1 Boring Old Man

^{from Google Maps®, Street View}

I assumed that this study was done by Quintiles because Amir Kalali was named as an author. However, the word "Quintiles" doesn’t appear in the on-line data supplement, on clinicaltrials.gov, or in the FDA documents. "Quintiles" is mentioned in the full text of the article in the acknowledgements and as Amir Kalali’s employer only – but nowhere else…

I failed in my goal of parsing out Quintiles’ specific contributions to the Lurasidone story. My guess is that they came into the picture at least for the last two studies based on the multinational sites and the speed to market [their specialty], but that’s just a guess. The CROs seem to make it their business to stay in the shadows. All Clinical Trials have simply "Sunovion Medical Director" as the Principle Investigator. And in this paper [Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo and olanzapine controlled study] … Quintiles’ presence is minimally acknowledged. My bet is that Quintiles ran the whole show in both – again my guess…

The clinicaltrials.gov changes database is in a confusing XML format, so I’ve summarized the parts of interest in this table:

There were 52 different sites used in this study [NCT00615433. In all revisions: John Sonnenberg PhD is listed as site PI for the Uptown Research Institute; Herbert Meltzer MD is site PI for the Vanderbilt Heart and Vascular Institute; and Steven Potkin is site PI for University of California at Irvine Medical Center. The Principle Investigator listed in the table is for the entire study.

^{In October 2009, Sepracor Inc., a U.S. pharmaceutical company with a focus in CNS and Respiratory therapies, was acquired by Dainippon Sumitomo Pharma Co., Ltd. [DSP], a top ten, stock exchange-listed pharmaceutical company based in Osaka, Japan. The move strengthened DSP’s North American based drug development pipeline and commercial capabilities. And brought together extensive expertise in two main treatment categories—disorders of the central nervous system [CNS] and respiratory diseases. In April 2010, DSP’s original U.S. subsidiary, Dainippon Sumitomo Pharma America, Inc. [DSPA] was merged into Sepracor. Sunovion is the new company born of this union.}
^{from the Sunovion website}

Drugmaker Paid Psychiatrist Nearly $500,000 to Promote Antipsychotic, Despite Doubts About Research
Propublica and Chicago Tribune
by Christina Jewett, ProPublica, and Sam Roe
Nov. 11, 2009

Chanile Hayes came under Dr. Michael Reinstein’s care after suffering a nervous breakdown. Hayes went from 140 pounds to nearly 300 in two years after taking Seroquel, a drug that Reinstein was paid to promote by its manufacturer, AstraZeneca. Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma. On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular. On the other, some worried that his research findings might be too good to be true.

As Reinstein grew irritated with what he perceived as the company’s slights, a top executive outlined the scenario in an e-mail to colleagues. "If he is in fact worth half a billion dollars to (AstraZeneca)," the company’s U.S. sales chief wrote in 2001, "we need to put him in a different category." To avoid scaring Reinstein away, he said, the firm should answer "his every query and satisfy any of his quirky behaviors."

Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of indigent, mentally ill residents in Chicago-area nursing homes. During this period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.

The AstraZeneca payments, filed as exhibits in a federal lawsuit, highlight the extent to which a leading drug company helped sustain one of the busiest psychiatrists working in local nursing facilities. In an interview and in response to written questions, Reinstein said industry payments he has received for speeches and other engagements have had no bearing on his research results or patient care. He said he does not "accept any money from corporations to study their medications. This eliminates any possible conflicts of interest."

But he does receive money from the Uptown Research Institute, a for-profit business that conducts industry and federally funded studies on psychotropic drugs to help mentally ill patients. Reinstein’s office in Uptown is adjacent to the research institute, which is owned by John Sonnenberg, a clinical psychologist who describes Reinstein as "a mentor of mine" and "brilliant." Sonnenberg said drugmakers and others pay his institute to do research, and the group, in turn, pays Reinstein a consulting fee "under $2,000 a month" and has for many years…