Comments on: Zoloft And Therapy Reduced Anxiety In Kids: Study http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/ News, Comment and Conversation Fri, 10 Feb 2012 21:10:05 +0000 http://wordpress.org/?v=2.6.2 By: Lisa Van S http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379994 Lisa Van S Sat, 01 Nov 2008 20:39:25 +0000 http://www.pharmalot.com/?p=17114#comment-379994 Dr March was a defennse expert for Solvay Pharmaceuticals in Taylor vs Solvay (Columbine). He is also the author of the TADS Study. Dr. Mosholder, under oath, testified before Congress, that the TADS Study didnt meet FDA Standards for approval. Dr March was a defennse expert for Solvay Pharmaceuticals in Taylor vs Solvay (Columbine). He is also the author of the TADS Study. Dr. Mosholder, under oath, testified before Congress, that the TADS Study didnt meet FDA Standards for approval.

]]> By: truthman30 http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379987 truthman30 Sat, 01 Nov 2008 19:00:21 +0000 http://www.pharmalot.com/?p=17114#comment-379987 Does anyone here trust the conclusions of this study? .. If so , perhaps they should consider the following information sourced from the original article before they decide .. http://content.nejm.org/cgi/content/full/NEJMoa0804633 Supported by grants (U01 MH064089, to Dr. Walkup; U01 MH64092, to Dr. Albano; U01 MH64003, to Dr. Birmaher; U01 MH63747, to Dr. Kendall; U01 MH64107, to Dr. March; U01 MH64088, to Dr. Piacentini; and U01 MH064003, to Dr. Compton) from the National Institute of Mental Health (NIMH). Sertraline and matching placebo were supplied free of charge by Pfizer. Dr. Walkup reports receiving consulting fees from Eli Lilly and Jazz Pharmaceuticals and fees for legal consultation to defense counsel and submission of written reports in litigation involving GlaxoSmithKline, receiving lecture fees from CMP Media, Medical Education Reviews, McMahon Group, and DiMedix, and receiving support in the form of free medication and matching placebo from Eli Lilly and free medication from Abbott for clinical trials funded by the NIMH; Dr. Albano, receiving royalties from Oxford University Press for the Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent Versions, but not for interviews used in this study, and royalties from the Guilford Press; Dr. Piacentini, receiving royalties from Oxford University Press for treatment manuals on childhood obsessive–compulsive disorder and tic disorders and from the Guilford Press and APA Books for other books on child mental health and receiving lecture fees from Janssen-Cilag; Dr. Birmaher, receiving consulting fees from Jazz Pharmaceuticals, Solvay Pharmaceuticals, and Abcomm, lecture fees from Solvay, and royalties from Random House for a book on children with bipolar disorder; Dr. Rynn, receiving grant support from Neuropharm, Boehringer Ingelheim Pharmaceuticals, and Wyeth Pharmaceuticals, consulting fees from Wyeth, and royalties from APPI for a book chapter on pediatric anxiety disorders; Dr. McCracken, receiving consulting fees from Sanofi-Aventis and Wyeth, lecture fees from Shire and UCB, and grant support from Aspect, Johnson & Johnson, Bristol-Myers Squibb, and Eli Lilly; Dr. Waslick, receiving grant support from Baystate Health, Somerset Pharmaceuticals, and GlaxoSmithKline; Dr. Iyengar, receiving consulting fees from Westinghouse for statistical consultation; Dr. March, receiving study medications from Eli Lilly for an NIMH-funded clinical trial and receiving royalties from Pearson for being the author of the Multidimensional Anxiety Scale for Children, receiving consulting fees from Eli Lilly, Pfizer, Wyeth, and GlaxoSmithKline, having an equity interest in MedAvante, and serving on an advisory board for AstraZeneca and Johnson & Johnson; and Dr. Kendall, receiving royalties from Workbook Publishing for anxiety-treatment materials. No other potential conflict of interest relevant to this article was reported. The views expressed in this article are those of the authors and do not necessarily represent the official views of the NIMH, the National Institutes of Health, or the Department of Health and Human Services. We thank the children and their families who made this study possible; and J. Chisar, J. Fried, R. Klein, E. Menvielle, S. Olin, J. Severe, D. Almirall, and members of NIMH's data and safety monitoring board. * The study investigators are listed in the Appendix. http://content.nejm.org/cgi/content/full/NEJMoa0804633 Does anyone here trust the conclusions of this study? ..
If so , perhaps they should consider the following information sourced from the original article before they decide ..

http://content.nejm.org/cgi/content/full/NEJMoa0804633

Supported by grants (U01 MH064089, to Dr. Walkup; U01 MH64092, to Dr. Albano; U01 MH64003, to Dr. Birmaher; U01 MH63747, to Dr. Kendall; U01 MH64107, to Dr. March; U01 MH64088, to Dr. Piacentini; and U01 MH064003, to Dr. Compton) from the National Institute of Mental Health (NIMH). Sertraline and matching placebo were supplied free of charge by Pfizer.

Dr. Walkup reports receiving consulting fees from Eli Lilly and Jazz Pharmaceuticals and fees for legal consultation to defense counsel and submission of written reports in litigation involving GlaxoSmithKline, receiving lecture fees from CMP Media, Medical Education Reviews, McMahon Group, and DiMedix, and receiving support in the form of free medication and matching placebo from Eli Lilly and free medication from Abbott for clinical trials funded by the NIMH; Dr. Albano, receiving royalties from Oxford University Press for the Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent Versions, but not for interviews used in this study, and royalties from the Guilford Press; Dr. Piacentini, receiving royalties from Oxford University Press for treatment manuals on childhood obsessive–compulsive disorder and tic disorders and from the Guilford Press and APA Books for other books on child mental health and receiving lecture fees from Janssen-Cilag; Dr. Birmaher, receiving consulting fees from Jazz Pharmaceuticals, Solvay Pharmaceuticals, and Abcomm, lecture fees from Solvay, and royalties from Random House for a book on children with bipolar disorder; Dr. Rynn, receiving grant support from Neuropharm, Boehringer Ingelheim Pharmaceuticals, and Wyeth Pharmaceuticals, consulting fees from Wyeth, and royalties from APPI for a book chapter on pediatric anxiety disorders; Dr. McCracken, receiving consulting fees from Sanofi-Aventis and Wyeth, lecture fees from Shire and UCB, and grant support from Aspect, Johnson & Johnson, Bristol-Myers Squibb, and Eli Lilly; Dr. Waslick, receiving grant support from Baystate Health, Somerset Pharmaceuticals, and GlaxoSmithKline; Dr. Iyengar, receiving consulting fees from Westinghouse for statistical consultation; Dr. March, receiving study medications from Eli Lilly for an NIMH-funded clinical trial and receiving royalties from Pearson for being the author of the Multidimensional Anxiety Scale for Children, receiving consulting fees from Eli Lilly, Pfizer, Wyeth, and GlaxoSmithKline, having an equity interest in MedAvante, and serving on an advisory board for AstraZeneca and Johnson & Johnson; and Dr. Kendall, receiving royalties from Workbook Publishing for anxiety-treatment materials. No other potential conflict of interest relevant to this article was reported.

The views expressed in this article are those of the authors and do not necessarily represent the official views of the NIMH, the National Institutes of Health, or the Department of Health and Human Services.

We thank the children and their families who made this study possible; and J. Chisar, J. Fried, R. Klein, E. Menvielle, S. Olin, J. Severe, D. Almirall, and members of NIMH’s data and safety monitoring board.

* The study investigators are listed in the Appendix.

http://content.nejm.org/cgi/content/full/NEJMoa0804633

]]> By: Lisa Van S http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379888 Lisa Van S Sat, 01 Nov 2008 00:51:01 +0000 http://www.pharmalot.com/?p=17114#comment-379888 One last comment, Candace Downing, at age 12 was prescribed Zoloft for test anxiety. She hung herself from her canopy bed. Parents must heed the Black Box Warnings. Candace and her family payed the ultimate price. One last comment, Candace Downing, at age 12 was prescribed Zoloft for test anxiety. She hung herself from her canopy bed. Parents must heed the Black Box Warnings. Candace and her family payed the ultimate price.

]]> By: Lisa Van S http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379886 Lisa Van S Sat, 01 Nov 2008 00:43:47 +0000 http://www.pharmalot.com/?p=17114#comment-379886 Paxil Study 329 was described as "remarkable". And now the Zoloft is deemed "Incredible". Reminds me of how Pfizer a few years back combined two negative studies to get one positive!!! And they'd like us to trust their math. I am sure the raw data would paint a much different picture. Paxil Study 329 was described as “remarkable”. And now the Zoloft is deemed “Incredible”. Reminds me of how Pfizer a few years back combined two negative studies to get one positive!!! And they’d like us to trust their math. I am sure the raw data would paint a much different picture.

]]> By: Doug Bremner http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379866 Doug Bremner Fri, 31 Oct 2008 20:50:55 +0000 http://www.pharmalot.com/?p=17114#comment-379866 Also the primary outcome of "much improved" on the CGI is misleading. let me give an example. Say the primary goal is to run a mile in 10 minutes (or whatever, I say as I sit in my office chair). If out of 100 people running, people wearing green shirts do it, on average, in 9 minutes 45 seconds, and people wearing red shirts do it in 10 minutes 15 seconds, you could have a result where 60% of the green shirts make the goal versus 25% of the red shirts, which sounds like a big deal, even though there is only a 5% difference in their times. Similarly, there is only a 9% difference between placebo and zoloft, and when I went back to look at the results, there was not a significant difference between placebo-zoloft or placebo-combination, only placebo-therapy for the anxiety scale! [no time-treatment interaction] They only had one doubtful comparison of scores at the end of treatment. Incredible results indeed. Also the primary outcome of “much improved” on the CGI is misleading. let me give an example. Say the primary goal is to run a mile in 10 minutes (or whatever, I say as I sit in my office chair). If out of 100 people running, people wearing green shirts do it, on average, in 9 minutes 45 seconds, and people wearing red shirts do it in 10 minutes 15 seconds, you could have a result where 60% of the green shirts make the goal versus 25% of the red shirts, which sounds like a big deal, even though there is only a 5% difference in their times.

Similarly, there is only a 9% difference between placebo and zoloft, and when I went back to look at the results, there was not a significant difference between placebo-zoloft or placebo-combination, only placebo-therapy for the anxiety scale! [no time-treatment interaction] They only had one doubtful comparison of scores at the end of treatment. Incredible results indeed.

]]> By: Doug Bremner http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379837 Doug Bremner Fri, 31 Oct 2008 17:17:34 +0000 http://www.pharmalot.com/?p=17114#comment-379837 WSJ quoted a doctor as saying the results of this study were "incredible". However if you compare this one to Study 329, effects of paroxetine on depression in children, the results are not that different. In the case of Study 329, 66% of kids treated with Paxil (paroxetine) were "much improved" or better as measured by the Clinical Global Impression Scale (CGI) [criteria used in the sertraline/Zoloft study] versus 48% of those treated with placebo, which they reported as statistically significant. However they did not find a significant change in their primary outcome [change in Hamilton Depression Scale score], and to report the study as positive is a violation of the rules of clinical trials, as pointed out in a subsequent letter to the editor. In fact, if you look at the actual data, the Ham D score went from a baseline of 19.0 in both groups, to 8.2 in the paroxetine group and 9.9 in the placebo group, only a 3% difference in a 56 point scale which was not significantly different. Compare that to the study of sertraline (Zoloft) in kids. Although there was a difference in "responders" based on much improved on the CGI of 60% versus 24% for placebo, when you look at the actual data, the Pediatric Anxiety Scale, a 30 point scale, went from 18.8 at baseline to 9.8 in the zoloft group, and from 19.6 to 12.6 in the placebo group, a difference of 9%, again, not reported as statistically significant. WSJ quoted a doctor as saying the results of this study were “incredible”. However if you compare this one to Study 329, effects of paroxetine on depression in children, the results are not that different. In the case of Study 329, 66% of kids treated with Paxil (paroxetine) were “much improved” or better as measured by the Clinical Global Impression Scale (CGI) [criteria used in the sertraline/Zoloft study] versus 48% of those treated with placebo, which they reported as statistically significant. However they did not find a significant change in their primary outcome [change in Hamilton Depression Scale score], and to report the study as positive is a violation of the rules of clinical trials, as pointed out in a subsequent letter to the editor. In fact, if you look at the actual data, the Ham D score went from a baseline of 19.0 in both groups, to 8.2 in the paroxetine group and 9.9 in the placebo group, only a 3% difference in a 56 point scale which was not significantly different. Compare that to the study of sertraline (Zoloft) in kids. Although there was a difference in “responders” based on much improved on the CGI of 60% versus 24% for placebo, when you look at the actual data, the Pediatric Anxiety Scale, a 30 point scale, went from 18.8 at baseline to 9.8 in the zoloft group, and from 19.6 to 12.6 in the placebo group, a difference of 9%, again, not reported as statistically significant.

]]> By: Andy http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379814 Andy Fri, 31 Oct 2008 13:24:11 +0000 http://www.pharmalot.com/?p=17114#comment-379814 thank you tom cruise thank you tom cruise

]]> By: AA http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379785 AA Fri, 31 Oct 2008 09:39:10 +0000 http://www.pharmalot.com/?p=17114#comment-379785 To add to the great comments already posted, 3 month isn't really long enough to decided if CBT by itself is more effective or just as effective as the combined treatment. As this study on Furious Seasons shows regarding CBT and Prozac for the study of depression, the longer CBT goes in comparison to the combined treatment, it turns out to be just as nearly effective. Short term, like the study on CBT and Zoloft for anxiety, the results are similar for all the treatments. http://tinyurl.com/yowcj5 AA To add to the great comments already posted, 3 month isn’t really long enough to decided if CBT by itself is more effective or just as effective as the combined treatment. As this study on Furious Seasons shows regarding CBT and Prozac for the study of depression, the longer CBT goes in comparison to the combined treatment, it turns out to be just as nearly effective. Short term, like the study on CBT and Zoloft for anxiety, the results are similar for all the treatments.

http://tinyurl.com/yowcj5

AA

]]> By: Sam http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379780 Sam Fri, 31 Oct 2008 08:51:18 +0000 http://www.pharmalot.com/?p=17114#comment-379780 I too would like to see the raw data. "... dramatically reduced the severity of anxiety disorders ..." does not necessarily mean improvement. Does "dramatically reduced" mean that the child became happier, or was the child's emotional tone depressed further by the drug so that they went below anxiety into uncaring apathy? "How do you feel about {whatever the child was anxious about} now?" could be answered with: "Better" or "About the same" or (apathetic/hopeless) "Who cares?" I too would like to see the raw data. “… dramatically reduced the severity of anxiety disorders …” does not necessarily mean improvement.

Does “dramatically reduced” mean that the child became happier, or was the child’s emotional tone depressed further by the drug so that they went below anxiety into uncaring apathy?

“How do you feel about {whatever the child was anxious about} now?”

could be answered with:

“Better”
or
“About the same”
or
(apathetic/hopeless) “Who cares?”

]]> By: Lisa Van S http://www.pharmalot.com/2008/10/zoloft-and-therapy-reduced-anxiety-in-kids-study/#comment-379753 Lisa Van S Fri, 31 Oct 2008 03:17:48 +0000 http://www.pharmalot.com/?p=17114#comment-379753 laurie, Really looks like the Paxil 329 Study, would love to see the raw data!!!!!!!!!!!!! laurie,

Really looks like the Paxil 329 Study, would love to see the raw data!!!!!!!!!!!!!

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