Summary:


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4272t1-part1.pdf

2 DR. PINE: Thank you.
13 The next speaker is Sheila Matthews.
14 MS. MATTHEWS: My name is Sheila
15 Matthews. I am the co-founder of Ablechild.org, a
16 national, nonprofit organization representing more
17 than 10,000 families.
18 Our organization is dedicated to informed
19 consent regarding the subjectivity of psychiatric
20 diagnoses and the dangers of the drugs used to
21 treat them.
22 I also have personal experience with the
0194
1 subject of today's hearing. Two years ago, my
2 brother-in-law, Michael, committed suicide while
3 under the influence of an antidepressant.
4 I'm sure the FDA considers my brother-in-
5 law's suicide, in fact the thousands of
6 antidepressant-induced suicides, anecdotal.
7 However, we the people, the consumers, do not.
8 By the FDA's own admission, only 1 to
9 10 percent of adverse drug reactions are reported.
10 While DTC marketing has skyrocketed the use of
11 psychiatric drugs, international warnings continue
12 to surface.
13 The FDA has done nothing to increase the
14 public's ability to report their adverse drug
15 reactions. You have set up a great deal for the
16 pharmaceutical industry, but a lousy one for the
17 consumer.
18 In accordance with the National Academy
19 of Science, which reported on the importance of
20 postmarketing surveillance, Ablechild conducted a
21 survey of 150 people at the Washington, D.C., Mall
22 this March. Ninety-eight percent had never heard
0195
1 of MedWatch, the FDA adverse reporting system.
2 In June, we helped commission a large
3 study on a thousand people covering all
4 fifty states. Ninety-six percent had never heard
5 of MedWatch, but, most importantly, ninety-seven
6 percent of the public said the government should
7 provide a public service campaign to inform them
8 where they could report drug side-effects.
9 On October 4, 2006, Congressman Dan
10 Burton issued a formal request to the FDA cosigned
11 by several members of Congress. This letter stated
12 that, "Given the results of DTC marketing and the
13 documented risks of the drugs, the FDA should
14 require all drug advertising to include information
15 regarding MedWatch."
16 It said that, "Granting consumers this
17 right would help spot serious side-effects of these
18 powerful drugs much sooner."
19 We agree. You cannot continue to dismiss
20 our reports as anecdotal, for we are in the tens of
21 thousands. It is actually your job to find out how
22 high these numbers go. As Congressman Burton
0196
1 wrote, "We firmly believe that this lack of
2 awareness of the MedWatch represents a threat to
3 the public's overall safety.
4 (Applause.)
5 DR. PINE: Thank