{"id":16238,"date":"2011-11-22T00:21:16","date_gmt":"2011-11-22T05:21:16","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=16238"},"modified":"2011-11-22T03:15:19","modified_gmt":"2011-11-22T08:15:19","slug":"2006-2","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/11\/22\/2006-2\/","title":{"rendered":"2006&#8230;"},"content":{"rendered":"\n<p align=\"justify\">Those of you who have been at this a while must giggle at people like me who are new to the scene as we discover things that you&#8217;ve known for a long time. I&#8217;ve been at this for a while now. I know that because I start looking something up, and find a link to something I personally already wrote, but hadn&#8217;t connected my new line of investigation. That happened yesterday. I was looking at the things Martin Keller signed onto after Study 329 [which was brought into question as soon as it was published in 2001] and I ran into the article below [again]. Here&#8217;s how I reproduced the abstract back in October [<u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/10\/24\/15285\/\"><font color=\"#200020\">the apogee&hellip;<\/font><\/a><\/strong><\/u>]:<\/p>\n<table width=\"100%\" cellspacing=\"0\" cellpadding=\"0\" border=\"0\" align=\"center\">\n<tr>\n<td>\n<blockquote>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/archpsyc.ama-assn.org\/cgi\/content\/full\/64\/4\/466\"><u><strong><font color=\"#200020\">Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States<\/font><\/strong><\/u><\/a><br \/>                                          <sup> by Charles B. Nemeroff, <font color=\"#9999559\">Amir Kalali<\/font>, Martin B. Keller,  Dennis S. Charney, <font color=\"#9999559\">Susan E. Lenderts,  Elisa F. Cascade, Hugo Stephenson<\/font>, and Alan F. Schatzberg<\/sup><br \/>                                           <strong><font color=\"#200020\">Archives of General Psychiatry<\/font><\/strong>. 2007 64(4):466-472.<\/div>\n<p>                         <\/p>\n<div align=\"justify\"><sup><strong><font color=\"#200020\">&#8230;<\/font><\/strong> <br \/>                                            <u><strong><font color=\"#200020\">Conclusions:<\/font><\/strong><\/u>  The effect on antidepressant prescribing volume observed in our  analysis of the Verispan data parallels earlier findings reported by  Medco Health Solutions, Inc, and NDC Health that the FDA actions have  had a significant effect on the prescribing of antidepressants to  children and adolescents. Together, these findings underline the  importance of presenting a fair balance within the media due to the  significant reach of this channel among prescribing physicians.<\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">I usually leave off the Author&rsquo;s Financial Disclosures, but in this case, they seemed pertinent:          <\/div>\n<blockquote>\n<div align=\"justify\"><sup><u><strong><font color=\"#200020\">Dr Nemeroff<\/font><\/strong><\/u>  has received grants from or performed research for the American  Foundation for Suicide Prevention, AstraZeneca, Bristol-Myers Squibb,  Forest Laboratories, Inc, Janssen Pharmaceutica, NARSAD: The Mental  Health Research Association, the National Institute of Mental Health,  Pfizer Pharmaceuticals, and Wyeth-Ayerst Laboratories; has been a  consultant to Abbott Laboratories, Acadia Pharmaceuticals, Bristol-Myers  Squibb, Corcept Therapeutics, Cypress Bioscience, Cyberonics, Eli Lilly  and Co, Entrepreneur&rsquo;s Fund, Forest Laboratories, Inc, GlaxoSmithKline,  i3 DLN, Janssen Pharmaceutica, Lundbeck, Otsuka America Pharmaceutical,  Inc, Pfizer Pharmaceuticals, <strong><font color=\"#990000\">Quintiles Transnational<\/font><\/strong>, UCB Pharma, and  Wyeth-Ayerst Laboratories; has been on the speakers bureau for Abbott  Laboratories, GlaxoSmithKline, Janssen Pharmaceutica, and Pfizer  Pharmaceuticals; is a stockholder in Acadia Pharmaceuticals, Corcept  Therapeutics, Cypress Bioscience, and NovaDel Pharma Inc; is on the  board of directors of the American Foundation for Suicide Prevention,  the American Psychiatric Institute for Research and Education, the  George West Mental Health Foundation, NovaDel Pharma Inc, and the  National Foundation for Mental Health; holds patents on a method and  devices for transdermal delivery of lithium [US 6,375,990 B1] and on a  method to estimate serotonin and norepinephrine transporter occupancy  after drug treatment using patient or animal serum [provisional filing  April 2001]; and holds equity in Reevax, BMC-JR LLC, and CeNeRx. <br \/>                                         <u><strong><font color=\"#200020\">Dr Kalali<\/font><\/strong><\/u>  is on the advisory board or speakers bureau of AstraZeneca  Pharmaceuticals LP, Bristol-Myers Squibb, GlaxoSmithKline, Janssen  Pharmaceutica, Pfizer Inc, and Shire. <br \/>                                         <u><strong><font color=\"#200020\">Dr Keller<\/font><\/strong><\/u>  has been a consultant to or has received honoraria from Collegium,  Cypress Bioscience, Cyberonics, Eli Lilly and Co, Forest Laboratories,  Inc, Janssen Pharmaceutica, Organon, Otsuka America Pharmaceutical, Inc,  Pfizer Inc, Pharmastar, Sepracor, Vela Pharmaceuticals Inc, and Wyeth  Pharmaceuticals; has received grants from or performed research for Eli  Lilly and Co, Forest Laboratories, Inc, Pfizer Inc, and Wyeth  Pharmaceuticals; and has been on the advisory board of Abbott  Laboratories, Bristol-Myers Squibb, Cyberonics, Cypress Bioscience, Eli  Lilly and Co, Forest Laboratories, Inc, GlaxoSmithKline, Janssen  Pharmaceutica, Novartis, Organon, Pfizer Inc, Sepracor, and Wyeth  Pharmaceuticals. <br \/>                                         <u><strong><font color=\"#200020\">Dr Charney<\/font><\/strong><\/u>  has consulting agreements with Abbott Laboratories, AstraZeneca,  Bristol-Myers Squibb, Cyberonics, Gene Logic Inc, the Institute of  Medicine, Neurogen Corp, the Neuroscience Education Institute, Novartis  Pharmaceuticals Corp, OREXIGEN Therapeutics, Inc, Organon International,  Otsuka America Pharmaceutical, Inc, <strong><font color=\"#990000\">Quintiles Transnational<\/font><\/strong>, and  Sepracore Inc; and has a confidentiality agreement with Forest  Laboratories, Inc, and Novartis Pharmaceuticals Corp. <br \/>                                         <u><strong><font color=\"#200020\">Dr Schatzberg<\/font><\/strong><\/u>  is a consultant to Eli Lilly and Co, Wyeth Pharmaceuticals, Corcept  Therapeutics, Bristol-Myers Squibb, Novartis, Abbott Laboratories,  Forest Laboratories Inc, <strong><font color=\"#990000\">Quintiles Transnational<\/font><\/strong>, and Lundbeck; is a  cofounder of Corcept Therapeutics and has equity in Forest Laboratories,  Pfizer Inc, and Merck and Co; and has received research funding from  GlaxoSmithKline and Wyeth Pharmaceuticals.<\/sup><\/div>\n<\/blockquote>\n<\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\"> At the time, I was focused on the fact that this article was accepted  in May 2006, just a few months before Drs. Carrol and Rubin <a target=\"_blank\" href=\"http:\/\/www.academia.org\/gadfly-or-watchdog\/\"><u><strong><font color=\"#200020\">challenged<\/font><\/strong><\/u><\/a>  Dr. Nemeroff&#8217;s article in the journal he edited  [Neuropsychopharmacology] and Dr. Nemeroff ended up stepping down as editor because of  undeclared conflicts of interest. Last month, I was thinking about Nemeroff&#8217;s  hubris in publishing such a PHARMA-friendly article and the irony that <u>all<\/u> the authors  in bold were later shown to have used ghost-writer Sally Laden and STI  to write articles [paid by GSK][<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/12\/01\/roaches\/\"><u><strong><font color=\"#200020\">roaches&#8230;<\/font><\/strong><\/u><\/a>]. Yesterday [<u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/11\/20\/a-walk-on-the-wrong-side-side-of-the-street\" target=\"_blank\"><font color=\"#200020\">a walk on the wrong side side of the street?&hellip;<\/font><\/a><\/strong><\/u>],  I was looking at the same article focusing on Martin Keller continuing to be a PHARMA sign-on lackey even after his poor show with Study 329. Now, I&#8217;m looking at the  same article from yet another angle.<\/p>\n<p align=\"justify\">This article iteslf is actually a complaint against the FDA and the media. After years of haggling, the FDA finally had a hearing about the complaint that Paxil and the other SSRI&#8217;s could cause suicidality in some adolescents, and subsequently required warnings to be appended to these drugs for children and adolescents. Nemeroff et al are implying that the suicidality thing might have been overdone, and as a result, prescription rates had fallen dramatically in the younger age group. Here&#8217;s the kicker &#8211; their argument was that kids are being deprived of effective treatment because of the FDA and media. Unbelievable! But you already knew that. <\/p>\n<p align=\"justify\"><strong><font color=\"#200020\">So why are Dr. Nemeroff, Dr. Charney, Dr. Keller, and Dr. Schatzberg &#8211; all Department Chairmen of prestigious Departments of Psychiatry &#8211; writing this article?<\/font><\/strong> None of them are even Child and Adolescent Psychiatrists! I expect we would all suspect that they were PHARMA prostitutes, and that was why they were writing [or signing on to] this article. But who was <strike>getting<\/strike> paying them to do it? That lead me to get curious about those people in the author list I&#8217;d never heard of a month ago, but I was still too naive to look them up [so I put them in a background color] &#8211; <font color=\"#9999559\">Amir Kalali MD<\/font>, &#8230; <font color=\"#9999559\">Susan E. Lenderts,  Elisa F. Cascade, Hugo Stephenson MD<\/font>.<\/p>\n<div align=\"justify\"><strong><font color=\"#200020\">Who are Amir Kalali MD, Susan E. Lenderts,  Elisa F. Cascade, and Hugo Stephenson MD?<\/font><\/strong>&nbsp; They all work for <a target=\"_blank\" href=\"http:\/\/www.quintiles.com\/about-us\/\"><u><strong><font color=\"#990000\">Quintiles Transnational<\/font><\/strong><\/u><\/a>, the largest <strong><font color=\"#400040\">Clinical Research Organization<\/font><\/strong> in the world. That&#8217;s who:<\/div>\n<ul>\n<div><em>As the global pioneer in pharmaceutical services, Quintiles helps  deliver new drugs and cures for the world&rsquo;s most challenging diseases. We  are the only fully integrated biopharmaceutical services company  offering clinical, commercial, consulting and capital solutions  worldwide. Our network of more than 20,000 engaged professionals in 60  countries around the globe works with an unwavering commitment to  patients, safety and ethics &mdash; ensuring a higher level of healthcare for  people. For our biopharmaceutical customers, we help them navigate risk  and seize opportunities in an environment where change is constant.<\/em><\/div>\n<\/ul>\n<div align=\"justify\">So we know &quot;who was <strike>getting<\/strike> paying them to do it?&quot; Three of the four Department Chairmen were on <strong><font color=\"#990000\">Quintiles<\/font><\/strong> payroll already. This was a <strong><font color=\"#990000\">Quintiles<\/font><\/strong> article\/project that was complaining that the FDA and Media were interfering with drug sales. Here&#8217;s some data from the article:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" height=\"242\" width=\"400\" vspace=\"5\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/quin-1.gif\" \/><\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" height=\"247\" width=\"400\" vspace=\"5\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/quin-2.gif\" \/><\/div>\n<div align=\"justify\">Where would four psychiatry department chairmen get that kind of data?             <\/div>\n<ul>\n<div align=\"justify\"><sup>We obtained retail pharmacy prescription data from Verispan, Yardley, Pa, a joint venture between Quintiles Transnational and McKesson, San Francisco, Calif. The Verispan data capture more than 1.4 billion patient-centric prescriptions per year, nearly half of all prescription activity in the United States. This data set includes prescriptions from a variety of retail channels [eg, national retail chains and mass merchandisers] from a near census of US pharmacies. The Verispan retail pharmacy database also captures information from all payer types, including cash&#8230;<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">The department chairmen wouldn&#8217;t get it anywhere. That&#8217;s the stuff of marketing research, and if you look into our foursome from <strong><font color=\"#990000\">Quintiles<\/font><\/strong> &#8211; that&#8217;s what they do [among other things]:<\/div>\n<ol>\n<div align=\"justify\"><a href=\"http:\/\/www.quintiles.com\/information-library\/experts\/amir-kalali-md\/\" target=\"_blank\"><u><strong><font color=\"#990000\">Amir Kalali MD<\/font><\/strong><\/u><\/a>: <font color=\"#990000\">Vice President, Medical and Scientific Services,<em> <\/em>CNS Global Therapeutic Team Leader<\/font><\/div>\n<ul>\n<div align=\"justify\"><font color=\"#990000\"><sup><em>Amir  Kalali, MD, is Vice President, Medical and Scientific Services, and CNS  Global Therapeutic Team Leader for Quintiles. He is an expert in CNS  clinical trial methodology, and is globally responsible for the medical  and scientific aspects of development programs in psychiatry and  neurology. Dr. Kalali is also Professor of Psychiatry at the University  of California, San Diego. As the Founding Chairman and current Executive  Secretary of the Executive Committee of the International Society for  CNS Drug Development, and as a member of the Scientific Committee of the  International Society for CNS Clinical Trials and Methodology, Dr.  Kalali actively facilitates scientific collaboration between academia,  government, and pharmaceutical industry scientists. Dr. Kalali is the  Editor of the journal Psychiatry and has published numerous  peer-reviewed papers.<\/em><\/sup><\/font><br \/>      <sup><strong><font color=\"#200020\">The Journal Psychiatry is now called <u><a target=\"_blank\" href=\"http:\/\/www.innovationscns.com\/\">Innovations in Clinical Neuroscience<\/a><\/u>. It&#8217;s a monthly on-line peer reviewed Journal published by Quintiles for psychiatrists. All of the &quot;academic&quot; authors above are on the <u><a target=\"_blank\" href=\"http:\/\/www.innovationscns.com\/about\/editorial-board\/\">Editorial Board<\/a><\/u>.<\/font><\/strong><br \/>     <\/sup><\/div>\n<\/ul>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/www.quintiles.com\/information-library\/experts\/hugo-stephenson\/\"><u><strong><font color=\"#990000\">Hugo Stephenson MD<\/font><\/strong><\/u><\/a>: <font color=\"#990000\">President of MediGuard<\/font><strong><font color=\"#200020\"><br \/>            <\/font><\/strong><\/div>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/www.quintiles.com\/information-library\/experts\/podcast-observational-research-through-online-patient-communities\/\"><u><font color=\"#990000\">Elisa F. Cascade<\/font><\/u><\/a><\/strong>: <font color=\"#990000\">Vice President of MediGuard<\/font><\/div>\n<ul>\n<div align=\"justify\"><sup><font color=\"#990000\"><em>MediGuard is a free medication monitoring service designed for     specifically for patients &#8211; allowing them to take a more active role in     their treatment through:<br \/>         1. MediGuard Safety Checks: Screening for drug-drug and drug-disease     interactions.         <br \/>         2. Sending you email alerts and updates as important safety information     arises for your medications.         <br \/>         3. Sharing feedback from other members on side effects and other important     information.         <br \/>         4. Providing you with a printable list of your medications.<\/em><\/font><\/sup><br \/>        <sup><strong><font color=\"#200020\">While <u><a target=\"_blank\" href=\"https:\/\/www.mediguard.org\/help\/what-is-iguard\">MediGuard<\/a><\/u> is an Internet &quot;service&quot; with 2.5 million subscribers. It is used by Quinitiles to track medication use for their marketing research &#8211; crossreferenced from patient records. Listen to the audio presentation by clicking on Elisa Cascade&#8217;s link.<\/font><\/strong><br \/>          <\/sup><\/div>\n<\/ul>\n<div align=\"justify\"><u><a href=\"http:\/\/www.quintiles.com\/locations\/susan-lenderts-nj-2009-hba-rising-star\/\" target=\"_blank\"><strong><font color=\"#990000\">Susan E. Lenderts<\/font><\/strong><\/a><\/u>: <font color=\"#990000\">Manager of Strategic Analytics<\/font><\/div>\n<ul>\n<div align=\"justify\"><strong><sup><font color=\"#200020\">[I have no idea what that means but they list her as a &quot;pharma manager&quot; and a &quot;rising star&quot;]<br \/>   <\/font><\/sup><\/strong><\/div>\n<\/ul>\n<\/ol>\n<hr width=\"90%\" size=\"1\" \/> <\/p>\n<div align=\"justify\">So, I have to start this post all over. Here&#8217;s what I think I should&#8217;ve said: <\/div>\n<ul>\n<div align=\"justify\"><strong><font color=\"#200020\">By early 2006, the collusion between the pharmaceutical industry and parts of academic psychiatry was rampant, out of control, often mediated through the clinical research organizations like Quintiles. Using their extensive marketing research networks, Quintiles found that the FDA Warnings of suicidality in adolescents on SSRIs was having a major impact on physician prescribing habits and that there was a dramatic fall in kids being put on these drugs. &lt;<em>Some Pharmaceutical Company or Companies<\/em>&gt; paid Quintiles to mount a campaign against the FDA\/Media to improve SSRI sales. Using their marketing research data, Quintiles wrote an article claiming that this fall in prescriptions meant that children and adolescents were being deprived of necessary and effective treatment. They got four Psychiatry Department Chairmen who were already on board [Nemeroff, Charney, Keller, and Schatzberg] to sign on as guest authors and got it published in the <em>Archives of General Psychiatry<\/em>. In this same time frame, Drs. Nemeroff and Charney et al published a ghost written <a href=\"http:\/\/www.nature.com\/npp\/journal\/v31\/n7\/full\/1301082a.html\" target=\"_blank\"><u>positive review<\/u><\/a> of a VNS stimulator that both had a financial interest in in a journal Dr. Nemeroff edited [<em>Neuropsychopharmacology<\/em>] without revealing those interests. Also in this time frame, Drs. Nemeroff and Keller et al <u><a href=\"http:\/\/www.nature.com\/npp\/journal\/v31\/n7\/full\/1301082a.html\" target=\"_blank\">published a study<\/a><\/u> fallaciously claiming that Risperdal augmentation of SSRIs was helpful in Treatment Resistant Depression [also in <\/font><\/strong><em><strong><font color=\"#200020\">Neuropsychopharmacology<\/font><\/strong><\/em><strong><font color=\"#200020\">]. <br \/><\/font><\/strong><\/div>\n<\/ul>\n<div align=\"justify\">We are eternally grateful for Drs. Carroll and Rubin, Senator Grassley and Paul Thacker, and many others for raising our awareness to this kind of manipulation of the psychiatric literature and getting it curbed. I expect it continues at some level, but not like 2006. I hope I was right to call 2006 an <u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/10\/24\/15285\"><font color=\"#200020\">apogee<\/font><\/a><\/strong><\/u>, the highest point on a curve that&#8217;s now falling&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Those of you who have been at this a while must giggle at people like me who are new to the scene as we discover things that you&#8217;ve known for a long time. I&#8217;ve been at this for a while now. I know that because I start looking something up, and find a link to [&hellip;]<\/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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-16238","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16238","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=16238"}],"version-history":[{"count":37,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16238\/revisions"}],"predecessor-version":[{"id":42372,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16238\/revisions\/42372"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=16238"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=16238"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=16238"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}