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From the LA TIMES, Thursday, September 23, 2004

 

 

 

PARENTS' CRUSADE FORCES DANGERS OF ANTIDEPRESSANTS INTO SPOTLIGHT

 

Too many found out too late about suicide and violent behavior risks in

children and demanded a response from the government.

 

 

By Elizabeth Shogren, Times Staff Writer

 

 

WASHINGTON - Seven years ago, Mark Miller's 13-year-old son, Matt, who

loved to ride bikes and play video games and excelled at making origami

animals, hanged himself in his bedroom closet. His parents were

devastated - and mystified.

 

" He had never threatened suicide, " Miller recalled. " The only thing that

had changed that week in his life was the medication. "

 

 

 

Seven days before his death, Matt had begun taking Zoloft, a popular

antidepressant prescribed by his doctor.

 

His father, struggling to understand what had happened, dived into the

Internet, where he found books on the risks of antidepressants. He was

soon convinced that the drug had caused Matt's death.

 

Miller helped start a website about the risks of the antidepressants. He

wrote to the Food and Drug Administration and his congressman to enlist

the government's help.

 

At first, no one took him seriously.

 

" I always felt people looked at me and said, 'That poor man, he's a

bereaved father and he wants to blame it on the medication,' " Miller

recalled.

 

But he gradually found other parents with stories like his. What began

as a lonely mission grew into a crusade of about a dozen enraged parents

motivated by the belief that their children were ripped from them by the

drugs that were supposed to help them.

 

 

Finally, the government listened.

 

Last week, two FDA advisory panels recommended that the agency require

companies to place prominent warnings - the kind boxed in dark lines -

that there is a risk that antidepressants can cause suicidal behavior in

children.

 

Doctors wrote an estimated 15 million prescriptions for nine

antidepressants for children and teenagers last year.

 

Congressional committees are investigating whether the drugs are safe

and whether the drug companies or the FDA improperly disguised or

underestimated the drugs' risks to children. The FDA will also explore

whether the drugs promote suicidal tendencies in adults and violent

behavior in patients of all ages.

 

The FDA recently found that in clinical trials involving nine

antidepressants taken by more than 4,000 children ages 6 to 18, hundreds

experienced suicidal behavior or thoughts, although none killed

themselves.

 

Miller said he and other parents like him had finally received

" vindication and validation of what we've been saying for so long. "

 

For years, as government agencies ignored his pleas, Miller was driven

by guilt - he had told his son to take the pills - and sustained by his

conversations with people seeking help because their loved ones had

become suicidal or violent while taking antidepressants.

 

" I always thought if I could just reach one more person before his son

or daughter did something tragic, it would be worth it. It has become a

very bittersweet labor of love, " Miller said.

 

Tom Woodward of suburban Philadelphia found Miller's website, but not

until it was too late.

 

When Julie Woodward, 17, was going through a " rough patch " last year, a

psychiatrist urged her to take Zoloft, which he assured the family was

mild, safe and effective. Seven days later, her father found her body

hanging in the garage.

 

The Woodwards' next-door neighbor, Doug Ross, a neuroscientist, turned

to the Internet, where he learned that just a month earlier, the FDA had

issued a warning that Paxil, another popular antidepressant, might be

linked to increased risk of suicidal thoughts and attempts in young

people.

 

It did not take long, Woodward recalled, before he and his wife were

" absolutely convinced that the drug had done this, " referring to Julie's

death.

 

The Woodwards found Miller's website, http://www.drugawareness.org .

They had long talks with Miller and other parents about the similar

circumstances surrounding their children's deaths.

 

The families grew convinced that some drug companies had suppressed

clinical trial data suggesting a link between the drugs and suicidal

behavior. They resolved to make the government do something.

 

Today, they regularly share information about new scientific studies and

plot strategies to push Congress to act.

 

" We've become very, very close to a lot of these other families, " Tom

Woodward said. " We are bound together by a parent's worst nightmare. "

 

Most of the families met for the first time in person in February at a

hotel bar in Bethesda, Md., where one FDA advisory panel was scheduled

to hear their stories the next day.

 

Their accounts helped persuade the panels to urge the agency to warn

doctors and families about the risk of suicide - and of the need to

vigilantly monitor patients. But at that point, the FDA stopped short of

suggesting that the drugs caused the suicidal behavior.

 

One of the most tireless members of the parents' group is Lisa Van

Syckel of New Jersey, whose daughter, 15-year-old Michelle, was put on

Paxil after having been misdiagnosed in 2000 as anorexic and depressed.

It turned out that Michelle had Lyme disease.

 

But while on the antidepressant, Michelle, who had never attempted to

harm herself or others, slammed her brother's head into a wall, went

after another teenager with a baseball bat and attempted to take her own

life. Van Syckel came across Miller's drug awareness website in 2002, as

she was trying to ease her daughter off Paxil. Soon she was spending

most of her time trying to get someone in power to warn other parents of

the dangers of antidepressants. Most political leaders ignored her

letters; one exception was Sen. Charles E. Schumer (D-N.Y.), who asked

her to join him at a news conference in New York calling on the FDA to

discourage the use of Paxil by children.

 

Then she turned to her own congressman, Rep. Michael Ferguson (R-N.J.).

Ferguson became a major force behind a House subcommittee's

investigation of the safety of the antidepressants and the role of drug

companies and the FDA. " It was [Van Syckel] who really got my attention

and prompted me to take an active and leading role, " Ferguson said. It

was not easy, he said, to get members of Congress to focus on the issue

during an election year, when the country was already absorbed by

terrorism and the war in Iraq.

 

But, he said, " we need to investigate this particular issue and get to

the bottom of why this is having such an enormous impact on our kids.

That cause has been moved forward light-years because of the powerful

personal stories of people like Lisa Van Syckel. "

 

Pressure from the families and members of Congress helped prod the FDA

to have its advisory committees assess data from clinical trials of

children on antidepressants.

 

Even the drug companies were impressed. " The families had an impact on

helping this to move forward, " said Dr. Joseph Camardo, medical director

for Wyeth Pharmaceuticals North America, which makes one of the popular

antidepressants. " I thought it was a great example of how the public can

and should be heard. "

 

The families were gratified when the advisory panels recommended last

week that the FDA put emphatic warnings on the drugs. Mark Miller, who

launched the crusade seven years earlier, called it " a wonderful first

step. " He added: " I didn't think it would happen in my lifetime. "

 

The parents will continue to press the FDA to extend the warnings to

adults and to add a warning that the drugs cause some people to become

hostile or even homicidal. They also want Congress to hold the FDA and

the drug companies accountable for failing to warn people sooner.

 

" I can't bear to think of the lives that have been lost in the

intervening years, " Miller said.

 

 

 

 

 

 

 

 

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