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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 26. This is the beginning of the thread.
Posted by rvanson on April 2, 2004, at 14:03:12
Los Angeles Times
A Godsend, Till a Life UnravelsFri Apr 2, 2004
By Alan Zarembo and Benedict Carey Times Staff Writers
INDIANAPOLIS — Traci Johnson believed it was God's plan for her to leave home to attend a tiny Bible college here — and she prayed every day for the Lord to provide for her tuition.
Then an unusual opportunity presented itself.
Eli Lilly & Co., the pharmaceutical giant headquartered a few miles from Indiana Bible College, was seeking healthy subjects for a live-in clinical drug trial. The 19-year-old freshman told her friends back home in Pennsylvania that the study was her best hope to stay in school.
"Trace, that don't sound right," her friend Colleen Jacoby told her. "I never heard of a human guinea pig".But the students at the Bible college knew all about the trials. They made perfect subjects for studies requiring healthy people — and they were used often, receiving hundreds, even thousands of dollars for a few weeks work.
If accepted into the study, she could make $150 a day for 49 days — more than a year's worth of her school expenses — for taking a drug known as duloxetine, an antidepressant that had already been given to thousands of people and was on the verge of approval by the Food and Drug Administration.
She had faith that God would find a way. "It was in his hands," she wrote in her diary.
Just before the new semester, a Lilly representative called. Her prayers were answered.A month later, she was dead.
The rest of the story is located at:
Posted by SLS on April 2, 2004, at 16:43:02
In reply to Duloxetine: antidepressant drug trial turns deadly, posted by rvanson on April 2, 2004, at 14:03:12
This was a very sad event. I'm not sure of its significance, though. What do you think happened? Do you feel that duloxetine carries a liability that other antidepressants do not? To me, it looks like a very safe and promising drug. I am eagerly awaiting its arrival.
- Scott
Posted by Ame Sans Vie on April 2, 2004, at 21:45:26
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by SLS on April 2, 2004, at 16:43:02
Posted by snapper on April 2, 2004, at 22:04:47
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by SLS on April 2, 2004, at 16:43:02
I have mixed feelings of hope for this new med. My mainstay for 8-9 yrs was fxr. I here that it is more potent on the NE aspect vs. SE. I am looking forward to it's release- I could never tolerate prozac- but found a way back to fxr more than once....I really wonder if it will hve any more novel of an AD effect then the other snri meds. Or will it just make us nervous, sweaty, and agitated, fatter and more sleepless.
I really hope it is sig. different - and yes it is a very, very sad fact of what happened to that girl !! I could'nt help but cry when I read the entire yahoo news clip!
S
Posted by Iansf on April 2, 2004, at 23:37:27
In reply to Duloxetine: antidepressant drug trial turns deadly, posted by rvanson on April 2, 2004, at 14:03:12
My god, the article says the study used doses six times that considered therapeutic for depression! What kind of study is that? Why in the world would Lilly test duloxetine using what would generally be regarded as an overdose? That's totally bizarre.
Posted by snapper on April 3, 2004, at 0:08:40
In reply to Duloxetine: antidepressant drug trial turns deadly, posted by Iansf on April 2, 2004, at 23:37:27
> My god, the article says the study used doses six times that considered therapeutic for depression! What kind of study is that? Why in the world would Lilly test duloxetine using what would generally be regarded as an overdose? That's totally bizarre.
I could be wrong , but I believe that when they do clinical trials, and especially with "normal" healthy subjects; they do this because they are in a very clinical controlled atmosphere or supposedly- the thing being that if some one in the "actual depressed population" would ingest that amount, they need to know that they would recover 'with out' (what they say in med. terms ) without 'sequele' also in studies -I believe that should something serious occur such as unexpected and severe adverse side effects or reactions, they would be able to provide prompt and appropriate medical intervention...Unfortantely they most likely did not see the poor girl as a serious risk for a potential suicide possibility. Sadly they missed something- that sad severe adverse effect in this case turned out to be death!! just my thoughts!!
Snapper
Posted by jack smith on April 3, 2004, at 2:21:09
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by SLS on April 2, 2004, at 16:43:02
>I am eagerly awaiting its arrival.
I don't think it is ever arriving. . . . Sorry to be a pessimist but with all the bs about AD's in the news lately, and the fact that this was supposed to have been approved a year and a half ago with a release date of February 2003 makes me think there is something we don't know about. I hope it comes out, but, frankly, I wouldn't bet a nickel on it. . . .
Check out this thread from over a YEAR ago.
http://www.dr-bob.org/babble/20030310/msgs/208072.html
JACK
Posted by rvanson on April 3, 2004, at 4:09:08
In reply to Re: Duloxetine: antidepressant drug trial turns deadly » SLS, posted by jack smith on April 3, 2004, at 2:21:09
> >I am eagerly awaiting its arrival.
>
> I don't think it is ever arriving. . . . Sorry to be a pessimist but with all the bs about AD's in the news lately, and the fact that this was supposed to have been approved a year and a half ago with a release date of February 2003 makes me think there is something we don't know about. I hope it comes out, but, frankly, I wouldn't bet a nickel on it. . . .<Nor would I. I think that the media overhypes the dangers of depression while overlooking the advantages of newer medications.....
I, for one, could never tolerate the histamine response of the "Tricyclic" class Anti-depressant meds like Imipramine, but so many P-docs these days shiver with fear , when you mention possibly using a dopamine enhancer, like the MAOI class meds.
In fact my current Pdoc says he wont prescribe the new segeline patch, no matter how well it may preform in the trials.
Oh well, yet another P-doc gets the boot by Rvanson :)
Posted by SLS on April 3, 2004, at 10:37:02
In reply to Re: Duloxetine: antidepressant drug trial turns deadly » SLS, posted by jack smith on April 3, 2004, at 2:21:09
Hi Jack.
> >I am eagerly awaiting its arrival.
> I don't think it is ever arriving. . . . Sorry to be a pessimist but with all the bs about AD's in the news lately,That is my fear.
> and the fact that this was supposed to have been approved a year and a half ago with a release date of February 2003 makes me think there is something we don't know about.
It was my understanding that there were only two issues that needed to be resolved before the FDA would grant final approval:
1. The condition of the factory building in which the drug is to be manufactured.
2. The wording of the label (package insert).
It looks like the investigation that used supposedly healthy volunteers in which the suicide occured was to study the pharmacokinetics of duloxetine. I have no idea why they would need to do such a study so late in the approval process.
- Scott
Posted by shadows721 on April 3, 2004, at 16:16:29
In reply to Duloxetine: antidepressant drug trial turns deadly, posted by rvanson on April 2, 2004, at 14:03:12
It does appear to me that the rapid decrease of the high dosage of this drug played a factor in this young woman's death. Since there was no note, it looks like this was an impulsive decision. She was predisposed to committing suicide from the previous history and should not have been accepted into this study.
What really got my attention was the comment by another in the study. She stated that people were laughing and crying inappropriately. That the room was like a mad house. That doesn't sit right with me. That sounds very odd. That sounds like this drug was really affecting one's mood too drastically. I have a feeling it had to do with dosage levels.
I am not a scientist, but it seems like this drug should have been tested on depressed people with no history of attempting suicide. How can you tell its really helping depression if the participants aren't depressed? For example, shouldn't a drug for high blood pressure be used on those with high blood pressure to see if it is effective?
I think there was a lack of conclusive data. In order to correctly conduct a study, there must be a group of those with the condition for which the medication is needed. Testing a drug on adults with no history of depression doesn't seem valid. It seems like a play with death to experiment so much on those without the condition for which the drug is not benefiting. That set of participants are only going to respond with side effects and no benefit.
Posted by Ame Sans Vie on April 3, 2004, at 16:42:16
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by shadows721 on April 3, 2004, at 16:16:29
> For example, shouldn't a drug for high blood pressure be used on those with high blood pressure to see if it is effective?
That was the point of this study, actually -- to test its cardiovascular side effects (arrhythmias, if I recall correctly). Studies testing its efficacy in depressed patients have already been completed.
Posted by shadows721 on April 3, 2004, at 18:23:30
In reply to Re: Duloxetine: antidepressant drug trial turns deadly » shadows721, posted by Ame Sans Vie on April 3, 2004, at 16:42:16
Yep, you are right that was mentioned. So, was it to see how much of the drug one's heart could stand? Still it didn't seem to me that they were taking in account that people were flipping out while they were doing that. I guess that statement about the mad house really stuck in my head. That sounded like they were inducing psychosis with those dosages while checking for arrythmias. That doesn't sound safe.
Posted by snapper on April 3, 2004, at 20:03:21
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by shadows721 on April 3, 2004, at 16:16:29
Shadows , I think you summed it up very well!!!
What the %$*%@! , is Eli Lilly thinking- this drug has its roots of conception dating way back to 1990 and more likely the 80's. Is it for Urinary Incontinence or DEPRESSION? I really do think that Lilly is "Playing Cards" that they don't know what to do with!! Effexxor and XR was heavily promoted as "Prozac with a Punch"- I never could tolerate Prozac, but some how tolerated FXR for 8-10 years much more easily. Who really knows I just know its not a "manufacturing thing" I really think it has to do with Market timing and wallstreet, and other things- If it was going to be a Novel AD wouldn't we all think that it would have been out before now. I am sorry for sounding so negative (obviously my depression speaking) but dang it I wish they would quit playing Russian Roulette with peoples brains; healthy subjects or not!
snapper
Posted by Sad Panda on April 4, 2004, at 1:36:09
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by snapper on April 3, 2004, at 20:03:21
> Effexxor and XR was heavily promoted as "Prozac with a Punch"- I never could tolerate Prozac, but some how tolerated FXR for 8-10 years much more easily.
>
>Same here. I hated Prozac, like Effexor.
I don't think Duloxetine is going to be a wonder drug.
I wish they marketed Atomoxetine for depression so that I could get it here in Australia. It makes more sense to me to have SRI's & NRI's seperate so you can alter the dosage of each to suit your needs.
Cheers,
Panda.
Posted by snapper on April 4, 2004, at 1:58:04
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by Sad Panda on April 4, 2004, at 1:36:09
> > Effexxor and XR was heavily promoted as "Prozac with a Punch"- I never could tolerate Prozac, but some how tolerated FXR for 8-10 years much more easily.
> >
> >
>
> Same here. I hated Prozac, like Effexor.
>
> I don't think Duloxetine is going to be a wonder drug.
>
> I wish they marketed Atomoxetine for depression so that I could get it here in Australia. It makes more sense to me to have SRI's & NRI's seperate so you can alter the dosage of each to suit your needs.
>
> Cheers,
> Panda.
>
.Esentially they do market the two -to a degree an sri plus reboxetine, but I don't think that is where the synergisim is connected- I think it's something within the compound of efx. itself and at higher doses etc, it effects in ascending order -low to med.=NE then middle dose SE+NE then 225 to 375 and above SE+NE and some dopamine!! We definitely need more options!
snapper
Posted by Keith Talent on April 4, 2004, at 3:41:02
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by snapper on April 4, 2004, at 1:58:04
I think that in Australia we need the use of stimulants as augmenting agents to become de rigeur.
Posted by Sad Panda on April 4, 2004, at 4:11:14
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by Keith Talent on April 4, 2004, at 3:41:02
> I think that in Australia we need the use of stimulants as augmenting agents to become de rigeur.
>
LOL! That'll happen. You are lucky to get them for ADD.:)
Cheers,
Panda.
Posted by SLS on April 4, 2004, at 7:10:36
In reply to Re: Duloxetine: antidepressant drug trial turns deadly » shadows721, posted by Ame Sans Vie on April 3, 2004, at 16:42:16
> > > It looks like the investigation that used supposedly healthy volunteers in which the suicide occured was to study the pharmacokinetics of duloxetine. I have no idea why they would need to do such a study so late in the approval process
> That was the point of this study, actually -- to test its cardiovascular side effects (arrhythmias, if I recall correctly).
Ah. Now that makes sense. Thanks. How did you find out?
- Scott
Posted by SLS on April 4, 2004, at 7:28:45
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by snapper on April 4, 2004, at 1:58:04
> We definitely need more options!
Of course! That is the point! That is exactly what duloxetine is - another option! Who cares how similar it is to other drugs, as long as it is different enough to get ME well!!! It is as simple as that.
How many people respond to Zoloft who do not respond to Prozac? How many people respond to Paxil who do not respond to Zoloft? How many people respond to Prozac who do not respond to Paxil? Talk about drugs being similar - there are people for whom Lexapro is better than Celexa. What's more, there are people who respond better to Celexa than they do to Lexapro! It is as simple as that.
For every new antidepressant that comes to market, a certain percentage of people who have been treatment-resistant to all others will respond and achieve remission. It is as simple as that.
I want to make duloxetine the very next drug I try. From everything I have read, it seems to be safe and effective. The FDA deems it so as well. For me, it is as simple as that.
- Scott
Posted by snapper on April 4, 2004, at 13:40:15
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by SLS on April 4, 2004, at 7:28:45
Scott, you make a very valid point. I will likely be in line to try it as well -but right now, being minimally medicated is killing me! I hope I don't have to go back on Effexor in the mean time cuz my pdoc seems to think all I want to do is change meds while in fact many of them have either pooped out-become less effective or the SE's were just intolerable!
Snapper
Posted by jdgjdg on April 5, 2004, at 22:30:15
In reply to Duloxetine: antidepressant drug trial turns deadly, posted by rvanson on April 2, 2004, at 14:03:12
They have known for a long time that these type of dosages(especially with teenagers and kids) can cause problems. This obviously shows the importance of slowly weaning off of these meds. I read about similar circumstances in the papers not too long ago. The statistics right now just can't prove what/who is responsible for these suicides. You have to take in consideration that these people are depressed. That is why they qualify for the studies in the first place. Jenn
Posted by Ame Sans Vie on April 6, 2004, at 8:23:45
In reply to Re: Duloxetine: antidepressant drug trial turns deadly » Ame Sans Vie, posted by SLS on April 4, 2004, at 7:10:36
It says so in the article :-)
"The drug already had been tested in 8,500 people, but the FDA wanted one last clinical trial to measure its effect on heart rhythm. It would use doses as much as up to five times that recommended for incontinence, and six times the dose for depression."
Posted by Rayray on April 11, 2004, at 11:54:28
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by snapper on April 3, 2004, at 0:08:40
> > My god, the article says the study used doses six times that considered therapeutic for depression! What kind of study is that? Why in the world would Lilly test duloxetine using what would generally be regarded as an overdose? That's totally bizarre.
>
> I could be wrong , but I believe that when they do clinical trials, and especially with "normal" healthy subjects; they do this because they are in a very clinical controlled atmosphere or supposedly- the thing being that if some one in the "actual depressed population" would ingest that amount, they need to know that they would recover 'with out' (what they say in med. terms ) without 'sequele' also in studies -I believe that should something serious occur such as unexpected and severe adverse side effects or reactions, they would be able to provide prompt and appropriate medical intervention...Unfortantely they most likely did not see the poor girl as a serious risk for a potential suicide possibility. Sadly they missed something- that sad severe adverse effect in this case turned out to be death!! just my thoughts!!
>
> Snapper
>I understand the need for drug companies to test drugs on healthy volunteers and the need to establish safety thresholds. What I haven't seen discussed regarding the recent suicide victim in the duloxetine trial is the role played by abrupt cessation of these meds.
According to the Miami Herald (3/22/04), "Johnson had taken duloxetine for 20 days during the study, which included doses as high as five times normal, but she had been on a placebo for four days when she died, according to Lilly."
Posters to these highly valuable boards write frequently of the horror shows attending sudden stoppage of meds -- particularly Effexor from what I see. I wish drug companies would pay more attention to this.
It would be a shame if what may be a significant breakthrough like duloxetine is delayed or derailed by media sensationalism or inadequate analysis.
Personally, I feel like I am "pooping out" on Zoloft 150mg + 300mg Wellbutin per day and am not sure where to go next. I was hoping duloxetine would be the answer.
Does anybody know anything about the current release status of Cymbalta or does this summer still look like a bet?
Rayray
Posted by SLS on April 12, 2004, at 7:08:07
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by Rayray on April 11, 2004, at 11:54:28
> Does anybody know anything about the current release status of Cymbalta or does this summer still look like a bet?
I e-mailed Eli Lilly the other day regarding this. I'm still waiting for an answer.
- Scott
Posted by striped_moose on April 13, 2004, at 20:50:07
In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by SLS on April 12, 2004, at 7:08:07
Saw this today on PuertoRico.com (dated today):
[quote]
Eli Lilly expects approval by this summer of a new depression drug called Cymbalta, estimated to earn up to $2 billion in annual sales. After Prozac’s patent expiration in 2001, the company is counting on new drugs such as Strattera (for attention-deficit disorder), Symbyax (depression), and protein kinase C (a beta inhibitor for diabetes) to increase sales. All three drugs are scheduled to be manufactured in Puerto Rico once the $125 million expansion of Eli Lilly’s state-of-the-art bulk manufacturing facility in Mayaguez is completed, adding 150 people to the plant’s work force.
[/quote]I thought the "problems with manufacturing" that they have been stating were the reason for the delay in getting the product to market were actual problems with an American plant. Apparently, they're expanding a factory and work force in Puerto Rico.
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