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"For all of us, our anxiety levels are higher because we know
that there are people invested in this one way or the other,'' said
Dr. Madelyn Gould, professor of clinical public health in
psychiatry. "Anything that has to do with drug treatment in kids is
so emotionally charged.''
The study had its beginnings early last year when GlaxoSmithKline
submitted to federal drug regulators the results of three trials of
its Paxil antidepressant in teenagers and other children. The
company had undertaken the studies to take advantage of a federal
law that delays by six months the introduction of cheaper, generic
versions of drugs when branded makers test medicines in
children.
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In GlaxoSmithKline's trials, depressed young people given Paxil
fared no better than those given placebos. It was a disappointing
result for GlaxoSmithKline but had no effect on its application for
the six-month extension. Still, a reviewer at the Food and Drug
Administration noticed something strange about the trials: teenagers
given Paxil suffered more problems of ''emotional lability,'' or
instability, than those given a placebo.
The reviewer, Dr. Andrew Mosholder, thought ''emotional
lability'' was overly broad. He asked the company to resubmit its
data, this time using a separate category for suicide.
That report, given in May to both American and British health
authorities, was alarming. Teenagers and younger children given
Paxil were much more likely to become suicidal than those given
placebos. In June, both the British and American authorities warned
doctors against prescribing Paxil to youngsters. Worried that the
problem could extend far beyond Paxil, the F.D.A. in July asked the
makers of eight other antidepressants to submit data from their
studies in youngsters.
In August, Wyeth issued a warning that doctors should avoid
prescribing Effexor to youngsters because it, too, seemed to cause
them to become more suicidal.
By September, the agency had received the other companies'
studies. Looking at them all, Dr. Mosholder concluded that children
given antidepressants were almost twice as likely as those given
placebos to become suicidal. He suggested the agency discourage the
drugs' use in children.
It would have been a monumental step. Antidepressants are among
the biggest-selling drugs in the world and have long been viewed by
doctors as relatively safe. Their use in children has been
soaring.
Dr. Mosholder's bosses at the Food and Drug Administration,
however, said the drug company data was inconsistent and that some
events termed ''possibly suicidal'' seemed innocent. Top agency
officials hired the Columbia researchers to review the data, and
they forbade Dr. Mosholder to speak about his conclusions to an
advisory panel reviewing the matter.
The silencing of Dr. Mosholder prompted outrage among critics of
antidepressants and the ongoing investigation by Senator Grassley.
It also has fostered skepticism about the Columbia study. Already,
Internet postings are questioning the backgrounds of the Columbia
researchers. One asks whether Kelly Posner, the lead investigator,
has participated in trials financed by the drug industry.
In a group interview in a conference room in the New York State
Psychiatric Institute, the researchers said they were unbiased.
Dr. Posner said that she had participated in some trials
sponsored by drug makers but never as a principal investigator. All
of the trials involved attention deficit disorder, not depression or
suicide, she said.
Her three colleagues said that they had never taken part in a
drug-company trial. And they said that their study, while hugely
controversial, was relatively simple: figuring out the appropriate
labels to place on the behaviors in the individual cases.
"We're just dealing with a lot of pieces of paper,'' Dr. Gould
said. "We're not dealing with people at all. And all the interesting
questions happen once we give the data over to the F.D.A.,'' where
the statistical analysis will occur.
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