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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 64 to 88 of 123. Go back in thread:
Posted by jhj on September 13, 2007, at 1:27:43
In reply to STAR*D study, 33% sucess with first AD, posted by sam123 on September 12, 2007, at 9:55:54
Please do not mention about STAR*D study here.You read the comments made on STAR*D study here in reponse to another thread."Without a placebo arm, the results are kind of meaningless.
Linkadge"
Then,here is one by another very knowledgable person to the same thread.
"Exactly - what waste of time, money and effort. It's also not clear what samples or populations the percentages refer to"
If you want to know about the person and the quality of that person,here it is.
"I'm a statistician so I'm hopefully not talking out of my a**e Fred"
Posted by sam123 on September 13, 2007, at 8:31:15
In reply to Re: STAR*D study, 33% sucess with first AD-sam123, posted by jhj on September 13, 2007, at 1:27:43
>
> Please do not mention about STAR*D study here.You read the comments made on STAR*D study here in reponse to another thread.
>
I disagree with that point and will post what I like where I like.
Posted by Larry Hoover on September 13, 2007, at 9:16:25
In reply to Re: News - Antidepressants Vindicated?))SAM, posted by jhj on September 13, 2007, at 0:47:25
> If placebo pill is able to work as well as ADs with out any side effect then,why people should be made suffer from the side effects and increased risk of suicidal tendancies? Thanks.
The problem is that placebos do not work as well as antidepressant drugs, and antidepressants do not increase suicidality.
Ecological studies, i.e. those that study real people in real life situations, clearly demonstrate the benefits of antidepressant medication. Only post hoc analysis of the artificial constructs known as clinical efficacy trials provide any suggestion of induced suicidality, but those suggestions can only properly be used to develop hypotheses for further study. Those further studies reveal the hypothesis to be unfounded, overall. Stratification by age does show a differential response in younger people, towards self-harm, but not completed suicide.
Full-text of 'Antidepressant treatment and the risk of fatal and non-fatal self harm in first episode depression: nested case-control study.'
http://www.bmj.com/cgi/content/full/330/7488/389Full-text of 'The relationship between antidepressant medication use and rate of suicide.'
http://archpsyc.ama-assn.org/cgi/content/full/62/2/165Am J Psychiatry. 2007 Jul;164(7):1044-9.
Relationship between antidepressants and suicide attempts: an analysis of the Veterans Health Administration data sets.Gibbons RD, Brown CH, Hur K, Marcus SM, Bhaumik DK, Mann JJ.
Center for Health Statistics, University of Illinois at Chicago, Chicago, IL 60614, USA. rdgib@uic.eduOBJECTIVE: In late 2006, a U.S. Food and Drug Administration advisory committee recommended that the 2004 black box warning regarding suicidality in pediatric patients receiving antidepressants be extended to include young adults. This study examined the relationship between antidepressant treatment and suicide attempts in adult patients in the Veterans Administration health care system. METHOD: The authors analyzed data on 226,866 veterans who received a diagnosis of depression in 2003 or 2004, had at least 6 months of follow-up, and had no history of depression from 2000 to 2002. Suicide attempt rates overall as well as before and after initiation of antidepressant therapy were compared for patients who received selective serotonin reuptake inhibitors (SSRIs), new-generation non-serotonergic-specific (non-SSRI) antidepressants (bupropion, mirtazapine, nefazodone, and venlafaxine), tricyclic antidepressants, or no antidepressant. Age group analyses were also performed. RESULTS: Suicide attempt rates were lower among patients who were treated with antidepressants than among those who were not, with a statistically significant odds ratio for SSRIs and tricyclics. For SSRIs versus no antidepressant, this effect was significant in all adult age groups. Suicide attempt rates were also higher prior to treatment than after the start of treatment, with a significant relative risk for SSRIs and for non-SSRIs. For SSRIs, this effect was seen in all adult age groups and was significant in all but the 18-25 group. CONCLUSIONS: These findings suggest that SSRI treatment has a protective effect in all adult age groups. They do not support the hypothesis that SSRI treatment places patients at greater risk of suicide.
Lar
Posted by ttee on September 13, 2007, at 9:17:48
In reply to Re: News - Antidepressants Vindicated?))SAM, posted by jhj on September 13, 2007, at 0:47:25
SAM -I understand what you are saying, but I don't think so much "faith" should be left to clinical trail data. It is my understanding that most all the AD clinical trials enroll subjects that are not like (unreal) us, and the majority of those with depression. They exclude people that have ever taken failed an AD, have any other psychiatric diagnosis, or any other common psychical health problems. It is no wonder that in the clinical trials that the placebo does well. The randomized subjects are primed to do well no matter what you do. I would argue that if there was a third arm in many of the studies, that gave no active pill, and no active placebo, lots of these less-ill to begin with patients will do about as well as both the active pill and placebo. In the real world, with patients like us at Babble, who many are much more ill, treatment resistant, anxiety disorders, and other psychiatric problems, in addition to other non-psychiatric health problems; I postulate that this class of patients does not experience the placebo effect that is found in the unrealistic patient group from the clinical trial. . Placebo rates are often around 30% or more in depression trials. You can't keep them on placebo forever but usually the response wanes over time. Someone with chronic and refractory depression has a much lower placebo response.
> I have come to conclusion after long thought that pdoctors around the world should provide placebo instead of antidepressants in the best interest of patients.The reason is that all the patients benefiting from ADs are due to faith in the treatment and hence,they would have the same benefits even if they take dummy pill assuming that the pills are actually antidepressants.Not only that they would also be saved from suffering the debilitating side effects of ADs and there would be no increase in suicidal tendancies.So,irrespective of whether patient is child or adult,psychiatrists should not have any problem in misleading person by providing placebo instead of active antidepressants in the benefits of patient.If placebo pill is able to work as well as ADs with out any side effect then,why people should be made suffer from the side effects and increased risk of suicidal tendancies? Thanks.
Posted by Larry Hoover on September 13, 2007, at 9:26:06
In reply to Re: STAR*D study, 33% sucess with first AD-sam123, posted by jhj on September 13, 2007, at 1:27:43
>
> Please do not mention about STAR*D study here.You read the comments made on STAR*D study here in reponse to another thread.
>
> "Without a placebo arm, the results are kind of meaningless.
>
> Linkadge"I missed the earlier discussion, but I'll join in this one.
The methodology for this study is entirely different than that used for placebo-controlled clinical efficacy trials.
> Then,here is one by another very knowledgable person to the same thread.
>
> "Exactly - what waste of time, money and effort. It's also not clear what samples or populations the percentages refer to"
>
> If you want to know about the person and the quality of that person,here it is.
>
> "I'm a statistician so I'm hopefully not talking out of my a**e Fred"First, this methodology is a within-group analysis, not a between-groups analysis. One homogenous population was selected, given a single treatment, and then proceeding to differing treatments according to displayed heterogeneity. The methodology is to demonstrate heterogeneity within the subject population, not heterogeneity in the treatment used.
The study, furthermore, is not yet complete. Published data, so far, are based on very limited samples of what will yet emerge. All we have, so far, are hints.
Lar
Posted by Larry Hoover on September 13, 2007, at 11:54:09
In reply to Re: STAR*D study, 33% sucess with first AD-sam123 » jhj, posted by Larry Hoover on September 13, 2007, at 9:26:06
> The study, furthermore, is not yet complete. Published data, so far, are based on very limited samples of what will yet emerge. All we have, so far, are hints.
>
> LarI meant the analysis of the data is not yet complete. There are reports from all levels of the studies, but I'm waiting for an overall analysis to emerge. Up until now, it's all been pieces of a puzzle.
Lar
Posted by sam123 on September 13, 2007, at 12:32:07
In reply to Re: STAR*D study, 33% sucess with first AD-sam123, posted by Larry Hoover on September 13, 2007, at 11:54:09
Thanks Lar. For me this has become a pointless
argument. I have been in remission for a decade,
so I have the proof I need.
Posted by Deputy Racer on September 13, 2007, at 12:51:26
In reply to Re: STAR*D study, 33% sucess with first AD-sam123, posted by jhj on September 13, 2007, at 1:27:43
>
> Please do not mention about STAR*D study here.You read the comments made on STAR*D study here in reponse to another thread.
>Please follow site guidelines. If you object to a post or find it offensive in some way, please use the "Notify Administrators" button on the bottom of the page, and one of us will address the problem. Discussion of the STAR*D study is allowed on this site.
If you have any questions regarding this policy, or any other policy regarding this site, please read the FAQ, located at http://www.dr-bob.org/babble/faq.html#civil
Dr Bob has ultimate authority over all administrative issues on this site, and may choose to revise or reverse any administrative action taken by a deputy.
Deputy Racer
Posted by Deputy Racer on September 13, 2007, at 12:54:38
In reply to Re: STAR*D study, 33% sucess with first AD-sam123, posted by sam123 on September 13, 2007, at 8:31:15
> >
>
> I disagree with that point and will post what I like where I like.Please follow the site guidelines. If you find a post objectionable or offensive, please use the "Notify Administrators" button on the bottom of the page, and one of us will address the issue.
If you have any questions about this or other posting policies, please read the FAQ, located at http://www.dr-bob.org/babble/faq.html#civil Follow ups to this issue should be directed to the Administration board, and should themselves be civil.
Dr Bob has ultimate authority at this site, and may choose to revise or reverse any administrative action taken by a deputy.
Deputy Racer
Posted by Larry Hoover on September 13, 2007, at 13:51:57
In reply to Re: STAR*D study, 33% sucess with first AD-sam123, posted by Larry Hoover on September 13, 2007, at 11:54:09
In response to these:
"I can argue that placebos work as well as antidepressants in most clinical trials becuase that is fact based."
"...if all popular ADs in the world were secretly replaced with sugar pills and no one was aware, the success rates of these pills would continue be the same."
"I have come to conclusion after long thought that pdoctors around the world should provide placebo instead of antidepressants in the best interest of patients."I believe these conclusions to be unsupported by the available evidence. If these statements were true, what would we find when we looked at the placebo-controlled clinical trial data?
If we assume equivalence between an antidepressant drug and placebo, then under the statistical assumptions that govern what we call 'significance', 19 times out of 20, there would be no significant difference between the two experimental groups. When we look at all available clinical trial data, including all the studies that were never published, is this the case? No.
Under those same assumptions, assuming equivalence, both placebo and the antidepressant should have similar frequency of being found to be statistically superior to the other. Is this the case? No.
But there are other ways to look at the data. We can rank them, even those studies where significant superiority was not obtained. If equivalent, then placebo and the antidepressant should have a similar likelihood of being superior. Is that the case? No. Mean, median, t-test, I don't care how you look at it, antidepresants and placebo are not found to be equivalent.
I've previously argued that you cannot form conclusions about equivalence from obtaining null results in clinical trials. There are a number of reasons why that is so. One is that you cannot know if you conducted an otherwise valid study, but used the wrong subjects. Nor can you know from the results if your methodology was sound. Nor can you exclude chance. You don't know if there wasn't a difference to be found, only that you failed to find one, under the conditions employed. Again, the scientific aphorism, "The absence of evidence is not evidence of absence."
There is no disorder known to man that exhibits a more robust placebo response in clinical trials than does major depression. In a clinical trial you get validation, attention, a chance to be heard, empathy. So maybe some people do just need more love, and that's a big reason why they're exhibiting depression. For others, the difficulty might be more 'mechanical', i.e. biochemical in nature. Lumping both groups together in a clinical trial is going to dilute the effect of a biological intervention. It just stands to reason.
Lar
Posted by polarbear206 on September 13, 2007, at 14:20:18
In reply to placebo vs. antidepressant, posted by Larry Hoover on September 13, 2007, at 13:51:57
> In response to these:
>
> "I can argue that placebos work as well as antidepressants in most clinical trials becuase that is fact based."
> "...if all popular ADs in the world were secretly replaced with sugar pills and no one was aware, the success rates of these pills would continue be the same."
> "I have come to conclusion after long thought that pdoctors around the world should provide placebo instead of antidepressants in the best interest of patients."
>
> I believe these conclusions to be unsupported by the available evidence. If these statements were true, what would we find when we looked at the placebo-controlled clinical trial data?
>
> If we assume equivalence between an antidepressant drug and placebo, then under the statistical assumptions that govern what we call 'significance', 19 times out of 20, there would be no significant difference between the two experimental groups. When we look at all available clinical trial data, including all the studies that were never published, is this the case? No.
>
> Under those same assumptions, assuming equivalence, both placebo and the antidepressant should have similar frequency of being found to be statistically superior to the other. Is this the case? No.
>
> But there are other ways to look at the data. We can rank them, even those studies where significant superiority was not obtained. If equivalent, then placebo and the antidepressant should have a similar likelihood of being superior. Is that the case? No. Mean, median, t-test, I don't care how you look at it, antidepresants and placebo are not found to be equivalent.
>
> I've previously argued that you cannot form conclusions about equivalence from obtaining null results in clinical trials. There are a number of reasons why that is so. One is that you cannot know if you conducted an otherwise valid study, but used the wrong subjects. Nor can you know from the results if your methodology was sound. Nor can you exclude chance. You don't know if there wasn't a difference to be found, only that you failed to find one, under the conditions employed. Again, the scientific aphorism, "The absence of evidence is not evidence of absence."
>
> There is no disorder known to man that exhibits a more robust placebo response in clinical trials than does major depression. In a clinical trial you get validation, attention, a chance to be heard, empathy. So maybe some people do just need more love, and that's a big reason why they're exhibiting depression. For others, the difficulty might be more 'mechanical', i.e. biochemical in nature. Lumping both groups together in a clinical trial is going to dilute the effect of a biological intervention. It just stands to reason.
>
> Lar
Larry,The last paragraph speaks volumes. My thoughts exactly!!!
Thanks,
Polarbear
Posted by linkadge on September 13, 2007, at 16:26:28
In reply to Re: News - Antidepressants Vindicated? » linkadge, posted by Larry Hoover on September 12, 2007, at 9:49:29
>No, again, because these are population >statistics. We don't need to know which subjects >were identified and which were not, nor which >were treated and which were not.
But my point is that without other factors to consider statistically, one can only wonder how the suicide rate increased so disproportionately to the reduced rate in suicide. The argument, "other factors are involved" can be used either way.
Linkadge
Posted by linkadge on September 13, 2007, at 16:28:27
In reply to Re: News - Antidepressants Vindicated? » linkadge, posted by Larry Hoover on September 12, 2007, at 9:50:59
>The data for 2005 will be available in December >of this year. We'll know soon enough
This data will still be too soon to make assumptions. If people are killing themselves so quickly after the reduced rate of suicide, they are probably dying in a manner ala Tracy Johnson.
Linkadge
Posted by linkadge on September 13, 2007, at 16:29:03
In reply to Re: News - Antidepressants Vindicated? » linkadge, posted by Larry Hoover on September 12, 2007, at 9:50:59
>The data for 2005 will be available in December >of this year. We'll know soon enough
This data will still be too soon to make assumptions. If people are killing themselves so quickly after the reduced rate of prescription, they are probably dying in a manner ala Tracy Johnson.
Linkadge
Posted by linkadge on September 13, 2007, at 16:31:04
In reply to Re: News - Antidepressants Vindicated? » linkadge, posted by Larry Hoover on September 12, 2007, at 10:25:34
>They really didn't know how to do them, early on
You got that right. The longer it goes like this the more the drug companies know how to design winning trails.
Linkadge
Posted by linkadge on September 13, 2007, at 16:39:59
In reply to Re: News - Antidepressants Vindicated?))SAM » jhj, posted by Larry Hoover on September 13, 2007, at 9:16:25
>If placebo pill is able to work as well as ADs >with out any side effect then,why people should >be made suffer from the side effects and >increased risk of suicidal tendancies? Thanks.
Exactly. Placebos do generally work as well as antidepressants to the point where **seriuos** thought goes into strategies to beat the placebo. Also, active placebos work better than placebos. That is why their use is fiercely opposed.
BTW. The logic, "I know I my drug works and thats all that matters" is true, but flawed.
I read an article on just how *shocked* many people are in clinical trials when they find out they have been receving the placebo. They say things like "there must be some mistake". "This can't be, I know I was getting the active drug, I could feel it", and on and on the list goes.
The problem is studies have shown the exact same pattern of bloodflow changes when somebody responds to an AD or a placebo. So, a placebo response is generally going to be impossable to pin down.
So, "I know it works" is not enough. Placebo responders know their drugs work too!!
Linkadge
Posted by linkadge on September 13, 2007, at 16:40:46
In reply to Re: STAR*D study, 33% sucess with first AD-sam123 » jhj, posted by Larry Hoover on September 13, 2007, at 9:26:06
>The methodology for this study is entirely >different than that used for placebo-controlled >clinical efficacy trials.
Exactly, thats why I don't care for the STAR*d.
Linkadge
Posted by linkadge on September 13, 2007, at 16:43:33
In reply to placebo vs. antidepressant, posted by Larry Hoover on September 13, 2007, at 13:51:57
>If these statements were true, what would we >find when we looked at the placebo-controlled >clinical trial data?
We might find analysis like this:
http://www.vaccinationnews.com/DailyNews/June2002/CanPlacebo25.htm
In a soon to be published study, Dr. Arif Khan, a psychiatrist at the Northwest Clinical Research Center in Washington, analyzed the Food and Drug Administration's database of 52 clinical trials in depression, involving nine new antidepressants, conducted from 1985 to 2000. ***Since the agency requires drug companies to report all data from all studies for drugs under development, the database can give a more accurate picture of a new drug's efficacy than the medical journals***, where positive findings are far more likely to be reported than negative ones.
Dr. Khan found that in only 48 percent of the 52 clinical trials was the antidepressant superior to the placebo.
Linkadge
Posted by linkadge on September 13, 2007, at 16:51:19
In reply to Re: placebo vs. antidepressant » Larry Hoover, posted by polarbear206 on September 13, 2007, at 14:20:18
>There is no disorder known to man that exhibits >a more robust placebo response in clinical >trials than does major depression. In a clinical >trial you get validation, attention, a chance to >be heard, empathy. So maybe some people do just >need more love, and that's a big reason why >they're exhibiting depression. For others, the >difficulty might be more 'mechanical', i.e. >biochemical in nature. Lumping both groups >together in a clinical trial is going to dilute >the effect of a biological intervention. It just >stands to reason.
A simpler explaination is the fact that depression is one of the few diseases where you are better when you say you are better. Most other diseases have some form of objective measurement involved.
Linkadge
Posted by Larry Hoover on September 13, 2007, at 18:00:20
In reply to Re: placebo vs. antidepressant » Larry Hoover, posted by linkadge on September 13, 2007, at 16:43:33
> >If these statements were true, what would we >find when we looked at the placebo-controlled >clinical trial data?
>
> We might find analysis like this:
>
> http://www.vaccinationnews.com/DailyNews/June2002/CanPlacebo25.htm
>
> In a soon to be published study, Dr. Arif Khan, a psychiatrist at the Northwest Clinical Research Center in Washington, analyzed the Food and Drug Administration's database of 52 clinical trials in depression, involving nine new antidepressants, conducted from 1985 to 2000. ***Since the agency requires drug companies to report all data from all studies for drugs under development, the database can give a more accurate picture of a new drug's efficacy than the medical journals***, where positive findings are far more likely to be reported than negative ones.
>
> Dr. Khan found that in only 48 percent of the 52 clinical trials was the antidepressant superior to the placebo.
>
> LinkadgeI think it's pretty important to also consider the rest of the text from your referenced article. Beginning with the next sentence after the part you copied:
"Does this really mean that antidepressants are on average no better than placebos for depression? In a word, no....
It turns out that the more severely depressed people are, the less likely they are to respond to a placebo. And people with more mild depressions get better with just about all treatments, including placebos. Since most clinical trials enroll less severely depressed patients, the observed difference between the response to an antidepressant and a placebo can be misleadingly small......it is easy to pick a group of mildly depressed patients and show that a placebo is equivalent to an antidepressant.....
There are other reasons that researchers may mistakenly conclude that placebos are as effective as antidepressants. For example, at least nine clinical trials included in Dr. Khan's meta-analysis lasted only four to five weeks. Yet we know that it can take up to six weeks and more for someone with depression to respond to an antidepressant. For example, studies have shown that about half of patients who had not improved after four weeks of antidepressant treatment responded by Week 6. So studies of short duration can exaggerate the efficacy of placebos.....But why does it matter whether a depressed patient gets better on a placebo or an antidepressant? Isn't the mere fact of improvement proof of efficacy? Well, the problem is that the placebo effect is only short-lived, while depression tends to be a chronic illness with a variable rate of recurrence. Patients who continue on placebos have more than double the risk of relapse to depression than those who stay on antidepressant medication.....At best, a placebo may give the patient a temporary boost if he is mildly depressed, but in a seriously depressed patient, it is right in more ways than one to call it a dummy pill."Lar
Posted by Larry Hoover on September 13, 2007, at 20:04:04
In reply to Re: placebo vs. antidepressant » Larry Hoover, posted by linkadge on September 13, 2007, at 16:43:33
> Dr. Khan found that in only 48 percent of the 52 clinical trials was the antidepressant superior to the placebo.
>
> LinkadgeI've looked far and wide, and I can't find the full-text of the above. If anybody knows of it, please let me know.
I like Khan's work. Very straight forward. Doesn't overinterpret his findings. Anyway, I've collected a few brief blurbs from some of his abstracts, all reviews of that same FDA database. My comments, if any, in square parentheses[].
"A statistically significant positive correlation was seen between placebo and antidepressant response magnitude (r =.40, p <.001) and between placebo response magnitude and the advantage of antidepressants over placebo (r = -.592, p <.0001). Only 21.1% of antidepressant treatment arms in trials with high placebo response (>30% mean change from baseline) showed statistical superiority over placebo compared with 74.2% in trials with a low placebo response (< or =30)." [The placebo response is more variable than the antidepressant response.]
"In the flexible dose trials, 59.6% (34/57) of the antidepressant treatment arms were statistically significant compared to placebo, whereas in the fixed dose trials only 31.4% (11/35) of the antidepressant treatment arms were statistically significant compared to placebo (chi(2)=6.9, df=1, p<0.01). These data suggest that the antidepressant dose schedule may influence trial outcome due in part to a significantly lower magnitude of symptom reduction with placebo in flexible dose trials (F=4.08, df=1, 48, p&<0.05) compared to fixed dose trials." [fascinating!]
In this one, my comments are embedded:
"The severity of depressive symptoms before patient randomization [more severe syptoms, greater difference between antidepressant and placebo], the dosing schedule [flexible dosing greater difference to placebo than fixed dose], the number of treatment arms [more treatment arms, greater difference], and the percentage of female patients [more females, greater placebo response, and lower difference] were significantly associated with the difference in response to antidepressant and placebo.""In the antidepressant-treated groups, the magnitude of symptom reduction was significantly related to mean initial Hamilton Rating Scale for Depression (HAM-D) score; the higher the mean initial HAM-D score, the larger the change. With placebo treatment, however, the higher the mean initial HAM-D score, the smaller the change." [redundant, but more explicit]
Thought-provoking, all in all.
Lar
Posted by sam123 on September 13, 2007, at 22:51:11
In reply to Re: placebo vs. antidepressant » linkadge, posted by Larry Hoover on September 13, 2007, at 20:04:04
>
> Thought-provoking, all in all.
>
> Lar
>
>Emperor ? Clothes ?
Posted by sam123 on September 13, 2007, at 23:21:12
In reply to Re: News - Antidepressants Vindicated?))SAM, posted by linkadge on September 13, 2007, at 16:39:59
>
> BTW. The logic, "I know I my drug works and thats all that matters" is true, but flawed.
>
I have tried a whole lota meds over several decades; some do nothing, some are annoying,
and some really do something.
Posted by jhj on September 14, 2007, at 0:01:10
In reply to Re: STAR*D study, 33% sucess with first AD-sam123, posted by sam123 on September 13, 2007, at 8:31:15
I disagree with that point and will post what I like where I like.You have misunderstood me.I am not stoping you from making any point.I mentioned about the thread in which i mentioned the findiings of star*d study and the responses i got.I completely endorse the findings of the study and i wrote in lighter vein about not mentioning. it.I think it was one of the most comprehensive study ever conducted on depression.
Posted by jhj on September 14, 2007, at 0:04:57
In reply to Please follow board guidelines » jhj, posted by Deputy Racer on September 13, 2007, at 12:51:26
Please do not mention about STAR*D study here.You read the comments made on STAR*D study here in reponse to another thread.I wrote the thing only lightly if you read entire post.I have no problem with any study conducted by anybody and certainly about the study which is conducted on such large scale like star*d.I did not find it objectionable to mention the study at all. that is why i did not use the notify the administrator button.Thanks.
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