![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1155 to 1179 of 8406. Go back in thread:
Posted by Anyuser on November 6, 2002, at 13:31:15
In reply to Re: Lexapro 'failed' trial: I get confused, posted by JLM on November 6, 2002, at 3:23:31
That is indeed an interesting read, sort of. Thank you for the link.
Do you believe that "antidepressants work, but just barely better than inert placebos"? I don't. The first time an AD kicked in for me, it was a transforming experience. I haven't been the same since. Ever since I have had a new definition of what it means to be "well." Better than well. Whether ADs work or not is a closed issue for me. The open issue remaining is coping with side effects.
Do you know who these authors are, and where they're coming from? Do a Google on them. Antonuccio and Danton are psychologists, not MDs. Danton is a hypnotist. They are big promoters of CBT, and apparently they are as critical of anxiolytics as they are of antidepressants. The Scientologists love these guys, although I realize guilt by association is unfair.
David Burns is the biggest CBT booster of all, and he is to be taken seriously. He studied under Beck, his self-help books are popular, and he influences the debate from his position at Stanford Med School. Have you read his books? I have. I am sure CBT works for many people. It's not for me. I simply can't get with it. Not at all. Not even in theory.
If you're depressed and starting from scratch, why would you believe these guys over university drug researchers funded by for-profit drug companies? People with more of a political axe to grind than I have would surely have an answer to that question. I just think maybe these guys aren't out to improve the FDA process so much as they want to deride ADs and promote CBT. I just hope family practice MDs don't read this article and prescribe fewer ADs to depressed patients that might benefit from them, however imperfect.
Posted by emmalie on November 6, 2002, at 17:25:52
In reply to An interesting read » JLM, posted by Anyuser on November 6, 2002, at 13:31:15
Just a thought. There are different kinds of people in the world. We can break them down into various categories, but here's a relatively new one: (1) those people whose feelings preside over their thoughts and (2) those people whose thoughts preside over their feelings.
For people in the second group, CBT is likely to be very helpful. Perhaps if your thoughts influence your feelings, then working to change irrational thought patterns will help you feel less anxiety/depression.
I am in the first group. I have never had an experience in my life where thinking about something in a new way changed how I was feeling (e.g., realizing that a situation really is safe and then having anxiety go away). For me, it seems like my feelings come first and then the flood of thoughts, not the other way around. For me, AD are extremely helpful with dulling the feelings in my body. Because my feelings aren't so powerful, I can then think about things more realistically.
Just my lay theory about another way to divide up the pie of human experience.
Posted by THOV on November 6, 2002, at 17:28:55
In reply to HELP!!! drink with lexapro?, posted by THOV on November 6, 2002, at 11:50:42
Can I drink while taking lexapro?
If I do what kind of reaction should i expect
and
are women prone to the sexual side effects...
or is it specific to men?
Posted by bridgette on November 6, 2002, at 17:50:41
In reply to Re: Lexapro and Wellbutrin, posted by Kara Lynne on November 5, 2002, at 15:57:28
I take 10mg of Lexapro and 150mg of Wellbutrin---both in the morning. Do you think it's placebo feeling well the 1st day on Wellbutrin (lexapro 5 weeks)? Right now, I'm thinking Wellbutrin is the best, I'm eager to hear what others think.
Posted by Kara Lynne on November 6, 2002, at 22:32:49
In reply to Re: Lexapro and Wellbutrin, posted by bridgette on November 6, 2002, at 17:50:41
I do think you could be feeling better quickly from the Wellbutrin. It doesn't take a long time to kick in like the SSRI's. And hey, if it is placebo effect, who cares! My doctor just prescribed Wellbutrin for me yesterday to add to the Lexapro. I'm not having the greatest time on Lexapro. I'm on 10 mgs and trying to get up to 20 (10 didn't really help me much and it's going on two months), but I can't get rid of the teeth clenching, muscle tension thing. I''ve taken Wellbutrin before and it has helped on and off. I'm encouraged to hear that it has helped you. Good luck.
Posted by ANXIETY ANN on November 6, 2002, at 22:53:02
In reply to Thoughts and feelings, posted by emmalie on November 6, 2002, at 17:25:52
> Just a thought. There are different kinds of people in the world. We can break them down into various categories, but here's a relatively new one: (1) those people whose feelings preside over their thoughts and (2) those people whose thoughts preside over their feelings.
>
> For people in the second group, CBT is likely to be very helpful. Perhaps if your thoughts influence your feelings, then working to change irrational thought patterns will help you feel less anxiety/depression.
>
> I am in the first group. I have never had an experience in my life where thinking about something in a new way changed how I was feeling (e.g., realizing that a situation really is safe and then having anxiety go away). For me, it seems like my feelings come first and then the flood of thoughts, not the other way around. For me, AD are extremely helpful with dulling the feelings in my body. Because my feelings aren't so powerful, I can then think about things more realistically.
>
> Just my lay theory about another way to divide up the pie of human experience.Emmalie,
I like your analogy, it makes perfect sense. I too am a person that feels too much. I agree that Anti-depressants help dull those rush of feelings that are constantly running around in the head. have you ever read the book "The highly Sensitive Person"? It talks about people like us. I highly recomend it.
Ann
Posted by jstme on November 7, 2002, at 1:38:05
In reply to Anyone switched to Lexapro? « ggrrl, posted by Dr. Bob on June 11, 2002, at 7:52:48
Has anyone on Lexapro gained weight?
Since I've been on it I've put on at least 15 pounds.
My Doctor says that isn't a side effect but I can't
figure out why I'm gaining weight so fast. I work out
5 days a week! I shouldn't be gaining weight...
Posted by dr. dave on November 7, 2002, at 3:58:57
In reply to dr dave can you answer?, posted by THOV on November 6, 2002, at 17:28:55
> Can I drink while taking lexapro?
> If I do what kind of reaction should i expect
> and
> are women prone to the sexual side effects...
> or is it specific to men?Drinking while taking an antidepressant is just not a good idea. If you do you are unlikely to drop down dead, but the alcohol is likely to hit you harder, and it may interfere with the antidepressant effect of the medication. So the best advice is not to drink at all.
There is an incidence of anorgasmia (inability to achieve orgasm) of about 2% in women taking Lexapro according to the recent trials, compared to less than 1% with placebo. A low incidence, but there is some risk.
Posted by wharfrat on November 7, 2002, at 9:27:00
In reply to Re: dr dave can you answer? » THOV, posted by dr. dave on November 7, 2002, at 3:58:57
> > Can I drink while taking lexapro?
> > If I do what kind of reaction should i expect
> > and
> > are women prone to the sexual side effects...
> > or is it specific to men?
>
> Drinking while taking an antidepressant is just not a good idea. If you do you are unlikely to drop down dead, but the alcohol is likely to hit you harder, and it may interfere with the antidepressant effect of the medication. So the best advice is not to drink at all.
>
> There is an incidence of anorgasmia (inability to achieve orgasm) of about 2% in women taking Lexapro according to the recent trials, compared to less than 1% with placebo. A low incidence, but there is some risk.Thov,drink you about 3 or 4 beers and you'll feel like you drank 7 or 8. I'm speaking from experience. 6 weeks on lex and feeling great, but I like beer and I'm gonna have one when I want one. My Doc said the same thing as Dr. Dave about interfering with the AD effect of the drug, but If not drinking at all would make me feel better than I do now, I'm afraid I'd be so happy and upbeat that no one could stand to be around me.Besides I'm a Texan, it's my duty to drink beer. However I'm not advocating alcohol use with lexapro or any other AD, just relating my experience & like Dr. Dave said, your not gonna drop dead. I might add that I'm on no other meds, so if you are taking a benzo as well be extremely careful. Just look at the little red label on the pill bottle with guy with the tornado and stars around his head.
As far as the sexual side effects for women. Just read some of the post. It sounds like to me that the ladies are having a hard time in the sack as well as the guys. Good luck and remember the old saying "See Dick drink, see Dick drive, see Dick die, Don't be a Dick" - Wharf
Posted by wharfrat on November 7, 2002, at 9:42:38
In reply to Anyone switched to Lexapro? « ggrrl, posted by Dr. Bob on June 11, 2002, at 7:52:48
Posted by AnxiousMe on November 7, 2002, at 10:02:48
In reply to Slight ringing in the ears, posted by kimc on October 11, 2002, at 18:36:22
> I have been on Lexapro for a month now taking 10mg. It has made me more anxious but is getting better. I am alittle concerned about a slight ringing sound in my ears. Only hear if everything else is totally quiet like at night or in a room with no noice. Will this go away
> I have been using Lexapro for about 3 weeks and have ringing in my ears too. It's most apparent when the room is quiet or when falling asleep. I was prescribed Lexapro becuase I have an anxiety disorder, and it has helped a lot. I am using 5 mg. per day. I had trouble sleeping intitially, sweat more, and decreased apetite. But the benefits so far outweigh the side effects. I hope the tenitis goes away ... but the physiological effects of my anxiety disorder are definately less!
Posted by pharmrep on November 7, 2002, at 10:24:47
In reply to newbie here » pharmrep, posted by Brandymac26 on November 4, 2002, at 15:30:37
> Just started lexapro 4 days ago, any suggestions on the best time to take it, and how long it actually takes to work? Thanks
** takes 1-2 weeks for most...day or night, but if you have trouble falling asleep...take in day.
Posted by AnxiousMe on November 7, 2002, at 10:45:57
In reply to Re: Lexapro -- Agitation, then fatigue!?/bottom » Cindylou, posted by pharmrep on October 6, 2002, at 13:58:26
The main side effect I have after taking Lexapro for almost 4 weeks is ringing in my ears. Will this fade over time?
Posted by pharmrep on November 7, 2002, at 10:58:27
In reply to Re: Lexapro 'failed' trial, posted by dr. dave on November 5, 2002, at 5:04:21
> > > I too get a bit tired of the ad nauseum claims of Lex's lower incidence of SE 's and efficiacy over Celexa.
> > >
> > > We hear a lot about how 'the published studies' demonstrate both things clearly, even thou the data is contradictory at best.
> > >
> > > Know what I would like to see? The UNPUBLISHED studies that would have had to have been submitted to the FDA for the approval of Lexapro. They can be obtained thru the Freedom of Information Act for those brave enough to do so. I would NOT be surprised to see several studies that show NO greater effect than either placebo or Celexa for that matter.
> > >
> > > All we have so far are the studies done by paid Forrest consulants, which may not be all that objective.
> > >
> > > Perhaps I will take the time to learn how to submit a FOIA request for the unpublished studies submitted to FDA. I bet there are some real gems in there.
> > >
> > > Like Dr. Dave, I have yet to hear a remotely plausible explaination for the claims of less SE's with Lexapro.
> > >
> > >
> > >
> > ============================================
> > Until the FDA has better oversight of the test results, the pharm. co.'s are allowed to cherry pick test results and throw out the undesired test results after having changed the test criteria until they get the result that they want - which the FDA never sees before adjudicating the drug's acceptance. Fox guarding the chicken coop.
> >
> > Alan
> >
>
> ==================================================
>
> Maybe Pharmrep could help us out with this.
>
> To my knowledge, there have been four efficacy studies on escitalopram, two in the US and two in Europe and Canada.
>
> Both US studies compared Lexapro with Celexa. Study MD-02 has not been presented, but we know it was a 'failed' study in the sense that it showed no statistically significant difference between Lexapro, Celexa and placebo (see Cipralex product monograph at www.cipralex.com, page 22.)
>
> The other study (MD-01, published by Burke et al) showed no statistically significant difference between Celexa and Lexapro on the measure they had previously defined as the primary outcome measure.
>
> One of the European studies compared Lexapro with Celexa (study 99003, described in papers by Lepola et al, Montgomery et al and Reines et al. Note that these are not seperate trials but the same trial reported several times.) Again this showed no statistically significant difference between Lexapro and Celexa on the previously defined main outcome measure.
>
> If there have been other trials comparing the efficacy of Celexa and Lexapro I'm sure we'd all like to know about them.*** no failed trials...all are on the table...and all of the studies are LOCF (last observation carried forward)
Posted by emmalie on November 7, 2002, at 11:02:37
In reply to Thoughts and feelings, posted by emmalie on November 6, 2002, at 17:25:52
Ann--
Yes, I've read the book. I also like The Highly Sensitive Person In Love. It talks about the challenges of being a "sensitive" person in intimate relationships (this is actually what I do my research on--I'm in a PH.D. program for psychology).If anyone out there has been able to change their feelings by thinking about things differently, I'd love to hear your stories.
Posted by mills on November 7, 2002, at 11:08:27
In reply to Re: Thoughts and feelings, posted by emmalie on November 7, 2002, at 11:02:37
This is a fascinating topic, and I am glad to see I have so many outspoken allies on this subject. For years (and I mean YEARS), I struggled with the idea of trying to 'change my feelings' through changing my thoughts, and it wearied me and exhausted me; now I focus on processing feelings. For the record, I too am a "highly sensitive" person.
> Ann--
> Yes, I've read the book. I also like The Highly Sensitive Person In Love. It talks about the challenges of being a "sensitive" person in intimate relationships (this is actually what I do my research on--I'm in a PH.D. program for psychology).
>
> If anyone out there has been able to change their feelings by thinking about things differently, I'd love to hear your stories.
>
>
Posted by Alan on November 7, 2002, at 14:01:53
In reply to Re: Lexapro 'failed' trial?/bottom » dr. dave, posted by pharmrep on November 7, 2002, at 10:58:27
> > > > I too get a bit tired of the ad nauseum claims of Lex's lower incidence of SE 's and efficiacy over Celexa.
> > > >
> > > > We hear a lot about how 'the published studies' demonstrate both things clearly, even thou the data is contradictory at best.
> > > >
> > > > Know what I would like to see? The UNPUBLISHED studies that would have had to have been submitted to the FDA for the approval of Lexapro. They can be obtained thru the Freedom of Information Act for those brave enough to do so. I would NOT be surprised to see several studies that show NO greater effect than either placebo or Celexa for that matter.
> > > >
> > > > All we have so far are the studies done by paid Forrest consulants, which may not be all that objective.
> > > >
> > > > Perhaps I will take the time to learn how to submit a FOIA request for the unpublished studies submitted to FDA. I bet there are some real gems in there.
> > > >
> > > > Like Dr. Dave, I have yet to hear a remotely plausible explaination for the claims of less SE's with Lexapro.
> > > >
> > > >
> > > >
> > > ============================================
> > > Until the FDA has better oversight of the test results, the pharm. co.'s are allowed to cherry pick test results and throw out the undesired test results after having changed the test criteria until they get the result that they want - which the FDA never sees before adjudicating the drug's acceptance. Fox guarding the chicken coop.
> > >
> > > Alan
> > >
> >
> > ==================================================
> >
> > Maybe Pharmrep could help us out with this.
> >
> > To my knowledge, there have been four efficacy studies on escitalopram, two in the US and two in Europe and Canada.
> >
> > Both US studies compared Lexapro with Celexa. Study MD-02 has not been presented, but we know it was a 'failed' study in the sense that it showed no statistically significant difference between Lexapro, Celexa and placebo (see Cipralex product monograph at www.cipralex.com, page 22.)
> >
> > The other study (MD-01, published by Burke et al) showed no statistically significant difference between Celexa and Lexapro on the measure they had previously defined as the primary outcome measure.
> >
> > One of the European studies compared Lexapro with Celexa (study 99003, described in papers by Lepola et al, Montgomery et al and Reines et al. Note that these are not seperate trials but the same trial reported several times.) Again this showed no statistically significant difference between Lexapro and Celexa on the previously defined main outcome measure.
> >
> > If there have been other trials comparing the efficacy of Celexa and Lexapro I'm sure we'd all like to know about them.
>
> *** no failed trials...all are on the table...and all of the studies are LOCF (last observation carried forward)
======================================
And how is this distinguishable from the actual practice of the continual changing of critetia to finally get the desired results? LOCF? Last observation OR is it last *entire* test result carried forward including prior "side effects"? What happens to the old test results including side effects? Are they published? Or are they kept confidential?Most importantly, if they are internal documents, are the internal documents available to the FDA or other oversight for consideration of their methodology before the approval takes place?
Or does it take a court order as in Dr. Healy's case to view, at the last minute in a court case, to view evidence that Paxil representatives and lawyers covered up as to whether Paxil was addictive or not? (Which they still deny).
Just wondering if Forest is provably different from other companies about how they do tests in this regard?
Alan
Posted by dr dave on November 7, 2002, at 15:07:30
In reply to Re: Lexapro 'failed' trial?/bottom » dr. dave, posted by pharmrep on November 7, 2002, at 10:58:27
> > > > I too get a bit tired of the ad nauseum claims of Lex's lower incidence of SE 's and efficiacy over Celexa.
> > > >
> > > > We hear a lot about how 'the published studies' demonstrate both things clearly, even thou the data is contradictory at best.
> > > >
> > > > Know what I would like to see? The UNPUBLISHED studies that would have had to have been submitted to the FDA for the approval of Lexapro. They can be obtained thru the Freedom of Information Act for those brave enough to do so. I would NOT be surprised to see several studies that show NO greater effect than either placebo or Celexa for that matter.
> > > >
> > > > All we have so far are the studies done by paid Forrest consulants, which may not be all that objective.
> > > >
> > > > Perhaps I will take the time to learn how to submit a FOIA request for the unpublished studies submitted to FDA. I bet there are some real gems in there.
> > > >
> > > > Like Dr. Dave, I have yet to hear a remotely plausible explaination for the claims of less SE's with Lexapro.
> > > >
> > > >
> > > >
> > > ============================================
> > > Until the FDA has better oversight of the test results, the pharm. co.'s are allowed to cherry pick test results and throw out the undesired test results after having changed the test criteria until they get the result that they want - which the FDA never sees before adjudicating the drug's acceptance. Fox guarding the chicken coop.
> > >
> > > Alan
> > >
> >
> > ==================================================
> >
> > Maybe Pharmrep could help us out with this.
> >
> > To my knowledge, there have been four efficacy studies on escitalopram, two in the US and two in Europe and Canada.
> >
> > Both US studies compared Lexapro with Celexa. Study MD-02 has not been presented, but we know it was a 'failed' study in the sense that it showed no statistically significant difference between Lexapro, Celexa and placebo (see Cipralex product monograph at www.cipralex.com, page 22.)
> >
> > The other study (MD-01, published by Burke et al) showed no statistically significant difference between Celexa and Lexapro on the measure they had previously defined as the primary outcome measure.
> >
> > One of the European studies compared Lexapro with Celexa (study 99003, described in papers by Lepola et al, Montgomery et al and Reines et al. Note that these are not seperate trials but the same trial reported several times.) Again this showed no statistically significant difference between Lexapro and Celexa on the previously defined main outcome measure.
> >
> > If there have been other trials comparing the efficacy of Celexa and Lexapro I'm sure we'd all like to know about them.
>
> *** no failed trials...all are on the table...and all of the studies are LOCF (last observation carried forward)==================================================
OK.... so what were the results of study MD-02? I only describe it as a 'failed trial' because that's how Lundbeck describe it in the product monograph. Are you saying that they are wrong? And if so, we need to see the results. If they are all on the table.
I'm glad you brought up LOCF, because as you know on LOCF analysis no trial has shown greater efficacy for Lexapro over Celexa at end-point. Again, if you disagree, let us all know which study contradicts this and we can all look at the results.
Posted by wharfrat on November 7, 2002, at 16:40:40
In reply to Re: 5 weeks lexapro, posted by ANXIETY ANN on November 6, 2002, at 9:22:12
> > > > > > 5 weeks now on lex, increased sex drive, very very weird dreams, less headaches, have dizzy feeling in the morning which is relieved by 2 ibuprofen (can't figure that one out), seems to wear off around 7pm, start feeling slight anxiety. Eating like crazy..crave carbs/sweets, gained 4 lbs in 5 weeks. See doc on monday, will evaluate then.
> > > > >
> > > > > I have been on lexapro 2 months. My sex drive is good but no orgasms..My appetite is better and I do crave sweets more but I dont find myself eating 24/7 like I did with other antidpressants. I felt dizzy and zoned out only the first few days..Iam not noticing any real bad side effects and I feel great. Mari
> > > >
> > > > I know what Ya'll mean about the sweets. Reese's stocks should be going up. Plowed thru my kid's halloween candy after he went to bed (I ought to be ashamed! NOT!!)Never been a big guy, around 140 LBs. forever. Gained 5 in 5 weeks. Never really cared for candy before either. Sex drive of an 18 year old, but it's always been that way. Got to really relax to "complete the mission" wink, wink. Otherwise feeling great. Headaches went away after about a week. Did I say I'm feeling really great? This reality has woken me up to the fact that my job really sucks!! But I could care less - Wharf
> > >
> > > Wharf...lol..you crack me up...I could relate to the halloween candy story..soon as my kids hit the door Im telling them "mommy has to check that candy before I eat...I mean you eat it." Im allot happier to on lexapro but as you said..sex drive is there but mission not complete!...Its funny how easier it is too see things now too. Im easily amused anyway but to feel really happy again is wonderful..have a great day....Mari :-)
> > >
> > >That's great for you guys, good to hear that some folks still have sex drive! I'm usually quite (blush), in the mood. But I might as well enter the convent now. I do agree about the eating and the halloween candy (blush, again). Must have put on 5 pounds in the last 3 weeks....Kat :-\
> >
> >
> LoL, Its good to see humor again!(something I did'nt always do before Lex)I too feel dizzy in the mornings and evenings, it does seem as though the Lexapro wears off towards the evening. I went to the doc yesterday and he said that it takes some peoples systems longer to get adjusted than others. He also said that I could take 5mg of lex in the am and 5mg in the pm if I thought it was wearing off. I do feel better mentally though. I too crave sweets but have actually lost weight since taking the lex.(If I keep eating that chocolate, Im sure that will change) The lack of orgasms is still an issue but am hoping for one soon! Its good to be able to hear other peoples stories and know that there are others as kooky as me out there! thanks Ann
>Who are you calling a Kook???
Just kiddin' - Wharf
Posted by cannoli on November 7, 2002, at 17:49:10
In reply to HELP!!! drink with lexapro?, posted by THOV on November 6, 2002, at 11:50:42
> second question....
> do women face sex s/e .......or is it just men as far as ejaculation....?
> why why why
I can't help with the question about drinking, but I can answer about sexual side effects. Women (at least some women) DEFINITELY have sexual problems with SSRIs - mainly difficulty reaching orgasm and decrease in sex drive.
Posted by cannoli on November 7, 2002, at 17:57:53
In reply to Re: dr dave can you answer? » THOV, posted by dr. dave on November 7, 2002, at 3:58:57
> There is an incidence of anorgasmia (inability to achieve orgasm) of about 2% in women taking Lexapro according to the recent trials, compared to less than 1% with placebo. A low incidence, but there is some risk.
These numbers are hard to believe, but then all of the reported percentages for sexual side effects seem absurdly low to me. But maybe I'm wrong. Let's ask: Is there anyone out there who has taken SSRIs for an extended period of time (2 years or more) who has NOT experienced loss of sex drive and/or difficulty with orgasm or ejaculation?
Posted by Anyuser on November 7, 2002, at 18:53:02
In reply to Re: Lexapro 'failed' trial? » pharmrep, posted by Alan on November 7, 2002, at 14:01:53
How would you improve the FDA regulatory process, and what would be the practical consequence to patients of such improvement?
Posted by JLM on November 7, 2002, at 20:27:22
In reply to Re: Lexapro 'failed' trial?/bottom » dr. dave, posted by pharmrep on November 7, 2002, at 10:58:27
> > > > I too get a bit tired of the ad nauseum claims of Lex's lower incidence of SE 's and efficiacy over Celexa.
> > > >
> > > > We hear a lot about how 'the published studies' demonstrate both things clearly, even thou the data is contradictory at best.
> > > >
> > > > Know what I would like to see? The UNPUBLISHED studies that would have had to have been submitted to the FDA for the approval of Lexapro. They can be obtained thru the Freedom of Information Act for those brave enough to do so. I would NOT be surprised to see several studies that show NO greater effect than either placebo or Celexa for that matter.
> > > >
> > > > All we have so far are the studies done by paid Forrest consulants, which may not be all that objective.
> > > >
> > > > Perhaps I will take the time to learn how to submit a FOIA request for the unpublished studies submitted to FDA. I bet there are some real gems in there.
> > > >
> > > > Like Dr. Dave, I have yet to hear a remotely plausible explaination for the claims of less SE's with Lexapro.
> > > >
> > > >
> > > >
> > > ============================================
> > > Until the FDA has better oversight of the test results, the pharm. co.'s are allowed to cherry pick test results and throw out the undesired test results after having changed the test criteria until they get the result that they want - which the FDA never sees before adjudicating the drug's acceptance. Fox guarding the chicken coop.
> > >
> > > Alan
> > >
> >
> > ==================================================
> >
> > Maybe Pharmrep could help us out with this.
> >
> > To my knowledge, there have been four efficacy studies on escitalopram, two in the US and two in Europe and Canada.
> >
> > Both US studies compared Lexapro with Celexa. Study MD-02 has not been presented, but we know it was a 'failed' study in the sense that it showed no statistically significant difference between Lexapro, Celexa and placebo (see Cipralex product monograph at www.cipralex.com, page 22.)
> >
> > The other study (MD-01, published by Burke et al) showed no statistically significant difference between Celexa and Lexapro on the measure they had previously defined as the primary outcome measure.
> >
> > One of the European studies compared Lexapro with Celexa (study 99003, described in papers by Lepola et al, Montgomery et al and Reines et al. Note that these are not seperate trials but the same trial reported several times.) Again this showed no statistically significant difference between Lexapro and Celexa on the previously defined main outcome measure.
> >
> > If there have been other trials comparing the efficacy of Celexa and Lexapro I'm sure we'd all like to know about them.
>
> *** no failed trials...all are on the table...and all of the studies are LOCF (last observation carried forward)Pharmrep,
Just to be clear here: you are saying that ALL the trials sent to FDA as a part of the NDA process have been published in the public domain? In other words, there is no trial data sitting at FDA that the public hasn't seen, or has NOT been published in the medical literature.
Frankly, I find this hard to believe but...
Posted by Dr. Bob on November 7, 2002, at 22:27:15
In reply to Re: Thoughts and feelings, posted by emmalie on November 7, 2002, at 11:02:37
> I also like The Highly Sensitive Person In Love.
I'd just like to plug the new double double quotes feature:
http://www.dr-bob.org/babble/faq.html#amazon
But I don't mean to be pushy. Did you deliberately not use it to link to Amazon? If so, I'd be interested in why, over at PBA:
http://www.dr-bob.org/babble/admin/20020918/msgs/7717.html
Thanks,
Bob
Posted by Alan on November 8, 2002, at 9:27:12
In reply to FDA » Alan, posted by Anyuser on November 7, 2002, at 18:53:02
> How would you improve the FDA regulatory process, and what would be the practical consequence to patients of such improvement?
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Take oversight of clinical trials away from the FDA and give it to the NIH. That is, accept as evidence only trials designed and supervised by the NIH.Failing that, ban cross-employment between the FDA and any company that it regulates for 10 or 15 years in either direction. Right now, there is a revolving door between the fox's house and the henhouse. It's bad enough that regulators are hired directly from the regulated companies. It's even worse that the FDA's "internal advocate" for a drug can and often does leave the FDA after approval of the drug to earn hundreds of thousands of dollars a year working for the maker of the drug.
Actually, we probably need both of the steps above.
And of course we need a law placing all directly or indirectly maker-funded research about a drug into the public domain when that drug receives FDA approval.
I also believe the "control groups" in the research should be better defined.
Alan
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