![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 76 to 100 of 116. Go back in thread:
Posted by SLS on August 6, 2004, at 12:17:00
In reply to Side-effects to be expected from Cymbalta/duloxeti, posted by Marilyn on August 6, 2004, at 11:18:15
> The truth is indeed what people need.
What exactly is this truth?
- Scott
Posted by Leo the Lion on August 7, 2004, at 16:25:32
In reply to Side-effects to be expected from Cymbalta/duloxeti, posted by Marilyn on August 6, 2004, at 11:18:15
The truth is indeed what people need, and they won't get it from so called antidepressantfacs.com
I don't know the intentions of the people running that site, but if they are not bad, they should be sterilized for the better good of humanity.
EX:
Case/Review Fatality related to a 30-g venlafaxine overdose30 grammes, that's 400 pills.
Take xxx aspirin - death
Drink 400 glasses of water within the hour - death
A case review is exactly that; a case review.
from http://www.antidepressantsfacts.com/pinealstory.htm
"...What actually happens when you increase serotonergic neuronal activity or elevate your serotonin levels is this: the stress hormones "Cortisol" & "Adrenaline" (Epinephrine) in the brain and body are triggered by increased serotonergic activity or elevated serotonin levels. ... They give the human personality a boost, producing a euphoric state, which can last for a prolonged period of time. In this manner SSRI-AntiDepressants initially produce the deceptive results the doctor and "patient" are both expecting. *"
I can tell you first hand that you do not get a "boost" from antidepressant.
A very heavy release of adrenalin can get you a boost. A heck load of cortisol make you feel wired in the most unpleasant sense of the word.
So, marilyn, drop dead.
'nuff said
Posted by Marilyn on August 7, 2004, at 18:28:01
In reply to Re: Side-effects to be expected from Cymbalta/duloxeti » Marilyn, posted by Leo the Lion on August 7, 2004, at 16:25:32
> So, marilyn, drop dead.
Well, we all have to die sometime, but until that time arrives I will continue to provide the truth to people who are unbeknown of the powerful physical and mental side-effects of these antidepressants.
I came accross another recent post regarding physical and mental side-effects due to another Lilly SSRI antidepressant known as Prozac (fluoxetine). You can find it at: http://forum.conductdisorders.com/ubbcgi/ultimatebb.cgi?ubb=get_topic&f=1&t=055041
Just another example of the side-effects to be expected with the new Lilly drug Cymbalta (duloxetine)
posted August 07, 2004 12:30
My personal experience withdrawing from Prozac. I felt like I was coming out of my skin, would feel like needles were shooting out of my fingertips,would have awful nightmares, shake out of control, felt sick to my stomach, it was without a doubt the worse thing I ever lived through, and it was at that time that I thought back to my daughter's withdrawal on zoloft, and it made me feel so bad for her and relieved she made it through it. I dont know many people(actually none)who have lived through this nightmare to even remotely share the experience of how it felt, so I feel I should share this here, just as general information/food for thought. My family all knew I was coming off the drug and was alert to my mouthyness, aggitation,all the physical symtoms, and it was living hell. I missed work until I could function.I tapered extremely slowly, right down to breaking open the capsules and putting the powder in something else so I could try and prevent withdrawals. I could feel episodes coming on. I would feel extremely sick, the shakes and the buzzing would start and I had to sit down for at least 30 minutes to ride it. I had a awful time. I am still on trazedone(which also interacted with the prozac)for sleep leftover from my own anxiety from my daughter. This drug is what I now feel is the reason for my excessive sweating! I googled sweat and trazedone and ended up reading a lot about some ADs having excessive sweating as a side effect. I am in the process of coming off of this drug now, as it isnt needed and am not seeing any of the nasty withdrawals I had on Prozac. I find the more I read, and lots of the fine print on how these drugs actually work in the brain/body help understand better. Makes you feel like a home grown scientist.Good luck.
Posted by SLS on August 7, 2004, at 20:26:18
In reply to Re: So, marilyn, drop dead, posted by Marilyn on August 7, 2004, at 18:28:01
> > So, marilyn, drop dead.
> Well, we all have to die sometime, but until that time arrives I will continue to provide the truth to people who are unbeknown of the powerful physical and mental side-effects of these antidepressants.Dear Marilyn,
I'm glad you were able to shrug off so easily the ingracious comments of the previous poster. I don't want you to drop dead. :-)
I still don't understand what your point is. These drugs have side effects. This is not news.
Is there anything else that you are trying to say beyond the fact that these drugs have side effects?
Thanks.
- Scott
Posted by Dr. Bob on August 8, 2004, at 2:32:21
In reply to Re: Side-effects to be expected from Cymbalta/duloxeti » Marilyn, posted by Leo the Lion on August 7, 2004, at 16:25:32
> The truth is indeed what people need, and they won't get it from so called antidepressantfacs.com
>
> they should be sterilized for the better good of humanity.
>
> Take xxx aspirin - death
>
> So, marilyn, drop dead.Please don't discuss specific ways of harming oneself, suggest that others be harmed, exaggerate or overgeneralize, or post under more than one name at the same time.
Sharing something about your own issues and their possible role in your reaction might be an interesting exercise -- and might help others respond to you supportively.
Anyone who has questions about this or about posting policies in general, or who is interested in alternative ways of expressing themselves, should see the FAQ:
http://www.dr-bob.org/babble/faq.html#civil
Also, follow-ups regarding these issues should be redirected to Psycho-Babble Administration.
Thanks,
Bob
Posted by caraher on August 12, 2004, at 11:27:31
In reply to Side-effects to be expected from Cymbalta/duloxeti, posted by Marilyn on August 6, 2004, at 11:18:15
Today's Indy Star had an article saying the FDA will agree with Lilly concerning the suicide in a Cymbalta trial earlier this year: http://www.indystar.com/articles/9/169521-6899-223.html
I was astounded that the "wean" period was only 4 days. I've never quit any antidepressant that abruptly myself and would be rather worried about doing so. Today the a coordinator for the study I'm in told me the suicide occurred 2 weeks after she last took duloxetine. Also, the new consent form I received today says that over 11,000 people have now taken the drug in trials.
Posted by Marilyn on August 13, 2004, at 10:52:32
In reply to Re: So, marilyn, please don't drop dead ? Marilyn, posted by SLS on August 7, 2004, at 20:26:18
> I still don't understand what your point is.
> These drugs have side effects.This is not news.
> Is there anything else that you are trying to
> say beyond the fact that these drugs have side
> effects?Dear Scott,
As a matter of fact, yes there is so much more I would like to say.
First of all, since 1987, SSRI antidepressants are heavily marketed being completely safe and effective drugs.
It is only very recently in this year, 2004, after so many reports of self-harm, suicidality and physical side-effects since 1987, that the FDA finally starts to recognize there should be stronger warning indications regarding these hazards.
How many children have been victimized throughout all of these years? And how many more children will suffer of unrecognized side-effects in the future?
I will give you an example of a young woman of 17 years of age who visited the doctor's office because she felt so tired prior to her school exam. He prescribed her the SSRI antidepressant Celexa also known as Cipramil and told her that it was completely safe to take and would give her more energy.
Ofcourse this doctor had his knowledge from a pharmaceutical representative and truely believed it would help her.
Within 5 days of ingesting Celexa, this young woman became a physical wreckage with severe signs of paraesteshia, extreme burnings in her face, arms and hands along with painful shooting sensations in her head, neck and spine.
3 years later the symptoms are still there in their severity. She never finished her exam.
She couldn't play the piano anymore. This young woman -now 20 years of age- as well as her parents are desperate. No specialist is able to help her. No medication against neuralgia works.My question to you is: if this would be your daughter, how would you feel? Would you still explain these side-effetcs away as something innocent and short lived? I doubt it.
So that is my point.
Marilyn
Posted by JLM on August 13, 2004, at 11:00:49
In reply to Re: Cymbalta/Duloxetine, posted by caraher on August 12, 2004, at 11:27:31
> Today's Indy Star had an article saying the FDA will agree with Lilly concerning the suicide in a Cymbalta trial earlier this year: http://www.indystar.com/articles/9/169521-6899-223.html
>
> I was astounded that the "wean" period was only 4 days. I've never quit any antidepressant that abruptly myself and would be rather worried about doing so. Today the a coordinator for the study I'm in told me the suicide occurred 2 weeks after she last took duloxetine. Also, the new consent form I received today says that over 11,000 people have now taken the drug in trials.
So, if it wasn't the drug, what was it then: the Easter Bunny?This is outrageous if you ask me.
Posted by Marilyn on August 13, 2004, at 11:19:44
In reply to Re: Cymbalta/Duloxetine, posted by JLM on August 13, 2004, at 11:00:49
> Today's Indy Star had an article saying the FDA
> will agree with Lilly concerning the suicide
>
> So, if it wasn't the drug, what was it then:
> the Easter Bunny? This is outrageous if you ask
> me.Dear "JLM",
I feel your outrage here. To be honest, I have
seen this coming for some time. Unfortuately the
pharmaceutical companies and the FDA are too much
intertwined with eachother and there are way too
much financial interests at stake. It is the unfortunate truth.Furthermore, what that article failed to uncover
was that Traci Johnson was most certainly not the
only participant who committed suicie on Cymbalta
(duloxetine).Knight Ridder News Service reports that Eli Lilly
acknowledges that 4 other suicides occurred
during clinical trials of Cymbalta.In this article:
Smith said there had been four suicides in the
clinical trials for duloxetine, out of 9,000
participants.He said it was "very, very rare" for healthy
participants to take their own life."The deaths in the study occurred with people who
actually were depressed when they started the
study."Marilyn
Posted by theo on August 13, 2004, at 12:25:57
In reply to Re: Cymbalta/Duloxetine, posted by Marilyn on August 13, 2004, at 11:19:44
The only people saying they are "healthy individuals" is themselves on the application. If an individual is willing to subject themselves to the testing of new antidepressants which could mean taking extremely high doses, they are either hoping to feel better or hoping they get accidently OD in my opinion, it's not just about the money they are getting paid, they are reaching out.
Posted by caraher on August 13, 2004, at 12:41:02
In reply to Re: Cymbalta/Duloxetine, posted by Marilyn on August 13, 2004, at 11:19:44
> Furthermore, what that article failed to uncover
> was that Traci Johnson was most certainly not the
> only participant who committed suicie on Cymbalta
> (duloxetine).Actually, the article DOES mention that: "As of this spring, four suicides had occurred among 4,124 depressed patients who had taken duloxetine, which is Cymbalta's scientific name, during clinical trials, according to a Lilly clinical psychiatrist, Dr. John R. Hayes."
There is a rumor that she'd been depressed previously and the point in another post about taking the volunteer's word is very well taken. I used to work in PET research and heard many tales of so-called "normal volunteers" lying to get into a study. The difference is that generally it's easier to figure out that someone lied about taking cocaine than it is to determine someone had previously been depressed.
Posted by SLS on August 13, 2004, at 14:10:33
In reply to Re: So, marilyn, please don't drop dead, posted by Marilyn on August 13, 2004, at 10:52:32
> > I still don't understand what your point is.
> > These drugs have side effects.This is not news.
> > Is there anything else that you are trying to
> > say beyond the fact that these drugs have side
> > effects?
>
> Dear Scott,
>
> As a matter of fact, yes there is so much more I would like to say.
>
> First of all, since 1987, SSRI antidepressants are heavily marketed being completely safe and effective drugs.I disagree with you. This has not been my observation.
I have been taking SSRIs since 1984 (indalpine). No one has ever portrayed to me that any antidepressant was "completely safe and effective". This is, in part, because I have had good doctors.
I have never seen an advertisement in print or on TV making any such claims. Have you ever had the opportunity to view a TV advertisement for an SSRI that has made such a claim? On the contrary. For years, I have seen the drug companies place in their adds a list of possible adverse effects, many of them being quite serious. They also go out of their way to say that their drug is not for everyone, and that THEIR DOCTOR should be the one to make such determinations.
Is this not true?
> It is only very recently in this year, 2004, after so many reports of self-harm, suicidality and physical side-effects since 1987, that the FDA finally starts to recognize there should be stronger warning indications regarding these hazards.
Which hazards? Which ones that are not already listed?
I am glad that the FDA has finally seen fit to recognize that drug-induced suicidal states are a possible adverse effect of antidepressant medications. They are. There are many medications that can alter brain function in ways that bring about changes in mood and cognition. These include, but are not limited to, antidepressants. Prednisone, one of the most common treatments for pain, inflammation, and autoimmune disease, can produce depression and psychosis, and has precipitated severe pathological behaviors. This is old news. The medical community should be better educated in this area it seems. It is unfortunate that the FDA should ask for label warnings after the fact, but it is good that this has been rectified. To give the drug companies the benefit of the doubt, they are investigating a disease for which one of the symptoms is suicide. Perhaps they are not entirely negligent for not having been able to distinguish the differences any earlier.
> How many children have been victimized throughout all of these years?
I don't know. Do you have an estimate?
> And how many more children will suffer of unrecognized side-effects in the future?
Of course, this question can be asked of almost any drug, or of almost any human endeavor. I'm not sure Tylenol has been around long enough for us to be certain that no more "unrecognized" side effects will yet be recognized. There are thousands of serious people in medicine who are always asking this question. You are not alone.
> I will give you an example of a young woman of 17 years of age who visited the doctor's office because she felt so tired prior to her school exam.
What is her name, and where can I find the facts of this case so that I might scrutinize them?
> He prescribed her the SSRI antidepressant Celexa also known as Cipramil and told her that it was completely safe to take and would give her more energy.
Ah. We are now talking about the behavior of a specific doctor. What is his name?
> Of course this doctor had his knowledge from a pharmaceutical representative and truely believed it would help her.
Of course? How do we know this? If you are going to make statements as if they were fact, please describe how you know this to be true.
> Within 5 days of ingesting Celexa, this young woman became a physical wreckage with severe signs of paraesteshia, extreme burnings in her face, arms and hands along with painful shooting sensations in her head, neck and spine.
This might be true. I have no reason to believe that such a thing is not a medical possibility. Again, though, I am sure you will provide the source of your information or allow us to scrutinize it for ourselves, no?
> 3 years later the symptoms are still there in their severity. She never finished her exam.
> She couldn't play the piano anymore. This young woman -now 20 years of age- as well as her parents are desperate. No specialist is able to help her. No medication against neuralgia works.
Has this case been published in any medical literature? I would be intereseted in reading it.
> My question to you is: if this would be your daughter, how would you feel?
Who's daughter is she? If you want an answer, lets get to the specific facts of this case. Who is this person?
> Would you still explain these side-effetcs away as something innocent and short lived?
> I doubt it.
"Innocent" as opposed to "sinister"? Do you think something sinister is going on?
I doubt it.
> So that is my point.
> MarilynMarilyn, your point is a very serious one. It probably deserves to have provided facts and references so that we can better assess its validity.
SSRIs are very powerful psychotropic drugs that are effective for many people and produce many side effects, some of which are serious. Among these are infrequent exacerbations of the illness itself. It is my opinion that these drugs belong in the pharmacopeia until better ones are discovered to supplant them.
- Scott
Posted by Marilyn on August 14, 2004, at 6:45:17
In reply to Re: So, marilyn, please don't drop dead, posted by SLS on August 13, 2004, at 14:10:33
> Who's daughter is she? If you want an answer,
> lets get to the specific facts of this case.
> Who is this person?Dear Scott,
Do medical physicians reveal the names of their patients to the public? Ofcourse not. That is confidential. They simply present the case and that's enough.
I am not asking you a difficult question. I am not asking you to play word games with me either. I am asking a question to your heart and I will ask it again:
If this would be your daughter, how would you feel? Would you still explain these side-effetcs away as something innocent and short lived?
The pharmaceutical companies are doing this for so many years despite the facts. Come on Scott, you cannot deny the commercial adds for Zoloft, Paxil, Effexor, etc.
One recent new fact is Health Canada advising canadians that newborns may be adversely affected when pregnant women take Selective Serotonin Re-uptake Inhibitors (SSRIs) and other newer anti-depressants during the third trimester of pregnancy.
Reported symptoms include: feeding and/or breathing difficulties, seizures, muscle rigidity, jitteriness and constant crying.
This advisory applies to the following anti-depressants: bupropion (whether used for depression or for smoking cessation), citalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline and venlafaxine.
http://www.hc-sc.gc.ca/english/protection/warnings/2004/2004_44.htm
To come back to my point, above mentioned side-effects are to expected from Cymbalta (duloxetine).
Marilyn
Posted by JLM on August 14, 2004, at 7:37:35
In reply to Re: So, marilyn, please don't drop dead, posted by SLS on August 13, 2004, at 14:10:33
> > > I still don't understand what your point is.
> > > These drugs have side effects.This is not news.
> > > Is there anything else that you are trying to
> > > say beyond the fact that these drugs have side
> > > effects?
> >
> > Dear Scott,
> >
> > As a matter of fact, yes there is so much more I would like to say.
> >
> > First of all, since 1987, SSRI antidepressants are heavily marketed being completely safe and effective drugs.
>
> I disagree with you. This has not been my observation.
>
> I have been taking SSRIs since 1984 (indalpine). No one has ever portrayed to me that any antidepressant was "completely safe and effective". This is, in part, because I have had good doctors.
>
> I have never seen an advertisement in print or on TV making any such claims. Have you ever had the opportunity to view a TV advertisement for an SSRI that has made such a claim? On the contrary. For years, I have seen the drug companies place in their adds a list of possible adverse effects, many of them being quite serious. They also go out of their way to say that their drug is not for everyone, and that THEIR DOCTOR should be the one to make such determinations.
>
> Is this not true?
>
> > It is only very recently in this year, 2004, after so many reports of self-harm, suicidality and physical side-effects since 1987, that the FDA finally starts to recognize there should be stronger warning indications regarding these hazards.
>
> Which hazards? Which ones that are not already listed?
>
> I am glad that the FDA has finally seen fit to recognize that drug-induced suicidal states are a possible adverse effect of antidepressant medications. They are. There are many medications that can alter brain function in ways that bring about changes in mood and cognition. These include, but are not limited to, antidepressants. Prednisone, one of the most common treatments for pain, inflammation, and autoimmune disease, can produce depression and psychosis, and has precipitated severe pathological behaviors. This is old news. The medical community should be better educated in this area it seems. It is unfortunate that the FDA should ask for label warnings after the fact, but it is good that this has been rectified. To give the drug companies the benefit of the doubt, they are investigating a disease for which one of the symptoms is suicide. Perhaps they are not entirely negligent for not having been able to distinguish the differences any earlier.
>
> > How many children have been victimized throughout all of these years?
>
> I don't know. Do you have an estimate?
>
> > And how many more children will suffer of unrecognized side-effects in the future?
>
> Of course, this question can be asked of almost any drug, or of almost any human endeavor. I'm not sure Tylenol has been around long enough for us to be certain that no more "unrecognized" side effects will yet be recognized. There are thousands of serious people in medicine who are always asking this question. You are not alone.
>
> > I will give you an example of a young woman of 17 years of age who visited the doctor's office because she felt so tired prior to her school exam.
>
> What is her name, and where can I find the facts of this case so that I might scrutinize them?
>
> > He prescribed her the SSRI antidepressant Celexa also known as Cipramil and told her that it was completely safe to take and would give her more energy.
>
> Ah. We are now talking about the behavior of a specific doctor. What is his name?
>
> > Of course this doctor had his knowledge from a pharmaceutical representative and truely believed it would help her.
>
> Of course? How do we know this? If you are going to make statements as if they were fact, please describe how you know this to be true.
>
> > Within 5 days of ingesting Celexa, this young woman became a physical wreckage with severe signs of paraesteshia, extreme burnings in her face, arms and hands along with painful shooting sensations in her head, neck and spine.
>
> This might be true. I have no reason to believe that such a thing is not a medical possibility. Again, though, I am sure you will provide the source of your information or allow us to scrutinize it for ourselves, no?
>
> > 3 years later the symptoms are still there in their severity. She never finished her exam.
>
> > She couldn't play the piano anymore. This young woman -now 20 years of age- as well as her parents are desperate. No specialist is able to help her. No medication against neuralgia works.
>
> Has this case been published in any medical literature? I would be intereseted in reading it.
>
> > My question to you is: if this would be your daughter, how would you feel?
>
> Who's daughter is she? If you want an answer, lets get to the specific facts of this case. Who is this person?
>
> > Would you still explain these side-effetcs away as something innocent and short lived?
>
> > I doubt it.
>
> "Innocent" as opposed to "sinister"? Do you think something sinister is going on?
>
> I doubt it.
>
> > So that is my point.
>
> > Marilyn
>
> Marilyn, your point is a very serious one. It probably deserves to have provided facts and references so that we can better assess its validity.
>
> SSRIs are very powerful psychotropic drugs that are effective for many people and produce many side effects, some of which are serious. Among these are infrequent exacerbations of the illness itself. It is my opinion that these drugs belong in the pharmacopeia until better ones are discovered to supplant them.
>
>
> - Scott
>Scott,
"Perhaps they are not entirely negligent for not having been able to distinguish the differences any earlier."
That doesn't wash. Lilly could have went ahead and
carried out the Beasly Protocol, as they had promised the FDA, and chose not to. Is that perhaps because they feared what the result would be?
Posted by SLS on August 14, 2004, at 8:01:51
In reply to If this would be your daughter,how would you feel?, posted by Marilyn on August 14, 2004, at 6:45:17
> > Who's daughter is she? If you want an answer,
> > lets get to the specific facts of this case.
> > Who is this person?
>
> Dear Scott,
>
> Do medical physicians reveal the names of their patients to the public?Do you know this person? That's all I really want to know. Is this something that has happened to you personally? This is not a word game. You seem to have told a story that you have no personal knowledge of. There a lots and lots of stories to be found on the Internet.
> I am not asking you a difficult question.
No. You are asking me an obviously rhetorical question.
What would you like to see happen with duloxetine?
- Scott
Posted by SLS on August 14, 2004, at 8:27:00
In reply to Re: So, marilyn, please don't drop dead, posted by JLM on August 14, 2004, at 7:37:35
> That doesn't wash. Lilly could have went ahead and
> carried out the Beasly Protocol, as they had promised the FDA, and chose not to. Is that perhaps because they feared what the result would be?
I am not at all familiar with this. Were they asked to do this in the early 1990s in association with the law suits? I'm sure they did fear what the result would be. Someone must have had some suspicians. What is the Beasly Protocol?Thanks.
You might want to take a look at the Cymbalta labelling. It does cite treatment-emergent suicides as an infrequent occurrence.
- Scott
Posted by JLM on August 14, 2004, at 8:45:13
In reply to Re: So, marilyn, please don't drop dead, posted by SLS on August 14, 2004, at 8:27:00
> > That doesn't wash. Lilly could have went ahead and
> > carried out the Beasly Protocol, as they had promised the FDA, and chose not to. Is that perhaps because they feared what the result would be?
>
>
> I am not at all familiar with this. Were they asked to do this in the early 1990s in association with the law suits? I'm sure they did fear what the result would be. Someone must have had some suspicians. What is the Beasly Protocol?
>
> Thanks.
>
> You might want to take a look at the Cymbalta labelling. It does cite treatment-emergent suicides as an infrequent occurrence.
>
>
> - ScottScott:
"The short attachments to this paper contain deposition transcript excerpts and a couple of exhibits from a public domain deposition of Eli Lilly's Dr. Charles Beasley. Dr. Beasley was, for several years, Lilly's "point man" on the issue of SSRI induced suicidality. It was he who flew immediately from Indianapolis to Boston, in January of 1990, to meet with Dr. Martin Teicher in an attempt to neutralize the now famous Teicher & Cole articleii. It was he who authored the "meta-analysis" of Lilly's studies, an analysis which, among other serious flaws, excluded 76 out of 97 actual suicides! And it was this same Dr. Beasley who was the principal author of a study protocol, written with the input of "somewhere between 10 and 100" in-house and outside scientists. But more of that below.
On one particular day in late 1990 or early 1991, Dr. Beasley was a scrivener. His attached handwritten notes chronicle the concerns and recommendations of several very prominent outside consultants. These private concerns, voiced only in the veiled secrecy of the hallowed halls of Lilly corporate headquarters. Dr. Gary Tollefson, who would later come in-house and rise to a high executive level position at Lilly, said that it is "possible [that a] small # get paradox." (See my Puzzling Paradox of Prozac Induced Suicidality graphic at www.JusticeSeekers.com.) When he was still on the outside looking in, Dr. Tollefson suggested that the "risk" was related to "akathisia" and he recommended prospective studies of "agitated dp [depression], using sophisticated suicide scales." He even intimated that the study results should be "published."
Dr. Jan Fawcett realized that the company had "group data," but told Lilly that it "should look at cases." This Committee will hear many compelling cases. Big Pharma will urge you to brand them as mere "anecdotes" and relegate them to the field of "hypothesis generators." But, as Dr. Fawcett obviously realized, considerable scientific truth inheres in each of these cases. Each merits careful, individual evaluation.
But it was Dr. Jerold Rosenbaum, one of the chief public apologists for Lilly in 1991iii , that put it most bluntly:
data problems . . . if exist won't find " don't look " means find then rechallenge
Why was it that Dr. Rosenbaum was so concerned about finding the phenomenon by reviewing the existing data? He doesn't say. But there are many reasons why he should have been. One was that nobody was looking for the phenomenon when the data was gathered. The investigators were not sensitive to it and the rating scales were inadequate to detect it. Another was that seriously suicidal people were excluded from most of the clinical trials. Another was the drop outs or "lost to follow up." Yet another was the assumed rarity of the phenomenon. If it was as rare as Teicher and Cole themselves postulated, then it would take a very large study indeed to have adequate statistical "power" to detect and measure it. These and other reasons militated against finding the "needle in the haystack."
But another reason, one about which I queried Dr. Beasley in the deposition, was what I shall call the "robbing Peter to pay Paul" phenomenon. It was expressed to Lilly by Dr. Gordon Parker of New South Wales in a letter dated August 24, 1990. If, as everyone was willing to assume, Prozac was an effective antidepressant, then it would certainly reduce suicidality for some patients. Dr. Parker assumed a 15% reduction of suicidality in the fluoxetine (FT) group. ABut what if a small percentage (say 1%) of the FT patients had a paradoxical increase in suicidal ideation. The overall analysis would show FT to be superior to PT as both a general antidepressant and in reducing suicidal ideation " and the paradoxical side-effect phenomenon would be buried." Buried! Like a needle in the haystack!
So, back to Dr. Rosenbaum's recommendation. "Find then rechallenge." What result would that yield? As noted above, somewhere between 10 and 100 Lilly scientists rejected RCT's and rejected large scale epi studies in favor of this prospective study design. Find the group which Dr. J. John Mann had labeled as a "small vulnerable subpopulation" of patients, and rechallenge them, in protected circumstances, with Prozac. In the spring of 1991 Lilly met with officials at the FDA and pledged to conduct the Beasley Rechallenge Protocol. But Lilly reneged on that pledge, and to its shame and discredit, the FDA did not force them to honor it. Consequently, there has been no systematic study via rechallenge.
However, many of the "cases" before this Panel have elements of challenge-dechallenge and rechallenge. So, too, do many of the "case reports" published in peer reviewed journals. The most dramatic example, of course, is the 1991 article by Rothschild & Lockeiv. In 1991, years before he became a paid litigation expert for Eli Lilly, Anthony Rothschild and his colleague wrote that "the Patients need to be reassured that the overwhelming symptoms [of akathisia and its concomitant suicidality] being experienced are the side effects of medication and are treatable."
IF this Committee really wants to get a handle on the issue, then it should couple its laudable comprehensive review of the existing data with an insistence of appropriately designed and conducted, independent, prospective studies, preferably via rechallenge.
This will take time. In the meantime, in view of the paucity of evidence of real antidepressant efficacy in the children/adolescent population, the Committee should recommend that the FDA couple a contraindication of all SSRI's for children/adolescents with a warning about the very real dangers of SSRI induced suicidality and aggression. There are those who will argue that such a "ban" will deprive those patients who benefit from these drugs of their drug of choice. Not true. Informed physicians and informed patients can still choose to encounter the risks. After all, the Supreme Court itself has held that "off label" prescribing is still legal in this country. "
If you want to test whether a side effect is indeed REAL, then a simple way to do it is:
1. give it to a healthy volunteer
2. see if it happens
3. if it does, take them off the drug, and see
if it resolves.
4. give them the drug AGAIN, and see if they become suicidial again.Challenge/Dechallenge/Rechallenge
That is what Dr. Beasely proposed, what Lilly promised the FDA, and what was never carried out.
And obviously you want to give the drug to a healthy volunteer, so you don't have the easy out of 'well of course they killed themselves, they were depressed'
Posted by theo on August 14, 2004, at 9:15:18
In reply to Re: So, marilyn, please don't drop dead » SLS, posted by JLM on August 14, 2004, at 8:45:13
Is there a "healthy" blood test? Do they get hooked up to a lie detector? No! They do just what the word means, volunteer. The woman that committed suicide had tried before and had she disclosed this, there is know way they would have included her in the drug trial.
Yes, I would be upset if she were my daughter, but would also realize she did volunteer and not try to place the blame on someone else.
Posted by alesta on August 14, 2004, at 9:16:28
In reply to Re: So, marilyn, please don't drop dead, posted by SLS on August 13, 2004, at 14:10:33
hi, scott,
i'm not siding with anybody here (i'm staying out of THIS one), but did you say in another post that you have dementia? are you kidding me? you’re brilliant! no worries. :)
-Amy
Posted by JLM on August 14, 2004, at 10:05:11
In reply to How do you know the volunteer is healthy? » JLM, posted by theo on August 14, 2004, at 9:15:18
> Is there a "healthy" blood test? Do they get hooked up to a lie detector? No! They do just what the word means, volunteer. The woman that committed suicide had tried before and had she disclosed this, there is know way they would have included her in the drug trial.
>
> Yes, I would be upset if she were my daughter, but would also realize she did volunteer and not try to place the blame on someone else.Ummm, unbelievable really....
If Lilly's TRAINED psychiatrists can't reliably distinguish between healthy people and sick people, then perhaps they shouldn't have MD licenses. I mean, I call me funny but ;)
Posted by JLM on August 14, 2004, at 10:16:56
In reply to Re: So, marilyn, please don't drop dead--SLS, posted by alesta on August 14, 2004, at 9:16:28
Once again we're back to the standard Corporate line
from Lilly.The argument seems to be that even thou she was in a healthy volunteer study, she had a history of depression, and that being the case, its obvious
that our wonderful pill wasn't the cause of her suicide.Well, in order to believe that, you have to believe that Lilly's clinical investigators are so incompetent as to mislabel a 'sick' person as healthy for the purposes of the trial. Or that they use extreme shoddy screening procedures. Or both for that matter.
I question whether they should even be conducting
clinical trials at all if they are that incompitent.So you have two options:
1. she really was NOT a healthy volunteer, and Eli
Lilly's crack scientists just happened to miss that. Wow, I'm sure impressed with their scientific prowess2. she really WAS a healthy volunteer, and Cymbalta was the cause
and just for fun I'll add option 3.
3. the Easter Bunny made her do it.
Posted by Marilyn on August 14, 2004, at 10:50:00
In reply to Re: If this would be your daughter,how would you feel?, posted by SLS on August 14, 2004, at 8:01:51
> Do you know this person? That's all I really want to know.
Dear Scott,
That is a much better question. Yes, I know this person personally.
> You seem to have told a story that you have no
> personal knowledge of.That is a very cheap pure speculative assumption. And is not true either. I have personal knowledge of the story I told.
> What would you like to see happen with
> duloxetine?Obviously you seem to have problems to answer my question Scott. Instead you ask me this question which is totally unrelevant. It doesn't matter. I think I have made my point clearly enough to you.
Marilyn
Posted by theo on August 14, 2004, at 10:56:17
In reply to Re: How do you know the volunteer is healthy? » theo, posted by JLM on August 14, 2004, at 10:05:11
A psychiatrist can only help someone that's honest. If you're running down the street naked, that's one thing. If a person who is depressed walks in and says they are fine and never attempted suicide, are you telling me a psychiatrist can see inside their mind and go nope, I can tell, because I am a doctor, that you have attemted suicide in the past.
I psychiatrist is only helpful when you tell them your condition, they are not mind readers and anyone can act one way when they are feeling completely the opposite when they want something, it's called acting.
Posted by SLS on August 14, 2004, at 11:23:29
In reply to Re: How do you know the volunteer is healthy? » theo, posted by JLM on August 14, 2004, at 10:05:11
> > Is there a "healthy" blood test? Do they get hooked up to a lie detector? No! They do just what the word means, volunteer. The woman that committed suicide had tried before and had she disclosed this, there is know way they would have included her in the drug trial.
> >
> > Yes, I would be upset if she were my daughter, but would also realize she did volunteer and not try to place the blame on someone else.
>
> Ummm, unbelievable really....
>
> If Lilly's TRAINED psychiatrists can't reliably distinguish between healthy people and sick people, then perhaps they shouldn't have MD licenses. I mean, I call me funny but ;)
>This young woman was in dire need of money to continue her education. I fear that she might have made herself look very acceptable as a healthy volunteer.
- Scott
Posted by JLM on August 14, 2004, at 11:45:38
In reply to Re: How do you know the volunteer is healthy? » JLM, posted by theo on August 14, 2004, at 10:56:17
> A psychiatrist can only help someone that's honest. If you're running down the street naked, that's one thing. If a person who is depressed walks in and says they are fine and never attempted suicide, are you telling me a psychiatrist can see inside their mind and go nope, I can tell, because I am a doctor, that you have attemted suicide in the past.
>
> I psychiatrist is only helpful when you tell them your condition, they are not mind readers and anyone can act one way when they are feeling completely the opposite when they want something, it's called acting.So, the MADRS and HAM-D are invalid measuring insruments? After all these are the instruments
that are used in clinical trials to establish the
benefit of the drug. Should we not trust these either since the patietnt migth be 'acting'? If you assume that, then you should also assume that
the results of any clinical trial for AD are probably not valid. You can't have valid results
without a valid way to measure them.See, I thought depression was like diabetes. At least I have/had read that on some promo material from Lilly/GSK/Forrest. Hrm......
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