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Dr. Bob is Robert Hsiung, MD,
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Posted by Geezer on August 7, 2002, at 11:15:45
In reply to Interesting article, posted by Anyuser on August 6, 2002, at 17:58:28
> Here is a link to an article in BusinessWeek about Forrest Laboratories, the makers of Celexa and Lexapro. The founder of Forrest Labs is the father of Andrew Solomon, the author of The Noonday Demon.
>
> http://www.businessweek.com/magazine/content/02_21/b3784001.htmGood article - gives a little balance to the "evil greedy drug company" argument, doesn't it. I wish I had an answer to Mitch's question as to why the FDA won't allow new and better drugs here in the US., after all, the US drug companies do their testing in Europe. I thought it was interesting the FDA "reached out" to Europe and killed the use of Amineptine for Europeans (now it's only available in South America - at a high cost I believe). My only thought would be to "privatize" the FDA (there might be a lot more to the solution than that)- nothing could be worse than the current FDA mess.
Geezer
Posted by SLS on August 10, 2002, at 9:37:13
In reply to Re: Interesting article » Anyuser, posted by Ritch on August 7, 2002, at 9:39:50
Hi Mitch.
How have you been doing?
> It would be nice if more pharm. companies would be interested in attempting to market meds that are already available in other countries that could be helpful here. I am thinking of moclobemide for one (why doesn't Roche try to get FDA approval here?).
First of all, it is my impression that moclobemide is really not a terribly effective drug - either for depression or social-phobia. Of course, some people respond well to it, but the non-selective irreversible MAOIs generally demonstrate superior efficacy. It is certainly worth a try, though. You never know, right?
- Don't give up on moclobemide until you reach 1200mg.
- Do not eat any more than 50mg of tyramine at any one meal.I would be very interested to know what drugs you would combine with moclobemide. Zyprexa would be interesting.
I tried moclobemide in December, 1996. I reacted very, very badly to it. It exacerbated my depression to a degree worse than I have ever experienced. I was curled up in a fetal position on the couch for days, wimpering in pain. No thoughts. Just mental pain.
Roche conducted trials of moclobemide in the US for the indication of social-phobia. I guess they figured they had a better chance of getting the FDA to approve a drug for an indication for which few drugs had yet been approved. The results were poor. I spoke to the head of the US moclobemide project just before it was discontinued. He told me that it was dead and that the trials had been terminated. I doubt they will revisit it.
> Also, the active metabolite of nortriptyline (I think E-10 OH-nortriptyline),
Isn't the parent compound active? What are the differences between them? What other drugs downregulate 5-HT receptors? In what ways does this help with depression? Is it simply an observed association or is there a hypothesis as to how it contributes to producing a remission?
Thanks.
> Why can't that be developed? Marketing active metabolits of older drugs is becoming more common (fexofenadine and cetirizine, ie.).
For every 1 drug brought to market, 100 are synthesized, researched, and discarded for various reasons, including projected profitability. It costs 800 million dollars and 12 years to get a drug approved by the FDA. I imagine there are a few miracle drugs that have ended up in landfills.
- Scott
Posted by Ritch on August 10, 2002, at 11:08:40
In reply to Re: Interesting article » Ritch, posted by SLS on August 10, 2002, at 9:37:13
> Hi Mitch.
>
> How have you been doing?
I have been doing better this summer than I have in *many* summers. I think the L-tyrosine and low-dose Depakote+Effexor+Wellbutrin is making a big difference this time. I am sleeping Ok, and I feel almost normal for a time of year I typically am very depressed. Of course, I am forcing myself to exercise a lot more-so that is contributing too.>
> > It would be nice if more pharm. companies would be interested in attempting to market meds that are already available in other countries that could be helpful here. I am thinking of moclobemide for one (why doesn't Roche try to get FDA approval here?).
>
> First of all, it is my impression that moclobemide is really not a terribly effective drug - either for depression or social-phobia. Of course, some people respond well to it, but the non-selective irreversible MAOIs generally demonstrate superior efficacy. It is certainly worth a try, though. You never know, right?
>
> - Don't give up on moclobemide until you reach 1200mg.
> - Do not eat any more than 50mg of tyramine at any one meal.
>
> I would be very interested to know what drugs you would combine with moclobemide. Zyprexa would be interesting.
>
> I tried moclobemide in December, 1996. I reacted very, very badly to it. It exacerbated my depression to a degree worse than I have ever experienced. I was curled up in a fetal position on the couch for days, wimpering in pain. No thoughts. Just mental pain.
>
> Roche conducted trials of moclobemide in the US for the indication of social-phobia. I guess they figured they had a better chance of getting the FDA to approve a drug for an indication for which few drugs had yet been approved. The results were poor. I spoke to the head of the US moclobemide project just before it was discontinued. He told me that it was dead and that the trials had been terminated. I doubt they will revisit it.I was considering moclobemide precisely because it *is* weak. I hyper-respond to antidepressants, due to bipolar and to general med sensitivities. It wouldn't surprise me at all if I responded well to 75mg twice daily! You see I am only taking 12.5mg of Effexor and 18.75mg of Wellbutrin right now. Any more of either one of those disrupts my sleep too much, or makes me too tired or too wired during the day. The trouble I have with antidepressants isn't really response, it is tolerance and hypomania. Also, stimulants and short half-life AD's like Effexor seem to work better than longer-half life AD's. The longer half-life ones seem to cause a lot of early morning awakenings and resultant daytime drowsiness. When that happens a lot, my cycling tends to worsen.
>
> > Also, the active metabolite of nortriptyline (I think E-10 OH-nortriptyline),
>
> Isn't the parent compound active? What are the differences between them? What other drugs downregulate 5-HT receptors? In what ways does this help with depression? Is it simply an observed association or is there a hypothesis as to how it contributes to producing a remission?OH, I was just thinking out loud about a medline abstract I read regarding E-10 OH-NT a long time ago. They recommended looking into developing it as a possible antidepressant. The 5-HT downregulation is common with many antidepressants-I think they were primarily looking at the anxiolytic effects. Nortripytline (the parent compound) *is* active. NT just happens to be the only tricyclic that I have had any success with. Amitriptyline is it's parent. Another study was done where they gave AMI to a group of people and measured the relative balance of AMI and NT in their blood. The people that had the highest remission rates had the highest NT blood levels. How active E-10 OH-NT compared to *it's* parent we probably will never know.
>
> Thanks.
>
> > Why can't that be developed? Marketing active metabolits of older drugs is becoming more common (fexofenadine and cetirizine, ie.).
>
> For every 1 drug brought to market, 100 are synthesized, researched, and discarded for various reasons, including projected profitability. It costs 800 million dollars and 12 years to get a drug approved by the FDA. I imagine there are a few miracle drugs that have ended up in landfills.
>
>
> - Scott
>
>
Posted by pharmrep on August 15, 2002, at 13:19:25
In reply to Re: Interesting article » SLS, posted by Ritch on August 10, 2002, at 11:08:40
Hi all, check your news sites, Lexapro was approved today. There are plenty of studies and clinical information posted as well if you havent already found some. (should be in pharmacies 1st week of September)
Posted by Anyuser on August 15, 2002, at 18:45:44
In reply to Lexapro approved » Ritch, posted by pharmrep on August 15, 2002, at 13:19:25
> There are plenty of studies and clinical information posted as well if you havent already found some.
Any new studies and clinical info posted? By that I mean very recent. Could you provide links? Thanks.
Posted by johnj on August 15, 2002, at 22:07:41
In reply to Lexapro approved » Ritch, posted by pharmrep on August 15, 2002, at 13:19:25
Can you tell me why some people have sommolence and others have insomnia due to the drug? I want to try something different, but insomnia is part of my problem. Does the side effect/s slowly go away as one is acclimated to the drug? Thank you
johnj
Posted by Ritch on August 15, 2002, at 22:08:43
In reply to Lexapro approved » Ritch, posted by pharmrep on August 15, 2002, at 13:19:25
> Hi all, check your news sites, Lexapro was approved today. There are plenty of studies and clinical information posted as well if you havent already found some. (should be in pharmacies 1st week of September)
PharmRep,
Yes, I heard about that. I was on Celexa with other meds for a couple of years. Next pdoc appt. is next week though, so no likelihood of any samples available just yet. I am willing to give it a trial. I will be looking at how it differs from Celexa as far as GI problems go (reflux, heartburn, diarrhea). Celexa has been the worst med I have ever taken for reflux trouble (except for a couple of NSAIDS). I am especially sensitive to SSRI's for GI troubles. OTOH, I only ever needed about 2-5mg of Celexa/day (and not much of any other antidepressant for that matter), so I am looking at a trial of 1-2mg of Lexapro every day.
Mitch
Posted by pharmrep on August 15, 2002, at 23:24:36
In reply to Re: Lexapro approved » pharmrep, posted by Ritch on August 15, 2002, at 22:08:43
gi issues with celexa were mostly in first 8 wks (ie...nausea for cx=21%/placebo 14%) and seemed to drop to placebo-like in long term studies (6-24 mo's...ie nausea..cx=6%/placebo=10%) Of course everyone responds differently, but the side effect profile is promising. Your Celexa dose sounds very low, but again, you could be ultra-sensative. I do know the 10mg pill for Lex will be scored...it sounds like you can try 5mg (or 2.5 if you like to use razors)
Posted by pharmrep on August 15, 2002, at 23:35:25
In reply to Re: Lexapro approved » pharmrep, posted by johnj on August 15, 2002, at 22:07:41
> Can you tell me why some people have sommolence and others have insomnia due to the drug? I want to try something different, but insomnia is part of my problem. Does the side effect/s slowly go away as one is acclimated to the drug? Thank you
> johnjWeird things these mind altering drugs do. Some people respond getting tired, while others get a "lift." I can tell you this...the FDA is allowing this statement in the package insert...side effects and discontinuation due to adverse events are equal to placebo. That is huge...there is always the "placebo-effect" that kicks in when you "study" a drug. Anyway, I would think that lex will probably effect you like celexa did, but at a lesser degree, perhaps no effect, but probably not the opposite..ie..if you had insomnia, you wont now have somnolence...and yes, some s/e that occur in first few months sometimes fade away with time (ie for celexa nausea is higher than placebo at 8 wks, but less at 6 months)
Posted by pharmrep on August 15, 2002, at 23:41:35
In reply to Re: Lexapro approved, posted by Anyuser on August 15, 2002, at 18:45:44
http://biz.yahoo.com/prnews/020815/nyth063_1.html
here is one...I'm still learning this hyperlink thing..sorry if not done right
Posted by Anyuser on August 16, 2002, at 10:02:55
In reply to some Lexapro clinical info » Anyuser, posted by pharmrep on August 15, 2002, at 23:41:35
Posted by Phil on August 16, 2002, at 12:23:33
In reply to some Lexapro clinical info » Anyuser, posted by pharmrep on August 15, 2002, at 23:41:35
Posted by Phil on August 16, 2002, at 12:36:50
In reply to Re: sexual s/e Phil, posted by pharmrep on August 5, 2002, at 22:37:56
I had my T checked and it's above normal. Doesn't sound like good advice to start on shooting it once a month.
Thanks anyway.
Posted by pharmrep on August 17, 2002, at 1:52:49
In reply to Re: sexual s/e Phil » pharmrep, posted by Phil on August 16, 2002, at 12:36:50
i thought the same thing...but really, I dont think it is higher. 6% for celexa over 5 years ago from "volunteered" input was low (more like in teens or so...some other ssri's can get over 30%). Sexual s/e werent mentioned back then (pre-viagra...etc). With all the talk about sexual side effects and overall feelings about the topic now, people arent shy about it...so celexa at 6% and Lexapro at 9% isnt necessarily worse...in fact, since the studies are less than a year old...it is probably more accurate. (Even if a little higher, it wasnt bad enough for patients to discontinue...placebo dropout was 4%...Lexapro was 6%)
Posted by .tabitha. on August 17, 2002, at 15:35:49
In reply to Re: sexual s/e Phil » pharmrep, posted by Phil on August 16, 2002, at 12:36:50
Posted by dr. dave on August 19, 2002, at 4:52:24
In reply to Anyone switched to Lexapro? « ggrrl, posted by Dr. Bob on June 11, 2002, at 7:52:48
The Danish Institute for Rational Pharmacotherapy has reviewed all of the available data comparing Lexapro and Celexa and has concluded there is no convincing evidence for any difference in tolerability, efficacy, or anything else. This is the only other independent review of the data apart from Micromedex I am aware of. It is only those linked with the manufacturers of Lexapro that are talking it up, and the only two independent reviews come to the same conclusion - there is no real difference. The story is on the Reuters news website.
Posted by Ritch on August 19, 2002, at 9:45:37
In reply to Re: Lexapro is no different from Celexa, posted by dr. dave on August 19, 2002, at 4:52:24
> The Danish Institute for Rational Pharmacotherapy has reviewed all of the available data comparing Lexapro and Celexa and has concluded there is no convincing evidence for any difference in tolerability, efficacy, or anything else. This is the only other independent review of the data apart from Micromedex I am aware of. It is only those linked with the manufacturers of Lexapro that are talking it up, and the only two independent reviews come to the same conclusion - there is no real difference. The story is on the Reuters news website.
>
>Hi Dave,
If that is the case, then the "s" isomer would truly be no more effective than the "r" isomer (or at least not more effective enough to be statistically significant). Also, given that logic, then the 10mg and 20mg tabs of Lexapro would simply be lower dose versions of Celexa. The first time I tried Celexa I took 10mg and then needed to increase it to 20mg, but it didn't seem to help much more (at that time). So, you are in essence saying that they are giving us lower doses and nobody will know any difference because the dose/response curve of Celexa (and other SSRI's) is so flat??
Mitch
Posted by Anyuser on August 19, 2002, at 11:12:18
In reply to Re: Lexapro is no different from Celexa, posted by dr. dave on August 19, 2002, at 4:52:24
Let's say you're a practicing physician (no offense intended, this is after all the internet). A threshold question is whether you are dubious of antidepressant drugs in general, never prescribe 'em, and instead prefer talk therapy. Let's say you do indeed prescribe antidepressants in your practice. The next question is whether you prescribe Celexa. Let's say you do indeed prescribe Celexa, and find through experience that it works for some but not all of your patients.
Now here comes a Forrest Labs marketing rep who says that Lexapro is better than Celexa. Everybody and their dog knows that the data that comes out of any drug manufacturer is of limited value, subject to bias, etc. Even so, maybe Lexapro is a little bit better than Celexa. Who knows, maybe it's a lot better. Then again, maybe Lexapro's not better at all, but identical to Celexa. There would be nothing remarkable about a new SSRI that works no better than all the other SSRIs. That would be old news. Then again, who knows why Zoloft is more effective that Paxil for some, and the reverse is true for others?
I'm pretty sure my pdoc doesn't consult the Danish Institute for Rational Pharmacotherapy (although I am generally very nervous about where he gets his nutty ideas, but let's put that aside). The institute, according to its website, "has the task of ensuring the population the most rational utilisation of the range of medicinal products available on the basis of both effectual and financial points of view." The only time a financial point of view enters into my relationship with my pdoc is if there is an issue as to whether my insurance will cover a medicine that he prescribes. Fortunately for me, that is never an issue. Let's say insurance issues don't enter into your decisions as to what to prescribe (but let us know if that is a mistaken assumption, let us know if you work for an HMO controlled by an insurance company).
Now let's say you have a patient whom you think might benefit from Celexa. Why wouldn't you write the prescription for Lexapro instead?
Posted by shar on August 19, 2002, at 12:42:43
In reply to How do you act on that information? » dr. dave, posted by Anyuser on August 19, 2002, at 11:12:18
>The institute, according to its website, "has the task of....on the basis of both effectual and financial points of view."
>The only time a financial point of view enters into my relationship with my pdoc is if there is an issue as to whether my insurance will cover a medicine that he prescribes. Fortunately for me, that is never an issue.
I don't know about others here, but the financial point of view for me is what it's all about. Without health insurance, and being unemployed, (does that spell Loser?), decisions about my meds are mostly narrowed down to what I can afford.
For example, I recently got off Effexor, because it's so expensive, but not before I had cut the dose in half to make the script last twice as long. Tried generic nortrip and was sick as a dog from it, so let that go--but it was very affordable.
So, any institute that is looking at financial concerns is tops in my book.
Shar
Posted by Anyuser on August 19, 2002, at 13:46:42
In reply to Tangent on Costs, posted by shar on August 19, 2002, at 12:42:43
Yours is a valid and important point. Cheaper generic citalopram is on its way, whether Lexapro is better or not, and that's a good thing.
You are not a loser, and your parenthetical question is what my pdoc calls "negative cognition." Chin up!
Posted by johnj on August 19, 2002, at 16:04:26
In reply to Re: Lexapro is no different from Celexa, posted by dr. dave on August 19, 2002, at 4:52:24
So the University of Nebraska's research was bogus? Whose research do we believe?
Posted by Maximus on August 19, 2002, at 17:26:48
In reply to Re: Lexapro is no different from Celexa, posted by dr. dave on August 19, 2002, at 4:52:24
Posted by Patson on August 19, 2002, at 23:10:54
In reply to Re: Lexapro is no different from Celexa, posted by dr. dave on August 19, 2002, at 4:52:24
I might guess that you sound an awful lot like a friend of mine who is a glaxo rep.... He's been telling me the same thing....
> The Danish Institute for Rational Pharmacotherapy has reviewed all of the available data comparing Lexapro and Celexa and has concluded there is no convincing evidence for any difference in tolerability, efficacy, or anything else. This is the only other independent review of the data apart from Micromedex I am aware of. It is only those linked with the manufacturers of Lexapro that are talking it up, and the only two independent reviews come to the same conclusion - there is no real difference. The story is on the Reuters news website.
>
>
Posted by Patson on August 19, 2002, at 23:18:08
In reply to Re: Lexapro side-effects » dr. dave, posted by Ritch on June 19, 2002, at 9:11:56
> > Just for accuracy of information... Celexa's patent in the US won't expire until 2003. There is also a six month exclusivity extension due to clinical studies conducted in children. In addition, a generic citalopram would take about 18 months to get approval from the FDA. A generic equivalent for Celexa then wouldn't be available until sometime in 2005.
> > The research shows Lexapro has no significant benefit over Celexa in terms of side-effects. People taking Lexapro 20mg report side-effects at the same rate as those on Celexa 40mg (86%).
> >
> > In the same study more people stopped taking Lexapro 20mg because of side-effects than those taking Celexa 40mg (10.4% vs 8.8%), but this difference was not statistically significant.
> >
> > The reason for this is that Lexapro is to all intents and purposes the same thing as Celexa but re-branded and re-patented. There is no evidence of the R-citalopram component they have removed doing anything of significance pharmacologically. To understand this 'new' drug you have to understand that the patent on Celexa just ran out, but the manufacturers can effectively renew the patent by isolating the active component and re-branding it.
> >
> > See more at http://www.guardian.co.uk/Archive/Article/0,4273,4434943,00.html
> >
> > The critical comments in the article are mine.
>
>
> Hi,
>
> Thanks for the article. It wouldn't surprise me a whole lot if the only advantage it winds up having is less medicine for your liver to clear out! I have always wondered about the "mechanism" versus "medicine" distinction between antidepressants when it comes to how they work and side-effects. SSRI's all tend to cause many similar wanted and unwanted effects. If they isolated the *active* isomer, then they probably isolated something that is *more* likely to cause typical SSRI wanted and *unwanted* effeects. It will be interesting to see the comments made here when people start "reporting" in about it.
>
> Mitch
>
Posted by pharmrep on August 19, 2002, at 23:46:50
In reply to Re: Lexapro side-effects, posted by Patson on August 19, 2002, at 23:18:08
> > > Just for accuracy of information... Celexa's patent in the US won't expire until 2003. There is also a six month exclusivity extension due to clinical studies conducted in children. In addition, a generic citalopram would take about 18 months to get approval from the FDA. A generic equivalent for Celexa then wouldn't be available until sometime in 2005.
>
>
> > > The research shows Lexapro has no significant benefit over Celexa in terms of side-effects. People taking Lexapro 20mg report side-effects at the same rate as those on Celexa 40mg (86%).
> > >
> > > In the same study more people stopped taking Lexapro 20mg because of side-effects than those taking Celexa 40mg (10.4% vs 8.8%), but this difference was not statistically significant.
> > >
> > > The reason for this is that Lexapro is to all intents and purposes the same thing as Celexa but re-branded and re-patented. There is no evidence of the R-citalopram component they have removed doing anything of significance pharmacologically. To understand this 'new' drug you have to understand that the patent on Celexa just ran out, but the manufacturers can effectively renew the patent by isolating the active component and re-branding it.
> > >
> > > See more at http://www.guardian.co.uk/Archive/Article/0,4273,4434943,00.html
> > >
> > > The critical comments in the article are mine.
> >
> >
> > Hi,
> >
> > Thanks for the article. It wouldn't surprise me a whole lot if the only advantage it winds up having is less medicine for your liver to clear out! I have always wondered about the "mechanism" versus "medicine" distinction between antidepressants when it comes to how they work and side-effects. SSRI's all tend to cause many similar wanted and unwanted effects. If they isolated the *active* isomer, then they probably isolated something that is *more* likely to cause typical SSRI wanted and *unwanted* effeects. It will be interesting to see the comments made here when people start "reporting" in about it.
> >
> > Mitch
> >
*** i dont get it...in 1 breath..the generic not being available til 2005 is stated, and in the next "patent beating" is thrown out? pick one (hint...its not patent beat) Next...the starting dose for Lex is 10mg...slightly higher in comparison to the higher titrated 40mg of Celexa...compare those side-effects equally, not the higher 20mg of Lex. (and its still "comparable to placebo" per the FDA)...And to understand this "new" drug is to know your isomer science..not this patent crap. (the Nobel Prize for chemistry was won in 2001 for the scientists who developed the technology Forest is using to create Lexapro...and at a lower cost than Celexa too.)
PS....you're right Mitch...only time will tell and then the truth will be known....so lets just watch and see.
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