freakoutcrazy

Blog des AK Psychiatriekritik der NFJ Berlin

Monat: Oktober, 2015

$8 Million Awarded to Family Of Man Who Died in Risperdal Trial

A California jury ruled that Johnson & Johnson’s Janssen Pharmaceutical and a psychiatrist are responsible for the death of 25-year-old Leo Liu. During a clinical trial for Risperdal, Liu died of a heart injury that was “further complicated” by the drug and ignored by the study doctors. Janssen was found 70% responsible for Liu’s death and ordered to pay $5.6 million to the family.

When Liu was first recommended for the Risperdal trial a pre-screening exam yielded abnormal electrocardiogram (EKG) readings and irregular blood tests, which indicated possible heart disease, according to a Fox 11 report.

Despite these results, Liu was cleared for the study and he began the Risperdal trial in February of 2009.  Just days after starting the study his condition worsened.  He died 5 days after his first Risperdal injection.

According to Law360, Doctors testified at the trial that Liu would have had a 50% better chance of surviving if the researchers would have transferred him to an acute-care facility when they first realized that his condition was worsening.

The family alleges that Liu’s psychiatrist convinced him to sign a consent form and enter the study and later received a “finder’s fee” of $30 thousand dollars from the drug company for his enrollment. The psychiatrist was found 30% responsible and ordered to pay the remainder of the settlement.

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Massive Number of Antidepressant Meta-Analyses Biased By Industry

A massive number of meta-analyses of antidepressant clinical trials have financial conflicts of interest and are unduly influenced by pharmaceutical companies, according to a review to be published in an upcoming issue of the Journal of Clinical Epidemiology.  Researchers also found that meta-analyses with industry ties almost never report any negative findings in their abstracts.

As researchers, regulators, and practitioners have become more aware of the biasing effects of financial conflicts of interest on psychiatric drug research, many have come to rely on meta-analyses that synthesize the data of several clinical trials. This is particularly true for antidepressant drug trials, where meta-analyses are used to shape clinical guidelines, and prescribing practices.

“Apparently, meta-analyses have become so popular that they can become a prime marketing tool,” researchers write in a new review of meta-analyses.

A new study led by Shanil Ebrahim of Stanford University reveals that meta-analyses are not immune to industry influence.  Until now, no studies have attempted to assess the extent and effects of industry involvement in meta-analyses of antidepressant trials.

The antidepressant market in the United States is enormous.  With some estimating that the market is close to $10 billion dollars per year.  The market is growing despite the fact that, in the last decade, several high-powered meta-analyses have questioned the effectiveness of the drugs and raised concerns about serious side effects, including suicide.

Ebrahim and his colleagues suggest that the influence of these studies may have spurred the pharmaceutical companies to become more involved in producing meta-analyses.

“Given that influential meta-analyses can be performed with more limited resources and faster than randomized trials, it is conceivable that the industry could easily help generate a large number of meta-analyses to support its products.”

The researchers collected every meta-analysis of randomized control trials evaluating antidepressants published since 2007. They included research on SSRIs, SNRIs, atypical antidepressants, tricyclic and tetracyclic antidepressants, monoamine oxidase inhibitors, melatonergic and nonmelatonergic antidepressants, and any antipsychotics approved for antidepressants, like quetiapine. They excluded studies that compared antidepressant drugs to alternative treatments, such as psychotherapy.

Ebrahim and his colleagues found that seventy-nine percent (147 out of 185) of all antidepressant meta-analyses published in the last seven years were generated by the pharmaceutical industry.

The nearly two hundred meta-analyses broke down like this:

  • 51 (28%) did not report sponsorship in the publication, but 11 of these, upon further investigation, included authors with ties to industry
  • 46 (25%) were sponsored by the manufacturer of the assessed drug
  • 41 (22%) received no funding
  • 33 (18%) supported by a government agency
  • 20 (11%) funded by a not-for-profit organization
  • 3 (2%) sponsored a for-profit organization other than the manufacturer

 

The researchers also identified several trends in the studies with industry authors that suggest bias in favor of the drugs. Meta-analyses that included an author with industry ties were twenty-two times less likely to make a negative statement about the drug in their abstract.

Even when the researchers excluded studies that had an employee of a drug manufacturer on the research team, they still found that studies with a financial conflict of interest (i.e. previous grants or speakers fees) were significantly less likely to make negative statements about the drugs.  In the 38 studies where no industry ties were identified, half reached a negative conclusion in their abstract.

The researchers conclude:

“Multiple reviews have shown that industry-sponsored trials are associated with higher treatment success and report more favorable efficacy results, even when the results of industry-sponsored studies were not really that favorable. It seems that the same enhancement of favorable conclusions is operating also in the level of meta-analyses.”

 

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Ebrahim, S., Bance, S., Athale, A., Malachowski, C., & Ioannidis, J. P. (2015). Meta-analyses with industry involvement are massively published and report no caveats for antidepressants. Journal of Clinical Epidemiology. (Abstract)

More Than Two-Thirds of Antidepressants Prescribed Against Guidelines

Results of a new study reveal that sixty-nine percent, or more than two-thirds, of patients prescribed antidepressant drugs have never, in their medical history, met the criteria for major depression. The study, published in the Journal of Clinical Psychiatry this month, also found that several demographic factors, like race and gender, were associated with the prescription of antidepressants.

“Many individuals who are prescribed and use antidepressant medications may not have met criteria for mental disorders. Our data indicate that antidepressants are commonly used in the absence of clear evidence-based indications,” the study authors conclude.

Previous studies have revealed that antidepressants were being over-prescribed and prescribed off-label.  But critics of these studies argued that they underestimated the lifetime prevalence of “mental disorders.”  This latest study seeks to address this criticism by conducting several in-depth interviews to more adequately estimate whether participants met criteria for “mental disorders” over their lifetime.

By analyzing the data from the Baltimore Epidemiologic Catchment Area (ECA), the researchers identified participants currently using antidepressant drugs and interviewed them.  Through the interviews, they assessed whether the participants had, over the course of their life, ever met the criteria for mood and anxiety disorders as they are defined in the diagnostic manual (DSM-III and DSM-III-R).

While several large-scale meta-analyses in the past decade have questioned the efficacy of antidepressants over the placebo effect in people diagnosed with depression, many maintained that the drugs were still necessary as a first-line treatment for severe depression or major depressive disorder (MDD). More recent studies have begun to undermine their effectiveness in MDD as well. Despite these findings, this study indicates that 69% of people taking antidepressants never met criteria for MDD and that “38% never met criteria for MDD, obsessive-compulsive disorder, panic disorder, social phobia, or generalized anxiety disorder in their lifetime.”

The new study also reveals that you are more likely to be prescribed an antidepressant if you are a women, white, report physical pain or discomfort to your doctor, or have recently visited a mental health care facility.

 

 

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Takayanagi, Y., Spira, A. P., Bienvenu, O. J., Hock, R. S., Carras, M. C., Eaton, W. W., & Mojtabai, R. (2015). Antidepressant use and lifetime history of mental disorders in a community sample: results from the Baltimore Epidemiologic Catchment Area Study. J Clin Psychiatry, 76(1), 40-44. doi:10.4088/JCP.13m08824  (Abstract)

Diagnosisgate: A Major Media Blackout Mystery

Remember “Colonel Mustard in the kitchen with the candlestick”?  From the game called “Clue” in which you tried to solve a murder mystery?  There’s a current, all-too-true and serious mystery involving devastating consequences – even death – for uncounted but vast numbers of people, but in this one the culprits are known to a very few, while their motives remain mysterious.

Until their identities are widely exposed, and their motives are known, the full story of the harm will never be known. It is astonishing that despite six stories in the major media — including a recent, groundbreaking Huffington Post series — and the filing of numerous lawsuits, the names and conduct of the culprits have consistently been omitted.

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‘I’d Rather Die Than Go Back to Hospital’: Why We Need a Non-medical Crisis House in Every Town

It was exciting going back to my old stamping ground.  Years ago I’d worked in one of the local community mental health teams and had referred many women to the Drayton Park Crisis House.  Walking up the steps of the house to meet Shirley brought back memories of standing there with desperate and suicidal clients, some of whom had told me that they would rather die than go back into hospital.  As you can imagine, to say I had been glad that there was an alternative would have been an understatement.

The house is a large Victorian villa which looks much like its neighbours in a typical North London street.  Shirley showed me round.   The house was as I remembered it: furnished in a homely, ‘Ikea’ type style, with a lovely, airy living and dining space at the back overlooking the garden.  Each resident has her own en-suite room, with a key, and there are cosy rooms for individual conversations and even massage. Residents’ children are also welcome.  If I have a mental health crisis, take me there or somewhere like it.  Unfortunately that’s unlikely to be possible – despite their overwhelming popularity there are still only a handful of crisis houses in the UK.  I was keen to find out from Shirley how and why Drayton Park happened, and what has sustained it for twenty years.  So on to my first question.

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