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Second, it is Violently Opposed... Third, it is Accepted as being Self-Evident." - Arthur Schopenhauer (1778-1860)
By Charly Groenendijk
AntidepressantsFacts June 4, 2004
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
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: A response by Dr. Ann Blake Tracy (www.drugawareness.org) & Vera Hassner Sharav (www.ahrp.org) follows.* Health Canada June 3, 2004
Response from Dr. Ann Blake Tracy:
JUNE, 4 2004
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.
Order Number: 800-280-0730
Response from Vera Hassner Sharav:
JUNE, 3 2004
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.
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.
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."
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."
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.
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.
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
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.
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