{"id":41413,"date":"2013-11-10T12:45:07","date_gmt":"2013-11-10T17:45:07","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=41413"},"modified":"2013-11-10T13:57:04","modified_gmt":"2013-11-10T18:57:04","slug":"what-has-been","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/11\/10\/what-has-been\/","title":{"rendered":"<em>what has been&#8230;<\/em>"},"content":{"rendered":"\n<div align=\"justify\" class=\"small\">I spent a childhood being groomed for science. That&#8217;s what the 1950s were about and all the vectors pointed that way. But there was a private bent towards history in there somewhere that never got around to flowering. As an adult doctor, it was the histories of my patients [and myself] that finally brought it to the fore and lead me to psychotherapy and psychoanalysis, and away from bench science. Science might have been a talent, but history was the interest, and it&#8217;s how I understand the world. I&#8217;ve always been awed by being <em>in history,<\/em> in the present without the clarity the future might bring. And after a career of hearing detailed personal histories, my awe at how contemporary decisions can have indelible but unimaginable consequences has only grown. As compelling as the injunction <em>be in the moment<\/em> can be, ignoring the past and future avoids equally compelling truth. It&#8217;s why I quote T.S. Eliot&#8217;s <a target=\"_blank\" href=\"http:\/\/www.artofeurope.com\/eliot\/eli5.htm\"><em>Burnt Norton<\/em><\/a> way too often:<\/div>\n<ul>\n<div align=\"justify\" class=\"small\"><em>Time present and time past<br \/>                    Are both perhaps present in time future,<br \/>                    And time future contained in time past.<br \/>                    If all time is eternally present<br \/>                    All time is unredeemable.<br \/>                    What might have been is an abstraction<br \/>                    Remaining a perpetual possibility<br \/>                    Only in a world of speculation.<br \/>                    What might have been and what has been<br \/>                    Point to one end, which is always present&#8230;<\/em><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">In the face of accumulating indictments, the question of how to deal with the patent corruption of science by commercial interests in the realm of the clinical trials of pharmaceuticals has finally moved to the foreground. That is nowhere more apparent than in my specialty, psychiatry, where the painful truth is that their corruption was [and is] abetted from inside of our ranks &#8211; so neither drug companies nor the leading psychiatrists hold the high ground at present. Here in the colonies, the battle is being fought in the courtrooms with suits against industry [an analogy to the gunslingers in our Old West or the Prohibition crime scene might be appropriate here]. Across the pond, there&#8217;s a strong movement for Data Transparency arising in multiple foci that&#8217;s jumped to the front burner as a solution to the myriad of ways in which our medical information has been grossly manipulated [emphasis on <em>grossly<\/em>]. I have no question that Data Transparency is <em>the<\/em> direction of choice, but the devil is in the details.<\/div>\n<p align=\"justify\" class=\"small\">The pharmaceutical industry as a whole is opposing unrestricted access to clinical trial data &#8211; with some citing concern for subject confidentiality, others claiming infringement on trade secrets [and their <em>competitive edge<\/em>]. And there&#8217;s a fault line developing among those fighting <em>for<\/em> Data Transparency. Some seem willing to compromise with industry&#8217;s concerns while others hold fast for <em>complete<\/em> access to the data from clinical trials. It&#8217;s hard not to personify this fault line. On one side, Ben Goldacre, Iain Chalmers, and the AllTrials movement are negotiating with GSK and the other pharmaceutical companies &#8211; aiming, it seems, at a treaty, temporizing on how transparent is transparent and who controls access. On the other side, David Healy leads joined by Peter G&oslash;tzsche of the Nordic Cochrane Centre warning of the dangers of anything this side of full access to clinical trial data. I have enormous respect for the accomplishments and good sense of the proponents of both points of view, and I don&#8217;t really think there&#8217;s a vindictive Marcel Clemenceau [the Treaty of Versailles that crushed Germany] or a conciliatory Neville Chamberlain [the Munich Agreement that appeased Hitler] in the mix. Ben Goldacre, Iain Chalmers, David Healy, Peter G&oslash;tzsche, AllTrials, RIAT, the Nordic Cochrane Centre are all heros of the realm to me &#8211; even when they disagree. But personified or not, there&#8217;s a long history of erroneous attempts at solving what seems the impossible dilemma when entrepreneurialism collides with rational health care and medical ethics, and the territory between scorched earth and  sleeping with the enemy remains to be defined.<\/p>\n<div align=\"justify\" class=\"small\">So back to Eliot and the lines that come next in his poem:<\/div>\n<ul>\n<div class=\"small\"><em>Footfalls echo in the memory<br \/>            Down the passage which we did not take<br \/>            Towards the door we never opened&#8230;<\/em><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">Why have so many attempts at reform met with such regular failure? Clinical trials were Kefauver&#8217;s and Lasagna&#8217;s 1962 solution to a problem. Now, clinical trials themselves have become the problem, all in spite of numerous other reforms [eg <a target=\"_blank\" href=\"http:\/\/en.wikipedia.org\/wiki\/ClinicalTrials.gov\">clinicaltrials.gov<\/a>] along the way. Was there some passage we failed to take? Some door we should&#8217;ve opened? Does reflecting on our history have lessons other than just to review our disappointments? <\/div>\n<p align=\"justify\" class=\"small\">One message from history is clear. A dilemma is, by definition, an unsolvable problem, what Fiona Godlee called an irreducible conflict [<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/07\/11\/a-sticky-wicket\/\">a sticky wicket&hellip;<\/a>].&nbsp; Previous approaches have aimed at definitive solutions. Whatever happens this time should be informed by the <span class=\"st\">na&iuml;vet\u00e9<\/span> of that approach. The goals of a commercial enterprise and those of health care are doomed to frequently remain at odds. So there <em>is<\/em> no final solution. It&#8217;s an ongoing conflict that needs to be under more or less constant observation &#8211; something like putting a criminal on parole with an attentive parole officer or auditing financial institutions. ClinicalTrials.gov wasn&#8217;t enforced. It wasn&#8217;t even monitored. So many ignored it, at least for results. Our history says that&nbsp; no matter what we do, it has to include both the resources and the&nbsp; mandate for oversight &#8211; indefinite, ongoing oversight. No more honor system and grand rhetoric. There&#8217;s just not enough honor in the marketplace to get the job done. The reason that Data Transparency is so important is that it&#8217;s the only tool that guarantees that oversight of clinical trials can occur, but transparency is immaterial if nobody&#8217;s looking.  <\/p>\n<div align=\"justify\" class=\"small\">There&#8217;s another historical hint in the comments from my last post. Dr. Bernard Carroll has spent his retirement years as a watchdog with his colleague Bob Rubin, and he adds yet another valuable piece that&#8217;s been missing in this <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/11\/09\/no-judgement-at-nuremberg\/#comment-251765\">comment<\/a>:<\/div>\n<blockquote>\n<div align=\"justify\"><em>The enabling of corporate malfeasance by highly visible KOLs is another  dark chapter in this story. Where are the professional and academic  societies when we need them to speak publicly about this stain?<\/em><\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">Where are the professional associations, the medical schools, academic medicine, and whatever groups stand as representing organized medicine? Medical ethics is their domain and an intrinsic responsibility. If these organizations want to persist, they have to step up to the plate by censuring offenders and asserting those standards. The same can be said for our journals. If they want to remain <em>academic<\/em> journals, they have to provide the safeguards that accompany their claim of being <em>an academy &#8211;<\/em> insisting on clinical trial registration, Data Transparency, accurate reporting of authorship, attention to conflicts of interest, and retraction of publications that don&#8217;t live up when exposed.<\/div>\n<p align=\"justify\" class=\"small\">The pharmaceutical industry itself is a relative newcomer to our commercial enterprises, emerging from the early makers of patent medicines and home remedies. We now inspect their facilities, assay their products for quality, and if they don&#8217;t live up the our codes, we shut them down. We see manufacturing pharmaceuticals as a privilege, not a right. If their plants are dirty, we close them. Hiding behind closed doors is verboten. How is distorting or withholding clinical trials any less essential than the quality of their their manufacturing processes? It isn&#8217;t, and it begs for the same scrutiny and the consequences needed to match the infractions.         <\/p>\n<p align=\"justify\" class=\"small\">But there&#8217;s   a glaring omission in this history we all already know. Companies  don&#8217;t commit fraud &#8211; people do. It&#8217;s part of that &quot;cost of doing  business&quot; argument that&#8217;s so regularly mentioned that it&#8217;s become a  figure of speech. This is the door we haven&#8217;t opened that can&#8217;t continue  to stay closed. We don&#8217;t have a surrogate legal system. We don&#8217;t fine  the Mafia or drug cartels, we punish their criminals. We don&#8217;t impound  the cars in vehicular homicides, we indict the drivers. And there&#8217;s  plenty of out-right crime accompanying the distortions in clinical trial  reporting, libraries filled with incriminating subpoenaed documents,  but no punishment of the perpetrators on the books. The only pertinent  question here is why hasn&#8217;t it happened?<\/p>\n<div align=\"justify\" class=\"small\">In a personal history, the things that didn&#8217;t happen are often as important as the things that did [and much harder to address after the fact]. The history of pharmaceutical clinical trial publications is a treasure trove of roads not traveled and doors left unopened, quick fixes without ongoing monitoring, opportunities lost or derailed. Data Transparency is an essential part of what&#8217;s needed to get us to maintain our focus on how they&#8217;re conducted, processed, and used. But Data Transparency is just part of a story of inattention that is as disastrous to medical care as it is to a developing child&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>I spent a childhood being groomed for science. That&#8217;s what the 1950s were about and all the vectors pointed that way. But there was a private bent towards history in there somewhere that never got around to flowering. As an adult doctor, it was the histories of my patients [and myself] that finally brought it [&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":[5],"tags":[],"class_list":["post-41413","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41413","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=41413"}],"version-history":[{"count":56,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41413\/revisions"}],"predecessor-version":[{"id":41469,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41413\/revisions\/41469"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=41413"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=41413"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=41413"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}