In article <bsb7oe$2pj7$1@pencil.math.missouri.edu>, VERACARE says...

To: Janet Woodcock; Mark McClellan MD; Robert Temple; Russell Katz
MD;

Thomas Laughren Cc: Joseph I Lieberman; Sen. Charles Schumer; Cong
Dennis Hassert; Sen. Pete Domenici; Sen Ron Wyden; Sen Mike DeWine;
Sen Jeff Bingaman; Sen John Edwards; Sen Edward M Kennedy; Sen
Christopher Dodd; Hillary Clinton; Daniel Troy; Warren Rumble

ALLIANCE FOR HUMAN RESEARCH PROTECTION   (AHRP) http://www.ahrp.org
Contact: Vera Hassner Sharav Tel: 212-595-8974 e-mail: veracare@ahrp.org

FYI

In a Communiqui to its membership  about regulatory action to protect
children from the hazards of Paxil and other antidepressants, The
National Association of School Psychologists acknowledges the leading
role played by The Alliance for Human Research Protection in
publicizing the action taken by UK regulators:

Following the UK ruling on Paxil, the American-based Alliance for
Human Research Protection (www.ahrp.org) and other patient advocacy
groups asked the FDA to immediately investigate this research in
order to determine if the agency should take similar action.
Approximately one week later, on June 19, 2003, the FDA took similar
action, saying that no one under age eighteen should be prescribed
the drug Paxil for major depression because the adult antidepressant
may increase a childs risk of suicide.

FDA's apparent reluctance to afford independent international experts
an opportunity--i.e., reasonable time--to present their analyses
of the clinical trial data--including unpublished concealed data--at
the forthcoming FDA advisory committee meeting, Feb 2-3, 2004,
raises concerns about the integrity of that meeting. Why would FDA
officials continue to resist presentations that would provide vital
information to the agency and the committee? How can FDA make an
evidence-based decision to protect children without the evidence
at hand?

October 2003 Drug Regulators Warn Against Using Paxil With Children
By Thomas B. Johnson, NCSP On June 10, 2003, the UK governments
Medicines and Healthcare Products Regulatory Agency issued a warning
that Seroxat (Paxil in the US) must not be used in the treatment
of children with depression.  The agency took this stand after
reviewing data from nine studies based on more than a thousand
children.  The City Editor of the Daily Mail in England, Alex
Brummer, reported that GlaxoSmithKline may have suppressed a series
of negative studies on its key antidepressant drug Seroxat, known
as Paxil in the US  In a highly unusual move, a team from the Good
Clinical Practice Unit of the Medicines and Healthcare Products
Regulatory Agency (MHRA) demanded access to all of GSKs files and
studies on Seroxat
(www.thisislondon.co.uk/news/business/articles/timid63975?version=1). After
their review of the studies, the UK agency concluded that the risk
of suicidal thoughts and self harm was two to three times greater
among those on Seroxat compared to those on a placebo drug
(www.number-10.gov.uk/output/page3851.asp).

FDA Action Following the UK ruling on Paxil, the American-based
Alliance for Human Research Protection (www.ahrp.org) and other
patient advocacy groups asked the FDA to immediately investigate
this research in order to determine if the agency should take similar
action.  Approximately one week later, on June 19, 2003, the FDA
took similar action, saying that no one under age eighteen should
be prescribed the drug Paxil for major depression because the adult
antidepressant may increase a childs risk of suicide.

They also advised that children and teenagers currently on the
medication should not stop the pills suddenly, emphasizing the
importance of medical supervision in order to taper off the medication
and avoid rebound side effects, such as shock-like sensations and
abnormal dreams.  The FDA also advised all makers of adult
antidepressants to submit research showing how their drugs affect
children. Three studies of Paxil found it didnt seem to help pediatric
depressionbut FDA scientists spotted some safety concerns and ordered
manufacturer GlaxoSmithKline to reanalyze the dataThat reanalysisfound
the risk of suicidal thoughts and suicide attempts was three times
greater among Paxil users, mostly teens, than among children given
dummy pills
www.ctv.ca/servlet/ArticleNews/story/CTVNews/1056372105025_14///). The
Vice President of Research and Development and chief medical officer
for GlaxoSmithKline, Dr. Anne Phillips, admitted that the adverse
effects can include mood fluctuations, increased crying, suicidal
thoughts and suicide attempts.

Canada Follows One of the worlds leading psychiatric/psychopharmacology
experts on antidepressants, Dr. David Healy (author of The
AntiDepressant Era and The Creation of Psychopharmacology), has
warned for years that SSRIs can trigger suicide in some users
including children and adults.  He also argued that Health Canada
should take the same kind of position they are taking on Paxil with
the other SSRIs. Canada recently followed the lead of the United
States and Britain, informing healthcare professionals and parents
that children under eighteen should not take Paxil because it can
trigger suicidal thoughts in some users
(www.ctv.ca/servlet/ArticleNews/story/CTVNews/10583690841_2///?hub=health).

Additional Warning From Effexors Manufacturer On August 30, 2003,
The Hartford Courant (Altimari and Dolan, see
http://www.ctnow.com/news/custom/newsat3/hc-wyeth0830.artaug30,0,5502972.sto
ry?coll=hc-headlines-newsat3) reported that the latest warning
against prescribing antidepressant drugs for children comes from
Wyeth Pharmaceuticals, makers of Effexor, an SSRI similar to Prozac,
Zoloft and Paxil. According to the Courant, Wyeth sent a two-page
letter (August 22) to healthcare workers in the US warning about
the hazards of prescribing Effexor for children. The Wyeth letter
states that Effexor was not effective in treating depression or
anxiety and was associated with increased "reports of hostility
and, especially in Major Depressive Disorder, suicide-related adverse
events such as suicidal ideation and self-harm." Wyeth spokesman
Douglas Petkus said the company decided to notify healthcare
professionals as a precaution."Companies typically don't release
data that is sent to the FDA, but in this case we felt it was
important for physicians to be aware of the studies because we know
it is being prescribed to children," Petkus said. He also noted
that Wyeth is still conducting clinical trials on adolescents.

Thomas B. Johnson, EdD, NCSP, is a licensed psychologist, state and
nationally certified school psychologist and Diplomate in Family
Psychology (Marital and Family Therapy).  He has served as a
Contributing Editor for the Communiqui with an emphasis on complementary
and alternative perspectives since 1996.

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Please be advised to IGNORE any and all responses
from a M. Probert and his Gang.  They have been exposed
repeatedly as kooks and worse!