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Posted on Sat, Apr. 17, 2004

Families long battle for antidepressant reform nears end

Associated Press

Mark Miller was sitting at his computer in the Bernstein-Rein Advertising agency when the e-mail appeared.

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 antidepressant.

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 SSRI-suicide connection.

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 now.

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 e-mail.

The Miller's mission began with 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 dollars.

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 Internet.

"The similarities were frightening," and it brought her to tears, she said.

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 harmless.

Kathy said they were furious when they learned the FDA first investigated the suicide relationship to antidepressants in 1991.

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 president.

"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 House.

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 matters.

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 now.

"I don't think the battle has been won, but it's an important first step," Tom said.

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