SEROQUEL is an antipsychotic medication purported to be a mood-stabilizing drug which is
manufactured by AstraZeneca. It was approved by the FDA to treat both the “highs and lows”
of bipolar disorder. Seroquel’s acknowledged side effects include potential heart failure,
sudden death, or pneumonia in older adults with dementia-related conditions.
Drugs.com provides some additional information about Seroquel and warns; “You may have thoughts
about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old.” http://www.
We bring this to you attention because AstraZeneca, one of the largest international pharmaceutical companies, is now enmeshed in
significant controversy. In fact, a front page report by Shankar Vedantam in today’s Washington Post (full text below) about AstraZeneca's
manipulation of research findings involving its antipsychotic, Seroquel (quetiapine) gets to the heart of the corrupting influence that
pharmaceutical companies have on American medicine--both on its research and clinical practice guidelines--psychiatry, in particular has
been compromised to its very own core.
See http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703 (Note: Washington Post subscription required for access).
The evidence of corruption in psychiatry is so overwhelming that a recent editorial in the American Journal of Psychiatry, the flagship journal
of the American Psychiatric Association acknowledges: "Even if most doctors are ethical, corporate grants, gifts and underwriting have
compromised psychiatry." Robert Freedman, the editor in chief, acknowledged: "The subsidy that each of us has been receiving is part of
what has fueled the excesses that are currently under investigation."
The Post reports: "The saga of ‘Study 15’ (a long-term trial by AstraZeneca for their antipsychotic drug Seroquel) has become a case study
in how drug companies can control the publicly available research about their products, along with other practices that recently have
prompted hand-wringing at universities and scientific journals, remonstrations by medical groups about conflicts of interest, and threats of
exposure by trial lawyers and congressional watchdogs."
Internal documents, the Post reports, show that company officials were worried because 45% of the Seroquel patients had experienced
what AstraZeneca physician Lisa Arvanitis termed "clinically significant" weight gain. The documents revealed that rather than "coming
clean" about the risk, the company put a "positive spin" on the study and praised Dr. Lisa Arvanitis for having: "done a great 'smoke and
Two years after those exchanges, in 1999, the documents show that "the company presented different data at an American Psychiatric
Association conference and at a European meeting. The conclusion they released: Seroquel helped psychotic patients lose weight."
Selective data presentation—which buries or even eliminates the negative and presents the positive only, is by definition, deception. Let
alone outright lying.
Study 15 was pivotal to AstraZeneca gaining FDA’s approval to market the drug. The burial of negative data suggests that the approval
process was tainted and the drug's license should be recalled.
This AstraZeneca / Seroquel story has “legs” (...has “staying power” and will be picked up and expanded upon through numerous media
sources and outlets), so do stay tuned.
Meanwhile, you can write to the FDA through their online comments and suggestions service – AstraZeneca’s Seroquel approvals were
based on false information provided to them by the company. They should seriously consider rescinding AstraZeneca’s license and
scrutinizing any research provided by them for other drugs they have brought to market.
FDA Contact: http://www.fda.gov/comments.html
All the best,
Rudi C. Loehwing
World Institute of Natural Health Sciences
Full Washington Post article text
A Silenced Drug Study Creates An Uproar
By Shankar Vedantam
March 18, 2009
The study would come to be called "cursed," but it started out just as Study 15.
It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better
than older drugs, but Study 15's results suggested otherwise.
As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data
drugmakers don't like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found -- and raised
serious concerns about an entire new class of expensive drugs.
Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The
drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based
AstraZeneca International -- including nearly $12 billion in the past three years.
The results of Study 15 were never published or shared with doctors, even as less rigorous studies that came up with positive results for
Seroquel were published and used in marketing campaigns aimed at physicians and in television ads aimed at consumers. The results of
Study 15 were provided only to the Food and Drug Administration -- and the agency has strenuously maintained that it does not have the
authority to place such studies in the public domain.
AstraZeneca spokesman Tony Jewell defended the Seroquel research and said the company had disclosed the drug's risks. Since 1997,
the drug's labeling has noted that weight gain and diabetes were seen in study patients, although the company says the data are not
definitive. The label states that the metabolic disorders may be related to patients' underlying diseases.
The FDA, Jewell added, had access to Study 15 when it declared Seroquel safe and effective. The trial, which compared patients taking
Seroquel and an older drug called Haldol, "did not identify any safety concerns," AstraZeneca said in an e-mail. Jewell added, "A large
proportion of patients dropped out in both groups, which the company felt made the results difficult to interpret."
The saga of Study 15 has become a case study in how drug companies can control the publicly available research about their products,
along with other practices that recently have prompted hand-wringing at universities and scientific journals, remonstrations by medical
groups about conflicts of interest, and threats of exposure by trial lawyers and congressional watchdogs.
Even if most doctors are ethical, corporate grants, gifts and underwriting have compromised psychiatry, said an editorial this month in the
American Journal of Psychiatry, the flagship journal of the American Psychiatric Association.
"The public and private resources available for the care of our patients depend upon the public perception of the integrity of our profession
as a whole," wrote Robert Freedman, the editor in chief, and others. "The subsidy that each of us has been receiving is part of what has
fueled the excesses that are currently under investigation."
Details of Study 15 have emerged through lawsuits now playing out in courtrooms nationwide alleging that Seroquel caused weight gain,
hyperglycemia and diabetes in thousands of patients. The Houston-based law firm Blizzard, McCarthy & Nabers, one of several that have
filed about 9,210 lawsuits over Seroquel, publicized the documents, which show that the patients taking Seroquel in Study 15 gained an
average of 11 pounds in a year -- alarming company scientists and marketing executives. A Washington Post analysis found that about
four out of five patients quit taking the drug in less than a year, raising pointed doubts about its effectiveness.
An FDA report in 1997, moreover, said Study 15 did offer useful safety data. Mentioning few details, the FDA said the study showed that
patients taking higher doses of the drug gained more weight.
In approving Seroquel, the agency said 23 percent of patients taking the drug in all studies available up to that point experienced significant
weight increases, compared with 6 percent of control-group patients taking sugar pills. In 2006, FDA warned AstraZeneca against
minimizing metabolic problems in its sales pitches.
In the years since, taxpayer-funded research has found that newer antipsychotic drugs such as Seroquel, which are 10 times as expensive,
offer little advantage over older ones. The older drugs cause involuntary muscle movements known as tardive dyskinesia, and the newer
ones have been linked to metabolic problems.
Far from dismissing Study 15, internal documents show that company officials were worried because 45 percent of the Seroquel patients
had experienced what AstraZeneca physician Lisa Arvanitis termed "clinically significant" weight gain.
In an e-mail dated Aug. 13, 1997, Arvanitis reported that across all patient groups and treatment regimens, regardless of how numbers
were crunched, patients taking Seroquel gained weight: "I'm not sure there is yet any type of competitive opportunity no matter how weak."
In a separate note, company strategist Richard Lawrence praised AstraZeneca's efforts to put a "positive spin" on "this cursed study" and
said of Arvanitis: "Lisa has done a great 'smoke and mirrors' job!"
Two years after those exchanges, in 1999, the documents show that the company presented different data at an American Psychiatric
Association conference and at a European meeting. The conclusion: Seroquel helped psychotic patients lose weight.
The claim was based on a company-sponsored study by a Chicago psychiatrist, who reviewed the records of 65 patients who switched
their medication to Seroquel. It found that patients lost an average of nine pounds over 10 months.
Within the company, meanwhile, officials explicitly discussed misleading physicians. The chief of a team charged with getting articles
published, John Tumas, defended "cherry-picking" data.
"That does not mean we should continue to advocate" selective use of data, he wrote on Dec. 6, 1999, referring to a trial, called COSTAR,
that also produced unfavorable results. But he added, "Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR."
Although the company pushed the favorable study to physicians, the documents show that AstraZeneca held the psychiatrist in light regard
and had concerns that he had modified study protocols and failed to get informed consent from patients. Company officials wrote that they
did not trust the doctor with anything more complicated than chart reviews -- the basis of the 1999 study showing Seroquel helped patients
For practicing psychiatrists, Study 15 could have said a lot not just about safety but also effectiveness. Like all antipsychotics, Seroquel
does not cure the diseases it has been approved to treat -- schizophrenia and bipolar disorder -- but controls symptoms such as agitation,
hallucinations and delusions. When government scientists later decided to test the effectiveness of the class of drugs to which Seroquel
belongs, they focused on a simple measure -- how long patients stayed on the drugs. Discontinuation rates, they decided, were the best
measure of effectiveness.
Study 15 had three groups of about 90 patients each taking different Seroquel doses, according to an FDA document. Approximately 31
patients were on Haldol. The study showed that Seroquel failed to outperform Haldol in preventing psychotic relapses.
In disputing Study 15's weight-gain data, company officials said they were not reliable because only about 50 patients completed the year-
long trial. But even without precise numbers, this suggests a high discontinuation rate among patients taking Seroquel. Even if every single
patient taking Haldol dropped out, it appears that at a minimum about 220 patients -- or about 82 percent of patients on Seroquel --
Eight years after Study 15 was buried, an expensive taxpayer-funded study pitted Seroquel and other new drugs against another older
antipsychotic drug. The study found that most patients getting the new and supposedly safer drugs stopped taking them because of
intolerable side effects. The study also found that the new drugs had few advantages. As with older drugs, the new medications had very
high discontinuation rates. The results caused consternation among doctors, who had been kept in the dark about trials such as Study 15.
The federal study also reported the number of Seroquel patients who discontinued the drug within 18 months: 82 percent.
Jeffrey Lieberman, a Columbia University psychiatrist who led the federal study, said doctors missed clues in evaluating antipsychotics
such as Seroquel. If a doctor had known about Study 15, he added, "it would raise your eyebrows."
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The "Business" of Drugs:
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