Charles Schulz under scrutiny for Seroquel study suicide

Is U of M department of psychiatry chair in the pocket of AstraZeneca?

Years later, as a medical student at the University of California-Los Angeles, Schulz still didn't know what field he would specialize in. He thought of practicing general medicine, but a visit to the Camirillo State Mental Hospital brought his life into focus.

At the time, conditions like schizophrenia and autism were generally considered to be untreatable. Camirillo was a progressive facility, and one of the few hospitals to offer hope.

"I...was stunned by how seriously ill the schizophrenic patients were and worried about who was going to care for them," Schulz explains in an email.

It was then that he decided to pursue psychiatry.

By the time he graduated from college and finished his residency, Schulz had begun to narrow his focus to schizophrenia in teenagers. Thorazine, Haldol, and Stelazine were the only drugs available at the time, and Schulz was troubled by their long-term side effects, such as impaired motor movement.

So when a second generation of antipsychotics known as Atypicals hit the market, Schulz plunged in with both feet. Throughout the '80s and '90s, Schulz earned headlines in high-profile scientific journals studying the new drugs.

In 1999, Schulz received an offer for a prestigious position at one of the best medical schools in the country. He accepted the offer to become the head of psychiatry at the University of Minnesota.

   

AROUND THIS TIME, AstraZeneca introduced a new pill to the world of antipsychotics: Seroquel.

According to AstraZeneca's marketing campaign, Seroquel was the next big thing in treating schizophrenia. It would make older drugs like Haldol and Thorazine look primitive.

But Seroquel wasn't exactly flying off the shelves. When Schulz came to the U of M, the drug was in its third year on the market and its sales paled in comparison to that of competitors.

In an effort to change this, AstraZeneca commissioned studies to prove Seroquel's superiority to the existing drugs on the market. Internal emails detail a plan to place the results of these studies in a scientific journal.

The man who would help make it happen was the University of Minnesota's new head of psychiatry: Charles Schulz. He was scheduled to present an analysis of the research at the upcoming American Psychiatric Association conference.

But in March 2000, all was not going according to plan.

"The data don't look good," AstraZeneca publications manager John Tumas wrote on March 23, 2000. "What seems to be the case is that we were highlighting the only good stuff, and that our own analysis supports the 'view out there' that we are less effective than Haloperidol and our competitors."

Yet Schulz painted a much rosier picture at the APA conference just two months later. Despite AstraZeneca's findings that Seroquel did not perform as well as older antipsychotics, Schulz declared it "significantly superior" to haloperidol, a competing medication.

"I hope that our findings help physicians better understand the dramatic benefits of new medications like Seroquel because, if they do, we may be able to help ensure patients receive these medications first," Schulz said in an AstraZeneca press release sent out that day.

That wasn't the last time Schulz did the heavy lifting to promote Seroquel. A review published in Science Direct claimed a generic version of Seroquel called quetiapine was superior to haloperidol in some measures and should be used as a "front-line treatment for schizophrenia."

While Schulz says he designed the study, AstraZeneca clearly had a strong hand. The third person listed as an author is Martin Brecher, the executive director of medical science for the drug company. A footnote at the end of the study credits the pharmaceutical company's role in preparing the article.

That's not the only questionable decision. A graph in one of the seven studies Schulz cites is actually incorrect, says Dr. Glen Spielmans, a psychiatry professor at Metro State University who analyzed Schulz's work for City Pages.

The article references an earlier trial conducted by five Japanese psychiatrists comparing the two drugs. Schulz's article shows a graph of quetiapine slightly outperforming haloperidol. However, the original study shows the two performed exactly the same, Spielmans says.

"How do you come up with this?" asks Spielmans. "Sometimes honest mistakes happen. I'm not at all implying that this was intentional cooking of the books or anything, but something's not right."

   

OVER THE YEARS, Schulz continued to conduct research funded by AstraZeneca. In 2001, he agreed to be the co-investigator for Study 41, designed to prove that Seroquel SR—a new, longer-lasting version of the drug—was more effective than a placebo.

AstraZeneca set up 45 study sites in the United States and four in Canada. For six weeks at a time, psychiatrists interviewed patients every few days.

But after a year of running the tests, it was clear that the study was a failure—Seroquel SR was barely more effective than a sugar pill. Instead of publishing the results, however, AstraZeneca decided to keep a lid on the data, according to internal emails.

"This information should be kept in the strictest confidence," warned Scott French, AstraZeneca's study delivery manager.

A month later, Seroquel's brand manager, Simon Hagger, also emphasized the importance of suppressing the negative data.

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18 comments
mindboggeling
mindboggeling

My heart goes out to Mrs. Weiss. I have worked in medical facilities most of my adult life and I do know there are Doctors with no integrity and Big Pharma feeds off people like that. Not all Drs. who do trials are immoral, but I really detest big Pharma. To me they were nothing more than legal drug pushers. It doesn't matter what pill is best for the patient, but what pharma the medical facility is in bed with. Schulz should be fired by the U! Otherwise the taint will stick.

guest
guest

This article is crap. There may have been errors in judgement that occurred. This article, however, is clearly misleading and sensationalistic. Ironically it is a sensationalistic and misleading article that purports that another individual is being sensationalistic and misleading to advance his own career.

It would be great if we didn't need pharmaceutical company funding for drug studies. It would be ideal if no company had to do it's own product research. But who is going to fund it then.. you?

Would this young man have killed himself without seroquel? Would have killed himself sooner? How do you know?

Vpatrick2011
Vpatrick2011

While I understand the Markingsons' feelings of grief, having lost a sibling to suicide, it is unrealistic to expect that any doctor can prevent suicide from happening. If you want to kill yourself, you can find a way, even in a locked psych unit.

Dan Markingson was in a clinical trial, and was monitored much more closely (I'm guessing weekly) than in usual clinical care, where he might be seen once every six months. Even though he was on active medication, there is never a guarantee that that particular medication is going to work in ANY area of medicine--not in oncology, not in surgery, and not in psychiatry.

Dan was an adult. He made his own choice to be in this clinical trial, and any clinical trial necessitates informed consent--consent that is obtained WHILE the patient is lucid.

Clinical trials at any university are non-profit, monitored by internal and external financial entities, and safety is monitored by an institutional review board. Money received by an investigator from sponsored clinical trials pays for the research space, the lights, and ink pens. I read that no wrong-doing was found in the 2007 hearings.

Again, while I sympathize with the Markingsons for the loss of a beloved family member, it is my most sincere wish that research--even industry-sponsored research--be encouraged, instead of thwarted. I wish that my brother had lived to see the benefit of the therapies that were only being investigated when he thought there were no other options.

Matt
Matt

"But after a year of running the tests, it was clear that the study was a failure—Seroquel SR was barely more effective than a sugar pill."

-It is clear to me that the author is unfamiliar with the purpose of this and any research trial comparing the effectiveness of two treatments, which is improve clinical outcomes and patient care, no matter what the final results are. To use the phrase "it was clear that the study was a failure" is clearly an attempt at sensational reporting from someone who has lost the ability to objectively report on this issue.

MNRes
MNRes

The whole story was wrapped up in one phrase when Schultz said, " Study 132 was designed to . . . receive FDA approval. All drug approvals are designed by the manufacturers to receive FDA approval, not to prove or disprove the drug's effectiveness or safety. Medicine for money is a terrible idea. Following the money is the fastest way to solve a crime and corporate medicine is criminal.

Greg Reaper
Greg Reaper

I see Astra still has some "corporate culture" issues. Astra is infamous for one of the largest sexual harrassment cases before the EEOC. So it does not surprise me that this spills over into other areas of professional ethics as well.Business Week has had a number of articles about the "Astra Culture"Here's an old one:http://www.businessweek.com/19... for Part 1http://www.businessweek.com/19... for Part 2

CZ
CZ

I think the issue here is not so much that he was conducting research funded by astrazeneca or that seroquel didn't work or even that he received money; the real issue is that Schultz was an irresponsible doctor. First he enrolled a patient into a trial who, by definition, was not "competent" to care for himself (when someone is on commitment or even a stay of commitment it means that they are not able to adequately ensure their own safety), so how was he "competent" to give consent?Then, in spite of obviously worsening disease, he and the other physicians taking care of him failed to either change his treatment, reassess him, reassess his drug regimen, or revoke the stay of commitment and ensure that he was appropriately looked after. Furthermore, they ignored his mother's concerns about his care and failed to address her issues in a respectful way. Worst of all, it does seem that their judgement was clouded by interest in their research and in protecting their study. As a physician, I hate to see cases like this. A lot of effective new drugs do come out as a result of research funded by big pharma (yes, we all hate to admit it) and Seroquel is not a bad drug (though probably not as effective for patients as affected by their disease as the one in the article was). It really is too bad when sloppy doctoring and irresponsible research practices make it all look so sinister.

CJ
CJ

I think Mary is asking a very important question. Why was her son allowed to enroll in a clinical study when it was obvious that he was not mentally competent to make any decisions? As evidences by the 72-hour hold. Because if Dan had committed a crime or some other irresponsible act a lawyer would have been easily able to argue that he was not competent to make decisions and didn't understand the consequences of his actions.

As the chair of this department it is Dr. Schultz's responsibility to make sure that all studies that are conducted under his watch are ethical and more importantly do no harm to the subjects involved. That doesn't appear to have happened and because of the obscene amount of money he has received it would seem that his own ability to make decisions is impaired.

Guest
Guest

This is character assassination, and guilt by association. There are probably serious issues with conflicts of interest with Dr. Schultz and others which are important, and deserving of further investigation, and (probably) sanction. No doubt. But there is not a shred of evidence presented that what happened to this poor young man was a result of the study or Seroquel. In fact, what is mentioned is that the investigations into his suicide confirm that it was unrelated to the study. This was a mentally ill young man - without locking someone up and restraining them you cannot create a situation in which it's impossible for someone to kill themselves. Journalism like this however just inflates the real, important issues of research fraud, over-marketing of expensive, barely-effective (at best) meds, etc. etc. into THEY'RE KILLING CHILDREN!! This sort of reporting doesn't inform the public, or further the debate. Treat your readers, CP, as people who could be concerned about research fraud, academic misdeeds, and Pharma malfeasance without bad actors needing to be barely a step above murderers. Come on.

DPinMinneapolis
DPinMinneapolis

I usually like City Pages for sheer entertainment value, but this is a pretty poor job. I understand the motivation and that these writers are trying to establish themselves by fanning flames and feigning outrage about these types of stories - but it would be a lot more credible if they'd show both sides. You hunted down a bunch of people who had a lot of negatives to say about this doctor, but where are his counterparts that can vouch for him? And man, the quote by this Mary Weiss? You're going to make his life miserable? You make this woman look obsessed and filled with ideas of revenge even though you wrote that it keeps being reviewed but no guilt is ever found. And seriously...I think we'd all take this nice paycheck from the big companies if they offered!

Maryweiss
Maryweiss

Dear DP,

I am this Mary Weiss who, yes, would like to make Dr. Schulz' life miserable. DP, I would gladly share with you the three letters I wrote to Dr. Schulz attempting to get Dan out of the CAFE Study. I addressed the rage I saw in Dan, which, after his death, I learned that actually has a name and is caused by the antipsychotics - akathisia. Please Google Dr. Joseph Glenmullen of Harvard who equates akathisia with 'an inner rage', and states it can make suicide look like a relief. Dr. Schulz, in his letter to me of April 28, 2004, asked me how this rage should be handled. The head of psychiatry knew how it should be handled. He had published a paper earlier on akathisia.

DP, I am not 'obsessed' with revenge, but rather want protection for others; I want this to happen to no one else. Yet it will continue if the pharmaceutical companies and the doctors who do their bidding are not somehow stopped. You can check the University of Minnesota's website and see that they have used Seroquel, an antipsychotic, in a clinical study to help people with public speaking. Imagine! Taking an antipsychotic if you get a bit nervous speaking in front of a crowd. And it is not solely antipsychotics; currently there are two studies at the university using Chantix, a extremely dangerous quit-smoking drug, to (1) help those with mental illness quit smoking, and (2) to help mentally ill who have quite smoking not relapse! Just think! You quit smoking, then you take a very dangerous drug so you don't start again. (Google Chantix and FDA and see what the FDA itself says about the drug.)

You say no one found fault; Google Dan Markingson and see if this bears out. Check out Vera Sharav's AHRP site, only one of very many. Yet, DP, Mr. Mannix's article was not mainly about Dan. It was about the effect the pharmaceutical companies are having on our lives. Do your research.

Mary

killer weed
killer weed

so, what wouldn't you do for money? if leading people to their deaths isn't a problem for you I'd struggle to imagine what would be.

jaymboller
jaymboller

Leave the ghost of Snoopy's creator alone, Andy. Jesus.

Jolene
Jolene

Another CP headline article that show, nay proves, that the best at CP is as good as the best of any other 'newspaper' in MSP. Kudos to CP and Andy for the article.

Unfortunately, the gap between the highs and lows at CP is near unsurmountable. Don't let the achievement gap discourage you though. Everyone has to start somewhere even if it is at CP.

killer weed
killer weed

as an investigator in New York in the early 2000s every one of my clients locked up in Riker's Island was placed on Seroquel upon intake. I was made to believe that it was common practice that had been going on for years. to a person it took vibrant, healthy men and made them dopey, delusional shells that drooled on themselves and couldn't hold a conversation for more than a few moments. now I can't help but wonder if it was all something similar to the Holmesburg prison experiments, only instead of Dow Chemical it's AstraZeneca.

Jp2020
Jp2020

Ty - How do I get a hold of you to speak to you about your experience at Rikers.

killer weed
killer weed

add an "ler" and put a dot between my names and send it to gmail.

Meegwich
Meegwich

If Schulz is quoted correctly (which I'm sure he was) then he states that Seroquel study #132 was designed to gain FDA approval. No chance of a negative outcome for the study!! This guy is unbelievable. Why doesn't the "U" run him out of town. How much embarrassment is enough.

 
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