Statement of Tom & Kathy Woodward at 9/13/2004 FDA Hearings

My name is Tom Woodward. My wife Kathy and I had four children. Julie, the oldest of our children, took her life on July 22, 2003.

Julie was a gentle and beautiful young girl – she was only 17. She was deeply loved and is sorely missed by all that knew her.

Julie was a normal teenager dealing with normal teenage issues -- she had no history of self-harm or suicide.

She was prescribed Zoloft and we were told that it was “safe, very mild, extremely effective” and “essential to her feeling better”.

Seven days after taking her first Zoloft tablet Julie hung herself in the garage of our home. We’ve since learned that Julie began experiencing Akathisia almost immediately after taking the first pill.

Julie never harmed herself in her 17 years – the only variable was 7 days of Zoloft. We are certain that Zoloft killed our daughter.

A recent JAMA article stated that the risk of suicide is 40 times greater during the first nine days of treatment.

I’m here today to do more than to simply tell you our family’s story – I believe this is a national crisis. The drug industry has oversold the purported benefits of SSRI drugs and aggressively promoted their use with 90% of the prescriptions being written “off-label”.

As the Spitzer lawsuit confirmed – drug companies have purposely deceived the public about the safety and efficacy of their drugs.

The problems associated with these drugs are particularly frightening in light of the Bush Administration’s “New Freedom Initiative” – a program designed to subject every school age child in this country to psychological testing.

The way these tests are designed many children will fail and inevitably be prescribed an SSRI – tragically some of these children will then go on to mutilate themselves, commit acts of violence and kill themselves as a direct result. We are too quick to medicate our children!

Our system of medical treatment is based on a sacred circle of trust. This trust has been broken. Children look to their parents to protect and guide them --- parents seek out the advice and counsel of physicians and mental health professionals – who in turn largely rely on the drug industry, opinion leaders and the FDA to allow them to fulfill their role as informed intermediaries.

The drug industry has employed tactics of deception, distortion, misdirection and manipulation.

Big Pharma’s money has corrupted the process and destroyed this sacred trust. They buy political influence that secures the placement of individuals within the FDA to do their bidding – such as Dan Troy -- whose mission is clear – damn the public and protect his former drug industry clients at all costs. Troy is more concerned with Tort Reform than with children’s lives.

Senior leadership at the FDA drag their feet and make Orwellian statements such as – “just because these drugs have not been proven to be effective does not necessarily mean they are ineffective” --- this gibberish is an insult to the American public and would be laughable if the consequences weren’t so terribly tragic.

Drug Industry CEO’s Hank McKinnell of Pfizer, and those at Glaxo, Wyeth, and Lilly ---- Senior leadership at the FDA -- Troy, Crawford, Temple, Katz & Laughren know the truth and therefore have blood on their hands.

I deeply appreciate the work of this committee – I know there are good people at the FDA trying to do the right thing in spite of the FDA’s current leadership.

Implement class wide – strongly worded black box warnings immediately – inclusive of Prozac – not some carefully worded drug industry version designed to protect their interests instead of the publics.

The FDA needs to be restored to its vitally important mission of protecting the welfare of the American public.