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Just some comments - Cas Liber ( talk · contribs) 12:44, 4 May 2015 (UTC)
Additionally, "STI had worked with SmithKline Beecham on its promotion of paroxetine for years" - vague and somewhat perjorative in tone - be nice to get a more exact time for this sentence Cas Liber ( talk · contribs) 02:42, 4 November 2015 (UTC)
Nice article. yep lots of scandal around this.
probably the most important thing to come out of all this was the black box warning about suicide in kids. please see PMID 24452997
here is the conclusion:
Leon, who was a member of the FDA committee for interpreting the data that became the basis of the ‘black box’ warning, acknowledged that the data were far from ideal for the purpose [51]. He concluded that the FDA had initiated ‘‘… a large de facto public health experiment.’’ He thought the results of this experiment could be evaluated in about 5 years as to ‘‘… whether the black box cost more lives than it saved.’’ As far as we know, such an official evaluation has not yet appeared in print.
However, in the decade following issuance of warnings regarding suicidality among young people taking antidepressants, there have been several observations.
- There was a measurable decrease in the diagnosis of depression and the prescribing of antidepressants in several countries including the US, UK, Canada, Australia, and Sweden.
- There was 'a measurable increase in the numbers of suicides among young people in the same countries, with the exception of the UK.
- There is no evidence of emergence of increased risk of suicide among young people who use antidepressants.
- A large independent study found that antidepressant medication (specifically fluoxetine) was the most
effective treatment for major depression in young people [15]. Also, there was no increase in treatmentemergent suicidality in that study [47]. A new metaanalysis of all fluoxetine studies confirmed both results [18, 48] (emphasis added)
Jytdog ( talk) 16:34, 6 May 2015 (UTC)
Comparing SSRI to TCA is like apples for oranges. — Preceding unsigned comment added by 92.0.75.164 ( talk) 09:12, 9 February 2021 (UTC)
In 2007 the FDA proposed that all anti-depressants include a boxed warning of an increased risk of suicidal thoughts and behaviour in young adults (18–24) during the first one to two months of treatment. [1] [n 1] A 2012 Cochrane Collaboration report on the use of SSRIs in children and adolescents suggested that fluoxetine (Prozac) might be the medication of first choice, although caution is advised because of an "increased risk of suicide-related outcomes in those treated with antidepressant medications." [n 2]
References
References
Doc James, it was Jytdog who added the blockquote, and I agree that the section is better without. Before he edited then removed the section, it looked like this (and the point was simply to end the article with a brief note about the current situation):
In 2007 the FDA proposed that all anti-depressants include a boxed warning of an increased risk of suicidal thoughts and behaviour in young adults (18–24) during the first one to two months of treatment. [1] [n 1] A 2012 Cochrane Collaboration report on the use of SSRIs in children and adolescents suggested that fluoxetine (Prozac) might be the medication of first choice, although caution is advised because of an "increased risk of suicide-related outcomes in those treated with antidepressant medications." [2]
Sarah (SV) (talk) 17:48, 6 May 2015 (UTC)
I would replace the quote ""increased risk of suicide-related outcomes in those treated with antidepressant medications." with something more like "although caution is advised because of a possible increased suicide risk" "possible" because of "Caution is required in interpreting the results given the methodological limitations of the included trials in terms of internal and external validity." andincreased suicide risk because of "Clinicians need to keep in mind that there is evidence of an increased risk of suicide-related outcomes in those treated with antidepressant medications." Doc James ( talk · contribs · email) 18:23, 6 May 2015 (UTC)
In 2007 the FDA required that all anti-depressants include a boxed warning of an increased risk of suicidal thoughts and behaviour in young adults (18–24) during the first one to two months of treatment. [1] As a result of the label and media attention on the issue, prescriptions of SSRIs decreased and rates of suicide among children and adolescents increased. [2] [3] The question of whether SSRIs increase the risk, of suicidal thoughts or completed suicide remains controversial, with some authorities flatly denying it [2] [3] and others acknowledging a possible increased risk in suicide ideation of uncertain importance. [1] all authorities agree that undertreatment of depression in children and adolescents is harmful. [2] [3] [1]
References
- ^ a b c Sarah E. Hetrick, et al, "Newer generation antidepressants for depressive disorders in children and adolescents," Cochrane Library, 14 November 2012. doi: 10.1002/14651858.CD004851.pub3 PMID 23152227
- ^ a b c Isacsson G, Rich CL. Antidepressant drugs and the risk of suicide in children and adolescents. Paediatr Drugs. 2014 Apr;16(2):115-22. doi: 10.1007/s40272-013-0061-1. PMID 24452997
- ^ a b c Cousins L, Goodyer IM. Antidepressants and the adolescent brain. J Psychopharmacol. 2015 PMID 25744620
I've read the source, and that section is now on Doc James' version, except for a couple of tweaks:
Whether antidepressants increase the risk of suicide is controversial. In 2007 the FDA required that all anti-depressants include a boxed warning of an increased risk of suicidal thoughts and behaviour in young adults (18–24) during the first one to two months of treatment. [1] [n 2] A 2012 Cochrane review found tentative data of an increased suicide risk. [2] Other reviews have concluded that the risk is not confirmed. [3]
Sarah (SV) (talk) 21:06, 6 May 2015 (UTC)
We had a long discussion about these here [6] and our resident expert on screen readers User:Graham87 suggested a solution I hope will work for all. Doc James ( talk · contribs · email) 23:06, 9 May 2015 (UTC)
I was trying to find a place to integrate this into the article. Would it make sense to include the definition for Outcome Switching in this article or include a link if it is mentioned elsewhere on Wikipedia?
Shaded0 ( talk) 16:29, 29 March 2016 (UTC)
I am somewhat concerned by misrepresentations such as the one I have just corrected (1 million documents given as fact was actually an estimate of 1 million pages). Further to this particular example, readers - and editors - may not know that the document supporting a drug approval application to the MRHA typically runs to several hundred thousand pages. I'm not sure that the MRHA's estimate of the amount of evidence they reviewed, especially in such a power-of-ten estimate is actually useful.
Reading on in the same document, the advice not to prosecute was given by independent legal counsel, Mr Robert O’Sullivan and Mrs Miranda Moore QC, not as stated in our article, government lawyers.
All the best:
Rich
Farmbrough, 23:00, 12 December 2016 (UTC).
Having considered the advice provided by counsel the Prosecution Division reached the conclusion that no offence has been committed contrary to the 1994 Regulations because the clinical trials conducted by GSK on the paediatric use of Seroxat, and GSK’s alleged failure to provide information from those trials, most likely did not fall within the regime implemented by those Regulations.
On 6 May 2015 User:SlimVirgin inserted a bots template to deny AWB access to this article. Whatever the issue was should have been resolved by now. A comment on this talk page or an explanation in the edit summary would have been helpful, too. Let's get this cleaned up. Chris the speller yack 16:15, 8 August 2017 (UTC)
I read this:
Published in July 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP), which listed Keller and 21 other researchers as co-authors, study 329 became controversial when it was discovered that the article had been ghostwritten by a PR firm hired by SmithKline Beecham; had made inappropriate claims about the drug's efficacy; and had downplayed safety concerns.[8][9][3] The controversy led to several lawsuits and strengthened calls for drug companies to disclose all their clinical research data. New Scientist wrote in 2015: "You may never have heard of it, but Study 329 changed medicine."[10]
A GSK gw that write the 'scientific' paper Study 329 = nothing else than a fraud. And the fact that JAACAP refuse to retract it, shows very much cleary how the GSK power can influence the 'science' as well. Wakefield work was rectracted for much less, so why this study is not retracted and why wikipedia fail to show the real importance of this attitude? When a fraudolent scientific work was discovered and not retracted? If not, then it's not science, but something else. Logical said.
Instead, the incipit/abstract of this article is complex, vague, unclear. What was the 'controversial' part in a total fraud like this one?
For the sake of wikipedia neutrality, a fraud must be called what is it, a fraud. And this is not indicated in the abstract, no word like this at all.
Cite error: There are <ref group=n>
tags on this page, but the references will not show without a {{reflist|group=n}}
template (see the
help page).
This article is rated B-class on Wikipedia's
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Just some comments - Cas Liber ( talk · contribs) 12:44, 4 May 2015 (UTC)
Additionally, "STI had worked with SmithKline Beecham on its promotion of paroxetine for years" - vague and somewhat perjorative in tone - be nice to get a more exact time for this sentence Cas Liber ( talk · contribs) 02:42, 4 November 2015 (UTC)
Nice article. yep lots of scandal around this.
probably the most important thing to come out of all this was the black box warning about suicide in kids. please see PMID 24452997
here is the conclusion:
Leon, who was a member of the FDA committee for interpreting the data that became the basis of the ‘black box’ warning, acknowledged that the data were far from ideal for the purpose [51]. He concluded that the FDA had initiated ‘‘… a large de facto public health experiment.’’ He thought the results of this experiment could be evaluated in about 5 years as to ‘‘… whether the black box cost more lives than it saved.’’ As far as we know, such an official evaluation has not yet appeared in print.
However, in the decade following issuance of warnings regarding suicidality among young people taking antidepressants, there have been several observations.
- There was a measurable decrease in the diagnosis of depression and the prescribing of antidepressants in several countries including the US, UK, Canada, Australia, and Sweden.
- There was 'a measurable increase in the numbers of suicides among young people in the same countries, with the exception of the UK.
- There is no evidence of emergence of increased risk of suicide among young people who use antidepressants.
- A large independent study found that antidepressant medication (specifically fluoxetine) was the most
effective treatment for major depression in young people [15]. Also, there was no increase in treatmentemergent suicidality in that study [47]. A new metaanalysis of all fluoxetine studies confirmed both results [18, 48] (emphasis added)
Jytdog ( talk) 16:34, 6 May 2015 (UTC)
Comparing SSRI to TCA is like apples for oranges. — Preceding unsigned comment added by 92.0.75.164 ( talk) 09:12, 9 February 2021 (UTC)
In 2007 the FDA proposed that all anti-depressants include a boxed warning of an increased risk of suicidal thoughts and behaviour in young adults (18–24) during the first one to two months of treatment. [1] [n 1] A 2012 Cochrane Collaboration report on the use of SSRIs in children and adolescents suggested that fluoxetine (Prozac) might be the medication of first choice, although caution is advised because of an "increased risk of suicide-related outcomes in those treated with antidepressant medications." [n 2]
References
References
Doc James, it was Jytdog who added the blockquote, and I agree that the section is better without. Before he edited then removed the section, it looked like this (and the point was simply to end the article with a brief note about the current situation):
In 2007 the FDA proposed that all anti-depressants include a boxed warning of an increased risk of suicidal thoughts and behaviour in young adults (18–24) during the first one to two months of treatment. [1] [n 1] A 2012 Cochrane Collaboration report on the use of SSRIs in children and adolescents suggested that fluoxetine (Prozac) might be the medication of first choice, although caution is advised because of an "increased risk of suicide-related outcomes in those treated with antidepressant medications." [2]
Sarah (SV) (talk) 17:48, 6 May 2015 (UTC)
I would replace the quote ""increased risk of suicide-related outcomes in those treated with antidepressant medications." with something more like "although caution is advised because of a possible increased suicide risk" "possible" because of "Caution is required in interpreting the results given the methodological limitations of the included trials in terms of internal and external validity." andincreased suicide risk because of "Clinicians need to keep in mind that there is evidence of an increased risk of suicide-related outcomes in those treated with antidepressant medications." Doc James ( talk · contribs · email) 18:23, 6 May 2015 (UTC)
In 2007 the FDA required that all anti-depressants include a boxed warning of an increased risk of suicidal thoughts and behaviour in young adults (18–24) during the first one to two months of treatment. [1] As a result of the label and media attention on the issue, prescriptions of SSRIs decreased and rates of suicide among children and adolescents increased. [2] [3] The question of whether SSRIs increase the risk, of suicidal thoughts or completed suicide remains controversial, with some authorities flatly denying it [2] [3] and others acknowledging a possible increased risk in suicide ideation of uncertain importance. [1] all authorities agree that undertreatment of depression in children and adolescents is harmful. [2] [3] [1]
References
- ^ a b c Sarah E. Hetrick, et al, "Newer generation antidepressants for depressive disorders in children and adolescents," Cochrane Library, 14 November 2012. doi: 10.1002/14651858.CD004851.pub3 PMID 23152227
- ^ a b c Isacsson G, Rich CL. Antidepressant drugs and the risk of suicide in children and adolescents. Paediatr Drugs. 2014 Apr;16(2):115-22. doi: 10.1007/s40272-013-0061-1. PMID 24452997
- ^ a b c Cousins L, Goodyer IM. Antidepressants and the adolescent brain. J Psychopharmacol. 2015 PMID 25744620
I've read the source, and that section is now on Doc James' version, except for a couple of tweaks:
Whether antidepressants increase the risk of suicide is controversial. In 2007 the FDA required that all anti-depressants include a boxed warning of an increased risk of suicidal thoughts and behaviour in young adults (18–24) during the first one to two months of treatment. [1] [n 2] A 2012 Cochrane review found tentative data of an increased suicide risk. [2] Other reviews have concluded that the risk is not confirmed. [3]
Sarah (SV) (talk) 21:06, 6 May 2015 (UTC)
We had a long discussion about these here [6] and our resident expert on screen readers User:Graham87 suggested a solution I hope will work for all. Doc James ( talk · contribs · email) 23:06, 9 May 2015 (UTC)
I was trying to find a place to integrate this into the article. Would it make sense to include the definition for Outcome Switching in this article or include a link if it is mentioned elsewhere on Wikipedia?
Shaded0 ( talk) 16:29, 29 March 2016 (UTC)
I am somewhat concerned by misrepresentations such as the one I have just corrected (1 million documents given as fact was actually an estimate of 1 million pages). Further to this particular example, readers - and editors - may not know that the document supporting a drug approval application to the MRHA typically runs to several hundred thousand pages. I'm not sure that the MRHA's estimate of the amount of evidence they reviewed, especially in such a power-of-ten estimate is actually useful.
Reading on in the same document, the advice not to prosecute was given by independent legal counsel, Mr Robert O’Sullivan and Mrs Miranda Moore QC, not as stated in our article, government lawyers.
All the best:
Rich
Farmbrough, 23:00, 12 December 2016 (UTC).
Having considered the advice provided by counsel the Prosecution Division reached the conclusion that no offence has been committed contrary to the 1994 Regulations because the clinical trials conducted by GSK on the paediatric use of Seroxat, and GSK’s alleged failure to provide information from those trials, most likely did not fall within the regime implemented by those Regulations.
On 6 May 2015 User:SlimVirgin inserted a bots template to deny AWB access to this article. Whatever the issue was should have been resolved by now. A comment on this talk page or an explanation in the edit summary would have been helpful, too. Let's get this cleaned up. Chris the speller yack 16:15, 8 August 2017 (UTC)
I read this:
Published in July 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP), which listed Keller and 21 other researchers as co-authors, study 329 became controversial when it was discovered that the article had been ghostwritten by a PR firm hired by SmithKline Beecham; had made inappropriate claims about the drug's efficacy; and had downplayed safety concerns.[8][9][3] The controversy led to several lawsuits and strengthened calls for drug companies to disclose all their clinical research data. New Scientist wrote in 2015: "You may never have heard of it, but Study 329 changed medicine."[10]
A GSK gw that write the 'scientific' paper Study 329 = nothing else than a fraud. And the fact that JAACAP refuse to retract it, shows very much cleary how the GSK power can influence the 'science' as well. Wakefield work was rectracted for much less, so why this study is not retracted and why wikipedia fail to show the real importance of this attitude? When a fraudolent scientific work was discovered and not retracted? If not, then it's not science, but something else. Logical said.
Instead, the incipit/abstract of this article is complex, vague, unclear. What was the 'controversial' part in a total fraud like this one?
For the sake of wikipedia neutrality, a fraud must be called what is it, a fraud. And this is not indicated in the abstract, no word like this at all.
Cite error: There are <ref group=n>
tags on this page, but the references will not show without a {{reflist|group=n}}
template (see the
help page).