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BY JACOB GOLDSTEIN AND SARA OLKON, email@example.com
September 12, 2004
The controversy over kids and antidepressants could force drug companies to reveal all.
Dana Kwiatkowski, a petite teenager with creamy white skin and dark ringlet curls, woke one winter morning obsessed with violent thoughts.
Then 15, the Cooper City High School sophomore planned to kill her mother, brother and herself.
Her mother, Lucy, had Dana hospitalized, but at Joe DiMaggio Children’s Hospital in Hollywood, the teen didn’t fare much better. She was convinced that staffers were poisoning her food and giving her injections while she slept.
”I couldn’t tolerate the fact that I was going insane,” she said.
Kwiatkowski was hospitalized a week after her doctor began cutting her dose of Paxil, an antidepressant that came on the market in 1992 and has since been prescribed to hundreds of thousands of kids.
Doctors at the hospital took her off Paxil and put her on other medication, and she was released after nine days.
Last month, Kwiatkowski and her mother sued GlaxoSmithKline, Paxil’s manufacturer. Studies suggest that the drug contributes to suicidal tendencies in some kids, especially when they start taking the drug or when they go off it. The Kwiatkowskis’ lawsuit alleges GSK knew this, but “fraudulently kept relevant information from potential Paxil users.”
The lawsuit comes amid a noisy public debate that includes the Food and Drug Administration, Congress, the pharmaceutical industry and the editors of leading medical journals. The debate extends beyond kids and antidepressants to encompass what drug companies reveal about their scientific studies and how doctors decide what to prescribe to their patients.
Last month, GSK settled a Paxil lawsuit brought by New York Attorney General Eliot Spitzer. Without admitting guilt, the company agreed to pay $2.5 million and to establish an online registry of its clinical trials — not just on antidepressants, but on all drugs.
The creation of the registry strikes at one of the lawsuit’s chief complaints against the company: that it widely disseminated the results of one study that suggested Paxil worked in kids, but ”concealed and suppressed” the results of two other studies that suggested the drug worked no better than sugar pills.
Critics have long leveled charges like these against the drug industry, which funds most of the clinical trials the FDA uses to determine which drugs to approve, and many of the studies published in medical journals.
”What you can say about kids and antidepressants you can say about a lot of other families of drugs: The most positive studies get published — often get published repeatedly — and the negative studies don’t get published,” said Dr. Marcia Angell, the former executive editor of the New England Journal of Medicine and the author of The Truth About the Drug Companies, a recent book critical of the pharmaceutical industry.
“So both doctors and patients get biased views of the drugs: They think they’re better than they are.”
Mary Anne Rhyne, a GSK spokeswoman, said the company had not buried Paxil data.
”We did do research, and we did try to share the results,” she said.
But according to court documents, an internal GSK memo from 1998 cited the mixed results of the various Paxil studies and set a goal to “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.”
A GSK statement issued earlier this summer said the memo “does not reflect the company position.”
Last week, a coalition of editors from leading medical journals — including the New England Journal of Medicine, the Journal of the American Medical Association and the Lancet — announced that, starting next year, any drug companies that want to publish in those journals will be required to post all of their clinical trials on an online registry.
Dr. Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, said the new policy was created not because of the kids and antidepressants controversy in particular, but because the entire system for disseminating clinical trial data is flawed.
”The whole area of patient care is being compromised by not having access to all the data,” she said. “We want all the studies. If you only know the positive ones, that’s not going to help you.”
Rhyne said GSK had not yet had time to evaluate the specifics of the journal editors’ announcement, but she said the registry could end up being a good thing for the industry.
”This is a discussion we want to be part of,” she said. “There’s an unacceptable lack of confidence in pharmaceutical industry research, and that has an impact on confidence in medicine.”
The creation of the registry may help manage the flow of data in years to come, but for the moment, regulators, doctors, parents and depressed kids are faced with uncertainty.
INTRODUCED IN ’80s
Paxil is a member of a popular class of antidepressants, known as SSRIs, which have been used widely since their introduction in the late 1980s. The drugs have come under intense scrutiny in the last year, as two new FDA analyses of existing data have questioned the safety of many of SSRIs when used in children and adolescents. This analysis was late in coming in part because the SSRIs, like many drugs, were approved based solely on studies in adults.
Prozac, the only antidepressant specifically approved for use in kids, fared best in these studies, which suggested the drug did not increase the risk of suicidal behavior. Paxil fared among the worst: Both FDA studies suggested the drug increased the likelihood of ”suicide-related events” such as suicidal thoughts or actions.
Last summer, the FDA advised doctors not to use Paxil to treat depression in children. The British equivalent of the FDA went further, warning against the pediatric use of all SSRIs except Prozac.
Congress held hearings on the issue last week, and an FDA committee is scheduled to meet Monday to consider issuing sterner warnings about the risks SSRIs may pose to children.
Meanwhile, as the public debate drags on, many doctors worry that parents will be scared away from seeking treatment for troubled kids — an outcome that could lead to ”more deaths and more problems from not treating all those kids,” said Dr. Suzanne Vogel-Scibilia, a psychiatrist on the board of the nonprofit National A
lliance for the Mentally Ill.
Vogel-Scibilia said the SSRI Zoloft helped lift her own son out of depression.
”He was sad, he was irritable, he was crying, he wasn’t doing well in school, he didn’t want to go out and play, he wasn’t sleeping,” she said. “He started on the medicine and he got better . . . He was wanting to do things, he was doing better in school, he was back to his old self.”
Stories like those abound, and studies suggest the combination of talk therapy and drugs may be the best way to treat depression in kids.
Dr. Jon Shaw, chief of child and adolescent psychiatry at the University of Miami medical school, cautioned against taking extreme positions on the issue: advocating SSRIs as a panacea on the one hand, or condemning them as useless killers on the other.
”There’s a danger in jumping to conclusions,” Shaw said. “It’s a complicated problem, and there’s still a search for truth.”