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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
Posted by Patson on August 28, 2002, at 0:37:45
In reply to Re: dosage » pharmrep, posted by Anyuser on August 22, 2002, at 17:39:26
There seems to be a question here... 10 = 40 This really means that 10 milligrams is equal to the EFFICACY of 40mg of celexa... right? If you can get a greater efficacy with fewer side effects then this would be a benefit... No? Is there such a thing as "too well" or "too much improvement?" This is my interpretation from what I have read so far. SSRIs are usually started low and titrated up to avoid side effects. I guess I'm confused on the 10 = 40....
10mg can not equal 40mg of medication.... But the results of 10 are greater than the results of 40.....
> What's curious to me is that nearly 2/3 of practitioners prescribe 20mg Celexa or less, and we're told that 10mg Lexapro=40mg Celexa, yet there seems to be no expectation that any practitioner would prescribe less than 10mg Lexapro.
>
> Oh well. Time will tell. Thanks for your answers.
Posted by pharmrep on August 28, 2002, at 1:51:43
In reply to Re: dosage, posted by Patson on August 28, 2002, at 0:37:45
> There seems to be a question here... 10 = 40 This really means that 10 milligrams is equal to the EFFICACY of 40mg of celexa... right? If you can get a greater efficacy with fewer side effects then this would be a benefit... No? Is there such a thing as "too well" or "too much improvement?" This is my interpretation from what I have read so far. SSRIs are usually started low and titrated up to avoid side effects. I guess I'm confused on the 10 = 40....
>
> 10mg can not equal 40mg of medication.... But the results of 10 are greater than the results of 40.....
>
>
>
> Thanks for your answers.
>
*** I dont get Dr. Dave...he says Lexapro is not tested. Most new drugs go against placebo...Lexapro went again placebo and Celexa! And did show improved efficacy. (If 10mg of Lex can do at least what 40mg of Celexa does...with fewer side effects, and with a cleaner drug-to-drug interaction profile, and with onset of action in 1-2 weeks...I would say that sounds like improvement.) Also, why are we talking about patent protection again? Lexapro is coming out now...3 years before a generic for Celexa is available...this is because Lex is proving to be better, and that's it...otherwise Forest could "milk" Celexa for awhile longer, then pull out Lexapro at the last minute...again...not what Forest is doing. And as far as marketing...I dont know what Lundbeck is doing in Europe, but in the US...it's like this. If a patient is not seeing the results they/or the DR. desires on any antidepressant (including Celexa), then switch to Lexapro, favorable s/e profile, lack of drug interactions, and rapid onset make Lexapro an attractive SSRI. And for new patients...the previous also applies, and since very tolerable, it's a good first try (only 6% of patients discontinued due to adverse events) If doctors usually switch from one AD to another 25+% of the time...6% would be a great improvement for them and of course the patients.
Posted by dr dave on August 28, 2002, at 2:02:47
In reply to Re: and that particular link... » dr dave, posted by IsoM on August 27, 2002, at 18:03:22
I didn't know that! I just found it through Google.
> 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 pharmrep on August 28, 2002, at 2:34:46
In reply to Re: and that particular link... » IsoM, posted by dr dave on August 28, 2002, at 2:02:47
Hi DR.Dave, Nice site...I noticed is was about 2 years old...any chance of any newer sites that might list more recent findings/or drugs since then? And I'm curious...how do you feel about isomer science in general...do you believe that it's all about money and getting a "new" drug out to replace an old one, or do you believe there can be a benefit to the single isomer/enantiomer over the racemic mixture?
Posted by dr dave on August 28, 2002, at 3:15:33
In reply to dosage/tested improvement » Patson, posted by pharmrep on August 28, 2002, at 1:51:43
It is repeatedly claimed Lexapro has fewer side-effects than Celexa. What does the data show? In the Burke et al trial 85.6% of those on Lexapro 20mg had side-effects compared to 86.4% on Celexa 40mg (not statistically significant). Not impressive, I would suggest. 10.4% of those on Lexapro 20mg discontinued because of side-effects compared to 8.8% of those on Celexa. So in fact more discontinued Lexapro than Celexa. But the result is not statistically significant and therefore likely to be a chance result.
The incidence of discontinuations on Lexapro 10mg a day was 4.2% compared to 2.5% on placebo. Again, not statistically significant. The overall rate of side-effects on Lexapro 10mg was 79.0% compared to 70.5% on placebo (not statistically significant). The comparison between Celexa 20 mg and placebo is not available as this dose was not used.
So the Burke study provides no data to support the claim that Lexapro has fewer side-effects than Celexa.
Gorman gives discontinuation rates for Lexapro in both doses as being 5.9% versus 2.2% for placebo (not statistically significant). No equivalent rate for Celexa is available. No more detail on side-effects is given in this, the most comprehensive analysis of the data currently available. Myself, I ask why not, if this is such a step forward in terms of side-effects.
These results are entirely consistent with the hypothesis that there is no statistically significant difference in side-effects between Lexapro and Celexa, and provide no evidence of the difference that is so widely claimed as being an established fact.
If there is other evidence to fit into this overall picture, this must be considered, but these results seem to suggest very powerfully that there is no significant difference in side-effects.
Decide for yourself on the basis of actual hard facts.
Posted by Kath on August 28, 2002, at 10:15:51
In reply to Re: Lexapro update, posted by pharmrep on July 31, 2002, at 2:04:24
This feels like a stupid question, but I just want to make sure. I have taken Celexa for 2 years & it works well for me. I sure hope it'll continue to be available. Will it have a different name once it "goes generic"?
Kath
> I am a Celexa rep, and will be marketing Lexapro once the FDA gives final approval (sometime in August is what we've been told). I have gone to extra training to know the differences between Celexa and Lexapro, and when the samples go to the Dr's, so will the studies (very impressive.)
> As far as efficacy...yes it will be more effective than Celexa or any antidepressant available...it will also be more tolerable with "side-effects and discontinuation due to adverse events comparable to placebo." That last quote is being allowed by the FDA...awesome. And most importantly...Lexapro is replacing Celexa because the technology to separate the isomers is just now available...so Ritch, you are partially right, but re-patent? Wrong...Celexa will still be available for 3 years before going generic. Dont lump Forest in with some other unethical pharm companies who get FDA approval years in advance, and then don't offer the new drug til the old one goes generic. Forest is moving to Lexapro because studies show Lexapro is better, and all our efforts will be in promoting the better drug. Hard to believe a company is giving up over $5 billion over the next 3 years...I guess the message Forest is sending is that it that sure Lexapro is that good.
Posted by ehb975 on August 28, 2002, at 20:36:02
In reply to Re: Wish I could » JaneB, posted by Ritch on June 11, 2002, at 23:04:41
Lexapro will be available beginning 9/5/02. I would caution you about switching from Celexa to Lexapro immediately. If you are well controlled on Celexa and comfortable with the therapy, you may want to seriously talk it over with your doc. You are altering the reuptake of seratonin in your brain and psychopharmacology is no perfect science. If you switch to Lexapro it's quite possible your seratonin levels will rise considerably due to the potency of this new isomer. No doubt there is much to be excited about with Lexapro. Just don't take this decision lightly.
Much luck to you!
Posted by ehb975 on August 28, 2002, at 21:00:51
In reply to when will lexapro be available?, posted by mopey on June 19, 2002, at 15:40:30
Reps will begin sampling on Thursday 9/5/02
Posted by Mr.Scott on August 28, 2002, at 23:11:45
In reply to Re: Dr. Dave - the Monstrous vs. the Miraculous » dr dave, posted by Ritch on August 28, 2002, at 0:36:42
Posted by dr. dave on August 29, 2002, at 5:34:09
In reply to Re: Lexapro update- Celexa availability?, posted by Kath on August 28, 2002, at 10:15:51
The important name to remember is citalopram - this is the proper name for 'Celexa', and anything generic will be called citalopram, plus possibly another trade name (like 'Celexa').
> This feels like a stupid question, but I just want to make sure. I have taken Celexa for 2 years & it works well for me. I sure hope it'll continue to be available. Will it have a different name once it "goes generic"?
>
> Kath
>
> > I am a Celexa rep, and will be marketing Lexapro once the FDA gives final approval (sometime in August is what we've been told). I have gone to extra training to know the differences between Celexa and Lexapro, and when the samples go to the Dr's, so will the studies (very impressive.)
> > As far as efficacy...yes it will be more effective than Celexa or any antidepressant available...it will also be more tolerable with "side-effects and discontinuation due to adverse events comparable to placebo." That last quote is being allowed by the FDA...awesome. And most importantly...Lexapro is replacing Celexa because the technology to separate the isomers is just now available...so Ritch, you are partially right, but re-patent? Wrong...Celexa will still be available for 3 years before going generic. Dont lump Forest in with some other unethical pharm companies who get FDA approval years in advance, and then don't offer the new drug til the old one goes generic. Forest is moving to Lexapro because studies show Lexapro is better, and all our efforts will be in promoting the better drug. Hard to believe a company is giving up over $5 billion over the next 3 years...I guess the message Forest is sending is that it that sure Lexapro is that good.
>
>
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