Seroquel® Study Casts Doubt on Effectiveness
Possible Inflated Results from Seroquel® Effectiveness Study
March 31, 2009 — At a national medical conference in 2000, Seroquel® was touted
as “significantly superior
” to the gold standard of schizophrenia treatment, Haldol®.
Dr. Charles Schulz, chief of psychiatry at the University of Minnesota, touted the “dramatic
benefits
” of Seroquel® in a press release by AstraZeneca. Newly released internal
documents show that AstraZeneca knew the research couldn’t support the claim a full two months
before Schulz went public.
Seroquel® had been on the market for three years when Dr. Schulz had prepared his study for the American Psychological Association (APA) conference. The study, which included an analysis of 1,800 patients in four separate trials, reported that patients on Seroquel® showed marked improvements. When AstraZeneca looked at the same data, it came to a different conclusion.
On March 23, 2000, AstraZeneca official John
Tumas warned, “The data don’t look good. In fact, I don’t know how we can
get a paper out of this.
” An internal
analysis concluded: “It is clear that a claim of superiority for Seroquel® over
haloperidol (Haldol®) could not be generated using these data.
”
Today, Seroquel® is used worldwide to treat a variety of psychiatric conditions. With
$4.5 billion in annual sales, AstraZeneca has placed a request to the FDA to approve Seroquel® for
major depression, which could greatly increase the drug’s sales. But there are experts who doubt
the value of the drug. According to Dr. Daniel Carlat, a psychiatrist at Tufts University in Boston, “It
[Seroquel®] does work, but it’s not necessarily better than the pills that are already
out there. And it does have some nasty side effects.
”
Did Corporate Ties Affect the ‘Science’ in the Studies?
Over a 10–year period, Schulz received at least $88,000 from AstraZeneca for consulting and drug
research, according to records at the Minnesota Board of Pharmacy. He also authored five studies on Seroquel®.
Schulz denied that his ties to the company affected his research. “I don’t think I would
have been comfortable standing in front of a poster that exaggerated the results,
” he said.
In 2003, Schulz published a paper in a scientific journal saying that multiple studies showed Seroquel® as comparable in effectiveness to Haldol®, but not better.
Seroquel® Side Effects: Increased Risk of Diabetes
While there is a question of the effectiveness of Seroquel® in comparison to other drugs on the market, there is little question to some of the risks Seroquel® places on patient health. According to company documents, AstraZeneca was aware of an increased risk of diabetes in otherwise healthy patients taking Seroquel®. For further information, please see:
