Zoloft: suicide: Tim (Woody) Witczak's case

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Thu, 30 Jun 2005 02:58:55 -0000

[sSRI-Research] Zoloft: suicide: Tim (Woody) Witczak's case

 

 

 

Paragraphs 3 and 4 read: " Since then, Witczak, 39, has been on a

crusade that has taken her to a federal courtroom in Minneapolis, the

hallways of the U.S. Capitol and the headquarters of the Food and

Drug Administration in Rockville, Md. "

 

" She currently is in federal court challenging Pfizer Inc., the maker

of Zoloft and the biggest pharmaceutical company in the world. She

contends that Pfizer did not sufficiently warn doctors and patients

about the drug's potential to cause suicidal tendencies, a claim that

Pfizer denies. "

 

 

http://www.startribune.com/stories/535/5463023.html

 

 

Two years after her husband hanged himself in their garage, there has

been no closure for Kimberly Witczak.

 

And there won't be until she's done pursuing those she thinks are

responsible for Tim (Woody) Witczak's death at 37. There was no

suicide note, but for Witczak, there was something equally damning --

a partially consumed bottle of the antidepressant Zoloft on the

kitchen counter of their south Minneapolis home.

 

Since then, Witczak, 39, has been on a crusade that has taken her to

a federal courtroom in Minneapolis, the hallways of the U.S. Capitol

and the headquarters of the Food and Drug Administration in

Rockville, Md.

 

She currently is in federal court challenging Pfizer Inc., the maker

of Zoloft and the biggest pharmaceutical company in the world. She

contends that Pfizer did not sufficiently warn doctors and patients

about the drug's potential to cause suicidal tendencies, a claim that

Pfizer denies.

 

Hers is not the only suit against Pfizer involving Zoloft -- there

are at least a dozen cases around the country. But it's one of a

handful to invoke a state " failure to warn " statute, with Witczak

asserting that the state law should supersede even FDA requirements

on disclosure.

 

Already, her testimony before FDA advisory committees has been among

those voices that forced drug companies to include warnings that

certain antidepressants can cause suicidal thoughts in those under

18. That's not enough for Witczak; she wants the stronger warnings to

cover adults, too.

 

Connections to suicide

 

Her case hinges on an assembly of corporate documents collected in

earlier lawsuits involving Zoloft and similar antidepressants. The

papers suggest that as far back as the mid-1980s, manufacturers and

regulators saw connections between a family of drugs known as

selective serotonin re-uptake inhibitors (SSRIs) and suicidal

tendencies.

 

A 1991 Pfizer document, for example, reported how a 52-year-old

patient " became acutely suicidal " 13 days after he started taking

sertraline (Zoloft) and that his condition improved once he stopped

taking the drug. A 1993 confidential Pfizer document reported that a

45-year-old woman had to be hospitalized after she developed

akathisia while on the drug. Akathisia is a neurological development

that results in extreme agitation that can lead to suicide.

 

Zoloft was introduced in 1992 and quickly became a blockbuster drug

for Pfizer. The drug had $3.3 billion in sales in 2004. Besides

depression, doctors also began prescribing it for " off-label " uses

such as migraines and moodiness. Tim Witczak was one of those who had

no symptoms of depression but was given a prescription for Zoloft by

his doctor for insomnia.

 

Pfizer said clinical trials and studies and reports fail to

demonstrate a connection between use of Zoloft and suicide.

 

" There's no scientific link to Zoloft and suicidal behavior. That's

the long and short of it, " said Bryant Haskins, a Pfizer

spokesman. " Zoloft has provided effective and life-saving treatment

to millions of patients since it's been on the market. "

 

Others note that Zoloft is a crucial drug in the arsenal against

major depression, a serious disease in the United States.

 

" Do we shoot ourselves in the foot if we don't treat this

catastrophic illness? " asked Dr. Paul Goering, medical director for

the psychiatry department at St. Paul's United Hospital. " If we

didn't have them [antidepressants], I don't know what I'd do. "

 

Goering said 10 percent of all untreated patients with major

depression commit suicide.

 

He said antidepressants should be prescribed after a thorough

conversation between doctor and patient and ongoing monitoring for

side effects. " If you start to see or feel these things [suicidal

thoughts], then let us know right away, " Goering said.

 

Prescription for insomnia

 

Witczak disputes assertions that her husband, Tim -- Woody to his

friends -- must have been depressed to commit such an ultimate act.

He was given Zoloft for insomnia as he immersed himself in a new,

high-level sales job.

 

 

" I went to two suicide support groups. They said it was undiagnosed

depression. I could accept that if I thought that was true. But it

wasn't, " Witczak said, describing her husband of 10 years as an

outgoing, caring " kid at heart. "

 

Witczak has been an effective spokeswoman for her cause.

 

" She's very articulate and has a very compelling story to tell, " said

Karin Hope, legislative aide to U.S. Rep. Jim Ramstad, R-Minn., who

has arranged for Witczak and her brother-in-law, Eric Swan, to meet

with congressional committees that have jurisdiction over the FDA and

drug safety.

 

" We were dealing in the abstract until we came in touch with her, "

said U.S. Rep. Maurice Hinchey, a New York Democrat who has been

battling the FDA over drug safety issues. " She put a human face on

the things we are trying to correct. "

 

Last October, the FDA ordered drug manufacturers to place " black box "

warnings on all antidepressants to warn doctors and patients about

the increased risk of suicidal thoughts and actions for children and

adolescents taking the drugs. The FDA issued the directive based on

the findings of advisory committees before which Witczak testified.

 

The FDA currently is asking pharmaceutical companies for clinical

studies of adults and suicide rates when using an

antidepressant. " We've just begun collecting data. It will take

awhile to evaluate, " FDA spokeswoman Susan Cruzan said.

 

Witczak and Swan have enlisted the help of Los Angeles attorney Karen

Barth Menzies and her law firm, Baum Hedlund. Barth Menzies has 12

Zoloft cases pending across the country and has filed lawsuits

involving other antidepressants in two dozen states.

 

Among the Zoloft cases handled by the Baum Hedlund firm and Barth

Menzies was the 1998 murder of comedian Phil Hartman by his wife,

Brynn, who then committed suicide. Tests later showed she had

ingested Zoloft, cocaine and alcohol on the day of the shootings.

 

Barth Menzies filed a suit on Witczak's behalf against Pfizer in May

2004. A motion by Pfizer is pending to dismiss the lawsuit on the

grounds that Minnesota state law cannot supersede the FDA's authority

to regulate drug safety. Witczak, with the court assistance of state

Attorney General Mike Hatch, contends that Pfizer failed to

sufficiently warn users of Zoloft about the suicide connection.

 

In an affidavit filed in the Witczak case opposing Pfizer's dismissal

motion, Dr. David Healy -- a British psychiatrist and believer in the

SSRI-suicide link -- asserts that Pfizer knew of Zoloft's risk for

more than 10 years. Healy is the author of a book published last year

titled, " Let Them Eat Prozac. "

 

" Pfizer has been far from fully forthcoming with the FDA about the

adverse reactions of Zoloft, which can lead certain vulnerable

patients to become suicidal, " Healy said in the affidavit dated March

14, 2005.

 

A birthday meeting

 

The Witczaks met in Chicago on Kim's birthday, June 1, 1990. She was

working at an ad agency there and later became a producer for the

Jenny Jones syndicated talk show; he was in sales for an Anheuser-

Busch distributor. They married in 1993 and moved to the Twin Cities

in 1994 for Woody's sales career. Kim eventually became an account

manager for Fallon Worldwide, a Minneapolis advertising agency.

 

In May 2003, Woody got involved in a startup company as vice

president of sales. The company sold energy-efficient lighting to

commercial and industrial customers. Witczak said he was excited

about being part of something from the ground up.

 

Anxiety over the new job and the new business caused Woody to have

trouble sleeping, Witczak said, and his family doctor prescribed

Zoloft. For the next two weeks Kimberly Witczak was on assignment in

New Zealand. Back home, Woody experienced night sweats, diarrhea and

physical agitation.

 

One evening shortly after Witczak returned from New Zealand, she was

in the kitchen when Woody entered after aimlessly driving around town.

 

" He was drenched. He'd been driving all day. He sat on the kitchen

floor in a fetal position and said, 'Kim, you gotta help me. My

head's outside my body,' " she recalled.

 

Kim calmed Woody down, and things seemed to go smoother, although he

complained about gruesome nightmares that he refused to describe.

 

On Monday, Aug. 4, Witczak left for an assignment in Detroit. She

talked to Woody on Tuesday morning and described him as excited from

a successful sales call. They booked a flight to St. Louis for a

friend's wedding in October and Woody booked a separate flight to Las

Vegas for a bachelor party the following weekend. When Witczak called

late Tuesday, there was a different Woody on the phone, she said. He

seemed " completely distracted. He was in a different state of mind. "

 

When Witczak failed to reach Woody by phone or e-mail on Wednesday,

she asked her father to go to the house. That's when Woody was found

dead, hanging in the couple's two-stall garage. One of his last acts

had been to search Google on the word " noose. "

 

David Phelps is at dphelps.