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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 4 to 28 of 38. Go back in thread:
Posted by McPac on June 19, 2003, at 10:54:04
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by turalizz on June 19, 2003, at 7:14:05
tura, but how can you get it if not approved in US (are you outside of US?)
Posted by Snoozy on June 19, 2003, at 10:58:28
In reply to Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 2:27:41
Ugghh - tell me about it! I have had this article from Time magazine (Time - can you get a more mainstream publication than that?) from September 1997 on depression and neurotransmitters.
"Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine, the neurotransmitter Prozac left behind. Approved in England just this past summer, it works quickly, has relatively mild side effects (constipation, dry mouth, low blood pressure) and might eventually be the therapy of choice for people with especially severe depression."
I had the impression that it would be on the market soon after I read this article, and I've been waiting. Looks like I'll be waiting a looong time. It's different from what's already on the market, not just a variation on the same-old, same-old. I had hope it might help me as I have not had good results with SSRI's. (The area pdoc that does nothing but drug research studies was doing a test of reboxetine in 1998-99, but I couldn't get in). Maybe it wouldn't do anything for me, but I'd like the chance to find out.
I would really love to know what the story is - is it opposition from other drug companies or what? It doesn't seem like the FDA has been overly cautious of late and it sounds like a pretty safe drug. Makes one wonder. I don't get this 'let's spend millions of dollars to get FDA approval to market Paxil or Zoloft for this condition'. My understanding of that is that they're simply going through hoops so they can put out ads on tv and in print and say 'this drug is a treatment for social anxiety disorder' or what have you. I heard something about Paxil trying to get approval to market it for hot flashes. Is it me or does something seem wrong with this situation?
Of course, it probably won't be long before all of the big drug companies merge into one entity. Then they can advertise with the one media conglomerate we'll have :)
> Been reading a lot about Reboxetine. Sounds VERY good. I suppose THAT is the reason that the pharmaceutical company-controlled FDA declined it's U.S. approval (I read that NO reason was given why).....puleeeeeze! translation, it wasn't approved because many ssri patients would have switched! These pharm. co's will protect their turf and do whatever they can to keep better drugs being approved. Everything I read, in many abstracts, point to Reboxetine being at least as good and even better for severe depression and having much less side effects than ssri's like Prozac. Block the better drug from approval and keep this crummy ssri monopoly going, what a joke. (1 abstract below; read MANY that were similar):
>
Posted by McPac on June 19, 2003, at 11:11:39
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by Snoozy on June 19, 2003, at 10:58:28
"Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine"
>>>>>>>Isn't increased norepin. bad for ocd though?
Posted by Barbara Cat on June 19, 2003, at 11:58:25
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 11:11:39
> "Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine"
>
> >>>>>>>Isn't increased norepin. bad for ocd though?Exactly my thought, although everything I've read on it looks intrigueing. I thought NE made anxiety worse, triggered hypomania, was involved in the fight/flight cortisol response, was excitatory. Something else is going on with these meds besides the obvious neurotransmitter model.
Posted by Caleb462 on June 19, 2003, at 12:04:23
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!) » McPac, posted by Barbara Cat on June 19, 2003, at 11:58:25
> > "Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine"
> >
> > >>>>>>>Isn't increased norepin. bad for ocd though?
>
> Exactly my thought, although everything I've read on it looks intrigueing. I thought NE made anxiety worse, triggered hypomania, was involved in the fight/flight cortisol response, was excitatory. Something else is going on with these meds besides the obvious neurotransmitter model.
>
>Well, yes.. that is the ACUTE reaction to increased norepinephrine. And in the first few weeks of treatment with Reboxetine, one might experienced increased anxiety. However... the adrenergic system downregulates in response to this increased NE... and after a few weeks, overall stress is DECREASED. That is the theory, anyway.
Posted by Jack Smith on June 19, 2003, at 12:10:22
In reply to Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 2:27:41
> Been reading a lot about Reboxetine. Sounds VERY good. I suppose THAT is the reason that the pharmaceutical company-controlled FDA declined it's U.S. approval (I read that NO reason was given why).....puleeeeeze! translation, it wasn't approved because many ssri patients would have switched! These pharm. co's will protect their turf and do whatever they can to keep better drugs being approved.
I understand your frustration with the FDA but these ssri conspiracy theories are really not plausible. Reboxetine is owned by Pharmacia, which is a pharmaceutical company. So, the "pharmaceutical company controlled FDA" in your theory is also controlled by Pharmacia. Pharmacia gets a lot of drugs approved, ie xanax, so why do you think that Pharmacia, a pharmaceutical company, would not want its own drug approved????
Anyway, Straterra is the same type of drug as Reboxetine, a NARI. Try that if you want to try reboxetine.
JACK
Posted by Jack Smith on June 19, 2003, at 12:13:48
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by turalizz on June 19, 2003, at 7:14:05
> Why would Lilly want anything like that in the market???
That's right, Lilly controls the FDA. That is how four other SSRI's got approved by the FDA. That is why Zoloft (pfizer) is the top selling ssri. That is why Lilly lost its lawsuit to keep its patent on prozac. That is why duloxetine (a Lilly SNRI) is still not approved.
The pharmaceutical companies are the cause of all of our problems.
JACK
Posted by McPac on June 19, 2003, at 12:17:26
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by Caleb462 on June 19, 2003, at 12:04:23
"Well, yes.. that is the ACUTE reaction to increased norepinephrine. And in the first few weeks of treatment with Reboxetine, one might experienced increased anxiety. However... the adrenergic system downregulates in response to this increased NE... and after a few weeks, overall stress is DECREASED. That is the theory, anyway".
>>>>>>>>>>>Caleb, but are increased norepin. drugs supposed/recommended to be avoided by most ocd'ers? Are they effective for ocd? Thanks in advance for your reply!!
Posted by Caleb462 on June 19, 2003, at 12:35:15
In reply to Caleb, (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 12:17:26
> "Well, yes.. that is the ACUTE reaction to increased norepinephrine. And in the first few weeks of treatment with Reboxetine, one might experienced increased anxiety. However... the adrenergic system downregulates in response to this increased NE... and after a few weeks, overall stress is DECREASED. That is the theory, anyway".
>
> >>>>>>>>>>>Caleb, but are increased norepin. drugs supposed/recommended to be avoided by most ocd'ers? Are they effective for ocd? Thanks in advance for your reply!!Well... I suppose that would depend on who you asked. In general, though.. I would say no.. norepinephrine meds do not need to be all out avoided by OCD patients. A selective norepinephrine med will not help OCD... but it may decrease OCD-related stress. As for reducing obsessions/compulsions, selective NRIs are quite ineffective.
Personally, as a GAD/OCD sufferer.. I tried to avoid things that will trigger the "fight or flight" response... rarely drink coffee, for instance.
However.. there is no hard and fast rule that OCD patients need avoid noradrenergic chemicals. For instance, the metabolite of Anafranil - desmethylclomipramine, is a potent inhibitor of norepinephrine reuptake.
Posted by McPac on June 19, 2003, at 13:15:35
In reply to Lilly controls the FDA--NOT, posted by Jack Smith on June 19, 2003, at 12:13:48
"The pharmaceutical companies are the cause of all of our problems."
No they're not.
Posted by stjames on June 19, 2003, at 13:17:31
In reply to Lilly controls the FDA--NOT, posted by Jack Smith on June 19, 2003, at 12:13:48
>
> The pharmaceutical companies are the cause of all of our problems.
>
> JACK
Gee, that is a sweeping generalization !
Posted by McPac on June 19, 2003, at 13:25:31
In reply to SSRI conspiracies--nonexistent., posted by Jack Smith on June 19, 2003, at 12:10:22
The fda is the pharm. co's puppet...not ONE single pharm. co. can control the fda because so many pharm. co's have huge power, when you have MANY co's with huge clout and power no single one will always get their way, but they as a group pull the fda's strings
Posted by McPac on June 19, 2003, at 13:38:33
In reply to Re: Caleb, (not approved in U.S.? FDA blows!), posted by Caleb462 on June 19, 2003, at 12:35:15
"As for reducing obsessions/compulsions, selective NRIs are quite ineffective".
"the metabolite of Anafranil - desmethylclomipramine, is a potent inhibitor of norepinephrine reuptake".
>>>>>>>>>>>>>>> How can the 2nd statement be true IF the 1st one is true too? (Is it because Anafranil also has SRI properties?) Thanks!!
Posted by McPac on June 19, 2003, at 14:52:25
In reply to SSRI conspiracies--nonexistent., posted by Jack Smith on June 19, 2003, at 12:10:22
http://www.zoloft-side-effects-lawyer.com/default.htm
No pharmaceutical company would EVER try to keep these side effects from being well-known would they,lol, they don't BOMBARD you with the "happy,pleasant" info and commercials and try to dismiss this stuff, why don't they use some of the school-shooters on ssri's in their commercials, lol, show all those dudes during their shooting rampages pausing to plug their ssri's, lol, those pharm. co's could probably teach the tobacco co's a few tricks,lol,...politicians are never crooked either! I'm not anti-Zoloft, just showing that it and the ssri's and the pharm. co's have another side as well, it works great for me in some ways, but there is another side for some, not as simple as "then don't take it", what if you have a problem where not taking it is even worse, then you pick your "poison", i.e. take this and suffer or don't take it and suffer, not much of a choice, Zoloft has been great for me for ocd/depression but ohhhhhh those extreme side effects, it works great for my niece too (without side effects) and anything that keeps that precious little squirt feeling better definitely cannot be all bad, gotta run, take care all!!!
Posted by Caleb462 on June 19, 2003, at 15:00:30
In reply to Caleb, (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 13:38:33
> "As for reducing obsessions/compulsions, selective NRIs are quite ineffective".
>
> "the metabolite of Anafranil - desmethylclomipramine, is a potent inhibitor of norepinephrine reuptake".
>
> >>>>>>>>>>>>>>> How can the 2nd statement be true IF the 1st one is true too? (Is it because Anafranil also has SRI properties?) Thanks!!
>Exactly... clomipramine (anafranil) is a highly potent SRI... the metabolite desmethylclomipramine being the highly potent NRI
Posted by Jack Smith on June 19, 2003, at 15:51:09
In reply to Re: Lilly controls the FDA--NOT, posted by stjames on June 19, 2003, at 13:17:31
> >
> > The pharmaceutical companies are the cause of all of our problems.
> >
> > JACK
>
>
> Gee, that is a sweeping generalization !
>Sarcasm. Read the post in full and what it is in response to.
Posted by Jack Smith on June 19, 2003, at 15:55:23
In reply to Re: SSRI conspiracies--nonexistent., posted by McPac on June 19, 2003, at 13:25:31
> The fda is the pharm. co's puppet...not ONE single pharm. co. can control the fda because so many pharm. co's have huge power, when you have MANY co's with huge clout and power no single one will always get their way, but they as a group pull the fda's strings
Reboxetine was probably not approved because it was not that effective. Note that Lilly did not attempt to get straterra approved for depression probably because they knew that it was not effective enough. Norepinephrine only agents have proven less effective for depression.
Check through the archives of this site and you will see that reboxetine did not exactly get reviewed well here.
JACK
Posted by Snoozy on June 19, 2003, at 16:46:56
In reply to Re: SSRI conspiracies--nonexistent., posted by Jack Smith on June 19, 2003, at 15:55:23
I'm wondering if the FDA has guidelines on how effective a drug must be to get approval. If there were no or few other drugs on the market to treat a specific condition, would they approve something that had a lower efficacy rating as opposed to a proposed drug for which there are many alternatives available?
I'm also wondering what, if any, type of political appointments (other than commissioner) are made there.
> Reboxetine was probably not approved because it was not that effective. Note that Lilly did not attempt to get straterra approved for depression probably because they knew that it was not effective enough. Norepinephrine only agents have proven less effective for depression.
>
> Check through the archives of this site and you will see that reboxetine did not exactly get reviewed well here.
>
> JACK
Posted by turalizz on June 19, 2003, at 17:19:36
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 10:54:04
> tura, but how can you get it if not approved in US (are you outside of US?)
Yes I am. (Outside US I mean)
Posted by NikkiT2 on June 19, 2003, at 17:25:26
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by Caleb462 on June 19, 2003, at 12:04:23
I tried reboxatine a good couple of years ago (so its been lisenced in UK alot longer than this past summer) and only lasted 3 weeks.. and for the three weeks I was on it, I cried and cried and cried the whole time.. and I am not someone who cries easily..
Nikki
Posted by Caleb462 on June 19, 2003, at 18:31:20
In reply to Re: SSRI conspiracies--nonexistent., posted by Jack Smith on June 19, 2003, at 15:55:23
> > The fda is the pharm. co's puppet...not ONE single pharm. co. can control the fda because so many pharm. co's have huge power, when you have MANY co's with huge clout and power no single one will always get their way, but they as a group pull the fda's strings
>
> Reboxetine was probably not approved because it was not that effective. Note that Lilly did not attempt to get straterra approved for depression probably because they knew that it was not effective enough. Norepinephrine only agents have proven less effective for depression.
>
> Check through the archives of this site and you will see that reboxetine did not exactly get reviewed well here.
>
> JACKTrue, but what about nortryptiline and desipramine? Aren't these approved and considered effective for depression. And isn't imipramine's main mode of action norepinephrine reuptake inhibition (over serotonin uptake inhibition, that is). These are mainly noradrenergic agents, although I may be mistaken.
Posted by turalizz on June 19, 2003, at 19:27:15
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by NikkiT2 on June 19, 2003, at 17:25:26
> I tried reboxatine a good couple of years ago (so its been lisenced in UK alot longer than this past summer) and only lasted 3 weeks.. and for the three weeks I was on it, I cried and cried and cried the whole time.. and I am not someone who cries easily..
>
> NikkiSee, that's what reboxetine does. It somehow seems to "intensify" the emotions. I became very emotional myself when I was on reboxetine.
But remember that apathy is a synptom of depression, and SSRI's are no good for that.Don't forget that depression is not like flue, symptoms change from person to person.
So why leave out something that can be useful to many patients?
Posted by McPac on June 19, 2003, at 20:34:08
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!) » NikkiT2, posted by turalizz on June 19, 2003, at 19:27:15
I spent 3 hrs last night reading one clinical study after another on Reboxetine from sites all over the world, including US, it was found AT LEAST as good as Prozac in every study and better for many depressive, anxiety, & social phobic conditions and much better for severe depression WITH significantly less side effects in every study.........it wasn't approved because many people would have switched and ditched their ssri's (of course now, after 10 years of being bombarded with ssri marketing hype, some folks wouldn't give up their ssri's for an actual vaccine CURE, lol,......Anafranil was available in TONS of countries for MANY, MANY years before the fda SOMEHOW approved it...TONS of ocd sufferers who had NOTHING before that suffered endlessly for YEARS when they could have been greatly and easily helped......oh yeah, all politicians are completely moral, upstanding people who could NEVER be involved in crooked shenanigans either, lol...financial executives too (Enron, Global Crossing, Imclone, World Com, and scores of others, they were all guys that would NEVER do anything crooked for a buck, lol, show me ANY industry where HUGE bucks can be made and you'll find some shenanigans, thank goodness for drugs and the co's that make and sell them, but there is good and bad shenanigans in that industry too, you don't think a multi-BILLION $$$$ company and guys with HUGE stakes at hand would try to hide and twist a few 'unpleasant' facts....some people believed Bill Clinton too ("I never had sexual relations with that woman").....swampland in Florida for sale, TAKE CARE EVERYBODY!!!!!!!
Posted by zeugma on June 19, 2003, at 21:45:33
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!) » NikkiT2, posted by turalizz on June 19, 2003, at 19:27:15
> > I tried reboxatine a good couple of years ago (so its been lisenced in UK alot longer than this past summer) and only lasted 3 weeks.. and for the three weeks I was on it, I cried and cried and cried the whole time.. and I am not someone who cries easily..
> >
> > Nikki
>
> See, that's what reboxetine does. It somehow seems to "intensify" the emotions. I became very emotional myself when I was on reboxetine.
> But remember that apathy is a synptom of depression, and SSRI's are no good for that.
>
> Don't forget that depression is not like flue, symptoms change from person to person.
> So why leave out something that can be useful to many patients?
>I wish there was more written on the differential aspects of these drugs instead of searching wildly for the "magic bullet" that will cure depression. Reboxetine and the noradrenergic TCA's have a different 'feel' to them which fits some personality types and disorders better than the SSRI's. The emotional intensification these drugs can induce is probably what makes them less suitable for OCD types, as OCD'ers already have enough emotional investment in their surroundings and don't need that level boosted even further. Similarly people undergoing a profound transient depression could probably use some of the apathy SSRI's can deliver.
This reasoning was behind the introduction of the concept of 'endogeneous depression' to explain what the TCA's reversed. Someone who is endogeneously depressed is not reacting to external circumstances in a functional way: the TCA's intensify emotional response in these people to bring them back to the normal variation in mood that people generally feel. It's clear that not all, or even most, depression can be 'endogeneous' or the SSRI's could never have displaced the TCA's in popularity. But the supposition that there is a type of depressed individual who responds best to NE reuptake inhibitors remains a tenable one.
Posted by Barbara Cat on June 19, 2003, at 21:52:48
In reply to tura Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 20:34:08
Yep, follow the money and you'll see who is beholden to whom. Even (especially) the Vatican. Unlike most corporations, I think the majority of drug company employees, researchers, etc., have good intentions at heart and really want to help. However, by the time it gets to marketing and the CFO, the whole intention has changed to one of greed. If the product helps someone, great, but overall do what it takes to lead the market share. I don't think everyone is evil necessarily, just scared. They have families to support and we live in an integrity-challenged time because we've come to believe that's the only way we can survive.
There is such disinformation and shenanigans in the business of antidepressants, et al, that the whole picture is very distorted. Sometimes the picture only starts becoming clear through anectdotal experience.
What really makes me laugh is how, when a med starts getting near the end of it's patent, copyright protection, they tweak a little isomer here and there and presto, it's a whole new 'improved' med protected for another 10 years and no competing generics are released. Or when the waters start getting too crowded with similar acting drugs, why, then gee, our drug is the best for social anxiety, ours is the best for PMS, ours is indicated in OCD -- even though they're basically the same friggin drug!!
Call me cynical, but in these very strange times, it's foolish to trust what any advertisment says about their product, or any research funded by the developing pharm company has to say about their trials. And don't forget how salespeople from pharm companies woo doctors and how many doctors get their scholarship money from - guess who - and how many symposiums on various mental disorders are sponsored by pharm companies (although you really have to sleuth this out) and the presenters might be a little biased. Or at the very least, influenced, because drug companies, whether directly or hidden, turn out to be the primary educators of our physicians. -- BarbaraC
> I spent 3 hrs last night reading one clinical study after another on Reboxetine from sites all over the world, including US, it was found AT LEAST as good as Prozac in every study and better for many depressive, anxiety, & social phobic conditions and much better for severe depression WITH significantly less side effects in every study.........it wasn't approved because many people would have switched and ditched their ssri's (of course now, after 10 years of being bombarded with ssri marketing hype, some folks wouldn't give up their ssri's for an actual vaccine CURE, lol,......Anafranil was available in TONS of countries for MANY, MANY years before the fda SOMEHOW approved it...TONS of ocd sufferers who had NOTHING before that suffered endlessly for YEARS when they could have been greatly and easily helped......oh yeah, all politicians are completely moral, upstanding people who could NEVER be involved in crooked shenanigans either, lol...financial executives too (Enron, Global Crossing, Imclone, World Com, and scores of others, they were all guys that would NEVER do anything crooked for a buck, lol, show me ANY industry where HUGE bucks can be made and you'll find some shenanigans, thank goodness for drugs and the co's that make and sell them, but there is good and bad shenanigans in that industry too, you don't think a multi-BILLION $$$$ company and guys with HUGE stakes at hand would try to hide and twist a few 'unpleasant' facts....some people believed Bill Clinton too ("I never had sexual relations with that woman").....swampland in Florida for sale, TAKE CARE EVERYBODY!!!!!!!
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Dr. Bob is Robert Hsiung, MD,
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