NY Times Does it Again – Drug Advertisers Get Front Page Coverage to Boost SSRI Market

Wed, 2 Jun 2004

The New York Times saw fit to print a report about preliminary, unpublished findings of a study whose authors claim to have “found that Prozac helps teenagers overcome depression far better than talk therapy.” The unexamined findings were “In the midst of a worldwide debate on whether depressed children should be treated with antidepressant drugs like Prozac.”

The study was sponsored by the National Institute of Mental Health, at a cost of $17 million to taxpayers. However, The Times reporter neglects to inform readers that the lead authors of the study-psychiatrists Dr. John March and Dr. Graham Emslie–have substantial, ongoing financial ties to antidepressant drug companies–including Eli Lilly, manufacturer of Prozac– that may present a significant conflict of interest.

Dr. March receives research support from Pfizer Inc., Eli Lilly and Co., and Wyeth, and is a speaker for and/or consultant to Solvay, GlaxoSmithKline, Pfizer Inc., Wyeth, Novartis, and Shire. See: Current Psychiatry, Vol. 2, No. 11 / November 2003 http://www.currentpsychiatry.com/2003_11/1103_ocd.asp

Dr. Emslie receives research grants from Eli Lilly, Novartis and Organon; and is a consultant / speaker’s bureau for Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Forest, Pfizer, McNeil, Otsuka, and Wyeth. He also serves on the Corporate Contributions and Research Committee for the American Academy of Child and Adolescent Psychiatry. See: American College of Neuropsychopharmacology, Executive Summary, http://www.cspinet.org/cgi-bin/integrity.cgi

Why didn’t NIMH seek independent psychiatrists to conduct the study? Could they not find psychiatrists who are not compromised by their financial ties to Eli Lilly and the other SSRI manufacturers? The Times didn’t ask.

The antidepressant drug manufacturers stand to gain billions of dollars from a front page article in the Times that announces beneficial drug findings-even if the announced findings are based on partial data and later overturned when the claims fail the test of a scientific examination by independent, credible experts.

Indeed, every independent, peer reviewed analysis of all previous antidepressant trials in children and adolescents-including by FDA’s own analysts–found that the unpublished data contradicted the positive claims made by investigators who were paid industry consultants.

Two previous Prozac studies in adolescents, by Dr. Emslie claimed beneficial findings but FDA’s statistical analysts disagreed, concluding: “based on the primary endpoint, there was no evidence of treatment effect.” See: FDA. CDER. Application 18-936 / SE 5-064 (Eli Lilly, fluoxetine, Prozac). Statistical Analysis. http://www.fda.gov/cder/foi/nda/2003/18936S064_Prozac%20Pulvules_statr.pdf

A 2004 meta-analysis of antidepressant trials in the British Medical Journal concluded: “Investigators’ conclusions on the efficacy of newer antidepressants in childhood depression have exaggerated their benefits. the clinical significance of the drug effect should be questioned.” See: Efficacy and safety of antidepressants for children and Adolescents by Jon N Jureidini, et al. BMJ, online at: http://bmj.bmjjournals.com/cgi/content/full/328/7444/879?

A meta-analysis published in The Lancet, the world’s most prestigious medical journal, shattered the credibility of previously published journal reports that claimed antidepressant drugs were “safe and effective” in children and adolescents. See: Craig J Whittington, Tim Kendall, et al, Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. The Lancet. Volume 363, April 24, 2004, pp. 1341-45 and Editorial, p. 1335

How do Times editors explain the paper’s failure to report the findings of the most authoritative analysis of both published and unpublished antidepressant pediatric data? http://www.thelancet.com/journal/journal.isa

At the very least the Times should have reported the NIMH-sponsored claimed findings by Drs. March, Emslie, et al, in the context of the authoritative, critical meta-analyses by investigators who have no financial ties to antidepressant drug companies.

The Times reports that of the 439 depressed youths enrolled in the NIMH year long study, 378 completed the first 12 weeks. What happened to the 61 adolescents who dropped out? The Times reports that there were 5 suicide attempts by teenagers taking Prozac compared to one in psychotherapy during those 12 weeks. How many suicide attempts occurred during the remainder of the study? How many completed the 12 month study? What other adverse effects did the adolescents testing Prozac suffer? The Times didn’t ask.

One questions also, the prominent placement of an unpublished, preliminary finding of partial data, by investigators whose previous reports were contradicted by several meta-analyses of the entire body of evidence, on the Times front page. A front page drug-related headline assures the Times continued income from its heaviest advertisers.

It does appear that the Times editors have learned nothing from the paper’s most recent journalistic debacle-that is, the paper’s tainted reports about Iraq’s phantom Weapons of Mass Destruction by Judith Miller. See: Daniel Okrent’s acknowledgement, http://www.nytimes.com/2004/05/30/weekinreview/30bott.html

The Times would do well to heed the recommendation of Slate editor, Jack Shafer, and create a column–Where We Went Wrong-to regularly revisit its news reports. The Times’ greatest failure to get it right is its medical news reports which are under the influence of the biotech/ pharmaceutical industry. These reports are in greatest need of such re-examination in light of subsequent information that, all too often, negates early reports about “landmark” research findings.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

http://www.nytimes.com/2004/06/02/health/02DEPR.html
The New York Times
June 2, 2004
Antidepressant Seen as Effective for Adolescents

By GARDINER HARRIS

PHOENIX, June 1 – In the midst of a worldwide debate on whether depressed children should be treated with antidepressant drugs like Prozac, a landmark government-financed study has found that Prozac helps teenagers overcome depression far better than talk therapy. But a combination of the two treatments, the study found, produced the best result.

The study, sponsored by the National Institute of Mental Health, was the first to compare psychotherapy and drug treatment for depressed adolescents. Statistically, the researchers found, talk therapy – in which a patient discusses problems with a therapist – was by itself no more effective in reducing the depression than treatment with placebos. But when combined with drug treatment, psychotherapy appeared to provide added benefit and to reduce the risk of suicide.

The findings are likely to reassure psychiatrists, pediatricians and others who increasingly prescribe antidepressants to teenagers and children. Millions of young people take the drugs.

Experts said that the study was notable for its size and for the fact that it was carried out without financing by drug manufacturers. Data on the effects of antidepressants in adolescents is in short supply. Most studies of the question have been small trials sponsored by pharmaceutical companies and have failed to show that the drugs are effective for depressed teenagers.

“This study should put to rest doubts about whether these drugs work in teenagers with severe depression,” said Dr. Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center and an author of the study, which was presented here on Tuesday at a meeting of psychiatric drug researchers.

Still, the findings are unlikely to resolve the controversy over whether Prozac and similar drugs lead a small number of teenagers and children to become suicidal.

Such concerns led the Food and Drug Administration to warn earlier this year that patients taking the drugs should be watched closely for signs of suicide or other harmful behavior in the first weeks of therapy. The agency is reanalyzing suicidal events that occurred during drug-company trials of antidepressants in children and teenagers. British drug regulators have banned the use of all but Prozac in those younger than 18.

The government study, called the Treatment for Adolescents with Depression Study, involved 439 youths ages 12 to 17 who were suffering from moderate to severe depression.

The adolescents were randomly assigned to be treated for a period of 36 weeks with either Prozac, the antidepressant drug made by Eli Lilly & Company; a form of talk therapy known as cognitive behavioral therapy; placebo pills; or a combination of Prozac and talk therapy.

The researchers collected data on the subjects for a year, but have only analyzed information from the first 12 weeks so far. Of the youths recruited for the study, 378 completed the first 12 weeks of treatment. Their mean age was 15. Depression levels were measured using several common psychological scales.

Using one measurement scale, the researchers found that after 12 weeks, 71 percent of the subjects who received Prozac and talk therapy responded well to treatment, compared with 61 percent of those who received Prozac alone, 43 percent of who received talk therapy alone and 35 percent of those who received a placebo treatment. By another measure, talk therapy alone fared no better than treatment with placebos.

The researchers also found that patients became significantly less suicidal, no matter which treatment they were given. No patient committed suicide during the trial. But the risk of a suicide attempt among the patients given Prozac was twice that of those who did not, the study found. There were five suicide attempts among those given Prozac and just one among other participants.

Dr. John March, a professor of psychiatry at Duke University and the study’s lead investigator, said that the findings showed Prozac’s benefits for depressed teenagers and children far outweighed its risks. “The take-home message is that these adverse events are extremely rare,” he said.

Dr. March acknowledged, however, that the controversy about suicide and antidepressant therapy was far from resolved. “We’re all holding our breath to see what the F.D.A. is going to do,” he said.

Psychologists, who are often the providers of talk therapy and who cannot prescribe drugs, are likely to be disappointed in the finding that cognitive behavioral therapy was found to be little better than a sugar pill. A recent major trial comparing drugs with talk therapy in children with attention-deficit disorder also showed that the drugs worked better.

But the findings of another study presented on Tuesday suggest that for some conditions, talk therapy may be more effective than antidepressants. That study compared cognitive behavioral therapy with Zoloft, an antidepressant similar to Prozac that is made by Pfizer, in teenagers who suffered from obsessive compulsive disorder. Those who received the talk therapy, the study found, improved more than those who were treated with the drug.

Dr. Thomas Insel, director of the National Institute of Mental Health, said he was pleased the results of the depression study were so clear. The institute spent $17 million over six years financing the trial. “The most striking thing about the study is that, in all groups, there was a dramatic decrease in the amount of suicidal thinking,” he said, suggesting that all the therapies were protective.

Dr. David Brent, a professor of psychiatry at the University of Pittsburgh not involved with the study, suggested that another form of talk therapy called interpersonal therapy might have fared better than cognitive behavioral therapy.

In interpersonal therapy, clinicians focus on a patient’s relationships with peers and family members and the way they see themselves. In cognitive behavioral therapy, clinicians teach patients to try to think more positively and do things that make them happy.

Dr. Brent said it was good news that drugs produced better results than talk therapy “because it’s hard to get people into cognitive therapy anymore. They just don’t want to take the time.”

The researchers said they plan to publish the preliminary results of the study this summer, with further analyses later.

Dr. Insel said that the most useful information from the study is yet to come. “We need to know which treatments work best for what kinds of kids and who may be the most vulnerable to the side effects,” he said. Those sorts of answers would come from more data analysis, he said.

“We’re going to get a lot out of this study that the public really needs to know right now,” Dr. Insel said.

Copyright 2004 The New York Times Company

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