{"id":4623,"date":"2011-01-19T14:05:47","date_gmt":"2011-01-19T19:05:47","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=4623"},"modified":"2011-01-19T17:19:19","modified_gmt":"2011-01-19T22:19:19","slug":"mifepristone-iv-the-gathering-storm","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/01\/19\/mifepristone-iv-the-gathering-storm\/","title":{"rendered":"Mifepristone IV: the gathering storm…"},"content":{"rendered":"\n
Corcept<\/font><\/strong> did indeed go public in the Spring of 2004, selling shares worth over $50 M. In September of 2005, the Stanford group published a third Mifepristone study online [in print in on March 2006]. At the time, Dr. Charles Nemeroff was the editor of Neuropsychopharmacology<\/strong> [the Journal that published the study]. His editorship ended abruptly not long thereafter. In April 2006, he and eight other authors published a "perspective" article in that Journal [VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms<\/a>. Neuropsychopharmacology<\/u><\/strong> (2006) 31,<\/strong> 1345–1355]. And then:<\/div>\n
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Journal Editor Quits Over Conflict of Interest<\/a>
Chronicle of Higher Education<\/strong>
August 26, 2006<\/div>\n

The editor of a medical journal has resigned after drawing sharp criticism for failing to disclose his financial ties to a medical-device manufacturer after publishing an paper that endorsed one of its products. The editor, Charles B. Nemeroff, chairman of Emory University’s department of psychiatry and behavioral sciences, was also a co-author of the paper, which said the device was an effective treatment for depression. The medical society that publishes the journal, Neuropsychopharmacology, <\/em>attributed his resignation, in part, to bad publicity over the paper.<\/sup><\/p>\n

All of that news<\/a><\/strong><\/u> comes from today’s Wall Street Journal,<\/em> which last month published a long article<\/a><\/strong><\/u> about the medical journal’s failure to note that Dr. Nemeroff and seven of his eight academic co-authors had financial ties to the manufacturer, Cyberonics Inc. A ninth co-author was an employee of the company. The medical journal subsequently published a correction noting those relationships.<\/sup><\/div>\n<\/blockquote>\n
I guess Dr. Nemeroff forgot what he’d written in 2003<\/strong><\/a> in his response to Drs. Carroll and Rubin: "Going forward, we intend to provide all financial disclosure information, even if it is not requested by the journal editor.<\/em><\/font><\/strong>" <\/div>\n

So back to the third Mifepristone study:<\/p>\n\n\n\n
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Psychotic major depression [PMD] is found to be a relatively common psychiatric condition that affects up to nearly 20% of patients with major depression. Previous studies by our group have shown rapid reversal of psychotic symptoms in some PMD patients treated with mifepristone, in addition to restoring a more normal afternoon cortisol release. The rationale for treating patients with PMD with a glucocorticosteroid receptor antagonist is further discussed. In total, 30 patients with PMD were treated with either 600 mg\/day mifepristone or placebo for 8 days in a randomized double-blind manner. The Hamilton Depression Rating Scale [HDRS] and the Brief Psychiatric Rating Scale [BPRS] were administered at baseline and again after 8 days of treatment. Cortisol and ACTH were measured hourly from 1800 to 0900 at baseline and after 8 days of treatment. Significantly, more patients in the mifepristone group [seven of 15] showed a 50% or greater decline on the BPRS positive symptom subscale, an index of psychotic symptoms, as compared to the placebo group [two of 15]. Patients who received mifepristone had lower HDRS and BPRS scores at study completion compared to those who received placebo, but these differences were not statistically significant… These results suggest that short-term use of mifepristone may be effective in the treatment of PMD and may re-regulate the HPA axis. Additional blinded studies are warranted.<\/sup><\/div>\n<\/td>\n<\/tr>\n<\/table>\n

This was an NIMH funded study – a double blind comparison of Placebo and Mifepristone [n=30] done by Stanford. The outcome measures were the same scales as before [Hamilton Depression Rating Scale, Brief Psychiatric Rating Scale, and the BPRS Positive Symptom Subscale]. Here are the raw results [mean with 1 SD above and below]: <\/p>\n

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The Analysis of Variance<\/strong><\/a> table showed no significance except time, though the BPRS[PSS] scores were reported in an unusual way:<\/div>\n