{"id":4566,"date":"2010-12-19T08:02:01","date_gmt":"2010-12-19T13:02:01","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=4566"},"modified":"2010-12-22T11:44:58","modified_gmt":"2010-12-22T16:44:58","slug":"inquiring-minds","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2010\/12\/19\/inquiring-minds\/","title":{"rendered":"inquiring minds…"},"content":{"rendered":"\n

A few days back, I mentioned my nagging concerns about the Paxil\/GSK\/STI<\/strong> story [message in a bottle…<\/font><\/a><\/strong>]. Given the amount of manipulation of the medical literature and the C.M.E. process by GlaxoSmithKline in promoting the drug, I was beginning to question how the drug got on the market in the first place. When I read<\/strong><\/a> that the infamous duo of Dr. Richard Borison and Bruce Diamond had done drug trials on Paxil for GSK, I wondered if the deceit even antedated its approval by the FDA – if they had been part of the approval process. I still don’t know the answer to that question, but I’m on the road to maybe finding out. I’ve certainly learned that there was manipulation of the FDA in approving Paxil from the testimony of Dr. Peter Breggin<\/font><\/strong><\/a> and Dr. Joseph Glenmullen<\/font><\/strong><\/a> who had access to GSK\/FDA documents. The "suicidality" data was mispresented and the "withdrawal information was misleading. They apparently knew about both of those things before the drug was approved and GSK [SKB] actively kept them out of the process.<\/p>\n\n\n
\n

In the Glenmullen Report<\/font><\/strong><\/a>, the data submitted to the FDA for Paxil was reanalyzed by Dr. Joseph Glenmullen. This is the Information as it was reported [one of several versions].<\/p>\n\n\n\n\n\n\n\n
 <\/td>\nPaxil<\/font><\/strong><\/td>\nPlacebo<\/font><\/strong><\/td>\nODDS<\/font><\/strong><\/td>\nProbability<\/font><\/strong><\/td>\n<\/tr>\n
 <\/td>\n\n
<\/td>\n<\/tr>\n
Number of subjects<\/font><\/strong><\/td>\n2963<\/em><\/td>\n554<\/em><\/td>\n <\/td>\n <\/td>\n<\/tr>\n
Suicide attempts<\/font><\/strong><\/td>\n42<\/td>\n3<\/td>\n2.60<\/td>\np=0.10<\/td>\n<\/tr>\n
Suicides<\/font><\/strong><\/td>\n   5 <\/u><\/td>\n  2  <\/u><\/td>\n0.47<\/td>\np=0.30<\/td>\n<\/tr>\n
Combined<\/font><\/strong><\/td>\n47<\/td>\n5<\/td>\n1.80<\/td>\np=0.33<\/td>\n<\/tr>\n<\/table>\n

But, in fact, the study had a "placebo wash out" period before the patients were randomized and put on treatments. 2 suicide attempts and 2 suicides occurred in that period. In the table above, they were coded into the placebo groups! Dr. Glenmullen shows us the real numbers in the next table:<\/p>\n\n\n\n\n\n\n\n
 <\/td>\nWash Out<\/font><\/strong><\/td>\nPaxil<\/font><\/strong><\/td>\nPlacebo<\/font><\/strong><\/td>\nODDS<\/font><\/strong><\/td>\nProbability<\/font><\/strong><\/td>\n<\/tr>\n
 <\/td>\n\n
<\/td>\n<\/tr>\n
Number of subjects<\/font><\/strong><\/td>\n3517<\/em><\/td>\n2963<\/em><\/td>\n554<\/em><\/td>\n <\/td>\n <\/td>\n<\/tr>\n
Suicide attempts<\/font><\/strong><\/td>\n2<\/td>\n42<\/td>\n1<\/td>\n8.00<\/font><\/strong><\/td>\np=0.01<\/font><\/strong><\/td>\n<\/tr>\n
Suicides<\/font><\/strong><\/td>\n  2  <\/u><\/td>\n   5 <\/u><\/td>\n  0  <\/u><\/td>\nAll on Paxil<\/font><\/strong><\/td>\n<\/tr>\n
Combined<\/font><\/strong><\/td>\n4<\/td>\n47<\/td>\n1<\/td>\n8.90<\/font><\/strong><\/td>\np<0.01<\/font><\/strong><\/td>\n<\/tr>\n<\/table>\n

<\/p>\n

Glenmullen illustrates some more examples of fudging, but this gives the flavor of the report. The difference is pretty significant<\/font><\/strong>!<\/div>\n<\/td>\n<\/tr>\n<\/table>\n

<\/p>\n

But now there’s something else bothering me. Dr. Nemeroff has been a part of the Paxil story from early on. We’ve long known about the various fundings from GSK to Emory, about Nemeroff’s personal involvement through GSK’s speaker’s bureau, about the NIMH grants to study Paxil, about his papers about Paxil, and now about GSK’s financing of a textbook that painted Paxil in a rosy light against a gradient of toxic side effects. But the POGO letter brought up something else that pushed Nemeroff’s involvement back even further:<\/div>\n
\n
POGO Letter to NIH on Ghostwriting Academics<\/a>
Project On Government Oversight<\/strong>
by Danielle Brian and Paul Thacker
November 29, 2010 [Revised December 9, 2010]<\/div>\n

<\/p>\n

According to the documents, GSK began to push sales of Paxil in the early 1990s with an extensive ghostwriting program run by the marketing firm Scientific Therapeutics Information (STI). For instance, STI wrote a proposal to organize GlaxoSmithKline’s Paxil Advisory Board Meeting in 1993 at the Ritz Carlton Hotel in Palm Beach, Florida. STI chose Dr. Charles Nemeroff of Emory University as their speaker to lay out the meeting’s agenda and objectives. Dr. Nemeroff apparently led discussions on how to “evaluate clinical research\/promotional programs” and “generate information for use in promotion\/education.” [Attachment A<\/font><\/strong>]<\/a><\/div>\n<\/blockquote>\n
<\/div>\n
Dr. Nemeroff had amassed an impressive research CV as a PhD in Neuroscience before going to medical school and training in Psychiatry. He finished his Psychiatric Residency in 1985 and joined the Duke Faculty. By 1989, he was Chief of Biological Psychiatry. By 1991, he was selected as Chairman of the Department of Psychiatry at Emory. In Academic Medicine, that is something of a meteoric rise, even for an MD-PhD. Six years out of training, most rising academic stars have just finished the tenure process and are not yet Chairman candidates. He was recruited and hired at Emory by Dr. Jeff Houpt, whose rise to Dean had also been meteoric – also from Duke. <\/div>\n

While Dr Nemeroff’s credentials and impressive resume were never in question, I always wondered why it all happened so fast. But the POGO letter raises yet another astronomical question. Nemeroff arrived at Emory in 1991. By the end of 1992 [December 29], Paxil was approved by the FDA. Then in September 1993, Dr. Nemeroff was not only on the Paxil Advisory Board at GSK [SKB], he was chosen to moderate the initial meeting scripted by Scientific Therapeutics Information<\/strong>‘s Sally Laden. That sounds like a position one would fill with a solid ally – someone who had been on board for a while. <\/p>\n

So now I’m wondering if Dr. Nemeroff was affiliated with GSK [SKB] before Paxil was approved?  before coming to Emory? involved in the Paxil FDA approval process itself? I don’t know the answers, but the information in the POGO letter makes those seem like reasonable questions. As they say, "Inquiring minds want to know"… <\/div>\n","protected":false},"excerpt":{"rendered":"

A few days back, I mentioned my nagging concerns about the Paxil\/GSK\/STI story [message in a bottle…]. Given the amount of manipulation of the medical literature and the C.M.E. process by GlaxoSmithKline in promoting the drug, I was beginning to question how the drug got on the market in the first place. When I read […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","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-4566","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4566","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=4566"}],"version-history":[{"count":0,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4566\/revisions"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=4566"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=4566"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=4566"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}