{"id":32021,"date":"2013-01-14T07:00:38","date_gmt":"2013-01-14T12:00:38","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=32021"},"modified":"2013-01-15T04:58:22","modified_gmt":"2013-01-15T09:58:22","slug":"foul","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/01\/14\/foul\/","title":{"rendered":"foul&#8230;"},"content":{"rendered":"\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/pharmagossip.blogspot.com\/2013\/01\/psychiatric-drug-facts-with-dr-peter.html\">Pharmagossip<\/a> has a post up that links to a post by <a target=\"_blank\" href=\"http:\/\/breggin.com\/index.php?option=com_content&#038;task=view&#038;id=117\">Peter Breggin<\/a> about some discovery documents from Eli Lilly in a time when the world was young. This from Dr. Breggin:<\/div>\n<blockquote>\n<div align=\"justify\"> <sup><strong>The sealed Prozac data from Eli Lilly also came from my investigations  of the company as a medical expert in product liability suits. The <em>British Medical Journal<\/em> [<em>BMJ<\/em>] recently obtained the sealed documents from an anonymous source and released them to the FDA and the U.S. Congress.<\/strong><\/sup> <\/div>\n<ul><sup><strong>   <\/p>\n<div align=\"justify\"> <a target=\"_self\" title=\"The Eli Lilly documents: Part I\" href=\"http:\/\/breggin.com\/index.php?option=com_docman&#038;task=doc_download&#038;gid=33\">The Eli Lilly documents: Part I<\/a><\/div>\n<div align=\"justify\"> <a target=\"_self\" title=\"The Eli Lilly documents: Part II\" href=\"http:\/\/breggin.com\/index.php?option=com_docman&#038;task=doc_download&#038;gid=34\">The Eli Lilly documents: Part II<\/a><\/div>\n<div align=\"justify\"> <a target=\"_self\" title=\"The Eli Lilly Documents: Part III\" href=\"http:\/\/breggin.com\/index.php?option=com_docman&#038;task=doc_download&#038;gid=35\">The Eli Lilly Documents: Part III<\/a><\/div>\n<div align=\"justify\"> <a target=\"_self\" title=\"The Eli Lilly documents: Part IV\" href=\"http:\/\/breggin.com\/index.php?option=com_docman&#038;task=doc_download&#038;gid=36\">The Eli Lilly documents: Part IV<\/a><\/div>\n<p><\/strong><\/sup><\/ul>\n<\/blockquote>\n<div align=\"justify\"> I got really lost following the timeline and their exact path from <em>sealed<\/em> into the public domain, and promise to try to get that in order soon. But for now, I just want to mention the two emails that Jack Friday points to on <strong><font color=\"#200020\">Pharmagossip<\/font><\/strong>. They&#8217;re from 1990 [Prozac was launched in 1987 and the first FDA hearings on SSRI suicidality were in 1991]. An Eli Lilly employee, Claude Bouchy, is writing to his superiors, apparently responding to a request from another corporate group asking that he change the physician reported identifier of adverse events on several subjects in a Prozac Trial. The documents are from another era &#8211; before there was a world wide web &#8211; so they&#8217;re printed by teletype, fading and marked up with notes and underlines. They&#8217;re pretty challenging to read so I&#8217;ve transcribed them below for convenience [<a href=\"http:\/\/breggin.com\/index.php?option=com_docman&#038;task=doc_download&#038;gid=36\" target=\"_blank\">link to the originals<\/a>]:<\/div>\n<p>                                                      <\/p>\n<table width=\"450\" cellspacing=\"0\" cellpadding=\"4\" border=\"0\" align=\"center\">\n<tr>\n<td>\n<div align=\"left\"><sup><strong>This is message #1    from: BOUCHY CLAUDE<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>November 13, 1990  10:49<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>To: THOMPSON LEIGH, WEINSTEIN ALLAN J, ZERBE ROBERT L<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>CC: MAYR GERHARD, TAUREL SYDNEY, WEBER HANS J<\/strong><\/sup><\/div>\n<p>                             <\/p>\n<div align=\"left\"><sup><strong>RE: ADVERSE DRUG EVENT REPORTING-SUICIDE FLUOXETINE<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>Hans Weber and I have problems with the directions our safety people are<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>getting from the corporate group (Drug Epidemiology Unit) and requesting that<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>we change the identification of events as they are reported by the physicians.<\/strong><\/sup><\/div>\n<p>                             <\/p>\n<div align=\"left\"><sup><strong>&#8211; GEB-FLM039(DEN #GE90100350A). On this one, our safety staff is requested to<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>change the event term &quot;suicide attempt (as reported by the pshysician) to<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>&quot;overdose&quot;.<\/strong><\/sup><\/div>\n<p>                             <\/p>\n<div align=\"left\"><sup><strong>&#8211; GEB-FLM025(DEN #GE 90090427A). On this one, it is requested that we change <\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>from &quot;suicidal ideation&quot; to &quot;depression&quot;.<\/strong><\/sup><\/div>\n<p>                             <\/p>\n<div align=\"left\"><sup><strong>Hans has medical problems with these directions and I have great concerns<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>about it. I do not think I could explain to the BGA, to a judge, to a reporter <\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>or even my family why we would do this especially on the sensitive<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>issue of suicide and suicide ideation.  At least not with the explanations<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>that have been given to our staff so far. I am quoting &quot;When an overdose<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>is taken in a suicide attempt, our Research Physicians prefer to list the<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>event term overdose&quot; even if &quot;when tracking suicides, we always look at all overd<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>ose and suicide attempt reports&quot;.<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>This issue has been argued back and forth for about a month between Bad Homborg<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>and Indy, therefore I am bringing it to your attention and await your<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>directions.<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>Regards,<\/strong><\/sup><\/div>\n<p>                             <\/p>\n<div align=\"left\"><sup><strong>Claude.<\/strong><\/sup><\/div>\n<\/td>\n<\/tr>\n<\/table>\n<p>                                         <\/p>\n<table width=\"450\" cellspacing=\"0\" cellpadding=\"4\" border=\"0\" align=\"center\">\n<tr>\n<td>\n<div align=\"left\"><sup><strong>November 14, 1990     06:47<\/strong><\/sup><\/div>\n<p>                     <\/p>\n<div align=\"left\"><sup><strong>To: THOMPSON LEIGH<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>CC: MAYR GEHARD, TAUREL SYDNEY, WEBER HANS J, <\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; WEINSTEIN ALLAN J, ZERBE ROBERT L<\/strong><\/sup><\/div>\n<p>                     <\/p>\n<div align=\"left\"><sup><strong>November 14, 1990     05:58 <\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>RE:ADVERSE EVENT REPORTING &#8211; SUICIDE FLUOXETINE<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>Thank you very much for your prompt answer and your detailed explanation. Hans<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>and I rediscussed the issue in depth.<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>Our point is the following: the physician has reported a suicide attempt. Do we<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>have the right to change it to some terminology which we may consider to be more<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>specific e.g. overdose, but which is not free from ambiguity and could be<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>regarded as inaccurate or misleading?<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>The term overdose is not free from ambiguity because there are clearly forms<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>of overdose which are not related to suicide attempts, for instance wrong<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>dose prescribed or dispensed error on the part of the patient etc &#8230; In fact<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>and perhaps more importantly, the dictionaries we have looked at [medical<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>dictionaries and non-medical] fail to associate [not to mention equal] the<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>concept of overdose with suicide attempt.<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>In addition, it can be argued that the event term overdose is inaccurate or<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>misleading because in this case the patient attempted suicide by taking<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>an overdose of barbituates and tricyclics and not, I repeat not, of fluoxetine.<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>Finally, on a very simple and non-scientific basis, I personally wonder whether<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>we are really helping the credibility of the excellent ADE system by calling <\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>overdose what a physician reports as suicide attempt and by calling depression<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>what the physician is reporting as suicide ideation. We fully realize that there<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>is no code in our DSM system for suicide ideation but it could be argued by<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>people who have little sympathy to the company or by regulatory authorities<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>that it is not a responsible way to deal with an issue which is getting so<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>much attention in the scientific and in the general press. It could also be<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>argued that the term depression is not specific in this case.<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>Of course, at the end of the day, we will do what we are told to do but Hans<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>and I felt that we had to bring these points to your attention.<\/strong><\/sup><\/div>\n<div align=\"left\"><sup><strong>Regards,<\/strong><\/sup><\/div>\n<p>                     <\/p>\n<div align=\"left\"><sup><strong>Claude<\/strong><\/sup><\/div>\n<\/td>\n<\/tr>\n<\/table>\n<p>                        <\/p>\n<div align=\"justify\">It&#8217;s apparent that Claude has been asked by the Drug Epidemiology Unit to change several reported Adverse Events from the way the physicians reported them [<em>suicide attempt<\/em> -&gt; <em>overdose<\/em>, <em>suicidal ideation<\/em> -&gt; <em>depression<\/em>]. So already we know a lot:<\/div>\n<ul>\n<li>they&#8217;re messing with the medical reporting in a clinical trial <\/li>\n<li>they&#8217;re worried that Prozac will look like it causes suicidal thinking<\/li>\n<li>they&#8217;re manipulating the outcome of the study to hide serious adverse events<\/li>\n<\/ul>\n<div align=\"justify\">Claude is calling foul on this kind of obvious falsification of data, though he doesn&#8217;t quite say it outright. Claude and Hans actually lay out a pretty good argument about the wages of sin, and seem to be recommending the high road [even though there&#8217;s a hint of some CYA in there too]. They go on to warn about the particular danger of this kind of sheenanigans on such a controversial and public issue. But just as we&#8217;re about to canonize Claude and Hans, they go over to the dark side, &quot;<em>Of course, at the end of the day, we will do what we are told to do<\/em>.&quot;<\/div>\n<p align=\"justify\">My reaction to these emails is mixed. On the one hand it&#8217;s disillusioning to see this kind of blatant corruption so early in the game. On the other hand, after so much speculation about what went on in the background, it&#8217;s confirming to read it there in black and white &#8211; almost a relief. But mainly, these people were messing with reporting suicide attempts &#8211; the worst side effect of all. They knew what they were denying, what it meant, and their reflex was to hide it in the word-play of reporting &#8211; change the data. A crime is being contemplated, one actually soon committed. And all of this is going on less than a year before the FDA Hearing on Prozac and suicidality in September 1991 where the freshly appointed Chairman of Emory Psychiatry, Dr. Charlie Nemeroff, will testify as Eli Lilly&#8217;s star witness &#8211; making his debut with a lie:<\/p>\n<blockquote>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/prozac\/2443T1.pdf#page=200\"><u><strong><font color=\"#200020\">FDA Hearing<\/font><\/strong><\/u><\/a><\/div>\n<div align=\"center\">September 20, 1991<\/div>\n<p>        <\/p>\n<div align=\"justify\"><sup><strong>&quot;I would suggest to you that  I have as little confidence in these anecdotal reports as I do in the  anecdotal report of Teicher, and that, in fact, there is no substitute  for controlled prospective double-blind clinical trials&hellip;&quot;<\/strong><\/sup><\/div>\n<p align=\"justify\"><sup><strong>             &quot;In conclusion, there is simply no scientific evidence  whatsoever, no placebo-controlled double-blind study that has  established a cause-and-effect relationship between antidepressant  pharmacotherapy of any class and suicidal acts or ideation.&quot;<\/strong><\/sup><\/p>\n<p align=\"justify\"><sup><strong>              &quot;As Drs. Potter and Fawcett have suggested, limiting the  availability of antidepressants could have a very profound adverse  effect in terms of increasing the morbidity and, in fact, mortality  associated with untreated depression.&quot;<\/strong><\/sup><\/p>\n<ul>\n<div><sup><strong>Dr. Charles Nemeroff, Professor and Chair<br \/>Department of Psychiatry <br \/>                   Emory University, Atlanta Georgia<\/strong><\/sup><\/div>\n<\/ul>\n<\/blockquote>\n<div align=\"right\"><strong>hat tip to Pharmagossip and Peter Breggin<\/strong>&nbsp;&nbsp;<img loading=\"lazy\" decoding=\"async\" width=\"63\" height=\"70\" border=\"0\" align=\"middle\" src=\"http:\/\/1boringoldman.com\/images\/hat-tip.gif\" \/><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Pharmagossip has a post up that links to a post by Peter Breggin about some discovery documents from Eli Lilly in a time when the world was young. This from Dr. Breggin: The sealed Prozac data from Eli Lilly also came from my investigations of the company as a medical expert in product liability suits. [&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_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-32021","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/32021","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=32021"}],"version-history":[{"count":51,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/32021\/revisions"}],"predecessor-version":[{"id":32116,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/32021\/revisions\/32116"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=32021"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=32021"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=32021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}