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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 81 to 105 of 166. Go back in thread:
Posted by linkadge on July 11, 2006, at 21:07:42
In reply to Re: couldn't have said it better myself, posted by Klavot on July 11, 2006, at 17:53:24
One example would be the fact that a drug company does not have to publish or disclose any information on failed drug trials.
Lilly can test prozac and have it fail 9 times out of 10. It is allowed to present the marginal results of a trail or two to get the drug approved.
Some people may not lable that as a conspiracy, but it does show that a company can call a drug "effective" when a analysis of all the information migh lead to no such picture.
Another example might be the fact that Glaxo was fined for supressing information about the likelyhood of paxil to induce suicidiality in children. I suppose they figure nobody wants to know that, so they keep it a secret, and now it has come to the surface.
Linkadge
Posted by linkadge on July 11, 2006, at 21:31:58
In reply to Re: couldn't have said it better myself, posted by Klavot on July 11, 2006, at 18:34:40
I am not against the idea of medication for depression at all. I don't think the idea of medicating depression is wrong.
I just think it is important that people know the whole truth about the drugs.
Some may argue that it is in the patient's best interest that an unrealistically rosey picture of drug performance be presented.
But, if the drugs don't work for you then it might be good to know the whole truth so that you aren't made to feel even crazier than you are.
I did very poorly on antidepressants, and so I was told that I had all sorts of other disorders. I was essentially told that the drugs worked 99% of the time, so I kept trying them. 30 something different psychiatric medications later, I threw in the towel. (I'm only 23).
I'm not telling people not to try drugs, or to have hope in them. I guess I just wish I had an accurate picture of the drugs performance so that I might look to other ways to heal.
Linkadge
Posted by linkadge on July 11, 2006, at 21:33:16
In reply to Re: couldn't have said it better myself, posted by SLS on July 11, 2006, at 18:41:25
>In my opinion, the real response to a drug will >occur whether or not a placebo is being >swallowed by the patient in the next room
Allong the same lines, a true responce to a placebo will occur whether or not an active drug is being swallowed by the patient in the next room.
Linkadge
Posted by gardenergirl on July 11, 2006, at 21:46:36
In reply to Re: couldn't have said it better myself, posted by Phillipa on July 11, 2006, at 19:17:13
> In my opinion the AD's dont work.
I think you're basing this opinion on a relatively small and skewed sample. Or maybe you're saying they don't work for you, which could indicate that depression is not what you're dealing with.
gg
Posted by Phillipa on July 11, 2006, at 22:09:10
In reply to Re: couldn't have said it better myself » Phillipa, posted by gardenergirl on July 11, 2006, at 21:46:36
gg what do you think I'm dealing with in your opinion as I've spent so much money on Ad's. I'm starting the lamictal. But I don't have mood swings. I would be forever grateful to you if you had any ideas. Just ideas. Thanks Phillipa ps it gets so frustrating as I want to go back to work.
Posted by SLS on July 12, 2006, at 5:45:59
In reply to Re: couldn't have said it better myself, posted by Phillipa on July 11, 2006, at 19:17:13
> Well as uninformed as I may be compared to a lot of you I base my position on the fact that not one of the antidepressants has done a thing in the ten years I'm been on them.
This is precisely where I feel I must have an advantage. I have responded robustly to antidepressants on several occasions. I know they work. I can work backwards from there.
- Scott
Posted by SLS on July 12, 2006, at 5:49:52
In reply to Re: couldn't have said it better myself, posted by linkadge on July 11, 2006, at 21:33:16
> >In my opinion, the real response to a drug will >occur whether or not a placebo is being >swallowed by the patient in the next room
>
> Allong the same lines, a true responce to a placebo will occur whether or not an active drug is being swallowed by the patient in the next room.
>
> LinkadgePrecisely. There is no need to have a placebo control for every investigation devised by man. The phenomenology of the placebo response is well quantized. It makes no sense to waste thousands of lives in the STAR*D protocol to test algorithms for drugs that have already been separated from placebo in previous trials.
- Scott
Posted by SLS on July 12, 2006, at 6:14:48
In reply to Re: couldn't have said it better myself » linkadge, posted by SLS on July 12, 2006, at 5:49:52
> > >In my opinion, the real response to a drug will >occur whether or not a placebo is being >swallowed by the patient in the next room
> >
> > Allong the same lines, a true responce to a placebo will occur whether or not an active drug is being swallowed by the patient in the next room.
> >
> > Linkadge
>
> Precisely. There is no need to have a placebo control for every investigation devised by man. The phenomenology of the placebo response is well quantized. It makes no sense to waste thousands of lives in the STAR*D protocol to test algorithms for drugs that have already been separated from placebo in previous trials.Here is an example of a study group smart enough to use the historical records of previous placebo-controlled investigations as comparators for their own three-tier antidepressant remission protocol. It seems to echo the STAR*D findings.
- Scott
Posted by SLS on July 12, 2006, at 7:45:29
In reply to Re: couldn't have said it better myself » linkadge, posted by SLS on July 12, 2006, at 5:49:52
> > >In my opinion, the real response to a drug will >occur whether or not a placebo is being >swallowed by the patient in the next room
> >
> > Allong the same lines, a true responce to a placebo will occur whether or not an active drug is being swallowed by the patient in the next room.
> >
> > Linkadge
>
> Precisely. There is no need to have a placebo control for every investigation devised by man. The phenomenology of the placebo response is well quantized. It makes no sense to waste thousands of lives in the STAR*D protocol to test algorithms for drugs that have already been separated from placebo in previous trials.I guess that was a unclear. What I meant to say is that it makes no sense to waste thousands of lives in a protocol that allocates subjects to a placebo when the drugs being used have already separated themselves from placebo countless of times previously in controlled trials.
- Scott
Posted by Klavot on July 12, 2006, at 8:02:12
In reply to Re: couldn't have said it better myself, posted by SLS on July 12, 2006, at 7:45:29
Apparently there is also correlation between too much sleep and Parkinson's; see
Posted by Phillipa on July 12, 2006, at 10:25:58
In reply to Re: couldn't have said it better myself, posted by SLS on July 12, 2006, at 7:45:29
Scott if you've never responded to an antidepressant does that mean I'm not depressed? That there is something physically wrong even through all my blood test, MRI's have been normal? Love Phillipa.
Posted by SLS on July 12, 2006, at 14:02:01
In reply to Re: couldn't have said it better myself » SLS, posted by Phillipa on July 12, 2006, at 10:25:58
> Scott if you've never responded to an antidepressant does that mean I'm not depressed? That there is something physically wrong even through all my blood test, MRI's have been normal? Love Phillipa.
Obviously, there is some percentage of people with major depression whom don't respond to currently available treatments. You may be in this group. It is also possible that you do not suffer from an affective illness at all, and that there is nothing to be gained from antidepressant therapy.
What is it about what you experience that leads you to believe that you are depressed?
In what ways does Valium help you?
- Scott
Posted by linkadge on July 12, 2006, at 15:52:02
In reply to Re: couldn't have said it better myself » Phillipa, posted by SLS on July 12, 2006, at 5:45:59
>This is precisely where I feel I must have an >advantage. I have responded robustly to >antidepressants on several occasions. I know >they work. I can work backwards from there
I don't call working short term, actually working. Cocaine works short term. MDMA works short term.
I don't think the antidepressants are any different. Why should they work long term? There certainly isn't any clincial data to support the hypothesis that they should work forever. That was just assumed I suppose.
First you filter out the people who don't respond at all, then you filter out the people who respond initially but whoose response poops out. What then do you have left?
Linkadge
Posted by linkadge on July 12, 2006, at 16:06:40
In reply to Re: couldn't have said it better myself » linkadge, posted by SLS on July 12, 2006, at 5:49:52
>It makes no sense to waste thousands of lives >in the STAR*D protocol to test algorithms for >drugs that have already been separated from >placebo in previous trials.
Like I said above, even the 'approved' group of antidepressants may only be better than placebo in 1 out of 10 trials, but because of the way the system works, a drug company can retain all information about failed drug trials. So, to continue to compare these drugs to placebo is absolutely necessary to get the whole picture.
For instance, had a placebo not been used in the SJW, sertaline, placebo trial, we wouldn't have seen that sertraline (a drug that has already supposedly 'separated' itself from placebo) actually performed worse than placebo.
Another reason why it is important to use a placebo to try and guage just how many people might be experiencing placebo effect is because placebo effect will likely not last as long as a real drug effect. So if a good portion of those 50% that ended up responding were actually experiencing placebo effect, then that information could be of major relavance to the patient's long term outcome.
Ie change the study title to, "50% of people can find relief by the third antidepressant but 45% can find relief by the third placebo".All of a sudden, that placebo tells us a whole lot more. To throw away that placebo, is only to fool yourself really.
Linkadge
Posted by linkadge on July 12, 2006, at 16:13:04
In reply to Re: couldn't have said it better myself, posted by SLS on July 12, 2006, at 6:14:48
The below link is not a trial, it is simply a separate summary of some of the inherent problems associated with our currant biases.http://biopsychiatry.com/antidepskep.htm
Linkadge
Posted by linkadge on July 12, 2006, at 16:16:24
In reply to Re: couldn't have said it better myself, posted by SLS on July 12, 2006, at 7:45:29
>I guess that was a unclear. What I meant to say >is that it makes no sense to waste thousands of >lives in a protocol that allocates subjects to >a placebo when the drugs being used have >already separated themselves from placebo >countless of times previously in controlled >trials.
Well, if the placebo is performing better than the active drug, then it makes no sense to waste thousands of lives in a protocol that allocates subjects to an active drug when placebos being used have already separated themselves from placebo countless of times previously in controlled trials.
"Countless" times is nonsensicle IMHO. Remember, a drug company does not have to disclose information about failed clinical trials. Therefore, of course, all you are going to see are the positive trials.
Linkadge
Posted by ttee on July 14, 2006, at 13:09:49
In reply to Re: couldn't have said it better myself » linkadge, posted by SLS on July 10, 2006, at 21:34:12
Off course Mirtazapine and Nortriptyline did not fare well in the Star*D study, as they are both off patent and the scientist don't have to worry about a drug company cutting off their funding.
> > Language, and heated tone asside, he made some very valid points. Why was a placebo arm not used?
>
> I don't believe it was the goal of the study to separate out an active treatment from a placebo. It was an attempt to test treatment algorithms in real-world clinical settings and determine treatment success rates. Placebo response rates in double-blind clinical trials are already well established.
>
> > Were thay afraid of what it might show ?
>
> What makes you think that they would be afraid to show anything? More conspiracy theories? They certainly weren't afraid to show the dismal results of the third step of their treatment algorithm. Neither mirtazapine nor nortriptyline monotherapy produced a remission rate of 20% for those who had failed to respond adequately to the two previous steps. Their reporting was manifestly unbiased. There was no attempt made to declare any of the treatments used as producing a remission rate of greater than 50%.
>
>
> - Scott
>
Posted by SLS on July 14, 2006, at 22:55:22
In reply to Re: couldn't have said it better myself, posted by ttee on July 14, 2006, at 13:09:49
> Off course Mirtazapine and Nortriptyline did not fare well in the Star*D study, as they are both off patent and the scientist don't have to worry about a drug company cutting off their funding.
You might want to read this:
http://www.nimh.nih.gov/healthinformation/stard_qa_general.cfm
- Scott
Posted by linkadge on July 15, 2006, at 0:33:56
In reply to Re: couldn't have said it better myself, posted by SLS on July 14, 2006, at 22:55:22
All I could detect from that document about the possability of drug company influence was:
"the pharmaceutical companies had no other input into the design or implementation of the study, nor did they have involvement in planning or conducting the data analyses, and they did not participate in preparing manuscripts for publication."
But the problem is, that there were associations and financial ties between the drug comapanies and certain individuals who did have hand in the study. So no, the drug company may not have directly influenced the study, but if one of the study's authorities is in a position where they can personally profit from the sucess of the drug in question, it does not completely absolve the study from a possable degree of corruption.Linkadge
Posted by linkadge on July 15, 2006, at 0:41:57
In reply to Re: couldn't have said it better myself, posted by SLS on July 14, 2006, at 22:55:22
The claim made by the first article I posted was this:
The two lead STAR*D investigators Dr. A. John Rush and Dr. Madhukar H. Trivedi receive consulting fees from or served on the advisory boards for Forest Pharmaceuticals (Celexa), Wyeth-Ayerst Laboratories (Effexor), and Bristol-Myers Squibb (Buspar); while Dr. Rush has such a relationship with GlaxoSmithKline (Wellbutrin) and Dr. Tiveldi has such a relationship with Pfizer (Zoloft); and Dr. Rush has an equity interest in Pfizer. Both have received speaker fees from Forest Pharmaceuticals; Dr. Rush has received speaker fees from GlaxoSmithKline; and Dr. Trivedi has received speaker fees from Wyeth-Ayerst Laboratories and Bristol-Myers Squibb.
-----------
That information may be incorrect, but if it is correct, it would seem to be reason enough to believe that data could be squewed in any possable direction.
Statistical analysis is not an exact science, and there are likely hundreds of ways to collect data in ones own favor. That is why I would think it necessary to produce a study in which those in charge don't give a rats behind if the drug fails.
Linkadge
Posted by cecilia on July 15, 2006, at 1:45:08
In reply to Re: couldn't have said it better myself, posted by linkadge on July 15, 2006, at 0:41:57
I think a study needs to be done on who participates in studies and why. The Star-D was supposed to be more like real world practice, because the participants had more choices in treatment options than in most studies, but since all the drugs used were ones already on the market, not experimental ones otherwise unavailable, I don't see what the participants got out of it other than free meds. If that was there primary reason for participation, than it's certainly not a random sample of depressed people, it's a sample of depressed low income people without insurance. In other words, people with plenty of reasons to be depressed that aren't fixable by meds. Cecilia
Posted by SLS on July 15, 2006, at 5:58:14
In reply to Re: couldn't have said it better myself, posted by cecilia on July 15, 2006, at 1:45:08
> I think a study needs to be done on who participates in studies and why. The Star-D was supposed to be more like real world practice, because the participants had more choices in treatment options than in most studies, but since all the drugs used were ones already on the market, not experimental ones otherwise unavailable, I don't see what the participants got out of it other than free meds. If that was there primary reason for participation, than it's certainly not a random sample of depressed people, it's a sample of depressed low income people without insurance. In other words, people with plenty of reasons to be depressed that aren't fixable by meds.
If this were true, it would then it becomes that much more significant that the medications used brought the majority of subjects into comlete remission, right?
In actuality, the demographics of the patient population entering the study was well documented. I thought that was made clear in the publication I cited.
Regarding the motivations of the patients, I think one could infer from their documented failed treatment histories that they were desperate for a different strategy of care from a new panel of experts.
"Representative of national ethnic and socioeconomic populations, the study participants were outpatients ages 18-75 who scored high enough on a standard depression rating scale to be diagnosed with major depression. They included some of the most chronic patients with depression. More than a third of the participants were under age 18 when they first experienced depression, 75 percent had at least two episodes of depression, and for 25 percent the current episode of depression had lasted for at least two years."
http://www.nimh.nih.gov/press/stard.cfm
Now, this is true, and it is indeed significant that the medications used brought the majority of subjects into comlete remission, right?
These drugs do work for the majority of people accurately identified as suffering from MDD. The evidence is overwhelming.
- Scott
Posted by cecilia on July 15, 2006, at 6:46:39
In reply to Re: couldn't have said it better myself, posted by SLS on July 15, 2006, at 5:58:14
Well, something about the study still doesn't make sense. The drugs used were common, frequently used AD's and yet presumably people wouldn't be allowed into the study if they had already tried them without success. Where did they find these people with chronic treatment resistant depression who had never tried any of the most frequently used meds? Still, it seems like this study did use a more varied population than most studies which have incredibly strict and specific criteria for inclusion. When I had rTMS in Canada it sounded like virtually everyone there had gone there because they had been refused inclusion in the rTMS study in my home city. I've never tried to get into a drug study, but I'm sure I'd be refused because I've tried so many meds, because I have anxiety as well as depression, because I have a number of medical problems with associated meds, and because my depression is chronic. (The latter was the stated reason I was refused the rTMS study.) Even though it was expensive and didn't work, I was just as glad to have the rTMS in Canada and not have to go through a possible "Sham" study. But anyway, I just think studies in general need to be reviewed to see how the selected population affects the results. It's no surprise for example that so many people here on Emsam reported anxiety and insomnia-the Emsam studies were testing for depression and specifically excluded participants with anxiety. Cecilia
Posted by cecilia on July 15, 2006, at 7:02:43
In reply to Re: couldn't have said it better myself, posted by SLS on July 15, 2006, at 5:58:14
You definitely have a more optimistic outlook than me, Scott! You see the glass as half full, the people who did achieve good results. I see the glass as half empty, all the people who went through the different phases of the study and still didn't get any better. And as others have pointed out, since there was no placebo arm we have no idea what percentage of the people with good results were placebo responders. It seems to me that a study with no placebo arm is going to have a much higher percentage of placebo responders than one without, simply because everyone knows for sure they are getting a real drug and have higher expectations. Cecilia
Posted by SLS on July 15, 2006, at 7:15:39
In reply to Re: couldn't have said it better myself, posted by cecilia on July 15, 2006, at 6:46:39
> Well, something about the study still doesn't make sense. The drugs used were common, frequently used AD's and yet presumably people wouldn't be allowed into the study if they had already tried them without success.
I don't think we can make this presumption. Not at all.
> Where did they find these people with chronic treatment resistant depression who had never tried any of the most frequently used meds?
Again, you are acting on a presumption that is never applied in any other clinical study of antidepressants. Placing people on drugs that they have tried already occurs all of the time in controlled trials using comparators.
In any event, people were described in detail before entering the study which drugs were to be used. Again, this was described in the publications I cited. STAR*D was a monumentally important study. That it was provided only 35 million dollars is shameful.
> Still, it seems like this study did use a more varied population than most studies which have incredibly strict and specific criteria for inclusion.
It is my contention that the problem with clinical trials of antidepressants is precisely that the inclusion criteria are not rigid enough. Too many people with mild to moderate psychogenic depressions are allowed to participate. That is why the rate of placebo response is so high, and perhaps why the rate of response for the active compound is so low.
> When I had rTMS in Canada it sounded like virtually everyone there had gone there because they had been refused inclusion in the rTMS study in my home city.
They were deselecting for difficult cases that would reduce their response rate. This is very much different from what we are discussing here.
> I've never tried to get into a drug study, but I'm sure I'd be refused because I've tried so many meds, because I have anxiety as well as depression, because I have a number of medical problems with associated meds, and because my depression is chronic.
Again, if this were a clinical trial designed to get a drug approved for marketing, you would be deselected in order to insure a high success rate.
STAR*D had no such designs, and thus did not deselect difficult to treat cases. On the contrary, the nature of their recruitment process skewed the patient population towards these cases. This makes the positive results they obtained all the more encouraging.
- Scott
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