Fwd: [SSRI-Research] Baum Hedlund/FDA testimony

February 24, 2004

JustSayNo

Tue, 24 Feb 2004 09:17:46 -0500

[sSRI-Research] Baum Hedlund/FDA testimony

Baum Hedlund/FDA testimony, press release

Karen Barth Menzies testified before the FDA Advisory Committee on February

2, 2004 regarding antidepressants and reports of suicidal risks for children

" Good morning, my name is Karen Barth Menzies. I am an attorney for Baum

Hedlund. We represent several thousand SSRI victims and we¹ve been doing

this for 12 years.

US Code of Federal Regulations 201.57 mandates that you require the drug

companies to warn when there is reasonable evidence; not causation;

reasonable evidence of an association of a serious risk. The clinical

researchers who did these trials on kids and the drug companies themselves,

confirmed that there are multiple events of suicidality caused by the drug.

The methodology that you are going to be using is designed to explain away

those events. Even Dr. Laughren admits, in the memo he gave you for this

hearing today, that there is evidence in these trials of an increased risk

of suicidality. Reasonable evidence is there. If there¹s reasonable evidence

you must make them warn.

Serious Risk? We certainly have that. Akathisia, psychosis, mania. When

you¹re looking at this data you¹re not just looking at the suicide, also

look for signs of akathisia and psychosis and mania. These aren¹t as easily

explained away by the drug companies by blaming the disease; by blaming the

victims.

When you take the potentially fatal risk and couple that with lack of

efficacy of these cases, why take that risk? Especially when it comes to our

kids.

Paul Leber predicted this day when he said that the FDA would come under

attack because they weren¹t as demanding as they ought to have been when

they were looking at the efficacy of the antidepressant products.

Put me out of business for the right reasons. Warn about these drugs. "

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