut-400-jobs/2010-09-14

Heard a few (very few) positions are being reassigned to SA Boston site.

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9. Bryan on September 15, 2010 9:09 AM writes...

Glinkst and Derek:

I've followed this very closely and the carcinogencity data are new; as far as I have been able to ascertain have not been disclosed in the public domain before yesterday.

It will be interesting to see what the discussion is when it goes up in front of the FDA tomorrow--the briefing questions are relatively straightforward and it is possible that some sort of conditional approval could occur (e.g. need for more monitoring with a safety plan, safety board, etc).

With regard to valvular heart disease propensity, the FDA stated based on the clinical findings that:

"These data allow one to rule out a 55% or greater increase in the relative risk for FDA-defined VHD with lorcaserin."

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10. Ty on September 15, 2010 10:04 AM writes...

Valid questions for fda to raise to the panel, but I am surprised at the harsh, negative tone, especially compared to the ones raised about Vivus' Qnexa a month ago. Partly understandable because Q was a combo pill of known (generic) drugs, while Lorc is a first-in-class innovation. They say encourage industry to develop innovative medicines for unmet medical needs on one side of their mouth but, when it comes down to the crunch time, they pull out from their old hat the preclinical data on rats at >10 the clinical dose (why/how arna ran such a rodent study for 2 years appalls me).

If Lorcaserin goes south, no one will ever try, even attempt to discover/develop a new drug for obesity. Ever. End of the road. No road.

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11. Dster on September 15, 2010 11:21 AM writes...

Ty's point, IMO, is a valid one. Obesity as a disease (even by some members of this readership) is not taken seriously. That's not to say Arena should be the torch-holder for obesity treatment. Although I'm sure there's a good reason somewhere, a 2 year rodent study doesn't make much sense from any angle. And considering the target/sensitivity/affinity of the molecule for the alternate target, and the oral administration, controlling the dosage to minimize side effects and acieve an acceptable TI seems, on the surface, very optimistic.

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12. Norbert Ferrocene on September 15, 2010 12:28 PM writes...

Ty: "(why/how arna ran such a rodent study for 2 years appalls me)"

It's a standard carcinogenicity study required by FDA for most drugs used for chronic diseases. Not something anyone would otherwise do voluntarily.

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13. In Vivo Veritas on September 15, 2010 12:29 PM writes...

Ty - they did the 2-year carc study in rats at those doses because that's a required safety index for the agency. All NME's have this done, and these experiments are designed to identify tox issues just like this one. And people wonder why it takes so long/is so expensive to bring a drug to market.

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14. Big Bad Chem Daddy on September 15, 2010 4:43 PM writes...

Speaking of obesity therapies, love to hear your thoughts on the med devices on Time's website today for freezing/exploding adipose cells for fat loss. I'd heard something about using ultrasound for adipose cell disruption being done in Europe, but Time isn't giving any details on that. Here's the link:
http://healthland.time.com/2010/09/15/new-fat-fighting-machines-real-fda-approved/?hpt=T2

Permalink to Comment

15. Ty on September 15, 2010 9:38 PM writes...

My bad. Didn't know about the preclinical carc study. Good to know and thank you for that. Although I don't think the rat tumor thing will be an issue in human (I guess their brain is kinda overstimulated at the dose for 2 years, messed up the hormonal system big time), it's ARNA's big mistake to leave the door open. Still, this is an old news and FDA allowed >7,000 people on this drug for 1~2 years.

Should remember that obesity is not the real threat per se. It's the secondary markers (bp, glucose, etc) that matters and that's where Lorc excelled, unlike other diet drugs. I expect positive vote tomorrow in the hands of doctors, although I am concerned about the FDA's stance down the line.

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16. David Formerly Known as a Chemist on September 16, 2010 12:20 PM writes...

Re #4 and #5:

Obesity is caused by an imbalance of food intake versus energy use. The developed world eats too much processed food that is high in calories, many more calories than are needed for the activities of a typical day. Obesity was not common prior to the 20th century, and steadily increased as economies shifted away from agrarian (ie, hard work and exercise) bases. It is not arrogant or foolish to state that obesity can be solved by decreasing caloric intake and increasing exercise. That's a simple fact. I'm not saying that's easy, because if it were, there would be very few obese people.

The fact is, obesity now affects over a third of US adults because of our lazy, complacent culture. America has gotten soft, fat, whiny, and entitled. "Exercise and diet control are too difficult, so give me a chemical to swallow instead, that will give me some of the self-control I lack". People eat too damn much food. Behavior modification is the answer, not a chemical. To quote one of my favorite movies, After Hours..."Lack of discipline".

Sorry, I hate our current culture of "my genes are to blame". Our genetics didn't suddenly change 100 years ago. America is becoming the land of excuses for everything.

Permalink to Comment

17. Anonymous on September 17, 2010 3:53 AM writes...

BioBrit and Anonymous(5):

No-one said obesity wasn't a horribly painful killer. However, the most commonly-quoted causes (endocrine and metabolic disorders) are in reality the least common. "The last 20 years of obesity research" reveal that those disorders exist, and can be treated with drugs; however, the same research shows clearly that in the vast majority of cases, obesity is caused by a fork.

While David's tone may be somewhat more aggressive than is strictly necessary, what he's saying is right.

Permalink to Comment

18. Anonymous on September 17, 2010 10:06 AM writes...

#16 and #17

Many people share your view of obesity. But it is wrong. No one in the obesity field would agree with you. Here's why.

(1) Most of the variation in body weight within a population is due to genes. The most compelling evidence is from twin studies, which show that up to 80% BMI variation is genetic -- comparable to the inheritance of height.

(2) The fact that the people in the US have become more obese over time is completely irrelevant to the question of whether obesity is genetic or whether obesity is due to a failure of willpower. The phenotype that results from a given set of genes is determined by environment, and people have very limited control over their environment. Even if they did, we don't understand which environmental factors are changing that are most important in controlling body weight (cars? saturated fat? high fructose corn syrup? television? prenatal nutrition? etc. etc...). The environmental changes in the US have shifted the mean body weight over recent history (everyone is getting fatter), but the evidence indicates that the distribution (who is on the fat end and who is on the lean end) is mostly genetic.

(3) There has never been a clinical trial of any psychological, behavioral, dietary, or exercise regimen that has achieved sustained, substantial (>10%) weight loss in the obese. Never. Many, many people have tried. So, for example, "going to gym" can make you healthier, but the evidence overwhelmingly indicates that it will not result in more than very modest sustained weight loss in most obese individuals.

If obesity is due to a failure of willpower, why do all of these interventions fail? The obese have powerful incentives to lose weight -- most of them desperately want to. The "put down the fork" argument essentially posits that the obese, as a class of people, suffer from some sort of general moral inferiority relative to the lean. Isn't it strange that this moral turpitude only
manifests itself in their body weight?

(4) It is no longer a mystery why body fat is defended by brain, and therefore why weight loss is so difficult. Pick up any review article on energy balance if you want to understand this on the molecular level.

Most people believe that they control their body weight because they have had the experience of voluntarily not eating (e.g. skipping dessert), and therefore extrapolate that their body weight is entirely subject to willpower. But this is no more true than the belief that because you can hold your breath, you can suffocate yourself simply by deciding not to breathe.

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19. Hap on September 17, 2010 10:13 AM writes...

1) So you're saying that genetics can't have changed in the last 100 years but human nature has? Whiskey Tango Foxtrot, over?

2) If America is so special with its "soft, fat, and whiny" culture, then why is much of Europe following the same path to obesity? They don't obviously have the same culture, so culture in and of itself can't be the cause.

Genes can't change in a 100 years for people, but conditions do. We can get more food than we need now, but for most of human history that wasn't the case - our desires are in part driven by adaptation to previous circumstances. (Also, being fat used to be socially positive - it meant you actually had enough money and power to get more food than was sufficient. Contrast with now, where fat means you don't have enough money or time to get good food, and hence eat the subsidized, cheaper food that isn't so good for you, at least in nutritive amounts).

Expecting human nature to change with circumstances and blaming people when it doesn't seems ahistorical.

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20. David Formerly Known as a Chemist on September 17, 2010 11:20 AM writes...

#18 and #19:

I agree that genetics predisposes toward or against obesity, but it isn't the only (or the major) factor. No matter what genes you have, if you eat calories equal to or less than the energy you use, you will either drop mass or remain at constant mass. And if you eat more calories than your body uses, you will gain mass. It's simply harder or easier from person to person I think we can all agree on that.

Genetics can determine how rapidly or slowly your body metabolizes (burns) calories. That's a genetic factor that we also probably agree on.

BUT...the epidemic of obesity is mostly due to the change in our diets over the past century. Rather than work on the farm all day (burning lots of calories), then cook a meal from scratch (without tons of added salt, sugars, and fats), we sit on our butts in an office (burning very few calories), go through the McDonalds drive-through and get a 1,000+ calorie meal, expending little to no energy to do so.

This isn't unique to American culture, it seems to be more the norm now in industrialized nations. We freed people from the farm, but trapped them in a lifestyle that's sedentary and weak. There was an article in the NYTs several weeks ago about how the army is finding a much larger proportion of their recruits who can't tolerate the basic physical exercises used to build strength and endurance during basic training, because of an upbringing consisting of video games, sodas, and fast food. Sad. We are becoming a soft nation. Some day we'll regret it.

So what do we do? Accept the fact that we're destroying our bodies with our modern lifestyles, and resort to swallowing chemicals to keep from getting obese? Or do we simply change our lifestyles? I for one changed my lifestyle 8 years ago and lost 22 pounds through exercise and portion control, and have kept 18 of those pounds off. Every day it's a struggle to not eat too much, because fatty, unhealthy food is ubiquitous and cheap in our society. But it all comes down to will power. Anyone can do it, if they make the choice to do it and stick to it. It's difficult, absolutely, but it's better than poisoning yourself with drugs. If I can do it, most people should be able to do it.

Permalink to Comment

21. Anonymous on September 17, 2010 11:32 AM writes...

#20 "I for one changed my lifestyle 8 years ago and lost 22 pounds...if I can do it, most people should be able to do it."

Sure. Extrapolate your n=1 personal experience to every other human. Ignore all the other data.

I hope you're not a scientist.

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22. Hap on September 17, 2010 11:39 AM writes...

Obesity rates across countries - see PDF here (pages 15-19, I think, have the data).

I think for most people, will power is OK, but that's a battle that most people have been fighting and losing in various ways since we came about (for example, sex and not having babies when you shouldn't). Expecting "will power" to work any better in this circumstance than in others (with similar predispositions, no less) is probably not a reasonable expectation. Some things (not subsidizing sugars, for example) would help, but we run our lives (and economies) by the idea that personal desires are all and expecting that to be disobeyed in this case is difficult. It can happen (people do it), but difficult, and like most difficult things, most people fail.

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23. David Formerly Known as a Chemist on September 17, 2010 11:42 AM writes...

#21:

"Sure. Extrapolate your n=1 personal experience to every other human. Ignore all the other data."

Oh, come on. I'm the only person you've ever heard of that exercised and cut back on food, resulting in losing mass? You have no other data points in your entire life's experience? Do you live in a tool shed?

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24. David Formerly Known as a Chemist on September 17, 2010 11:50 AM writes...

#22

I agree with you completely, Hap. But as a society, I think we should somehow find a way to encourage people to change their lifestyles to solve this problem, rather than simply putting a chemical in their mouth. I don't have the answer, and agree with you that most people fail. But somehow, taking the difficult route needs to become preferable to the easy route. We've been somewhat successful in decreasing the smoking rate in the US (it took a long time, and there's a long way to go), so I'm hopeful we can make some headway with obesity through behavior modification as well. I'm not willing to simply say it's hopeless.

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25. Anonymous on September 17, 2010 11:58 AM writes...

#23 "Oh, come on. I'm the only person you've ever heard of that exercised and cut back on food, resulting in losing mass? You have no other data points in your entire life's experience? Do you live in a tool shed?"


It was really cold outside today, so global warming must be a myth.

That organism looks like it was designed, so evolution must be wrong.


This is why you can't persuade everyone with science.

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26. Hap on September 17, 2010 12:03 PM writes...

But I don't think the smoking rate reduction is entirely willpower - it is mostly people who don't like smoking who have shown the willpower to impose taxes and to make lots of places unavailable for smoking, and the taxes and unpopularity of smoking drive some people to quit. In this case, it's much more a systemic effect (making institutions less accepting of smoking and either passing its costs onto those who do it or imposing ones of their own) rather than depending on people to quit on their own. In that sense, obesity is more difficult because it doesn't immediately impose costs on others while smoking does. Even in countries where health care is paid for by everyone, I don't know of methods which have been either been able to be put in to place or have been effective at reducing obesity.

I don't think people are perfectable, but we will do the right thing, though usually when there's no other choice.

Permalink to Comment

27. sean on September 17, 2010 12:45 PM writes...

Derek, please don't try to take credit for "being right" about lorcaserin. Your article from May of 2009 says nothing about rats and tumors. It couldn't because there was no public knowledge of it at that time (unless you were on the receiving end of a leak - kidding of course).

The efficacy was met. Period. It was an either/or guideline and even the negativistic FDA had to say so, albeit begrudgingly. Yes, they weigh the efficacy against the risks. Weighed against the risks MINUS RATS, lorcaserin would have passed. The VHD and other AEs were not denial issues for 10 members of the panel. If you watched yesterday's AdCom that was clear.

So you had no idea in 2009 that the rat data was going to derail lorcaserin. You must admit, you were right but for the wrong reasons.

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28. Hap on September 17, 2010 12:58 PM writes...

"So, other than your husband getting shot, how was the play, Mrs. Lincoln?"

Marginal efficacy + long-term toxicity issues = bye-bye, I think.

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29. sean on September 17, 2010 3:35 PM writes...

Hap! My man. You missed my point. But that's OK. Maybe if you re-read my post?

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30. Hap on September 17, 2010 4:02 PM writes...

"Weighed against the risks MINUS RATS, lorcaserin would have passed."

Mrs. Lincoln, how was that play, anyway?

Permalink to Comment

31. Hap on September 17, 2010 4:08 PM writes...

It doesn't take that much negative data on health for a chronic disease drug with marginal efficacy to fail. If it hadn't been rat tox, it could have been something else, and it would still have fit the original prediction.

If you have a drug that works, but only marginally, then it doesn't take all that much of a risk to make it go away or not be sold at all. Drugs with significant risks aren't going to get through the FDA unless they have proportionate benefits.

Permalink to Comment

32. petros on September 17, 2010 4:25 PM writes...

Some questionable points made in the comments

Hap
Do COX-2 inhibitors really sqaure with you comment "If you have a drug that works, but only marginally, then it doesn't take all that much of a risk to make it go away or not be sold at all. "

and as for the comments about food and diet. In almost all US states portions are gross compared to European standards. Allied to the need to drive anywhere is it suprising that the obesity figures are so bad in every state?

Permalink to Comment

33. Hap on September 17, 2010 4:46 PM writes...

1) I thought (but could be wrong yet again) that COX-2 inhibitors were really effective, but had good replacements in various areas. They got nailed because the risks were only commensurate with their benefits for a small fraction of the people taking them - they were oversold, and so got pulled altogether rather than restricted to the small set of people for whom they would be particularly useful because companies couldn't be trusted not to sell them to every Tom, Dick, and Harry.

2) Are the obesity figures for Europe that much better than those for the US? Based on the link I cited above, that's hard to imagine, with OECD rates >50%.

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34. Charles Marascalco. on September 18, 2010 9:50 AM writes...

I am sorry to see that lorcaserin has not come up to par with the FDA. Hopefully this will be temporary. Looking foreward for more information and eventual FDA passage

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35. SJ on September 19, 2010 7:25 PM writes...

Well, all I can say is I was one of the lorcaserin study particpants for a year and we were continually checked for side effects with regular medical exams, bloodwork, EKGs and echocardiograms. I was almost never hungry, though I'm one of the "lucky" ones for whom medicare has caused a tremendous increase in appetite.

I had plenty of energy to exercise and lost 55 pounds during that year, so it was sure effective for me.

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36. SJ on September 19, 2010 7:26 PM writes...

Oops. That should have been MENOPAUSE, not medicare, LOL.

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37. DW on September 27, 2010 4:18 PM writes...

I am reading all of this with interest. I was in the 2 year Arena study for Lorcaserin. We were not ever told if we were given the placebo or the real thing, so I can't be sure, but I did notice a marked difference in hunger along with headaches and some ringing in the ears.

From what I understand, our specific study only had two people who lost a significant amount of weight (meaning over 25 pounds). I don't know exactly how many we actually had in the study in that clinic.

I don't think I was even supposed to know that information, but the woman who gave the ecco-cardiograms spilled to me while we were talking during the exam.

Permalink to Comment

38. Brian on October 22, 2010 2:35 AM writes...

All too often the FDA are accused of acting according to their own agenda, and that agenda being contrary to their mandate.
The little faith that I do have in the FDA's function, has been marginally restored in terms of their pending rejection of Lorcaserin.
Good God people, do we not have enough drugs with marginal efficacy, and not so marginal, long term side effects? You do not have to be very clever to understand how these drugs found FDA approval.
Obesity, other than that defined by problems associated with metabolic disorders, is embedded in the social structure. People are taught and induced to over eat. The major advertizing drive in the 'Food Industry' is EAT, and all the PLEASURES derived from such EATING. People need to be re-taught how to eat properly, and the prescribing of some 'brain active' drug is not going to achieve that.
Good on you this time FDA - for being sensible, and reject a drug that is only one enantiomer removed from becomming a 'new recreational drug'...

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39. partial agonist on June 27, 2012 3:27 PM writes...

approved!

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