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.

Internal emails reveal doubts about the Seroquel studies
Internal emails reveal doubts about the Seroquel studies
courtesy of Mary Weiss

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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