Sheila Matthews — (2006 FDA Hearings)

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THE FDA PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE HEARINGS 2006

DR. PINE: Thank you. The next speaker is Sheila Matthews. MS. MATTHEWS: My name is Sheila Matthews. I am the co-founder of Ablechild.org, a national, nonprofit organization representing more than 10,000 families.
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. Two 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.
However, we the people, the consumers, do not. By the FDA’s own admission, only 1 to 5 percent of adverse drug reactions are reported.
While DTC marketing has skyrocketed the use of 11 psychiatric drugs, international warnings continue 12 to surface.
The FDA has done nothing to increase the public’s ability to report their adverse drug reactions. You have set up a great deal for the pharmaceutical industry, but a lousy one for the consumer.
In accordance with the National Academy of Science, which reported on the importance of post-marketing surveillance, Ablechild conducted a survey of 150 people at the Washington, D.C., Mall 22 this March. Ninety-eight percent had never heard of MedWatch, the FDA adverse reporting system.
In June, we helped commission a large study on a thousand people covering all fifty states. Ninety-six percent had never heard of MedWatch, but, most importantly, ninety-seven percent of the public said the government should provide a public service campaign to inform them where they could report drug side-effects.
On October 4, 2006, Congressman Dan Burton issued a formal request to the FDA cosigned by several members of Congress. This letter stated that, “Given the results of DTC marketing and the documented risks of the drugs, the FDA should require all drug advertising to include information regarding MedWatch.”
It said that, “Granting consumers this right would help spot serious side-effects of these powerful drugs much sooner.”
We agree. You cannot 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 wrote, “We firmly believe that this lack of awareness of the MedWatch represents a threat to the public’s overall safety.
(Applause.)
DR. PINE: Thank