Psycho-Babble Medication Thread 109458

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Re: Marketing, Lexapro, etc. - in general (Long)

Posted by Alan on September 7, 2002, at 0:52:21

In reply to Am I bleeding?, posted by pharmrep on September 7, 2002, at 0:35:53

This is what's becoming an old trick to keep revenues up. Lexapro doesn't give you anything you weren't already getting in Celexa, it's just sort of "purified". By doing that, they can get a new patent for what is essentially the same medication. And by investing many times as much money in marketing as they do in development, the drug companies can convince an amazing number of naive doctors that Lexapro actually IS newer, better, and amazingly free of all the side effects and withdrawal phenomena that have emerged with all previous miracle drugs for the mind.

And speaking of side effects, get a load of the statistics cited on for instance sexual dysfunction. You wonder how a doctor can cite numbers like that without smirking all the way to the bank. He HAS to know they're fictitious. He can't be that blind to his own patients. Can he?

The whole thing is pretty close to putting new paint on an old pill and selling it again. The makers of Prozac tried to do the same thing but had to abandon it before getting to market because the "purified" Prozac turned out to cause dangerous heart arrhythmias.

The patent on Prozac was close to expiring and its manufacturer was scrambling to hold on to revenues and came out with a "new" prozac to treat PMS.

It makes you think. If they can get a patent on Prozac Weekly, the same active ingredient as normal Prozac in a different delivery matrix, they're not patenting medications -- they're patenting the physical pills!!!

So why don't they just patent something like a 2 mg (or whatever size) pill of every med to begin with? Then when that patent is about to expire, they can "invent" a 1 mg pill and patent that as a new medication that needs only half the dosage of the old one. Hell, with enough money spent on marketing, they can probably persuade tens of thousands of doctors that the 1 mg pill has less than half the side effects of the old, obsolete, addictive 2 mg pill.

It's a good thing for the drug companies that the FDA exists to keep a short leash on the patent office and other arms of government. Otherwise all kinds of rational thinking might break loose.


To make a profit these days, the co's have to differentiate. The best way to do that within a single class of drugs is to claim to have fewer side effects. Because of a serious loophole in our laws about drug research, they just keep doing trial after trial until they figure out how to get some of them to come out as desired. Then they negotiate with the FDA about what trials to include and how to summarize them in the prescribing info.

We need to change our laws so that as part of the price for approval of a drug, ALL studies on its use in humans (at the least) get placed into the public domain. That way it won't be as easy to make distorted claims. For instance, the public and the FDA have seen only a small fraction of SKB/GSK's studies on Paxil. In the majority of them it worked worse than placebo to a statistically significant degree*. At least that's what plaintiffs in one of the class-actions suits alleged, promising to provide supporting evidence. It just shouldn't be legal to hide things like that. And now that scandals like the HRT and cox-2 inhibitor surprises are emerging (i.e. it affects more than just us "head cases") I think there's some chance the regulatory environment may change.

=============
* Still, that's an average response. It doesn't negate the fact that some people respond and some of those respond extremely well. Statistical truth and statistical inference, important as they are, have considerable limits. The closer you narrow it down to an individual case, the fuzzier the picture gets until there is no statistical picture at all when dealing with a sample of one. Just because the number of people doing well on a drug is less than the number doing well on placebo does not prove that all those people are experiencing a placebo effect or spontaneous remission. Some of them may very well be experiencing a bona fide pharmacologically therapeutic effect. It's just that one can't prove it statistically. With the right tools, one could hypothetically prove it chemically or by doing repeated double-blind crossover trials on one or more individuals.



 

Otherwise all kinds of rational thinking might... » Alan

Posted by _alii_ on September 7, 2002, at 1:17:20

In reply to Re: Marketing, Lexapro, etc. - in general (Long), posted by Alan on September 7, 2002, at 0:52:21

...break loose.

Alan,

That sentence alone slayed me. Thank you for a thought provoking post. The smile and chuckle from that sentence though is what made me respond.

Namaste.

--Alii

 

Re: (Long)see bottom » Alan

Posted by pharmrep on September 7, 2002, at 2:10:04

In reply to Re: Marketing, Lexapro, etc. - in general (Long), posted by Alan on September 7, 2002, at 0:52:21

> This is what's becoming an old trick to keep revenues up. Lexapro doesn't give you anything you weren't already getting in Celexa, it's just sort of "purified". By doing that, they can get a new patent for what is essentially the same medication. And by investing many times as much money in marketing as they do in development, the drug companies can convince an amazing number of naive doctors that Lexapro actually IS newer, better, and amazingly free of all the side effects and withdrawal phenomena that have emerged with all previous miracle drugs for the mind.
>
> And speaking of side effects, get a load of the statistics cited on for instance sexual dysfunction. You wonder how a doctor can cite numbers like that without smirking all the way to the bank. He HAS to know they're fictitious. He can't be that blind to his own patients. Can he?
>
> The whole thing is pretty close to putting new paint on an old pill and selling it again. The makers of Prozac tried to do the same thing but had to abandon it before getting to market because the "purified" Prozac turned out to cause dangerous heart arrhythmias.
>
> The patent on Prozac was close to expiring and its manufacturer was scrambling to hold on to revenues and came out with a "new" prozac to treat PMS.
>
> It makes you think. If they can get a patent on Prozac Weekly, the same active ingredient as normal Prozac in a different delivery matrix, they're not patenting medications -- they're patenting the physical pills!!!
>
> So why don't they just patent something like a 2 mg (or whatever size) pill of every med to begin with? Then when that patent is about to expire, they can "invent" a 1 mg pill and patent that as a new medication that needs only half the dosage of the old one. Hell, with enough money spent on marketing, they can probably persuade tens of thousands of doctors that the 1 mg pill has less than half the side effects of the old, obsolete, addictive 2 mg pill.
>
> It's a good thing for the drug companies that the FDA exists to keep a short leash on the patent office and other arms of government. Otherwise all kinds of rational thinking might break loose.
>
>
> To make a profit these days, the co's have to differentiate. The best way to do that within a single class of drugs is to claim to have fewer side effects. Because of a serious loophole in our laws about drug research, they just keep doing trial after trial until they figure out how to get some of them to come out as desired. Then they negotiate with the FDA about what trials to include and how to summarize them in the prescribing info.
>
> We need to change our laws so that as part of the price for approval of a drug, ALL studies on its use in humans (at the least) get placed into the public domain. That way it won't be as easy to make distorted claims. For instance, the public and the FDA have seen only a small fraction of SKB/GSK's studies on Paxil. In the majority of them it worked worse than placebo to a statistically significant degree*. At least that's what plaintiffs in one of the class-actions suits alleged, promising to provide supporting evidence. It just shouldn't be legal to hide things like that. And now that scandals like the HRT and cox-2 inhibitor surprises are emerging (i.e. it affects more than just us "head cases") I think there's some chance the regulatory environment may change.
>
> =============
> * Still, that's an average response. It doesn't negate the fact that some people respond and some of those respond extremely well. Statistical truth and statistical inference, important as they are, have considerable limits. The closer you narrow it down to an individual case, the fuzzier the picture gets until there is no statistical picture at all when dealing with a sample of one. Just because the number of people doing well on a drug is less than the number doing well on placebo does not prove that all those people are experiencing a placebo effect or spontaneous remission. Some of them may very well be experiencing a bona fide pharmacologically therapeutic effect. It's just that one can't prove it statistically. With the right tools, one could hypothetically prove it chemically or by doing repeated double-blind crossover trials on one or more individuals.
>
> ***** Do you just want to get kicked off? All your statements appear without any proof-sources. You speak like somebody who hasnt read any studies at all. Have you? Do you know anything about isomer science? Yes, Prozac failed this twice, because the molecule didnt lend itself to being separated well. I dont see how over 9 studies and the FDA can all be biased to Forest. Do you really believe that?..."negotiate with the FDA"? "figure out how to control trial results" You're funny.

 

Re: Blocked for one week » pharmrep

Posted by Dinah on September 7, 2002, at 4:34:05

In reply to Re: (Long)see bottom » Alan, posted by pharmrep on September 7, 2002, at 2:10:04

> > You speak like somebody who hasnt read any studies at all. Have you? Do you know anything about isomer science? Yes, Prozac failed this twice, because the molecule didnt lend itself to being separated well. I dont see how over 9 studies and the FDA can all be biased to Forest. Do you really believe that?..."negotiate with the FDA"? "figure out how to control trial results" You're funny.

Pharmrep, I've asked you before to be civil, not to be sarcastic, jump to conclusions about others or their experiences, or post anything that could lead to others being feeling accused or put down.

So now, I'm sorry, but now I'm going to have to block you for one week.

Dinah

 

EXCEED with Lexapro

Posted by Anyuser on September 7, 2002, at 9:58:54

In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by dr dave on September 5, 2002, at 2:31:05

FWIW, here's a link to a Forest press release on "Examining Clinical Experience with Escitalopram in Depression"

http://www.frx.com/servlet/financial.displayDoc?doc_id=09-05-2002/0001795321

 

Sorry, it is Nortriptyline not Nortryptaline » psycHarvard

Posted by johnj on September 7, 2002, at 10:37:56

In reply to Re: Fewer s/e with Lexapro - ?, posted by psycHarvard on September 6, 2002, at 23:35:03

thanks for the info, but your condescending tone is not appreciated. There are people with mood disorders that are not as ignorant as you apparently think. Who knows, the pressure of your job could lead you down the same path as many of us. It didn't hit me until 27.

 

Re: Blocked for one week » Dinah

Posted by johnj on September 7, 2002, at 10:45:57

In reply to Re: Blocked for one week » pharmrep, posted by Dinah on September 7, 2002, at 4:34:05

Dinah:

Considering how much pharmrep has been verbally abused at times what do you expect? Did you read the psycHarvard's response to me? Whoever it is made me feel like an ass, like I couldn't even spell my own med, but then again neither could he. Define what is appropriate when someone makes you feel stupid? If that is the case block psycHarvard for a week. And before you respond to this just remember you can't tell me HOW the post made me feel.
johnj

 

WHAT IS ALL THIS BICKERING ABOUT???????

Posted by hawkeye on September 7, 2002, at 11:17:04

In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by Phil on September 6, 2002, at 8:27:35

Why is everyone so critical of Lexapro without even trying it or giving it a chance to prove itself????

Did it ever cross your mind that what Forest Labs says about Lexapro is true???????

Surely, Lexapro couldn't be less effective than Celexa.

I suspect that it's because we all have been disappointed by drugs in the past.

No one is forcing you to take Lexapro - No one is shoving it down your throat.

Why all of this pre-judgement?

We all know that the only way to judge a drug is to try it. Why shouldn't someone who is taking Celexa try Lexapro?????

Do you think Forest would risk its reputation of success with Celexa by introducing a dud into the market???

I started taking Lexapro yesterday evening??? Why? Because maybe it will help me. Maybe it will fit my condition. Yes, it's a crap-shoot, but I have no reason to disparage something that I haven't tried.

I have taken Celexa and found it to be one of the few drugs that really worked for me. But I stopped it because of unacceptable side-effects. I am looking forward to seeing if Lexapro is any more effective without those side-effects. I will let you know.

 

Re: Redirected to Administrative Board » johnj

Posted by Dinah on September 7, 2002, at 11:39:52

In reply to Re: Blocked for one week » Dinah, posted by johnj on September 7, 2002, at 10:45:57

Since discussions on posting policies are supposed to be posted to the Admin board, I am redirecting my reply there.

Here is a link, or you can follow the links at the top of the page.

http://www.dr-bob.org/babble/admin/20020725/msgs/7319.html

All further discussion of posting policies should take place there.

Thanks,

Dinah

 

Re: WHAT IS ALL THIS BICKERING ABOUT??????? » hawkeye

Posted by johnj on September 7, 2002, at 12:21:46

In reply to WHAT IS ALL THIS BICKERING ABOUT???????, posted by hawkeye on September 7, 2002, at 11:17:04

Hawkeye:
Please continue to post your experiences I am slated for a trial in the near future and it will be my first ssri, and hopefully a welcome switch from my current TCA. Any input would be greatly appreciated. Heck, I think even Celexa is worth a try, but by pdoc said lets wait until Lexapro comes out. Thanks
johnj

 

Hey, if it's good enough for a rat... » johnj

Posted by Phil on September 7, 2002, at 13:02:54

In reply to Re: WHAT IS ALL THIS BICKERING ABOUT??????? » hawkeye, posted by johnj on September 7, 2002, at 12:21:46

How did rats get to the lab? "Well, the rats are doing well, let's bring in the humans." Why don't they test stuff on, say, the Shetland pony?
Or alligators? The forced swim test with alligators would be more interesting than rats.
Anyway, I'm starting Lex Tuesday and will let you know also.
I'm telling my pdoc that I demand samples, ball point pens, and a coffe mug. If it works really well, I'll demand a Lexapro windbreaker.

 

Re: Soloman's book » ZyprexaNumbTongue

Posted by Phil on September 7, 2002, at 13:19:11

In reply to Re: severe depression, posted by ZyprexaNumbTongue on September 6, 2002, at 15:46:52

You need to read the book; scanning is not the same. Andrew Soloman knew depression. The book is an incredible work from someone that was hammered hard by depression.
To say his problems were just issue related, in my opinion, is an insult to the author and sufferers of depression in general.

 

Re: Soloman's book

Posted by Roastmarshmellows on September 7, 2002, at 15:55:39

In reply to Re: Soloman's book » ZyprexaNumbTongue, posted by Phil on September 7, 2002, at 13:19:11

> You need to read the book; scanning is not the same. Andrew Soloman knew depression. The book is an incredible work from someone that was hammered hard by depression.
> To say his problems were just issue related, in my opinion, is an insult to the author and sufferers of depression in general.

Im not ZyprexaNumbTongue, but I have looked at Solomon's book. I agree with ZNT that much of Solomon's book is introspective psychobabble BS. Solomon seems to have a lot of issues and a person like that isnt likely to have the melancholia subtype of depression as much.

Id also like to say that I wish I had a rich daddy like Solomon, so that I could write my own book about my own depression experiences and get it published. I wonder if Solomon's book would have been published had he not had rich connections. Probably not.

In all honestly, there is a guy on here named LostboyinNC who could write a book ten times better than Solomon, which would be more informative than Solomon's. Whether LostBoyinNC could actually get it published is another story, as LostBoy is not rich, the guy doesnt have any connections in the publishing world.

I also wish I had a rich daddy like Solomon who could go to the ends of the Earth looking for a better antidepressant for me. I understand this is what happened with Andrew Solomon. My parents dont even like to admit I have major depression, much less are they going to exert themselves trying to find something to help me.

My Mom told me if I just smiled real big and built a campfire and sang campfire songs and roasted marshmellows that my severe depression would be gone. I wonder if thats what Solomon's mom told him?

 

Re: Rich daddies who bail out their sons

Posted by Roastmarshmellows on September 7, 2002, at 16:00:50

In reply to Re: Soloman's book » ZyprexaNumbTongue, posted by Phil on September 7, 2002, at 13:19:11

I know one thing, I cant even get SS disability for my severe depression. It sure would be nice to have a rich daddy like Andrew Solomon does, whose daddy is CEO of a huge pharmaceutical company to help me out with some cash from time to time. Bet that would take a lot of the stress out of my situation.

 

Re: Blocked for 8 weeks » Roastmarshmellows

Posted by Dinah on September 7, 2002, at 17:22:58

In reply to Re: Soloman's book, posted by Roastmarshmellows on September 7, 2002, at 15:55:39

Please don't continue to reregister while blocked. I am now blocking you for 8 weeks.

Dr. Bob will be back tomorrow or Monday and you may appeal this decision with him if you like.

Dinah

 

Re: 'Poop out' » dr dave

Posted by jane d on September 7, 2002, at 21:15:38

In reply to Re: 'Poop out' » johnj, posted by dr dave on September 4, 2002, at 13:41:42

> I haven't really found that people on SSRIs are more likely to relapse than people on other antidepressants. I do find that people can feel better on an antidepressant for a while and then relapse - which doesn't necessarily mean the drug has stopped working.
>
> Antidepressants can successfully elevate an individuals mood, but it can be the case that the factors that have led to that depressive state in the first place can continue and overwhelm what effect the drug has had. I don't think people's mood state can be permanently elevated by a drug such that other influences cannot have an effect. If someone's life is chronically difficult, be that because of external problems or because of unhelpful ways of thinking or reacting to circumstances, this can lead to depression. Antidepressants can alter the balance of positive and negative influences on that persons mood, but if the difficulties continue they can reverse that shift. If your life has felt devoid of pleasure for six months, that exerts a certain downward pressure on your mood. If your life has felt devoid of pleasure for six years, that is going to depress your mood more strongly. In this situation the pressures that are chronically exerting a negative influence on your mood need to be identified and sorted out, as any medication may be fighting an unwinnable battle.


> I haven't really found that people on SSRIs are more likely to relapse than people on other antidepressants. I do find that people can feel better on an antidepressant for a while and then relapse - which doesn't necessarily mean the drug has stopped working.
>
> Antidepressants can successfully elevate an individuals mood, but it can be the case that the factors that have led to that depressive state in the first place can continue and overwhelm what effect the drug has had. I don't think people's mood state can be permanently elevated by a drug such that other influences cannot have an effect. If someone's life is chronically difficult, be that because of external problems or because of unhelpful ways of thinking or reacting to circumstances, this can lead to depression. Antidepressants can alter the balance of positive and negative influences on that persons mood, but if the difficulties continue they can reverse that shift. If your life has felt devoid of pleasure for six months, that exerts a certain downward pressure on your mood. If your life has felt devoid of pleasure for six years, that is going to depress your mood more strongly. In this situation the pressures that are chronically exerting a negative influence on your mood need to be identified and sorted out, as any medication may be fighting an unwinnable battle.
>

Dave (and anyone else out there),

For some reason this description resonated with me in a way that other descriptions of non physical factors in depression haven't. I'm not sure why. I'm definately a fan of medication but I've not been able to recapture that first feeling of really being "ok" that I experienced the first time.

Among other things, I've been wondering how this view fits with the seeming success of maintenance medication. Does maintenance medication only work to prevent a long lasting relapse in people exposed to periodic short term stresses? Or does it give some small level of protection against chronic stresses - enough for mild ongoing problems. Or could it be not the medication itself, but just change - any change - in your brains neurochemistry that gives you a window in which habits of thought and feeling are no longer so firmly embedded?

A muddled Jane staring out from behind the "medication camp" lines.

 

Re: Fewer s/e with Lexapro - where's the evidence? » psycHarvard

Posted by dr. dave on September 9, 2002, at 9:03:54

In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by psycHarvard on September 6, 2002, at 23:01:56

PsycHarvard's posts have been interesting but fail to provide any evidence of fewer side-effects with Lexapro compared to Celexa. I haven't been quite clear as to whether PsycHarvard is saying that there are fewer side-effects. If he is, I would be interested to know what evidence is behind the claim.

 

Re: Fewer s/e with Lexapro - where's the evidence? » dr. dave

Posted by Geezer on September 9, 2002, at 11:15:51

In reply to Re: Fewer s/e with Lexapro - where's the evidence? » psycHarvard, posted by dr. dave on September 9, 2002, at 9:03:54

> PsycHarvard's posts have been interesting but fail to provide any evidence of fewer side-effects with Lexapro compared to Celexa. I haven't been quite clear as to whether PsycHarvard is saying that there are fewer side-effects. If he is, I would be interested to know what evidence is behind the claim.

Dr. Dave,

I suspect the reason you are not receiving an answer to your question (evidence of less side effects for Lexapro vs Celexa) is because there isn't any SCIENTIFIC EMPERICAL evidence. If we are to continue using psychological "evidence" (in the form of HAMD testing and other such nonsense) we never will have scientific evidence. Psychology is very much like Philosophy-subjective, anecdotal, metaphysics. It does a great disservice to those of us with genetically transferred, biochemical, and PHIOLOGICAL (interesting post mortum studies on depressed suicide victums-malformations in prefrontal cortex and hippocanthus [spelling]) brain disorders. When genetic markers, intracelular ADs, and diagnostic blood tests come into play, then maybe we will see scientific evidence. Until that time people will use the FDA as there proof source for efficacy.......the most powerful impediment to medical progress that ever existed.

Best regards,

Geezer

 

Redirect: evidence? and FDA

Posted by Dr. Bob on September 9, 2002, at 17:10:32

In reply to Re: Fewer s/e with Lexapro - where's the evidence? » dr. dave, posted by Geezer on September 9, 2002, at 11:15:51

> If we are to continue using psychological "evidence" (in the form of HAMD testing and other such nonsense) we never will have scientific evidence. Psychology is very much like Philosophy-subjective, anecdotal, metaphysics. It does a great disservice to those of us with genetically transferred, biochemical, and PHIOLOGICAL (interesting post mortum studies on depressed suicide victums-malformations in prefrontal cortex and hippocanthus [spelling]) brain disorders. When genetic markers, intracelular ADs, and diagnostic blood tests come into play, then maybe we will see scientific evidence. Until that time people will use the FDA as there proof source for efficacy.......the most powerful impediment to medical progress that ever existed.

I'd like discussion of the pros and cons of different types of evidence -- and of the FDA -- to be redirected to Psycho-Social-Babble, thanks.

Bob

PS: And follow-ups regarding posting policies to be redirected to Psycho-Babble Administration.

 

Re: Fewer s/e with Lexapro - where's the evidence?

Posted by moxy1000 on September 9, 2002, at 22:49:59

In reply to Re: Fewer s/e with Lexapro - where's the evidence? » dr. dave, posted by Geezer on September 9, 2002, at 11:15:51

Dr. Dave, I believe evidence has already been offered to you but it seems as if the conclusions arrived at in any clinical studies are usually contrary the conclusions you draw for yourself, as far as I can tell from your posts.

I would not think that a direct comparison of Celexa's side effect profile versus Lexapro's side effect profile would be of any value to you, would it? I mean, there are different patient populations involved, different dosages of each agent given. Lexapro's side effect profile was based on a 8 week study, dosed at 10-20 mg (the starting/maintanance dose and the maximum dose.) Celexa's side effect profile was based on a 6 week study, dosed from 10-80 mg (half the starting dose of 20mg to 20mg past the max dose of 60mg.)

If there are is still value to you, even recognizing those vast differences in study design, I would be happy to post the numbers for you. But keep in mind, both studies were sponsored by the manufacturer, and from your prior posts, I know you don't care for those types of studies, either.

I guess what I'm saying is if you will overlook those "flaws" I will go through the work to get the information for you. If those things are too bothersome to get past in the first place, then what's the point? I don't mean to sound cynical, but you've been a tough critic on this board and I guess I just thought you were past convincing at this point. (And that's not necessarily a bad thing.)

 

Re: Fewer s/e with Lexapro - where's the evidence?

Posted by jane d on September 10, 2002, at 0:33:19

In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by moxy1000 on September 9, 2002, at 22:49:59

> I would not think that a direct comparison of Celexa's side effect profile versus Lexapro's side effect profile would be of any value to you, would it? I mean, there are different patient populations involved, different dosages of each agent given. Lexapro's side effect profile was based on a 8 week study, dosed at 10-20 mg (the starting/maintanance dose and the maximum dose.) Celexa's side effect profile was based on a 6 week study, dosed from 10-80 mg (half the starting dose of 20mg to 20mg past the max dose of 60mg.)

Moxy,

As I recall that was exactly the point made near the beginning of this thread. When the company did a study that did include a direct comparison bwtween Celexa, Lexapro and placebo in the same study with the same population, they didn't release the data on the Celexa so that this comparison could not be made. Is this incorrect? If it's true why wouldn't Forest release the numbers? I've always thought that what's missing is just as interesting as what is reported. (see Sherlock Holmes http://www.obtuse.com/juniper-docs/misc/silver_blaze.html :) )

Jane

PS I'm interested in any information you can provide. I don't think I'm in the market for a new SSRI this year but anything's possible.

 

Re: Fewer s/e with Lexapro - where's the evidence? » moxy1000

Posted by dr. dave on September 10, 2002, at 4:42:08

In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by moxy1000 on September 9, 2002, at 22:49:59

> Dr. Dave, I believe evidence has already been offered to you but it seems as if the conclusions arrived at in any clinical studies are usually contrary the conclusions you draw for yourself, as far as I can tell from your posts.
>
> I would not think that a direct comparison of Celexa's side effect profile versus Lexapro's side effect profile would be of any value to you, would it? I mean, there are different patient populations involved, different dosages of each agent given. Lexapro's side effect profile was based on a 8 week study, dosed at 10-20 mg (the starting/maintanance dose and the maximum dose.) Celexa's side effect profile was based on a 6 week study, dosed from 10-80 mg (half the starting dose of 20mg to 20mg past the max dose of 60mg.)
>
> If there are is still value to you, even recognizing those vast differences in study design, I would be happy to post the numbers for you. But keep in mind, both studies were sponsored by the manufacturer, and from your prior posts, I know you don't care for those types of studies, either.
>
> I guess what I'm saying is if you will overlook those "flaws" I will go through the work to get the information for you. If those things are too bothersome to get past in the first place, then what's the point? I don't mean to sound cynical, but you've been a tough critic on this board and I guess I just thought you were past convincing at this point. (And that's not necessarily a bad thing.)
>
>
>
>

I don't think evidence of a significantly different side-effect profile has been presented. Studies have been done which would answer the question in as unbiased and objective way as possible (randomised double-blind trials, comparing equivalent doses), and these should provide the most reliable data. If these presented evidence that there was a significant difference - well, that would be evidence. But they don't.

I've presented almost all of the available data from these trials, as it is an important question which has a fair amount of research done on it. The data are clear in failing to show any significant difference. Maybe there is a difference - my point is that even if we take the results at face value, they don't support the claim.

 

Re: The hard, cold facts about Lexapro » ZyprexaNumbTongue

Posted by SLS on September 10, 2002, at 7:11:17

In reply to The hard, cold facts about Lexapro, posted by ZyprexaNumbTongue on September 6, 2002, at 14:37:39

> 1) Lexapro is formally classified as an SSRI. Lexapro is not a truly new or novel antidepressant such as a CRF-Antagonist, subsance P drug, an MAOI patch or other drug.

The majority of people posting on PB do not respond equally to all of the SSRIs. It is my impression that the same is true in the general population of depressed individuals. I think the words "truly new or novel" might be interpreted differently by those for whom Celexa has been the only SSRI that they have responded to. There are many of them. Still, it does not seem intuitive that Lexapro would have any advantage over Celexa as far as efficacy is concerned. However, it is conceivable that r-citalopram interferes with the therapeutic action of s-citalopram. If this were the case, Lexapro would be more effective than Celexa.

It doesn't hurt to have more *superficially* similar drugs available for the same illness unless it somehow discourages the development of those that are very dissimilar. I don't know if this is true or not.


- Scott

 

Re: Lexapro and New Development of Drugs » SLS

Posted by IsoM on September 10, 2002, at 12:46:47

In reply to Re: The hard, cold facts about Lexapro » ZyprexaNumbTongue, posted by SLS on September 10, 2002, at 7:11:17

Scott, the nice thing about making Lexapro is it didn't involve any 'development' of a new drug. It just took an already existing drug, citalopram (Celexa) & applied a relatively new technology to it - the separation of isomers of a racemic mixture. So, in theory, this in now way should slow or restrict the developments of new medications.

As far as I can tell, Forest labs do not develop new drugs so much as market those that weren't picked up by other companies. They take ones that show promise & work with those developers to fix them up for use (I'm dumbing their processes way down as I don't know all they do myself).

The inactive isomer of citaprolam should not in theory interfere with the efficiency of the active one but would only bind to certain sites causing an increase of side effects in only those who would be affected. There are many people who take Celexa with no side effects at all - I'm one. I've never noticed anything different in a negative way that I could attribute to Celexa. So presumably, Lexapro wouldn't do anything different for me. The reason that Dr. Dave doesn't believe that the r-isomer of Celexa causes interference with the efficiency of the s-isomer is that (to the best of my knowledge) inactive isomers of other meds have never interfered with the active isomers before. He would be even more aware than me of any other cases where interference resulted previously. All that has resulted from inactive forms before has been an increase of side effects. Mind you, we're still discovering new things in sciences that we never knew about before, which is why I'm still keeping an open mind.

Nice to talk with you again, by the way. I hope you're feeling a little better. I have, at last, found that my new doctor does understand narcolepsy enough to know I have it & has now prescribed Dexedrine for me. Unfortunately, both the adrafinil & modafinil (Provigil) pooped out on me. I've honestly never experienced a drug poop-out before & did NOT expect it.

 

Re: Fewer s/e with Lexapro - where's the evidence?

Posted by moxy1000 on September 10, 2002, at 18:45:51

In reply to Re: Fewer s/e with Lexapro - where's the evidence? » moxy1000, posted by dr. dave on September 10, 2002, at 4:42:08

Overall, Dr. Dave, after doing some extensive research today, I think you are absolutely right in saying that presently that are is a lack of "overwelming" evidence. In all three studies I've found, involving both Celexa and Lexapro, only one presented a table of treatment emergent side effects comparing the two active agents. (This was the table in Clinical Psychiatry, April 2002, included in the study presented by Dr. Burke.) It was a double blind, placebo controlled trial, but I've left out the placebo numbers for space sake. (The placebo rates, as we'd expect, were lower then the two active drugs.)

The table looks like this:
Nausea Celexa 40mg 22% Lexapro 10mg 21%
Diarrhea Celexa 40mg 11% Lexapro 10mg 10%
Insomnia Celexa 40mg 11% Lexapro 10mg 10%
Dry Mouth Celexa 40mg 10% Lexapro 10mg 10%
Ejaculation Dis. Cx 40mg 4% Lexapro 10mg 9%

The only major difference in tolerability in the Burke study, was in the drop out rates.

2.5% dropped out on placebo due to side effects
4.2% dropped out on Lex 10mg due to side effects
8.8% dropped out on Cel 40mg due to side effects

(Perhaps the rate of side effect occurance potentially the same for both Lexapro and Celexa, but the severity of those side effects differ? That could explain the higher Celexa drop out rate.)

At any rate, I think the biggest difference between Celexa and Lexapro in this study was in the area of efficacy. On every testing instrument used (HAM-D, MADRS, CGI-I) Lexapro at 10 mg was at least as effective as Celexa 40mg. (And how often is it possible to jump into Celexa therapy at 40mg? Starting dose is usually 20mg.) I think that's where the earlier onset of improvement in depressive symptoms comes in for Lexapro.

I think it's standard for all SSRI's to take 4-6 weeks for improvement in depressive symptoms (at least that is what is stated in the package inserts of all available treatments.) Sure, not every patient is the same, some probably respond to therapy sooner (I took wellbutrin and felt it kick in after a couple weeks), some may never respond at all, some may feel better after a month or longer. But, If Lexapro can offer the majority of patients, as it appears that it can from all efficacy studies available, earlier relief at 1-2 weeks, would that not be an improvement over not only Celexa, but some other AD's as well?

Let's say for the sake of argument that the side effect profile is essentially the same. Wouldn't having the ability to offer depressed patients relief sooner be an advantage? After all, from all indications, both Lex and Celexa look like they are pretty well tolerated to begin with.

I hope this info helped.


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