![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 453 to 477 of 8406. Go back in thread:
Posted by pharmrep on September 21, 2002, at 19:06:34
In reply to Re: feeling ill again » babs, posted by Roman on September 21, 2002, at 18:24:35
> I wonder what physiological effects can be attributed to the Celexa R-enantiomer. Wouldn't it be interesting to know if you're experiencing withdrawal from half of your previous Celexa therapy?
>
> Since the R-enantiomer is blamed for much of Celexa's s/e profile, it can't be inert. Therefore, a physiological response to the sudden absense of half the Celexa molecule (30mg R-enantiomer) is possible.
>
> What do you think?
>
*** interesting concept...although i cant swear it isnt possible, neither Celexa (nor Lexapro) have been associated with discontinuation syndrome (like paxil and effexor can be) The 1st few weeks is usually the toughest to adjust to any new med (hang in there)
Posted by hawkeye on September 21, 2002, at 19:40:53
In reply to Re: LEXAPRO » hawkeye, posted by pharmrep on September 14, 2002, at 9:57:47
Does this data mean that approx. 7mgs of Lexapro is the functional equivalent of 40mgs of Celexa?
[7mgs of Lex. raises brain seretonin by %2100;
40mgs of Cel raises brain seretonin by %2000"The new study shows that Lexapro (the S-enantiomer of citalopram), when given at 2 mg/kg subcutaneously (s.c.), was more than twice as potent as Celexa at 4 mg/kg s.c. (2.0 mg/kg S-enantiomer + 2.0 mg/kg R-enantiomer) in increasing brain serotonin levels (about 300 percent vs. 200 percent, respectively). In contrast to Lexapro, the R-enantiomer of citalopram, when given at 2.5 mg/kg s.c., did not increase brain serotonin levels."
http://biz.yahoo.com/prnews/020624/nym009_1.html
It has been my understanding that while 40mgs of Celexa is the recomended dosage, that comparable results may also be obtained at 20mgs.
"In a 6-week fixed-dose study, patients received citalopram, 20 or 40 mg/day, or placebo (n=64 to 70 per group). Patients treated with citalopram 40 mg/day, showed significantly greater improvement than placebo-treated patients. The difference between the lower dose of citalopram and placebo was not significant. "
"The effectiveness of citalopram in preventing relapse was assessed in two long-term studies. Depressed patients who responded to citalopram during an initial 6 or 8 weeks of acute treatment (fixed doses of 20 or 40 mg/day in one study and flexible doses of 20-60 mg/day in the second study) were randomized to continue on citalopram or receive placebo. The number of patients who received citalopram and placebo was 257 and 116, respectively. In both studies, patients who continued on citalopram experienced significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. In the fixed-dose study, the relapse rates were similar at the 20 and 40 mg/day doses, namely 10% and 12%, respectively. "
http://www.mentalhealth.com/drug/p30-c04.html#Head_3
So, maybe 5mgs of Celexa Professional Edition will be more than enough.
Posted by hawkeye on September 21, 2002, at 19:44:21
In reply to Question for PharmRep Re: Dosage Equivalent Celexa, posted by hawkeye on September 21, 2002, at 19:40:53
Calculations are Wrong.
Sorry
Posted by hawkeye on September 21, 2002, at 20:04:33
In reply to Re: LEXAPRO » hawkeye, posted by pharmrep on September 14, 2002, at 9:57:47
Does this data mean that approx. 7mgs of Lexapro is the functional equivalent of 20mgs of Celexa?
[7mgs of Lex. raises brain seretonin by %1050;
20mgs of Cel raises brain seretonin by %1000"The new study shows that Lexapro (the S-enantiomer of citalopram), when given at 2 mg/kg subcutaneously (s.c.), was more than twice as potent as Celexa at 4 mg/kg s.c. (2.0 mg/kg S-enantiomer + 2.0 mg/kg R-enantiomer) in increasing brain serotonin levels (about 300 percent vs. 200 percent, respectively). In contrast to Lexapro, the R-enantiomer of citalopram, when given at 2.5 mg/kg s.c., did not increase brain serotonin levels."
http://biz.yahoo.com/prnews/020624/nym009_1.html
It has been my understanding that while 40mgs of Celexa is the recomended dosage, that comparable results may also be obtained at 20mgs.
"The effectiveness of citalopram in preventing relapse was assessed in two long-term studies. Depressed patients who responded to citalopram during an initial 6 or 8 weeks of acute treatment (fixed doses of 20 or 40 mg/day in one study and flexible doses of 20-60 mg/day in the second study) were randomized to continue on citalopram or receive placebo. The number of patients who received citalopram and placebo was 257 and 116, respectively. In both studies, patients who continued on citalopram experienced significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. In the fixed-dose study, the relapse rates were similar at the 20 and 40 mg/day doses, namely 10% and 12%, respectively. "
http://www.mentalhealth.com/drug/p30-c04.html#Head_3
So, maybe 5mgs of Celexa Professional Edition will be enough. Or, 7mgs will be more than enough (by dividing a 10mg tablet and then subdividing one half again)
Posted by Alice Anne on September 21, 2002, at 23:43:32
In reply to feeling ill again, posted by babs on September 21, 2002, at 17:54:35
Hi babs, I'm still playing around with my 2.5 mgs. and not having fun yet. Weird pressure headache, spaciness--just not comfortable. I feel like there's a band of led behind my eyes. I imagine at the full 10mgs. I'd be quite a case. But your two good days were a good sign. Hope you feel better.
Posted by pharmrep on September 21, 2002, at 23:59:42
In reply to Question for PharmRep Re: Dosage Equivalent Celexa, posted by hawkeye on September 21, 2002, at 19:40:53
> Does this data mean that approx. 7mgs of Lexapro is the functional equivalent of 40mgs of Celexa?
>
> [7mgs of Lex. raises brain seretonin by %2100;
> 40mgs of Cel raises brain seretonin by %2000
>
> "The new study shows that Lexapro (the S-enantiomer of citalopram), when given at 2 mg/kg subcutaneously (s.c.), was more than twice as potent as Celexa at 4 mg/kg s.c. (2.0 mg/kg S-enantiomer + 2.0 mg/kg R-enantiomer) in increasing brain serotonin levels (about 300 percent vs. 200 percent, respectively). In contrast to Lexapro, the R-enantiomer of citalopram, when given at 2.5 mg/kg s.c., did not increase brain serotonin levels."
>
> http://biz.yahoo.com/prnews/020624/nym009_1.html
>
> It has been my understanding that while 40mgs of Celexa is the recomended dosage, that comparable results may also be obtained at 20mgs.
>
> "In a 6-week fixed-dose study, patients received citalopram, 20 or 40 mg/day, or placebo (n=64 to 70 per group). Patients treated with citalopram 40 mg/day, showed significantly greater improvement than placebo-treated patients. The difference between the lower dose of citalopram and placebo was not significant. "
>
> "The effectiveness of citalopram in preventing relapse was assessed in two long-term studies. Depressed patients who responded to citalopram during an initial 6 or 8 weeks of acute treatment (fixed doses of 20 or 40 mg/day in one study and flexible doses of 20-60 mg/day in the second study) were randomized to continue on citalopram or receive placebo. The number of patients who received citalopram and placebo was 257 and 116, respectively. In both studies, patients who continued on citalopram experienced significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. In the fixed-dose study, the relapse rates were similar at the 20 and 40 mg/day doses, namely 10% and 12%, respectively. "
>
> http://www.mentalhealth.com/drug/p30-c04.html#Head_3
>
> So, maybe 5mgs of Celexa Professional Edition will be more than enough.** 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 Dr. Bob on September 22, 2002, at 0:00:12
In reply to Re: LEXAPRO/lobotomy...HAHAHA!!!!, posted by URCONFUSED on September 21, 2002, at 16:39:34
> URCONFUSED
Sorry, but I'd like you to choose a name that's less likely to lead others to feel accused or put down. Thanks,
Bob
PS: Follow-ups regarding posting policies should be redirected to Psycho-Babble Administration; otherwise, they may be deleted.
Posted by pharmrep on September 22, 2002, at 0:07:15
In reply to CORRECTED POST (I Think), posted by hawkeye on September 21, 2002, at 20:04:33
> Does this data mean that approx. 7mgs of Lexapro is the functional equivalent of 20mgs of Celexa?
>
> [7mgs of Lex. raises brain seretonin by %1050;
> 20mgs of Cel raises brain seretonin by %1000
>
> "The new study shows that Lexapro (the S-enantiomer of citalopram), when given at 2 mg/kg subcutaneously (s.c.), was more than twice as potent as Celexa at 4 mg/kg s.c. (2.0 mg/kg S-enantiomer + 2.0 mg/kg R-enantiomer) in increasing brain serotonin levels (about 300 percent vs. 200 percent, respectively). In contrast to Lexapro, the R-enantiomer of citalopram, when given at 2.5 mg/kg s.c., did not increase brain serotonin levels."
>
> http://biz.yahoo.com/prnews/020624/nym009_1.html
>
> It has been my understanding that while 40mgs of Celexa is the recomended dosage, that comparable results may also be obtained at 20mgs.
>
> "The effectiveness of citalopram in preventing relapse was assessed in two long-term studies. Depressed patients who responded to citalopram during an initial 6 or 8 weeks of acute treatment (fixed doses of 20 or 40 mg/day in one study and flexible doses of 20-60 mg/day in the second study) were randomized to continue on citalopram or receive placebo. The number of patients who received citalopram and placebo was 257 and 116, respectively. In both studies, patients who continued on citalopram experienced significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. In the fixed-dose study, the relapse rates were similar at the 20 and 40 mg/day doses, namely 10% and 12%, respectively. "
>
> http://www.mentalhealth.com/drug/p30-c04.html#Head_3
>
> So, maybe 5mgs of Celexa Professional Edition will be enough. Or, 7mgs will be more than enough (by dividing a 10mg tablet and then subdividing one half again)** if Lexapro is "comparable to placebo" with side effects, adverse events, and has a quick onset...why are you wanting to use less? I know that not everybody responds the same, and that 10mg will work for the majority of people...using less than 10mg should be for those patients in the minority who are showing a "sensitivity" different than most other people. Wouldnt you agree?
Posted by IsoM on September 22, 2002, at 1:43:56
In reply to Re: LEXAPRO/lobotomy...HAHAHA!!!!, posted by URCONFUSED on September 21, 2002, at 16:39:34
URCONFUSED, a lot of people seem to have a flattening of emotions on SSRIs. It's not that unusual. I'm not affected like that - emotions are sharper & more real for me but when I was talking to my biology prof once (she's about my age & we got along great) about anti-depressants, she said when she was prescribed an SSRI briefly, she felt strangely unmoved by anything. Things that would normally make her sad (or happy) instead made her completely detached with a "could care less" attitude. She didn't like the blunting effect & discontinued them. I've also heard that from a few others who've taken SSRIs. Don't be too quick to discount other's reactions, even if yours aren't similar.
Posted by IsoM on September 22, 2002, at 1:53:13
In reply to Re: feeling ill again » Roman, posted by pharmrep on September 21, 2002, at 19:06:34
Pharmrep, I'm sure I'm unusual, though not unique, with my senstivity to stopping SSRIs. I NEVER lost my symptoms when stopping Paxil, even after almost 1/2 year & switching over to Celexa. I ended up going back on 5 mg to keep symptoms at bay. It was only when I started adrafinil that the symptoms went & didn't come back & I was able to quit the Paxil completely.
But even with Celexa, if I miss the dose as I did one day in a rush to make an appointment, I can feel the beginnings of vertigo, queasiness, & a degree of malaise. I normally take my Celexa first thing in the morning but didn't that day till evening. I was starting to feel pretty weird. And yes, it was the same discontinuation symptoms, not illness. I never get sick, colds, or anything else, so I know for a certainty what it was.
So I suppose in more susceptible persons, discontinuation problems may arise with stopping any SSRI.
Posted by hawkeye on September 22, 2002, at 7:05:02
In reply to why/see bottom » hawkeye, posted by pharmrep on September 22, 2002, at 0:07:15
".why are you wanting to use less?"
Because at 10 mgs I was having unacceptable sexual side effects. Because the drug is working so well for my depression I am trying to find a way to keep with it.
One additional thought, You say that at 5mg the onset of the anti-depressant effect is slower than at 10mg. Perhaps the way to go for those who are known to be sensitive to this drug from their experience with Celexa would be to start at 10mgs to get a rapid antidepressant response and then cut back to 5mg to reduce the side effects.
Bummer for me that I am having these side effects at 10mgs/day. For me the side effects at 10 mgs of Lexapro are as severe as they were at 40mgs of Celexa.
Posted by babs on September 22, 2002, at 9:47:59
In reply to Re: why/see bottom, posted by hawkeye on September 22, 2002, at 7:05:02
Just wanted to say thanks to eveyone for your support and input! I'll keep you posted.
Posted by pharmrep on September 22, 2002, at 10:26:10
In reply to Re: discontinuation syndrome with Celexa » pharmrep, posted by IsoM on September 22, 2002, at 1:53:13
> Pharmrep, I'm sure I'm unusual, though not unique, with my senstivity to stopping SSRIs. I NEVER lost my symptoms when stopping Paxil, even after almost 1/2 year & switching over to Celexa. I ended up going back on 5 mg to keep symptoms at bay. It was only when I started adrafinil that the symptoms went & didn't come back & I was able to quit the Paxil completely.
>
> But even with Celexa, if I miss the dose as I did one day in a rush to make an appointment, I can feel the beginnings of vertigo, queasiness, & a degree of malaise. I normally take my Celexa first thing in the morning but didn't that day till evening. I was starting to feel pretty weird. And yes, it was the same discontinuation symptoms, not illness. I never get sick, colds, or anything else, so I know for a certainty what it was.
>
> So I suppose in more susceptible persons, discontinuation problems may arise with stopping any SSRI.** As I said before...I can not like most of you...refer to specific syptoms like you all can since I am not taking an AD. I can only speak in generalities...and only be specific when speaking with each of you individually. So if I seem to speak about "majority" often...dont think I am leaving you out, I care about how you are doing and what reactions you have. I just normally work with large numbers of patients and doctors and refer to pooled info a lot, good luck to all and hang in there
Posted by Alan on September 22, 2002, at 11:01:11
In reply to generalities » IsoM, posted by pharmrep on September 22, 2002, at 10:26:10
> ** As I said before...I can not like most of you...refer to specific syptoms like you all can since I am not taking an AD. I can only speak in generalities...and only be specific when speaking with each of you individually. So if I seem to speak about "majority" often...dont think I am leaving you out, I care about how you are doing and what reactions you have. I just normally work with large numbers of patients and doctors and refer to pooled info a lot, good luck to all and hang in there
============================================Therein lies the problem.
Statistics don't apply to individual cases. So when using statistics to reply to an individual the practice at some level is meaningless - particularly re: individual side effects.
Posted by Ritch on September 22, 2002, at 11:07:14
In reply to Re: why/see bottom, posted by hawkeye on September 22, 2002, at 7:05:02
> ".why are you wanting to use less?"
>
> Because at 10 mgs I was having unacceptable sexual side effects. Because the drug is working so well for my depression I am trying to find a way to keep with it.
>
> One additional thought, You say that at 5mg the onset of the anti-depressant effect is slower than at 10mg. Perhaps the way to go for those who are known to be sensitive to this drug from their experience with Celexa would be to start at 10mgs to get a rapid antidepressant response and then cut back to 5mg to reduce the side effects.
>
> Bummer for me that I am having these side effects at 10mgs/day. For me the side effects at 10 mgs of Lexapro are as severe as they were at 40mgs of Celexa.
Hawkeye,When I was started on Celexa for the first time a few years ago-when it was available in the US for the first time-I started at 10mg (half a 20mg tab) first off. I felt better, had some side effects, but they weren't real bad. Then later on as my depression worsened (mid-winter bpII seasonal), my pdoc had me up it to 20mg. I felt a *little* better, but my side effects got a lot worse, so I backed down to 10mg and added some Wellbutrin (which did the trick). Anyhow, over about 3 years of being on and off Celexa (most on-and with other AD's,etc.), I found that 5mg and 10mg of Celexa felt pretty much the same (but with 5mg being much more tolerable). Even 2.5 didn't feel much different than 5.0mg. So, in my experience, the range of 2.5-10mg felt little different except for s/e. I think they need to put a score on those 5mg tabs of Lexapro. If they do, I might give Lexapro a try. Even scored *2.5mg* tabs would be neat (esp. for those that take other meds with it).
Mitch
Posted by pharmrep on September 22, 2002, at 11:11:57
In reply to Re: generalities » pharmrep, posted by Alan on September 22, 2002, at 11:01:11
>
> > ** As I said before...I can not like most of you...refer to specific syptoms like you all can since I am not taking an AD. I can only speak in generalities...and only be specific when speaking with each of you individually. So if I seem to speak about "majority" often...dont think I am leaving you out, I care about how you are doing and what reactions you have. I just normally work with large numbers of patients and doctors and refer to pooled info a lot, good luck to all and hang in there
> ============================================
>
> Therein lies the problem.
>
> Statistics don't apply to individual cases. So when using statistics to reply to an individual the practice at some level is meaningless - particularly re: individual side effects.
>
>
** dont start...I have spent loads of time to hear from many individuals here and elsewhere on individual responses...and from Dr's and their individual patients too. I believe I bring an open/objective mind to the table here, and enjoy responding to questions...as I prefaced before...I can work with individuals here or give "pooled" info for those who are interested.
Posted by Anyuser on September 22, 2002, at 11:51:11
In reply to SSRI's have a flat dose-response curve » hawkeye, posted by Ritch on September 22, 2002, at 11:07:14
How much WB did you add to your 10mg Celexa? Do you take it every day, or as needed to counter s/e?
Do you think you are especially sensitive to SSRIs, or do you think that the manufacturers prescribe too much drug? Hard question to answer, I suppose. My pdoc thinks all AD manufacturers prescribe in too-high amounts.
Thanks for your help.
Posted by Ritch on September 22, 2002, at 14:06:05
In reply to How much WB? » Ritch, posted by Anyuser on September 22, 2002, at 11:51:11
> How much WB did you add to your 10mg Celexa? Do you take it every day, or as needed to counter s/e?
>
> Do you think you are especially sensitive to SSRIs, or do you think that the manufacturers prescribe too much drug? Hard question to answer, I suppose. My pdoc thinks all AD manufacturers prescribe in too-high amounts.
>
> Thanks for your help.Hi,
I am med-sensitive to nearly all AD's, due to being bipolar. I am especially sensitive to SSRI's for some reason, but they do help with anxiety/mood a lot (which is good and sometimes bad). I think the doses are way too high for many folks like me because they are developed for trials for unipolar depressives and they are targeting efficacy as a monotherapy (just my guess here). Also, maintenance doses of AD's can be much lower and stave off relapse in a lot of folks. That's what I need-I just want a med regime that is low-dose that I can just take all the time and just forget about it-but that's easier said than done.
AD-wise, I switched from Celexa(+buproprion) to Effexor(+bupropion) about two-three months ago. The main reason was I get little or no nocturnal reflux from Effexor as opposed to Celexa (and Prozac, etc.). Let's see, when I was in the middle of wintertime BPII depression, I was taking 2.5-5mg of Celexa + 75-150mg bupropion. The bupropion wasn't added to counter s/e from the Celexa, I just don't respond to a serotonergic AD well during my BPii depressions, I need a stim-like med for it to clear up. When I am in a part of the year when my moods are mixed or generally hypo that much AD (either Celexa or bupropion) would have me climbing the walls.
Mitch
Posted by David Smith on September 22, 2002, at 21:32:21
In reply to Re: please re-register » URCONFUSED, posted by Dr. Bob on September 22, 2002, at 0:00:12
> > URCONFUSED
>
> Sorry, but I'd like you to choose a name that's less likely to lead others to feel accused or put down. Thanks,Thank you Dr. Bob.
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?
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