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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1175 to 1199 of 8406. Go back in thread:
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 The UNPUBLISHED studies that would have had to have been submitted to the FDA for the approval of Lexapro.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 Perhaps I will take the time to learn how to submit a FOIA request for the unpublished studies submitted to FDA.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?
===============================================
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
Posted by Anyuser on November 8, 2002, at 9:46:08
In reply to Re: FDA » Anyuser, posted by Alan on November 8, 2002, at 9:27:12
More drugs approved? Fewer drugs approved? Should Lexapro, for instance, have been approved?
Posted by Alan on November 8, 2002, at 13:33:06
In reply to What would the result be? » Alan, posted by Anyuser on November 8, 2002, at 9:46:08
> More drugs approved? Fewer drugs approved? Should Lexapro, for instance, have been approved?
============================================The result would be medications that have the proper kind and amount of oversight in a way that there would be, by comparison, no conflict of interest.
I think that it speaks for itself that the quality of drugs would increase substantially.
Lexapro research? Suffers from the same conflicts of interest as with any other newly introduced medication as of now...
Alan
Posted by Anyuser on November 8, 2002, at 14:10:37
In reply to Re: What would the result be? » Anyuser, posted by Alan on November 8, 2002, at 13:33:06
Posted by Alan on November 8, 2002, at 14:28:21
In reply to In other words, fewer drugs, less choice (nm) » Alan, posted by Anyuser on November 8, 2002, at 14:10:37
From the results of the current system of oversight one would have no problem whatsoever asserting that quantity does not equal quality...especially if one takes into consideration that doing the most amount of good for the most amount of people is paramount.
From what I see and read in credible media, bboards like these, and the research that is out there, much of the drugs and drug marketing is set up in such a cookie cutter, commercially driven fashion that there's any wonder the most and severe complaints are seen with the very drugs (modern AD's) that are a product of the present system. (see link in next post).
But if secrecy and quantitiy is what one's after instead of full disclosure and the least amount of harm being done to the least amount of patients, one can always stick with the present system.
The politics of medicine has shifted more to the "free market will solve everything" model at the patient's expense.
Alan
Posted by Alan on November 8, 2002, at 14:31:19
In reply to In other words, fewer drugs, less choice (nm) » Alan, posted by Anyuser on November 8, 2002, at 14:10:37
http://www.guardian.co.uk/Archive/Article/0,4273,4201752,00.html
Special attention given to the World Health Organisation's two paragraph's worth about the newer AD's.
Alan
Posted by johnj on November 8, 2002, at 15:35:21
In reply to Re: In other words, fewer drugs, less choice » Anyuser, posted by Alan on November 8, 2002, at 14:31:19
"One of the main selling points of the SSRIs when they arrived in the early 1990s was that people did not become physically dependent on them as they had on older antidepressants - the benzodiazepines such as Valium and Librium."
Posted by dr. justin on November 8, 2002, at 17:01:49
In reply to Re: dr dave can you answer?, posted by wharfrat on November 7, 2002, at 9:27:00
wharf,
Totally off subject, but I had to thank you for the first good laugh I've had in a while. My best friend in college (Northern Arizona U.) was a Texan, and he had all sorts of sayings, including the classic, "I'm a Texan and it's my duty to drink." I can't count the times we were cut off at the bar and he'd loudly pronounce that one. Most of us here go too long without simply joys like a good laugh, plus your post forced some great memories to the surface. Thanks...
justin
Posted by Alan on November 8, 2002, at 18:13:07
In reply to In other words, fewer drugs, less choice (nm) » Alan, posted by Anyuser on November 8, 2002, at 14:10:37
PS. Such a question would imply that our choice consists of less effective drugs being dressed up to look better than they actually are!
Would anyone really do that? Surely not for trivial incentives like profit...
Posted by Anyuser on November 8, 2002, at 18:53:38
In reply to Re: In other words, fewer drugs, less choice » Anyuser, posted by Alan on November 8, 2002, at 18:13:07
I suppose it's just an eensy bit more complicated than that. I would be in favor of both the increased disclosure of information that you advocate, and also less FDA restriction. I would be opposed to making the perfect the enemy of the good. That is, approving only perfect drugs (there is no such thing). The possibility that a drug company might make a profit doesn't trouble me in the least. In fact, I'm looking for a good investment. Any recommendations?
Posted by Geezer on November 8, 2002, at 21:49:04
In reply to Re: In other words, fewer drugs, less choice, posted by Anyuser on November 8, 2002, at 18:53:38
Anyuser,
How very well said!! A little additional "freedom & incentive" to develope something more than another split isomer SSRI would be most welcome by those of us with TRD, as well.
I have completed my eighth ECT treatment as of this morning and will begin taking Parnate tomorrow morning. I don't look to the FDA to facilitate any drug benefits on my behalf regardless of maker, motive, or disclosure.
Thanks for the post,
Geezer
Posted by Alan on November 8, 2002, at 23:32:55
In reply to Re: In other words, fewer drugs, less choice, posted by Anyuser on November 8, 2002, at 18:53:38
> I suppose it's just an eensy bit more complicated than that. I would be in favor of both the increased disclosure of information that you advocate, and also less FDA restriction.
How is less FDA oversight going to improve the quality of testing that has been found to be inadequate? There are too many conflicts of interest as I mentioned before. NIH would be much more qualified and dispassionate to provide improved (not perfect) oversight.
>I would be opposed to making the perfect the enemy of the good. That is, approving only perfect drugs (there is no such thing).
Surely this is an exaggeration. Who said anything about perfect drugs?....only a process by which the testing is done with the betterment of *true* results being the motivating factor, not profits.
>The possibility that a drug company might make a profit doesn't trouble me in the least. In fact, I'm looking for a good investment. Any recommendations?
The most profitiable business on the planet today needs to make more profit? See paragraph directly above. Quantitiy does not equate with improvement in quality. The outcome of the "shotgun" effect is intrinsicically not for the betterment of the patient.
Posted by Alan on November 8, 2002, at 23:39:58
In reply to Re: In other words, fewer drugs, less choice » Anyuser, posted by Geezer on November 8, 2002, at 21:49:04
> Anyuser,
>
> How very well said!! A little additional "freedom & incentive" to develope something more than another split isomer SSRI would be most welcome by those of us with TRD, as well.A rather limited example to assert your point. The explosion of AD's in the last 10 years has been facilitated by the very process that has given us medications by the World Health Organisation's standards as being the top medications for patient's complaints, far ahead of anything else. If it isn't broke, don't fix it is what i hear being said?
>
> I have completed my eighth ECT treatment as of this morning and will begin taking Parnate tomorrow morning. I don't look to the FDA to facilitate any drug benefits on my behalf regardless of maker, motive, or disclosure.
>
> Thanks for the post,
>
> GeezerWho do and have you looked to may I ask then?
Alan
Posted by Dr. Bob on November 9, 2002, at 1:25:01
In reply to Re: In other words, fewer drugs, less choice » Anyuser, posted by Alan on November 8, 2002, at 23:32:55
> How is less FDA oversight going to improve the quality of testing that has been found to be inadequate?
I'd like discussion of FDA policies, etc., to be redirected to Psycho-Social-Babble. Thanks,
Bob
PS: And follow-ups regarding posting policies to be redirected to Psycho-Babble Administration.
Posted by charly on November 10, 2002, at 8:07:21
In reply to Anyone switched to Lexapro? « ggrrl, posted by Dr. Bob on June 11, 2002, at 7:52:48
Hi,
I've been on 10mgs of Lexapro for over 3 weeks and am still getting daily headaches. From others experiences, how long before they go away?
My depression has gone away, which is great, but headaches aren't fun.
Thanks,
charly
Posted by wharfrat on November 10, 2002, at 10:55:13
In reply to Anyone switched to Lexapro? « ggrrl, posted by Dr. Bob on June 11, 2002, at 7:52:48
Thanks Dr. Bob, I kind of would like people to get back on the subject "Anyone switched to Lexapro" and take their FDA complaints elsewhere.No offense to anyone, I'm just tired of conspiracy theories that's all. I for one am more interested in how this med is working for people, be it good or bad and how everybody is doing.
So, my question to anybody out there is this.
Has anyone been "newly" diagnosed and been put on lexapro without ever having been on an antidepressant before and how is it working for them?
Posted by Phyl on November 10, 2002, at 11:54:22
In reply to Re: Thanks Dr. Bob on Redirect, posted by wharfrat on November 10, 2002, at 10:55:13
> Thanks Dr. Bob, I kind of would like people to get back on the subject "Anyone switched to Lexapro" and take their FDA complaints elsewhere.No offense to anyone, I'm just tired of conspiracy theories that's all. I for one am more interested in how this med is working for people, be it good or bad and how everybody is doing.
> So, my question to anybody out there is this.
> Has anyone been "newly" diagnosed and been put on lexapro without ever having been on an antidepressant before and how is it working for them?I have never been on any medication other than for BP. I was put on Lexapro for anxiety -- i.e., worrying. I also am a "first class" insomniac. I have never been diagnosed as being depressed.
I notice very little difference during the daytime on Lexapro, which I take in the morning. I take 7.5 mg. and will probably stay on this dosage. What I DO notice is that I am always very tired from about 6:00 p.m. on. My internist asked me to force myself to stay awake until normal bedtime for me (11:00 p.m.) but I am so sleepy, I just can't stay up. (Last night, I went to bed at 7 p.m!) I find that I fall asleep pretty quickly (which is most unusual for me) and sleep about four hours straight (also unusual for me). I might wake up several times after that, but I fall asleep again. I also notice that I feel tired in the morning and don't want to get up but, once up, I am fine. Lexapro seems to act as a "sleeping pill" for me, but it also seems to slow down my brain so that I am not constantly going over things in my head when I am trying to fall asleep. So far, so good.
Posted by ANXIETY ANN on November 10, 2002, at 12:20:23
In reply to Lexapro and headaches, how long do they last?..., posted by charly on November 10, 2002, at 8:07:21
Hi Charly,
my experience with Lexapro has been pretty good, in the beginning I had horrible headaches. THis lasted for about a week. now after about 4 weeks I only get occasional headaches and nausea. I do get dizzy in the am and pm but I hope that will go away soon. Hang in there for the headaches, everyone is different so it just may take your body longer to get used to the drug.
good luck Ann
Posted by charly on November 10, 2002, at 14:00:10
In reply to Re: Lexapro and headaches, how long do they last?..., posted by ANXIETY ANN on November 10, 2002, at 12:20:23
> Hi Charly,
> my experience with Lexapro has been pretty good, in the beginning I had horrible headaches. THis lasted for about a week. now after about 4 weeks I only get occasional headaches and nausea. I do get dizzy in the am and pm but I hope that will go away soon. Hang in there for the headaches, everyone is different so it just may take your body longer to get used to the drug.
> good luck AnnI appreciate the encouragement. The first 2 weeks I felt energized, now I feel a bit sluggish. Perhaps it's the pot I smoke once in a while.
Regards,
charly
Posted by bridgette on November 10, 2002, at 15:09:09
In reply to Thank you Ann (nt), posted by charly on November 10, 2002, at 14:00:10
I have been on Lexapro for 6 weeks but I had Wellbutrin added 5 days ago and either the Lexapro really kicked in OR the Wellbutrin did the trick. I definately feel better---I'm guessing it's the addition of Wellbutrin, but the real question is is when you are on two drugs----how does one know which one???? I added 150mg of Wellbutrin SR----I have even thought about asking for more Wellbutin and cut out the Lexapro, but it's too earlt to do that and, maybe it's the combo that works. I do worry (not much) about the seizure risk w/Wellbutrin (though a small risk w/the SR) because I like a glass of wine at night. Any thoughts on any of this???
Posted by Katarina on November 10, 2002, at 15:23:01
In reply to Lexapro and headaches, how long do they last?..., posted by charly on November 10, 2002, at 8:07:21
> Hi,
>
> I've been on 10mgs of Lexapro for over 3 weeks and am still getting daily headaches. From others experiences, how long before they go away?
> My depression has gone away, which is great, but headaches aren't fun.
> Thanks,
> charlyHi Charly,
I'm on Lexapro, too and it's been 4 weeks. I feel awful on it. I have headaches, the throbbing kind, dizziness and much anxiety. I have called with updates. My doc put me on Serax for the anxiety. Which is o.k., but not the answer. He wanted to raise my dosage but again I think it's not the answer. I shall call again about changing meds. For me this one sucks! But I hope for you it will work. In any case, good luck! Let us know how you fare in the long run.
Cheers,
-Kat
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