AHRP org: Gov study confirms relative harm of atypical antipsychotics in youth...

AHRP org: Gov study confirms relative harm of atypical antipsychotics in youth...

Joined: April 19th, 2005, 7:01 pm

September 23rd, 2008, 2:33 am #1

<H3 class=post-title>http://ahrp.blogspot.com/</H3>
<H3 class=post-title><FONT color=#000066>Government study confirms relative harm of newer antipsychotics in youth</FONT></H3>
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<DIV><FONT color=#000066></FONT>A government sponsored study comparing an old and two most prescribed new antipsychotics (i.e. major tranquilizers a.k.a neuroleptics) in children aged 8 to 19, confirms that widely promoted second generation neuroleptic drugs--Zyprexa and Risperdal--pose even higher risks of harm for children's health than the old neuroleptic (Molindone).

The authors report in The American Journal of Psychiatry [abstract below]: "Risperidone and olanzapine did not demonstrate superior efficacy over molindone for treating early-onset schizophrenia and schizoaffective disorder.

Olanzapine and risperidone were associated with significantly greater weight gain. Olanzapine showed the greatest risk of weight gain and significant increases in fasting cholesterol, low density lipoprotein, insulin, and liver transaminase levels. Molindone led to more self-reports of akathisia."

The New York Times reports that "half of the children in the study stopped taking their drug within two months, either because it had no effect or was causing serious side effects, like rapid weight gain. The children receiving Zyprexa gained so much weight that a government oversight panel monitoring safety ordered that they be taken off the drug."

<STRONG>The authors conclude: </STRONG>

"The safety findings related to weight gain and metabolic problems raise important public health concerns, given the widespread use of second-generation antipsychotics in youth for nonpsychotic disorders."

The Times reports that Dr. Jon McClellan of the University of Washington, a co-author of the new study and of the current guidelines for treating childhood schizophrenia, said in a telephone interview that older schizophrenia drugs should now be considered as an alternative in some cases.

"I think the reason the use of these newer drugs has gone up so fast is that there was this widespread assumption that they were safer and more effective than what we had before. Well, we're seeing now that that's not the whole story."

There we have it --psychiatry's paradigm of care is based on invalid "widespread assumptions" NOT scientific evidence. What's more, psychiatry's "widespread assumptions" -- promoted by psychiatry's leadership-- are crafted by the marketing divisions of the pharmaceutical industry.

Financially compromised psychiatrists have been lending the veneer of legitimacy to industry propaganda. Psychiatry's treatment guidelines are the product of industry's marketing goals and junk science--not medicine.

Does anyone care about the human casualties resulting from psychiatry's commercially-driven paradigm of care ?

How many children's mental and physical health were undermined by practice recommendations promoted by prominent psychiatrists at premier academic institutions--notably, Harvard University, Columbia University, New York University, University of Texas, University of Pittsburgh, Stamford University, University of North Carolina--all of whose practice recommendations rest on "assumptions"?

It's time to hold FDA officials accountable:

What was the scientific evidence that led Dr. Laughren to approve any antipsychotic drug for use in children?

The psychiatric establishment and FDA officials who have promoted the use of antipsychotics or turned a blind eye to the burgeoning misuse of pharmacopeia's most toxic drugs have betrayed their professional and public responsibility.


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Joined: April 19th, 2005, 7:01 pm

September 23rd, 2008, 9:44 am #2


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Tips For Parenting A Child With Bipolar Disorder
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<P class=listentab><A class=listen href="javascript:NPR.Player.openPlayer(94881427, 94881411, null, NPR.Player.Action.PLAY_NOW, NPR.Player.Type.STORY, '0')">Listen Now</A> <SPAN class=duration>[17 min 49 sec]</SPAN> <A class=add href="javascript:NPR.Player.openPlayer(94881427, 94881411, null, NPR.Player.Action.ADD_TO_PLAYLIST, NPR.Player.Type.STORY, '0')">add to playlist</A>
</DIV><!-- START TOP RESOURCE POSITION --><!-- START INSET COLUMN --><!-- END INSET COLUMN --><!-- START STORY CONTENT -->
<SPAN class=program>Tell Me More,</SPAN> <SPAN class=date>September 22, 2008 · </SPAN>Every parent hopes their child's misbehavior can be easily corrected with a time out or appropriate punishment. But many parents find themselves unprepared when their children are diagnosed with bipolar disorder, a mental illness. In this week's <EM>Behind Closed Doors</EM>, Dr. Ellen Leibenluft, Dr. Carl Bell and author Cassandra Joubert discuss parenting children with the illness."

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Joined: April 19th, 2005, 7:01 pm

September 23rd, 2008, 10:09 am #3


[Emphasis Added]

http://medicine.plosjournals.org/perlse ... 30185&ct=1

The Latest Mania: Selling Bipolar Disorder<!-- end title area --><!-- start authors -->
<P class=authors>David Healy
<!-- end authors --><!-- start affiliations -->
<P class=affiliations>
<!-- end affiliations --><!-- start footnote section -->
<P class=notes><A name=N101></A><STRONG>Funding:</STRONG> The author received no specific funding to write this article.

<P class=notes><A name=N102></A><STRONG>Competing Interests:</STRONG> DH has been a speaker, consultant, or clinical trialist for Lilly, Janssen, SmithKline Beecham, Pfizer, Astra-Zeneca, Lorex-Synthelabo, Lundbeck, Organon, Pierre-Fabre, Roche, and Sanofi. He has also been an expert witness in ten legal cases involving antidepressants and suicide or homicide and one case involving the patent on olanzapine (Zyprexa). None of these interests played any part in the submission or preparation of this paper.

<P class=notes><STRONG>Citation:</STRONG> Healy D (2006) The Latest Mania: Selling Bipolar Disorder. PLoS Med 3(4): e185 doi:10.1371/journal.pmed.0030185

<P class=notes><STRONG>Published:</STRONG> April 11, 2006
<P class=notes>Copyright: © 2006 David Healy. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

<P class=notes><A name=N104></A>David Healy is at the North Wales Department of Psychological Medicine, Cardiff University, Cardiff, Wales, United Kingdom. E-mail: [url=mailto:healy_hergest@compuserve.com]healy_hergest@compuserve.com[/url]
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<A name=journal-pmed-0030185-e001><IMG alt="" src="http://medicine.plosjournals.org/archiv ... 5.e001.jpg" border=0></A>
One of the most famous direct-to-consumer television adverts for a drug begins with a vibrant woman dancing late into the night. A background voice says, “Your doctor probably never sees you when you feel like this.” The advert cuts to a shrunken and glum figure, and the voiceover now says, “This is who your doctor usually sees.” Cutting again to the woman, in active shopping mode, clutching bags with the latest brand names, we hear: “That's why so many people with bipolar disorder are being treated for depression and not getting any better—because depression is only half the story.” We see the woman again depressed, looking at bills that have arrived in the post before switching to seeing her again energetically painting her apartment. “That fast- talking, energetic, quick tempered, overdoing it, up-all-night you,” says the voiceover, “probably never shows up at the doctor's office, right?”

No drugs are mentioned. But viewers are encouraged to log onto www.bipolarawareness.com, which takes them to a Web site called “Bipolar Help Center,” <STRONG>sponsored by Lilly Pharmaceuticals, the makers of olanzapine (Zyprexa)</STRONG>. The Web site contains a “mood disorder questionnaire” (http:/<WBR style="content: attr(alt)" alt="&#8203;">/<WBR style="content: attr(alt)" alt="&#8203;">www.bipolarhelpcenter.com/<WBR style="content: attr(alt)" alt="&#8203;">resources/<WBR style="content: attr(alt)" alt="&#8203;">mdq.jsp). In the television advert, we see our heroine logging onto www.bipolarawareness.com and finding this questionnaire. The voice encourages the viewer to follow her example: “Take the test you can take to your doctor, it can change your life….getting a correct diagnosis is the first step in treating bipolar disorder. Help your doctor to help you.”

<STRONG>This advert markets bipolar disorder</STRONG>. The advert can be read as a genuine attempt to alert people who may be suffering from one of the most debilitating and serious psychiatric diseases—manic-depressive illness. Alternatively, the advert can be read as an example of what has been termed disease mongering [1]. Whichever it is, it will reach beyond those suffering from a mood disorder to others who will as a consequence be more likely to see aspects of their personal experiences in a new way that will lead to medical consultations and in a way that will shape the outcome of those consultations. Adverts that encourage “mood watching” risk transforming variations from an emotional even keel into potential indicators of latent or actual bipolar disorder. This advert appeared in 2002 shortly after Lilly's antipsychotic olanzapine had received a license for treating mania. The company was also running trials aimed at establishing olanzapine as a “mood stabilizer,” one of which was recently published [2].
<A id=s2></A>
Mood Stabilization
From the 1950s on, the depressions of manic-depressive illness have been treated with antidepressants and the manias with antipsychotics or lithium. Lithium was the only agent thought to be prophylactic against further episodes of manic-depressive illness [3]. But lithium was not originally referred to as a mood stabilizer. The term “mood stabilizer” had barely been heard of before 1995 when Abbott Laboratories got a license for using the anticonvulsant sodium valproate (Depakote) for treating acute mania [4].

<STRONG>After 1995, there was a dramatic growth in the frequency with which the term “mood stabilizer” appeared in the title of scientific articles </STRONG>(see Figure 1). By 2001, more than a hundred article titles a year featured this term.<STRONG> Repeated reviews make it clear that the academic psychiatric community still has not come to a consensus on what the term “mood stabilizer” means [</STRONG><STRONG>5–7</STRONG><STRONG>]. But this lack of consensus did not get in the way of the message that patients with bipolar disorders needed to be detected and once detected needed mood stabilizers, and perhaps should only be given these drugs and not any other psychotropic drug</STRONG>s [8,9].

<DIV class=figureFM><A id=JOURNAL-PMED-0030185-G001 name=JOURNAL-PMED-0030185-G001></A><A title="Click for larger image" href="http://medicine.plosjournals.org/perlse ... 5&id=50480" target=_blank><IMG height=202 src="http://medicine.plosjournals.org/archiv ... g001-M.jpg" width=330 border=1></A>
Figure 1. Articles Elicited by Medline Using the Mesh Term “Mood Stabilizer”</DIV>
<DIV class=pullQuote>
The growth of awareness of mood stabilization was sensational.
</DIV>
The first group of drugs to colonize this new mood stabilizer niche was <STRONG>anticonvulsants</STRONG>. Anticonvulsants are beneficial in epilepsy and were until recently widely thought to be beneficial by quenching the increased risk of succeeding epileptic fits brought about by fits that have gone before. Robert Post in the 1980s suggested that anticonvulsants might stabilize moods by a comparable quenching of the kindling effect of an episode of mood disorders on the risk of further episodes [10]. It was this idea that provided a pharmacological rationale for treatment of bipolar disorders that was so attractive to pharmaceutical companies, and, in their hands, the growth of awareness of mood stabilization and of bipolar disorders was sensational.

Bipolar disorders entered the DSM <EM>(Diagnostic and Statistical Manual of Mental Disorders)</EM> in 1980. At the time, the criteria for bipolar I disorder (classic manic-depressive illness) involved an episode of hospitalization for mania. Since then, the community-based disorders bipolar II disorder, bipolar disorders NOS (not otherwise specified), and cyclothymia have emerged. With their emergence, estimates for the prevalence of bipolar disorders have risen from 0.1% of the population having bipolar I disorder (involving an episode of hospitalization for mania) [11] to 5% or more when the definition of bipolar disorders includes the aforementioned community disorders [12]. A range of academic institutions has also grown more interested in the condition.

There has always been a rationale to using antipsychotics in bipolar disorders, as they are effective in acute manic states [13,14]. However, no companies making antipsychotics had previously sought a license for <EM>prophylaxis</EM> against bipolar disorders. Against a background of epidemiological studies indicating that the prevalence of bipolar disorders might be greater than previously thought [15,16], and growing academic interest in the condition, <STRONG>Lilly, Janssen, and Astra-Zeneca, the makers of the antipsychotics olanzapine, risperidone, and quetiapine (Seroquel), respectively, marched in on the new territory to market these drugs for prophylaxis of bipolar disorder. </STRONG>This, in turn, greatly expanded the number of companies with an interest in making the “bipolar market.” There was, however, no consensus on a theoretical rationale that would lead the average clinician to think these three drugs might “quench” the propensity to further affective episodes, as opposed to simply assist in the management of acute manic states.

But the increased prevalence estimates were based on community surveys that had no clear disability criterion, while acute treatment trials of antipsychotics for mania, and prophylactic trials of lithium for manic-depressive illness, have for the most part been conducted on bipolar I disorder. This necessarily raises the prospect that increased efforts to detect and to treat people risks crossing the line where the benefits of treatment outweigh its risks.

Along with this expansion in prevalence estimates came new journals, <EM>Bipolar Disorders</EM> (http:/<WBR style="content: attr(alt)" alt="&#8203;">/<WBR style="content: attr(alt)" alt="&#8203;">www.blackwellpublishing.com/<WBR style="content: attr(alt)" alt="&#8203;">journal.asp?ref=1398-5647) and the <EM>Journal of Bipolar Disorders</EM> (published by Lippincott, Williams, and Wilkins), <STRONG>a slew of bipolar societies, and annual conferences, many heavily funded by pharmaceutical companies. There is a growing amount of patient Web site and patient support materials that in the case of Zyprexa state that “bipolar disorder is often a lifelong illness needing lifelong treatment; symptoms come and go, but the illness stays; people feel better because the medication is working; almost everyone who stops taking the medication will get ill again and the more episodes you have, the more difficult they are to treat” [</STRONG><STRONG>17</STRONG><STRONG>]. Information available from Janssen (the makers of Risperdal) states “medicines are crucially important in the treatment of bipolar disorders. Studies over the past twenty years have shown beyond the shadow of doubt that people who receive the appropriate drugs are better off in the long term than those who receive no medicine” [</STRONG><STRONG>18</STRONG><STRONG>].</STRONG>
<A id=s3></A>
What Lies Beneath
<STRONG>There is, however, much less evidence than many might think to support these claims for the prophylactic drug treatment of manic-depressive illness (bipolar I). And there is almost no evidence to support such claims in the case of whatever community disorders (bipolar II, bipolar NOS, cyclothymia) are now being pulled into the manic-depressive net by the lure of bipolar disorder</STRONG>.

With the possible exception of lithium for bipolar I disorder, <STRONG>there are no randomized controlled trials to show that patients with bipolar disorders in general who receive psychotropic drugs are better in the long term than those who receive no medicine </STRONG>[19]. This may stem in part from difficulties in conducting trials on psychotropic drugs that last more than a few weeks in conditions as complex as manic-depressive illness. One short-term, randomized, placebo-controlled trial (in which patients were only followed for up to 48 weeks) that some see as a basis for claiming that olanzapine may be prophylactic in bipolar disorder [2] has been regarded by others as indicating that this drug produces a withdrawal-induced decompensation when stopped [20]. Even in the case of lithium, there is some dispute over what has been demonstrated [19], with the best evidence stemming from large open studies in dedicated lithium services rather than from randomized trials [21].

This evidence of benefit for one agent (lithium) and possible benefit for one more (olanzapine) must be weighed against two harms associated with use of antipsychotics: (1) <STRONG>a consistent body of evidence indicates that regular treatment with antipsychotics in the longer run increases mortality [</STRONG><STRONG>22–26</STRONG><STRONG>]; and (2) there is evidence that in placebo-controlled trials of antipsychotics submitted in application for schizophrenia licenses there is a statistically significant excess of completed suicides on active treatment [</STRONG>27].<STRONG> A range of problems associated with antipsychotics, from increased mortality to tardive dyskinesia, never show up in the short-term trials aimed at demonstrating treatment effects in psychiatry.</STRONG>

But aside from these hazards, there are also grounds to question whether the treatment effects that some think have been demonstrated in bipolar disorder trials translate into therapeutic efficacy. If use of these agents based on demonstrated effects leads on to efficacy, admissions for bipolar disorder might be expected to fall, but the evidence for this is difficult to find. In North Wales before the advent of modern pharmacotherapy, patients with bipolar I disorder had on average four admissions every ten years. In contrast, against a background of a constant incidence of bipolar I disorder, and dramatic improvements in service provision, bipolar I patients show a 4-fold increase in the prevalence of admissions despite being treated with the very latest psychotropic medications [11]. This is not ordinarily what happens when treatments “work,” but quite often is what happens when treatments have effects.

The selling of bipolar disorder stresses that the disorder takes a fearsome toll of suicides. And indeed the controversy surrounding the provocation of suicide by antidepressants has been recast by some as a consequence of mistaken diagnosis. If the treating physician had only realized the patient was bipolar, they would not have mistakenly prescribed an antidepressant. Because of the suicide risk traditionally linked to patients with bipolar disorders who needed hospitalisation, most psychiatrists would find it difficult to leave any person with a case of bipolar disorder unmedicated. <STRONG>Yet, the best available evidence shows that unmedicated patients with bipolar disorder do <EM>not</EM> have a higher risk of suicide.</STRONG>

Storosum and colleagues analyzed all placebo-controlled, double-blind, randomized trials of mood stabilizers for the prevention of manic/depressive episode that were part of a registration dossier submitted to the regulatory authority of the Netherlands, the Medicines Evaluation Board, between 1997 and 2003 [28]. They found four such prophylaxis trials. They compared suicide risk in patients on placebo compared with patients on active medication. Two suicides (493/100,000 person- years of exposure) and eight suicide attempts (1,969/100,000 person-years of exposure) occurred in the group given an active drug (943 patients), but no suicides and two suicide attempts (1,467/100,000 person-years of exposure) occurred in the placebo group (418 patients). Based on these absolute numbers from these four trials, I have calculated (see Figure S1 showing calculation, and see Figure 2) that <STRONG>active agents are most likely to be associated with a 2.22 times greater risk of suicidal acts than placebo </STRONG>(95% CI 0.5, 10.00).

<DIV class=figureFM><A id=JOURNAL-PMED-0030185-G002 name=JOURNAL-PMED-0030185-G002></A><A title="Click for larger image" href="http://medicine.plosjournals.org/perlse ... 5&id=50484" target=_blank><IMG height=176 src="http://medicine.plosjournals.org/archiv ... g002-M.jpg" width=330 border=1></A>
Figure 2. Author's Graph of <EM>p</EM>-Value Function Based on Data in [30]
(Illustration: Sapna Khandwala)
</DIV><A id=s4></A>
The Bipolar Future
<STRONG>Until recently the general clinical wisdom was that it was very rare for manic-depressive illness to have an onset in the preteen years.</STRONG> <STRONG>But there is now a surge of diagnoses of bipolar disorder in American children [</STRONG><STRONG>29</STRONG><STRONG>,</STRONG><STRONG>30</STRONG><STRONG>], even though these children do not meet the traditional criteria for bipolar I disorder (from the <EM>Diagnostic and Statistical Manual of Mental Disorders</EM>) [</STRONG><STRONG>31</STRONG><STRONG>]. The mania for pediatric bipolar disorder hit the front cover of the American edition of <EM>Time</EM> in August 2002, which featured nine-year-old Ian Palmer and a cover title <EM>Young and Bipolar</EM>, with a strapline, <EM>why are so many kids being diagnosed with the disorder, once known as manic-depression?</EM></STRONG>

A recent book, <EM>The Bipolar Child</EM> [32], brings out the extent of the current mania. Published in 2000, this book sold 70,000 hardback copies in six months in the US. As the <EM>Star Telegram</EM> reported in July 2000 [33], <EM>The Bipolar Child</EM> made all the difference to Heather Norris, whose mother, after reading it, challenged her physician to correct Heather's diagnosis from ADHD, treatment of which had made her daughter worse, to the correct diagnosis of bipolar disorder. <STRONG>As a result, Heather, at the age of two, became the youngest child in Tarrant County, Texas, to have a diagnosis of bipolar disorder. </STRONG>The <EM>Star Telegram</EM> article noted that “along with the insurance woes, lack of treatment options and weak support systems that plague most families with mentally ill children, parents of the very young face additional challenges. Finding the proper diagnosis for treatment is a nightmare because of scant research into childhood mental illness and the drugs that combat them.”

If we consider adults alone for a moment, there is already the potential for creating an “epidemic” of bipolar disorder, because people are being diagnosed with the condition based on operational criteria that depend upon subjective judgements (rather than an objective criterion of disability, such as hospitalization or being off work for a month). The potential is compounded in the pediatric domain by the fact that the diagnosis is based on caregiver reports with little scope in most clinical practice for critical scrutiny of the social forces that may lead to these reports. Experts that appear willing to go so far as to accept the possibility that the first signs of bipolar disorder may be patterns of overactivity in utero [32] can only further compound these problems. If the resulting diagnoses were provisional, aimed at researching the natural history of childhood irritability, rather than reaching diagnoses that lead on to pharmacotherapy, there might be little problem. <STRONG>However, drugs such as Zyprexa and Risperdal are now being used for preschoolers in America with little questioning of this development [</STRONG><STRONG>31</STRONG><STRONG>].</STRONG>

Far from research bringing a skeptical note to bear on clinical enthusiasm, it appears to be adding fuel to the fire. <STRONG>What might once have been thought of as sober institutions, such as Massachusetts General Hospital, have run trials of Risperdal and Zyprexa on children with a mean age of four years old [</STRONG><STRONG>34</STRONG><STRONG>,</STRONG><STRONG>35</STRONG><STRONG>]. Massachusetts General Hospital in fact recruited trial participants by running its own television adverts featuring clinicians and parents alerting parents to the fact that difficult and aggressive behavior in children aged four and up might stem from bipolar disorder</STRONG>. This does more than recruit patients with a clear disorder; it suggests that everyday behavioral difficulties may be better seen in terms of a disorder. Given that bipolar disorder in children is all but unrecognised outside the US, it seems likely that a significant proportion of these children will not meet conventional DSM criteria for bipolar I disorder. And given that it is all but impossible for a short-term trial of sedative agents in pediatric states characterized by overactivity <EM>not</EM> to show some rating scale changes that can be regarded as beneficial, the outcomes of this research are likely to appear to validate the diagnosis and increase the pressure for treatment.

Several years after Heather Norris was diagnosed with bipolar disorder, the rationale for mood stabilization was greatly weakened by the results of the largest-ever randomized trial of immediate versus deferred anticonvulsant therapy for people who had experienced a single seizure [36]. The trial found that although immediate antiepileptic drug treatment reduces the occurrence of seizures in the next 1–2 years, such treatment does not affect long-term remission in individuals with single or infrequent seizures. <STRONG>The use of psychotropic medication for bipolar disorders was based on an analogy with epilepsy, rather than on demonstrations of proven clinical benefits over the long term or on the basis of a correction of a known pathophysiology.</STRONG> <STRONG>The absence of a solid theoretical or empirical basis for using psychotropic medication as “mood stabilizers” raises questions as to what lies in store for the Heather Norris's and others of this world exposed to these complex psychotropic agents from such a young age.</STRONG>
<A id=s5></A>
Supporting Information<A id=JOURNAL-PMED-0030185-SG001 name=JOURNAL-PMED-0030185-SG001></A>
Figure S1. Episheet Showing Author's Relative Risk Calculation, Based on Data in [30]
(792 KB XLS).
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<OL class=references>
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[*]<A id=JOURNAL-PMED-0030185-B21 name=JOURNAL-PMED-0030185-B21></A>Tondo L, Baldessarini RJ, Floris G (2001) Long-term clinical effectiveness of lithium maintenance treatment in types 1 and 11 bipolar disorders. Br J Psychiatry 178:184–190 Supplement 41. <A class=find href="http://medicine.plosjournals.org/perlse ... -B21">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B22 name=JOURNAL-PMED-0030185-B22></A>Joukamaa M, Heliovaara M, Knekt P, Aromaa A, Raitasalo R, et al. (2006) Schizophrenia, neuroleptic medication and mortality. Br J Psychiatry 188:122–127. <A class=find href="http://medicine.plosjournals.org/perlse ... -B22">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B23 name=JOURNAL-PMED-0030185-B23></A>Healy D (2006) Neuroleptics and mortality: A 50-year cycle: Invited commentary on… schizophrenia, neuroleptic medication and mortality. Br J Psychiatry 188:128. <A class=find href="http://medicine.plosjournals.org/perlse ... -B23">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B24 name=JOURNAL-PMED-0030185-B24></A>Brown S, Inskip H, Barraclough B (2000) Causes of the excess mortality of schizophrenia. Br J Psychiatry 177:212–217. <A class=find href="http://medicine.plosjournals.org/perlse ... -B24">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B25 name=JOURNAL-PMED-0030185-B25></A>Mortensen PB (2003) Mortality and physical illness in schizophrenia. In: Murray R, Jones P, Susser E, editors. The epidemiology of schizophrenia Cambridge: Cambridge University Press. pp 275–287.
[*]<A id=JOURNAL-PMED-0030185-B26 name=JOURNAL-PMED-0030185-B26></A>Osby U, Correia N, Brandt L, et al. (2001) Mortality and causes of death in schizophrenia in Stockholm County, Sweden. Schizophr Res 45:21–28. <A class=find href="http://medicine.plosjournals.org/perlse ... -B26">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B27 name=JOURNAL-PMED-0030185-B27></A>Healy D (2004) Shaping the intimate. Influences on the experience of everyday nerves. Soc Stud Sci 34:219–245. <A class=find href="http://medicine.plosjournals.org/perlse ... -B27">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B28 name=JOURNAL-PMED-0030185-B28></A>Storosum JG, Wohlfarth T, Gispen de Wied CC, Linszen DH, Gersons BP, et al. (2005) Suicide-risk in placebo controlled trials of treatment for acute manic episode and prevention of manic-depressive episode. Am J Psychiatry 162:799–802. <A class=find href="http://medicine.plosjournals.org/perlse ... -B28">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B29 name=JOURNAL-PMED-0030185-B29></A>Findling RL, Kowatch RA, Post RM (2003) Pediatric bipolar disorder. A handbook for clinicians London: Martin Dunitz.
[*]<A id=JOURNAL-PMED-0030185-B30 name=JOURNAL-PMED-0030185-B30></A>Isaac G (2001) Bipolar not ADHD. Unrecognized epidemic of manic-depressive illness in children Lincoln (Nebraska): Writers Club Press. (http:/<WBR style="content: attr(alt)" alt="&#8203;">/<WBR style="content: attr(alt)" alt="&#8203;">www.iuniverse.com) 102 p.
[*]<A id=JOURNAL-PMED-0030185-B31 name=JOURNAL-PMED-0030185-B31></A>Harris J (2005) The increased diagnosis of juvenile “bipolar disorder,” what are we treating? Psychiatr Serv 56:529–531. <A class=find href="http://medicine.plosjournals.org/perlse ... -B31">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B32 name=JOURNAL-PMED-0030185-B32></A>Papolos D, Papolos J (2000) The bipolar child. New York: Random House. 416 p.
[*]<A id=JOURNAL-PMED-0030185-B33 name=JOURNAL-PMED-0030185-B33></A>Brooks K (2000 July 19) Families with mentally ill children confront health care shortcomings, undeserved stigma of “bad parenting.” Fort Worth Star-Telegram: 1.
[*]<A id=JOURNAL-PMED-0030185-B34 name=JOURNAL-PMED-0030185-B34></A>Mick E, Biederman J, Dougherty M, Aleardi M (2004) Comparative efficacy of atypical antipsychotics for pediatric bipolar disorder [abstract]. Acta Psychiatr Scand 110:29. <A class=find href="http://medicine.plosjournals.org/perlse ... -B34">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B35 name=JOURNAL-PMED-0030185-B35></A>Mick E, Biederman J, Aleardi M, Dougherty M (2004) Open trial of atypical antipsychotics in pre-schoolers with bipolar disorder [abstract]. Acta Psychiatr Scand 110:29. <A class=find href="http://medicine.plosjournals.org/perlse ... -B35">Find this article online</A>
[*]<A id=JOURNAL-PMED-0030185-B36 name=JOURNAL-PMED-0030185-B36></A>Marson A, Jacoby A, Johnson A, Kim L, Gamble C, et al. (2005) Immediate versus deferred antiepileptic drug treatment for early epilepsy and single seizures: A randomised controlled trial. Lancet 365:2007–2013. <A class=find href="http://medicine.plosjournals.org/perlse ... -B36">Find this article online</A></LI>[/list]<!-- end: references --><!-- end: articletype wrapper --><!-- end : main contents wrapper -->
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Joined: April 19th, 2005, 7:01 pm

September 23rd, 2008, 10:30 am #4


http://www.socialaudit.org.uk/58040-DH.htm#Dear


<TABLE cellPadding=0 width="100%" border=0>
<TBODY>
<TR>
<TD width="76%"><FONT size=5>Coleg Meddygaeth Prifysgol Cymru
University of Wales College of Medicine</FONT>
</TD>
<TD width="24%"><IMG height=133 alt="hergest.bmp (2190 bytes)" src="http://www.socialaudit.org.uk/hergest.gif" width=108></TD></TR>
<TR>
<TD width="76%">Adran Meddygaeth Seicolegol / Department of Psychological Medicine</TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%">Adran Cymru y Gogledd / North Wales Department</TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%"></TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%"><FONT size=2>Pennaeth Adran / Head of Department</FONT></TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%"><FONT size=2>Yr Athro /Professor Michael J. Owen</FONT></TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%"></TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%"><FONT size=2>Bangor</FONT></TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%"><FONT size=2>Dr. D. Healy (Cyfarwyddwr)</FONT></TD>
<TD width="24%"></TD></TR></TBODY></TABLE><FONT size=2>

&nbsp;

<DIV align=left>
<TABLE cellPadding=0 width="100%" border=0>
<TBODY>
<TR>
<TD width="76%"></FONT><SMALL><FONT face=Arial>Alan Milburn, Secretary of State for Health</FONT></SMALL><FONT size=2></FONT></TD>
<TD width="24%"><FONT face=Arial>7 December 2001</FONT><FONT size=2></FONT></TD></TR>
<TR>
<TD width="76%"><FONT face=Arial>Department of Health</FONT></TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%"><FONT face=Arial>Richmond House, 79 Whitehall</FONT></TD>
<TD width="24%"></TD></TR>
<TR>
<TD width="76%"><FONT face=Arial>London SW1A 2NS</FONT></TD>
<TD width="24%"></TD></TR></TBODY></TABLE></DIV>
<BLOCKQUOTE>
<FONT face=Arial size=2><A name=Dear>Dear</A> </FONT><FONT face=Arial><FONT size=1>&nbsp;</FONT><SMALL>Mr Milburn</SMALL></FONT><FONT size=2>
</FONT><FONT face=Arial>
Our Ref: DH/JT
</FONT><FONT size=4>
RE: ADVERSE EFFECTS AND PRESCRIPTION ONLY STATUS
</FONT><FONT face=Arial>

I’m copying this letter to Dr Keith Jones of the MCA as I suspect you will wish some input from the MCA on this point and copying him in on the letter may expedite the process. There would seem very little point in writing to Dr Keith Jones on his own as any letters that I have written to the MCA recently have not been answered.

As a historian of psychopharmacology I have been particularly interested in the question of prescription only status of psychotropic and other drugs. My understanding is that one of the primary reasons for prescription only status is so that physicians, who it is thought will be in a better position to quarry out information about the hazards of drugs, than you for instance would be, when it comes to treating you, will quarry out such hazards and will factor such issues into account when deciding on what medication to give you for whichever complaint you should present with.

In a recent series of articles in the Archives of General Psychiatry and the American Journal of Psychiatry, a research group in Michigan have presented data from the published literature and from trials submitted to the FDA on both antidepressants and antipsychotics and the numbers of suicides in those trials both on new antidepressants and new antipsychotics as well as older antidepressants and older antipsychotics and on placebo.

As an aside companies have it would appear in some instances coded as placebo suicides and suicidal acts, suicides and suicidal acts that did not happen on placebo. I have written to the MCA, alerting them to this but have received no response from them on the significance of this, which I believe is methodologically indefensible.

But to come to the main point, as you will see from the enclosed table of studies on antipsychotics in the case of Lilly’s Olanzapine and AstraZeneca’s Quetiapine the data published by Khan et al show gaps for suicide attempts. In order to determine what the risks of treatment might be, it is very important for a clinician such as me to have these gaps filled in. The companies have the data. There is however no way to access this data within the public domain. The scientific literature apparently does not contain the answers. The only way to access the data is through the companies. As I understand the legal basis for prescription only arrangements, there is a moral and probably a legal requirement on companies to supply this data if a request is made for it.

I have written to AstraZeneca and to Eli Lilly. The responses from both companies were initially unsatisfactory. Follow-up letters in the case of Eli Lilly have produced the attached response where you see they state frankly that they will not supply the data.

In an era when evidence based medicine is so trumpeted, it is difficult to know how to handle this lack of important evidence. I’m writing to ask you if you could clarify whether there is any obligation on companies to provide such data. If not I wonder whether you would feel it appropriate to inform clinicians around the UK generally that there may be significant data on all medications that is being withheld from them?

I would appreciate a response at your earliest convenience.
<FONT size=2><FONT size=3>
Yours sincerely,</FONT>

<DIV align=left>
<TABLE cellSpacing=1 cellPadding=0 width="50%" border=0>
<TBODY>
<TR>
<TD width="100%">David Healy MD FRCPsych</TD></TR>
<TR>
<TD width="100%">Director, North Wales Department of Psychological Medicine &nbsp; (Honorary Consultant Psychiatrist)
CC Dr Keith Jones, MCA
</TD></TR></TBODY></TABLE></DIV></FONT>
<P align=center><STRONG>Table 1</STRONG></FONT>

<TABLE cellSpacing=1 cellPadding=7 width=517 border=1>
<TBODY>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial>Drug</FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>Patient No</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial>Suicides</FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial>Suicide Attempts</FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial><STRONG>Risperidone</STRONG></FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>2,607</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial><STRONG>9</STRONG></FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial><STRONG>43</STRONG></FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial>Comparator</FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>621</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial>1</FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial>5</FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial>Placebo</FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>195</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial>0</FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial>1</FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial><STRONG>Olanzapine</STRONG></FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>2,500</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial><STRONG>12</STRONG></FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial><STRONG>?</STRONG></FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial>Comparator</FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>810</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial>2</FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial><STRONG>?</STRONG></FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial>Placebo</FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>236</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial>1</FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial><STRONG>?</STRONG></FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial><STRONG>Quetiapine</STRONG></FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>2,523</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial><STRONG>1</STRONG></FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial><STRONG>?</STRONG></FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial>Comparator</FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>426</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial>0</FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial>2</FONT></TD></TR>
<TR>
<TD vAlign=top width="32%"><FONT face=Arial>Placebo</FONT></TD>
<TD vAlign=top width="22%"><FONT face=Arial>206</FONT></TD>
<TD vAlign=top width="18%"><FONT face=Arial>0</FONT></TD>
<TD vAlign=top width="27%"><FONT face=Arial>0</FONT></TD></TR></TBODY></TABLE><FONT face=Arial>
Khan A, Khan SR, Leventhal RM, Brown WA (2001). Symptom reduction and suicide risk among patients treated with placebo in antipsychotic clinical trials: an analysis of the Food and Drug Administration Database. American J Psychiatry 158, 1449-1454.</FONT>
<FONT size=2>
</BLOCKQUOTE>
<DIV align=left>
<TABLE cellSpacing=1 cellPadding=0 width="100%" border=0>
<TBODY>
<TR>
<TD width="100%"></FONT><FONT size=1>Uned Hergest, Ysbyty Gwynedd, Bangor, Gwynedd LL27 2PW</FONT></TD></TR>
<TR>
<TD width="100%"><FONT size=1>Ffôn: (01248) 384452 Ffacs: (01248) 371397</FONT></TD></TR>
<TR>
<TD width="100%"><FONT size=1>Hergest Unit, Gwynedd Hospital, Bangor, Gwynedd LL27 2PW</FONT></TD></TR>
<TR>
<TD width="100%"><FONT size=1>Tel: (01248) 384452 Fax: (01248) 311397</FONT></TD></TR></TBODY></TABLE></DIV>
<STRONG><FONT size=3>CLICK HERE TO READ ON
</FONT></STRONG><FONT size=2>or HERE for full index of this correspondence "</FONT>
</FONT></FONT>
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Joined: April 19th, 2005, 7:01 pm

September 23rd, 2008, 10:42 am #5

<H3 class=post-title>http://ahrp.blogspot.com/</H3>
<H3 class=post-title><FONT color=#000066>Government study confirms relative harm of newer antipsychotics in youth</FONT></H3>
<DIV class=post-body>
<DIV><FONT color=#000066></FONT>A government sponsored study comparing an old and two most prescribed new antipsychotics (i.e. major tranquilizers a.k.a neuroleptics) in children aged 8 to 19, confirms that widely promoted second generation neuroleptic drugs--Zyprexa and Risperdal--pose even higher risks of harm for children's health than the old neuroleptic (Molindone).

The authors report in The American Journal of Psychiatry [abstract below]: "Risperidone and olanzapine did not demonstrate superior efficacy over molindone for treating early-onset schizophrenia and schizoaffective disorder.

Olanzapine and risperidone were associated with significantly greater weight gain. Olanzapine showed the greatest risk of weight gain and significant increases in fasting cholesterol, low density lipoprotein, insulin, and liver transaminase levels. Molindone led to more self-reports of akathisia."

The New York Times reports that "half of the children in the study stopped taking their drug within two months, either because it had no effect or was causing serious side effects, like rapid weight gain. The children receiving Zyprexa gained so much weight that a government oversight panel monitoring safety ordered that they be taken off the drug."

<STRONG>The authors conclude: </STRONG>

"The safety findings related to weight gain and metabolic problems raise important public health concerns, given the widespread use of second-generation antipsychotics in youth for nonpsychotic disorders."

The Times reports that Dr. Jon McClellan of the University of Washington, a co-author of the new study and of the current guidelines for treating childhood schizophrenia, said in a telephone interview that older schizophrenia drugs should now be considered as an alternative in some cases.

"I think the reason the use of these newer drugs has gone up so fast is that there was this widespread assumption that they were safer and more effective than what we had before. Well, we're seeing now that that's not the whole story."

There we have it --psychiatry's paradigm of care is based on invalid "widespread assumptions" NOT scientific evidence. What's more, psychiatry's "widespread assumptions" -- promoted by psychiatry's leadership-- are crafted by the marketing divisions of the pharmaceutical industry.

Financially compromised psychiatrists have been lending the veneer of legitimacy to industry propaganda. Psychiatry's treatment guidelines are the product of industry's marketing goals and junk science--not medicine.

Does anyone care about the human casualties resulting from psychiatry's commercially-driven paradigm of care ?

How many children's mental and physical health were undermined by practice recommendations promoted by prominent psychiatrists at premier academic institutions--notably, Harvard University, Columbia University, New York University, University of Texas, University of Pittsburgh, Stamford University, University of North Carolina--all of whose practice recommendations rest on "assumptions"?

It's time to hold FDA officials accountable:

What was the scientific evidence that led Dr. Laughren to approve any antipsychotic drug for use in children?

The psychiatric establishment and FDA officials who have promoted the use of antipsychotics or turned a blind eye to the burgeoning misuse of pharmacopeia's most toxic drugs have betrayed their professional and public responsibility.


</DIV></DIV>
<P itxtvisited="1"><EM>"...Testifying for the defense, psychiatrist Dr. Roger Epstein said he diagnosed Reynolds with bipolar disorder on Aug. 8, less than a month before the shooting. </EM>

<P itxtvisited="1"><EM>The doctor said Reynolds had complained of impulsiveness, depression, isolation, irritability and loss of sleep. He was prescribed a mood stabilizer called Zyprexa and seemed to be doing better at a second visit on Aug. 24..."</EM>
<P itxtvisited="1"><EM>http://www.presstelegram.com/news/ci_10375718</EM>
<H1 class=articleTitle id=articleTitle itxtvisited="1">Man considered suicide before killing</H1><!--subtitle--><!--byline-->
<!--date-->

<P itxtvisited="1"><BR itxtvisited="1">LONG BEACH -- A Long Beach man charged with the 2006 murder of his Alcoholics Anonymous sponsor testified in court Wednesday that he had planned to shoot himself in front of his fellow AA members but instead turned the gun on his sponsor.
<DIV class=articleBody id=articleBody itxtvisited="1">
<P itxtvisited="1">Scott Gordon Reynolds, 29, is charged with the first degree murder of Uriel Noriega, who was gunned down outside St. Luke's Episcopal Church, 525 Seventh St., on Sept. 2, 2006. If convicted, he faces 50 years to life in prison.
<P itxtvisited="1">"I was gonna put (the gun) to my head and pull the trigger," Reynolds said.
<P itxtvisited="1">Reynolds has pleaded not guilty. But testifying in his own defense in Long Beach Superior Court, he answered questions clearly and concisely about how and why he shot Noriega.
<P itxtvisited="1">After joining AA and getting sober, Reynolds said he confided in Noriega, his sponsor, that he was gay. Reynolds had told only one other person - his mother - about his sexuality, according to testimony.
<P itxtvisited="1">When Defense Attorney Natasha Khamashta asked him why he did not want others to know about his homosexuality, Reynolds replied: "I just wanted to fit in and be normal."
<P itxtvisited="1">Reynolds said he was enraged when he later found out that Noriega, who was gay, told his secret to other AA members.
<P itxtvisited="1">Noriega had also been seeing a fellow member on whom Reynolds had a crush, according to testimony. Reynolds flew into a jealous rage and went to Noriega's home. He became even more angry when he said Noriega shut the door in his face.

<P itxtvisited="1">The AA group had been his only social circle, Reynolds said. <STRONG>He had intended to kill himself in front of St. Luke's, where the group held meetings</STRONG>, but that changed when he saw Noriega's face, he said.
<P itxtvisited="1">"You pointed the gun at him," Deputy District Attorney Patrick O'Crowley said.
<P itxtvisited="1">"Yes," Reynolds replied.
<P itxtvisited="1">"You knew the gun was loaded," O'Crowley said.
<P itxtvisited="1">"Yes," Reynolds replied.
<P itxtvisited="1">"You pulled the trigger once ... twice ... a third time," O'Crowley said.
<P itxtvisited="1">"Yes," Reynolds replied.
<P itxtvisited="1">Noriega fell to the ground and Reynolds continued shooting, according to testimony. <STRONG>Reynolds later said he couldn't recall how many times he shot his sponsor. </STRONG>
<P itxtvisited="1">When O'Crowley showed a picture of Noriega's bullet-riddled body, Reynolds bowed his head for a moment, but showed little emotion.
<P itxtvisited="1"><STRONG>Testifying for the defense, psychiatrist Dr. Roger Epstein said he diagnosed Reynolds with bipolar disorder on Aug. 8, less than a month before the shooting. </STRONG>
<P itxtvisited="1"><STRONG>The doctor said Reynolds had complained of impulsiveness, depression, isolation, irritability and loss of sleep. He was prescribed a mood stabilizer called Zyprexa and seemed to be doing better at a second visit on Aug. 24. </STRONG>
<P itxtvisited="1">But Reynolds testified that he had feelings of anger and would frequently talk to himself in the months leading up to the murder.
<P itxtvisited="1">"I remember I wasn't feeling well," he said.
<P itxtvisited="1">"In your wildest imagination did you ever think you were going to get away with it?" Khamashta asked.
<P itxtvisited="1">"No," Reynolds said.
<P itxtvisited="1">Closing arguments are expected to begin today in the courtroom of Judge Jesse Rodriguez.
<P itxtvisited="1">[url=mailto:kelly.puente@presstelegram.com]kelly.puente@presstelegram.com[/url], 562-499-1305 "
</DIV>
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Joined: April 19th, 2005, 7:01 pm

September 23rd, 2008, 11:33 am #6

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Joined: April 19th, 2005, 7:01 pm

September 23rd, 2008, 12:48 pm #7


http://www.emedicine.com/EMERG/topic338.htm

"Neuroleptic malignant syndrome: All of the major tranquilizers have been implicated in the development of neuroleptic malignant syndrome (NMS), <STRONG>a life-threatening derangement that affects multiple organ systems and results in significant mortality</STRONG>. Hypothalamic D-2 receptor blockade results in an elevated temperature set point; impairment of heat-dissipating mechanisms; and increased calcium release from the sarcoplasmic reticulum resulting in increased contractility, which results in hyperthermia and muscle rigidity..."

"...<STRONG>Patients with neuroleptic malignant syndrome are critically ill and frequently sustain end-organ damage to the brain,</STRONG> liver, heart, lungs, and kidneys. Consequently, appropriate laboratory tests to monitor such damage are indicated..."

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http://members.aol.com/atracyphd/syndrome.htm

"<STRONG>The</STRONG> <STRONG>serotonin syndrome is a hypersotonergic state which is a very dangerous and a potentially fatal side effect of serotonergic enhancing drugs which can have multiple psychiatric and non-psychiatric symptoms.</STRONG> It is a condition which has been <STRONG>on the rise since the 1960's</STRONG> when we began using more and more drugs which directly affect serotonin. This is a toxic condition which requires heightened clinical awareness in order to prevent, recognize, and treat the condition promptly. Promptness is vital because, as we just mentioned, the serotonin syndrome can be fatal and death from this side effect can come very rapidly. This syndrome is a toxic hyperserotonergic state whose rate of incidence is unknown, but is on the rise. The suspected cause of that increase is the introduction of the new selective serotonergic enhancing agents in clinical practice - the SSRIs.<STRONG> This disorder, brought on by excessive levels of serotonin, is difficult to distinguish from the neuroleptic malignant syndrome because the symptoms are so similar. The neuroleptic malignant syndrome is a serious condition brought on by the use of the neuroleptic drugs.</STRONG>

"The symptoms of the serotonin syndrome are: euphoria, drowsiness, sustained rapid eye movement, overreaction of the reflexes, rapid muscle contraction and relaxation in the ankle causing abnormal movements of the foot, clumsiness, restlessness, feeling drunk and dizzy, muscle contraction and relaxation in the jaw, sweating, intoxication, muscle twitching, rigidity, high body temperature, mental status changes were frequent (including confusion and hypomania - a "happy drunk" state), shivering, diarrhea, loss of consciousness and death. (The Serotonin Syndrome, AM J PSYCHIATRY, June 1991)..."
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