![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 314 to 338 of 8406. Go back in thread:
Posted by ZyprexaNumbTongue on September 6, 2002, at 14:37:39
In reply to Sharing info a little at a time...hmmmm..? (nm), posted by Phil on September 6, 2002, at 12:42:25
Somebody here must set the record straight and stick to the hard facts about Lexapro. Rather than using emotional claims to incite enthusiasm for this new antidepressant. Here are the hard, cold facts about Lexapro.
1) Lexapro is formally classified as an SSRI. Lexapro is not a truly new or novel antidepressant such as a CRF-Antagonist, subsance P drug, an MAOI patch or other drug.
2) Lexapro has been tweaked pharmacologically to supposedly remove some undesireable side effects like SSRI delayed ejaculation. This may...or may not be true. Only time will tell. The studies which claim this are studies done by forest labs, which should be taken with a grain of salt.
3) When reading studies about psychiatric drugs, several things must be kept in mind. First, educated people are skeptical about statistical studies. Unless the studies are done by TOTALLY objective organisations who have no conflicts of interest with the drug. In plain English, any study done abou Lexapro doesnt have a huge amount of credibility unless done by an organisation totally unconnected to Forrest Labs and is not being paid by Forrest Labs.
The U.S Census Bureau is an example of an objective organisation, with no conflicts of interest. Pharmaceutical companies however, have conflicts of interest out the wazoo and thus are unlikely to be able to remain truly objective and honest about their drugs.
Its imperative that any studies done about Lexapro, the organisation doing the study must have no conflicts of interest with Lexapro or Forest Labs. In the case of the Forest Labs/Lexapro studies, you have automatic built in conflicts of interest. Therefore, you should real these studies with EXTREME skepticism.
It should also be remembered that when the other SSRIs came out (Prozac, Paxil, Zoloft) that the studies which came along with these SSRIs also indicated low levels of sexual dysfunction such as delayed ejaculation. This was quickly proven to be untrue and sexual dysfunction has been proven to be a major reason why depressives discontinue SSRIs.
Statisics can be skewed, distorted, etc. to make a product look good or better than the competition. The odds of this happening are higher when he statistics are done by the company which makes the product in question.
4) The studies dont describe the TYPES of depressives in the Lexapro studies. All too often, antidepressant clinical trials turn away those with the severe form of depression known as the melancholia subtype (true severe depression) and actively recruit those with milder to moderate depressions (dysthmics). This is a poor way to assess the effectiveness of a new antidepressant. Id like to know how many melancholic depressives were included in Lexapro clinical trials.
My best is that most of the people who took part in Lexapro studies were dysthymics or people with moderate depression. People who by and large could still function in life without drugs, people who could still work, etc.
We need more drug clinical trials where the people recruited are those with SEVERE melancholia type major depression, not dysthymics and moderate depressives. My prediction is that many antidepressants on the market would not be approved so fast by the FDA if this were to happen.
Of course, many drug companies would love it if they could develop "cleaner" SSRIs which have no real side effects such as delayed ejacuation, weight gain, etc. Why? Because then they would be able to target the HUGE dysthymia market and sell more Lexapro. Lets face it, there is a lot of dysthymia in this country, but dysthmics can still work, function in life, etc. Drugs arent really needed to combat dysthymia. There are other ways. However the drug companies would like EVERYBODY to take these SSRI drugs, simply cause it means bigger profits. But most dysthmics wont tolerate a lot of side effects, whereas a person with severe melancholia type depression will tolerate a lot of side effects.
thus there is motivation to develop newer SSRIs which have minimal side effects...to get all the dysthymics on antidepressants. This is pathetic.
5) and finally as LostBoyinNC has pointed out, remember who "pharmrep" is. Pharmrep is a Lexapro drug salesman for Forest Labs. The more Lexapro that is sold, the bigger the profits for Forest Labs...and the better paycheck pharmrep gets. Thus he may not exactly have the depressives true welfare in mind. Like any salesman, they want to sell their wares, in this case Lexapro.
Posted by IsoM on September 6, 2002, at 15:06:50
In reply to The hard, cold facts about Lexapro, posted by ZyprexaNumbTongue on September 6, 2002, at 14:37:39
I agree with most of what you've written but do reserve judgement about some. But one thing I do disagree with is to infute the motives of someone you've never met face-to-face. It's important to not include personal opinions of others here.
I may sound naive but I prefer to believe what someone states about themself until proven otherwise. We can gather all the hard facts from different studies but we can't gather facts on what an individual's motives are that easily.
While I take these posts with a grain of salt, I believe pharmrep, while touting Lexapro, does hope that it's as good as it claims to be. Whether I think it is, doesn't matter. But I think his motives are essentially good. Just as I believe Dr. Dave's motives are too.
Making comments about someone's motives doesn't advance your views, but will only serve to make them less credible to others.
Posted by ZyprexaNumbTongue on September 6, 2002, at 15:12:38
In reply to The hard, cold facts about Lexapro, posted by ZyprexaNumbTongue on September 6, 2002, at 14:37:39
Hi Pharmrep, I would like to know about the types of depressives who took part in these Lexapro clinical trials.
1) How many of them had severe depression, the type generally referred to as the "melancholia subtype" of depression? This type of depression is also known as endogenous depression and consists of severe deteriorations in sleeping cycles especially severe insomnia, losing weight and appetite without trying, losing sex drive and losing sexual functioning, losing normal cognition such as inability to concentrate, remember, decide, think clearly, etc. Also, melancholic depressives tend to lose their sense of taste and smell. Did Lexapro restore sense of smell and taste?
2) How many of the depressives in the Lexapro trials were recruited and had milder to moderate forms of depression known as "dysthymia."
3) what were the full remission rates for Lexapro?
4) What were the full remission rates for the people who had the severe melancholic form of depression? Or did these people just get a "response" and improve some, but not get totally well?
How many of these depressives in the Lexapro trials were considered disabled and unable to work? Did Lexapro restore their disability and make them undisabled and able to work?
These are very important questions for you. I am not sure you will even know the answers to these questions, but Im asking anyway.
thanks,
Posted by Anyuser on September 6, 2002, at 15:23:46
In reply to The hard, cold facts about Lexapro, posted by ZyprexaNumbTongue on September 6, 2002, at 14:37:39
FWIW, the manufacturer has tried out Lexapro on severely depressed patients: http://www.docguide.com/news/content.nsf/news/8525697700573E1885256C280059CC1D?OpenDocument&c=Depression&count=10&id=389736e1a5d7a79d85256c270052d0a8
Posted by ZyprexaNumbTongue on September 6, 2002, at 15:46:52
In reply to severe depression » ZyprexaNumbTongue, posted by Anyuser on September 6, 2002, at 15:23:46
> FWIW, the manufacturer has tried out Lexapro on severely depressed patients: http://www.docguide.com/news/content.nsf/news/8525697700573E1885256C280059CC1D?OpenDocument&c=Depression&count=10&id=389736e1a5d7a79d85256c270052d0a8
Hmmmmm but it says the "manfacturer" of Lexapro has tried it out on severely depressed patients. What about organisations not tied to the manufacturere? What were the results?
Have there been any tests to compare the results of Lexapro in severe, melancholic type depression with the results of say high dose Effexor, bilateral/bifrontal ECT or high dose MAOIs? Im just curious.
the manufacturer is likely to say about anything about Lexapro, keep in mind.
the article didnt mention remission rates from Lexapro in severe depression. The goal in severe depression is full remission, not a 50% "response."
Did you know that to get approval as a new antidepressant by the FDA, all a drug has to prove is that it reduces HAMD scores by 50%? Thats all. A drug doesnt have to prove it causes full remission, just a response.
How much money was spent bringing Lexapro to market BTW?
Furthermore, how do you know whether Solomon's son had the real deal, melancholia subtype of depression? I scanned his book and it has lots of introspective BS stuff in it, that reminded me more of a "issues" type depression than an endogenous depression that needs ECT.
ZyprexaNumbTongue
Posted by Anyuser on September 6, 2002, at 16:10:00
In reply to Re: severe depression, posted by ZyprexaNumbTongue on September 6, 2002, at 15:46:52
Posted by Dinah on September 6, 2002, at 16:23:41
In reply to The hard, cold facts about Lexapro, posted by ZyprexaNumbTongue on September 6, 2002, at 14:37:39
>
> 5) and finally as LostBoyinNC has pointed out, remember who "pharmrep" is. Pharmrep is a Lexapro drug salesman for Forest Labs. The more Lexapro that is sold, the bigger the profits for Forest Labs...and the better paycheck pharmrep gets. Thus he may not exactly have the depressives true welfare in mind. Like any salesman, they want to sell their wares, in this case Lexapro.As IsoM pointed out, please do not jump to conclusions about others.
Here is a link to the civility guidelines of this site.
http://www.dr-bob.org/babble/faq.html#civil
Dinah (filling in for Dr. Bob)
Posted by ZyprexaNumbTongue on September 6, 2002, at 16:33:33
In reply to Re: The hard, cold facts about Lexapro, posted by Dinah on September 6, 2002, at 16:23:41
> >
> > 5) and finally as LostBoyinNC has pointed out, remember who "pharmrep" is. Pharmrep is a Lexapro drug salesman for Forest Labs. The more Lexapro that is sold, the bigger the profits for Forest Labs...and the better paycheck pharmrep gets. Thus he may not exactly have the depressives true welfare in mind. Like any salesman, they want to sell their wares, in this case Lexapro.
>
> As IsoM pointed out, please do not jump to conclusions about others.
>
> Here is a link to the civility guidelines of this site.
>
> http://www.dr-bob.org/babble/faq.html#civil
>
> Dinah (filling in for Dr. Bob)Why is that jumping to conclusions about others, Dinah? Maybe you need to increase the dosage of your neuroleptic? Its obvious to me you cant think clearly.
Dinah...listen to me. THINK!!! I know you are schizoaffective which makes clear thinking possibly difficult for you, but try harder.
Pharmrep is a drugsalesman for Forest Labs, the company that makes Lexapro.
Pharmrep constantly brags about Lexapro in his posts, his posts have a very salesman ring about them. Anyone can see this.
Pharmrep makes Lexapro sound as if its the best SSRI,
Pharmrep gets paid by Forest Labs, the company that makes Lexapro.
Dinah, thats NOT jumping to conclusions about others. Its simple logic, common sense and business savvy on pharmrep's case.
I dont appreciate you telling me that Im "jumping to conclusions bout others when the handwriting in on the wall, clear as it could be.
Posted by ZyprexaNumbTongue on September 6, 2002, at 16:46:15
In reply to Re: The hard, cold facts about Lexapro, posted by ZyprexaNumbTongue on September 6, 2002, at 16:33:33
Hi Pharmrep, Ive been thinking about a lot of your posts and I have a suggestion for you. I have wondered if you have ever tried a low dose atypical anti-psychotic drug such as Zyprexa or Seroquel? It might help you to think more clearly and to be more objective. It might enable you to see that you have a conflict of interest with regards to Lexapro and bragging about it constantly on here.
Just a suggestion from someone who has been around the block and knows what he is talking about. Forest Labs doesnt make any atypicals that I know of, but Eli Lilly makes a great one called Zyprexa. Might wanna ask your doctor about it. Tell him you are having problems thinking clearly.
Zyprexa Numb Tongue
Posted by Dinah on September 6, 2002, at 16:46:28
In reply to Re: The hard, cold facts about Lexapro, posted by ZyprexaNumbTongue on September 6, 2002, at 16:33:33
Posted by Anyuser on September 6, 2002, at 17:43:17
In reply to Re: Blocked for a week (nm) » ZyprexaNumbTongue, posted by Dinah on September 6, 2002, at 16:46:28
Posted by moxy1000 on September 6, 2002, at 18:30:16
In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by Dinah on September 6, 2002, at 9:03:22
WOW. ZyprexaNumbTongue has insulted me and his posts were not even directed at me. Ouch. Anyway, I'm surprised at the continued references to MAOI's. I didn't think those were widely taken anymore b/c of the nasty s/e's and the list of foods you cannot eat while taking an MAOI. Are they coming back in fashion? I really thought they were only for really tough cases where nothing else had worked. Am I wrong or just uninformed?
Posted by LLL on September 6, 2002, at 18:33:58
In reply to Whoa....that's the nastiest I've seen it get, posted by moxy1000 on September 6, 2002, at 18:30:16
Posted by psycHarvard on September 6, 2002, at 22:52:01
In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by Phil on September 6, 2002, at 8:27:35
> May I ask what your involvement was in the studies?
No personal involvement in the studies... I talk all over the U.S. and Europe on behalf of most of the pharma... the information that I post is not my opinion... in a way it is but I am working off what I have seen in the majority of pats and from all the information I have seen in learning extensively the products that I have talked about.
> We're uninformed about Lexapro because of a lack of subjective information.
> I'd like the answer to three questions, if you will. Sexual SE, less or more than Celexa- -That depends on if you look in the P.I. for Lexapro and Celexa and compare them.... Lexapro rates are slightly higher we are talking about rates that are not even clinically important.
Now the reason for this is simple.... 5HT will always cause a little sexual dysfunction... in the studies conducted on Celexa... which was a few years ago now pats were not as forth coming as they are now in admitting sex dys....as they are now... now you can have a hard time telling what this really means in the end.... the Lexapro P.I. states sex dys as 9% for delayed ejaculation.... not always a bad thing.... the rate is very low..... you should always look for AEs under 10%.... anything under this is acceptable... the other rates for Lexapro as far as I know is impotence 3% and for females decreased libido 2% and anorgasmia 2%..... so what I am saying is that the real studies are the ones that the pats who are starting on Lexapro will talk about..... but for the majority of the population they will experience rates similar to these... there will always be pats that cannot tolerate even the best of any med.... and no one knows why...
Weight gain, less or more than Celexa-
Weight gain...weight loss in Lexapro... comparable to Celexa... and they are both comparable to placebo in regards to that also.
-Emotional blunting and apathy, less or more than Celexa... this is not so easily to measure as you know depression like many of the disorders are very subjective in measurement.... so that is something that I cannot comment on for the majority of people... it really is a case by case feeling emitted by the pat... as far as I know no studies have been conducted in this area.
> I'll be switching to Lexapro from Celexa early next week. Any info appreciated.
You can start Lexapro therapy the next day after stopping Celexa... 10mg is what they should start you on....My time is very limited and I am not always able to get to a computer... but when I can I will answer your questions.
Posted by psycHarvard on September 6, 2002, at 23:01:56
In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by Dinah on September 6, 2002, at 9:03:22
> > I am trying to keep this as simple as possible...
>
> Well, if you were speaking only to me, it would probably be best to keep it as simple as possible. But a lot of people on this site are quite comfortable with this sort of talk (moreso than my pdoc in fact) and would relish a complex explanation. Then they could translate for those of us who need a simpler explanation. :)
>
> > I have a lot of information that I am willing to share but I will only mention a bit at a time.
> >
>
> Well it's your choice of course, but again, I think people would enjoy hearing it all at once. It might take a while to digest it all, but it might also allow the information to be coalesced in a way that hearing it a bit at a time wouldn't allow. So feel free to hit us with it all at once.
>
> > at any rate the SNRIs available only hit both 5HT and NE at the highest titrated dose so if you are on anything less you have fallen for a marketing ploy.... not that I do not believe that they are efficacious.
> >
> Hmm. Okay, as I admitted, I am *not* one of the people who understand neurotransmitters that well. Are you saying that a SNRI such as Effexor is doing for both 5HTP and NE what Lexapro will do for only 5HTP? Or am I totally misunderstanding? Because I have to say that Effexor was just as bad at sexual side effects for me as a straight SSRI. The fact that its effect on NE was disastrous for me is probably beside the point.
>Yes you do have it a little wrong... if you hit on multiple neurotransmitters you will basically only have increased AEs... yes sex dys can be one of them (AEs... sorry.. Adverse Events) so if you hit on one very selectively then you should have increased potency with fewer AEs...
> At any rate, the whole discussion is probably only important from a theoretical point right now. Phil and others are going to try Lexapro. In just a few short weeks, the anecdotal evidence will start coming in. And I trust the anecdotal evidence more than all the studies in the world because in my experience it has been more accurate. I've had doctors tell me over and over again that this or that experience can't be caused my my med, when I come here and find out it's pretty common.
>
> You are exactly correct... the real events are the ones that effect you...... all the studies do have some bearing for the majority of the population but there will be some pats that have AEs with any med..... I mean think about it... some people and nuts... allergies... it all depends on a much bigger picture... and not even science can predict or comment on in such a way that will answer your questions...
Posted by psycHarvard on September 6, 2002, at 23:13:15
In reply to Who are you? » psycHarvard, posted by Anyuser on September 6, 2002, at 11:48:29
> In my opinion, any posters that announce themselves as a physician, whether teaching, research, or clinical, should identify themselves further. Dr. Dave did this, sort of, by linking to an article in which he was quoted and identified.
>Sorry I am not Dave and I have had people contact me before and my time is limited and I am only doing this to shed a little light for the people that are confused.
> Pharmrep let us know where he is coming from, so we can take into account his bias when weighing what he has to say. I suspect there is a least one other poster on this topic with commercial interests, who has not been as candid as pharmrep.
Well if you think that my commercial interests are in Forest you may .... lets just say.... Celexa has treated about 40 million pats..... and now Lexapro.... perhaps more in the next wee while... so what I am saying is... by me telling everyone who reads this page (perhaps say 100 people) that Lexapro is the most amazing drug go and get on it tomorrow.... do you really think that this in any way would ever effect Lexapro and its share .... the pats will decide for themselves... if they start on Lexapro and it works... good.... and if it does not work then everyone in the world will know and the F.D.A. will be wrong and the multitudes of people in Europe on Escitalopram will also be wrong... so I don't mean to be so blunt but to think that I would waste my time doing this to some how make people take Lexapro is really silly...
Posted by psycHarvard on September 6, 2002, at 23:35:03
In reply to Re: Fewer s/e with Lexapro - ? » psycHarvard, posted by johnj on September 6, 2002, at 11:23:27
> I have a question for you maybe you can give me a hint upon the causes. I am at 50 mg nortrypline,
sorry I assume you mean Nortryptaline
600 mg lithobid, and 15 to 22.5 or tranzene.
Sounds as if you have severe panic attacks...manic...based on the meds you are on.
I have depression with a high level of anxiety. The problem is if I excercise I feel like crap after a regime has been started. Sometimes the next day I will feel more depressed and have sleep disturbances. I have taken care to watch the time I work out, what I do and what I eat. I take in enough sodium so it is not a spike in lithium. I believe it is the TCA somehow. Have you ever run across this? What have atheletes used that have been sucessful to treat anxiety and depression.
This is not something that I want to comment on... I do not want to put information on here that may mislead you as all pats are different on meds... I have not come across this... I know you have probably spoken to your psyc about it and they will know you much better than I do.
I am hoping a switch to lexapro will give me the power back to help myself through excercise. Also, what is the deal with increased anxiety with ssri's? I went to a Celexa board and almost 90% complained of worsening anxiety. Any thoughts? Thank you.
> PS. I tried remeron and it gave me a "sponge head" and messed with short term memory.Yes SSRIs do cause increased Anx in the first few weeks... that is why a lot of psycs now start there pats off on an SSRI and Wellbutrin... in combination for a few weeks...
In regards to Lexapro and increased Anx... the info that I am aware of shows that the rates of anxiety will decrease as early as week one or two and after that remain low... and that the rates prior to this... the first week or so shows that it is not increasing actually comparable to placebo... but in some pats as I keep on saying they may find an initial increase... or they may find that they feel better as early as a few days...
Posted by pharmrep on September 7, 2002, at 0:01:22
In reply to Re: Serious question for pharmrep, posted by ZyprexaNumbTongue on September 6, 2002, at 15:12:38
> Hi Pharmrep, I would like to know about the types of depressives who took part in these Lexapro clinical trials.
>
> 1) How many of them had severe depression, the type generally referred to as the "melancholia subtype" of depression? This type of depression is also known as endogenous depression and consists of severe deteriorations in sleeping cycles especially severe insomnia, losing weight and appetite without trying, losing sex drive and losing sexual functioning, losing normal cognition such as inability to concentrate, remember, decide, think clearly, etc. Also, melancholic depressives tend to lose their sense of taste and smell. Did Lexapro restore sense of smell and taste?
>
> 2) How many of the depressives in the Lexapro trials were recruited and had milder to moderate forms of depression known as "dysthymia."
>
> 3) what were the full remission rates for Lexapro?
>
> 4) What were the full remission rates for the people who had the severe melancholic form of depression? Or did these people just get a "response" and improve some, but not get totally well?
>
> How many of these depressives in the Lexapro trials were considered disabled and unable to work? Did Lexapro restore their disability and make them undisabled and able to work?
>
> These are very important questions for you. I am not sure you will even know the answers to these questions, but Im asking anyway.
>
> thanks,
>
> ********* Wow, tough questions...here's what I can offer: In Gorman, all patients scored at least 22 on the MADRS which meets criteria for a major depressive episode. Candidates were excluded if there was evidence of active suicide ideation or attempt, or if they had any DSM-IV Axis I disorder other than major depression. Study had 1321 patients.
In Burke, same as Gorman and No concomitant psychotropic medication was permitted, except zolpidem for insomnia. (491 patients )
In Wade, same as Gorman, except patients were also excluded if met criteria for mania, or any bipolar disorder, schizophrenia or any psychotic disorder, ocd, eating disorders, mental retardations, any pervasive developmental disorder or cognitive disorder. Not allowed were any antipsychotics, antidepressants, hypnotics, anxiolytics, antiepileptics, barbiturates, chloralhydrate or other 5HT receptor agonists or ec treatment or behaviour therapy. (380 patients)
Other studies are out, but I only have posters which are limited on info...If I get full blown study...I will update.
As for remission rates...Need to get the specifics in the Rappaport study....it was just approved for the indication (maintenance therapy..based on achieved remission) last week from FDA. All I know is it was a good result as far as 6 months post med and not having relapse. (actual remission #'s vary...I just know it was a good "response" and another "positive" study. As for disabled...dont know anything about that.
"WHEW" that was a lot of typing...hope that helps.
Posted by pharmrep on September 7, 2002, at 0:35:53
In reply to Re: questions » ZyprexaNumbTongue, posted by pharmrep on September 7, 2002, at 0:01:22
I cant believe I did all that work typing and researching before reading all the Posts. It does take time to be here sometimes...I like it, and I learn too. I appreciate others who do the same...especially Dr's who have a professional insight that not everyone has...so hang in there everyone...and keep it peaceful.
Posted by Alan on September 7, 2002, at 0:52:21
In reply to Am I bleeding?, posted by pharmrep on September 7, 2002, at 0:35:53
This is what's becoming an old trick to keep revenues up. Lexapro doesn't give you anything you weren't already getting in Celexa, it's just sort of "purified". By doing that, they can get a new patent for what is essentially the same medication. And by investing many times as much money in marketing as they do in development, the drug companies can convince an amazing number of naive doctors that Lexapro actually IS newer, better, and amazingly free of all the side effects and withdrawal phenomena that have emerged with all previous miracle drugs for the mind.
And speaking of side effects, get a load of the statistics cited on for instance sexual dysfunction. You wonder how a doctor can cite numbers like that without smirking all the way to the bank. He HAS to know they're fictitious. He can't be that blind to his own patients. Can he?
The whole thing is pretty close to putting new paint on an old pill and selling it again. The makers of Prozac tried to do the same thing but had to abandon it before getting to market because the "purified" Prozac turned out to cause dangerous heart arrhythmias.
The patent on Prozac was close to expiring and its manufacturer was scrambling to hold on to revenues and came out with a "new" prozac to treat PMS.
It makes you think. If they can get a patent on Prozac Weekly, the same active ingredient as normal Prozac in a different delivery matrix, they're not patenting medications -- they're patenting the physical pills!!!
So why don't they just patent something like a 2 mg (or whatever size) pill of every med to begin with? Then when that patent is about to expire, they can "invent" a 1 mg pill and patent that as a new medication that needs only half the dosage of the old one. Hell, with enough money spent on marketing, they can probably persuade tens of thousands of doctors that the 1 mg pill has less than half the side effects of the old, obsolete, addictive 2 mg pill.
It's a good thing for the drug companies that the FDA exists to keep a short leash on the patent office and other arms of government. Otherwise all kinds of rational thinking might break loose.
To make a profit these days, the co's have to differentiate. The best way to do that within a single class of drugs is to claim to have fewer side effects. Because of a serious loophole in our laws about drug research, they just keep doing trial after trial until they figure out how to get some of them to come out as desired. Then they negotiate with the FDA about what trials to include and how to summarize them in the prescribing info.We need to change our laws so that as part of the price for approval of a drug, ALL studies on its use in humans (at the least) get placed into the public domain. That way it won't be as easy to make distorted claims. For instance, the public and the FDA have seen only a small fraction of SKB/GSK's studies on Paxil. In the majority of them it worked worse than placebo to a statistically significant degree*. At least that's what plaintiffs in one of the class-actions suits alleged, promising to provide supporting evidence. It just shouldn't be legal to hide things like that. And now that scandals like the HRT and cox-2 inhibitor surprises are emerging (i.e. it affects more than just us "head cases") I think there's some chance the regulatory environment may change.
=============
* Still, that's an average response. It doesn't negate the fact that some people respond and some of those respond extremely well. Statistical truth and statistical inference, important as they are, have considerable limits. The closer you narrow it down to an individual case, the fuzzier the picture gets until there is no statistical picture at all when dealing with a sample of one. Just because the number of people doing well on a drug is less than the number doing well on placebo does not prove that all those people are experiencing a placebo effect or spontaneous remission. Some of them may very well be experiencing a bona fide pharmacologically therapeutic effect. It's just that one can't prove it statistically. With the right tools, one could hypothetically prove it chemically or by doing repeated double-blind crossover trials on one or more individuals.
Posted by _alii_ on September 7, 2002, at 1:17:20
In reply to Re: Marketing, Lexapro, etc. - in general (Long), posted by Alan on September 7, 2002, at 0:52:21
...break loose.
Alan,
That sentence alone slayed me. Thank you for a thought provoking post. The smile and chuckle from that sentence though is what made me respond.
Namaste.
--Alii
Posted by pharmrep on September 7, 2002, at 2:10:04
In reply to Re: Marketing, Lexapro, etc. - in general (Long), posted by Alan on September 7, 2002, at 0:52:21
> This is what's becoming an old trick to keep revenues up. Lexapro doesn't give you anything you weren't already getting in Celexa, it's just sort of "purified". By doing that, they can get a new patent for what is essentially the same medication. And by investing many times as much money in marketing as they do in development, the drug companies can convince an amazing number of naive doctors that Lexapro actually IS newer, better, and amazingly free of all the side effects and withdrawal phenomena that have emerged with all previous miracle drugs for the mind.
>
> And speaking of side effects, get a load of the statistics cited on for instance sexual dysfunction. You wonder how a doctor can cite numbers like that without smirking all the way to the bank. He HAS to know they're fictitious. He can't be that blind to his own patients. Can he?
>
> The whole thing is pretty close to putting new paint on an old pill and selling it again. The makers of Prozac tried to do the same thing but had to abandon it before getting to market because the "purified" Prozac turned out to cause dangerous heart arrhythmias.
>
> The patent on Prozac was close to expiring and its manufacturer was scrambling to hold on to revenues and came out with a "new" prozac to treat PMS.
>
> It makes you think. If they can get a patent on Prozac Weekly, the same active ingredient as normal Prozac in a different delivery matrix, they're not patenting medications -- they're patenting the physical pills!!!
>
> So why don't they just patent something like a 2 mg (or whatever size) pill of every med to begin with? Then when that patent is about to expire, they can "invent" a 1 mg pill and patent that as a new medication that needs only half the dosage of the old one. Hell, with enough money spent on marketing, they can probably persuade tens of thousands of doctors that the 1 mg pill has less than half the side effects of the old, obsolete, addictive 2 mg pill.
>
> It's a good thing for the drug companies that the FDA exists to keep a short leash on the patent office and other arms of government. Otherwise all kinds of rational thinking might break loose.
>
>
> To make a profit these days, the co's have to differentiate. The best way to do that within a single class of drugs is to claim to have fewer side effects. Because of a serious loophole in our laws about drug research, they just keep doing trial after trial until they figure out how to get some of them to come out as desired. Then they negotiate with the FDA about what trials to include and how to summarize them in the prescribing info.
>
> We need to change our laws so that as part of the price for approval of a drug, ALL studies on its use in humans (at the least) get placed into the public domain. That way it won't be as easy to make distorted claims. For instance, the public and the FDA have seen only a small fraction of SKB/GSK's studies on Paxil. In the majority of them it worked worse than placebo to a statistically significant degree*. At least that's what plaintiffs in one of the class-actions suits alleged, promising to provide supporting evidence. It just shouldn't be legal to hide things like that. And now that scandals like the HRT and cox-2 inhibitor surprises are emerging (i.e. it affects more than just us "head cases") I think there's some chance the regulatory environment may change.
>
> =============
> * Still, that's an average response. It doesn't negate the fact that some people respond and some of those respond extremely well. Statistical truth and statistical inference, important as they are, have considerable limits. The closer you narrow it down to an individual case, the fuzzier the picture gets until there is no statistical picture at all when dealing with a sample of one. Just because the number of people doing well on a drug is less than the number doing well on placebo does not prove that all those people are experiencing a placebo effect or spontaneous remission. Some of them may very well be experiencing a bona fide pharmacologically therapeutic effect. It's just that one can't prove it statistically. With the right tools, one could hypothetically prove it chemically or by doing repeated double-blind crossover trials on one or more individuals.
>
> ***** Do you just want to get kicked off? All your statements appear without any proof-sources. You speak like somebody who hasnt read any studies at all. Have you? Do you know anything about isomer science? Yes, Prozac failed this twice, because the molecule didnt lend itself to being separated well. I dont see how over 9 studies and the FDA can all be biased to Forest. Do you really believe that?..."negotiate with the FDA"? "figure out how to control trial results" You're funny.
Posted by Dinah on September 7, 2002, at 4:34:05
In reply to Re: (Long)see bottom » Alan, posted by pharmrep on September 7, 2002, at 2:10:04
> > You speak like somebody who hasnt read any studies at all. Have you? Do you know anything about isomer science? Yes, Prozac failed this twice, because the molecule didnt lend itself to being separated well. I dont see how over 9 studies and the FDA can all be biased to Forest. Do you really believe that?..."negotiate with the FDA"? "figure out how to control trial results" You're funny.
Pharmrep, I've asked you before to be civil, not to be sarcastic, jump to conclusions about others or their experiences, or post anything that could lead to others being feeling accused or put down.
So now, I'm sorry, but now I'm going to have to block you for one week.
Dinah
Posted by Anyuser on September 7, 2002, at 9:58:54
In reply to Re: Fewer s/e with Lexapro - where's the evidence?, posted by dr dave on September 5, 2002, at 2:31:05
FWIW, here's a link to a Forest press release on "Examining Clinical Experience with Escitalopram in Depression"
http://www.frx.com/servlet/financial.displayDoc?doc_id=09-05-2002/0001795321
Posted by johnj on September 7, 2002, at 10:37:56
In reply to Re: Fewer s/e with Lexapro - ?, posted by psycHarvard on September 6, 2002, at 23:35:03
thanks for the info, but your condescending tone is not appreciated. There are people with mood disorders that are not as ignorant as you apparently think. Who knows, the pressure of your job could lead you down the same path as many of us. It didn't hit me until 27.
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