"All Truth passes through Three Stages: First, it is Ridiculed...
Second, it is Violently Opposed...
Third, it is Accepted as being Self-Evident." - Arthur Schopenhauer (1778-1860)

  www.AntidepressantsFacts.com -Archive  

All Truth passes through Three Stages: First, it is Ridiculed... Second, it is Violently Opposed...Third, it is Accepted as being Self-Evident.- Arthur Schopenhauer (1778-1860) By Charly Groenendijk
June 4, 2004

  Response to Prozac/Sarafem (fluoxetine) disinformation  

Response to Prozac/Sarafem disinformation
Significant conflict of interests! Lead authors of study, psychiatrists Dr. John March and Dr. Graham Emslie, have substantial ongoing financial ties to antidepressant drug companies including Eli Lilly, manufacturer of Prozac/Sarafem (fluoxetine)...

Go to PROZAC/SARAFEM (Fluoxetine) SIDE-EFFECTS: Cases & Reviews

UPDATE AUG, 18  2004:
In the midst of federal investigations into the marketing & safety of antidepressants, Dr. Graham Emslie (TMAP co-developer) keeps on deceiving the public by promoting Prozac and other SSRI's as perfectly safe to use. See: Teens with Depression Show Improvement When Medication, Therapy Combined

A NewYorkTimes article ANTIDEPRESSANT SEEN AS EFFECTIVE FOR ADOLESCENTS June, 2  2004, suggests Prozac/Sarafem (fluoxetine) being a safe SSRI-antidepressant for use in children despite recent self-harm, aggression & suicide warnings for use of SSRI-antidepressants in children & adolescents. Abovementioned warnings were issued by the following drug regulators:
* Health Canada June 3, 2004
* FDA (United States) March 22, 2004
* TGA (Australia) March 11, 2004
* MHRA (United Kingdom) Dec 10, 2003.
A response by Dr. Ann Blake Tracy (www.drugawareness.org) & Vera Hassner Sharav (www.ahrp.org) follows

Response from Dr. Ann Blake Tracy:

JUNE, 4  2004
Yesterday you likely saw that a new study came out in the news stating that Prozac is good for children. On NBC Evening News you saw Sherri Walton and her teen daughters, Katie and Kendell, from Paradise Valley, AZ defending Prozac and talking about how wonderful the drug has been for them.

Now for the rest of the story . . . Sherri is one of the many moms on an SSRI who regularly end up with daughters on these drugs as well. They start on the drugs and begin to think they are going crazy because they do not realize it is the drug making them feel that way. Then they think it must be inherited and their kids need something too. The presentation to the FDA by Sherri and her daughter Katie was one out of only TWO parents who came to the FDA to defend these drugs. Both presentations were by mothers on the drugs themselves.

Katie Walton testified along with her mother to the FDA. She stated that she BECAME SUICIDAL WHILE ON AN ANTIDEPRESSANT and then a doctor found the right combination of medications for her. So that was part of what you did not hear on that broadcast.

Now let us look at the information we have on this study that was supposed to assure the world that Prozac is safe for kids. We were told that 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.

I want to know where the evidence is that they were doing better. Show me the criteria that demonstrates improvement when the suicide rate for those taking Prozac was DOUBLE and the suicide attempts were FIVE TIMES HIGHER for those on Prozac than those on placebo! Yet they have the nerve to attempt to tell us that the patients became significantly less suicidal. Clearly the results of this study does not demonstrate that.

Why did the study go for 36 weeks while they only analyzed the first 12 weeks? What happened in the next 24 weeks if they were already trying to kill themselves at a FIVE TIMES GREATER RATE those first 12 weeks than those who only took a sugar pill? Who did the math here to determine that this was evidence they were doing better?!

Was Dr. Graham Emslie who decided that the children were feeling so much better? Why was he a part of this study and not disqualified due to his conflicts of interest? Just how much money has he already made from drug companies in doing studies on SSRI antidepressants and children? Would he ever do research for these companies again if the study results in this study turned out negative for antidepressants in children?

How anyone could report those statistics and then draw those conclusions is beyond me. But if they have done research for these companies in the past or hope to in the future do you really think they could have done it any other way? Someone should be asking how many of the others involved in this study had done research for Lilly on Prozac previously or one of the other SSRIs and how much they have made? Now there is a question for a great investigative reporter.

Seriously, no one could be that bad at math . . . unless it paid really well or protected themselves in some way. What has me really stumpted is why reporters did not ask any of these questions before putting it on the evening news or in the newspapers.

Ann Blake Tracy, Ph.D.
Executive Director, International Coalition For Drug Awareness
Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare
& audio tape on safe withdrawal: "Help! I Can't Get Off My Antidepressant!"

Order Number: 800-280-0730
Website: www.drugawareness.org

Response from Vera Hassner Sharav:

JUNE, 3  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

(scroll down to the bottom)

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,

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.

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?

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,

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
e-mail: veracare@ahrp.org

The New York Times
June 2, 2004

Antidepressant Seen as Effective for Adolescents


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.