[Paleopsych] NYT: F.D.A. Links Drugs to Being Suicidal

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F.D.A. Links Drugs to Being Suicidal
NYT September 14, 2004

BETHESDA, Md., Sept. 13 - Top officials of the Food and
Drug Administration acknowledged for the first time on
Monday that antidepressants appeared to lead some children
and teenagers to become suicidal.

Dr. Robert Temple, director of the F.D.A.'s office of
medical policy, said after an emotional public hearing here
that analyses of 15 clinical trials, some of which were
hidden for years from the public by the drug companies that
sponsored them, showed a consistent link with suicidal

"I think that we now all believe that there is an increase
in suicidal thinking and action that is consistent across
all the drugs,'' Dr. Temple said, summarizing the agency's
presentation to a special advisory committee. "This looks
like it's a true bill.''

The acknowledgement, made after the hearing, comes a year
after the agency suppressed the conclusions of its own
drug-safety analyst, Dr. Andrew Mosholder, who first found
a link between the drugs and suicide in teenagers and
children. Agency officials wrote in internal memorandums
that Dr. Mosholder's analysis was unreliable, and they
hired researchers at Columbia University to re-analyze the
same data. That study recently reached conclusions nearly
identical to Dr. Mosholder's.

The testimony came before an advisory committee of 31
independent experts that the F.D.A. has charged with making
a recommendation about the labeling and use of
antidepressants in children and teenagers.

Family members of suicide victims at the hearing angrily
denounced agency officials for the delay in admitting the
risk of antidepressants in children. The British health
authorities decided in December to ban the use of most
antidepressants in children and teenagers.

Mathy Milling Downing of Laytonsville, Md., whose
12-year-old daughter hanged herself in January, said:
"Candace's death was entirely avoidable had we been given
the appropriate warnings. "The blood of these children is
on your hands.''

Agency officials said that they had no regrets about the
months of study. "I don't think the data were at that time
reliable,'' Dr. Temple said. "Scaring people needlessly" or
overdoing a warning is worrisome, he added.

The most popular pills are Zoloft, made by Pfizer; Paxil,
made by GlaxoSmithKline; and Prozac, made by Eli Lilly &
Company. In 2002, nearly 11 million children and teenagers
were prescribed antidepressants.

The risk of suicide among patients given the pills is very
small. If 100 children and teenagers are given
antidepressants, 2 or 3 will become suicidal who otherwise
would not have had they been given placebos, agency
officials said. None of the children in the trials
committed suicide, but some thought about or attempted
suicide, researchers found.

In March, the agency required antidepressant manufacturers
to include on labels a warning that therapy with
antidepressants could lead some patients, both adults and
children, to become suicidal. The committee must decide
whether this warning is strong enough or whether the drugs
should be banned for children. The advisory committee is
expected to make a decision on Tuesday. The F.D.A. normally
follows recommendations of its advisory committees.

It is a complex task. Most studies of the drugs have failed
to show that they have any effect on depression in children
and teenagers. But the drugs have proven effective in
adults, and studies suggest that teenage suicide rates have
dropped in countries where use of antidepressants is
widespread. A large study of depressed teenagers conducted
by the National Institute of Mental Health recently found
that Prozac was far more effective in treating depression
in children and teenagers than was talk therapy.

Several speakers noted that clinicians would have almost
nothing to offer depressed teenagers and children if
antidepressants were banned. Suicide is the third leading
cause of death among teenagers, trailing only homicide and
accidents. Without treatment, many more teenagers will die,
several experts said. If the committee suggests an even
stronger warning, some patients will resist therapy and
could perhaps die, some speakers said.

The issue has roiled the agency and is likely to transform
the way the drug industry markets its products. Committees
in both the House and Senate have begun investigations
following disclosures that Dr. Mosholder's analysis had
been suppressed.

The New York State attorney general Eliot Spitzer, filed
suit against GlaxoSmithKline, charging the drug maker with
fraud for failing to disclose the results of clinical
trials of Paxil that found no benefit while promoting the
drug to physicians. The company settled the suit this
summer by promising to disclose the results of all of its
clinical trials of its marketed products dating back to

Editors of the nation's top medical journals have said they
will not to accept for publication trials that have not
been publicly registered, and legislation is expected to be
offered in both the House and the Senate requiring the
disclosure of the results of all major drug tests on

For some bereaved parents, Monday's hearing was a chance to
take drug makers and the F.D.A. to task.

Mark and Cheryl Miller of Overland Park, Kan.,, told the
committee that their 13-year-old son, Matthew, had
committed suicide seven months ago while taking Zoloft.

"Why haven't parents like Cheryl and myself and countless
others been told the truth?'' Mr. Miller asked.

But others said that antidepressants had helped millions.
Dr. Suzanne Vogel-Sibilia of Beaver, Pa., said that she had
brought her 15-year-old son, Tony, to the hearing to
represent what she said were the vast majority of patients
who had been helped by the drugs.

"Please help me preserve my future," Tony told the
committee. "Don't take away my medication."

Claims that antidepressants cause patients to become
acutely suicidal have been made since 1991, just three
years after Prozac was introduced. But drug makers and
regulators long dismissed these claims, saying they were
anecdotal reports without any basis in rigorous clinical

Then last year, GlaxoSmithKline announced that tests of
Paxil had found that teenagers and children who took the
pill were more likely to become suicidal than those given
placebos. The announcement was quickly followed by a
similar one from Wyeth, the maker of Effexor, another
antidepressant. Suddenly, the anecdotal reports were being
confirmed by clinical trials.

Still, just how the drugs may lead some people to become
suicidal remains the subject of fierce debate. Many of
those at the hearing said that the pills had brought a
change in the personalities of their friends and relatives.
Alice Erber said that Paxil caused her 21-year-old son,
Jake Steinberg, to throw himself in June from the 24th
floor of a Manhattan office building.

"If he had not taken Paxil, he would be alive today,'' Ms.
Erber said.

But Dr. Temple speculated that some people taking the pills
become suicidal because they are actually getting better.
As their depression improves, he said, they gain the energy
to act on suicidal thoughts that their illness had

"I think the work is cut out for us tomorrow,'' Dr. Wayne
Goodman, chairman of the advisory committee, said at the
end of Monday's hearing.


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