hiding uptown

Posted on Wednesday 30 November 2011

from Google Maps®, Street View

So, I was wrong. It happens. In a recent post [in the shadows…], I said this:
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…

How does that relate to my street scenes from Chicago? What’s wrong with my guess? It’s a kind of long story. Last night, I was procrastinating. I’m on a panel Friday night, and by all rights I should’ve been preparing, but instead I was doodling around on the computer. I’d run across a video presentation by Vanderbilt Professor Dr. H. Y. Meltzer for Latuda® – a Sunovion-made infomercial including Dr. Steven Potkin, a Professor from UC Irvine. The window was still open, so I watched it, incredulous as always that Professors of Medicine were making commercials for a drug company. In the video, Dr. Meltzer said that he was the "Principle Investigator" for the study [Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo and olanzapine controlled study]. Well, I had looked at the Clinical Trial [NCT00615433] when I was trying to find evidence of Quintiltes’ involvement, and I remembered that it had said Study Director: Medical Director, MD Sunovion, and it still did. clinicaltrials.gov has a link that says History of Changes with each trial. It holds the records of the revisions made to a clinical trial protocol along the way. Why not follow it? Beats preparing for the panel.

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


02/13/08 DainipponSPA Recruiting John Sonnenberg Uptown Research Institute
03/18/08 DainipponSPA Recruiting John Sonnenberg Uptown Research Institute
02/22/10 DainipponSPA Active
not recruiting
John Sonnenberg Uptown Research Institute
03/16/10 DainipponSPA Completed John Sonnenberg Uptown Research Institute
02/11/11 Sunovion Completed [all site investigators] All sites
02/15/11 Sunovion Completed [all site investigators] All sites
03/04/11 Sunovion Completed Medical Director MD Sunovion
03/16/11 Sunovion Completed Medical Director MD Sunovion
09/09/11 Sunovion Completed Medical Director MD Sunovion

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.

Side story I:
Seprachor was an American Pharmaceutical Company primarily making pulmonary drugs since 1984. In 2009, the company was in financial trouble:
    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
In the process, Dainippon Sumitomo Pharma acquired a US sales force.

Side story II:
This one is harder to tell. John Sonnenberg PhD runs Uptown Research Institute [shown above in the corner]. Their office is next door to the Community Mental Health Services. No, it’s not a Community Mental Health Center, it’s the private psychiatric practice of Dr. Michael Reinstein. Here’s a sampler about Dr. Reinstein and the Uptown Research Institute:
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

Dr. Michael ReinsteinChanile 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.

In an e-mail, an AstraZeneca executive says Reinstein should get careful treatment because of his potential worth to the company.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…

This next clip about Reinstein’s use of Clozaril is much worse and should be read in toto [In Chicago’s Nursing Homes, a Psychiatrist Delivers High-Risk Meds, Cut-Rate Care]. There are plenty of other equally disturbing reports about Reinstein and Sonnenberg. Just google michael reinstein md. And in spite of Sonnenberg’s denials, this is clearly a shared enterprise with a fabricated separation to deflect conflict of interest charges. It’s kind of hard to see how John Sonnenberg can run a 52 site multinational clinical trial from a Chicago store-front, but this is the very Agency in charge of the Lurasidone D1050231 Trial that I’ve been discussing – the one that Drs. Meltzer and Potkin are so excited about.

Back to the Main Event:
So, looking back to the table of changes for the clinical trial of Latuda® [D1050231], it should make sense. John Sonnenberg and his Uptown Research Institute conducted the clinical trial for Dainippon Sumitomo Pharma. In 2009 Dainippon Sumitomo Pharma acquired Sepracor and created Sunovion in early 2010. In the meantime, Dr. Reinstein and Uptown Research were the focus of a lot of negative and embarrassing attention, being included in suits against AstraZeneca’s Seroquel. Here, I’m back to guessing again, but I suspect that Sunovion needed to sanitize D1050231 and distance themselves from Reinstein and Sonnenberg, so they brought in Quintiles to clean things up and help them with their FDA process and other things. So Dr. Herbert Y. Meltzer was not the Principal Investigator of the clinical trial like he said in the video. He was a Principle Investigator of the Vanderbilt site, one of fifty-two sites. The Study Principal Investigator was John Sonnenberg PhD operating out of that Chicago store-front next to and affiliated with a major dangerous pill mill operated by Dr. Michael Reinstein [that needs shutting down yesterday]. I doubt that anyone reading the article in the American Journal of Psychiatry pictured that store-front as the research facility behind the article [or Dr. Reinstein as a psychiatric consultant]…

Addendum: Perhaps you recall Dr. Reinstein’s Seroquel Pamphlet on Diabetes from long ago:
    December 1, 2011 | 12:26 AM

    Reinstein the Clozaril KIng’s handwritten notes http://dida.library.ucsf.edu/pdf/iov09b10 of how much $$$$ AstraZeneca paid…. those are internal documents.

    December 1, 2011 | 12:49 AM

    While part of me feels that it owes some modicum of respect to Dr Reinstein– if only for reasons of professional decorum– I must say that doctors like him make my stomach turn. Assuming these reports are true, there is no other explanation for his behavior (and that of AstraZeneca) except pure, raw greed.

    I know a few doctors who follow the same strategy (if not to quite the same extent as Dr R): they fill their schedules with chronically mentally ill and/or developmentally disabled patients (most of whom can’t even talk to the doctor), load them up on antipsychotics, benzos, and sedatives– increasing the dose when the caregiver says “he yells at night”– see them every 3 to 6 months for 5-10 minutes at a time, and walk away with a nice paycheck.

    This is not medicine. In my view, this is tantamount to taxpayer-funded genocide.

    December 1, 2011 | 1:27 AM


    What kind of guy does that? And how does he still have a license after the Clozaril debacle? As SteveBMD says, a real stomach turner.

    I was a little stunned to find the Sonnenberg/Reinstein connection with Latuda. Their numbers were bad enough already without throwing in the Chicago Street scene factor…

    December 1, 2011 | 1:42 AM


    I wrote my comment before I saw yours.

    Upon viewing that document, I uttered three words: the first and last were the name of the Messiah of Israel. The second started with “F.”

    December 1, 2011 | 7:52 AM

    Has the lay press gotten a hold of this? Seriously Mickey, I’d get friendly with someone from the Atlanta Constitution and move this stuff from the blogosphere to the papers!

    December 1, 2011 | 3:32 PM

    Chicago Tribune wrote about Reinstein a while back


    and then there is this


    “Conclusion: An unexpected, yet welcome, clinical effect of quetiapine is its apparent propensity to induce weight loss and improve glycaemic control in patients who gain weight and develop diabetes on clozapine therapy. The results of this retrospective study support the safety and tolerability of clozapine-quetiapine combination therapy.

    Dr.Michael Reinstein received $500,000 for the next decade, from AstraZeneca the makers of Seroquel (quetiapine) to promote their product.”

    Keep on blogging away, ppl will eventually hear us!

    December 1, 2011 | 3:56 PM

    Here’s another


    Tuesday, October 12, 2010
    AstraZeneca & Novartis Paid Chicago Doctor of Death to Illegally promote Seroquel & Trileptal

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