{"id":43118,"date":"2014-01-16T14:36:34","date_gmt":"2014-01-16T19:36:34","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=43118"},"modified":"2014-01-16T16:33:28","modified_gmt":"2014-01-16T21:33:28","slug":"why-12","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/01\/16\/why-12\/","title":{"rendered":"why?…"},"content":{"rendered":"\n

What follows is a letter<\/a> to the APA Assembly members that appeared on the APA website on Tuesday. I’ve posted it below for your perusal. It’s so far off the mark that it’s hard for me to respond to so I’ll defer that for the moment and stick to what it doesn’t do.<\/p>\n

For the extent of his tenure as Chair of the DSM-5 Task Force, Dr. Kupfer, his wife Dr. Ellen Frank [a member of his Pittsburg faculty and the DSM-5 Mood Disorders Group], and another of his University of Pittsburg faculty, Dr. Paul Pilkonis [a consultant to the DSM-5 Instrument Assessment Study Group] have collaborated with Dr. Robert Gibbons [also a consultant to the DSM-5 Instrument Assessment Study Group] to develop Computerized Adaptive Tests that measure "dimensions" [anxiety and depression]. Both before and during the Revision process, Dr. Kupfer has strongly advocated for including "dimensions" in the DSM-5 classifications. The "dimensions" were only removed from the manual proper to Section 3 [further study] in the final approval meeting of the Board of Trustees in December 2012. The tests developed have been officially a commercial product since at least November 2011 [with Gibbons, Kupfer, Frank, and Pilkonis as stockholders]. None of the principles [Kupfer, Frank, Gibbons, or Pilkonis] declared this clear COI publicly until after the DSM-5 had gone to press in December 2012. And it wasn’t common knowledge until July 2013 when it was discovered after they accused a critic of a COI [which had, in fact, been declared].<\/p>\n

The letter below plays around legalistically with the timeline and the details, but completely ignores the most obvious of points. Why<\/font><\/strong> was this multifaceted tangle of Conflicts of Interest kept secret until the DSM-5 process was ended? Why<\/font><\/strong> did Dr. Kupfer who repeatedly defended the DSM-5 Task Force’s transparency not declare this one? How<\/font><\/strong> could Dr. Kupfer in good conscience, participate in writing letters to Dr. Allen Frances and recently to Dr. Bernard Carroll accusing them of COI when he was sitting on this? I suppose there’s a further question. Is this letter the APA’s final investigation of this story? Is there no higher standard for someone with a position at this high level? While there a number of inaccuracies in this letter, the failure to even address the central issue here is beyond disturbing.<\/p>\n\n\n\n\n\n
\n
January 14, 2014<\/font><\/div>\n


<\/font><\/p>\n

Dear Assembly Members,
I was recently made aware of a conflict of interest disclosure issue involving Dr. David Kupfer and his ownership interest in a company called Psychiatric Assessments, Inc. [PAI]. Upon receipt of this information, I took the matter to the Board of Trustees. The Board of Trustees and APA leadership take conflict-of-interest principles and guidelines very seriously. They instructed APA staff to review the matter and report back their findings. Below is a summary of the situation with APA’s findings.<\/font><\/div>\n

<\/td>\n<\/tr>\n

\n
Sincerely,<\/font>   <\/div>\n<\/td>\n
\n
Mindy Young, MD<\/font><\/div>\n
Speaker of the Assembly<\/font><\/div>\n
American Psychiatric Association<\/font><\/div>\n<\/td>\n<\/tr>\n
\n
<\/td>\n<\/tr>\n
\n
BACKGROUND<\/div>\n
    <\/p>\n
    Dr. Bernard Carroll and others in recent blog postings and listserv conversations questioned:<\/div>\n
      \n
    1. \n
      whether Dr. Kupfer’s ownership interest in a company called Psychiatric Assessments, Inc. or PAI, was disclosed to APA;<\/div>\n<\/li>\n
    2. \n
      whether that PAI interest influenced the DSM-5’s decision to include dimensional measures in Section 3 for further study; and<\/div>\n<\/li>\n
    3. \n
      whether DSM-5’s inclusion of dimensional measures gives any product PAI may create a more favorable commercial advantage because of Dr. Kupfer’s role as chair of the DSM-5 Task Force. We also reviewed disclosures in the American Journal of Psychiatry [“AJP”] and JAMA Psychiatry.<\/div>\n<\/li>\n<\/ol>\n
      From 2002-2011, Dr. Kupfer, Dr. Frank, and Dr. Gibbons and several others, who were not involved in DSM-5, worked on an NIMH grant to create Computer Adaptive Tests [CAT] based on multidimensional response theory. Dr. Gibbons was the principal investigator and subcontracted with the University of Pittsburgh on the grant. Drs. Kupfer and Frank worked on the grant through the University of Pittsburgh. This grant resulted in several tests being developed. In November 2011, Dr. Gibbons formed a company, PAI and on January 3, 2012, Dr. Gibbons gave a 5% interest each to four people involved in the NIMH grant, including Drs. Kupfer and Frank, who are spouses. Dr. Ellen Frank was a Member of the Mood Disorders Work Group, and Robert Gibbons, PhD was an advisor to the Diagnostic Assessment Instruments Study Group for DSM-5. After reviewing the blog and listserv postings, interviewing people involved with instrument selection for DSM, reviewing the literature, internal documents relating to DSM-5’s recommendations on dimensional measures, and conflict of interest policies and disclosures, APA has drawn the following conclusions:<\/div>\n

      <\/span><\/ul>\n

      FINDINGS<\/div>\n
        <\/p>\n
      1. \n
        APA’s conflict of interest forms called for disclosure of any financial interest, including stock ownership, in any company related to the field of psychiatry.<\/em><\/div>\n
          \n
          We believe that Drs. Kupfer, Frank and Gibbons should have disclosed their interest in PAI on APA’s conflict of interest form in 2012, and they did not do so. Dr. Kupfer did include his stock ownership in PAI on his April 2013 disclosure. Even though PAI has no product or revenue, and never has had a product or revenue, it is a company related to psychiatry and the stock interest should have been disclosed.<\/div>\n<\/ul>\n<\/li>\n
        • \n
          The stock interest in PAI did not influence DSM-5’s move toward dimensional measures.<\/em><\/div>\n
            \n
            Use of dimensional measures dates back to the 1960s and the Hamilton Depression Scale. The Patient Health Questionnaire-9 [PHQ-9] scale was developed for DSM-III’s diagnosis of major depressive disorder by Dr. Spitzer and his colleagues. DSM-IV, released in 1994, discussed the benefits of dimensional measures. And, before the DSM-5 Task Force was formed, beginning in 2003, there were entire conferences dedicated to exploring the use of dimensional measures in DSM-5. The dimensional measures used in field testing were selected by the end of 2010 – over a year before PAI was formed. Drs. Kupfer, Gibbons, and Frank did not advocate for inclusion of CAT in DSM-5. Their work on CAT was well known to the DSM-5 Instrument Study Group because of the NIMH grant and their publications, but it was not considered viable for DSM-5 because of its complexity and immaturity.<\/div>\n<\/ul>\n<\/li>\n
          • \n
            PAI will not gain financially from DSM-5’s inclusion of dimensional measures in Section 3 or if CAT is included in future versions of DSM.<\/em><\/div>\n
              \n
              If and when PAI develops a commercial product with CAT, it will not have any greater advantage because of DSM-5’s inclusion of dimensional measures in Section 3 than the dozens of dimensional measures currently being marketed by others. If CAT is developed commercially, PAI will not gain any special financial benefit if included in DSM because APA’s policy is to not include any measure in unless the owner agrees to provide it for free to clinicians and researchers.<\/div>\n<\/ul>\n<\/li>\n
            • \n
              Drs. Gibbons, Frank and Kupfer disclosed their interest in PAI publicly in AJP before disclosing it in JAMA Psychiatry..<\/em><\/div>\n
                \n
                Drs. Gibbons, Frank, Kupfer and others who worked on the NIMH grant published an article on CAT-Anxiety in August 2013 in the American Journal of Psychiatry, which included disclosure regarding their ownership interest in PAI. Thus, in APA’s journal, there is no disclosure issue. The non-disclosure issue arose in connection with a JAMA Psychiatry article. We understand the facts to be as follows. Drs. Gibbons, Kupfer, Frank and the other NIMH investigators submitted a paper on CAT for publication in JAMA Psychiatry in August 2011 – three months before PAI was formed. The article was published over a year later in November 2012 with the disclosure that “The CAT-DI will ultimately be made available for routine administration and its development as a commercial product is under consideration.” In November 2013 – three months after disclosure in AJP, the authors published a letter entitled “Failure to Report Financial Disclosure Information” in JAMA Psychiatry. The details of that disclosure and whether it satisfies JAMA Psychiatry’s standards are between the authors and JAMA Psychiatry.<\/div>\n<\/ul>\n<\/li>\n

                <\/span><\/ol>\n

                CONCLUSION<\/div>\n
                  \n
                  Dr. Kupfer should have disclosed to APA his interest in PAI in 2012. Dr. Kupfer’s interest in PAI, which came after the decision had been made to include dimensional measures in DSM-5, did not influence DSM-5’s inclusion of dimensional measures for further study in Section 3. Interest in inclusion of these measures in DSM-5 began with conferences starting in 2003. If and when PAI develops a commercial product with CAT, it will not have any greater advantage than the dozens of dimensional measures currently being marketed by others.<\/div>\n<\/ul>\n<\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

                  What follows is a letter to the APA Assembly members that appeared on the APA website on Tuesday. I’ve posted it below for your perusal. It’s so far off the mark that it’s hard for me to respond to so I’ll defer that for the moment and stick to what it doesn’t do. For 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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-43118","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/43118","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=43118"}],"version-history":[{"count":15,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/43118\/revisions"}],"predecessor-version":[{"id":43133,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/43118\/revisions\/43133"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=43118"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=43118"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=43118"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}