In article <br7ogl$vi8$1@pencil.math.missouri.edu>, VERACARE says...
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) http://www.ahrp.org
Contact: Vera Hassner Sharav Tel: 212-595-8974 e-mail:
FYI
LATEST NEWS ALERT from British Medicines and Healthcare Products
Regualtory Agency:
"Use of Selective Serotonin Reuptake Inhibitors (SSRIs) in children
and adolescents with major depressive disorder (MDD) - only fluoxetine
(Prozac) shown to have a favourable Balance of risks and benefits
for the treatment of MDD in the under 18s."
The British government has taken action to ban the use of antidepressant
drugs of the selective serotonin reuptake inhibitors (SSRIs) in
children and adolescents under the age of 18. They did this on the
basis of an independent review of the safety and efficacy of the
SSRI class in the treatment of children with major depression.
http://www.mhra.gov.uk/
The review was undertaken by the Expert Working Group of the Committee
on Safety of Medicines (CSM). The CSM has advised that THE BALANCE
OF RISKS and BENEFITS for the treatment of major depressive disorder
in under 18s IS JUDGED TO BE UNFAVORABLE for the following:
sertraline (Zoloft), citalopram (Celexa) and escitalopram (Lexapro)
and unassessable for fluvoxamine (Luvox). Only fluoxetine (Prozac)
has been shown in clinical trials to have a favourable balance of
risks and benefits for the treatment of MDD in the under 18s.
Meanwhile, the FDA has convened an advisory committee meeting to
be held on Feb 2, 2004. However, FDA officials are attempting to
block testimony by the very experts who provided the compelling
scientific evidence that led the British authorities to take this
action.
SSRIs are aggressively advertised and are, therefore, widely
prescribed.
However, the drugs have not shown a proven benefit greater than
placebo for depression in company controlled clinical trials.
See: The Emperor's New Drugs: An Analysis of Antidepressant Medication
Data Submitted to the U.S. Food and Drug Administration. By Irving
Kirsch, Thomas J. Moore, and Alan Scoboria and Sarah S. Nicholls.
http://journals.apa.org/prevention/volume5/pre0050023a.html
Since their marketing in 1991, SSRIs have been at the center of
controversy because of evidence showing that they cause severe
adverse effects, even causing a small number of people--including
children--to become suicidal.
Furthermore, SSRIs cause severe withdrawal symptoms in a significant
number of patients who are trying to stop taking them.
See: http://www.socialaudit.org.uk/5100what.htm#5.1
The drugs' manufacturers had vigorously denied evidence of harmful
effects for years. But the concealed evidence came to light in
several US lawsuits, and was further corroborated in a series of
investigative reports in the Guardian and by Panorama for the British
Broadcasting Corp.
AHRP has the tapes of two Panorama programs.
The problem has been exacerbated by the FDA--the agency whose mission
is to protect the public health is instead protecting the drug
companies.
FDA has remained silent about the evidence in its possession--some
dating back to 1996--demonstrating the drugs' hazards.
Instead, FDA remained silent as drug manufacturers misled physicians
and the public about the drugs' hazards with false claims of their
safety and effectiveness against depression.
Indeed, GlaxSmithKline issued a Dear Doctor letters warning physicians
in the UK about the hazards of Paxil for children--but no such
explicit warning letter was issued to US doctors.
Paxil was the first drug to be banned for children in Britain.
Prozac is the only antidepressant doctors in the UK are permitted
to prescribe for children. It was approved for pediatric use by the
FDA even though it has shown to bed helpful to only 1 in 10 depressed
children.
The following documents provide detailed information about the
drugs:
Message sent to health professionals including a leaflet for patients
(183KB)
http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/cemss
ri_101203.pdf
A question and answer document (131KB)
http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ssriq
a_101203.pdf
Overview of regulatory status and CSM advice relating to major
depressive disorder (MDD) in children and adolescents including a
summary of available safety and efficacy data (300KB)
http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ssrio
verview_101203.pdf
http://www.guardian.co.uk/uk_news/story/0,3604,1103563,00.html THE
GUARDIAN
Drugs for depressed children banned Sarah Boseley, health editor
Wednesday December 10, 2003 The Guardian
Modern antidepressant drugs which have made billions for the
pharmaceutical industry will be banned from use in children today
because of evidence, suppressed for years, that they can cause young
patients to become suicidal.
The Medicines and Healthcare Products Regulatory Agency (MHRA) told
doctors last night not to prescribe all but one of the antidepressants
known as selective serotonin reuptake inhibitors (SSRIs).
The exception is Prozac, which is licensed for use in depressed
children in the US. But the MHRA will warn that, at best, it helps
only one child in 10.
The decision has big implications for drug regulation.
The agency - which is the government's watchdog body on drug safety
- has reached this point only after intense pressure from patients
and campaigners.
They were concerned about patients - at first mainly adults - who
appeared to have become suicidal on the drugs, and others who had
got hooked and suffered distressing symptoms when they tried to
stop taking them.
Public unease about these potential side-effects prompted the agency
to investigate last year. It has looked at the details of clinical
trials of depressed children that were in the hands of the drug
companies in the late 1990s. These studiesrevealed the problem of
suicidal behaviour in children, but the companies did not draw it
to the attention of the regulators in the US or the UK.
It has become clear from the investigation that the regulators
generally see only a summary of the data resulting from trials. It
is prepared for them by the drug company only when it is seeking a
licence.
The agency became aware of a problem with Seroxat in children this
year only when the manufacturer, GlaxoSmithKline, submitted data
from trials which finished in 1996.
Pressure for a change in the regulatory system will inevitably grow.
Two of the SSRI class of drugs have already been banned - or,
technically, contra-indicated in children - by the agency.
The first, in June, was Seroxat, which goes by the generic name
paroxetine;
the second, in September, was Efexor (venlafaxine); joining them
now will be Lustral (sertraline), Cipramil (citalopram), Cipralex
(escitalopram) and Faverin (fluvoxamine).
Trials on children have not been carried out in all the drugs, but
the completed studies show a worrying increase in suicidal behaviour
among those on SSRIs compared with those given a placebo (sugar
pill).
None of the drugs has a licence for use in children with depression
in the UK, but GPs have prescribed more and more SSRIs for children.
It is estimated that as many as 50,000 children on antidepressants
in Britain.
The agency will warn that patients should not stop their medication
suddenly to avoid withdrawal symptoms.
The ban will cause problems for doctors because insufficient
counsellors and psychotherapists are available to offer the alternative
treatment of therapy, and the bill to the NHS for such treatment
would be much higher than the cost of the drug prescriptions.
Drug companies began clinical trials on the safety and efficacy of
the SSRIs in children only after prompting by the US food and drug
administration in the early 90s.
David Healy, the director of the North Wales department of psychological
medicine, said: "It was standard practice for the FDA approving
drugs like Seroxat (Paxil in the US) for adults in 1991 to write
to the company and say this drug will also be used in children -
it would be helpful if you could run trials in children so we can
see what the safety profile is."
But trials that did not produce favourable results were neither
published nor sent to the FDA or the MHRA.
The first major Seroxat trial in children was finished by 1996, but
the results were not published until 2001. Data was also gathered
in 1996 after a trial of Lustral, manufactured by Pfizer, showing
that 9% of depressed children on the drug became suicidal.
Dr Healy, whose own researches led to the establishment of the SSRI
review, said yesterday: "They should have known by 1996 that there
was a problem.
GSK and Pfizer were asked to do this by the regulators so that we
knew what the safety issues were."
The drug companies dispute that a problem exists. Only a tiny
minority of children taking the drug become suicidal and their
depression could be the real cause, they claim. GSK says several
trials, not just one, were needed to establish whether its drug
caused problems.
The SSRI review group, which has advised the Committee on the Safety
of Medicines of the agency to ban the drugs from use in children,
will now look at the safety and efficacy of the drugs in adults.
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