Charles Schulz under scrutiny for Seroquel study suicide

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

"You will all be aware that we are under clear instruction from the highest level within AstraZeneca at this time not to discuss the details surrounding trial 41 with any external customers," Hagger wrote in an email to fellow employees.

A few years later, AstraZeneca decided to re-run the trial in the hope of achieving more favorable results. Now named Study 132, the design was almost exactly like Study 41, save for a few minor variable changes.

This time, however, the results demonstrated longer-lasting Seroquel's positive effects.

Study 132 was published in the Journal of Clinical Psychiatry in June 2007. Schulz is listed as the second author, even though all of the trial sites were held out of the country. Six of the other seven authors of the study are employees of AstraZeneca or on the company's advisory board.

Studies 41 and 132 represent a widespread controversy in clinical trials controlled by pharmaceutical companies. Industry-designed studies almost always produce favorable results or never see the light of day, explains Dr. Eric Campbell, a Harvard Medical School professor who has studied this trend.

"If a study is funded by industry, it's very likely—if not certain—that by the time that study reaches publications, it's going to favor that company's products and services," says Campbell. "At the end of the day, what matters for the drug companies is getting new drugs to market. And convincing physicians to use them, regardless of whether they're better."

Schulz says more than marketing interests were at stake. "Study 132 was designed for the approval of the long-acting quetiapine," he maintains, adding that all the data were properly submitted. "It was designed in order to receive FDA approval."

   

MARKINGSON HAD COLLECTED a strange assortment of items in the few months he lived in the halfway house: a pile of clothes clearly too big to fit, a couple of books, and an old raincoat.

Weiss stepped into the bathroom; she was visiting within two hours of finding out her son had died. No one had bothered to clean up after the coroner came to collect Markingson's body—or if they did, hadn't done a very thorough job. A few inches of black fluid still ringed the bottom of the bathtub.

"I was in shock," says Weiss. "I was just numb."

In Markingson's wallet, Weiss found a $20 check from the CAFE study.

The next few weeks went by like she was watching someone else's life. Weiss couldn't accept that she would never see her son again. She wanted to understand why it had happened.

Weiss began digging up documents and filed a formal request with the University of Minnesota, obtaining a file of her son's medical records. She was stunned by what she found.

It turned out that when Markingson arrived at Fairview, his doctor, Stephen Olson, had approached him about a treatment plan involving the CAFE study. Olson was also the principal investigator for the study, and has received more than $100,000 from AstraZeneca over the years.

More alarming was that Schulz—the man to whom Weiss had appealed for help getting her son out of the program—was a co-investigator on the CAFE study.

"He had the opportunity to take Dan out of the study," Weiss says of Schulz. "He had the opportunity and he didn't."

In summer 2005, Weiss hired two attorneys to represent her in a malpractice lawsuit against Schulz, Olson, the University of Minnesota, and AstraZeneca.

One of the lawyers was Dr. Chris Barden. As both a psychologist and an attorney, he had the expertise to dissect the complicated case.

Barden subpoenaed Schulz for two depositions over the course of the next year. On video camera, Barden pressed the professor on his long history of taking money from pharmaceutical companies and whether it influenced his judgment in the CAFE study.

"From '99 through the time that Dan Markingson was a subject in the CAFE study—that is through 2004—how much money have you received from drug firms?" Barden asked.

"I can only make an estimate," Schulz replied, pegging the number somewhere between $150,000 and $180,000.

In a separate deposition, Barden read an excerpt from a bioethics book arguing for the importance of informing patients about a doctor's financial ties to drug companies.

"Do you agree or disagree with that statement?" asked Barden

"I don't agree with that statement," replied Schulz, arguing that disclosing this information could "confuse" the situation.

"Have you had any training in biomedical ethics?" pressed Barden.

"I've taken the courses at the University of Minnesota that are required for us to participate in clinical research."

"And isn't this part of that training?"

"I'm not aware," said Schulz. "I don't recall that."

A cornerstone of Barden's case was Markingson's monetary value to the U of M as a patient. The university stood to make $15,648 for every subject who completed the trial—a total of $327,000.

But the judge ruled that there wasn't enough evidence to prove culpability. Olson settled for $75,000—an amount Weiss says didn't even cover her legal fees. Schulz, AstraZeneca, and the U of M got off scot-free.

   

ON A WEDNESDAY morning in March 2009, Weiss sat at a long, rectangular conference table in the Minnesota Capitol building. It had been five years since her son's suicide, and her anger had not ebbed one bit.

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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!

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.

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.

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.

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.

 
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