{"id":43851,"date":"2014-02-09T15:45:24","date_gmt":"2014-02-09T20:45:24","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=43851"},"modified":"2014-02-09T19:53:07","modified_gmt":"2014-02-10T00:53:07","slug":"a-grief-observed-ii","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/02\/09\/a-grief-observed-ii\/","title":{"rendered":"a grief observed II…"},"content":{"rendered":"
I thought I could describe a state; make a map of sorrow. Sorrow, however, turns out to be not a state but a process…<\/font><\/em><\/div>\n
A Grief Observed,C.S. Lewis, 1961<\/font><\/em><\/div>\n

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To their credit, Lisa Cosgrove of the Safra Center and her colleagues stayed on the case: <\/div>\n
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Tripartite Conflicts of Interest and High Stakes Patent Extensions in the DSM-5<\/a><\/div>\n
by Cosgrove L. · Krimsky S. · Wheeler E.E. · Kaitz J. · Greenspan S.B. · DiPentima N.L.a<\/div>\n
Psychotherapy and Psychosomatics<\/font><\/strong>. 2014 83:106-113.<\/div>\n
[full text on-line<\/a>]<\/div>\n

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Background<\/font><\/strong><\/u>: The revision process for and recent publication of the DSM-5 initiated debates about the widening of diagnostic boundaries. The pharmaceutical industry had a major financial stake in the outcome of these debates. This study examines the three-part relationship among DSM panel members, principal investigators [PIs] of clinical trials for new DSM-5 diagnoses, and drug companies. <\/div>\n
Methods<\/font><\/strong><\/u>: Financial conflicts of interest [FCOI] of DSM panel members responsible for some new diagnoses in the DSM-5 and PIs of clinical trials for related drug treatments were identified. Trials were found by searching ClinicalTrials.gov. Patent and revenue information about these drugs was found using the US Food and Drug Administration’s Orange Book and manufacturer Annual Reports. <\/div>\n
Results<\/font><\/strong><\/u>: Thirteen trials met inclusion criteria [testing drugs for some new DSM disorders]. Sixty-one percent of the DSM Task Force members and 27% of Work Group members reported FCOI to the trial drug manufacturers. In 5 of the 13 trials [38%], PIs reported ties other than research funding to the drug manufacturer. In 3 of the trials [23%], a PI had financial ties to the drug manufacturer and was also a DSM panel member who had decision-making authority over the revision process. <\/div>\n
Conclusions<\/font><\/strong><\/u>: These findings suggest that increased transparency [e.g., registration on ClinicalTrials.gov] and mandatory disclosure policies [e.g., the American Psychiatric Association’s disclosure policy for DSM-5 panel members] alone may not be robust enough strategies to prevent the appearance of bias in both the DSM revision process as well as clinical decisions about appropriate interventions for DSM disorders.<\/div>\n<\/blockquote>\n
I try not to say this too often, but this is one of those articles that bears reading in full. The details of these particular Conflicts of Interest are worth looking at the specifics and what they mean in the title when they say …High Stakes Patent Extensions<\/a>. And now to the Newsweek article that puts all of this into lay terms:<\/div>\n
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A Pill for Every Ill<\/a><\/div>\n
Newsweek<\/font><\/strong><\/div>\n
By John Ericson<\/div>\n
February 6, 2014<\/div>\n
[full text online<\/a>]<\/div>\n

… When the APA released the fifth edition of its manual in May 2013, it was instantly criticized by several researchers and clinicians, who claimed that some of the revisions and modifications reflected the agenda of an editorial panel that did not have the public’s best interest in mind. For example, many therapists and parents denounced the decision to define Asperger’s syndrome as a part of the autism spectrum rather than a stand-alone diagnosis. Some said it would skew statistics. Others said it would mess with identities…<\/p>\n

… That, however, wasn’t the biggest concern. Other experts, including Sheldon Krimsky, professor of Urban & Environmental Policy & Planning at Tufts University, have pointed out that changes to the DSM can also be big business, with lots of downstream profit for everyone involved. If, for example, the DSM-5 finds a new "indication" for a particular drug, the developer can renew its patent and keep generic competitors off the market for another three years.<\/font><\/strong> For most industries, this would have a pretty modest impact on revenue. But in the business of curing ills, in which price tags can be very high and demand is often buoyed by nature, those three years can make a huge difference.<\/div>\n<\/blockquote>\n
What? I didn’t know that. Back to the Cosgrove et al paper for a moment, they found 13 trials on clinicaltrials.gov that were testing drugs for the new DSM-5 diagnoses:<\/div>\n