[india-drug] SSRIs: Promotion versus risk

["Dr. Sumant Goel" <profgoel@yahoo.com>]

selective serotonin reuptake inhibitors: Promotion versus risk
----------------------------------------------------------------



OTTAWA -- The benefits of antidepressants prescribed
to thousands of Canadian toddlers, children and teens
have been exaggerated and the risks downplayed,
according to a disturbing new report that's raising
concerns about the drugs' potential for harm. 

And the researchers who wrote it conclude there is no
evidence to justify prescribing these drugs to
children.
 
The Australian team reviewed six published studies of
Prozac, Paxil and Zoloft _ drugs known as SSRIs, or
selective serotonin reuptake inhibitors _ as well as
Effexor. 

According to the study, published in today's edition
of the British Medical Journal: 

- Children who took a placebo showed strong
improvement and those who took the real drugs didn't
do significantly better. Two small studies found no
advantage for the antidepressants over the placebo. 

- In one study, 11 of 93 adolescents taking Paxil had
a serious adverse event, compared to two of 87
children taking a placebo. The Australian team says
that, despite this striking difference, the study's
authors concluded Paxil was ''generally well
tolerated'' and that most side effects were not
serious, even though seven of the youth on Paxil had
to be admitted to hospital during treatment. Five were
admitted with side effects that have been linked with
SSRIs, including suicidal thinking. But ''only one
serious event (headache) was judged by the treating
investigator to be related to paroxeteine (Paxil)
treatment.'' 

- Drug companies paid for the trials and ''otherwise
remunerated'' the authors of at least three of the
four bigger studies. Two of the authors of one study
testing Paxil in teens were employees of
GlaxoSmithKline, which makes the drug. In another
study of the Pfizer drug Zoloft, Pfizer paid all the
authors, and the study supervisor held stock options
in Pfizer. Funding for another study of Prozac was
originally attributed to the U.S. National Institute
of Mental Health, but U.S. Food and Drug
Administration records show Eli Lilly, manufacturer of
Prozac, paid for the study. 

- The authors of the four larger studies ''exaggerated
the benefits, downplayed the harms, or both,'' raising
serious concerns over whether the medical journals
that published their work bothered to properly
scrutinize their data. 

- Overall, the numbers of children studied were small,
the followup period short and the dropout rates high.
The Australian team fears biased reporting and
''overconfident recommendations'' are misleading
doctors, patients and their families and that many are
overlooking non-drug treatments that are ''probably
both safer and more effective.'' 

The study, led by researchers at the Women and
Children's Hospital in North Adelaide, comes on the
heels of a U.S. report showing that the number of
children and adolescents taking Paxil and other
antidepressants increased 49% between 1998 and 2002,
with the biggest jump in preschoolers. 

None of the drugs has been approved in Canada for
anyone under 18, but doctors are prescribing them
''off-label'' -- which they are allowed to do -- to
children as young as three for depression, anxiety,
social phobia, attention problems and
obsessive-compulsive disorder. 

In a statement, Pfizer said that it plans to send a
detailed response to the British Medical Journal,
regarding ''inaccuracies and omissions'' in the
report. 

Health Canada issued a public advisory in January
about the increased risk of suicide in children taking
SSRIs. In February, an expert advisory panel asked
Health Canada to require drug makers to add new
warnings in materials provided to doctors.

Dr. Sumant Goel
Belgaum India



________________________________________________________________________
Yahoo! India Matrimony: Find your partner online. http://yahoo.shaadi.com/india-matrimony/

Access Essential Drugs Monitor #32 at http://www.who.int/medicines/mon/mon32.shtml

The INDIA-DRUG discussion group is a partnership between SATELLIFE
(www.healthnet.org), WHO Essential Drugs and Medicines Policy
(www.who.ch), and the Delhi Society for the Promotion of the
Rational Use of Drugs (DSPRUD) in India.

To send a message to india-drug, write to: india-drug@healthnet.org
To subscribe or unsubscribe, write to: majordomo@healthnet.org
in the body of the message type: subscribe india-drug OR unsubscribe india-drug
To contact a person, send a message to: india-drug-help@healthnet.org