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.
The lead author was Melissa DelBello, 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.
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 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…
A double-blind, randomized, placebo-controlled study of quetiapine as adjunctive treatment for adolescent mania
by Delbello MP, Schwiers ML, Rosenberg HL, and Strakowski SM
Journal of the American Academy of Child and Adolescent Psychiatry
2002 41(10):1216-23.
Abstract
OBJECTIVES: 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: 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: 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: 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.
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After this 2002 article, Dr. DelBello was an author on nine more articles about Seroquel financed by AstraZeneca 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], but it was not industry funded. She continues to be an NIMH Grant recipient.
Grassley’s floor statement on payments to doctors 2008
http://finance.senate.gov/newsroom/ranking/release/?id=158c9871-4559-419f-9e2d-ff4d0a7c177f
“Another interesting thing happened while I was looking into Dr. DelBello.
According to the letter I received from the University of Cincinnati, Dr. Del Bello failedto report other money that she received from big drug companies.
It turns out that Dr. DelBello had a company which she established for “personalfinancial purposes.
AstraZeneca, the maker of Seroquel, paid MSZ Associates Inc., an Ohio Corporation,over $60,000.
And where do you think is the address for MSZ Associates? You got it, the Departmentof Psychiatry at the University of Cincinnati.
This situation is unfortunate on so many levels.
It is unfortunate for the University of Cincinnati that relied on the representations of itsfaculty; it is unfortunate for patients who once believed that their doctor was not for sale; and itis unfortunate that we are in a day and age where a bill promoting transparency for millions andmillions of dollars going from big drug companies to American doctors is necessary.
This is just one example of a doctor who has been receiving large amounts of moneyfrom drug companies.”
CABF bpkids meet your Scientific Advisor DelBello, in Grassley’s floor speech http://tinyurl.com/3psjfz5