{"id":64004,"date":"2016-03-13T18:24:48","date_gmt":"2016-03-13T22:24:48","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=64004"},"modified":"2016-03-13T23:07:43","modified_gmt":"2016-03-14T03:07:43","slug":"what-can-be-done","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/03\/13\/what-can-be-done\/","title":{"rendered":"what can be done…"},"content":{"rendered":"
Usually, when I run across an important article that’s available on-line, I just suggest reading it and add my own comments. This time, I’m both suggesting reading it and I’m pulling quotes too. Read in isolation, the quotes below sound like injunctions<\/em> but that’s not how they’re written – more as suggestions<\/em>. So the imperative<\/em> voice is my own, not Fava’s. I offer no apologies for that…<\/sup><\/font><\/strong><\/div>\n
<\/p>\n
I belatedly became aware of the magnitude of the Conflict of Interest [COI] problems in our literature in 2008 with the revelations of Senator Chuck Grassley<\/font> and his investigator Paul Thacker<\/font>. But in the years since, I’ve realized that by then what was once unthinkable had already verged on routine, particularly in the industry-sponsored clinical drug trials, particularly in psychiatry. Recently, we’ve seen several articles advocating an even further laxing of COI standards. In this editorial, Dr. Fava goes beyond just decrying the COI problem – he lays out how it came into being and the forces that sustain it. Then he talks about what we can do about the problem… <\/div>\n
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The Hidden Costs of Financial Conflicts of Interest in Medicine<\/a><\/div>\n
by Giovanni Fava<\/div>\n
Psychotherapy and Psychosomatics<\/font><\/strong>. 2016 85:65-70.<\/div>\n
[full text on-line<\/a>]<\/div>\n

A series of three articles by Lisa Rosenbaum in the New England Journal of Medicine called for a reexamination of the views and regulations of financial conflicts of interest in medicine. Her conclusions appeared to be clear: ‘The bad behavior of the few has facilitated impugning of the many.’ The effects of this behavior were amplified by journalists who fed a vicious cycle in which each story generates more distrust in the public. Dr. Rosenbaum suggested that current restrictive rules may ‘undermine potentially productive research collaborations, dissemination of expertise, and public trust.’ She acknowledged that studies by pharmaceutical companies are more likely to have outcomes favorable to the sponsor and that physicians who attend events funded by pharmaceutical companies tend to prescribe the featured drugs. However, she claimed that these interactions might actually be beneficial to the patient and that much of the harm was ‘invented’. Dr. Rosenbaum’s views were in sharp contrast with the history of the journal where they were published. The New England Journal of Medicine pioneered the need of disclosure of financial conflicts of interests and the importance of having authors of editorials and review articles free from commercial ties, yet time seems to be ripe for getting rid of these worries and to return to business as usual.<\/p>\n

A recent viewpoint published in the JAMA moves toward this direction. Also, these authors complain of the policies on conflicts of interest that were developed in reaction to a limited number of investigators but, once introduced, applied to all. They suggested substituting the pejorative term of ‘conflict of interest’ with ‘confluence of interest’. A name change can be important. When withdrawal reactions started being described following the discontinuation of second-generation antidepressant drugs [selective serotonin reuptake inhibitors, SSRI] they were promptly labeled as ‘discontinuation syndromes.’ The name successfully conferred a harmless nature, which was in sharp contrast with the withdrawal reactions that occurred with other drugs like benzodiazepines. SSRI thus replaced benzodiazepines in the treatment of anxiety disorders, even though discontinuation syndromes of SSRI are actually withdrawal reactions, and the clinical evidence was pointing to just the opposite [benzodiazepines are more effective, with fewer side effects]. The shift from benzodiazepines to SSRI has probably been the most successful achievement of pharmaceutical propaganda in psychiatry, with full endorsement of guidelines and professional societies. Will the term ‘confluence of interest’ achieve the same success? Let us examine the development of the problem, its implications and what can be done about it…<\/div>\n<\/blockquote>\n
He goes on to tell a story about how each intended solution has become a part of the problem rather than achieving the intended reform – sacrosanct things like Evidence Based Medicine, Randomized Clinical Trials, Meta-analysis, C.M.E., Treatment Guidelines, Review Articles, Screening, even the dramatic change in how medical information is communicated [from Journals and Meetings to the Internet]. In only a couple of pages, he gives us a candid and clear narrative of how the malignant COI problem arose and grew to its current dominance. He even throws in a couple of examples of the medication myths that arose in marketing meetings rather than from clinicians’ experience: downplaying medication withdrawal<\/font><\/em> by calling it a discontinuation syndrome;<\/font><\/em> using antidepressants instead of benzodiazepines for anxiety – a perversion of the risk\/benefit equation. This timeline\/narrative of the COI invasion is simply a must-read. But the gold mine is in the latter part of the article in the section he calls What Can Be Done?<\/font><\/strong><\/em><\/div>\n
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This is the part where I turn Dr. Fava’s thoughtful suggestions into stone tablets from Mount Sinai – rules for a better future. Again, no apologies…<\/font><\/strong><\/sup><\/div>\n
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[1] Definition of Financial Conflict of Interest<\/font><\/strong><\/div>\n

<\/p>\n

"Researchers with substantial conflicts of interest are not suitable for writing and participating in reviews, editorials, meta-analyses and guidelines …"<\/p>\n

"… the industry may interact with academic investigators through consulting agreements that benefit the university but not the investigator, eliminating any source of direct financial benefit for the individual from the company."<\/div>\n<\/blockquote>\n
I wasn’t kidding about the stone tablet part. While these injunctions may seem too rigid, we tried it the other way and it has been a disaster. At this point, these are the only right things to do…<\/div>\n
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[2] The Pursuit of Critical Thinking in Clinical Practice and Research<\/font><\/strong><\/div>\n

"Preserving intellectual freedom in the setting of proliferating connections between pharmaceutical and biotechnology industries and the physicians is a major ethical challenge of medicine today. Loosening rules that were developed over an incredible sequence of scandals and jeopardized the credibility of medicine would not offer a suitable solution…"<\/p>\n

"As Wilkes commented on the consequences of inappropriate industry-physician interactions: ‘When trust goes, so does the healing power of physicians.’ Similarly, medical journals do not lose their function to the extent that they foster critical thinking as to clinical matters and do not lose their credibility. Such critical thinking may also be increased by the opportunity at scientific meetings for in-depth discussions among clinical scientists with no substantial conflicts of interest – a pause from information overload."<\/div>\n<\/blockquote>\n
This is too important to turn into an injunction. Dr. Fava makes good suggestions, but in my mind, it brings up the whole topic of Continuing Medical Education [CME] and I’ll have my say about that in a later blog post [see also Boycotting Commercial Medical Education and Professional Societies<\/font><\/em> below]. Suffice it to say here that "Loosening rules that were developed over an incredible sequence of scandals and jeopardized the credibility of medicine would not offer a suitable solution<\/font><\/em>" is an understatement.<\/div>\n
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[3] The Inadequacy of EBM<\/font><\/strong><\/div>\n

"Recently, Richardson and Doster suggested the consideration of three dimensions in the process of evidence-based decision: baseline risk of poor outcomes from an index disorder without treatment, responsiveness to the treatment option, and vulnerability to the adverse effects of treatment. EBM is focused on the potential benefits that therapy may entail as to baseline risk, but it is likely to neglect the other two dimensions. A rational approach to treatment takes into account the balance between potential benefits and adverse effects applied to the individual patient."<\/p>\n

"EBM certainly made an important contribution to questioning unsubstantiated therapeutic claims. Time has come, however, to become more aware of its considerable limitations, including overall reductionism, disregard of patient-physician relationships and patient preferences, and insufficient consideration of problems related to financial conflicts of interest."<\/div>\n<\/blockquote>\n
Evidence Based Medicine<\/font><\/em> is a term that has given me a headache from the very first time I ever heard it. Taken literally, it’s redundant. What about medicine isn’t evidence-based? On the other hand, it has been used as a weapon to defend positions that are manifestly absurd, and attack others inappropriately. I would only add something to Dr. Fava’s last sentence above, "… an inappropriate reliance on clinical trial results, particularly industry orchestrated short-term clinical trials.<\/font><\/em>"<\/div>\n
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[4] Support of Researchers Free from Substantial Conflict of Interest<\/font><\/strong><\/div>\n

<\/p>\n

At the same time, researchers without substantial conflicts of interest need support. Otherwise, the scientific community would soon drain itself of a reservoir of truly independent experts who can be called upon to advise policy makers on the safety and efficacy of treatments, the hazards of chemicals and the safety of technology. Lines of support for independent researchers, including priority for obtaining grants from public agencies supported by taxpayers’ money and for editorship positions in medical journals, have been outlined [38<\/a>].<\/div>\n<\/blockquote>\n
Of course this is correct. I don’t know how one does that, but it sure needs doing. I would add that I don’t see Clinical Trials of drugs as research<\/font><\/em>. In my mind, it’s product testing,<\/font><\/em> and needs to be even more tightly regulated with full data access for independent review.<\/div>\n
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[5] Boycotting Commercial Medical Education and Professional Societies<\/font><\/strong><\/div>\n

<\/p>\n

"The process of regaining intellectual independence does not only involve researchers but also each clinician and society member. Fugh-Berman and Hogenmiller suggested that, in many cases, CME stands for Commercial Medical Education and argued that avoidance of industry-sponsored CME is associated with more rational prescribing. The misleading indications of Commercial Medical Education are more dangerous when sponsoring is subtle and not clearly disclosed. Similar considerations may apply to certain professional societies that are inadequate in handling issues related to conflicts of interest and produce guidelines that are biased. Boycotting such initiatives and societies may yield important effects. Such stands have personal costs but are in line with the expression of intellectual freedom."<\/div>\n<\/blockquote>\n
There is nothing I enjoy much more than talking about matters medical with respected colleagues. That’s the fun part of writing this blog and it was a carefully guarded part of my career[s]. That said, I’ve never attended a "Commercial Medical Education<\/font><\/em>" course or program, and I stopped belonging to the American Psychiatric Association<\/font><\/em> long ago. As I mentioned above, CME is too big a topic to discuss here. But the propaganda-conduit aspects of the C.M.E. system currently available has to go. It’s often more like "sleeping with the enemy<\/font><\/em>" than education.<\/div>\n

I’ve shamelessly and unapologetically co-opted Dr. Fava’s editorial by turning his suggestions into rules. Frankly, I think we’ve come to that at this point. But I reiterate that his editorial isn’t written that way. Over the years of writing this blog, I’ve been awed at how frequently and effectively efforts that began as reforms [or at least looked that way] have been perverted into tools for the opposite purpose. Continuing Medical Education was introduced to force doctors to stay current – a perfectly reasonable goal. But it became corrupted to the point where I almost think we’d be better off without it. We’ve seen that Professional Organizations and Medical Societies can be as destructive as constructive – and in the case of psychiatry, the former has unfortunately been all too common in our recent past. Clinical Trials became required as a way of insuring that inert compounds were kept off the market, but have become a way of allowing statistical efficacy to substitute for clinical efficacy. Guidelines have been a particularly easy mark to introduce programs that lead to overmedication. In psychiatry, even our diagnostic system, introduced as an attempt at reform, has been used to advance any number of inappropriate agendas. <\/p>\n

So I added a dash of absoluteness to Dr. Fava’s suggestions, sort of like I overuse bold<\/font><\/strong> and italic<\/font><\/em> highlighting in what I write. I don’t like it when others do that, but I can’t seem to stop. I guess it’s my way of saying, "Listen up. This stuff’s really important. The commercial intrusion into medical care in my medical lifetime has been massive and it’s time to put up a fight before it becomes any more institutionalized.<\/font><\/em>" It’s refreshing to read an editorial like this that goes beyond my frenetic bold<\/font><\/strong> and italic<\/font><\/em> highlighting – something that provides a clear diagnosis of the problem and a prescription for What Can Be Done<\/font><\/strong><\/em>…<\/div>\n","protected":false},"excerpt":{"rendered":"

Usually, when I run across an important article that’s available on-line, I just suggest reading it and add my own comments. This time, I’m both suggesting reading it and I’m pulling quotes too. Read in isolation, the quotes below sound like injunctions but that’s not how they’re written – more as suggestions. So the imperative […]<\/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-64004","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/64004","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=64004"}],"version-history":[{"count":30,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/64004\/revisions"}],"predecessor-version":[{"id":64035,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/64004\/revisions\/64035"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=64004"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=64004"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=64004"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}