{"id":4618,"date":"2011-01-13T21:35:10","date_gmt":"2011-01-14T02:35:10","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=4618"},"modified":"2011-07-09T23:50:00","modified_gmt":"2011-07-10T03:50:00","slug":"tanfords-chatzberg-redux","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/01\/13\/tanfords-chatzberg-redux\/","title":{"rendered":"Mifepristone 0: $tanford’s $chatzberg redux<\/em>…"},"content":{"rendered":"\n

Dr. Alan Schatzberg<\/font><\/strong> was Chairman of Psychiatry<\/font><\/strong> at Stanford [1991-2010], coeditor of the book Psychopharmacology<\/font><\/strong>, and recent past-President of the American Psychiatric Association<\/font><\/strong>. From 1998 through 2008, he was the Principle Investigator on NIMH grants studying the use of MIFEPRISTONE <\/strong>[RU-486] in the treatment of Psychiatric Disorders – primarily Psychotic Depression. The relationship between the corticosteriods and Depression has long tantalized researchers – and that relationship remains suggestive but elusive. RU-486 is mainly known as the "morning after" pill – an "abortifactant." It interferes with the action of most of the steroid hormones [progesterone, glucocorticoids, androsteroids]. So the research hypothesis in such a study would be that blocking the effect of the glucocorticoids ["stress hormones"] might improve the lot of the severely depressed. So far, so good. <\/p>\n

The fly in the ointment? Dr. Schatzberg and Stanford have the patent for RU-486. The patent was turned over to Corcept<\/strong>, a company founded by Dr. Schatzberg to develop its use in depression, aiming toward FDA approval. Both Dr. Schatzberg [$6 M] and Stanford were invested in Corcept <\/strong>[Stanford later sold its stock in 2002]. In the summer of 2008, Senator Chuck Grassley, investigating Conflicts of Interest in Medicine [Psychiatry], began to investigate Stanford and Dr. Schatzberg. Both vigorously denied wrong-doing, but Dr. Schatzberg stepped down from [or was relieved of his position on] this grant. There was much ado about this [for good reason] and Stanford put up a web-site<\/font><\/strong><\/a> for the relevant documents.<\/p>\n

That brings us to today. Two prominent oversight web-sites have posts up about the same thing: Pharmalot<\/font><\/strong> [Stanford, Taxpayer-Funded Research & Disclosures<\/font><\/a><\/strong>] and POGO<\/font><\/strong> [The Ugly Underbelly of Medical Research<\/font><\/strong><\/a>].They point to some recently obtained NIMH emails that reveal that the NIMH DSMB<\/font><\/strong> [Data Safety Monitoring Board<\/font><\/strong>] met in May 2009 and voted unanimously to shut down Stanford’s MIFEPRISTONE<\/strong> study immediately [and permanently]. The blogs ask why that wasn’t posted on Stanford’s ‘transparency’ web site? Other documents in that same time frame were there. It’s a fine question, but the answer is obvious. Who wants to look that bad? in public?<\/p>\n

The Data Safety Monitoring Board<\/font><\/strong> "monitors clinical trials to ensure participant safety and to protect the validity and integrity of data." In simple terms: Are the research subjects safe? Is the study directed towards answering the research question?<\/div>\n
<\/div>\n
In case it’s not clear, the answer to both questions was a loud "No!<\/font><\/strong>" There’s no way Schatzberg or Stanford can spin what happened here in a positive way. It stinks to high heaven from cradle to grave. It was a scenario designed to get a drug on the market for psychotic people to make some money, poorly done. When Schatzberg left, it was turned over to Endocrinologists, and the NIMH correctly recognized that they couldn’t manage the patients [and maybe a lot more]. The NIMH DSMB<\/font><\/strong> further response to Insel’s return email is telling:<\/div>\n
<\/div>\n
I’ve never seen a comment like "but we’re done with the mifeprestone aspect<\/font><\/strong>" in a context like this. I expect they could’ve replaced "[ personal and deliberative information ]<\/em>" with something like "[ choice words ]<\/em>" or maybe the famous "[ expletive deleted ]<\/em>".<\/div>\n

<\/p>\n

On being elected APA President, Dr. Schatzberg sent a letter<\/strong><\/a> to all APA member denying all wrong-doing, describing Senator Grassley’s investigation as an "attack," and ending with a paranoid twist:<\/div>\n
\n
Being attacked for doing good by those on the outside is something we must all combat with facts as I have in this letter and as Stanford has through its responses to the Senator, but we must also recognize and confront that we have our own internal destructive elements both in our profession and in our organization. <\/em><\/div>\n<\/blockquote>\n
\"PaulSchatzberg did the same thing when he lawyered up in response to POGO’s recent expose<\/a><\/strong> of his relationship with ghost-writers for his book [with Dr. Charles Nemeroff] Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care<\/font><\/strong><\/u>. He seems to think POGO’s Investigator, former Senator Grassley staffer Paul Thacker now with POGO, has a grudge against him. There’s another way to look at that. Paul Thacker is a competent investigator who is out to finally expose the sleazy things Schatzberg has gotten away with for years [I guess it just depends on your point of view]. And I suppose the "internal destructive elements both in our profession and in our organization<\/em>" are Psychiatrists who are fed up with he and his cohorts perverting the specialty for their own unethical and unscientific ends. I’m proud to throw my lot in with those "elements<\/em>."<\/div>\n

Drs. Nemeroff and Schatzberg became Chairmen of Psychiatry Departments at the same time [1991]. For almost two decades, they and others shepherded a transformation of Psychiatry that not only allowed the pharmaceutical industry to use academic medicine as a marketing tool, they joined in the fun with their own ventures. And they used NIMH Grant money and their positions in the field to further the interests of their industry affiliates and their own businesses.<\/p>\n

Today’s posts by Pharmalot<\/font><\/strong> [Stanford, Taxpayer-Funded Research & Disclosures<\/font><\/a><\/strong>] and POGO<\/font><\/strong> [The Ugly Underbelly of Medical Research<\/font><\/strong><\/a>] expose a lot more than simply the omission of an embarrassing set of emails on the Stanford web site. They point to a Conflict of Interest so blatant that the term doesn’t do it justice. They show that the actual study design and implementation were so mishandled that the NIMH<\/font><\/strong> axed the study permanently when it was reviewed. They expose the fact that Stanford University not only didn’t pick up the magnitude of the Conflict of Interest and poor research design with their own oversight procedures, Stanford itself was directly involved<\/u> as the holder of the patent for the drug itself. And for all of that, we still have no idea<\/strong><\/a> if RU-486 might help in psychotic depression, nor is it likely we ever will know. In this case, perhaps Stanford should return the money it received from the NIMH<\/font><\/strong> and formally censure Dr. Schatzberg. Emory University didn’t do that when Dr. Nemeroff did a similar thing, so Stanford has an opening to both redeem its reputation and take the lead towards reestablishing scientific and academic integrity to medical research…<\/div>\n","protected":false},"excerpt":{"rendered":"

Dr. Alan Schatzberg was Chairman of Psychiatry at Stanford [1991-2010], coeditor of the book Psychopharmacology, and recent past-President of the American Psychiatric Association. From 1998 through 2008, he was the Principle Investigator on NIMH grants studying the use of MIFEPRISTONE [RU-486] in the treatment of Psychiatric Disorders – primarily Psychotic Depression. The relationship between the […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","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":[2],"tags":[],"class_list":["post-4618","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4618","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=4618"}],"version-history":[{"count":1,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4618\/revisions"}],"predecessor-version":[{"id":11301,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4618\/revisions\/11301"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=4618"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=4618"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=4618"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}