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FDA
Hearing Testimony December 13, 2006 Psychopharmacologic
Drugs Advisory Committee My
name is Our
organization is dedicated to informed consent regarding the subjectivity
of psychiatric diagnoses, and the dangers of the drugs used to treat them.
I
also have personal experience with the subject of today’s hearing; 2
years ago my brother-in-law, Michael, committed suicide while under the
influence of an antidepressant. I’m
sure the FDA considers my brother-in-law’s suicide, in fact, the
thousands of antidepressant induced suicides ---“anecdotal.”
But we, the people, the consumers, -- do not.
By
the FDA’s own admission, only 1 to10 percent of adverse drug reactions
are reported. While Direct to
Consumer Marketing has skyrocketed the use of psychiatric drugs,
international warnings continue to surface. The FDA has done nothing to
increase the public’s ability to report their adverse drug reactions.
So
you’ve set up a great deal for the Pharmaceutical industry – but a
lousy one for the consumer. In
accordance with the National Academy of Sciences report on drug safety,
which cited the importance of post marketing surveillance, Ablechild
conducted a survey of 150 people at the Washington DC Mall last year. 98%
of them had never even heard of Medwatch – the FDA adverse reporting
system. In
June, we helped commission a larger study on 1000 people from 18 major
cities. 96%
had never heard of Medwatch. But
most importantly, 97 percent of
the public said the government should provide a public service campaign to
inform them where they could report serious adverse reactions to
prescription drugs. On
The
letter stated that given the results of Direct to Consumer Marketing on
the public, and the documented risks of the drugs, the FDA should mandate
all drug advertising to include Medwatch.
It said that granting consumers this right would help spot serious
side effects of these powerful drugs much sooner. We
agree. You
can’t continue to dismiss our reports as anecdotal – for we are in the
tens of thousands. It is
actually your job to find out
how high these numbers go. As
Congressman Burton has said, “We firmly believe that this lack of
awareness of the Medwatch system represents a serious threat to the
public’s overall safety. This
is completely unacceptable.” Mandate the Marketing of Medwatch. |
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