{"id":11148,"date":"2011-07-07T11:31:43","date_gmt":"2011-07-07T15:31:43","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=11148"},"modified":"2011-07-07T11:34:50","modified_gmt":"2011-07-07T15:34:50","slug":"big-money-for-a-freshman","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/07\/07\/big-money-for-a-freshman\/","title":{"rendered":"big money for a freshman…"},"content":{"rendered":"
While Harvard’s recent action has focused our attention on Joseph Biederman, he was only one of the many academic psychiatrists spotlighted by Senator Grassley and investigator Paul Thacker in their 2008 probe of financial Conflicts of Interest and undeclared pharmaceutical income. The list was long: Dr. Charles Nemeroff<\/font><\/strong>, Dr. Joseph Biederman<\/font><\/strong>, Dr. Melissa DelBello<\/font><\/strong>, Dr. Timothy Wilens<\/font><\/strong>, Dr. Thomas Spencer<\/font><\/strong>, Dr. Alan Schatzberg<\/font><\/strong>, Dr. Martin Keller<\/font><\/strong>, Dr. A. John Rush<\/font><\/strong>, Dr. Karen Wagner<\/font><\/strong>, Dr. Jeffrey Bostic<\/font><\/strong>, <\/font><\/strong>and former head of the National Institute of Mental Health, Dr. Frederick Goodwin<\/font><\/strong>. Who is Dr. Melissa Delbello<\/font><\/strong>? Another Child Psychiatrist [in Cincinnati] focusing on the ‘Bipolar Child’ – working for AstraZeneca<\/font><\/strong>, the maker of Seroquel<\/font><\/strong>: <\/div>\n
\n
What Conflict? The NIH And A Bucket Of Money<\/font><\/a><\/strong> <\/u>
Pharmalot<\/font><\/strong>
By Ed Silverman
April 8th, 2008<\/div>\n

In his quest to peel back the curtain on the interplay between pharma and docs, Chuck Grassley offered an interesting example last week while speaking on the Senate floor. He noted that an ‘inconclusive’ 2002 study in the Journal of the American Academy of Child and Adolescent Psychiatry on AstraZeneca’s Seroquel was used to devise guidelines for treating bipolar disorder with antipsychotics.<\/sup><\/strong><\/p>\n

The lead author was Melissa DelBello<\/a><\/u>, a University of Cincinnati professor, who in 2003 received more than $100,000 from AZ, which sells Seroquel and paid her $80,000 in 2004. The money was for lectures, consulting, advisory board work and travel reimbursement. DelBello later reported $100,000 in outside income to the university between 2005 and 2007, although AZ says she was paid $238,000. She collected from other drugmakers, too.<\/sup><\/strong><\/p>\n

Whatever the real numbers, there’s another issue – DelBello receives grant money from the National Institutes of Health and, as Grassley noted, “universities are supposed to monitor conflicts of interest when their researchers receive NIH grants.” [Take a look<\/a><\/u> at section (c)(1) and (2)]. And the NIH is also supposed to monitor conflicts, at least involving payments exceeding $10,000 over a 12-month period…<\/sup><\/strong><\/div>\n<\/blockquote>\n
I wondered where Seroquel<\/font><\/strong> was. Biederman was working two sides of the Atypical Antipsychotic street [Risperdal and Zyprexa][bipolar kids: biedermania and super angry\/grouchy\/cranky irritability…<\/font><\/a><\/u><\/strong>]. Surely Seroquel<\/font><\/strong> was in the mix. Well, it was. They got it into the Bipolar Child literature before the others: <\/div>\n
\n
A double-blind, randomized, placebo-controlled study of quetiapine as adjunctive treatment for adolescent mania<\/font><\/u><\/a><\/strong>
by Delbello MP, Schwiers ML, Rosenberg HL, and Strakowski SM<\/sup>
Journal of the American Academy of Child and Adolescent Psychiatry<\/font><\/strong>
2002 41(10):1216-23. <\/div>\n

<\/p>\n

Abstract
OBJECTIVES<\/u>: This randomized, double-blind, placebo-controlled study examined the efficacy and tolerability of quetiapine in combination with divalproex (DVP) for acute mania in adolescents with bipolar disorder. It was hypothesized that DVP in combination with quetiapine would be more effective than DVP alone for treating mania associated with adolescent bipolar disorder. Furthermore, it was hypothesized that quetiapine would be well tolerated.
METHOD<\/u>: Thirty manic or mixed bipolar I adolescents (12-18 years) received an initial DVP dose of 20 mg\/kg and were randomly assigned to 6 weeks of combination therapy with quetiapine, which was titrated to 450 mg\/day (n = 15) or placebo (n = 15). Primary efficacy measures were change from baseline to endpoint in Young Mania Rating Scale (YMRS) score and YMRS response rate. Safety and tolerability were assessed weekly.
RESULTS<\/u>: The DVP + quetiapine group demonstrated a statistically significantly greater reduction in YMRS scores from baseline to endpoint than the DVP + placebo group (F(1,27) = 5.04, p =.03). Moreover, YMRS response rate was significantly greater in the DVP + quetiapine group than in the DVP + placebo group (87% versus 53%; Fisher exact test, p =.05). No significant group differences from baseline to endpoint in safety measures were noted. Sedation, rated as mild or moderate, was significantly more common in the DVP + quetiapine group than in the DVP + placebo group.
CONCLUSIONS<\/u>: The findings of this study indicate that quetiapine in combination with DVP is more effective for the treatment of adolescent bipolar mania than DVP alone. In addition, the results suggest that quetiapine is well tolerated when used in combination with DVP for the treatment of mania.<\/sup><\/strong><\/div>\n<\/blockquote>\n
At first glance, it looks as if the results were as advertised:<\/div>\n


[recolored for clarity]<\/sup> <\/p>\n

But there were some real problems. First, the dropout rate in the Seroquel<\/font><\/strong> group was really high [8\/15 versus 1\/15]:<\/div>\n


[truncated for simplicity]
<\/sup><\/p>\n

And then the difference doesn’t look so impressive when viewed over time – particularly with a >50% drop-out rate:<\/div>\n


[recolored for clarity]<\/sup><\/p>\n

Frankly, I’m a little surprised at how little effect the Seroquel<\/font><\/strong> had. One of my personal complaints about these Atypial Antipsychotic studies is that they interpret some change in a rating scale in a disease-specific way. Seroquel<\/font><\/strong> is, after all, a major tranquillizer and quiets agitation of any kind. That has little to do with mania in my humble opinion. You could do that with any tranquillizer-like drug.<\/em><\/sup><\/div>\n

After this 2002 article, Dr. DelBello was an author on nine more articles about Seroquel<\/font><\/strong> financed by AstraZeneca<\/font><\/strong> before the Grassley probe. Since targeted by Grassley, she is a listed author on one review article recommending Atypical Antipsychotics for Bipolar Youths [Pharmacotherapy of bipolar disorder in children and adolescents: recent progress<\/a><\/strong>], but it was not industry funded. She continues to be an NIMH Grant<\/font><\/strong><\/u><\/a> recipient.<\/p>\n

I’d like to comment on this statement from her abstract: "It was hypothesized that DVP in combination with quetiapine would be more effective than DVP alone for treating mania associated with adolescent bipolar disorder.<\/strong>" Other than the fact that Seroquel <\/font><\/strong>is a "calmer-downer," what is the basis for that hypothesis? In the full text, she lists Seroquel’s <\/font><\/strong>receptor affinities, but gives no reason that might he related to Mania. My complaint here is not just about Dr. DelBello’ article, it’s about all of the Atypical Antipsychotic literature with Bipolar Disorder. Why? Why give an antipsychotic to people who aren’t psychotic? The only reason I can think of is to "calm them down" – behavior control, symptomatic treatment. The articles don’t say that. They vaguely imply that there’s something "disease specific" in recommending their use. To my knowledge, there is no such disease specificity…<\/div>\n","protected":false},"excerpt":{"rendered":"

While Harvard’s recent action has focused our attention on Joseph Biederman, he was only one of the many academic psychiatrists spotlighted by Senator Grassley and investigator Paul Thacker in their 2008 probe of financial Conflicts of Interest and undeclared pharmaceutical income. The list was long: Dr. Charles Nemeroff, Dr. Joseph Biederman, Dr. Melissa DelBello, Dr. […]<\/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-11148","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11148","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=11148"}],"version-history":[{"count":23,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11148\/revisions"}],"predecessor-version":[{"id":11170,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11148\/revisions\/11170"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=11148"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=11148"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=11148"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}