Seroquel back in news

[Anonymous]

This story began in 2003, when Dr. Stephen Olson, a psychiatrist at the University of Minnesota used the threat of involuntary commitment to coerce a psychotic young man named Dan Markingson into the so-called "CAFÉ" study: an AstraZeneca-funded trial of antipsychotic drugs aimed at patients experiencing their first psychotic episode. His mother, Mary Weiss, objected to her son's enrollment and tried desperately for months to get Dan out of the study, warning Olson and his co-investigator, Charles Schulz, that her son's condition was deteriorating and that he was in danger of committing suicide. Her warnings were consistently ignored. On May 8, 2004, five months into the CAFÉ study, Dan died after trying to decapitate himself with a box-cutter.

 

[Anonymous]

The study sponsor, AstraZeneca was in the process of settling a half-billion dollar federal fraud investigation, in which unsealed documents suggested that AstraZeneca was rigging, spinning and burying studies in order to market their antipsychotic drug, Seroquel. Some of those studies appeared to lead to the University of Minnesota. Specifically, they led to Charles Schulz, the Chair of the Department of Psychiatry and a well-compensated AstraZeneca consultant.
Thus far, we have buried trials 15, 31, 56 and are considering COSTAR," an AstraZeneca official wrote in 1999. "The larger issue is how do we face the outside world when they begin to criticize us for suppressing data." As it turned out, the outside world would be brutally critical. In Mother Jones, I wrote about the role Schulz played in the self-described "smoke and mirrors job" that AstraZeneca performed on Study 15, a notorious trial that cast serious doubt on the efficacy of Seroquel and linked it to weight gain and diabetes. A year later, Andy Mannix of City Pages did the same with Schulz and the burial of Study 41, which showed an extended-release version of Seroquel to be no better than placebo.

The AstraZeneca study in which Dan Markingson died appeared to be little better. Psychiatric experts I spoke to called it a "non-study" with "very little value." It appeared to be designed not to produce scientifically valid results, but rather to generate a positive marketing message for AstraZeneca. "It looks like an entirely marketing-driven exercise," one expert said.

 

[Anonymous]

Dude, who cares.

 

[Anonymous]

The study sponsor, AstraZeneca was in the process of settling a half-billion dollar federal fraud investigation, in which unsealed documents suggested that AstraZeneca was rigging, spinning and burying studies in order to market their antipsychotic drug, Seroquel. Some of those studies appeared to lead to the University of Minnesota. Specifically, they led to Charles Schulz, the Chair of the Department of Psychiatry and a well-compensated AstraZeneca consultant.
Thus far, we have buried trials 15, 31, 56 and are considering COSTAR," an AstraZeneca official wrote in 1999. "The larger issue is how do we face the outside world when they begin to criticize us for suppressing data." As it turned out, the outside world would be brutally critical. In Mother Jones, I wrote about the role Schulz played in the self-described "smoke and mirrors job" that AstraZeneca performed on Study 15, a notorious trial that cast serious doubt on the efficacy of Seroquel and linked it to weight gain and diabetes. A year later, Andy Mannix of City Pages did the same with Schulz and the burial of Study 41, which showed an extended-release version of Seroquel to be no better than placebo.

The AstraZeneca study in which Dan Markingson died appeared to be little better. Psychiatric experts I spoke to called it a "non-study" with "very little value." It appeared to be designed not to produce scientifically valid results, but rather to generate a positive marketing message for AstraZeneca. "It looks like an entirely marketing-driven exercise," one expert said.

Seriously, Mother Jones is the least credible source of news full of lies and loopy left wing garbage. Go spew your communist bullshit somewhere else DIP SHIT.

 

[Anonymous]

Seriously, Mother Jones is the least credible source of news full of lies and loopy left wing garbage. Go spew your communist bullshit somewhere else DIP SHIT.

condition for which no approved drug treatment exists.

Carl Elliott, a bioethicist at the University of Minnesota, filed a complaint with the Food and Drug Administration about the university’s research practices in the Seroquel XR study.

THE NEW YORK TIMES
By KATIE THOMAS
APRIL 17, 2015

The article seemed to offer a glimmer of hope: The antipsychotic drug Seroquel XR reduced some of the disorder’s worst symptoms in a significant number of patients. “It was an exciting development,” recalled Mark F. Lenzenweger, a professor at Binghamton University and Weill Cornell Medical College and an expert in borderline personality disorder.

In the realm of clinical trials, however, reality is sometimes far messier than the tidy summaries in medical journals. A closer look at the Seroquel XR study shows just how complicated things can get when a clinical trial involves psychiatric disorders and has its roots in intersecting and sometimes competing interests: a drug company looking to hold onto sales of a best-selling drug, a prominent academic with strong ties to the pharmaceutical industry and a university under fire for failing to protect human study subjects.

The trial was paid for by AstraZeneca, the maker of Seroquel XR, and was conducted by Dr. S. Charles Schulz, the head of psychiatry at the University of Minnesota.

 

[Anonymous]

In December, eight bioethicists from the university — including Carl Elliott, interviewed earlier by TIME here — called for the appointment of an independent board to investigate what went wrong. Meanwhile, ongoing media reports on the case reveal deep problems with the way clinical drug trials are designed, funded and carried out. (More on Time.com: Glass Ceiling Not Always Bad? Only 3 of Top Pharma-Earning Docs Are Women)
In 2008, the St. Paul Pioneer-Press published an investigation of the Markingson death, which was followed up by Elliott himself in a horrifying exposé for Mother Jones magazine in late 2010. On Wednesday, Minneapolis City Pages revisited the story, with yet more revelations about Schulz’ connections with AstraZeneca.

Writes Andy Mannix:

The issue will soon come to a head. The U of M has been investigating a complaint about Schulz’s connections to Big Pharma and is expected to issue the results in a matter of weeks.
“If there’s any question that the investigation was superficial, it ought to be by an independent group that can determine what the facts are,” says Jerome P. Kassirer, former editor of the New England Journal of Medicine, who is familiar with the circumstances surrounding the Markingson case. “It looks worrisome to me.”

 

[Anonymous]

Re: Seroquel back in news STANFORD

Seriously, Mother Jones is the least credible source of news full of lies and loopy left wing garbage. Go spew your communist bullshit somewhere else DIP SHIT.

Law and Biosciences Blog Law and Biosciences Blog
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HOW NOT TO RUN A DRUG STUDY: THE UNIVERSITY OF MINNESOTA PUTS ON A CLINIC
DECEMBER 14, 2012 • BY MATT LAMKIN • COMMENTS [21]
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At Scientific American, Dr. Judy Stone is using a notorious case of research misconduct at the University of Minnesota (where I studied bioethics) to walk through the requirements of ethical research on human subjects and the many ways they can be violated. It can be difficult to keep up with the research scandals at Minnesota’s Psychiatry Department over the years, so for the sake of clarity: this is the one involving Dan Markingson, a young man who killed himself while participating in an industry-funded clinical trial of Seroquel (the “CAFE” study).
The problems with the CAFE study and the way Markingson was treated would fill a book. Carl Elliott, a bioethicist (and my former academic advisor) at the University of Minnesota, has been relentless in seeking to keep Markingson’s story in the public eye and to hold his own university accountable for its conduct. You can read Elliott’s account here, but here are some of the lowlights:
In 2003, 26 year-old Dan Markingson was suffering from psychosis and was threatening to kill people, including his own mother. A judge ordered Markingson involuntarily committed on the recommendation of a UMN doctor named Stephen Olson. Dr. Olson then persuaded the judge to release Markingson, but only on the condition that he followed Olson’s treatment program.

 

[Anonymous]

Seriously, Mother Jones is the least credible source of news full of lies and loopy left wing garbage. Go spew your communist bullshit somewhere else DIP SHIT.

http://www.health.umn.edu/nytimes

Does Dr. Schulz’s involvement with AstraZeneca as a member of the Scientific Advisory Board represent a conflict of interest?

A: This matter is currently under review by the University’s Conflict of Interest office. Dr. Schulz had ended most of his AstraZeneca activities prior to becoming co-PI on this study and he did work with the University to develop a conflict of interest management plan.

 

[Anonymous]

http://blogs.scientificamerican.com...hs-have-occurred-during-your-clinical-trials/

 

[Anonymous]

dude, you keep posting this like we give a shit. With layoffs looming less than a week away we really don't care about a product that is losing share everyday. The study is not used in sales so go away will ya.

 

[Anonymous]

So the news is that AZ is crooked?? My God, we've known that for years! All AZ has to do is bring out their massive checkbook, pay the little government fine, and it's business as usual. This is AZ's SOP! Until they put some of these scumbags at AZ in jail, it will continue, and has continued!

 

[Anonymous]

condition for which no approved drug treatment exists.

Carl Elliott, a bioethicist at the University of Minnesota, filed a complaint with the Food and Drug Administration about the university’s research practices in the Seroquel XR study.

THE NEW YORK TIMES
By KATIE THOMAS
APRIL 17, 2015

The article seemed to offer a glimmer of hope: The antipsychotic drug Seroquel XR reduced some of the disorder’s worst symptoms in a significant number of patients. “It was an exciting development,” recalled Mark F. Lenzenweger, a professor at Binghamton University and Weill Cornell Medical College and an expert in borderline personality disorder.

In the realm of clinical trials, however, reality is sometimes far messier than the tidy summaries in medical journals. A closer look at the Seroquel XR study shows just how complicated things can get when a clinical trial involves psychiatric disorders and has its roots in intersecting and sometimes competing interests: a drug company looking to hold onto sales of a best-selling drug, a prominent academic with strong ties to the pharmaceutical industry and a university under fire for failing to protect human study subjects.

The trial was paid for by AstraZeneca, the maker of Seroquel XR, and was conducted by Dr. S. Charles Schulz, the head of psychiatry at the University of Minnesota.

Seriously Dude, move out of your mother's basement and get a life. Get off of the ultra liberal blogs, get a real job, and learn something real. You are using paraphrases from already far left liberal sources like these opinion pieces are factual. The NY Times and Katie Thomas specifically are notorious anti capitalist, anti business rags for the far left.
Again, we don't give a shit what these people think. We have much bigger problems just trying to hold onto our jobs so we don't have to move in with out parents like you did.

 

[Anonymous]

Hospital, psychiatrists in Texas feel blowback from kickback schemes
Separate investigations lead to a $21 million settlement with a county hospital, and resignations from two state psychiatrists
April 27, 2015 | By Evan Sweeney
Kickback schemes involving state employees and healthcare facilities are alive and well in Texas. Over the last several weeks, separate fraud investigations have cost one hospital more than $21 million and forced the resignation of two state psychiatrists who took payments from AstraZeneca.

 

[Anonymous]

Hospital, psychiatrists in Texas feel blowback from kickback schemes
Separate investigations lead to a $21 million settlement with a county hospital, and resignations from two state psychiatrists
April 27, 2015 | By Evan Sweeney
Kickback schemes involving state employees and healthcare facilities are alive and well in Texas. Over the last several weeks, separate fraud investigations have cost one hospital more than $21 million and forced the resignation of two state psychiatrists who took payments from AstraZeneca.

Hey Evan. We don't give a shit OK. Go sell your gutter sludge somewhere else. Send it to Nancy Pelosi, she believes all of your left wing lies.

 

[Anonymous]

Seriously Dude, move out of your mother's basement and get a life. Get off of the ultra liberal blogs, get a real job, and learn something real. You are using paraphrases from already far left liberal sources like these opinion pieces are factual. The NY Times and Katie Thomas specifically are notorious anti capitalist, anti business rags for the far left.
Again, we don't give a shit what these people think. We have much bigger problems just trying to hold onto our jobs so we don't have to move in with out parents like you did.

http://www.forbes.com/sites/judystone/2015/05/27/why-the-umn-research-scandal-threatens-us-all/

 

[Anonymous]

http://www.forbes.com/sites/judystone/2015/05/27/why-the-umn-research-scandal-threatens-us-all/

News flash, AZ is a shit company that lacks ethics and trades patient health first for profits. Tell us something we don't already know asshole. We work here so this is not news to us. Take it somewhere else, PLEASE.

 

[Anonymous]

One of the most notorious trials in the AstraZeneca deception was called Study 15, which compared Seroquel to Haldol, an older antipsychotic developed in the 1960s. Haldol is often chosen as a comparator drug in antipsychotic studies because it is easy to beat. Yet Study 15 had returned some unexpected results. For one thing, it showed that patients on Seroquel gained a significant amount of weight – a fact that AstraZeneca went on to hide for years by burying and spinning its data. In a 1997 email, for example, AstraZeneca physician Lisa Arvanitis is congratulated on the “great smoke-and-mirrors job” she has done on Study 15. But the weight gain was only one problem. Study 15 also showed that Seroquel was no more effective than Haldol. In fact, on some measures, it performed worse. This fact had to be hidden as well, which the company accomplished by cherry-picking the results that would be published and those that would be buried. In one email, a company employee named John Tumas identified the buried studies and asked, “How are we going to face the outside world when they accuse us of suppressing data?”

By the time AstraZeneca had recruited Charles Schulz to present a “meta-analysis” of Seroquel studies at the 2000 meeting of the American Psychiatric Association, the company had conducted an internal analysis showing that Seroquel was no more effective than Haldol. (“The data don’t look good,” wrote one company analyst. “In fact, I don’t know how we can get a paper out of this.”) Yet this was not what Schulz told the APA. In his presentation and in press releases, Schulz claimed that Seroquel was “significantly superior” to Haldol. He spoke about the “dramatic benefits” of the drug. Yet in March 2009, when Schulz was caught, the University of Minnesota backed him fully. As the St. Paul Pioneer Press reported, “A U spokesman said that the dean of the medical school, Dr. Deborah Powell, is aware of the controversy over Schulz's research and has offered him her full support.”

 

[Anonymous]

Now you have really shown your own stupidity. If a drug blocks dopamine it is an effective treatment. One is not more effective than another in this class unless the dose equivalent is not matched.

Since you absolutely nothing about this TA, please up your dose, sit in the basement and contemplate your next conspiracy of people against you.