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Posted by pharmrep on August 23, 2002, at 23:20:37
In reply to Re: Lexapro clinical data, posted by dr. dave on August 23, 2002, at 8:21:18
Interesting article...I would like to see a test done In US to see if similar data seen. Anyway...point taken. I have a question for you. How do you feel about "dual action" or "dual mechanism" for an AD? Do you believe there is any "advantage?"
PS Sorry you've been taking a beating recently...I used to get it when I started too....dont give up..."chin up" ol'chap.
Posted by pharmrep on August 23, 2002, at 23:35:29
In reply to Re: Sanchez study, posted by moxy1000 on August 23, 2002, at 11:19:54
> I heard about the sanchez study but it was my understanding that it wasn't finished yet (at least it wasn't back in June.) Maybe they're still getting the data ready for submission?
>
*** It's done...as are 8 others....it's just a matter of finding them online...or hitting up your psych after 9/5, they can make a copy of their studies for you (and they will be getting plenty of them and samples starting 9/5...within 1 week...85+% of doctors should have been seen by at least 1 rep)
Posted by Patson on August 24, 2002, at 0:42:54
In reply to Re: Lexapro clinical data, posted by moxy1000 on August 23, 2002, at 11:21:40
Simply call Forest Professional Affairs Dept. at 1-800-678-1605. They can send you the studies, or provide the information you need to find them on your own. The studies are all published and public information.
Posted by pharmrep on August 24, 2002, at 0:47:47
In reply to Re: Lexapro clinical data, posted by Patson on August 24, 2002, at 0:42:54
> Simply call Forest Professional Affairs Dept. at 1-800-678-1605. They can send you the studies, or provide the information you need to find them on your own. The studies are all published and public information.
** did you get them? I asked my buddy Derek over there...he said not out til later. (like around 9/5). If you can get them...more power to you.
Posted by IsoM on August 24, 2002, at 0:58:14
In reply to Re: Question » IsoM, posted by pharmrep on August 23, 2002, at 22:28:57
Do you know anyone with a scanner or any way you could get access to a scanner? They're remarkably cheap unless you want the absolute best. Surely, in your line of work, there must be some place to use a scanner?
Posted by Ritch on August 24, 2002, at 1:15:52
In reply to Re: scoring » Ritch, posted by pharmrep on August 23, 2002, at 9:39:16
> > > > PharmRep,
> > > >
> > > > Why can't most SSRI manufacturer's go for the very low-dose maintenace dosages with scored tablets instead of liquids? I realize that it probably is far cheaper to "tool" for a liquid version, than to create dies and whatnot for low-dose tablets (and add scoring to the costs). However, given that you mention that about 2/3 of the prescribers are on the low-dose end, why not market very low-dose tablet alternatives? With Celexa, the max. I can tolerate every day is nowhere near 10mg. A 5mg tablet of Lexapro that is scored FOUR-WAYS to enable one to take a quarter-tablet would be a fine marketing idea, HINT-HINT
> > > >
> > > > Mitch
> > > >
> > > ** I think it boils down to this...efficacy just isnt seen at lower doses, and the "majority" of patients see the right amount of effectiveness at the starting doses. In your case, you just happen to be more sensitive and only lower doses are tolerable...unfortunately...you are in the minority. One other thought...have you considered that when you "cut" your own tabs, that since the active ingredients are so trace that you may not be getting a "therapeutic" dose? I know that the scored tablets are ok, but any further splitting might be giving you a placebo sometimes. (I dont know this for fact with Celexa...I am just theorizing with you since all manufacturing is done differently.)
> >
> >
> > I take a low-dose SSRI primarily to help prevent panic attacks and several of them (including Celexa) work rather well for that. It seems that with SSRI's I only need that small amount to make a big difference. Also, at higher doses they (all of them) tend to precipitate hypomania (I am bipolar). That is primarily the "sensitivity" issue. I had a general practictioner who disbelieved strongly that it wasn't doing me any good to take such a small amount, so "why take any at all". That was before a study was done that showed people could take as little as 15mg of Prozac every week as a *maintenance* to prevent panic. Then Prozac weekly came out after that (but not specifically for that condition). I wonder how many people out there on *maintenance* regimes for panic would find the four-way scored 5mg Lexapro tabs very convenient. The data you provide about dosages probably relate to "acute" treatment for depression only (which is the only formal indication for Celexa and Lexapro thus far-here in the US anyhow). There are many people who are being treated for anxiety disorders with SSRI's as well.
> >
> > thanks,
> >
> > Mitch
> >
> >** I am fascinated to hear that such a low dose (of any med) can still work for somebody in an off label application. I know that panic attack studies (for the indication) are being done. It will be interesting to see what mg is recommended.
> PS You didnt comment on the "scoring" theory.
PharmRep,I have been pill chopping with SSRI's and bupropion for quite some time now with good results. I made my own liquid Prozac for several years. Scoring, just makes it easier to break a tablet cleanly, that's all. It provides a stress relief that makes the resultant dose easy to break with your fingers and more evenly halved or quartered, that's all.
Mitch
Posted by pharmrep on August 24, 2002, at 1:18:21
In reply to Re: Question about Scanner and Studies » pharmrep, posted by IsoM on August 24, 2002, at 0:58:14
> Do you know anyone with a scanner or any way you could get access to a scanner? They're remarkably cheap unless you want the absolute best. Surely, in your line of work, there must be some place to use a scanner?
** Its all about personal delivery and conversation...not faxes and scanners. (You can answer questions and add comments through machines) Anyway...I will figure a way out to get them and post them...just need a little more time.
Posted by pharmrep on August 24, 2002, at 1:24:00
In reply to Re: scoring » pharmrep, posted by Ritch on August 24, 2002, at 1:15:52
> > > > > PharmRep,
> > > > >
> > > > > Why can't most SSRI manufacturer's go for the very low-dose maintenace dosages with scored tablets instead of liquids? I realize that it probably is far cheaper to "tool" for a liquid version, than to create dies and whatnot for low-dose tablets (and add scoring to the costs). However, given that you mention that about 2/3 of the prescribers are on the low-dose end, why not market very low-dose tablet alternatives? With Celexa, the max. I can tolerate every day is nowhere near 10mg. A 5mg tablet of Lexapro that is scored FOUR-WAYS to enable one to take a quarter-tablet would be a fine marketing idea, HINT-HINT
> > > > >
> > > > > Mitch
> > > > >
> > > > ** I think it boils down to this...efficacy just isnt seen at lower doses, and the "majority" of patients see the right amount of effectiveness at the starting doses. In your case, you just happen to be more sensitive and only lower doses are tolerable...unfortunately...you are in the minority. One other thought...have you considered that when you "cut" your own tabs, that since the active ingredients are so trace that you may not be getting a "therapeutic" dose? I know that the scored tablets are ok, but any further splitting might be giving you a placebo sometimes. (I dont know this for fact with Celexa...I am just theorizing with you since all manufacturing is done differently.)
> > >
> > >
> > > I take a low-dose SSRI primarily to help prevent panic attacks and several of them (including Celexa) work rather well for that. It seems that with SSRI's I only need that small amount to make a big difference. Also, at higher doses they (all of them) tend to precipitate hypomania (I am bipolar). That is primarily the "sensitivity" issue. I had a general practictioner who disbelieved strongly that it wasn't doing me any good to take such a small amount, so "why take any at all". That was before a study was done that showed people could take as little as 15mg of Prozac every week as a *maintenance* to prevent panic. Then Prozac weekly came out after that (but not specifically for that condition). I wonder how many people out there on *maintenance* regimes for panic would find the four-way scored 5mg Lexapro tabs very convenient. The data you provide about dosages probably relate to "acute" treatment for depression only (which is the only formal indication for Celexa and Lexapro thus far-here in the US anyhow). There are many people who are being treated for anxiety disorders with SSRI's as well.
> > >
> > > thanks,
> > >
> > > Mitch
> > >
> > >** I am fascinated to hear that such a low dose (of any med) can still work for somebody in an off label application. I know that panic attack studies (for the indication) are being done. It will be interesting to see what mg is recommended.
> > PS You didnt comment on the "scoring" theory.
>
>
> PharmRep,
>
> I have been pill chopping with SSRI's and bupropion for quite some time now with good results. I made my own liquid Prozac for several years. Scoring, just makes it easier to break a tablet cleanly, that's all. It provides a stress relief that makes the resultant dose easy to break with your fingers and more evenly halved or quartered, that's all.
>
> Mitch
>
> *** Maybe I wasnt clear...here is the thought...let's say that the active materials in the tablet comprise 10%, the other 90% is filler. If you make your own additional cuts besides the scored one on the pill, how do you know you are actually getting any therapeutic dose, and not just filler? (you are assuming univeral/even distribution.)
Posted by Ritch on August 24, 2002, at 9:46:28
In reply to last try for scoring » Ritch, posted by pharmrep on August 24, 2002, at 1:24:00
Posted by oracle on August 25, 2002, at 3:02:28
In reply to I am assuming universal distribution (nm) » pharmrep, posted by Ritch on August 24, 2002, at 9:46:28
Why do you assume this ? It is not going to happen in a pill that not ~100 % active.
You need to compound to make sure you are getting active meds in your micro dose.
Posted by Ritch on August 25, 2002, at 9:43:19
In reply to Re: I am assuming universal distribution (Why), posted by oracle on August 25, 2002, at 3:02:28
> Why do you assume this ? It is not going to happen in a pill that not ~100 % active.
>
> You need to compound to make sure you are getting active meds in your micro dose.I used to make a liquid out of Prozac. I made a liquid out of Celexa before, too (using a pill crusher, etc.). Quartering the tabs into chunks doesn't seem to make much of a difference. Perhaps Celexa has a long enough half-life that any uneven dosings are obscured. If the tablets do not have active medication+buffer/filler distributed evenly throughout a tablet (except on the outer shell), wouldn't that call into question whether or not each pill contains the correct total amount of medication (if it wasn't uniformly distributed)?
Posted by oracle on August 25, 2002, at 14:21:32
In reply to Re: I am assuming universal distribution-why not? » oracle, posted by Ritch on August 25, 2002, at 9:43:19
If the tablets do not have active medication+buffer/filler distributed evenly throughout a tablet (except on the outer shell), wouldn't that call into question whether or not each pill contains the correct total amount of medication (if it wasn't uniformly distributed)?
Nope. The pill disolves and goes into solution
once taken so even distribution in solid form is not a goal.
Posted by johnj on August 25, 2002, at 22:27:53
In reply to Re: Celexa and Japan » johnj, posted by IsoM on August 23, 2002, at 20:17:16
IsoM
Sorry for the late post, we just moved and finally have the internet hooked up again. My DX is major depression w/agitated anxiety. It has been hard to figure out which is primary and even the pdocs are not able to tell me which. My suspiscion is the anxiety leads to depression.
I like what you said about sleepy, yet wired. That was me before my depression at 27, nearly 10 years ago. It was a panic attack followed by a drop into the depths of despair that cannot be explained but can only known by those that have experienced it.
I take nortryptline(TCA), lithium as an augument to the AD and tranxene at 22.5 mg. I have not heard of provigil. what exactly is it?
My wife is Japanese and a wonderful person. People with social difficulties, and I experience some, would find Japan quite difficult. That is just my opinion. If you are foreign and in a smaller city you will get stared at most of the time. In the large cities, Tokyo, Osaka, people won't pay you much mind, but it is too crowded for me. I am sure there is a balance there, like living with monks practicing zen or martial arts.
Take care, I always enjoy your posts. They are uplifting. I do have high hopes for lex/celex, but will wait a while. The exam is an engineering exam (8 hours), but we get a book of equations so I think I might be ok. I am reading Dr. Burns book and trying to implement some of it into my thinking. I have always thought therapy was bunk, but now I am not so sure.
Cheers
johnj
Posted by pharmrep on August 26, 2002, at 0:59:02
In reply to Re: I am assuming universal distribution-why not? » oracle, posted by Ritch on August 25, 2002, at 9:43:19
> > Why do you assume this ? It is not going to happen in a pill that not ~100 % active.
> >
> > You need to compound to make sure you are getting active meds in your micro dose.
>
> I used to make a liquid out of Prozac. I made a liquid out of Celexa before, too (using a pill crusher, etc.). Quartering the tabs into chunks doesn't seem to make much of a difference. Perhaps Celexa has a long enough half-life that any uneven dosings are obscured. If the tablets do not have active medication+buffer/filler distributed evenly throughout a tablet (except on the outer shell), wouldn't that call into question whether or not each pill contains the correct total amount of medication (if it wasn't uniformly distributed)?
>
***sorry guys..didnt want to create an issue...I dont how Celexa is distributed...I just know that crushing a scored 20mg to get 2.5 or less could be difficult to measure and doses might not be uniform, especially if tablets not evenly mixed throughout. (I know some manufacturers dont have uniform pills. and the active ingredient is often under the score-mark...since that is where the only "split" is thought to be made)
Posted by Dinah on August 26, 2002, at 1:57:46
In reply to Re: distribution » Ritch, posted by pharmrep on August 26, 2002, at 0:59:02
> >
> ***sorry guys..didnt want to create an issue...I dont how Celexa is distributed...I just know that crushing a scored 20mg to get 2.5 or less could be difficult to measure and doses might not be uniform, especially if tablets not evenly mixed throughout. (I know some manufacturers dont have uniform pills. and the active ingredient is often under the score-mark...since that is where the only "split" is thought to be made)Wow. That is very interesting to know. I guess I had always assumed that the active and inactive ingredients were mixed thoroughly somewhere else and then poured or molded into pills and then dipped in a coating. It never even ocurred to me that pill manufacturing might be so complex that the active ingredient would be centered and then surrounded by the inactive materials. I sometimes splt a Depakote pill, and now I'll have to really think about that. It's not scored at all.
Hmmm. Something to think about. Thanks!
Posted by Ritch on August 26, 2002, at 9:41:58
In reply to Re: distribution » Ritch, posted by pharmrep on August 26, 2002, at 0:59:02
> > > Why do you assume this ? It is not going to happen in a pill that not ~100 % active.
> > >
> > > You need to compound to make sure you are getting active meds in your micro dose.
> >
> > I used to make a liquid out of Prozac. I made a liquid out of Celexa before, too (using a pill crusher, etc.). Quartering the tabs into chunks doesn't seem to make much of a difference. Perhaps Celexa has a long enough half-life that any uneven dosings are obscured. If the tablets do not have active medication+buffer/filler distributed evenly throughout a tablet (except on the outer shell), wouldn't that call into question whether or not each pill contains the correct total amount of medication (if it wasn't uniformly distributed)?
> >
> ***sorry guys..didnt want to create an issue...I dont how Celexa is distributed...I just know that crushing a scored 20mg to get 2.5 or less could be difficult to measure and doses might not be uniform, especially if tablets not evenly mixed throughout. (I know some manufacturers dont have uniform pills. and the active ingredient is often under the score-mark...since that is where the only "split" is thought to be made)Thanks everybody. Now I am curious about pill manufacturing technology, not necessarily creating the active medication, but how the active and inactive portions of a pill are blended together and why, how the pill is stamped/scored, imprinted. etc. I am still bewildered why the inactive fillers and active medication are not always diffused homogoneously throughout a pill. The only way I could get a consistent dose of Lexapro would be to crush the entire tablet and make a homemade liquid I guess...
Mitch
Posted by pharmrep on August 26, 2002, at 14:14:33
In reply to Re: distribution, thanks oracle-PharmRep » pharmrep, posted by Ritch on August 26, 2002, at 9:41:58
Posted by Anyuser on August 26, 2002, at 16:18:48
In reply to Forest...not Oracle (nm) » Ritch, posted by pharmrep on August 26, 2002, at 14:14:33
The article is entitled "Anti-Depressant May Not Be Cure-All." Here's a link: http://wire.ap.org/APnews/?SITE=JRCPORT&FRONTID=HOME
Posted by oracle on August 26, 2002, at 17:16:42
In reply to The Associated Press chime in, posted by Anyuser on August 26, 2002, at 16:18:48
> The article is entitled "Anti-Depressant May Not Be Cure-All." Here's a link: http://wire.ap.org/APnews/?SITE=JRCPORT&FRONTID=HOME
It is my observation that the general press
is the last place to get information of a medical nature.
Posted by utopizen on August 26, 2002, at 19:08:28
In reply to Re: The Associated Press chime in, posted by oracle on August 26, 2002, at 17:16:42
That and the Zoloft ads..
People take Zoloft after seeing an animated rock explain to them that "Nerve A" can send to "Nerve B" without bouncing off too much on the drug.
I still crack up over them...
But just remember- "A chemical imbalance may be to blame."
Just exactly what drug DO you take in order to think up using animated rocks to sell a psychotropic? I doubt it's Zoloft that creative director took to think that up.
Posted by dr dave on August 27, 2002, at 16:36:52
In reply to Dr. Dave - why do you hate this drug?, posted by moxy1000 on August 23, 2002, at 11:58:34
The time has come to reveal my connections with the drug industry. In the last five years I have had about five meals in restaurants paid for by drug companies but I can't remember which ones. I have also eaten countless sandwiches provided by drug companies at many many lunchtime meetings, but I am entirely indiscriminate as to which company are paying. I have no other financial connections with drug companies, and never have. I have no connections with drug companies apart from seeing drug reps. Oh, and I did accept a small clock from the Lundbeck rep approx value £5 (about $8).
Why am I saying all this stuff? Because I am angry. My reading of the research is that Lexapro hasn't been proved to be superior to any anti-depressant. All independent bodies which have assessed the evidence agree, including the FDA (see Associated Press article quoted above). Claims for this drug are being made which are just not justified, and they are legitimated by vague referrals to 'positive studies', which when you examine them closely don't really show convincing results.
I am angry because I think science is being corrupted. There is no known mechanism whereby removing r-citalopram could make s-citalopram work better. The clinical studies, when you look at them in detail and peel away the hype, confirm this to be the case. The biggest analysis so far of which I am aware, by Gorman in collaboration with Forest, shows no statistically significant difference between Lexapro and Celexa at end-point when drop-outs are factored in (LOCF analysis) on the two main measurements used (MADRS and CGI).
I am so sick of my patients hoping desparately that a new pill will relieve their misery and then being cruelly disappointed when it doesn't, confirming in their own minds that they will never get better. It is monstrous not to tell people the truth about what they can expect from changing antidepressant - of course sometimes it can be miraculous, but you can't guarantee it and you have to be straight with people about the likelihood of a new antidepressant helping. If people believe they are being put on a far superior drug which is very effective against depression, how do they feel when it doesn't work? Often they will feel that it proves they have an untreatably severe condition, so they lose hope, are more depressed, and question whether it's worth continuing to try to change things.
So when I see claims being made which I think are as misleading as this, I get angry. This is not about claims for how well a new, improved washing powder works, this is about untold human misery. We must be as truthful and realistic about things as we can possibly be, and that is very, very far from being the case with the marketing of this product.
The use of single-enantiomer drugs to extend patent protection is no secret and you can read more about it more in this article from 'Chemical & Engineering News'
http://pubs.acs.org/cen/coverstory/7843/7843scit1.html> Dr. Dave, I have spent a few hours this morning reading your recent posts, and the more I read, the more I am convinced that you have some sort of hidden agenda against Lexapro.
>
> I'm surprised I didn't notice it sooner. I am taking a "wait and see" attitude with Lexapro. I know you're in Europe, But I would like to ask what your opinion is of Lexapro's release in the U.S. I ask because Forest has a U.S. patent on Celexa until at least 2005. Why would they stop marketing a billion dollar drug and start marketing Lexapro if it had, as you say repeatedly, no advantages over Celexa?
>
> Also, I think it's worth pointing out that this company (Forest) has a vested interest in Depression. Did you know Howard Soloman, the CEO of Forest, has a son who has battled depression his entire life? Andrew wrote a book about his battle, called the "Noonday Demon." (Andrew, by the way, mentions nothing of Celexa or any Forest product in his book.) Also, did you know Howard's wife committed suicide? This is common knowledge in the U.S. Business Week did a cover story about this a few months ago.
>
> My point is that I believe this company has been touched to the core by this disease called depression. I also believe that they are releasing Lexapro in the U.S. because it would be unethical to delay the release of a superior treatment like Lexapro, simply because Celexa still had life left in it's patent.
>
> I would be interested to hear your response.
Posted by IsoM on August 27, 2002, at 17:23:17
In reply to Re: Dr. Dave - why do you hate this drug? » moxy1000, posted by dr dave on August 27, 2002, at 16:36:52
Posted by IsoM on August 27, 2002, at 18:03:22
In reply to Re: Dr. Dave - why do you hate this drug? » moxy1000, posted by dr dave on August 27, 2002, at 16:36:52
Thanks for a link that allows us to view that page on chiral drugs. I notice it would normally need a user ID & password. Thanks again.
Posted by Anyuser on August 27, 2002, at 18:57:38
In reply to Re: Dr. Dave - why do you hate this drug? » moxy1000, posted by dr dave on August 27, 2002, at 16:36:52
What else makes you angry in addition to escitalopram? Wouldn't your statements, which I have excerpted, below, apply with equal force, for example, to nefazodone, St. John's wort, omega-3 oils, anticonvulsants prescribed for depression, or SAMe?
> Why am I saying all this stuff? Because I am angry. My reading of the research is that XXX hasn't been proved to be superior to any anti-depressant. All independent bodies which have assessed the evidence agree, including the FDA Claims for this drug are being made which are just not justified, and they are legitimated by vague referrals to 'positive studies', which when you examine them closely don't really show convincing results.
>
> I am angry because I think science is being corrupted. . . .
>
> I am so sick of my patients hoping desparately that a new pill will relieve their misery and then being cruelly disappointed when it doesn't, confirming in their own minds that they will never get better. It is monstrous not to tell people the truth about what they can expect from changing antidepressant - of course sometimes it can be miraculous, but you can't guarantee it and you have to be straight with people about the likelihood of a new antidepressant helping. If people believe they are being put on a far superior drug which is very effective against depression, how do they feel when it doesn't work? Often they will feel that it proves they have an untreatably severe condition, so they lose hope, are more depressed, and question whether it's worth continuing to try to change things.
>
> So when I see claims being made which I think are as misleading as this, I get angry. This is not about claims for how well a new, improved washing powder works, this is about untold human misery. We must be as truthful and realistic about things as we can possibly be, and that is very, very far from being the case with the marketing of this product.
>
Posted by Ritch on August 28, 2002, at 0:36:42
In reply to Re: Dr. Dave - why do you hate this drug? » moxy1000, posted by dr dave on August 27, 2002, at 16:36:52
>.....I am so sick of my patients hoping desparately that a new pill will relieve their misery and then being cruelly disappointed when it doesn't, confirming in their own minds that they will never get better. It is monstrous not to tell people the truth about what they can expect from changing antidepressant - of course sometimes it can be miraculous, but you can't guarantee it and you have to be straight with people about the likelihood of a new antidepressant helping. If people believe they are being put on a far superior drug which is very effective against depression, how do they feel when it doesn't work? Often they will feel that it proves they have an untreatably severe condition, so they lose hope, are more depressed, and question whether it's worth continuing to try to change things.....
>Dr. Dave,
Obviously, you are talking about treatment-resistant unipolar depressive patients who have had at least one or two trials with different antidepressants with little or no success (and understandably yearning for a new "miracle" medication). S-citalopram, possibly, at best, probably offers a very clean (low-SE profile) choice for a clinician seeing a "typical" patient (presenting for the 1st time) with a major depressive episode requiring medical attention. However, there will likely be the occasional treatment-resistant few who might respond well to an antidepressant switch to this medication (and a much "fewer" group-who might respond "miraculously" to this as opposed to s+r-citalopram). The pragmatist part of my thinking, says: "Go ahead and switch them around, play the musical chair game with the AD's, but you will get one or two, here and there, that get well, and that's worth the trials." You talk about "science" being corrupted. I understand your anger about that. So, do we spoil the occasional few for scientific idealism, to save a lot more from being disillusioned by fraudulent capitalistic opiates? Do we.. "let the buyer beware", "keep hope alive", "there's a chance it might work" or decide in advance that a treatment-resistant patient will *likely* not benefit from something new.. so no sense in trying it? What it all boils down to is-what's worse? Risk disillusioning and letting down a patient duped by advertisements from drug companies (when the drug fails to live up to the patient's expectations), or letting down the occasional rare (treatment-resistant) patient who could benefit from the medication.
Mitch
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