KANSAS CITY, Mo. - Mark Miller was sitting at
his computer in the Bernstein-Rein Advertising agency when the
On a Monday in March, Miller got a message that he'd been waiting
to see for nearly eight years. It was a warning from the Food and
Drug Administration. "Cautions for Use of Antidepressants in Adults
and Children," was the e-mail's title.
The March 22 advisory warned doctors prescribing antidepressants,
also know as SSRI drugs, to monitor patients for worsening
depression and suicidal thinking while taking drugs such as Paxil,
Prozac and Zoloft. The FDA asked 10 drug makers to add or strengthen
suicide-related warnings on their labels.
The message was a bittersweet victory the Millers and families
across the country who have been battling for changes in the ways
antidepressants are prescribed. The Millers lost their 13-year-old
son, Matt, to suicide in 1997, after he began taking an
In early February, Miller testified before an FDA advisory
committee in Washington. Miller was fifth on the list and followed
by more than two dozen families. For two minutes each, many shed
tears and practically begged the FDA to warn other families. Experts
also were on hand, and a few spoke strongly to the possibility of an
Before their son's death, Miller and his wife Cheryl, who live in
Overland Park, Kan., couldn't tell you what the acronym SSRI meant.
Selective serotonin reuptake inhibitors, the class of drugs that
antidepressants are a part of, is in their everyday vocabulary
In the years following Matt's death, the Millers have been on a
crusade of sorts and their mission was simple.
"Just get the warning on the drugs," Miller said.
The FDA is currently examining new studies to find a possible
SSRI-suicide link and expects to have answers next year.
An Eli Lilly spokeswoman stressed that no conclusions have been
reached about the safety of the drugs. She said Lilly's best selling
SSRI, Prozac, has been prescribed to more than 40 million people.
Lilly said they will make changes on the Prozac label and support
the FDA's warning.
"Since suicidal thinking is an inherent part of depression,
(Lilly) believes careful monitoring of patients is very important
and worthwhile," Lilly spokeswoman Jennifer Yoder said in an
The Miller's mission began with www.drugawareness.org. Mark
taught himself how to make Web pages and created the site that later
spawned the International Coalition for Drug Awareness.
Almost half a million hits have come to the site, which shares
stories of countless families that say their loved ones, young and
old, took their lives while on antidepressants. Others say they are
survivors and nearly committed suicide while taking SSRIs.
Mark and Cheryl continued their campaign to seek justice after
the site was built. They filed a wrongful death lawsuit against
Pfizer, the maker of Zoloft, and lost. They appealed in federal
court and lost again. Miller said only one family has won a similar
case against a drug company, and they were awarded millions of
So they continued to rally and appeared on Good Morning America
before the FDA hearing to share their story.
The Woodward family, 1,100 miles away in North Wales, Penn.,
wished they'd got the warning sooner.
Last year Kathy Woodward read the Miller's story on the
"The similarities were frightening," and it brought her to tears,
Their daughter was "the smartest, the best and the most
beautiful," in their entire family.
She was 17 last July when she hung herself in her parents' home
after taking Zoloft for a week. She was told the drug was mild and
Kathy said they were furious when they learned the FDA first
investigated the suicide relationship to antidepressants in
They began collecting research and soon were convinced that
Zoloft killed their daughter. Tom Woodward, Julie's father, also
spoke before the FDA committee in February.
After Julie's death, Kathy said they sent letters to her friends
and classmates warning them about Zoloft. They even wrote to the
"We had no warning: Julie had never hurt herself; there was no
mark on her entire body," the letter to the White House said. "The
FDA, your agency, should have issued warnings."
They got a polite response but no action from the White
But in early March, Sen. Christopher Dodd, D-Conn., and
colleagues including Sen. Hillary Clinton, D-NY, and Sen. John
Edwards, D-N.C., wrote FDA Commissioner Mark McClellan. They asked
for answers. They wanted to make sure families and physicians had
all the necessary information.
Days after the FDA's warning was announced, Rep. Joe Barton of
Texas presented McClellan with a list of records requests about the
issue. Barton chairs a subcommittee that investigates such
Before the FDA issued the warning last month, the Woodward family
and friends planned to go to Pfizer headquarters in Manhattan with
pictures of their daughter. They have postponed the protest for
"I don't think the battle has been won, but it's an important
first step," Tom