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Dr. Bob is Robert Hsiung, MD,
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Posted by Alan on September 22, 2002, at 22:50:41
In reply to dont start » Alan, posted by pharmrep on September 22, 2002, at 11:11:57
There should be a law requiring that as one requirement for getting a drug approved, all data on formal and informal trials in humans must be placed into the public domain.
For a long time (and still to some extent), the makers of recent antidepressants have been able to hide the known adverse effects and the fact that the the drugs have performed no better (and often worse) than placebo in a majority of their trials.
I was reading an analysis recently which stated that if you took the entire population of people to whom SSRIs are administered after a diagnosis of clinical depression and then you screened them by the criteria used for selecting patients for clinical trials, 90% of them would be excluded from participation in such trials. So they aren't typical enough to go into the research, but then researchers turn around and make recommendations based on a sample representing 10% of the population of interest and apply those recommendations to 100% of the population of interest.
A large proportion of that 100% probably has a brain chemistry more like that of healthy volunteers than like that of the patients in the clinical trials. Thus one would expect the (highly problematic) healthy-volunteer trials to be more predictive of results than the clinical trials based on criteria that include only 10% of prospective users.
Comments?
Posted by pharmrep on September 23, 2002, at 1:17:01
In reply to Re: dont start » pharmrep, posted by Alan on September 22, 2002, at 22:50:41
> There should be a law requiring that as one requirement for getting a drug approved, all data on formal and informal trials in humans must be placed into the public domain.
>
> For a long time (and still to some extent), the makers of recent antidepressants have been able to hide the known adverse effects and the fact that the the drugs have performed no better (and often worse) than placebo in a majority of their trials.
>
> I was reading an analysis recently which stated that if you took the entire population of people to whom SSRIs are administered after a diagnosis of clinical depression and then you screened them by the criteria used for selecting patients for clinical trials, 90% of them would be excluded from participation in such trials. So they aren't typical enough to go into the research, but then researchers turn around and make recommendations based on a sample representing 10% of the population of interest and apply those recommendations to 100% of the population of interest.
>
> A large proportion of that 100% probably has a brain chemistry more like that of healthy volunteers than like that of the patients in the clinical trials. Thus one would expect the (highly problematic) healthy-volunteer trials to be more predictive of results than the clinical trials based on criteria that include only 10% of prospective users.
>
> Comments?
************** you appear to be pretty pessimistic...what is your proofsource for your "analysis?"...do you really think all pharm companies are bad?
PS there is a law...it passed in 1998 Freedom of information act...no study done is private...thats why you see both positive and negative trials. (and believe me...every pharm co knows what the others are studying so as to see if the outcome is positive or negative in its findings)
Posted by Geezer on September 23, 2002, at 12:34:16
In reply to Re: dont start » pharmrep, posted by Alan on September 22, 2002, at 22:50:41
Alan,
Very good point. One might also consider any significant drug testing (in terms of large test populations, conducted over a long period of time) is only carried out in Europe - not in the US. The FDA will not allow European testing to be considered in qualifying a drug for safety or efficacy, prior to release in this country. The American drug companies sponsor the European testing and wisely so. The adverse drug reactions and interactions will be found in Europe first. This gives the drug company the opportunity to report to the FDA, thereby reducing legal exposure.
Then we have the testing itself to consider. HAMD is a subjective, psycho-social, allegorical report with no basis in emperical medical science.
Your point re: test population bias is also well taken. I am a 30%er - a member of that 30% refractory to contemporary drug treatment. I have a chronic, treatment refractory, major unipolar, atypical depression. This disease (in my case) is a genetically transferred, biochemical, physiologic, brain disorder. I am doubtful I would be recruited for any contemporary, meaningful drug study here in the US.
Like you, I would like to see the Freedom of Information Act applied to drug studies but don't believe that will happen anytime soon.
My opinion only, no disrespect intended. I am assuming the topic is appropriate for this board.
Good cheer
Posted by pharmrep on September 23, 2002, at 12:51:50
In reply to Re: dont start » Alan, posted by Geezer on September 23, 2002, at 12:34:16
> Very good point. One might also consider any significant drug testing (in terms of large test populations, conducted over a long period of time) is only carried out in Europe - not in the US. The FDA will not allow European testing to be considered in qualifying a drug for safety or efficacy, prior to release in this country. The American drug companies sponsor the European testing and wisely so. The adverse drug reactions and interactions will be found in Europe first. This gives the drug company the opportunity to report to the FDA, thereby reducing legal exposure.
>
> Then we have the testing itself to consider. HAMD is a subjective, psycho-social, allegorical report with no basis in emperical medical science.
>
> Your point re: test population bias is also well taken. I am a 30%er - a member of that 30% refractory to contemporary drug treatment. I have a chronic, treatment refractory, major unipolar, atypical depression. This disease (in my case) is a genetically transferred, biochemical, physiologic, brain disorder. I am doubtful I would be recruited for any contemporary, meaningful drug study here in the US.
>
> Like you, I would like to see the Freedom of Information Act applied to drug studies but don't believe that will happen anytime soon.
>
> My opinion only, no disrespect intended. I am assuming the topic is appropriate for this board.
>
> Good cheer** why dont you think the Freedom of info act is being used currently...it most definitely is...drug companies keep each other in check with it all the time and often use each others studies in the field...I agree..any one of the "scales" by itself is not very strong...but in combination...the ham-d, ham-a, madres, and cgi (cgi being not from the patient but from the doctor) can be compelling if the scores are consistent
Posted by Geezer on September 23, 2002, at 15:02:22
In reply to no secrets/see bottom » Geezer, posted by pharmrep on September 23, 2002, at 12:51:50
Hi pharmrep,
In respectful response to your post. Simply because the freedom of info. act exists does not mean it is automatically applied to drug testing. The application of the act usually requires litigation from the person making the request. Since the drug companies are not the issue in this case, they are not the legal governing authority, the request would go to the FDA and other governing bodies of responsibility-this often times requires a lawyer. I think it is great if the drug companies cross check each other. I spent 30 years in the medical device industry (cardiac pacemakers) and I believe we were required to follow the same rules you are.
As for the testing - I often put that argument forward - knowing full well there is no biomedical testing available to PROVE anything. My objective is to gain respect for the refractory mood disorders as medical brain disorders, to accomplish this we must rid ourselves of the social scientists and encourage real medical research. So...can we please "agree to disagree" on this point.
I think you should be proud of your work and your company - the drugs manufactured by Forest and other companies are to some degree helpful for 70% of the people who use them.....how can that be anything but good? The other 30% of us have to look deeper and work harder. I believe if the drug companies were left unfettered(sp), with the proper incentives, you might one day help us as well. No point in doing so now......governing authorites would not allow you to market "radical drugs".
Good cheer
Posted by Alice Anne on September 23, 2002, at 15:44:55
In reply to Re: dont start » Alan, posted by Geezer on September 23, 2002, at 12:34:16
So have you tried Lexapro, or are you saying you would never do so and have lost all faith in SSRI's?
Posted by Alice Anne on September 23, 2002, at 15:48:08
In reply to Re: dont start » Alan, posted by Geezer on September 23, 2002, at 12:34:16
Those with chronic, treatment refractory, major unipolar, atypical depression-- such as myself.
Posted by moxy1000 on September 23, 2002, at 18:11:42
In reply to Txment Refract. Maj.Unipolar Depressive Seeks Same, posted by Alice Anne on September 23, 2002, at 15:44:55
I think one reason a lot of drug companies don't market/test drugs for "atypical" patients (i.e. treatment refractory, unipolar, manic, etc.) is because your average, run of the mill type depression is where the money is at. (And pardon my terminology - I say "average" meaning patients that meet the criteria for major depression and nothing else. Nothing about a depressive episode or any mental illness is "average.") Anyway, atypical patients are called "atypical" for a reason - they are in some way different from the standard depressed patient. They may be depressed, yes, but then they may also bring some other illnesses to the table along with the depression that makes them especially hard to treat. Being bi-polar, or manic, or refractory makes treatment much more difficult, as many already know.
I think the reason drug companies are not knocking themselves out to find cures for these different illness combinations is because the population suffering them is too small (in relative terms) for the manufacturers to make a profit on. Depression is suffered by millions and millions of people each year, and yes, there are many who suffer from some variation of depression along with another illness. But if you were going to invent a drug, would you try to invent one that could benefit millions or a medicine that would help a much smaller segment of the population? Just from a financial standpoint, it makes more sense for the drug companies profit margins to try to market drugs that will help as many people as possible.
This is just my theory. I think it makes sense to some extent that atypical patients are excluded from certain studies - Number one, SSRI's are not marketed or promoted for bipolar individuals or manic depressives. This is probably over simplifying things a bit, but if a drug has never claimed to work for those particular illnesses, why should the drug be tested in individuals suffering from those illnesses? Maybe they are tested in those specific patient populations, the drug doesn't work, and it's just never published...who knows. My assumption is always this: SSRI's generally work for the same types of illnesses - if two have been proven to work for G.A.D., I can usually safely assume that all will work for that condition. I think it's interesting to note that NOT ONE ssri has ever claimed to be beneficial for manic or bipolar patients. I think the expectation by many of us is simply to high for a single agent to live up to. Maybe in a few years something will become available that is a "cure all," but as many of us know, that day has not yet arrived.
Perhaps we should just expect SSRI's to be effective for the illnesses they are indicated for. I guess I'm suggesting that we take the indications of SSRI's at face value. If a certain agent (or similar agent) is not indicated for what ails you, it probably isn't going to work. I realize "off label" prescribing goes on all the time, but I wouldn't point a finger at a drug that never claimed it would be able to help me in the first place.
Posted by Geezer on September 23, 2002, at 18:23:07
In reply to Txment Refract. Maj.Unipolar Depressive Seeks Same, posted by Alice Anne on September 23, 2002, at 15:44:55
Lost all faith in SSRIs.
Posted by Geezer on September 23, 2002, at 19:01:52
In reply to Txment Refract. Maj.Unipolar Depressive Seeks Same, posted by Alice Anne on September 23, 2002, at 15:44:55
Alice Anne,
Please pardon my abrupt response re: SSRIs. I don't mean to bad-mouth any drug, most of them help most people. I think those of us who are refractory accept drug cocktails as a way of life. We seem to be going down the same road...I would be interested to here any experiences you would wish to share.
Geezer
Posted by Geezer on September 23, 2002, at 19:56:54
In reply to atypicals, posted by moxy1000 on September 23, 2002, at 18:11:42
Moxy,
All good points. Drug companies must apply a risk to benefit ratio and if they end up on the wrong side of the profit line they won't be around long.
I think what we are referring to as "atypical depression" is actually the atypical features specifer that might be applied to the major depressive episode in either Unipolar or Bipolar disorder. I have read somewhere that it is very common in Bipolar II (I think-don't have the reference). Atypical Features Specifer appears on page 203 of my DSM-IV-TR/American Psychiatric Association.
The factor of treatment resistance accounts for our smaller numbers - correct too many TRDs would bias the results just as too many normals would - hence my desire for MEDICAL testing. I agree - by definition TRDs have to be treated "off label".
I wouldn't want to point a finger at drug but I would like a less painful trial and error (mostly error) process to arrive at a proper DX and eventually appropriate treatment. Maybe the orthan drug program would be a good plan.
Good cheer
Posted by Alice Anne on September 23, 2002, at 20:28:04
In reply to Re: Txment Refract. Maj.Unipolar Depressive Seeks Same » Alice Anne, posted by Geezer on September 23, 2002, at 19:01:52
I understand your response-- Almost 10 yrs ago a much more naive version of myself walked out of my psychiatrist's office with some Paxil samples, thinking I was finally going to get out of hell. Ten years later I'm still engaged in chemical warfare trying to find something that helps. Have you found relief in any of the other meds? MAO's, trycyclics, anti-psychotics, etc. etc.?
Posted by alaskagirl on September 23, 2002, at 21:34:15
In reply to Anyone switched to Lexapro? « ggrrl, posted by Dr. Bob on June 11, 2002, at 7:52:48
Pharmrep, can Lexapro be used to treat anxiety?
I was on Celexa 2 years ago for depression/anxiety
and it worked within 5 days. However, it later
caused me to develop colitis. I've tried numerous
drugs since then, but nothing has worked as well
as Celexa.I started Lexapro 9 days ago at 5mg
for 5 days (for anxiety, no depression this time),
and have bumped the dosage to 10mg for the last 4
days. My stomach has tolerated the Lexapro well,
however, it's not helping at all with the anxiety.If Lexapro does help with anxiety, does it take
longer than the typical 1-2 weeks Lexapro treats
depression?Also, I'm suffering from insomnia and am wondering
if this is a temporary side effect that will go
away, or if it will last with continued use?Thank you for your help!
Posted by pharmrep on September 24, 2002, at 0:21:49
In reply to Question for Pharmrep regarding Lexapro Anxiety, posted by alaskagirl on September 23, 2002, at 21:34:15
> Pharmrep, can Lexapro be used to treat anxiety?...........Yes
> I was on Celexa 2 years ago for depression/anxiety
> and it worked within 5 days. However, it later
> caused me to develop colitis. I've tried numerous
> drugs since then, but nothing has worked as well
> as Celexa.
>
> I started Lexapro 9 days ago at 5mg
> for 5 days (for anxiety, no depression this time),
> and have bumped the dosage to 10mg for the last 4
> days. My stomach has tolerated the Lexapro well,
> however, it's not helping at all with the anxiety.
>
> If Lexapro does help with anxiety, does it take
> longer than the typical 1-2 weeks Lexapro treats
> depression? ...............at 10mg it worked at 1-2wks for most people
>
> Also, I'm suffering from insomnia and am wondering
> if this is a temporary side effect that will go....... insomnia was found in 9%, but should subside with time
> away, or if it will last with continued use?...........if you dont already, take it in the morning...not at night
>
> Thank you for your help!
Posted by Geezer on September 24, 2002, at 10:07:31
In reply to Re: Txment Refract. Maj.Unipolar Depressive Seeks Same, posted by Alice Anne on September 23, 2002, at 20:28:04
Hi,
I was DXed in 1963 but never treated until 1973. Had plenty of self medicating drug abuse in the past (can't honestly blame anyone but myself for the possible neuro. brain damage). Clean and dry since 1985. Admitted to various psyc. wards 10 times between 1973 and 2002.
Think I have taken nearly all the TCAs - had some improvement with Ludiomil for several years but nothing close to remission. Took all the MAOIs (including one from Europe on a test basis) but this goes back to the 70s, can't remember benefit, only side effects. I had almost complete remission from Prozac for the years 97/98, then poop out and have not had any response from serotonin ADs since that time. I have no start up symptoms and can cold turkey from high doses with no withdrawal. Had only one experience with an AP-Remeron = sever anxiety/panic attack at first dose increase - resolved with 1mg Klonopin. Wellbutrin at 400mg does nothing. Will have another try at Parnate. After that its ECT or the "big dirt nap".
Sorry to be so negative, promise to be more uplifting as we go......but always honest.
Good cheer
Posted by Alice Anne on September 24, 2002, at 12:25:36
In reply to Re: Txment Refract. Maj.Unipolar Depressive Seeks Same » Alice Anne, posted by Geezer on September 24, 2002, at 10:07:31
Thank you for your honesty. God, I wish there were some kind of brain scan they could put us through that could once and for all identify exactly which chemicals were out of balance and adjust them accordingly. I think we're getting closer, but not nearly close enough. Hopefully these problems will be obsolete in 10 years. Wish they were now.
Posted by Geezer on September 24, 2002, at 13:13:03
In reply to Re: Txment Refract. Maj.Unipolar Depressive Seeks Same, posted by Alice Anne on September 24, 2002, at 12:25:36
Agreed!! You have just reinforced my "biomedical testing for biomedical brain disorder rant". I know about the progress in testing methods (can't come soon enough) but I am concerned about the obstacles standing in the way of new drug development.
Have you ever had experience with a Neurologist? I just have a "hankering" to see a real medical doctor.
Posted by Alice Anne on September 24, 2002, at 13:36:43
In reply to Re: Txment Refract. Maj.Unipolar Depressive Seeks Same » Alice Anne, posted by Geezer on September 24, 2002, at 13:13:03
Hmmm. No, I have not had experience with a neurologist. Had an MRI a couple of years ago to rule out some other cdxs-- nothing showed, thank God. I wonder what, if anything, you could learn-- what do you think? I know there is some institute (Amen?) where they make claims about being able to see into your brain (the guy wrote "Change Your Brain Change Your Life"), but my doctor thinks it's, well...suspect. He explained it to me scientifically, but I can't remember how. So I'm still waiting for the big Brain Wave of the future. You're right-- testing methods can't come soon enough, and the obstacles are many for drug testing, especially in the US. I'm off with my addled self for the day--- take care.
Posted by xiola on September 24, 2002, at 20:03:57
In reply to Re: LEXAPRO/lobotomy...HAHAHA!!!!, posted by URCONFUSED on September 21, 2002, at 16:39:34
i've been on 150mg of wellbutrin 2x a day and my doctor just added 10mg of lexapro, as well. she did this after i told her i was having anxiety. does this sound like too much to any of you? i haven't started on the lexapro yet.
Posted by Geezer on September 24, 2002, at 21:31:06
In reply to Lexapro Wellbutrin, posted by xiola on September 24, 2002, at 20:03:57
The dosage for each drug is within normal range and I don't believe there is any negative interaction between the two. As to how well they manage your symptoms....it is a trial and error process. I don't mean to sound insensitive....we all go through the same process because there is no medical test to predict response.
Very best wishes
Posted by pharmrep on September 24, 2002, at 23:47:05
In reply to Lexapro Wellbutrin, posted by xiola on September 24, 2002, at 20:03:57
> i've been on 150mg of wellbutrin 2x a day and my doctor just added 10mg of lexapro, as well. she did this after i told her i was having anxiety. does this sound like too much to any of you? i haven't started on the lexapro yet.
** Lexapro being the single isomer of celexa should be a good combo..."cel-well" has been used a lot and Lex-well is already getting used some now...the wellbutrin is to help with some of the sexual side effects often associated with ssri's. 10mg of Lexapro is the starting dose, and about 80%+ patients will not need to titrate up. Good luck, and keep us posted.
PS anxiety might feel better in 1 week or so, so let us know how youre doing.
Posted by CarolinaGirl on September 25, 2002, at 15:21:26
In reply to Anyone switched to Lexapro? « ggrrl, posted by Dr. Bob on June 11, 2002, at 7:52:48
I have switched computers to try and send this
message, forgive the previous empty ones. I am on 5 mgs of lexapro. This is the end of the second week for me. My Pdoc started me at this dose because in the past I have had side effects
from other SSRI's. Creepy crawly, not quite fitting into my skin......The budgies (my mama's
term from a long time ago)feelings. This is kind of a last chance for me I guess.
I have GAD and insomnia. I guess I don't really know what normal feel like.After the second day on lexapro....no more ambien. That is a plus. One less pill to take! I feel less anxious except when I smoke.
That seems to negate the effect of the lexapro.
ANyway, so far so good. I will check back in in a week or so to share my thoughts on this medicine.
Posted by sebastian on September 26, 2002, at 13:48:02
In reply to Re: why/see bottom, posted by hawkeye on September 22, 2002, at 7:05:02
I was staring to notice bad side-effects from my Zypexa 10mgs, told my doc, and he reduced it to 5mgs, after awhile I started to enjoy this so much I told him I could handle anouther decrese, we argued over 2.5 or 0mgs. Somehow we came to 0mgs. Well within a week my mind was racing so fast that I couldn't eat, sleep. Called my doc, instantly he put me 2.5mgs . Went in to see him later got put on 5mgs, now I wonder should I be on 7.5mgs. I tryed to call him and ask but he never returned the call. Anyways it was fun to loose the side-effects for awhile.
Posted by dr. dave on September 27, 2002, at 6:13:23
In reply to Re: Dosage/see bottom » hawkeye, posted by pharmrep on September 21, 2002, at 23:59:42
Again, the claim has been made that Lexapro has fewer side-effects than Celexa. This has been extensively discussed on this thread and the relevant data have been posted.
http://www.dr-bob.org/babble/20020821/msgs/118023.html
They clearly fail to demonstrate any significant difference. Despite repeated calls for any other research data which might back up the claim, none have appeared. So it is puzzling that this claim is again presented as fact.
The repeated statement of unsubstantiated claims leads to confusion. For instance, it has been said that r-citalopram cannot be inert because it is blamed for side-effects from Celexa. While it is true that this is claimed, there is no evidence to show that it is true. Removing r-citalopram does not cause a significant decrease in side-effects. But if the claim is made often enough, people begin to take it as fact and make deductions which stray further and further from what the research actually shows.
If there is now evidence that Lexapro has significantly fewer side-effects than Celexa, It would be very useful to see it.
> ** great question. 10mg of Lex is at least as efficacious as 40mg of cx...but with less s/e, less drug to drug interactions, and less discontinuation due to adverse events, and will work as fast as 1-2 weeks for most people. It is linear, however...5mg will not work as fast, and is not the recommended starting dose. In general, for most drugs many doctors reduce dosages to avoid side effects, but since Lexapro at 10mg is "comparable to placebo" it shouldnt be needed. In the Dr's I've seen...I would say 95%+ are starting w/ 10mg...only a few have gone to 20mg (only 2 weeks out now) and maybe a few Dr's are just "set in there ways" and are starting with 5mg (for a week or so...then up to 10mg) So far...I have only heard good responses from them, but most of their patients havent been back for their "monthly" visit...I'll hear more in about 2 weeks or so.
> PS...the starting dose for celexa was 20mg (62% of patients stayed there)...40mg was at about 30% (for a total of 92% of all Celexa prescriptions...the last 8% were at 60mg or higher.) I think Lexapro at 10mg will be effective for 80%+ of patients...then 15mg+ will make up the last 20%
Posted by Mr. SadPuppyDog on September 27, 2002, at 12:39:01
In reply to Re: Txment Refract. Maj.Unipolar Depressive Seeks Same » Alice Anne, posted by Geezer on September 24, 2002, at 13:13:03
Geezer, I agree with what you are saying. However I must also say Im VERY skeptical anything like you are talking about will ever occur on a large scale in psychiatry. To have the sort of thing you are talking about occur on a large scale and take over, we really need to formally integrate psychiatry into Neurology and just let Neurologists treat the serious forms of mental illness. Severe mental illness needs to be 100% "medicalised" and people with severe forms of this stuff just need to be given to Neurology to fix. Psychiatry does a poor job of it and Im skeptical psychiatry will ever achieve high tech status in medicine.
Mr. Sad PuppyDog
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