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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 15 of 15. This is the beginning of the thread.
Posted by football on April 22, 2007, at 2:52:56
www.socialaudit.org.uk/docs/Adweb.pdf
The most interesting part IMO...
"Much of the bedrock evidence put before the regulators appears suspect for
this reason. Publicly available data from the US Food & Drug
Administration (FDA) shows that fluoxetine (Prozac) was licensed in spite
of, rather than because of, clear-cut evidence of efficacy from controlled
trials:
• The FDA relied on four pivotal studies designated as “adequate and
well-controlled trials which provided evidence of efficacy” of
fluoxetine. (FDA, 1988)
• Of these four placebo-controlled trials, three permitted the use of “of
concurrent psychotropic medication”, and one-quarter of the enrolled
patients (135/540) took benzodiazepines (or chloral) as well as
fluoxetine.
• If these 135 patients are excluded from the analysis in these three trials,
fluoxetine does not show statistically significant efficacy over placebo
(Breggin & Breggin, 1994).
• The one study that did prohibit the use of other such medicines was also
the only one of the four to find no statistically significant difference
between fluoxetine and placebo."
How the hell did it ever get FDA approval?
Posted by linkadge on April 22, 2007, at 7:57:48
In reply to Interesting read if you have some time to kill., posted by football on April 22, 2007, at 2:52:56
Probably would now (hopefully) would not be approved today under the same evidence.
Linkadge
Posted by Klavot on April 22, 2007, at 8:47:35
In reply to Interesting read if you have some time to kill., posted by football on April 22, 2007, at 2:52:56
One form of placebo remission is psycho-psomatic remission, i.e. physical remission induced through psychiatric effects. When dealing with psychiatric illness, the distinction between pharmacologically induced remission and psycho-psomatic remission thus becomes blurred. I do not think that psycho-psomatic remission should be regarded purely as placebo remission when dealing with psychiatric illnesses. I believe that placebo-medicating a psychiatric patient *does* constitute a legitimate form of treatment.
The comparison should be (IMHO): what are the remission rates for depression patients (a) receiving fuoxetine, and (b) not receiving *any* treatment. Because even if fluoxetine is useless as an antidepressant and it only induces a placebo effect, the only way a patient will benefit from that placebo effect is by having the drug prescribed to them through a doctor.
Perhaps there should be more comparison trials: take for example all five or six SSRIs and administer them in the same trial under the same conditions to a homogeneous group of depression patients. If the Zoloft group for example experiences a 60 % remission rate and the Prozac group only 40 %, then we might say that, on average, not only is Zoloft a better drug than Prozac, but that, assuming Prozac does not actually aggrevate depression, this means Zoloft does posses a super-placebo treatment effect.
Klavot
Posted by Klavot on April 22, 2007, at 8:53:21
In reply to Re: Interesting read if you have some time to kill., posted by Klavot on April 22, 2007, at 8:47:35
Sorry, I think that should be "somatic", not "psomatic".
Posted by Phillipa on April 22, 2007, at 10:06:37
In reply to Re: Interesting read if you have some time to kill., posted by Klavot on April 22, 2007, at 8:53:21
So why do so many say it works? Not me it didn't but a lot of people do and feel better? Just trusting the doc? Love Phillipa
Posted by notfred on April 22, 2007, at 10:31:53
In reply to Interesting read if you have some time to kill., posted by football on April 22, 2007, at 2:52:56
Consider the source:
Breggin & Breggin, 1994
Posted by notfred on April 22, 2007, at 10:32:47
In reply to Interesting read if you have some time to kill., posted by football on April 22, 2007, at 2:52:56
>
> How the hell did it ever get FDA approval?
Well, good thing it did. It works in some people.
Posted by Klavot on April 22, 2007, at 11:43:03
In reply to Re: Interesting read if you have some time to kill. » Klavot, posted by Phillipa on April 22, 2007, at 10:06:37
> So why do so many say it works? Not me it didn't but a lot of people do and feel better? Just trusting the doc? Love Phillipa
Probably because it does work, for many people.
My point was simply that I think the issue of placebo should be treated differently in psychiatric treatment.
Klavot
Posted by Jedi on April 22, 2007, at 13:42:53
In reply to Interesting read if you have some time to kill., posted by football on April 22, 2007, at 2:52:56
Hi,
Dr. David L. Dunner at the University of Washington was the PDOC who took me off of Nardil for a trial on Prozac. This was with a diagnosis of treatment resistant major atypical depression. I already had several failed trials on SSRIs, including Prozac. He was listed on Dr. Goldberg's Depression Central as one of the "The Best Psychiatrists in the U.S.A. Specializing in the Treatment of People with Mood Disorders". That is why I picked him. His suggestion, if the Prozac didn't work, was ECT. The following article shows that Dr. Dunner had more than a small interest in Prozac.
JediHow Prozac Was Approved
Published in FreeRepublic.com "A Conservative News Forum"
Culture/Society Front Page News Keywords: PROZAC FDA LILLY
Source: Prozac Truth Web Site
Published: 02/27/2000 Author: Jim Harper
Posted on 02/27/2000 12:28:54 PST by nicksdad
The following information has been gathered through the
Freedom Of Information ActA little background before we begin.
Prozac was allowed on the US market 12-29-1987. What happened shortly before and after 12-29-1987 regarding Prozac, Lilly and the FDA is where The Hidden Truth comes out.
We do not use undisclosed sources. The information disclosed is all a Public Record, it has just been obscured from the public by the interested parties mentioned in this article.
The Beginning
1982 David Dunner of the University of Washington begins receiving money that will total over $1.4 million dollars from Lilly for his research and seminars.
Dunner was part of the FDA's Psychopharmacologic Drugs Advisory Committee that is responsible for reviewing new drug applications brought before the FDA. These members are asked if they might have any conflict of interest with each Pharmaceutical Manufacture presenting new drugs before The Committee. Dunner responded to this question by stating "no pending commitments at the present time". The FDA accepted his answer as truthful.
Dunner had already been paid by Lilly for conducting a clinical trial on 100 people. Prozac was the drug used on his clinical trials.
Dunner had already given 5 seminars sponsored by Lilly (Prozac Manufacture) before this date. He failed to bring this to the committees attention. The seminars were regarding "depressive disorders." Dunner also failed to disclose that he had two additional seminars already booked for him by Lilly that would take place after Prozac was approved.
Dunner appeared in Pittsburg 1 day after Prozac was approved conducting a seminar on Prozac, while being paid by Lilly.
Dunner received another Lilly grant 5 days after Prozac was approved to conduct a new study on the effects of Prozac on sleep patterns.
1985 Lilly conducted test on Prozac and found the drug not to be significantly more effective than the placebo, an FDA statistician suggested to Lilly that the test results be evaluated differently causing the results to come out more favorable for Prozac.
1985 Guidelines constructed by Lilly for the clinical trials excluded the reporting of "adverse experiences caused by depression". The FDA admits this skewed the results.
1986 Medical Doctor for the FDA Richard Kapit gives this review of Prozac "Prozac may exacerbate certain depressive symptoms and signs. Certain clinical risks of mild to moderate severity did appear to be associated with the use of Prozac, as determined by review of the safety data in the New Drug Application submission. These potential risks include intensification of the vegetative signs and symptoms of depression. It is suggested that labeling be developed which advises physicians about the possible exacerbation of the vegetative manifestations of depressive illness. If the drug is marketed, post-marketing studies should be required to assess more precisely the severity of these potential risks."
The FDA safety review discovered that Lilly failed to report information about psychotic episodes during Prozac's testing. The FDA did nothing to reprimand Lilly for omitting this data.
1987 Two months before Prozac was approved for the market there had already been 27 deaths from controlled clinical trials. 15 were from suicides, 6 by overdose, 4 by gunshot and 2 by drowning. All were confirmed to be directly related to taking Prozac. An additional 12 deaths were reported but, could not be directly related to Prozac.
1991 Shortly before a hearing on Prozac in August 1991 an FDA executive Paul Leber noted his concern about "the large number of reports of all kinds on Prozac (more than 15,000)". Paul Leber pressured personnel in charge of the agency's adverse reporting system to discount the large number of reports of adverse reactions to Prozac as "of Limited value".
1992 By 1992 Prozac has had 28,600 adverse reactions reported to the FDA. Plus an additional 1,700 deaths. The Commissioner of the FDA, David Kessler states "Although the FDA receives many adverse event reports, these probably represent only a fraction of the serious adverse events encountered by providers. Only about one percent of the serious events are reported to the FDA, according to one study".
Let us look at the math regarding the above statement. 28,600 reported adverse reactions - equates to 2,860,000 adverse reactions if Commissioner David Kessler's study is correct.
If Mr. Dunner did the above today, he would go to prison.
Posted by Klavot on April 22, 2007, at 14:00:50
In reply to More on Prozac Approval » football, posted by Jedi on April 22, 2007, at 13:42:53
> By 1992 Prozac has had 28,600 adverse reactions reported to the FDA. Plus an additional 1,700 deaths.
I find it hard to believe that Prozac could have caused 1700 deaths in the US and still be FDA approved. And that's only up to 1992. If that statistic were true, by now there would be many thousands more who have also died from Prozac.
Klavot
Posted by Klavot on April 22, 2007, at 14:06:24
In reply to More on Prozac Approval » football, posted by Jedi on April 22, 2007, at 13:42:53
> By 1992 Prozac has had 28,600 adverse reactions reported to the FDA. Plus an additional 1,700 deaths.
I suppose they're counting suicides, which I think is a bit sneaky. That would be like counting heart attacks as an adverse reaction to Lipitor.
Klavot
Posted by linkadge on April 22, 2007, at 14:42:28
In reply to More on Prozac Approval » football, posted by Jedi on April 22, 2007, at 13:42:53
Thanks for the info.
Linkadge
Posted by Sebastian on April 22, 2007, at 15:33:20
In reply to Interesting read if you have some time to kill., posted by football on April 22, 2007, at 2:52:56
I belive it. I stoped taking it several times because it did nothing. Tried all forms of it brand and at least 2 generics.
Posted by Larry Hoover on April 22, 2007, at 16:15:32
In reply to Re: More on Prozac Approval » Jedi, posted by Klavot on April 22, 2007, at 14:00:50
> > By 1992 Prozac has had 28,600 adverse reactions reported to the FDA. Plus an additional 1,700 deaths.
>
> I find it hard to believe that Prozac could have caused 1700 deaths in the US and still be FDA approved. And that's only up to 1992. If that statistic were true, by now there would be many thousands more who have also died from Prozac.
>
> KlavotOf course, your analysis has hit it right on the head. There is no way this drug would still be available, anywhere in the world, if mortality was even a fraction of those numbers. Let's not forget that the extraordinarily conservative British analysis of pediatric data gave Prozac the only approval for child and adolescent use, based on both efficacy *and* safety.
I am amazed at how much credibility these unreferenced reports receive. The history of antidepressant drug development parallels the development of pharmacological vigilance.
Throughout the 80's, and into the 90's, there was no formal ADR (adverse drug reaction) reporting system in North America. It was done on an ad hoc basis, by doctors on their own initiative.
In early 1990, Dr. M. Teicher published the first case reports of suicidality in inpatients treated with Prozac. But prior to this article, the incidence of reports of suicidality associated with Prozac submitted to the FDA (as percentage of prescriptions written) was the same as that for Desyrel (trazodone), also then a relatively new antidepressant. Following a huge amount of publicity on the subject, reports of similar Prozac-related reactions began to flow into the FDA in larger numbers. Therefore, a special sitting of the FDA's Psychopharmacological Drugs Advisory Committee was convened to study the matter.
All told, through August 1991, the FDA had received 14,100 reports of adverse reactions occurring in connection with Prozac since the drug's approval in l987. Of those, there were only 880 reports of suicide attempts associated with Prozac use, while three million Americans had been given or were taking Prozac. That's an incidence of less than .03% I have no idea where that figure of 1700 deaths came from, but I have it on good authority that 76.8% of statistics are made up on the spot. In any case, using NIMH population data also presented to the Committee, 73,000 suicide attempts would have been expected from that population.
Anyway, the Committee concluded that the spike in reporting represented a change in vigilance, rather than a change in incidence, because the ad hoc reporting up until 1990 had not shown any difference between Desyrel and Prozac. Well, actually Desyrel was worse, but let's not split hairs.
Here's a transcript of the entire hearing:
http://www.fda.gov/ohrms/dockets/ac/prozac/2443T1.PDFFormal ADR reporting was not even instituted until 1993, and it was not mandatory, even then. This is an evolving process. Clinical trial protocols themselves were still under development, in this era. *No* drug was then properly tested, according to current criteria.
One more point. There is one drug that is profoundly and significantly associated with suicide, both when used alone or in combination with other drugs. Ethanol. Booze. Just for the record.
You have to consider the context, to understand any numbers being tossed around.
Lar
Posted by Jedi on April 22, 2007, at 17:28:39
In reply to More on Prozac Approval » football, posted by Jedi on April 22, 2007, at 13:42:53
Well guys, 30 lashes for me. That article published in FreeRepublic.com was a very poor reference. I usually check out the things I pass on a lot better than I did this time.
I apologize,
Jedi
This is the end of the thread.
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