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Why We Can't Trust Journal Articles--Bias

It is all about the trail of money Bad Pharma by Dr. Ben Goldacre is documents that the advocacy groups have all been corrupted by pharma, and where figures of available, half their funding comes from pharma.  An example of this influence to push drugs is the approach to mental illness found in the DSM-5 and earlier additions. 

Positive bias averaged 32% (range 11 to 69%) in a study which compared to the raw data submitted to the FDA in drug submissions for approval, a 2008 NEJM article revealed.   The raw was obtained from the FDA through the Freedom of Information Act.  http://healthfully.org/index/id9.html, http://content.nejm.org/cgi/content/short/358/3/252
 

Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy between 11-69% average 32%, 12 anti-depressants involving 12,54 patients, published results compared to FDA outcomes.  “According to the literature it appears that 94% of the trials conducted were positive.  By contrast FDA analysis showed that 51% were positive …. studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome.   The FDA uses raw data from the submitting drug companies for each study. This makes great sense, as the FDA statisticians can then compare their analyses to the analyses from drug companies, in order to make sure that the drug companies were analyzing their data accurately…. Unlike the FDA, journals are not checking raw data.   That is every single drug approved by the FDA for depression between 1987 and 2004. Just a few of many tales of data suppression and/or spinning can be found below:

                            Data reported on only 1 of 15 participants in an Abilify study

                            Data hidden for about 10 years on a negative Zoloft for PTSD study

                            Suicide attempts vanishing from a Prozac study

                            Long delay in reporting negative results from an Effexor for youth depression study

                            Data from Abilify study spun in dizzying fashion. Proverbial lipstick on a pig.

                            A trove of questionable practices involving a key opinion leader

                            Corcept heavily spins its negative antidepressant trial results

It is all about the trail of money Bad Pharma by Dr. Ben Goldacre is documents that the advocacy groups have all been corrupted by pharma, and where figures of available, half their funding comes from pharma.  An example of this influence to push drugs is the approach to mental illness found in the DSM-5 and earlier additions.  Where pharma goes with its tobacco ethics, people are harmed. 

Psychologists petition against DSM-5 revisions

February 10, 2012 | By Tracy Staton

British psychiatrists and psychologists are engaging in target practice with the under-construction DSM-5. The "bible" of mental illness, the Diagnostic and Statistical Manual of Mental Disorders is under revision, and critics say the changes pathologize normal behavior and benefit drug companies over patients, The Guardian reports.

Some 11,000 psychologists have signed a petition against revisions they say classify some normal, expected behaviors--including bereavement--as mental illnesses and create questionable new disorders. "The proposals in DSM-5 are likely to shrink the pool of normality to a puddle with more and more people being given a diagnosis of mental illness," Til Wykes, professor of clinical psychology at Kings College London, said, as quoted by The Guardian.

The British Psychological Society has opposed the DSM changes, The Telegraph says, and psychiatrists in the U.S. have also taken issue with some of them. "DSM5 will radically and recklessly expand the boundaries of psychiatry," Duke University's Allen Frances said (as quoted by The Telegraph). "Many millions will receive inaccurate diagnosis and inappropriate treatment."


The DSM revisions are important because the manual not only guides treatment and diagnosis in the U.S., but insurance coverage as well. Broadening the definitions of disorders treated with psychotropic drugs stands to increase sales, and some question whether drug companies have too much influence over the revision process. It's "hard to avoid the conclusion that DSM-5 will help the interests of the drug companies," University of Central Lancashire's David Pilgrim said, as quoted by Reuters.   

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Shyness could be defined as a mental illness

Shyness, bereavement and eccentric behaviour could be classed as a mental illness under new guidelines, leaving millions of people at risk of being diagnosed as having a psychiatric disorder, experts fear.

 

Under changes planned to the diagnosis handbook used by doctors in the US, common behavioral traits are likely to be listed as a mental illness, it was reported. The fifth edition of the Diagnostic and Statistical Manual (DSM) of Mental Disorders could also include internet addiction and gambling as a medical problem. Although the guidelines are not used in the UK, experts said they feared it would affect thinking on the subjects. 

 

"We need to be very careful before further broadening the boundaries of illness and disorder," Simon Wessely, of the Institute of Psychiatry at King's College London, told the Daily Mail.

 

"Back in 1840 the census of the United States included just one category for mental disorder.  By 1917 the American Psychiatric Association recognised 59, rising to 128 in 1959, 227 in 1980, and 347 in the last revision. Do we really need all these labels?  Probably not. And there is a real danger that shyness will become social phobia, bookish kids labelled as Asperger's and so on."  Peter Kinderman, head of the Institute of Psychology at the University of Liverpool, said it was not "humane" to describe shy or bereaved people as "mentally ill".

 

The British Psychological Society has opposed the changes to the DSM while psychiatrists in the US have also spoken out against them.  A petition launched to try to stop the publication of the new edition was backed by 11,000 signatures from psychologists.  There are fears the new classifications are being driven by drug companies seeking to profit from a greater number of illnesses while the private health care system in the States requires a diagnosis recognised by the manual for a patient to be treated as ill.

 

"DSM5 will radically and recklessly expand the boundaries of psychiatry. Many millions will receive inaccurate diagnosis and inappropriate treatment.," said Allen Frances of Duke University, North Carolina.

 





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Disclaimer:  The information, facts, and opinions provided here is not a substitute for professional advice.  It only indicates what JK believes, does, or would do.  Always consult your primary care physician for medical advice, diagnosis, and treatment. 




Positive bias averaged 32% (range 11 to 69%) in a NEJM article, 2008.  The study of neuroleptic drugs made a comparison of 74 journal articles to the raw data which was obtained by FOIA (Freedom of Information Act) from the FDA. See http://healthfully.org/index/id9.html, or http://content.nejm.org/cgi/content/short/358/3/252