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Recommended Exposing Pharma |
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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 |
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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." ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ 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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Enter supporting content here
INTERNAL SITE SEARCH ENGINE by Google
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
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