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 safety."
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 commercial impact."
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