{"id":26536,"date":"2012-08-29T13:14:12","date_gmt":"2012-08-29T17:14:12","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=26536"},"modified":"2012-08-29T18:14:09","modified_gmt":"2012-08-29T22:14:09","slug":"the-lesson-of-study-329-uh-oh","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/08\/29\/the-lesson-of-study-329-uh-oh\/","title":{"rendered":"the lesson of Study 329: uh-oh!\u2026"},"content":{"rendered":"\n

Study 329 has an extensive literature of its own familiar to most people with any interest in the relationship between the pharmaceutical industry and acadenic psychiatry. For the moment, I’d like to hold my focus on the raw data finally posed this month [the Appendices below]: The top four entries are summaries released after the successful New York suit<\/font><\/strong><\/u><\/a> in 2004, but the raw data was only recently released [August 2, 2012] after an inquiry by Peter Doshi [a movement…<\/font><\/a><\/strong><\/u><\/strong>]. In an earlier post [the lesson of Study 329: the basics…<\/font><\/a><\/strong><\/u>], I extracted the raw data in Appendix C:<\/font><\/strong> and showed that there was no<\/u> separation of the Placebo and Paroxetine groups [others have done the same using more sophisticated software and the LOCF correction method]. <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Unipolar major depression<\/font>: Study 329<\/font><\/u><\/a><\/strong> <\/p>\n
<\/td>\n<\/tr>\n
table of contents<\/sup><\/font><\/strong><\/em> <\/p>\n
<\/td>\n		posted in <\/sup><\/font><\/strong><\/em> <\/p>\n
<\/td>\n		file<\/sup><\/font><\/strong><\/em> <\/p>\n
<\/td>\n<\/tr>\n
Study synopsis acute<\/font><\/strong><\/td>\n2004<\/td>\nPDF (0.03Mb)<\/a><\/u><\/td>\n<\/tr>\n
Study synopsis continuation<\/em><\/font><\/strong> <\/td>\n2004<\/td>\nPDF (0.03Mb)<\/a><\/u><\/td>\n<\/tr>\n
Full study report acute <\/font><\/strong><\/td>\n2004<\/td>\n PDF (0.97Mb)<\/a><\/u><\/td>\n<\/tr>\n
Full Study report continuation<\/em><\/font><\/strong> <\/td>\n2004<\/td>\nPDF (0.56Mb)<\/a><\/u><\/td>\n<\/tr>\n
 <\/td>\nAppendix A: Protocol \t\t \t\t <\/font><\/strong><\/td>\n2012<\/td>\nPDF (19Mb)<\/a><\/u><\/td>\n<\/tr>\n
 <\/td>\nAppendix B: Patient Data Listings by Demographic <\/font><\/strong><\/td>\n2012<\/td>\nPDF (18Mb)<\/a><\/u><\/td>\n<\/tr>\n
 <\/td>\nAppendix C: Patient Data Listings by Efficacy <\/font><\/strong><\/td>\n2012<\/td>\nPDF (18Mb)<\/a><\/u><\/td>\n<\/tr>\n
 <\/td>\nAppendix D: Patient Listings of Adverse Events <\/font><\/strong><\/td>\n2012<\/td>\nPDF (8Mb)<\/a><\/u><\/td>\n<\/tr>\n
 <\/td>\nAppendix E: Patient Data Listings of Vital Signs <\/font><\/strong><\/td>\n2012<\/td>\nPDF (3.5Mb)<\/a><\/u><\/td>\n<\/tr>\n
 <\/td>\nAppendix F: Patient Data Listings of Lab Values <\/font><\/strong><\/td>\n2012<\/td>\nPDF (23.5Mb)<\/a><\/u><\/td>\n<\/tr>\n
 <\/td>\nAppendix G: CRF Tabulations by Patient <\/font><\/strong><\/td>\n2012<\/td>\nPDF (53Mb)<\/a><\/u><\/td>\n<\/tr>\n
 <\/td>\nAppendix H: CRF for Adverse Experiences <\/font><\/strong><\/td>\n2012<\/td>\nPDF (60Kb)<\/a><\/u><\/td>\n<\/tr>\n<\/table>\n

What does the raw data tell us about the adverse effects, specifically suicidality? This is what the article said – 11 serious adverse events. Appendix H: lists the case numbers of the Serious Adverse Events [the ones with red asterix were the 11 taking Paroxetine]: <\/p>\n

<\/p>\n

Here are the comments on those cases from Appendix G: The lighter oneswere the ones I called, one more than they listed. They didn’t count 329.001.00065:<\/p>\n


[Extracted from Appendix G:]<\/sup><\/p>\n

Then in Appendix D: they listed these Adverse Events under Emotional Lability<\/em>:<\/p>\n

<\/a>
[truncated to fit the page. Click for the full table]<\/sup><\/p>\n

9 suicidal events in 8 patients. The difference seems to be in the Relative Days<\/font><\/strong> column. In the article, they only counted the information from the first eight weeks, even though the subjects continued on medication thereafter – adding 329.002.0058, 329.004.00015, and 329.005.00011. The fact that they cut-off the Adverse Events at 8 weeks is not mentioned in the article. Below is the comparison among Placebo<\/font><\/strong>, Imipramine<\/font><\/strong>, and Paroxetine<\/font><\/strong> from Appendix D: for Hostility and Emotional Lability [AKA Suicidality]:<\/p>\n


the lightened dots are two adverse events in the same subject<\/sup><\/p>\n

The world doesn’t need another version of how to interpret this graph – there are far too many already. I question the multiple tries at statistical comparison because there were a variable number of subjects continuing and dealing with drop-outs is imponderable. Suffice it to say that if I had been able to see this graph when this study was published, I’m sure I would’ve said "Uh-Oh!" when I looked at the blue dots, particularly compared to the red ones.<\/div>\n","protected":false},"excerpt":{"rendered":"

Study 329 has an extensive literature of its own familiar to most people with any interest in the relationship between the pharmaceutical industry and acadenic psychiatry. For the moment, I’d like to hold my focus on the raw data finally posed this month [the Appendices below]: The top four entries are summaries released after the […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-26536","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/26536","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=26536"}],"version-history":[{"count":76,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/26536\/revisions"}],"predecessor-version":[{"id":26637,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/26536\/revisions\/26637"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=26536"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=26536"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=26536"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}