As this month began, a landmark research study and an unusual lawsuit by the state
of New York added to the current controversy about whether children and adolescents
with depression should be treated with the popular antidepressant medications
known as selective serotonin reuptake inhibitors (SSRIs), a class of drugs which
includes the best-selling Prozac and Paxil.
On June 1, researchers carrying out a federally funded study
at Duke University announced preliminary findings that Prozac works
significantly better than talk therapy to combat depression in adolescents,
although a combination of the two treatments is the optimum. The early data
also suggest that Prozac does not, in fact, raise the risk of suicide in
adolescents, and that the benefits of taking it far outweigh the risks if a
teen is battling moderate to severe depression.
On June 2, New York State Attorney General Eliot Spitzer filed a
consumer-fraud lawsuit against the manufacturer of the antidepressant Paxil,
charging that international pharmaceutical giant GlaxoSmithKline deliberately
suppressed negative data about Paxil's safety and efficacy when prescribed
for depression in children and adolescents.
Specifically, Spitzer's lawsuit alleges that the company suppressed the
results of four studies it conducted that failed to demonstrate Paxil's
effectiveness against depression in children, and suggested possible
increased risk of suicidal thinking and acts. Out of the five studies it
conducted, Glaxo released the results only of the one that showed mixed
results on efficacy in children and teens, the suit alleges.
As the New York Times story on the lawsuit notes, the suit highlights
two particular issues about antidepressants that have recently made
headlines and captured medical and public attention. One is the previously
mentioned question of whether some antidepressants, specifically some SSRIs,
can actually increase suicidal tendencies, especially in children and
adolescents. The other is whether, and to what extent, drug companies pick
and choose among the data they present to the U.S. Food and Drug
Administration when seeking FDA approval for a drug, presenting only those
studies that support the drug's efficacy and safety and suppressing any that
reach the "wrong" conclusions.
"Doctors should have access to all scientifically sound information so that
they can prescribe appropriate medication for their patients," Spitzer said
of his lawsuit. "By concealing critically important scientific studies on
Paxil, Glaxo impaired doctors' ability to make the appropriate prescribing
decision for their patients and may have jeopardized their health and
The suit, filed in New York State Supreme Court, also stated that an
internal Glaxo document from 1998 shows that the company intended to "manage
the dissemination of [the] data in order to minimize any potential negative
It alleges that Glaxo misrepresented the drug to its sales representatives
who promote Paxil to physicians, as having "remarkable efficacy and safety
in the treatment of adolescent depression," despite the company's studies
that suggested differently.
Glaxo issued a statement the same day asserting that the company "has acted
responsibly in conducting clinical studies in pediatric patients and
disseminating data from those studies.... All pediatric studies have been
made available to the FDA and regulatory agencies worldwide."
"As for the 1998 memo, it is inconsistent with the facts and does not
reflect the company position," the statement continues.
Paxil has been approved by the FDA for the treatment of depression in adults
but not in children. The only antidepressant that has been approved to treat
depression in children is Prozac, which is made by Eli Lilly & Co.
It is, however, legal for doctors to use their discretion to prescribe
medications for uses other than the approved ones, if clinical practice has
shown them to be useful. They are especially likely to do so if the
medications are similar to ones that are approved for those uses.
This widespread practice is called "off-label" prescribing.
U.S. sales of Paxil to treat mood disorders in children and adolescents
totaled $55 million in 2002, the lawsuit states. The suit seeks the return
of all profits Glaxo has earned as a result of the alleged misconduct.
Meanwhile, according to a New York Times report, the researchers for
the Duke University study announced at a psychiatric meeting in Phoenix that
the 12-week data showed that a combination of Prozac plus "talk" therapy
worked best for depressed teenagers, with 71 percent of these patients
responding well to treatment. Prozac alone worked next best, improving
depression in 61 percent of the young patients. Talk therapy alone
(specifically, cognitive-behavioral therapy, which previous studies have
shown to be the most effective type of talk therapy at combating depression)
worked only slightly better than a placebo. Only 43 percent of the patients
treated with cognitive-behavioral therapy, versus 35 percent of those taking
a placebo pill, showed significant improvement. None of the 378 teens aged
12 to 17 committed suicide, although there were six attempts.
The Duke team, whose research is being funded solely by the federal National
Institutes of Mental Health with no drug-company involvement, is currently
analyzing the data from the rest of the year-long study.
Sue Wilson is a journalist who writes frequently on health and science topics for such outlets as the New York Times, WNET, and UNICEF
The comments section is provided as a free service to our readers. Gotham Gazette's editors reserve the right to delete any comments. Some reasons why comments might get deleted: inappropriate or offensive content, off-topic remarks or spam.