May 4, 2013

At the University of Minnesota, the answer is apparently $1,446. If harmless clerical errors were to blame for oddities like this, that fact should be easy to clarify simply by looking at the relevant documents.  But if there are systematic issues with the administration of clinical trials that makes it possible to bill for a visit with a dead subject, those issues would be important for other universities and private trial sites as well. 
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Categorized in: Blogs, Featured Blogs, Research, Schizophrenia/Psychotic Disorders, Schizophrenia/Psychotic Disorders, Suicide | Tagged as: Antipsychotics, billing, Dan Markingson, Quintiles, Schizophrenia, University of Minnesota

April 15, 2013

It is not often that you will find an issue on which the editors of The Lancet and Guinea Pig Zero agree, but the need to investigate the University of Minnesota is one of them. At this point, it still not clear who will prevail: those who want to honor the Department of Psychiatry, or those who want to have it investigated.
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Categorized in: Blogs, Featured Blogs

March 16, 2013

Psychiatrists at the University of Minnesota forced a young man into a profitable study of antipsychotic drugs over the objections of his mother, who desperately warned that his condition was deteriorating and that he was in danger of killing himself. On May 8, 2004, Mary Weiss’ only son, Dan Markingson, committed suicide. A petition to the governor of Minnesota now asks for an investigation.
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Categorized in: Antipsychotics, Blogs, Coercion, Featured Blogs, Research, Schizophrenia/Psychotic Disorders, Suicide, Uncategorized | Tagged as: Antipsychotics, AstraZeneca, CAFE study University of Minnesota, Dan Markingson, Human Rights, psychiatric medication, Seroquel, Stephen Olson

January 18, 2013

In the business of clinical trials, the most valuable commodities are the research subjects. Filling clinical trials is hard, and filling them quickly is even harder. That’s why in 2000 a clinical investigator told the HHS Office of the Inspector General that research sponsors were looking for three things from research sites: “No. 1—rapid enrollment. No. 2 — rapid enrollment. No. 3 — rapid enrollment.”
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Categorized in: Antipsychotics, Blogs, Featured Blogs, Industry, Research, Schizophrenia and Psychosis, Schizophrenia/Psychotic Disorders, Schizophrenia/Psychotic Disorders | Tagged as: Antipsychotics, CAFE study, clinical trials, Dan Markingson, Schizophrenia, University of Minnesota

January 10, 2013

In early 2009, antipsychotic fraud was making headlines.  Eli Lilly had announced in January that it would plead guilty to charges that it had illegally marketed Zyprexa. The company agreed to pay a record-breaking $1.42 billion in penalties. Meanwhile, AstraZeneca …
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Categorized in: Antipsychotics, Blogs, Featured Blogs, Industry, Research, Schizophrenia/Psychotic Disorders | Tagged as: Antipsychotics, AstraZeneca, Charles Schulz, Mike Howard, Schizophrenia, Seroquel, University of Minnesota

December 7, 2012

The recent research scandals out of the University of Minnesota’s Department of Psychiatry may be alarming, but they are not new. Back in the 1990s, when the university was working its way towards a crippling probation by the National Institutes of Health (for yet another episode of misconduct (this time in the Department of Surgery), the Department of Psychiatry hosted two spectacular cases of research wrongdoing, both of which resulted in faculty members being disqualified from conducting research by the FDA.
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Categorized in: Addiction, Antidepressants, Antipsychotics, Blogs, Featured Blogs, Industry, Schizophrenia and Psychosis, Schizophrenia/Psychotic Disorders, Schizophrenia/Psychotic Disorders, Substance Abuse/Addiction, Suicide, Uncategorized | Tagged as: Antipsychotics, Barry Garfinkel, CAFE study, Charles Schulz, clinical trials, corruption, fraud, James Halikas, Psychosis, research misconduct, Schizophrenia, Stephen Olson, University of Minnesota

November 21, 2012

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz. But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.
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Categorized in: Antipsychotics, Blogs, Featured Blogs, Research, Schizophrenia and Psychosis, Schizophrenia/Psychotic Disorders, Schizophrenia/Psychotic Disorders, Suicide | Tagged as: CAFE study, CATIE study, Dan Markingson, Jean Kenney, mental health, psychiatric medication, Schizophrenia, Stephen Olson, University of Minnesota

November 19, 2012

Ever since critics began asking questions about the death of Dan Markinson in a clinical trial at the University of Minnesota, the General Counsel for the university, Mark Rotenberg, has responded with a uniform message: the case has already been investigated many times, and no wrongdoing has ever been found. That’s how Rotenberg responded to my article about the case in Mother Jones, and that’s how he responded last week to the news that the Board of Social Work had issued a “corrective action” to the study coordinator for the clinical trial in which Markingson died.
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Categorized in: Blogs, Featured Blogs, Industry, Schizophrenia and Psychosis, Schizophrenia/Psychotic Disorders, Suicide | Tagged as: CAFE study, clinical trials, coming off psychiatric drugs, Markingson, mental health, Schizophrenia, Seroquel, University of Minnesota

November 15, 2012

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz. But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.
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Categorized in: Antipsychotics, Blogs, Featured Blogs, Schizophrenia and Psychosis, Schizophrenia/Psychotic Disorders, Schizophrenia/Psychotic Disorders, Suicide | Tagged as: Antipsychotics, CAFE study, clinical trials, Dan Markingson, Jean Kenney, Schizophrenia, Seroquel, University of Minnesota

November 14, 2012

In the “agreement for corrective action” against CAFE study coordinator Jean Kenney last week, the Board of Social Work cited Kenney’s failure to respond to “alarming voicemail messages” from family members of Dan Markingson. Presumably, the Board is referring to a message left by his mother, Mary Weiss, which warned, “Do we have to wait until he kills himself or someone else before anyone else does anything?” The failure of Kenney and Stephen Olson to take the warnings of Mary Weiss seriously has been one of the most disturbing aspects of this case. In a deposition for the lawsuit filed by Weiss, Kenney was questioned about her response. Here is an excerpt. (The initial questions come from Gale Pearson, an attorney for Mary Weiss.)

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Categorized in: Antipsychotics, Blogs, Featured Blogs, Industry, Research, Schizophrenia and Psychosis, Schizophrenia/Psychotic Disorders, Suicide | Tagged as: Antipsychotics, AstraZeneca, CAFE study, clinical trials, Dan Markingson, Jean Kenney, Psychosis, Schizophrenia, University of Minnesota

November 12, 2012

Out here in Minnesota, where the snow is gently falling, many of us are hunched over our computers, puzzling over a document just posted by the state Board of Social Work. It concerns the death of Dan Markingson (or as the document calls him, “Client #1”). Markingson, of course, was a young man under a commitment order who was coerced into a profitable Seroquel marketing study at the University of Minnesota over the objections of his mother, and whose condition spiraled downward until he committed suicide.
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Categorized in: Antipsychotics, Blogs, Featured Blogs, Schizophrenia/Psychotic Disorders, Suicide | Tagged as: Antipsychotics, AstraZeneca, atypical antipsychotics, CAFE study, clinical trials, Dan Markingson, Jeanne Kenney, Mary Weiss, Schizophrenia, Seroquel, University of Minnesota

August 7, 2012

Beginning in the 1990s, a number of pharmaceutical and biotechnology companies began to set up bioethics advisory boards, ostensibly to obtain guidance about controversial ethical issues. Over the years, the ties between industry and bioethics have gradually grown closer, with companies setting up endowed chairs and hiring bioethics consultants. Yet very little is known about how bioethics advisory boards work. What exactly is their purpose? Do they prevent ethical wrongdoing, or do they provide ethical cover?
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Categorized in: Blogs, Featured Blogs | Tagged as: bioethics, conflict of interest, pharmaceutical industry, public relations

August 6, 2012

Everyone knows how muckraking is supposed to work.  An investigative reporter uncovers hidden wrongdoing; the public is outraged; and the authorities move quickly on behalf of justice and righteousness.  There can be failure at any of these points, of course.  …
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Categorized in: Blogs, Featured Blogs, Research | Tagged as: clinical trials, investigative journalism, muckraking, scandals

July 20, 2012

Carl Elliott writes on the discrepancy between New Zealand’s response to a research scandal – which lead to a national debate and dramatic reforms – and the silence following clinical trial scandals in the U.S.
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Categorized in: Antipsychotics, Blogs, Featured Blogs, Industry, Psychiatric Drugs, Schizophrenia/Psychotic Disorders, Suicide, Uncategorized | Tagged as: bioethics, Cartwright Inquiry, clinical trials, Dan Markingson, ethics, research, scandals, University of Minnesota

July 18, 2012

Imagine for a moment that you are seriously injured in a medical research study and require expensive medical care.   Imagine further that the study in which you are injured is scientifically worthless, deceptive and exploitative – sort of like the …
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Categorized in: Blogs, Featured Blogs, Uncategorized

May 24, 2012

In June, I will be returning to Washington for the annual Pharmed Out conference, a project located at Georgetown University Medical Center.  It is one of my favorite events of the year, in part because of the wide array of …
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Categorized in: Blogs

April 30, 2012

These are not happy times for the embattled drug maker AstraZeneca.  The patent for Seroquel has expired; the company’s profits have plummeted; and its CEO, David Brennan, has just been escorted to the exit door.  It seems like a good …
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Categorized in: Bipolar, Blogs, Schizophrenia/Psychotic Disorders | Tagged as: AstraZeneca, atypical antipsychotic, Seroquel

April 12, 2012

Everyone knows that some attorneys have a reputation for playing hardball.  In fact, many of us even seek out attorneys who play hardball. But sometimes “playing hardball” becomes something entirely more disturbing, like a deranged major league pitcher hurling a …
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Categorized in: Antipsychotics, Blogs, Psychiatric Drugs, Schizophrenia/Psychotic Disorders

April 8, 2012

If the past decade had an emblematic moment for clinical research, it was probably November 12, 2005, the day when Bloomberg Markets published its cover story, “Big Pharma’s Shameful Secret.” In that issue, Bloomberg reporters laid out the story of …
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Categorized in: Blogs, Research

April 1, 2012

If I were in charge of distributing NIH grant money, I’d be sending a lot of it to researchers like Erick Turner, a psychiatrist at Oregon Health and Sciences University and a former FDA reviewer.  You might remember Turner’s name from …
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Categorized in: Blogs, Uncategorized