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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
On Tue, 28 Oct 2003 00:02:00 -0500, Mark D Morin
wrote: On Tue, 28 Oct 2003 03:30:23 +0000, jake wrote: I think most readers are intelligent enough to form their own opinions based the entire text rather than paragraphs quoted here and there. clearly you do not think any such thing ..as your spinning would then be redundant Clearly you perhaps you should clean your spectacles(or get some if you dont wear them) if you wish to talk of clearly.. FWIMBW I posted it in another group in its entirety.. you on the contrary added to it.. and linda are the two who cut and paste info from the alert. I will disuss issues but not your obsession with Linda.. AFAIAA concern with violating copyright is the issue.. rather than your uglyminded interpretations.. For most readers..I supect the original Reuters headline is clear enough.. Watch for Suicide with Depression Drugs, FDA Says Mon October 27, 2003 02:31 PM ET WASHINGTON (Reuters) - The U.S. Food and Drug Administration issued a public health advisory on Monday to alert doctors to reports that children and teen-agers with major depression thought about or attempted suicide in several clinical trials of antidepressants. "Nevertheless, it is not possible at this point to rule out an increased risk of these adverse events for any of these drugs, including Paxil (paroxetine)." Close supervision of high-risk patients should accompany initial drug therapy," the FDA advised. i.e., nothing new. nothing new? that's correct really ..? its always been public knowledge that children are attempting suicide whilst antidepressants are tested on them in clinical trials has it? It is certainly new to the millions of people prescribed these prescribed these drugs by a GP ..without an initial psychiatric assessment..let alone any monitoring or supervision of any kind..close or otherwise.. It's been on the warning lables and general print outs each patient gets from the pharmacist for ages. NO it has not been on inserts for "ages" the drug companies have been forced by court cases and been overidden by regulatory bodies.. kicking and screaming all the way to do such.. Stock prices fall as a result of such warnings. Furthermore as global operators the amount of information revealed ...as to adversive reactions..varies from country to country depending upon what each national legistature has insisted upon. In any event an insert from the pharmacy hardly constitutes monitoring or supervision.. Not to mention the hundreds of thousands ordering them on the internet without ever seeing a doctor.. 3) it notes that depression (not medication) is the leading cause of suicide "But it said it is hard to tell whether the drugs actually caused the suicide, because depression is the leading cause of suicide." hardly the same Try reading the sentence you quoted again. perhaps you should ..without your alterations.. no alterations jake. (not medication) exists nowhere in the text..it is your addition.. The report certainly does not rule out suicidal depression brought on by medications as in the case of the Paxil "normal volunteers.. Just what part of "it said it is hard to tell whether the drugs actually caused the suicide" do you fail to understand? I understand it just fine. Then why persist in the stale... old discredited drug company spin that the suicidal ideation has nothing to do with the drug but is a symptom of the depression? that normal volunteers become suicidal in drug trials has totally discredited that idea.. what part don't you understand very droll... just a slightly different spin than what the original poster put on it by selectively quoting The only spin I see is yours. Thats probably because of your particular set of biases--Linda being one of the biggest. I will discuss issues ..such as children attempting suicide whilst undergoing clinical trials for drug companies..but your obsession with Linda you will have to deal with on your own.. I find it interesting that you have never (or not in the past two years anyway) corrected linda when she has been blatently wrong. The many times she has summarized an article and said something 180 degrees opposite what the article said. Not once have you called her to task for her slander, her lies, her vindictiveness. Who is it that is biased jake? I will discuss issues with you but not your obsession with Linda frankly it is really tedious.. the thread is about concern that children given ADs in clinical trials are attempting suicide..not how much you hate another poster.. -- "Until the philosophy which holds one race superior and another inferior is finally and permanently discredited and abandoned; until there is no longer any first-class and second-class citizens of any nation; until the color of a man's skin is of no more significance than the color of his eyes; until the basic human rights are equally guaranteed to all, without regard to race -- until that day, the dreams of lasting peace and world citizenship and the rule of international morality will remain but a fleeting illusion, to be pursued but never attained." Haile Sellassie |
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
On Tue, 28 Oct 2003 07:46:56 GMT, "Jon Quixote"
wrote: In news message: , jake typed: On Mon, 27 Oct 2003 20:54:57 -0500, Mark D Morin wrote: snipt the whole thing--and when reading it NB: 1) it is acknowledging that it is saying nothing new That the FDA is concerned enough to put out an alert is certainly new. and headine despite your attempts at minimisation. Not sure what you mean about how "new" this alert is - IIRC, I read the warning *presented* in the alert close to a decade ago in a Paxil brochure. The point appears to be twofold: 1. Some people commit suicide while under clinical trials (or afterword) 2. There isn't any way they can determine whether it's the drug's fault or the fact(?) that the people taking the drug are, in all likelihood, depressed, and hence at highest risk for suicide regardless of whether they are on these medications or not. IMO this is more of a FDA attempt to heighten general public awareness of the risk rather than an attempt to present it as "new". I believe you and Mark are disagreeing over interpretation based on differences of phrasing - you appear to be contending that for the FDA to issue an alert is new, whereas Mark appears to be contending that the information the FDA is presenting isn't new. So far as I can tell, you're both "right", but not for the reason the other thinks. Again, if I read this disagreement correctly, you are correct, AFAIK, the FDA has not previously issued a *general* alert for public consumption regarding the *possible* link between antiDs and rare increase in suicidal ideation. Mark is correct in that the information that is being presented in the alert regarding that *possible* link is NOT new, and has been included with most if not all antidepressant literature for quite a long time, including the warning to the prescriber to monitor the patient's initial exposure to the drug closely due to the *possible* risk of increased ideation. If I misinterpreted either side, my apologies for jumping in on that particular part of y'all's conversation. If the FDA had listened to Mark of course..they would have realized that would have been no need to send out this alert to all doctors and health care professionals.. In the real world..the data from their studies convinced them there was.... despite the attempt to generalise to suicides in general in AD treated patients the report actually is concerned with CHILDREN who are attempting suicide more often when taking the AD than those recieving a placebo. this is headline news... here is the actual alert http://www.fda.gov/cder/drug/advisory/mdd.htm FDA PUBLIC HEALTH ADVISORY October 27, 2003 Subject: REPORTS OF SUICIDALITY IN PEDIATRIC PATIENTS BEING TREATED WITH ANTIDEPRESSANT MEDICATIONS FOR MAJOR DEPRESSIVE DISORDER (MDD) Dear Health Care Professional: The Food and Drug Administration (FDA) would like to call your attention to reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). While occurrences of suicidality are not unexpected in patients with MDD, preliminary data suggest an excess of such reports for patients assigned to several of these antidepressant drugs compared to those assigned to placebo. FDA has completed a preliminary review of such reports for 8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine*, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied under the pediatric exclusivity provision, and has determined that additional data and analysis, and also a public discussion of available data, are needed. FDA plans to hold an advisory committee meeting before the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee on February 2, 2004. I guess they should just abandon the meeting huh? as all the data and findings are on the insert?? sheesh.. here is the previous Talk paper that was not "ages ago " but only four months ago June 19, 2003 FDA Talk Paper http://www.fda.gov/bbs/topics/ANSWER.../ANS01230.html FDA Statement Regarding the Anti-Depressant Paxil for Pediatric Population The Food and Drug Administration (FDA) said today it is reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents under the age of 18 treated with the drug Paxil for major depressive disorder (MDD). Although the FDA has not completed its evaluation of the new safety data, FDA is recommending that Paxil not be used in children and adolescents for the treatment of MDD. There is currently no evidence that Paxil is effective in children or adolescents with MDD, and Paxil is not currently approved for use in children and adolescents. Other approved treatment options are available for depression in children. Paxil is approved for use in adults for the treatment of Obsessive Compulsive Disorder (OCD), MDD, Panic Disorder, Social Anxiety Disorder (SAD), Generalized Anxiety Disorder, and Post-traumatic Stress Disorder. There is no evidence that Paxil is associated with an increased risk of suicidal thinking in adults. Three well-controlled trials in pediatric patients with MDD failed to show that the drug was more effective than placebo. The new safety information that is currently under review was derived from trials of Paxil in pediatric patients. Following its review of the same data, the UK Department of Health issued a Press Release on June 10 stating that paroxetine (brand name Seroxat in the UK) must not be used to treat children and teenagers under the age of 18 years for depressive illness because UK authorities have concluded that there is an increase in the rate of self harm and potentially suicidal behavior in this age group, when paroxetine is used for depressive illness. I note that elsewhere you claimed that "normal" (presumably meaning "non-depressed") people committed suicide while taking the drugs in question during their trials - where did you get that from? I didn't see any hint of such a statistic. No..I said became suicidal nobody did for a long time..the drug company supressed the results of their safety trials showing this..and only gave then to researchers when a court forced then too.. http://www.abc.net.au/pm/s312381.htm Researcher and academic raises questions about common anti-depressants PRINT FRIENDLY EMAIL STORY PM Archive - Wednesday, 13 June , 2001 00:00:00 Reporter: Mark Colvin MARK COLVIN: Now more on a story we brought you yesterday on the question surrounding some of the most widely prescribed anti-depressant drugs. The questions were raised by a researcher in Wales who has been delving into the archives of one of the big drug companies. He's Dr David Healy of the North Wales Department of Psychological Medicine, a leading expert on, and critic of, anti-depressants and he's on the line now from Wales. Dr Healey how did you find this new information? Where, where were you digging? DAVID HEALY: Okay, well roughly a year-and-a-half ago now in the university department here, we had - as part of some research - to look at how the anti-depressants work, given one of the anti-depressants that acts on the serotonin system - Zoloft, and another anti-depressant that has no action from the serotonin system, to a group of medical and nursing colleagues here. We found that Zoloft could make some absolutely normal people better than well, but equally it made two of our normal volunteers acutely suicidal. Now I've also been involved in some legal actions where people have committed suicide or homicide on, on SSRI's [Selective Serotonin Reuptake Inhibitor] and following our work here I was curious to look at the healthy volunteer archives that companies like SmithKline and Pfizer have. MARK COLVIN: SmithKline which is now, I think, called Glaxo SmithKline, is that right? DAVID HEALY: That is the case yes. You see in order to get these drugs onto the market in the first instance, they've got to do what are phase one studies which usually involve giving the drug either once, or over the course of a few weeks, to several hundred healthy volunteers. MARK COLVIN: Are these documents closely guarded secrets, or were they easy for you to get? DAVID HEALY: Well no they are a closely guarded secret. My understanding is that very few other people have ever seen any of this work. And the interesting thing about this is the companies portray themselves as being in a scientific business, but in actual fact the emphasis I think needs to be on the business rather than the science, because one of the cardinal rules of science is that you make all of your data freely available. MARK COLVIN: Are you saying then that because of business reasons they covered up information which they should have released? DAVID HEALY: Well what I'm saying is the company responses on an issue like this will be that the findings from their healthy volunteer work is proprietary data and that you would never get a response like that from a university department. MARK COLVIN: But what did it say? Did it confirm your feeling that these drugs had side effects or could give people withdrawal symptoms? DAVID HEALY: Yes it did. What the argument from the companies has been is when people who are depressed become suicidal or nervous on their drug that that's the illness. Now what the healthy volunteer work shows is that during the 1980s when this was actually being done, several years before these drugs reached the marketplace, that healthy volunteers being put on these drugs were becoming agitated at a rate of up to one in four. And in the case of Glaxo SmithKline's drug Paroxotine, they were concerned about withdrawal problems from the drug, and showed that in some instances when people had only been on the drug for two or three weeks, that there were up to 85 per cent of the healthy volunteers involved having withdrawal problems from the drug. MARK COLVIN: Some experts here were saying there shouldn't really be any big surprise about this because all drugs have side effects and all drugs have some form of withdrawal symptom. Is that a fair argument? DAVID HEALY: Well yes, SRI's were sold as a new group of drugs, which unlike the benzodiazepines - Valium, Librium and drugs like that - were not going to make people physically dependant. The withdrawal problems from Paroxotine appeared to be as great as the, if not greater than, any of the physical dependence that was caused by Valium and Librium during the 1980s. MARK COLVIN: So drugs like Prozac and Seroxat, Aropax, drugs like that, are just as physically dependent you say as drugs like Valium which were widely blamed for addicting a lot of people and these drugs were supposed to liberate people from that possibility of addiction. DAVID HEALY: That's right yes, and furthermore, in some of the clinical trial work that has been done since by the companies, what they've done is they've done what are called long-term trials, and during the course of these people who have appeared to respond to the drug are then re-randomised to placebo, and when they get unwell the companies have been saying, "well look this is evidence that they have again become clinically depressed, and that the people who are on the drug haven't become as likely to become depressed, and therefore this is evidence that you should take our drug in the longer term. It will ward off future episodes of depression". But knowing what I know now and knowing what I believe the companies knew then, this all looks very unsatisfactory to me now in that the most, the simplest way to explain people becoming unwell after the drug is halted, is in terms of a discontinuation problem from the drug. And rather than this being evidence that you should continue with the drug, this really is evidence that clinicians should be thinking about how to wean people off these drugs safely. MARK COLVIN: Dr David Healy thank you very much indeed. Dr David Healy of the North Wales Department of Psychological Medicine who has been researching in the archives of Glaxo SmithKline. |
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
"jake" wrote in message ... It is certainly new to the millions of people prescribed these prescribed these drugs by a GP ..without an initial psychiatric assessment..let alone any monitoring or supervision of any kind..close or otherwise.. Not to mention the hundreds of thousands ordering them on the internet without ever seeing a doctor.. you realize that this is a problem with the doctors and internet drug pushers, not with the medications themselves. right? -kelly |
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
On Tue, 28 Oct 2003 06:30:33 +0000, jake wrote:
AFAIAA concern with violating copyright is the issue.. rather than your uglyminded interpretations.. This is coming from someone who routinely reposts the entire article rather than simply provide a link? It's been on the warning lables and general print outs each patient gets from the pharmacist for ages. NO it has not been on inserts for "ages" It has been here perhaps you should ..without your alterations.. no alterations jake. (not medication) exists nowhere in the text..it is your addition.. don't know what you are talking about jake--nothing was inserted nor deleted in my cutting and pasting. the thread is about concern that children given ADs in clinical trials That's not what the thread says jake ================================================== == Ruby stepped toward him. "Edward," she said softly. "Learn this from me. Holding anger is a poison. It eats you from inside. We think that hating is a weapon that attacks the person who harmed us. But hatred is a curved blade. And the harm we do, we do to ourselves. "Forgive, Edward, Forgive. Do you remember the lightness you felt when you first arrived in heaven?... No one is born with anger. And when we die, the soul is freed of it. But now, here, in order to move on, you must understand WHY you felt what you did, and WHY you no longer need to feel it. "Yo need to forgive your father." Mitch Albom, "the five people you meet in heaven" http://home.gwi.net/~mdmpsyd/index.htm |
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
On Tue, 28 Oct 2003 08:54:03 +0000, jake wrote:
despite the attempt to generalise to suicides in general in AD treated patients the report actually is concerned with CHILDREN who are attempting suicide more often when taking the AD than those recieving a placebo. this is headline news... here is the actual alert http://www.fda.gov/cder/drug/advisory/mdd.htm and where are the nondepressed controls you were talking about who became suicidal? ================================================== == Ruby stepped toward him. "Edward," she said softly. "Learn this from me. Holding anger is a poison. It eats you from inside. We think that hating is a weapon that attacks the person who harmed us. But hatred is a curved blade. And the harm we do, we do to ourselves. "Forgive, Edward, Forgive. Do you remember the lightness you felt when you first arrived in heaven?... No one is born with anger. And when we die, the soul is freed of it. But now, here, in order to move on, you must understand WHY you felt what you did, and WHY you no longer need to feel it. "Yo need to forgive your father." Mitch Albom, "the five people you meet in heaven" http://home.gwi.net/~mdmpsyd/index.htm |
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
On Tue, 28 Oct 2003 03:24:45 -0800, "kc"
wrote: "jake" wrote in message .. . It is certainly new to the millions of people prescribed these prescribed these drugs by a GP ..without an initial psychiatric assessment..let alone any monitoring or supervision of any kind..close or otherwise.. Not to mention the hundreds of thousands ordering them on the internet without ever seeing a doctor.. you realize that this is a problem with the doctors You blame the doctors for believing drug company disinformation and lies? One primary purpose of such advisories is to correct such disinformation as to the safety and prescribing practices.. and internet drug pushers, sadly many such sites employ doctors on a commission only basis to prescribe to strangers not with the medications themselves. nice try.. the use of SSRIs to treat depression is problematic and of increasing concern..whatever spin might be used to hide thr fact right? -kelly |
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
"jake" wrote in message ... On Tue, 28 Oct 2003 03:24:45 -0800, "kc" wrote: "jake" wrote in message .. . It is certainly new to the millions of people prescribed these prescribed these drugs by a GP ..without an initial psychiatric assessment..let alone any monitoring or supervision of any kind..close or otherwise.. Not to mention the hundreds of thousands ordering them on the internet without ever seeing a doctor.. you realize that this is a problem with the doctors You blame the doctors for believing drug company disinformation and lies? no, i blame doctors for not requiring psych consults before perscribing psyc meds. i blame the doctors for not monitoring patients who need to be monitored. i don't see any disinfo here. the med inserts say that suicide is a risk in ANY depressed patient, and indeed it is. if the docs hand out a pill and ignore a suicidal patient, how on earth can that be the drug co's fault? One primary purpose of such advisories is to correct such disinformation as to the safety and prescribing practices.. execpt there was no disinformation. this advisory doesn't tell anyone anything new. the use of SSRIs to treat depression is problematic and of increasing concern..whatever spin might be used to hide thr fact seriously, i have no idea what your little agenda is all about, but SSRIs, among other depression treatments, save MANY more lives than you claim they take. i've said it before. don't like them, don't take them. but there's no reason to wage a campaign against an entire class of meds that have saved so many lives. -kelly |
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
On Tue, 28 Oct 2003 08:40:42 -0500, Mark D Morin
wrote: On Tue, 28 Oct 2003 06:30:33 +0000, jake wrote: AFAIAA concern with violating copyright is the issue.. rather than your uglyminded interpretations.. This is coming from someone who routinely reposts the entire article rather than simply provide a link? are you being deliberately obtuse? Its not my issue..and I did not post the article here.. It's been on the warning lables and general print outs each patient gets from the pharmacist for ages. NO it has not been on inserts for "ages" It has been here perhaps you should ..without your alterations.. no alterations jake. (not medication) exists nowhere in the text..it is your addition.. don't know what you are talking about jake--nothing was inserted nor deleted in my cutting and pasting. the words "(not medication)" arrived from where then? the thread is about concern that children given ADs in clinical trials That's not what the thread says jake the thread says nothing..contributors to it do.. the subject line is FDA Alert: Watch for Suicide of Kids on AD's 10/27/03 on my newsreader anyhow.. ================================================= === Ruby stepped toward him. "Edward," she said softly. "Learn this from me. Holding anger is a poison. It eats you from inside. We think that hating is a weapon that attacks the person who harmed us. But hatred is a curved blade. And the harm we do, we do to ourselves. "Forgive, Edward, Forgive. Do you remember the lightness you felt when you first arrived in heaven?... No one is born with anger. And when we die, the soul is freed of it. But now, here, in order to move on, you must understand WHY you felt what you did, and WHY you no longer need to feel it. "Yo need to forgive your father." Mitch Albom, "the five people you meet in heaven" http://home.gwi.net/~mdmpsyd/index.htm -- "Until the philosophy which holds one race superior and another inferior is finally and permanently discredited and abandoned; until there is no longer any first-class and second-class citizens of any nation; until the color of a man's skin is of no more significance than the color of his eyes; until the basic human rights are equally guaranteed to all, without regard to race -- until that day, the dreams of lasting peace and world citizenship and the rule of international morality will remain but a fleeting illusion, to be pursued but never attained." Haile Sellassie |
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FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
On Tue, 28 Oct 2003 06:37:18 -0800, "kc"
wrote: "jake" wrote in message .. . On Tue, 28 Oct 2003 03:24:45 -0800, "kc" wrote: "jake" wrote in message .. . It is certainly new to the millions of people prescribed these prescribed these drugs by a GP ..without an initial psychiatric assessment..let alone any monitoring or supervision of any kind..close or otherwise.. Not to mention the hundreds of thousands ordering them on the internet without ever seeing a doctor.. you realize that this is a problem with the doctors You blame the doctors for believing drug company disinformation and lies? no, i blame doctors for not requiring psych consults before perscribing psyc meds. i blame the doctors for not monitoring patients who need to be monitored. i don't see any disinfo here. the med inserts say that suicide is a risk in ANY depressed patient, and indeed it is. if the docs hand out a pill and ignore a suicidal patient, how on earth can that be the drug co's fault? One primary purpose of such advisories is to correct such disinformation as to the safety and prescribing practices.. execpt there was no disinformation. this advisory doesn't tell anyone anything new. really..? you were aware of the following by some sort of precognition or ESP then..I presume "While occurrences of suicidality are not unexpected in patients with MDD, preliminary data suggest an excess of such reports for patients assigned to several of these antidepressant drugs compared to those assigned to placebo. " unfortunately the FDA guessed most doctors and health care professionals did not possess your speciaslpowers and issed an alert.. the use of SSRIs to treat depression is problematic and of increasing concern..whatever spin might be used to hide thr fact seriously, i have no idea what your little agenda is all about, but SSRIs, among other depression treatments, save MANY more lives than you claim they take. this was the promise..and the sales proposition.. time has proved the confidence misplaced.. it has yet to be shown that SSRIs "save childrens lives" in any way shape or form.. i've said it before. don't like them, don't take them. but there's no reason to wage a campaign against an entire class of meds that have saved so many lives. so lets just sweep the victims and ruined lives under the carpet then... I know..why dont we just abandon all safety and regulatory bodies entirely..and give children whatever drugs the multinationals see fit to produce? -- "Until the philosophy which holds one race superior and another inferior is finally and permanently discredited and abandoned; until there is no longer any first-class and second-class citizens of any nation; until the color of a man's skin is of no more significance than the color of his eyes; until the basic human rights are equally guaranteed to all, without regard to race -- until that day, the dreams of lasting peace and world citizenship and the rule of international morality will remain but a fleeting illusion, to be pursued but never attained." Haile Sellassie |
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