By David Phelps, Star Tribune
June 18, 2005, 11:07 PM
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@startribune.com.
Source:
http://www.startribune.com/dynamic/story.php?template=print_a&story=5463023
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