By Jesse Marx
By Chris Parker
By Jake Rossen
By Jesse Marx
By Michelle LeBow
By Alleen Brown
By Maggie LaMaack
By CP Staff
"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.