{"id":24039,"date":"2012-06-05T21:07:07","date_gmt":"2012-06-06T01:07:07","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=24039"},"modified":"2012-06-06T08:33:17","modified_gmt":"2012-06-06T12:33:17","slug":"24039","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/06\/05\/24039\/","title":{"rendered":"nullified…"},"content":{"rendered":"\n

While historians have the advantage of freedom from contemporary drama and knowing the outcome, they lose the passion of the moment. The moments after the introduction of the DSM-III were certainly dramatic at the time. For all intents and purposes, with the DSM-III, psychiatry had declared itself a biological science, free from the shackles of conjecture and speculation, but it was the introduction of Eli Lilly’s Prozac in 1987 that instantiated this change in the general culture – something of a wonder drug<\/em>. – the debut of the age of a new psychopharmacology. GSK’s Paxil was something of a late comer.<\/p>\n

These days, we know about ghost-writing, industry-sponsored research articles, speakers bureaus, conflicts of interest, and the general level of pharma-babble that contaminated every nook and cranny of the commercialization of psychiatry. But back in the those days, it wasn’t apparent – hidden behind a firewall that wasn’t fully pierced until the last 5 or 6 years. So GSK’s Paxil was in the thick of the SSRI wars for market share that raged throughout the patent-life of these drugs. Dr. Charlie Nemeroff and the medical writing firm, STI [Scientific Therapeutic Information<\/em>], were there from the start – shepherded by STI’s Sally Laden. She chose Dr. Nemeroff, the new chairman of psychiatry at Emory University, to moderate their <\/font><\/strong>Paxil kickoff meeting<\/font><\/strong><\/a><\/u> in 1993:<\/div>\n
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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<\/font><\/strong>’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<\/font><\/strong> 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<\/a><\/strong>]<\/sup><\/div>\n<\/blockquote>\n
That was the beginning of a long and productive relationship between STI’s Ms. Laden and Dr. Nemeroff.  in 1999, she negotiated STI’s writing a GSK financed textbook, Recognition and Treatment of Psychiatric Disorders<\/font><\/strong>, for Dr. Nemeroff and Alan Schatzberg [“quintessential resource”…<\/font><\/strong><\/u><\/a>]. Ms. Laden’s GSK connection was much wider than just Dr. Nemeroff [roaches…<\/font><\/a><\/strong><\/u>]. But she was still with him in 2006 [sally’s world…<\/font><\/a><\/strong><\/u>] in another ghost-writing endeavor for another company. Dr. Nemeroff remained an important figure in GSK’s Paxil Marketing effort. This is from a 2000 brochure<\/font><\/strong><\/u><\/a> created by STI about PSYCHnet, a GSK speakers program promoting Paxil. Dr. Nemeroff was involved in training other KOL’s to give presentations using GSK slide kits:<\/div>\n
<\/div>\n
Notice ·<\/font>The Role of Norepinephrine in Depression<\/font><\/strong>.This was a period of major competition among the antidepressant manufacturers. Paxil had come late and was followed by Effexor, a drug that effected both<\/u> Serotonin and<\/u> Norepinephrine [an SNRI instead of just an SSRI], a selling point in the market share wars. This particular GSK presentation was designed to say that Paxil had an effect on Norepinephrine too<\/u> – a talking point for the GSK sales promotion efforts. Dr. Nemeroff not only trained others to give these talks, he gave a lot of them himself: <\/div>\n
<\/div>\n
I find this next graph almost inconceivable [from Senator Grassley’s investigation]. It’s Dr. Nemeroff’s presentations for GSK-Psychnet per<\/strong> month!<\/strong> – 269 in 6 years, all over the country. In the brochure, they said their speakers contracted for >4\/year and <15\/year [I guess some presenters are more special than others]:<\/div>\n
 <\/div>\n

Another sign of those times, alliances between academia, the NIMH, and industry were seen as valuable, encouraged. Translational science was big, and the NIMH has a number of programs designed to foster university\/private sector collaboration. Dr. Insel came to the NIMH in 2002 after directing such a program in Atlanta at Emory. In 2003, Dr. Nemeroff received a collaborative grant from NIMH, the EMORY-GSK-NIMH COLLABORATIVE MOOD DISORDERS INITIATIVE<\/font><\/strong><\/u><\/a>.<\/p>\n

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This application, in response to RFA: MH-03-008 (National Cooperative Drug Discovery Groups for the Treatment of Mood Disorders or Nicotine Addiction, NC 336-MD\/NA<\/font><\/strong>), proposes the creation of"The Emory-GSK-NIMH Collaborative Mood Disorders Initiative." This unique opportunity to accererate antidepressant drug development brings together expertise of three complementary research groups: the Emory University School of Medicine Department of Psychiatry and Behavioral Sciences, the Mood and Anxiety Disorders Program at NIMH and the Center for Excellence in Drug Discovery (CEDD) in Psychiatry of GlaxoSmithKline (GSK), one of the largest multinational pharmaceutical companies. The two major goals of the current application are the development of innovative new models for basic and clinical research in mood disorders and the intensive scrutiny of 5 novel GSK antidepressant candidates in preclinical and clinical paradigms…<\/sup><\/div>\n<\/blockquote>\n
That Emory\/GSK\/NIMH grant ran concomitantly with Dr. Nemeroff’s heavy participation in GSK’s Psychnet speaker days. This is an article from 2008 when Senator Charles Grassley and his Investigator, Paul Thacker, began to look at Dr. Nemeroff’s Conflicts of Interest: <\/div>\n
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Top Psychiatrist Didn’t Report Drug Makers’ Pay<\/font><\/strong><\/u><\/a>
New York Times<\/font><\/strong>
By GARDINER HARRIS
October 3, 2008<\/div>\n

<\/p>\n

… In 2004, Emory investigated Dr. Nemeroff’s outside consulting arrangements. In a 14-page report, Emory’s conflict of interest committee detailed multiple “serious” and “significant” violations of university procedures intended to protect patients. But the university apparently took little action against Dr. Nemeroff and made no effort to independently audit his consulting income, documents show. Universities, too, can benefit from the fame and money the deals can bring — a point Dr. Nemeroff made in a May 2000 letter stamped “confidential” that he sent to the dean of Emory’s medical school. The letter, which was part of a record from a Congressional hearing, addressed Dr. Nemeroff’s membership on a dozen corporate advisory boards [some of the companies’ names have since changed].<\/p>\n

“Surely you remember that Smith-Kline Beecham Pharmaceuticals donated an endowed chair to the department and that there is some reasonable likelihood that Janssen Pharmaceuticals will do so a<\/sup>s well,” he wrote. “In addition, Wyeth-Ayerst Pharmaceuticals has funded a Research Career Development Award program in the department, and I have asked both AstraZeneca Pharmaceuticals and Bristol-Meyers [sic] Squibb to do the same. Part of the rationale for their funding our faculty in such a manner would be my service on these boards”…<\/p>\n

For all his fame in the world of psychiatry, Dr. Nemeroff has faced ethics troubles before. In 2006, he blamed a clerical mix-up for his failing to disclose that he and his co-authors had financial ties to Cyberonics, the maker of a controversial device that they reviewed favorably in a journal he edited. The Cyberonics paper led to a bitter e-mail exchange between Dr. Nemeroff and Claudia R. Adkison, an associate dean at Emory, according to Congressional records. Dr. Adkison noted that Cyberonics had not only paid Dr. Nemeroff and his co-authors but had also given an unrestricted educational grant to Dr. Nemeroff’s department. “I can’t believe that anyone in the public or in academia would believe anything except that this paper was a piece of paid marketing,” Dr. Adkison wrote on July 20, 2006.<\/p>\n

Two years earlier, unknown to the public, Emory’s conflict of interest committee discovered that Dr. Nemeroff had made more serious blunders, including failing to disclose conflicts of interest in trials of drugs from Merck, Eli Lilly and Johnson & Johnson. His continuing oversight of a federally financed trial using GlaxoSmithKline medicines led Dr. Adkison to write Dr. Nemeroff on July 15, 2004, that “you must clearly certify on your annual disclosure form that you do not receive more than $10,000 from GSK.” In a reply dated Aug. 4, Dr. Nemeroff wrote that he had already done so but promised again that “my consulting fees from GSK will be less than $10,000 per year throughout the period of this N.I.H. grant.”<\/p>\n

When he sent that letter, Dr. Nemeroff had already earned more than $98,000 that year from GlaxoSmithKline. Three weeks later, he received another $3,844.56 for giving a marketing talk at the Passion Fish Restaurant in Woodbury, N.Y. From 2000 through 2006, Dr. Nemeroff earned more than $960,000 from GlaxoSmithKline but listed earnings of less than $35,000 for the period on his university disclosure forms, according to Congressional documents…<\/sup><\/div>\n<\/blockquote>\n

So in 2000, Dr. Nemeroff’s extensive ties with Industry were noted at Emory. In 2004, Emory’s Conflict of Interest Committee had investigated him, found a number of improprieties, and insisted he sign a pledge that he would not make > $10,000\/year from GSK specifically – a pledge he ignored. It was not until 2006 when he omitted Conflict of Interest disclosure in an article in a journal he himself edited and he was "busted" and removed as editor that Emory acted, but he remained chairman until 2008 when Senator Grassley investigated and showed the actual extent of his GSK involvement. Meanwhile, his publication rate during this period of time was uneffected. Meanwhile, he was on the Boards of many other companies and an active member in a lot of other psychiatric organizations. <\/div>\n

Reviewing all of this, it’s hard to imagine that it all really happened, and that it took a Senate Investigation to finally put  an stop to it, or at least slow it down. It was quite a juggling act, and it went on for years. I doubt there’s another story like this in all of medicine. One could legitimately ask what was the point? Was this about money? or power? or prestige? Whatever it was about, it’s part of the back-story of psychiatry that continued for a quarter of a century and plagues us yet today.<\/p>\n

 <\/p>\n

For the NIMH to give Dr Nemeroff a research grant with this record is an affront to patients and psychiatrists alike. Indefensible at face value. An explanation is not good enough. The award needs to simply be nullified and the NIMH reviewers involved relieved of their positions… <\/div>\n","protected":false},"excerpt":{"rendered":"

While historians have the advantage of freedom from contemporary drama and knowing the outcome, they lose the passion of the moment. The moments after the introduction of the DSM-III were certainly dramatic at the time. For all intents and purposes, with the DSM-III, psychiatry had declared itself a biological science, free from the shackles of […]<\/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-24039","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24039","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=24039"}],"version-history":[{"count":92,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24039\/revisions"}],"predecessor-version":[{"id":42382,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24039\/revisions\/42382"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=24039"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=24039"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=24039"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}