Seroquel: A Silenced Drug Study Creates An Uproar

Seroquel is not FDA approved for children.  It has a black box suicide warning for kids and the elderly.  See FDA drug label here:  http://tmap.wordpress.com/the-drugs/ 

 

Quote from story: “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.

  

Letters to the editor: letters@washpost.com 


Washington Post

 

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 lose weight.

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 — dropped out.

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.”  

 

Link to story: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html?hpid=moreheadlines

 


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10 Responses to “Seroquel: A Silenced Drug Study Creates An Uproar”

  1. Laura McConnell Says:

    If you are interested, there is a public search engine (or sorts) for adverse events.

    for example, this is a search for reports to the FDA regarding seroquel & suicidal ideation:

    http://www.fdable.com/aers/advanced_query/84bd79497dbc

  2. NM Says:

    I took Seroquel for 5 weeks and feel absolutly awful. I began the drug in May 1st and Just got off it a week ago, June 9th Having bad
    stomach cramps and chest pain. Trying to stay alive.
    Chest pains are really bad and I’ve lost 7 pounds in
    9 days. I had no physical problems before taking this drug.
    It was prescribed “off label” for mild depression and insomnia. Do whatever you can to spread the word that
    this drug is toxic to peoples health. Doctor gave me free samples for 4 weeks and I then I filled prescription and took it for one more week before having to go off it immediately. It helped me sleep but left me very drowsy in the morning. Anxiety got worse than before taking it. I don’t know what it has done to me. Still doing labs to find out what it did to my body. I went back to doctor for a follow up visit. She quickly covered her ass by writing me 7 prescriptions for other drugs. She had no idea or did I about the side effects. After the fact, she claimed that she advised me of the side effects which is bullshit. She said that she thought the gains out weighed the side effects. Did I mention this pill costs $5 per pill without a prescription and $1 per pill with a prescription. Corporate greed and the medical industry trying to cover this up. All doctors need to get this drug off the shelves immediately….Please help pass the word. I don’t want anyone else to suffer the bad side affects. Let me know if you need any more info.
    I live in Portland Oregon. Portlandrelocation@yahoo.com

  3. NM Says:

    OOps. Spelled a couple words wrong in last comment.
    I noticed after reading. I wanted to add that I’m not seeing the same doctor anymore who prescribed the Seroquel and
    I didn’t fill the 7 prescriptions that she gave me after I reported the side effects. She’s denying any knowledge of the side effects yet she claims she advised me of them.
    Typical doctor who listens to pharmaceutical reps but does no research. We now have to research everything a doctor gives us before consuming it. Lesson learned on my part.
    Hopefully I can detox from the medicine without any affects to my body. Any doctor/nurse that says there is no withdrawal symptoms of this drug has either not taken it themself or does not know the actual physical pain it can cause to the internal system.

  4. Drug Study Says:

    the drug’s labeling has noted that weight gain and diabetes were seen in study patients

    • Your Friend Says:

      Hi Drug Study,

      I check out the web link you provided and I really like the Alternative Medicine section.

      Thank you for your comment.

      Your Friend

  5. annette bradshaw Says:

    my daughter Rebecca Bradshaw was medicated with seraquel. her ovaries were rotted out and she had diabetes she was also going blind, when she refused to take the drug her psychiatrist Dr Wendy Jackson put her on a compulsory treatment order and forced this drug on her, when she was released from hospital she shaved her head then killed herself, she was 17

    • Concerned Mum Says:

      I was wondering if your daughter lived in USA or Australia. We live in Australia & my daughter has just started seeing a Dr Wendy Jackson as well. My daughter has just began prescripton medication as well.

      • annette Says:

        I live on the north coast of australia. Dr Wendy Jackson put my daughter on adult drugs and used her as a guinue pig She overdosed my daughter daily. it has costed me thousands to demand an inquest for Becky. Dr Wendy Jackson is still practicing her craft. My daughter is dead because she trusted her …….My email is abradshaw66@gmail.com If your child dies under a psychiatrist there is nothing you can do about it. Theres not one day I dont pray that these doctors become accountable for the thousands of lives they destroy. Annette Bradshaw

      • Annette Says:

        I just found out that my nethew who just turned 4 was told by his doctor to see a pediatrition (Dr Lennon.)That quak prescribed that little boy 5 mg of prozac once a day for 2 weeks then double the dose there after. the only problem that little boy has is he suffers anxiety when he cant stay with his mummy… wtf …. all children have that until they grow up.

  6. Anonymous Says:

    In australia our goverment just passed a law in ACT Doctors will not need parental consent to medicate children 13 yrs and over.
    Teachers have the govermental right to administered compulsory psycotropic drugs whilst your child attends school without your consent.


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