What the data really shows about suicides

Paragraphs 5 & 6 read:  "The claimed causal linkage is negated by the facts: In October 2004, the American Psychiatric Association published the following:

"In 2003, U.S. physicians wrote 15 million antidepressant prescriptions for patients under age 18, according to FDA data. In the first six months of 2004, antidepressant prescriptions for children increased by almost 8 percent, despite the new drug labeling."

http://www.ahrp.blogspot.com/

Pharma Spin and Child Suicide Rates

Today's news reports about an increase suicide rate in 2004 offer an opportunity to witness how the media unwittingly disseminates pharmaceutical industry generated propaganda.

According to the Center for Disease Control and Prevention's Annual Summary of Vital Statistics, the suicide rate rose more than 18 percent in those 1 to 19 years old from 2.2 per 100,000 in 2003, to 2.6 per 100,000 in 2004. In those 15 to 19 years old, the figures reflected a more than 12 percent rise in suicide, from 7.3 per 100,000 in 2003 to 8.2 per 100,000 in 2004.

"The rise occurred at the same time that the Food and Drug Administration mandated heightened warnings on the labels of selective serotonin reuptake inhibitors (SSRIs), a particular class of antidepressant medications that includes Prozac, Paxil and Zoloft."

The linkage between the increased suicide rate and warnings on SSRI labels was manufactured by antidepressant drug companies and their PR firms who have embarked on a campaign to keep physicians and parents uninformed about the risks posed by the drugs prescribed.

The claimed causal linkage is negated by the facts: In October 2004, the American Psychiatric Association published the following:

 

"In 2003, U.S. physicians wrote 15 million antidepressant prescriptions for patients under age 18, according to FDA data. In the first six months of 2004, antidepressant prescriptions for children increased by almost 8 percent, despite the new drug labeling."

 

See: American Psychiatric Association, News & Notes Survey Paints Bleak Picture of Health Insurance Coverage and Premiums, Psychiatric Services October 2004, 55:1192-1193 online at: [ Link]

 

So, if antidepressant prescriptions for children INCREASED by almost 8% in the first six months of 2004, how could an INCREASED suicide rate the same year be blamed on reduced use of antidepressants???



 

The "authorities" quoted in today's media reports make bald, unsubstantiated pronouncements asserting causal links between the black box warnings and the finding of increased suicide rates. This is known as an ecological fallacy. Those who present themselves as "authorities"-- Dr. Nemeroff and Dr. Fassler--should be more judicious about making scientifically invalid claims.

Dr. Charles Nemeroff's financial ties to manufacturers are legendary. He has even been found to have put his name to a ghostwritten article and published it in a journal that he previously was the editor in chief of. (See, for example: Wall Street Journal; New York Times editorial, and more: [Link] [Link] .

And Dr. David Fassler, a spokesman for the American Psychiatric Association and the American Academy of Child & Adolescent Psychiatry, has never found fault with prescribing any psychotropic drug or drug combination for children.

The media fell for an industry planted "news" item inappropriately linking suicide rates and antidepressant use. The media had fallen for industry's manufactured myths before. For example, the mythological "chemical imbalance" in the brain of depressed persons who, it was claimed, needed an SSRI antidepressant to increase serotonin levels.

When will medical news reporters and science editors adopt of a bit of skepticism rather than disseminate Big Pharma's planted spins?

[ Link] Child Suicide Rate Spikes Nearly 20 Percent ABC News Medical Unit

Feb. 5, 2007 - February 5, 2007 - Child and teen suicide rates rose for the first time in more than a decade in 2004 - and many psychological experts said the stronger warning labels that led to a drop in the number of prescriptions for antidepressant drugs may be to blame.
According to the Center for Disease Control and Prevention's Annual Summary of Vital Statistics released Monday, the suicide rate rose more than 18 percent in those 1 to 19 years old, from 2.2 per 100,000 in 2003 to 2.6 per 100,000 in 2004.
In those 15 to 19 years old, the figures reflected a more than 12 percent rise in suicide, from 7.3 per 100,000 in 2003 to 8.2 per 100,000 in 2004.
The rise occurred at the same time that the Food and Drug Administration mandated heightened warnings on the labels of selective serotonin reuptake inhibitors (SSRIs), a particular class of antidepressant medications that includes Prozac, Paxil and Zoloft.
The "black box" warnings were added in March 2004 over concerns that the medications led an increase in suicidal thinking in patients. The prescribing of these medications to children subsequently dropped by 20 percent.
Not all experts said there was a clear link between the warning labels and the increase in suicide rates, but many believe the association is too dramatic to ignore.
"I have no doubt that there is such a relationship," said Dr. Charles Nemeroff, chairman of the department of psychiatry and behavioral sciences at the Emory University School of Medicine. "The concerns about antidepressant use in children and adolescents has paradoxically resulted in a reduction in their use, and this has contributed to increased suicide rates."
"This is very disturbing news," said Dr. David Fassler, clinical professor of psychiatry at the University of Vermont College of Medicine. "The adolescent suicide rate has been declining steadily since the early 1990s. "The sudden increase in the adolescent suicide rate," Fassler continued, "corresponds to the significant and precipitous decrease in the use of SSRI antidepressants in this age group."
The nonprofit group Mental Health America has also called for a further look into the FDA's decision to strengthen warnings on SSRIs. "As a result of the agency's activities, dramatic decreases in the use of SSRIs in the adolescent population were noted," said David Shern, president of Mental Health America in a statement issued Monday. "Other research has indicated a general relationship between the use of SSRIs and decreasing suicide rates in the general population.
"We must therefore wonder if the FDA's actions and the subsequent decrease in access to these antidepressants have caused an increase in youth suicide."
Warning Labels May Scare Doctors, Parents Some doctors say the additional black box warnings may have led medical professionals to be less confident in prescribing antidepressants. "In the state of Michigan, we have found that our colleagues in pediatrics have become increasingly uncomfortable with the prescription of SSRIs following the institution of the black box warning," said Dr. Sheila Marcus of the section of child and adolescent psychiatry at the University of Michigan Hospitals.
"The past history of such FDA warnings has revealed that they create barriers to care and unnecessarily frighten families away from seeking treatment," Nemeroff said.
Whether SSRIs actually increase the likelihood that a child or teen will commit suicide is still unclear. Studies at the time did show that young patients taking the drugs did have increased thoughts of suicide. But whether increased thoughts lead to increased action when it comes to suicide is still a matter of debate. "There could be a small relationship, but we don't have the evidence to support that there is a causal link at this point in time," said Bernadette Melnyk, dean and professor of nursing at the Arizona State University College of Nursing and Healthcare.
"What we know about the link between antidepressants and suicide is they can cause an increase in suicidal thinking, but no study has shown an increase in suicides as a result of antidepressants," said Lori Evans, project coordinator of Treatment of Adolescent Suicide Attempters.
"We do not have the data to know if there has been a significant decrease in the amount of prescriptions given to teens since the warning. Therefore we certainly cannot say there is a causal link."
But Fassler said the new figures suggest that the black box warnings may be doing more harm than good.
"The FDA decision to place a black box warning on these medications remains controversial," Fassler said. "To this day, there are no data demonstrating that SSRI antidepressants increase the actual risk of suicide.
"Conversely, the current data suggest that the decreased use of these medications is, in fact, associated with an increase in actual deaths attributable to suicide."
More Evidence Needed
Despite the suggestions of a connection between the drop in SSRI prescriptions and the spike in child and teen suicides, more research will be needed before a conclusive link can be drawn.
And some say the government has not yet sought an adequate answer to the question of whether this link truly exists.
"I don't think that we know for sure, and that is the fundamental problem here," said Dr. Bennett Leventhal, director of the Center for Child Mental Health and Developmental Neuroscience at the University of Illinois. "The NIH, CDC and other agencies have failed their responsibility of funding proper studies with enough power to answer the important questions about medical treatment of suicide in children, as well as the side effects of these medications."
Another possibility is that a shortage in child therapists could lead to a decreased ability of children and teens to seek psychological help when it is needed. "We lack approximately 30,000 child psychiatrists in the U.S., so the gaps in mental health services for those children and youth who need them are huge," said Bernadette Melnyk, dean and professor of nursing at the Arizona State University College of Nursing and Healthcare. "With one out of four children and teens affected by a mental health problem, less than 25 to 30 percent receive any treatment."
Leventhal said the lack of trained professionals means young patients must sometimes wait a long time for treatment. "Depression is horrible, but waiting without treatment is worse," he said. "Imagine if we tolerated that for cancer or heart disease."
But the fact that the jump in youth suicide corresponded with the changes in SSRI labeling has many suggesting that the government re-examine its policy toward antidepressant warnings. "I hope the FDA studies this report carefully," Fassler said. "I think they have an obligation to monitor the impact of their regulatory decisions and to make such modifications as may be appropriate based on subsequent research findings."
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This commentary was originally posted on the CHAADA Blog in February 2007, when the latest attempts of PhRMA and psychiatrists to discredit the Black Box warnings started going full force:

One of the many unethical things an "expert" may commonly do is lie for a summary or position statement. When people trust the expert opinion over the actual facts and do not check into it for themselves, they can believe a lot of false things. You can find examples of this in many studies. The abstract may read much differently than the results, and the results are often explained away in the discussion if the authors don't like them. The latest spin on suicide is just one example. The increasing suicide rate that was observed was among older teens, the group using the most "antidepressants." The younger children up to age 12 used the drugs the least and had the fewest suicides.

See below.

Fourth sentence reads:  "Most of the suicides were among older teens, according to the data, published in the journal Pediatrics."

Seventh sentence reads:  "Prescriptions for antidepressants for kids up to age 12 dropped by 6.8 percent in 2004 compared to 2003, and by less than 1 percent among 13- to 19-year-olds"

Last sentence reads:  "The data are preliminary, however, and the CDC expects to make a fuller report in the next few months.

http://www.intelihealth.com/IH/ihtIH/WSIHW000/333/8988/535862.html

Youth suicide rates have risen in the United States in recent years, after 10 years of decline. New data from the Center from Disease Control and Prevention show that the suicide rate in people under age 20 rose 18% -- from 1,737 deaths to 1,985 deaths -- between 2003 and 2004. Before that, it had declined each year from 1990 to 2003. Most of the suicides were among older teens, according to the data, published in the journal Pediatrics. It was the only cause of death that increased for children from 2003-2004. The Associated Press quotes experts who say a drop in antidepressant use in the wake of "black box" warnings about the drugs could be a factor in the suicide increase. Prescriptions for antidepressants for kids up to age 12 dropped by 6.8 percent in 2004 compared to 2003, and by less than 1 percent among 13- to 19-year-olds, with greater drops seen in 2005, the AP says. The data are preliminary, however, and the CDC expects to make a fuller report in the next few months.

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"Antidepressants" are not effective

via email:

We sent this out to you before and it has just come out on a google alert
again with perfect timing considering what has been hitting the headlines the
past few days - the black box warnings being blamed for an increase in teen
suicide because they say that prescribing of the drugs decreased after the
warning. But, did prescribing of antidepressants to children go up or down during
the period of time they are discussing. We will address that subject next.

Now, the question this study poses is, if the drugs do not show
effectiveness, why would not prescribing them lead to an increase in suicide among
children?


Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org and author of
Prozac: Panacea or Pandora? - Our Serotonin Nightmare
and audio Help! I Can't Get Off My Antidepressant!
(Order Numbers: Voice: 800-280-0730, Fax: 801-335-4727
or e-mail to atracyphd2@ aol.com with ORDER in
the heading)

Antidepressants are widely believed to be exceptionally effective
medications. The data, however, tell a different story. Kirsch et al. (2002a) analyzed
the data sent to the U.S. Food and Drug Administration by the manufacturers
of the six most widely prescribed antidepressants (fluoxetine [Prozac],
paroxetine [Paxil], sertraline [Zoloft], venlafaxine [Effexor], nefazodone
[Serzone] and citalopram [Celexa]). Their research showed that although the response
to antidepressants was substantial, the response to inert placebo was almost
as great. The mean difference was about two points on the Hamilton Rating
Scale for Depression (HAM-D). Although statistically significant, this
difference is not clinically significant (Jacobson et al., 1999). More than half of
the clinical trials sponsored by the pharmaceutical companies failed to find
significant drug/placebo difference, and there were no advantages to higher
doses of antidepressants. The small difference between antidepressant and
placebo has been referred to as a "dirty little secret" by clinical trial
researchers (Hollon et al., 2002), a secret that was believed by FDA officials to be
"of no practical value to either the patient or prescriber" (Leber, 1998, as
cited in Kirsch et al., 2002b).

In light of these data, what should be done in clinical contexts? Some have
suggested that antidepressants continue to be prescribed, even if their
effects are largely placebo effects. If nothing else, these agents can be used as
active placebos. Given the side effects of these medications, we suggest an
alternative approach. There are many interventions that seem to be as
effective or nearly as effective as antidepressants. These include physical exercise,
bibliotherapy and psychotherapy (Kirsch et al., 2002b). Psychotherapy has
the further advantage of demonstrated superiority to medications in long-term
comparative studies (Antonuccio et al., 2002). Given these data,
antidepressant medication might best be considered a last resort, restricted to patients
who refuse or fail to respond to other treatments.

http://www.psychiatrictimes.com/showArticle.jhtml?articleID=175802224


Antidepressants Versus Placebos: Meaningful Advantages Are Lacking

By Irving Kirsch, Ph.D., and David Antonuccio, Ph.D.
http://www.psychiatrictimes.com/print.jhtml;jsessionid=ABN3ZYUYMSJUYQSNDLRCKHSCJUNN2JVN?articleID=175802224&urlprefix=
Psychiatric Times September 2002 Vol. XIX Issue 9

(Please see _Counterpoint article_ http://www.psychiatrictimes.com/p020909.html by Michael E. Thase, M.D.)
(This is a preview of the Rumble in Reno II scheduled for Oct. 18. The
debate between Kirsch and Thase will focus on the issues highlighted in these
point/counterpoint articles. Brochures for this conference are available online
at -Ed.)

Antidepressants are widely believed to be exceptionally effective
medications. The data, however, tell a different story. Kirsch et al. (2002a) analyzed
the data sent to the U.S. Food and Drug Administration by the manufacturers
of the six most widely prescribed antidepressants (fluoxetine [Prozac],
paroxetine [Paxil], sertraline [Zoloft], venlafaxine [Effexor], nefazodone
[Serzone] and citalopram [Celexa]). Their research showed that although the response
to antidepressants was substantial, the response to inert placebo was almost
as great. The mean difference was about two points on the Hamilton Rating
Scale for Depression (HAM-D). Although statistically significant, this
difference is not clinically significant (Jacobson et al., 1999). More than half of
the clinical trials sponsored by the pharmaceutical companies failed to find
significant drug/placebo difference, and there were no advantages to higher
doses of antidepressants. The small difference between antidepressant and
placebo has been referred to as a "dirty little secret" by clinical trial
researchers (Hollon et al., 2002), a secret that was believed by FDA officials to be
"of no practical value to either the patient or prescriber" (Leber, 1998, as
cited in Kirsch et al., 2002b).
 

Previous reports of vanishingly small drug/placebo differences (Kirsch and
Sapirstein, 1998) were met with skepticism (e.g., Klein, 1998). In contrast,
the basic findings from this new meta-analysis have been accepted as accurate
(e.g., Thase, 2002). The dispute is no longer about the small size of the
average drug/placebo difference, but rather about how to interpret this fact and
what to do about it.
 

Various interpretive possibilities have been raised. One of the most popular
theories is that there may be a subset of patients for whom at least some
antidepressants are very effective, but that their relative lack of efficacy
with other patients masks effect (e.g., Thase, 2002). Specifically, whereas
mildly depressed patients respond to both drugs and placebos, more severely
depressed patients respond only to active drugs. The FDA data contradict this
hypothesis. Although severely depressed patients benefited more from medication
than mildly depressed patients due to a phenomenon known as regression toward
the mean, they also benefited more from placebo than their more mildly
depressed counterparts.
 

Of course, one can never rule out the possibility of undetected moderator
variables. But if there are hidden moderators, the overall mean difference
between drug and placebo (two points on the HAM-D) constrains the conclusions
that can be drawn from them. If the mean drug/placebo difference is greater than
two points for a subset of medications or patients, then it must be less
than two points for the others. For example, if the mean difference between drug
and placebo is four points for half of the patients (which is still a rather
small drug effect), then the mean effect of antidepressants on the other
patients must be zero, and if it is more than four points for half the patients,
then the medications must be interfering with responsiveness in at least some
others who would fare better on placebo.
 

Another popular hypothesis is that drug effects are more stable than placebo
effects, resulting in lower relapse rates. This hypothesis is also
contradicted by the data. A meta-analysis of relapse prevention trials published
between 1973 and 1990 indicated that 71% of the drug response was duplicated by
placebo (Walach and Maidhof, 1999). Kirsch et al.'s meta-analysis also examined
response to treatment as a function of the duration of the trial. The data
indicated that responses to both drug and placebo decrease over time. Contrary
to conventional wisdom, however, the correlation between duration of the
trial and response to treatment was higher for active medication (r=-0.84) than
for placebo (r=-0.62), suggesting a steeper decline in effectiveness for
active drugs than for placebo (Kirsch et al., 2002b).
 

In light of these data, what should be done in clinical contexts? Some have
suggested that antidepressants continue to be prescribed, even if their
effects are largely placebo effects. If nothing else, these agents can be used as
active placebos. Given the side effects of these medications, we suggest an
alternative approach. There are many interventions that seem to be as
effective or nearly as effective as antidepressants. These include physical exercise,
bibliotherapy and psychotherapy (Kirsch et al., 2002b). Psychotherapy has
the further advantage of demonstrated superiority to medications in long-term
comparative studies (Antonuccio et al., 2002). Given these data,
antidepressant medication might best be considered a last resort, restricted to patients
who refuse or fail to respond to other treatments.
 

Dr. Kirsch is professor of psychology at University of Connecticut and
former president of Division 30 of the American Psychological Association.
 

Dr. Antonuccio is professor of psychiatry and behavioral sciences at
University of Nevada School of Medicine, and director of and staff psychologist for
the stop smoking program at the Reno Veterans Affairs Medical Center.
 

References
 

Antonuccio DO, Burns DD, Danton WG (2002), Antidepressants: a triumph of
marketing over science? Prevention & Treatment 5:Article 25. Available at:
www.journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.
 

Hollon SD, DeRubeis RJ, Shelton RC, Weiss B (2002), The emperor's new drugs:
effect size and moderation effects. Prevention & Treatment 5:Article 28.
Available at: www.journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed
Aug. 2.
 

Jacobson NS, Roberts LJ, Berns SB, McGlinchey JB (1999), Methods for
defining and determining the clinical significance of treatment effects:
description, application, and alternatives. J Consult Clin Psychol 67(3):300-307.
 

Kirsch I, Moore TJ, Scoboria A, Nicholls SS (2002a), The emperor's new
drugs: an analysis of antidepressant medication data submitted to the U.S. Food
and Drug Administration. Prevention & Treatment 5:Article 23. Available at:
www.journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.
 

Kirsch I, Sapirstein G (1998), Listening to Prozac but hearing placebo: a
meta analysis of antidepressant medication. Prevention & Treatment 1: Article
0002a. Available at: www.journals.apa.org/prevention/volume-1/toc-jun26-98.html.
Accessed Aug. 2, 2002.
 

Kirsch I, Scoboria A, Moore TJ (2002b), Antidepressants and placebos:
secrets, revelations, and unanswered questions. Prevention & Treat-ment 5:Article
33. Available at: www.journals.apa.org/prevention/volume5/toc-jul15-02.html.
Accessed Aug. 2.
 

Klein DF (1998), Listening to meta-analysis but hearing bias. Prevention &
Treatment 1:Article 0006c. Available at:
www.journals.apa.org/prevention/volume1/toc-jun26-98.html. Accessed Aug. 2, 2002.
 

Thase ME (2002), Antidepressant effects: the suit may be small, but the
fabric is real. Prevention & Treatment 5:Article 32. Available at:
www.journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.

Walach H, Maidhof C (1999), Is the placebo effect dependent on time? A
meta-analysis. In: How Expectancies Shape Experience, Kirsch I, ed. Washington,
D.C.: American Psychological Association, pp321-332.

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