Tag Archives: SSRI’s

Suicidal Behavior After FDA Warnings

On June 18, the British Medical Journal published an article by Christine Lu et al, titled Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study

Here’s the conclusion paragraph from the abstract:

“Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.”

Note the slightly rebuking tone directed against the FDA and the media.

SOURCE OF DATA

The researchers interrogated the claims databases (2000-2010) of eleven medical insurance groups who collectively cover about 10 million people in 12 geographically scattered US locations.  All groups were members of the Mental Health Research Network (MHRN).

The general concept behind this sort of research network is that computerized insurance claims data represent an enormous repository of potentially very useful information, which researchers can readily tap for answers to questions that are difficult to resolve with smaller-scale data.  MHRN’s website, under the tab “Funding“, states:

“Initial funding for the MHRN is through a 3-year cooperative agreement with the National Institute of Mental Health (U19 MH092201 “Mental Health Research Network: A Population-Based Approach to Transform Research”) and through a supplement from NIMH to the existing Cancer Research Network funded by the National Cancer Institute.

During the initial funding cycle, the MHRN developed core infrastructure for collaborative research and conducted four developmental research projects to test and leverage that infrastructure in specific clinical areas.”

The Lu et al study is one of these four projects.

MHRN’s “virtual data warehouse” contains information on inpatient and outpatient treatment, and outpatient pharmacy data.  It also contains, for deceased members, the date and cause of death.

The present study included all adolescents (10-17), young adults (18-24), and adults (20-64) in the eleven insurance groups.

VARIABLES STUDIED

From the pharmacy data, the authors calculated the quarterly percentages of individuals who were dispensed an antidepressant.

The frequency of suicide attempts was measured by the quarterly incidence of “poisoning by psychotropic agents,” (ICD-9 code 969), that resulted in inpatient or ER treatment.

The frequency of completed suicides per 100,000 members was also calculated quarterly.  Although the other data elements are presented for each quarter up to the end of 2010, the completed suicide data stops at the end of 2008.  The authors explain:  “There is generally a lag time of 12-24 months for both reporting of deaths and availability of data; therefore we analyzed data on deaths up to and including 2008.”

TIME FRAME

The study’s time frame was from the first quarter of 2000 to the last quarter of 2010.  The researchers divided this time frame into three segments:

1.  The pre-warning phase (2000, q1 – 2003, q3)
2.  The phase-in period (2003, q4 – 2004, q4)
3.  The post-warning period (2005, q1 – 2010, q4)

The FDA black box warnings were mandated in October 2004.

The authors justify the use of a phase-in period as follows:

“To deal with the possibility of an anticipatory response to the warnings, we considered the last quarter of 2003 to the last quarter of 2004 as a ‘phase-in’ period that spanned the entire period of FDA advisories, the boxed warning, and intense media coverage, and excluded these five data points from the regression models.”

Regression, in this context, basically means finding a line-of-best-fit through a series of points which represent data on a graph.

RESULTS

The study included approximately the following numbers of individuals:

Adolescents (10-17)                1.1 million
Young adults (18-29)              1.4 million
Adults (30-64)                            5    million

The results for the three age groups are set out in graph form and are designated Figures 1, 2, and 3.

Let’s start with the adolescent graphs (Fig 1)

Fig. 1 Rates of antidepressant use, psychotropic drug poisonings, and completed suicides per quarter before and after the warnings among adolescents enrolled in 11 health plans in nationwide Mental Health Research Network

Fig 1 Lu et al

 

 

Adolescents (10-17)

 

 

 

 

 

 

 

 

 

 

 

The graph is divided into three parts.  The upper part shows antidepressant use, quarter by quarter, for the period of the study (2000, q1 – 2010, q4).  Each dot represents the percentage of the 1.1 million adolescents that were taking antidepressants in that particular quarter.  So in the first quarter of 2000, a little over 1.5%  were taking the drugs, and so on.

The middle part of the figure shows the percentage of adolescents who were treated for psychotropic drug poisoning in each quarter.

And the lower part shows the number of completed suicides (per 100,000) in the group, plotted quarterly, and graphed as a continuous line (the dark green line) rather than as dots.  The lighter lines represent the 95% confidence interval.  In other words, the chances are 95% that the true suicide rate for the population lies between these lines.

The slightly darker vertical band that goes up through the middle of all three graphs is the phase-in period (2003, q 4 – 2004, q4).  The solid lines in the upper and middle sections are the regression lines for the pre and post warnings data.  The post lines are curves because the authors report that this fitted the data better.  The orange dotted lines in the post area are simply the projection of the pre-warning regression lines; i.e. a projection of what purportedly would have happened if the warnings had not been issued.  Completed suicide data for the last two years of the study was not available.

. . . . . . . . . . . . . . . .

The data for the young adults (Fig 2) is presented similarly.

Fig 2 Rates of antidepressant use, psychotropic drug poisonings, and completed suicides per quarter before and after the warnings among young adults enrolled in 11 health plans in nationwide Mental Health Research Network

Fig 2 Lu et al

 

Young Adults (18-29)

 

 

 

 

 

 

 

 

 

 

 

The data for older adults is shown in Fig. 3

 

Fig 3 Rates of antidepressant use, psychotropic drug poisonings, and completed suicides per quarter before and after the warnings among adults enrolled in 11 health plans in nationwide Mental Health Research Network 

Fig 3 Lu et al

 

Older Adults (30-64)

 

 

 

 

 

 

 

 

 

 

 

 

The FDA warnings were not aimed at adults.  The authors state that the adults were included in the study  “…as a ‘control’ group.”

From all of this data, the authors draw the following results/conclusions:

1.  The FDA safety warnings, plus the media coverage, “decreased antidepressant use.”

2.  There were simultaneous increases in suicide attempts by young people.

3.  It is essential to monitor “unintended consequences” of black box warnings and media reporting.

4.  Completed suicides did not change for any group.

The main thrust of the article is expressed in the final paragraph:

“Undertreated mood disorders can have severe negative consequences. Thus, it is disturbing that after the health advisories, warnings, and media reports about the relation between antidepressant use and suicidality in young people, we found substantial reductions in antidepressant treatment and simultaneous, small but meaningful increases in suicide attempts. It is essential to monitor and reduce possible unintended effects of FDA warnings and media reporting.”

Again, we see the rebuking tone aimed at the FDA and the media.

NIH PRESS RELEASE

As mentioned earlier, the study was funded by the National Institute of Mental Health (NIMH), which is a division of the US National Institutes of Health (NIH).  The study was published on June 18.  On June 19, NIH issued a two-page press release via its own website, Medline Plus.

Here are some quotes from the press release, interspersed with my comments and observations.

“Teen suicide attempts rose nearly 22 percent after the U.S. Food and Drug Administration (FDA) warned about dangers of antidepressants, a new study finds.”

This statement is false.  What the study found was that within the HMO Research Network’s insurance plans in ten states, psychotropic drug poisonings (including, incidentally, according to the press release, poisonings by marijuana, amphetamines, and Ecstasy), that required medical treatment, rose by the stated amount.  This is only one method of attempting suicide, and in many cases might not be attempted suicide at all.  The study provided no information on the incidence of confirmed suicide attempts measured as such.  Incidentally, ICD-9 code 969, which Lu et al used as a proxy measurement for suicide attempts, also includes “poisoning by caffeine”!

The statement is also misleading, in that the changes in the rates of psychotropic poisonings were measured not against the previous rate of poisoning as is implied in the above quote, but against the projected rate, based on the 2000 – 2003 regression line.  This is critical because regression lines can be extraordinarily poor predictors, as any stock market analyst can attest.

Regression lines are also easy to manipulate by the simple expedient of delineating the time boundaries to show a desired trend.  In the present study, for instance, the exclusion of the phase-in data from the pre-warning regression analysis definitely had the effect of lowering the poisoning trend projection in the young adult group (Fig 2), and probably had this effect in the adolescent group (Fig 1).  Excluding the phase-in data from the regression analysis was an arbitrary decision.  The researchers might just as readily have used a simple pre-post cutoff based on the quarter in which the warnings were mandated.

It is also noteworthy that the percentage changes in antidepressant prescriptions and psychotropic poisonings were assessed solely on the 4th quarter of 2006.  The authors’ statement on this matter is interesting:

“In addition, we also provided absolute and relative differences (with 95% confidence intervals)…in the second year after the warnings (that is, in the last quarter of 2006), which were estimated by comparing the overall changes in outcome attributable to the warnings with counterfactual estimates of what would have happened without the warnings.”

Note the unwarranted causal implication (“attributable”), and the assumption that the authors knew what would have happened had the warnings not been issued.  “Counterfactual” according to my Webster’s means “contrary to fact”.  I’m not sure what the authors had in mind in describing their projections this way.

There is also, I think, a suggestion in the above quote that the result applies to the general population.  This, however, would only be the case if in fact the group of individuals studied had been selected at random from the US population.  This is emphatically not the case.  The study group comprised all the individuals between ages 10 and 65 who were enrolled in the eleven MHRN insurance groups in the 12 states..  This group, for instance, is certainly not representative of uninsured people, nor of people in other locations.

. . . . . . . . . . . . . . . .

“Following the warnings, antidepressant prescriptions for young people fell by more than a fifth. At the same time, suicide attempts rose, possibly because depression was being undertreated, according to background information in the study.”

This statement is false.  What the study found was that antidepressant prescriptions for adolescents (10-17) declined from a peak of about 1.9% in 2003, q3 to a low of about 1.3% in 2008, q2, and then climbed to about 1.7% in 2010, q 3 (Fig 1).  But the figures for young adults (18-24), who are presumably included in the term “young people” as used above, remained remarkably constant at about 4% from 2004, q1 to 2010, q4.  The only “fall” for this group is a notional fall from the trend line. (Fig. 2)

Again in this quote, we see the implied causal link to suicide attempts, and even a suggested explanation:  “possibly because depression was being undertreated.”  The study provides no information on general nationwide trends in the frequency of suicide attempts, and even if suicide attempts were trending upwards during the period in question, there are many other possible explanations.  Also in this quote we see the invalid substitution of the term “suicide attempts” for psychotropic drug poisonings.

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“‘We found a substantial reduction in use of antidepressants in youth, and also in adults — who were not targeted by the warning,’ said lead author Christine Lu, an instructor in population medicine at the Harvard Pilgrim Health Care Institute in Boston.”

Here again, this statement is false.  The antidepressant use data for young (Fig 2) and older (Fig 3) adults remained almost perfectly flat in the post-warning period.  As noted earlier, the only falls were from the projected trend lines.

. . . . . . . . . . . . . . . .

“Lu attributes the drop in prescriptions to the FDA’s warning and resulting media coverage. ‘To a certain extent, the FDA’s black box warning was legitimate, but the media emphasis was really on suicide without noting the potential risk of undertreatment of depression. Because of that, there has been an overreaction, and that overreaction has sent alarming messages to parents and young people,’ she said.”

Note the skilful tightrope walking.  Dr. Lu and the NIH want to bash the media for publicizing the link between antidepressants and suicidal activity, but at the same time not overly antagonize the FDA.  The media ignored the “potential risk of undertreatment”; the media overreacted; the media caused alarm.  Big bad journalists need to get into line!

. . . . . . . . . . . . . . . .

Then we have a truly magnificent piece of psychiatric spin:

“Although the initial studies showing an increased risk of suicide in teens taking antidepressants prompted the black box warnings, researchers never proved that the medications were the cause of the increased risk of suicide, only that there was a link.

Likewise, though the current research finds a strong association between the uptick in suicides and the drop in antidepressant use, Lu and her colleagues weren’t able to definitively show that a decrease in antidepressant prescriptions was directly responsible for the recent increase in suicide attempts.”

The deliberations and the data on which the FDA black box warnings were based were comprehensive, and showed a clear link between antidepressant use in young people and suicidal activity.  And the evidence was sufficient to convince the FDA to take action.

The findings in the Lu et al study do not come even close to this standard.  But by counterposing them in this way, the NIH is trying to convey the impression that the findings of the present study are comparable in quality to the earlier work.

Note also the blatant falsehood:  “…the current research finds a strong association between the uptick in suicides and the drop in antidepressant use…”  [Emphasis added] In fact, the Lu et al study found no increase in completed suicides.  They stated clearly in their abstract:  “Completed suicides did not change for any group.”

. . . . . . . . . . . . . . . .

“Coverage of the warning may have had unintended consequences, Lu said. Doctors may have been less willing to prescribe antidepressants and parents may have been fearful of letting their children take them, she said.

The lesson, Lu said, is that the media and the FDA should strive for the right balance so potential overreactions don’t occur.”

Again, big bad media needs to get in line and print only what psychiatrists tell them to print (“the right balance”).

. . . . . . . . . . . . . . . .

“Undertreating depression is worse than the slight increase in suicidal thoughts antidepressants may cause, Lu said. ‘It’s also a reminder for doctors to weigh the risk of a drug with the risk of not treating or undertreating the condition,’ she said.”

This is extremely misleading.  Note how the concerns on which the boxed warnings were based are dismissed:  “…the slight increase in suicidal thoughts antidepressants may cause.”

The pediatric meta-analysis data on which the FDA deliberated in 2003-2004 are written up in detail (131 pages) here.  Tarak Hammad et al published the formal journal report in 2006.  It is clear that great pains were taken to include in the primary outcome measure only adverse events that had clear suicidal potential.  The primary outcome, which was labeled “suicidal behavior or ideation”, contained three elements:

  • Suicide attempts, and/or
  • Preparatory actions towards imminent suicidal behavior, and/or
  • Suicidal ideation

The overall risk ratio (drug vs. placebo) for the three elements combined was found to be 1.95 (95% CI, 1.28 – 2.98).  The risk ratio for suicidal behavior (first two items) was 1.90 (95% VCI, 1.00 – 3.63).  In other words, the individuals in the studies who took the drug were about twice as likely to have made a suicide attempt, and/or made preparations for imminent suicide, and/or had been actively thinking about suicide than those who took the placebo.  This is emphatically not something to be dismissed as “a slight increase in suicidal thoughts…”

Hammad et al acknowledged the limitations of their study, but went on to state:

“Despite the limitations, the observed signal of risk for suicidality represents a consistent finding across trials, with many showing RRs [risk ratios] of 2 or more. Moreover, the finding of no completed suicides among the approximately 4600 patients in the 24 trials evaluated does not provide much reassurance regarding a small increase in the risk of suicide because this sample is not large enough to detect such an effect.”

They also provide the following interpretation of their findings:

“…when considering 100 treated patients, we might expect 1 to 3 patients to have an increase in suicidality beyond the risk that occurs with depression itself owing to short-term treatment with an antidepressant.” [Emphasis added]

In addition, since the issuing of the black box warnings in 2004, there have been two studies confirming the link between suicidal activity and antidepressants.

Olfson et al 2006 found:

“…in children and adolescents (aged 6-18 years), antidepressant drug treatment was significantly associated with suicide attempts (OR [odds ration], 1.52; 95% CI, 1.12-2.07 [263 cases and 1241 controls]) and suicide deaths (OR, 15.62; 95% CI, 1.65-infinity [8 cases and 39 controls]).”

And Olfson et al 2008 found:

“Among children, antidepressant treatment was associated with a significant increase in suicide attempts (odds ratio [OR] = 2.08, 95% confidence interval [CI] = 1.06 to 4.10; cases, N = 51; controls, N = 239; p = .03).”

PRESS COVERAGE

The Lu et al article, and the authors’ conclusions, received wide coverage in the general media. Most of the mainstream media simply regurgitated the gist of the study plus the press release with additional quotes from two of the authors, Christine Lu, PhD, and Steven Soumerai, ScD, both from Harvard’s Department of Population Medicine.

Both the Washington Post and The Boston Globe delivered the authors’ message pretty much without reservation.  Here’s a quote form the Washington Post:

“…Wednesday’s study wrote that while the government’s actions in 2003 and 2004 were legitimate and thorough, ‘FDA advisories and boxed warnings can be crude and inadequate ways to communicate new and sometimes frightening scientific information to the public.’ Likewise, researchers argue that while media attention can create much-needed awareness…sometimes ‘the information may be oversimplified and distorted when communicated in the media.'”

And from The Boston Globe:

“The study’s authors say that patients and doctors, frightened by news coverage that exaggerated the risk of antidepressants, shunned treatment that might have prevented the suicide attempts.”

In fact, there is no information in the report as to whether the victims of the poisonings had taken antidepressants or not.

And amazingly,

“Steven B. Soumerai, a coauthor and a Harvard professor of population medicine, said black box warnings typically have little effect on physician behavior, unless they are accompanied by news reports.”

In his attempt to castigate the press for publicizing the black box warnings, has Dr. Soumerai inadvertently shot psychiatry in the foot?  Do psychiatrists actually pay more attention to news reports than to FDA warnings?

Bloomberg also ran the standard story:

“A widely publicized warning by U.S. regulators a decade ago about risks for teenagers taking antidepressants led to plummeting prescriptions and increased suicide attempts, Harvard University researchers said.”

Note the clearly implied causality (“led to”), the exaggeration (“plummeting”) and the mischaracterization of psychotropic poisonings as “suicide attempts.”

“‘After the widely publicized warnings we saw a substantial reduction in antidepressant use in all age groups,’ said Lu, an instructor in population medicine at Harvard Pilgrim Health Care Institute, in a telephone interview. ‘Warnings, especially widely publicized warnings, may have unintended consequences.'”

“Lu said the focus by the media on the risk of suicide, even though the review of data found no increase in completed suicides, frightened patients and parents.”

Again, the big bad media frightening patients and parents.

But Bloomberg also obtained some rebuttal quotes from Marc Stone, MD, a senior medical reviewer at the FDA:

“‘It’s a stretch to say that the people that are committing suicide or the increase in suicide attempts has to do with the prescription of antidepressants,’ Stone said in a telephone interview. ‘There’s absolutely nothing in the study to say that these are the people who would have been prescribed the antidepressants if it weren’t for the warnings.'”

“There are other issues that could be influencing the drop in antidepressant prescription and rise in poisonings, Stone said. The data presented in the study shows a steady increase before the warnings in antidepressant prescription rates for adolescents while drug poisonings remained relatively steady. The rise in poisonings after the warnings when prescriptions declined slightly in that group doesn’t show a link between the two events, he said.

‘They’re describing a very strange phenomenon in society that’s supposedly being held back by antidepressant use,’ Stone said. ‘It doesn’t stand up to what we know about the mental health situation in the United States.'”

I could find nothing in the New York Times, the Wall Street Journal, or the LA Times about the study or the press release.

Medscape, a web resource for physicians and other health professionals, toed the party line:

“The safety warnings were covered widely in the media and led to a decrease in antidepressant use by young people, but at the same time, there was an increase in suicide attempts, Christine Y. Lu, PhD, of the Department of Population Medicine, Harvard Medical School in Boston, Massachusetts, and colleagues found.”

Again, note the inaccurate characterization of drug poisonings as “suicide attempts”.

“The researchers say that it is possible that the warnings and extensive media attention led to ‘unexpected and unintended population level reductions in treatment for depression and subsequent increases in suicide attempts among young people.'”

And the focus on the “extensive media attention”.

The APA drew attention to the Lu et al study in a Psychiatric News Alert, but the tone of the piece was appropriately and, I must say, surprisingly, skeptical.  The only quote was from Mark Olfson:

“Mark Olfson, M.D., M.P.H., a professor of psychiatry at Columbia University Medical Center and an expert in mood disorders, told Psychiatric News that ‘the new findings shed little light on the complex associations between anxiety and depressive disorders, antidepressant treatment, and the risk of self-harm and suicide. The measure of suicide attempts used in this study, psychotropic poisonings (ICD-9 code 969), is only loosely related to suicide attempts. Most suicide attempts in young people do not involve poisoning by psychotropic drugs and most intoxications do not represent suicide attempts.’

Because of the recent substantial increase in unintentional poisonings from stimulants, Olfson stated that the increase in psychotropic overdose could be a result of an underlying substance use disorder rather than suicide. ‘This trend [of psychotropic overuse by youth], which may be driven by complex societal factors, deserves study and clinical attention,’ Olfson concluded.”

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Finally, the most reasonable interpretation of the Lu et al data is that following the black box warnings, the long-standing increase in the use of antidepressant drugs was halted, but suicide rates remained about the same (N = 7.5 million).

SOME HISTORY

This is not the first attempt to discredit/undermine the black box warnings for these drugs.  In September 2007, Robert Gibbons, PhD et al published Early evidence on the effects of regulators’ suicidality warnings on SSRI prescriptions and suicide in children and adolescents in the American Journal of Psychiatry.  The paper was based on a study of US and Dutch SSRI prescription rates to children and adolescents from 2003 to 2005, and was funded by NIMH grant.  The authors reported the following results:

“SSRI prescriptions for youths decreased by approximately 22% in both the United States and the Netherlands after the warnings were issued. In the Netherlands, the youth suicide rate increased by 49% between 2003 and 2005 and shows a significant inverse association with SSRI prescriptions. In the United States, youth suicide rates increased by 14% between 2003 and 2004, which is the largest year-to-year change in suicide rates in this population since the Centers for Disease Control and Prevention began systematically collecting suicide data in 1979.”

And drew the following conclusions:

“In both the United States and the Netherlands, SSRI prescriptions for children and adolescents decreased after U.S. and European regulatory agencies issued warnings about a possible suicide risk with antidepressant use in pediatric patients, and these decreases were associated with increases in suicide rates in children and adolescents.”

The report contains a graph showing a sharp increase in suicide rates for children and adolescents (5 – 19) between 2003 and 2004.

Gibbons Fig 2

The data for this graph was extracted from the CDC WONDER Compressed Mortality Database (up to 2002) and from the CDC WISQARS Injury Mortality Report Database (2003 – 2004).  On the face of it, this graph does seem to show a dramatic increase in completed suicides for this age group between 2003 and 2004.  But when we look at the bigger picture, this trend is not so obvious.

On July 1, I extracted completed suicide rate and population data from the CDC website for the period 1979 to 2010.  The Gibbons et al graph is for ages 5 – 19.  I was unable to obtain that graph from the CDC site, but I was able to collate the raw data and draw the graph using Excel software.  Here’s the graph:

Suicides per 100,000, 1979-2010

As can be readily seen, the increase in the suicide rates for this age group from 2003 to 2004 does not appear as marked or as noteworthy when viewed against the wider background.  Drawing conclusions from short-term trends is fraught with potential for error.  Dr. Gibbons et al were obviously aware of these issues, and provided a lengthy discussion/argument in support of the relevance of the associated trends.  Nevertheless, here’s their closing paragraph:

“In December 2006, the FDA’s Psychopharmacologic Drugs Advisory Committee recommended that the black box warning be extended to cover young adults, and in May 2007, the FDA asked drug manufacturers to revise their labels accordingly. If the intent of the pediatric black box warning was to save lives, the warning failed, and in fact it may have had the opposite effect; more children and adolescents have committed suicide since it was introduced. If as a result of extending the black box warning to adults there is a 20% decrease in SSRI prescriptions in the general population, we predict that it will result in 3,040 more suicides (a 10% increase) in 1 year (17). If the FDA’s goal is to ensure that children and adults treated with antidepressants receive adequate follow-up care to better detect and treat emergent suicidal thoughts, the current black box warning is not a useful approach; what should be considered instead is better education and training of physicians.”

The Washington Post ran an article on the Gibbons et al study, Youth Suicides Increased As Antidepressant Use Fell, September 6, 2007.  The article included the following quotes:

“Thomas Insel, director of the National Institute of Mental Health, said, ‘We may have inadvertently created a problem by putting a ‘black box’ warning on medications that were useful.’ He added, ‘If the drugs were doing more harm than good, then the reduction in prescription rates should mean the risk of suicide should go way down, and it hasn’t gone down at all — it has gone up.'”

“The trend lines do not prove that suicides rose because of the drop in prescriptions, but Gibbons, Insel and other experts said the international evidence leaves few other plausible explanations.” 

Given the behavior of the trend line since 2004, these quotes suggest, at the very least, an over-reaction from the authors and from the NIMH.  And the fact that the NIMH funded both studies suggests that they may have an agenda:  to promote antidepressant drugs as safe, and to downplay any indications to the contrary.

If the NIMH genuinely wants to explore the sources/causes of suicide, they need to recognize three facts:

1.  Suicide is a complex, psychosocial phenomenon, and its roots/causes vary enormously from individual to individual, and from community to community.  Psychiatry routinely asserts that the root, or major cause, of suicide is depression, but this assertion is meaningless because suicidal activity/rumination is one of psychiatry’s defining features of depression.  A genuine understanding of human actions involves so much more than assigning labels.

2.  The facts surrounding any completed suicide are always, by the nature of the matter, at least partially hidden.

3.  Any attempt to understand suicide must involve a detailed, open-minded exploration of individual cases.  Variables that appear associated with suicide trend lines provide, at best, suggestions that might inform these explorations, but can also be very misleading.

ANECDOTAL INFORMATION

At the present time, there is a great deal of anecdotal information, on the Internet and elsewhere, to the effect that individuals who were not previously suicidal, became so, shortly after starting SSRI’s.  The psychiatrist Joseph Glenmullen drew attention to this graphically and convincingly in Prozac Backlash (2000).  Here’s a quote:

“…the key elements in these stories appeared to be the ‘dramatic change’ observed in these people after starting Prozac, how ‘out of character’ their behavior was on the drug, and the often extraordinary degree of violence not only toward themselves but toward others.”

Elsewhere in the book, Dr. Glenmullen makes it clear that his comments apply, not only to Prozac, but to all drugs in the SSRI category.  Psychiatrist Peter Breggin has made similar points.  AntiDepAware has accumulated an enormous amount of anecdotal information on this matter.

Psychiatry tends to dismiss these kinds of concerns as “anecdotal”.  In this context, “anecdotal” usually means:  based on casual or incidental information rather than on systematic observations and evaluations.  In particular, the term suggests a subjective, rather than an objective approach.

But in fact, the raw data for virtually all psychiatric research is anecdotal in this sense.  If a person reports suicidal ruminations after taking an SSRI, this is anecdotal.  But if a study participant reports that he’s feeling better after taking an SSRI, this is also anecdotal.  And if 20 people make essentially similar statements, that’s 20 anecdotal statements.  And if they make these statements by answering 17 questions on the Hamilton Rating Scale for Depression, then we have 340 anecdotal statements.  The fact that the HDRS-17 is widely used, and yields numerical data which can be collated into rows and columns and analyzed with sophisticated computer programs doesn’t alter the fact that the raw data is anecdotal.

No one on this side of the issue is suggesting that a large proportion of people taking antidepressant drugs kill themselves.  If that were the case, then the drugs would have been removed from the market long ago.  What is being contended, however, is that these drugs are inducing strong suicidal urges in a relatively small proportion of individuals who had not previously had thoughts of this kind, and that some of these people are succumbing to these urges, and are taking their own lives.  That is indeed anecdotal information.  But it’s also very important, and it warrants investigation even if it involves only a fraction of one percent of the people taking the drugs.  To dismiss these widespread and credible contentions on the basis of the dogmatic insistence that the drugs are wholesome, or that the individuals were probably suicidal to begin with, is simply unconscionable.  This is particularly the case in that firstly, the proof of the wholesomeness of these products is also, ultimately, based on anecdotal information, and secondly, there is no way to reliably identify the individuals concerned prior to prescribing the drugs.

Prescribing these psychoactive drugs is like playing Russian roulette with someone else’s life.  The notion that this information should be suppressed because it might scare people from taking the products is cruel, callous, and irresponsible.  Psychiatry’s persistent and self-serving efforts to suppress this information is a national, and indeed, worldwide, scandal.

The Lu et al study, and the NIH press release, reminds me of a statement made by Patrick B. Kwanashie, Assistant Attorney General in Connecticut, after the Adam Lanza murders/suicide:

“Even if you can conclusively establish that Adam Lanza’s murderous actions were caused by antidepressants, you can’t logically from that conclude that others would commit the same actions as a result of taking antidepressants.  So it’s simply not legitimate, and not only is it not the use to which they are proposing to put the information not legitimate, it is harmful, because you can cause a lot of people to stop taking their medications, stop cooperating with their treating physicians just because of the heinousness of what Adam Lanza did.”

PSYCHIATRY’S SUPPRESSION OF INFORMATION

The Lu et al study has been subjected to a great deal of criticism.  These criticisms have been cogent and valid, but there is also a bigger picture.  The Lu et al study was never meant to be about science.  It was about spin and PR.  Its purpose was to attack and embarrass the media in order to keep them in line.  The fundamental message in the study, and in the NIH press release, is:  If you reporters print bad things about antidepressants, this will lead to reduced usage of these products, which in turn will lead to more suicides, and you will have blood on your hands!  Psychiatry is intellectually and morally bankrupt.  It has no valid response to its critics and is increasingly resorting to this kind of spin and PR.

Organized psychiatry realizes that it has lost the present debate on its logical/scientific merits.  They realize that their only hope for survival as a profession hinges on their ability to control the media.  In the pursuit of this objective, there truly are no depths to which they will not sink.

Over the past two decades, I have become convinced of two things:

1.  SSRI’s, and possibly other psychiatric drugs, are inducing strong suicidal and violent urges in some people.
2.  This information is being systematically suppressed by psychiatry and by the NIMH.  To the extent that they acknowledge it at all, they pretend that this suppression is in the public interest.

If there was ever a time when we need courageous and well-informed reporting, it is now.  Let us hope that the press has sufficient integrity and courage to resist psychiatry’s tawdry blackmail, to follow the evidence, and to print the truth.   In this context, it is very encouraging that neither the New York Times, nor the LA Times, nor the Wall Street Journal took the Lu et al bait.

It is time to end the charade.  The link between psychiatric drugs and suicide/violence needs urgent study by independent, adequately funded investigators who are given access to all the information.

SSRIs and Persistent Pulmonary Hypertension of the Newborn (PPHN)

There’s a new study in the January 2014 issue of the BMJ:  Grigoriadis et al, Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysisThanks to Nanu Grewal for the link.

PPHN is a relatively rare condition.  The authors report that the estimated prevalence is about 1.9 per 1000 live births.  The disease is essentially a failure of the newborn’s circulatory system to switch from oxygen supply via the placental blood, to oxygen supply via the baby’s own lungs.  The condition is usually diagnosed at birth or shortly thereafter.  Symptoms include:  rapid and difficult breathing, fast heart rate, and blue skin color.  PPHN is a serious condition.  A 2010 article by Robin Steinhorn, MD, states:

“Even with appropriate therapy, the mortality for PPHN remains between 5-10%.  In addition, approximately 25% of infants with moderate or severe PPHN will exhibit significant neurodevelopmental impairment at 12-24 months.”

Delaney et al (2012) describe PPHN as “…a syndrome without either optimally effective preventative or treatment strategies,” and states that it “…remains a major cause of morbidity and mortality in neonatal centers across the globe.”

The BMJ article is a meta-analysis, combining the data from seven previous studies that examined the link between maternal use of SSRI’s and PPHN.  Here are their results:

 

SSRI Use Odds Ratio Confidence Interval 95% Statistical Significance
Early pregnancy 1.23 0.58-2.60 NS
Any time in pregnancy 1.55 0.79-3.04 NS
Most or all of pregnancy 3.33 1.58-7.02 S (0.002)
Late pregnancy 2.50 1.32-4.73 S (0.005)

 

Essentially what this means is that a woman who used SSRI’s for “most or all” of her pregnancy had a 3.33 times greater risk of delivering a child with PPHN than a woman who had not used SSRI’s.  The risk for late pregnancy use was 2.50 times greater.

Given a baseline prevalence estimate of 1.9 per 1000 births, and an odds ratio of 2.5, the expected incidence of PPHN in late-pregnancy SSRI cases would be about 4.75 (2.5 x 1.9).  This represents an excess of 2.85 cases per 1000 as compared to the general prevalence.

CONCLUSIONS

In the article’s abstract, the authors concluded:

“The risk of persistent pulmonary hypertension of the newborn seems to be increased for infants exposed to SSRIs in late pregnancy, independent of the potential moderator variables examined.  A significant relation for exposure to SSRIs in early pregnancy was not evident.”

In the text of the article a more detailed analysis was offered:

“Depression during pregnancy must not be left untreated, as the potential for untoward effects is not negligible and can extend into the postpartum period. Selection of treatment is based on several factors, and antidepressant drugs may be necessary, especially in severe depressive episodes…Although the odds for persistent pulmonary hypertension of the newborn seem to be greater with the use of SSRIs later in pregnancy, despite the limitations of the original studies, the risk is still low. Results from this meta-analysis still concur with earlier statements…that fewer than about 1 infant in 100 will develop persistent pulmonary hypertension of the newborn after antenatal exposure to SSRIs. Although this condition is serious and death rates between 5% and 10% have been reported, when it is associated with other conditions (such as some congenital malformations, meconium aspiration, sepsis, and idiopathic disease), it can be managed favourably…The death rate in infants with persistent pulmonary hypertension of the newborn who have been exposed to SSRIs, however, remains unknown (although one study did report 9.1% of the infants died who were exposed to SSRIs compared with 9.5% of those who were not exposed…”

The deference to the “need” for antidepressant drugs is noteworthy.  This kind of disclaimer has become almost routine in research of this kind.

In my view the essential point of the article is that it demonstrates one more serious adverse effect of these drugs.

Antidepressants and Suicide

There was an interesting article, Antidepressant regulations tightened following suicide, in the Copenhagen Post on January 7.  Thanks to Mad in America for the link. It is reported that Danilo Terrida, aged 20, committed suicide in 2011

“…eleven days after he was prescribed antidepressants following an eight-minute-long conversation with a doctor.” 

The doctor has been deemed responsible for the suicide by the National Agency for Patients’ Rights and Complaints.  According to its website:

“The National Agency for Patients’ Rights and Complaints functions as a single point of access for patients who wish to complain about the professional treatment in the Danish health service.”

As a result of this case, Sundhedsstyrelsen, the Danish Health and Medicines Authority, has issued a directive requiring a more thorough assessment before these drugs can be prescribed to people aged 18 to 24.

Here are some quotes from the article:

“The case has sparked a debate about the dangers of psychiatric drugs, and in Politiken newspaper today Peter Gøtzsche, medical researcher and leader of the Nordic Cochrane Center at Copenhagen’s Rigshospitalet, wrote that antidepressants have caused healthy people to commit suicide.”

“He [Gøtzsche] added that psychiatric medication often does more harm than good and that patients would often be better off without medication.”

“‘Doctors cannot cope with the paradox that drugs that can be useful for short-term treatment can be highly dangerous when used for years and even create the illnesses that they were supposed to prevent, or even bring on an even worse illness,’ Gøtzsche wrote.”

So, we have one more piece of confirmation of something that’s been known for years.  Antidepressants increase the risk of suicide for some individuals, especially in the period immediately following initiation.  For decades, the pharmaceutical companies and the psychiatrists spun this embarrassing fact as evidence that the drugs were working.  The story went like this:  when people are deeply depressed, they lack the energy or motivation to even take their own lives.  But as the antidepressant “kicks in,” the person begins to feel more motivation, though still considerably depressed.  So he kills himself.

And psychiatry actually embraced and promulgated that nonsense.  Today it is clear that the drugs, especially the serotonin boosters, actually generate suicidal thoughts and intentions in some individuals, especially young people.

Requiring a more thorough assessment, as the Danes plan to do, seems a fairly minimal precaution, but it’s better than the 8-minute conversation that Danilo Terrida got.  The ongoing problem, however, is that there is, as far as I know, no way to identify those people who pose particular risk in this regard, other than intensive individualized monitoring for all people who are prescribed these products.  It seems unlikely that screening of that magnitude will become general practice, given the frequency with which antidepressants are being prescribed.  So instead of an 8-minute interview, there’ll be a 30-minute interview, but the results may not be much different.

In addition, this whole issue needs to be publicized more in order to ensure that clients are making informed choices.

Antidepressants and Liver Failure

Last month (December 2013) the American Journal of Psychiatry published Antidepressant-Induced Liver Injury: A Review for Clinicians, by Voican C.S. et al.  The study was a literature search from 1965 onwards.

Here are the authors’ results:

  • All antidepressants can induce hepatotoxicity, especially in elderly patients and those taking more than one drug
  • Liver damage is generally unpredictable and unrelated to dose
  • Liver damage can occur within a few days of initiation
  • Antidepressant-induced liver failure can be life threatening
  • Antidepressants with higher risk for liver failure include: iproniazid, nefazodone, phenelzine, imipramine, amitriptyline, duloxetine, bupropion, trazodone, tianeptine, and agomelatine
  • Antidepressants with lower risk: citalopram, escitalopram, paroxetine, and fluvoxamine
  • Although an infrequent event, antidepressant-induced liver injury may be irreversible

 

 

Sandy Hook Massacre: The Unanswered Question

On December 27, 2013, Connecticut State Police issued a 7,000-page, heavily redacted, report on the massacre that occurred at Sandy Hook Elementary School just over a year earlier (December 14, 2012).  For the record, I have not read the 7,000-page report, but I have read the Wikipedia article Sandy Hook Elementary School shooting, last updated January 4, 2013, and several media reports on the matter, including reports from the New York Times, the Hartford Courant, and the Washington Post.

Obviously there is an enormous volume of material in the official reports and in the various media reports and comments.  But there is still one major unanswered question.  Was Adam Lanza under the influence of a psychopharmaceutical product(s) at the time of the shooting or in the period immediately prior to the shooting?  There is a report in the record that he took Celexa (citalopram) for a short while in 2006, but no reports of psychiatric treatment since that time.  But there are some reasons for doubt.

ABLECHILD’S FREEDOM OF INFORMATION REQUEST

On August 22, 2013, Connecticut Assistant Attorney General, Patrick B. Kwanashie, during a freedom of information hearing on this matter, stated that releasing this information could “… cause a lot of people to stop taking their medications.”  He made his statement in response to AbleChild’s request for Adam Lanza’s medical records, especially with regards to any psychiatric drugs that he might have taken.  The hearing was videotaped.  Here is an excerpt, transcribed verbatim, from Mr. Kwanashie’s response.  The excerpt begins at about 1 hour 4 minutes into the tape.

“Therefore it is simply not sure that if you don’t fall into one of those categories, what you have to advance reasons that you actually do have a real interest in the [unclear] medical records.  The plaintiff, the complainant have not shown any such interest.  The complainant is proposing that they can make generalizations, generalized from one single incident, no matter how the uh outcome of the use of antidepressants, or thee thee thee causal link between the use of antidepressants and the kind of violence that took place in Newtown.  You just can’t, that’s not a legitimate use of information, of that information.  You can’t generalize just from one case.  Even if you can conclusively establish that Adam Lanza, his his uh his murderous actions, were caused by antidepressants, you can’t logically from that conclude that um um in others would uh, would uh commit the same actions as a result of taking antidepressants.  Um, um, so it’s simply not legitimate, and not only is it not the use to which they are proposing to put the information not legitimate, um it is harmful, because you can cause a lot of people um to stop taking their medications, stop cooperating with their treating physicians, um um just because of the heinousness of uh what Adam Lanza did.  As thee, as thee thee material, the FDA material that they submitted show, it would take a lot of studies uh over a long period of time and among, and within various demographic groups to even begin to uh establish causal links between antidepressants and uh uh aggressive actions or suicidal behavior.  And thee thee informed uh uh, the informed opinion has not quite reached that the point to to say definitively that there’s a causal link between uh between uh the use of antidepressants and uh and uh violent behavior.  Having correlations, there are correlations, but to say there are correlations doesn’t necessarily mean there is, the relationship is causal.  And uh uh this is an issue the FDA is still grappling with, and so far it’s been willing to do is is ask the drug makers to put warnings on their on their products and to advise physicians, treating physicians, to follow monitor their uh their  uh patients closely uh uh at the uh the beginning of uh uh the taking of antidepressants.  Um so it’s a complex issue, um and to pretend that you can just based on this one case make uh recommendations as to how people should uh uh how we should make judgment choices is a disservice to the public and illustrates why these types of reports should not be made available, because in the wrong hands they can be the source of the source of mischief.”

The hesitancies make the material a little difficult to read, but I think the message is clear:  AbleChild should be denied access to the documents in question because they are likely to draw and publicize unwarranted assumptions from these documents, and this might induce large numbers of people to stop taking the drugs in question.

Mr. Kwanashie’s statement is extraordinary for three reasons:

1.  The issue on the table was whether or not AbleChild had a “legitimate interest” (as defined by the statute and regulations) in the material.  This was essentially a legal/technical matter, and the complainant’s attorney Jonathan Emord had outlined various legal reasons in support of their right to the information.

What appeared to be expected from the Assistant Attorney General, who represented the State of Connecticut, was a rebuttal also based on legal issues and technicalities.  Instead, he launched gratuitously into these controversial waters, and provided, in my view, a glimpse of what seems to be going on behind the scenes.

It is of note that when he had finished these remarks, the hearing chairperson drew him back to the legal issues and asked him some clarificatory questions on those matters.

2.  Mr. Kwanashie has unquestionably conveyed the impression that there is some information that is being suppressed, and that it is being suppressed for the reasons that he outlined; i.e. so that people would not stop taking their pills.

3.  Mr. Kwanashie was not speaking as a private individual, but rather as the representative of the State of Connecticut.  He had almost certainly been authorized by his superiors to make the statement in question, and presumably the statement reflects the state’s stance on this issue generally, i.e. not just in the Adam Lanza case.

It’s possible, of course, that Mr. Kwanashie was confused or inadequately prepared for the hearing.  But that seems unlikely.  He is 59 years old, has been licensed to practice law in Connecticut since 1988, and draws a salary of $142,000.  Denying a freedom of information request is not a trivial matter, and the notion that he would go to such a hearing unprepared is hard to credit.  This is especially the case in that the Lanza shooting is probably the highest profile case that the State of Connecticut has encountered in decades.

So what we have is a credible indication that Adam Lanza was taking psychoactive “medication” around the time of the murders.  But the State of Connecticut will not release this information because such a release might induce large numbers of people to stop taking antidepressants.

A MINNESOTA TOWN HALL MEETING

A December 13, 2013, article called Newtown One Year Later, The Missing Link on the AbleChild site contained a link to a video.  The video is of a town hall meeting that Minnesota Congresswoman Betty McCollum held with some of her constituents in Oakdale, Minnesota eleven months earlier, on January 26, 2013.  At about 39 minutes and 30 seconds into the video, a member of the audience made the following comments:

“…I agree with Congresswoman McCollum that we need to have a dialogue with what’s going on with these gun issues.  I’m, we’re blindly running into gun control and a violation of the second amendment – but we’re not even sure if we have a  gun control problem.  I’ve been reading things where a lot of these kids – the Sandy Hook kid and the kid up in Red Lake Minnesota and Aurora – they’re all on Prozac and Ritalin and is this a psychopharmaceutical issue that’s causing these kids to do. – I mean – I think we need to have a,  I think we need to bring not only with both sides of the aisle but both sides of the issue together and examine exactly what’s going on here.  Is this a gun problem or is it a – you know – it could be anything.  But I think before we jump into legislating one portion of this we need to examine the entire issue and find out what’s going on.  Thank you very much.”

Here’s Congresswoman McCollum’s verbatim response:

“To that, let me tell you something: that, to quote my grandmother (so I use nice words here), frosted my cookies.  We can’t study, federally – we’re prohibited from studying the effects of some of the drugs that you were just talking about as it relates to people who go out and commit violent acts with guns.  We’re prohibited from studying that.  It’s an NRA square bolt.  That’s why I’d never be at 100%.  I think we have an obligation to study those kinds of issues.  So that’s why we need a dialogue.  It is prohibited from the CDC – the Centers of Disease Control – to study this.  It’s wrong!  And that’s why we need to get the lobbying efforts out of the discussion, just saying here’s your scorecard and they only highlight certain issues.  And they don’t give you everything else that they’re involved in. And that’s why I’m here and that’s why I’m glad you’re here.  So that we can talk and listen to one another.  And so I really am feeling very good that you’re here today.”

In the December 13 article, AbleChild describe their unsuccessful attempts to obtain additional information from Congresswoman McCollum concerning the CDC “rule.”

My interpretation of the Congresswoman’s words in the town hall meeting is that there is some kind of prohibition within the government on researching this topic, and that this prohibition is connected to lobbying – presumably by the pharmaceutical industry.

According to Wikipedia, Congresswoman Betty Louise McCollum is 59 years old, and is the U.S. Representative for Minnesota’s 4th congressional district, serving since 2001. She is a member of the Democratic-Farmer-Labor Party (DFL).  She currently serves on the United States House Appropriations Committee and the following subcommittees:  Subcommittee on Interior, Environment and Related Agencies, United States House Appropriations Subcommittee on Defense.   She also previously served on the House Committee Education and the Workforce; House Committee on Government Reform; House Committee on Resources; and House Committee on the Budget.  So she is mature and not, I imagine, given to flights of fancy.  She appears credible; she seems to have some personal knowledge of the “rule”; and there is nothing to suggest that she is making this stuff up.

Why is the media not all over this?  The town hall meeting was held almost a year ago.  To date the video has had only 307 hits.

WHITE HOUSE PETITION

And let’s not forget that a petition to formally investigate the link between psychopharmaceutical products and violence was removed from the White House petition website in December of 2012 without explanation, even though it was well on the way to obtaining the requisite number of signatures.

Is the US government, or any branch, or agency, of the US government deliberately suppressing research into the widely-suspected link between psychopharmaceutical products and mass shootings?  And if so, is this suppression the result of pharmaceutical lobbying?

If in fact, as many of us suspect, there is a causal link between the mass shootings and psychopharma products, shouldn’t this be a matter of urgent national importance?  Whose interests would be served by the suppression of this information?  Has the constitutional supremacy of We The People been usurped by They The Drug Companies?  By what distorted “logic” can a government collude with the notion of keeping people in the dark concerning a devastating drug effect in order to ensure that individuals keep taking these drugs?  I encourage my readers to check out both videos, and perhaps recommend that your friends and contacts do the same.  Perhaps there’s an innocent interpretation to all this.  If so, I’d be very grateful if someone could explain it to me.

FINALLY

In 2000, Joseph Glenmullen, MD, a psychiatrist, published Prozac Backlash – a critical look at the adverse effects of Prozac and other serotonin boosters.  Here’s a quote from the final chapter:

“We do know, from documented clinical experience and research, that these drugs have led to suicidal and violent urges in some patients.  We desperately need warnings for patients and doctors, together with information on prevention and coping with suicidal and violent impulses when they occur.  Additional research to help us understand the phenomenon is desirable but should not be merely a ploy to delay such warnings and preventive steps.” (p 336)

And that was more than 13 years ago!

Causes of High Mortality in People Labeled ‘Mentally Ill’

ANOTHER VIDEO FROM DR. LIEBERMAN

On October 28, Jeffrey Lieberman, MD, President of the APA, made another video.  This one is titled An Important Look at Mortality in Mental Illness: A Decade of Data on Psychotropic Drugs, and was made for Medscape.  You can see the transcript at the same site.  Medscape is a web resource for medical practitioners.

The video is Dr. Lieberman’s commentary on an article that appeared in JAMA Psychiatry online on August 28:  Comparative Mortality Risk in Adult Patients With Schizophrenia, Depression, Bipolar Disorder, Anxiety Disorders, and Attention-Deficit/Hyperactivity Disorder Participating in Psychopharmacology Clinical Trials, by Arif Khan, MD, et al.

Dr. Lieberman tells us that:

“The bottom line from this very good and important study, which was carried out with a large amount of data obtained from the administrative database of the FDA, is that psychotropic drugs are in the aggregate very beneficial — not just in suppressing patients’ symptoms, but in extending their overall survival and reducing mortality. In the ongoing debate in the literature as well as in the media about whether psychotropic drugs are overprescribed or are potentially detrimental to health, as physicians we must always be aware that medications should be used only when indicated and very judiciously in all people, particularly in children and the elderly — but we should never withhold them when they are needed, because they are very beneficial in terms of therapeutic effects. They should not be avoided, and their benefits are not substantially mitigated by concerns about adverse effects and shortened life spans.”

and

“They found, as has been previously reported many times, that individuals who have psychiatric disorders, and particularly schizophrenia, bipolar disorder, and depression, have lower overall survival (increased mortality). Of interest, being on a psychotropic medication (antipsychotic, mood stabilizer, bipolar medication or a combination of drugs) was associated with increased survival and lower mortality in patients with schizophrenia or bipolar disorder.”

WHAT THE ARTICLE ACTUALLY SAYS

The JAMA Psychiatry article by Arif Khan et al searched the FDA data bases for Summary Basis of Approval (SBA) reports of new and supplemental drug applications for 28 drugs approved between 1990 and 2011.

The researchers extracted mortality and drug exposure information from these SBA reports and collated the results.  The combined analysis included data on 92,542 clients.

The authors drew the following conclusions.

“These data suggest that increased mortality rates reported in population studies are detectable among adult patients with psychiatric illnesses participating in psychopharmacological trials. Furthermore, 3- to 4-month exposure to modern psychotropic agents, such as atypical antipsychotic agents, selective serotonin reuptake inhibitors, and selective serotonin-norepinephrine reuptake inhibitors does not worsen this risk. Given the inherent limitations of the FDA SBA reports, further research is needed to support firm conclusions.”

 So as you can see, there’s a huge discrepancy between the conclusions drawn by the authors and the “conclusions” promoted by Dr. Lieberman on his Medscape video.  Dr. Lieberman stated that:

“…psychotropic drugs are in the aggregate very beneficial — not just in suppressing patients’ symptoms, but in extending their overall survival and reducing mortality.” [Emphasis added]

The researchers point out that these studies entailed only 3-4 month exposure to the drugs – clearly not enough time to make any kind of definitive statement about reductions in mortality rates.  This is especially true in that psychiatrists routinely tell their clients that they need to take the drugs for extended periods – sometimes for life.

The researchers also point out that the FDA’s SBA reports have some “inherent limitations” with regards to the present study.  They discuss some of these limitations:

“Because of the abbreviated and variable form of FDA SBA reports, we could not assess premorbid history, age and sex of the clinical participant, family history, course of  illness, or details of any autopsy reports. Furthermore, deaths occurring among clinical trial participants exposed to placebo or active comparators were infrequent and difficult to interpret.”

and

“In addition, we could not fully evaluate all the clinical trial data for a variety of reasons. First, the data included in the FDA SBA reports in general consist of data from the registration or “pivotal” trials. These are only a fraction of studies conducted, and unfortunately data from the others cannot be accessed via the FOIA as interpreted by the FDA.” [Emphasis added]

And again, they stress the need for caution in interpreting their findings:

“Our results suggest that further detailed analysis of the clinical trial data by the FDA or the pharmaceutical companies is required before any firm conclusions can be drawn.

Furthermore, it is desirable to acquire much longer-term data, such as a decade in duration, regarding potential mortality risk when exposed to psychotropic agents based on the findings from the population studies. To obtain definitive results, prospectively designed studies are required.” [Emphases added]

DISCUSSION

It is clear that Dr. Lieberman has significantly misrepresented the results of the Khan et al study.  So there are two possibilities:  either he was genuinely confused, or he is consciously attempting to deceive medical practitioners who rely on Medscape.

The notion that he is genuinely confused is hard to sustain because in the first half of his video, he makes it clear that he is aware of the debate concerning the mortality-drugs link.  He says:

“This is important, because it has previously been suggested (and this fact has been used by critics of psychotropic medications) that psychotropic drugs, particularly the second-generation antipsychotic medications or mood-stabilizing drugs, contribute to side effects and medical comorbid conditions that shorten survival and increase mortality. These findings suggest that the opposite is true. Being on the medication in no way increased mortality; in fact, it actually reduced mortality, despite the fact that the studies that were obtained and analyzed were largely acute treatment studies of short duration, not the long duration that patients take these medications.”

Dr. Lieberman is obviously aware of the widely-expressed concerns that neuroleptics and SSRI’s are contributing to the increased mortality of people who take these drugs.  He is also aware that the toxic effects of these products are cumulative, and that most of the mortality effects become apparent in the long-term, rather than in the first 3-4 months.

He should also be aware of the following studies:

Bralet M C, et al, Cause of mortality in schizophrenic patients: prospective study of years of a cohort of 150 chronic schizophrenic patients, Encephale. 2000 Nov-Dec;26(6): 32-41. [original article in French].

“Concerning the comparisons between the deceased subjects and the survivors, there were five significant differences: gender, age, duration of the illness, neuroleptic dosage, negative symptoms (BPRS negative subscale). The deceased subjects were older, there was more men, the duration of the illness and the neuroleptic dosage were higher and the BPRS negative subscale was lower. These five variables were introduced in the discriminant analysis to explore notably their respecting weight. The corresponding power of the five variables were in decreasing order: neuroleptic dosage, negative symptoms, age, gender, duration of the illness.” [Emphasis added]

Honkola J, et al, Psychotropic medications and the risk of sudden cardiac death during an acute coronary event, Eur Heart J. 2012 Mar: 33(6): 745-751.

“The use of psychotropic drugs, especially combined use of antipsychotic and antidepressant drugs, is strongly associated with an increased risk of SCD [sudden cardiac death] at the time of an acute coronary event.”

Osborn DP, et al, Relative risk of cardiovascular and cancer mortality in people with severe mental illness from the United Kingdom’s General Practice eRsearch Database, Arch Gen Psychiatry. 2007 Feb; 64(2): 242-9.

“…a higher prescribed dose of antipsychotics predicted greater risk of mortality from CHD [coronary heart disease] and stroke.”

Berg K, et al, Pre-Admission Use Of Selective Serotonin Reuptake Inhibitors Is Associated With ICU Mortality, presentation American Thoracic Society 2012 International Conference, San Francisco.

“After adjusting for age, gender, ICD-9 diagnosis, disease severity and co-morbidities, the researchers found that patients on SSRI/SNRI’s prior to admission to the ICU were 73 percent more likely to die in the hospital (p<0.001), and that the increase in risk persisted at one year.”

Newcomer JW, Antipsychotic medications: metabolic and cardiovascular risk, J Clin Psychiatry. 2007; 68 Suppl 4:8-13.

“…psychotropic agents, including some antipsychotic medications, are associated with substantial weight gain, as well as with adiposity-dependent and possibly adiposity-independent changes in insulin sensitivity and lipid metabolism, which increase the risk of diabetes and cardiovascular disease.”

Sernyak MJ et al, Association of diabetes mellitus with use of atypical neuroleptics in the treatment of schizophrenia, Am J Psychiatry. 2002 Apr; 159(4):561-6.

“In this large group of patients with schizophrenia, receipt of a prescription for atypical neuroleptics was significantly associated with diabetes mellitus.”

American Diabetes Association Professional Tool #1: Screening and Monitoring in a High-Risk Population: Antipsychotic Medications and the Risk of Diabetes and Cardiovascular Disease

“A 2004 American Diabetes Association (ADA) Consensus Development Conference concluded that certain SGAs [second generation antipsychotics] are associated with the potential for rapid weight gain, deterioration in lipoprotein profile and increased risk of type 2 diabetes. Although the mechanisms underlying these effects remain incompletely understood, these potential side effects are of significant concern because of the association between these adverse cardiometabolic events and risk for diabetes and premature cardiovascular mortality.”

Weinmann S et al, Influence of antipsychotics on mortality in schizophrenia: Systematic review, Schizophr Res. 2009 Aug; 113(1):1-11

“There is some evidence that long-term exposure to antipsychotics increases mortality in schizophrenia. More rigorously designed, prospective studies are urgently needed.” [Emphasis added]

On the basis of all this, it is difficult to avoid the conclusion that  Dr. Lieberman made and published this video with the express purpose of deceiving medical practitioners who rely on Medscape for up-to-date information.  He never once drew attention to the authors’ own cautionary statements.  Even his presentation’s title (as shown on the transcript) is misleading: An Important Look at Mortality in Mental Illness: A Decade of Data on Psychotropic Drugs.  Combining the words “mortality” and “decade” in a title gives the impression that mortality figures were tracked for a ten-year period.  This was emphatically not the case.  What was analyzed was a decade’s worth of data, all of which involved a 3-4 month follow-up period.

His statement towards the end of the video is unambiguous:

“They [psychotropic drugs] should not be avoided, and their benefits are not substantially mitigated by concerns about adverse effects and shortened life spans.”

When we remember the truly horrendous adverse effects of neuroleptics, SSRI’s, and benzodiazepines, it is an extraordinarily sweeping – even reckless – statement.

By way of contrast with Dr. Lieberman’s sweeping statement, here’s what Michael Birnbaum, MD, a psychiatrist at Zucker Hillside Hospital in New York said when asked by Medpage for a comment:

“The majority of the studies included in this paper were of 3 to 4 months’ duration, and so what we really need to do now is appreciate the long-term effects of these medications on the brain and the body…Our psychiatric patients are often on these medications for months if not years, so it would be important for us to recognize the potential impact of these medications on mortality long term.”

Of course Dr. Birnbaum is not an eminent thought leader like Dr. Lieberman.

Psychiatry is under attack on a wide range of fronts.  The attacks are founded, and psychiatry has no rational, coherent response.  All they can do is repeat their spurious mantra that all significant problems of thinking, feeling, and/or behaving are brain illnesses that need to be treated with drugs.  They are blind and indifferent to the damage and disempowerment that they leave in their wake, and they grasp at any straw to support and promote their position.  They appear to be incapable of critical self-appraisal.

INCIDENTALLY

Dr. Khan, psychiatrist, the principal author of the JAMA study, received $1,518,215 from pharmaceutical companies in the period 2010-2012 [Dollars for Docs].  At the present time he serves as Medical Director for two pharmaceutical companies:   Columbia Northwest Pharmaceuticals LLC, and Rhine Pharmaceuticals LLC, of Bellevue, Washington (from his curriculum vitae).

Dr. Khan owns and operates Northwest Clinical Research Center in Bellevue, Washington.  NWCRC is a prolific producer of psychiatric research.  They publish papers in journals, and on posters which are displayed at various medical association conferences.  I looked at two of their articles published in 2011:  Weisler RH, Khan A, et al, and Khan A, Cutler AJ, et al.  Both of these studies found favorable results for their sponsors’ products (Bristol-Myers Squibb and Forest Labs respectively).

MORTALITY AND PSYCHIATRIC “DIAGNOSES”

It is indeed the case that people who are assigned psychiatric “diagnoses” have generally higher mortality rates than the general population.  This fact is frequently presented as proof that the conditions in question are real illnesses.

The logic, however, is fallacious.  Mountain-climbers have higher than average mortality, but nobody would suggest that mountain climbing is an illness.  The same could be said of people who routinely ride bicycles in heavy traffic, engage in unprotected sex, work in dangerous occupations, etc…

The excess mortality associated with psychiatric “diagnoses” derives from two main sources:

Firstly, the DSM criteria that define these so-called illnesses contain many items that are, I suggest, intrinsically linked to higher mortality.  These include:  disorganized behavior; poor nutrition; lack of goal-directed activity; risk-taking; distractibility; disrupted sleep pattern; agitation; attempted suicides; feelings of guilt; social isolation; animosity towards others; outbursts of anger; neglect of health; etc… Psychiatry uses items like these to define “mental illnesses,” and then “discovers” that the people with these “illnesses”  have a high mortality rate.  In fact, the high mortality rate is built into their very definitions of these conditions.

Secondly, the drugs that psychiatry uses to “treat mental illnesses” all have toxic effects, which over time create medical problems and lower life expectancy.

So, instead of helping these individuals overcome these problems and lead fruitful and longer lives, psychiatry drugs them, often involuntarily, and thereby shortens their lives even further.

Psychiatry is not something good that needs some minor corrections.  It is something flawed and rotten that needs to be criticized, exposed, and ostracized.

The Dangers of SSRI’s

SSRI’S AND SUICIDE

Bob Fiddaman has a post up today called MHRA Consultant Calls for Antidepressant Use in Young.  The article highlights some of the dangers associated with SSRI’s, and also describes some of the attempts to suppress or discount the significance of this information.

Apparently in 2010, Swedish psychiatrist Göran Isacsson, MD, PhD, published a paper in Acta Psychiatrica Scandinavica.  The piece was titled Antidepressant medication prevents suicide in depression, and reported that of a group of 1,077 depressed people who had committed suicide, only 15.2% had measurable amounts of antidepressants in the blood stream at the time of the suicide.

This claim was challenged by Janne Larsson, a Swedish journalist, who asked to see the actual data.  This request was consistently denied, but:

“After many legal wrangles the Karolinska Institutet were forced to admit in court that the actual figure quoted by Isacsson [15.2%] was way off the mark. The true percentage of those who had antidepressants in their blood when they committed suicide was a staggering 56%.”

Acta Psychiatrica Scandinavica retracted Isacsson’s article.

SSRI’S UNSAFE FOR CHILDREN

Bob also draws attention to a recent article in BMJ (open) Suicide-related events in young people following prescription of SSRIs and other antidepressants: a self-controlled case.  One of the authors is Stephen J. W. Evans, BA, MScC, Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine.  He is an expert member of the Pharmacovigilance (Drug Safety) and Risk Assessment Committee at the European Medicines Agency.

Evans et al are proposing that MHRA’s position, that SSRI’s are not recommended for children, be re-evaluated.  MHRA (Medicines and Healthcare products Regulatory Agency) is approximately the UK equivalent of the FDA.

SSRI’S AND BIZARRE BEHAVIOR

Bob then lists six fairly high profile incidents in which people who were taking SSRI’s went “crazy.”

“Depression did not cause any of the above bizarre incidents. Depression symptoms, do not include holding up garages, impersonating police officers, robbing banks, running around wielding an axe, stealing shopping trolleys and driving a stolen golf cart whilst firing random bullets on a golf course.”

and asks the question:

“Were they all misdiagnosed or did they all have a reaction to the medication [SSRIs] they were taking at the time?”

Bob’s article is detailed and compelling, and well worth reading.  We, on this side of the debate, have made a great deal of headway, but pharma-psychiatry has not given up.  There are still profitable markets out there, and thar’s gold in them thar pills.

We need to keep up the pressure; keep exposing the lies and the destructiveness.  Please read Bob’s article, and pass it on.

Pharma Corruption of Healthcare

I’ve been reading another great book:  Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare, by Peter C. Gotzsche [Radcliffe Publishing, 2013].

The book is an exposé of pharma’s fraudulent research and marketing.  The author is a Danish physician who has been involved in clinical trials of drugs, and in drug regulatory matters.  He is a professor at the University of Copenhagen.  He has published more than 50 papers, including papers in the BMJ, Lancet, JAMA, Annals of Internal Medicine, and the New England Journal of Medicine.

Most of the book is concerned with pharma corruption in general medicine.  But there are two chapters that deal with pharma and psychiatry: Chapters 17 and 18.

Here are the subheadings for these chapters:

17.  Psychiatry, the drug industry’s paradise

  • Are we all crazy or what?
  • Psychiatrists as drug pushers
  • The chemical imbalance hoax
  • Screening for psychiatric disorders
  • Unhappy pills
  • Prozac, a terrible Eli Lilly drug turned into a blockbuster
  • Exercise is a good intervention
  • Further lies about happy pills

18.  Pushing children into suicide with happy pills

  • Glaxo study 329
  • Concealing suicides and suicide attempts in clinical trials
  • Lundbeck’s evergreening of citalopram
  • Antipsychotic drugs
  • Zyprexa, another terrible Eli Lilly drug turned into a blockbuster
  • The bottom line of psychotropic drugs

Here are some quotes:

“Psychiatry is the drug industry’s paradise as definitions of psychiatric disorders are vague and easy to manipulate.” (p 191)

“Few psychiatrists are willing to admit that their specialty is out of control and they will continue to tell you that many patients are underdiagnosed.” (p 193)

“The psychiatrists are running amok.” (p 195)

“Leading psychiatrists are often highly effective drug pushers.” (p 197)

“…the sure way of making us all crazy is to screen for mental disorders.” (p 201)

“It is abundantly clear that suicides, suicidality and violence caused by SSRIs are grossly underestimated, and we also know the reasons.  First, there is outright fraud.  Second, many suicidal events have been coded as something else.  Third, the drug industry has taken great care to bias its trials by only recruiting people at very low risk of committing suicide.” (p 223)

“The drug companies have caused tremendous harm by their widespread illegal and aggressive promotion of the drugs for off-label use…” (p 229)

“Like for the SSRIs, there are many perverse trials supporting antipsychotics for virtually everything.” (p 230)

“I therefore estimate that 200,000 of the 20 million patients treated with Zyprexa have been killed because of the drug’s harms.” (p 232)

Anyone who has any lingering doubts as to the flawed and destructive nature of psychiatry might usefully take a look at this book.

 

Disclosure:  I have no financial interest in this book or in any books that I recommend on this website.

Antidepressants Being Handed Out Like Candy

There’s an interesting exposé in the London Daily Mail, September 29, titled Critics claim antidepressants are being handed out like sweets…  Thanks to Leonie and Antidepaware on Twitter for the link.

To find out how easily people could get prescriptions for antidepressants, the Mail sent

“…three women of differing ages — all of whom had no current mental health issues — to their doctors, reporting fictional symptoms of mild depression which had lasted for three to six weeks.”

Two of the three volunteers were given prescriptions for SSRI’s without difficulty.  The third was not offered a prescription, but instead was encouraged to exercise and make some dietary changes.

The article points out that there was a 7.5% increase in antidepressant prescriptions in the UK from 2011 to 2012.

The article contains two comments on its findings.

The first comments are from Dr. Des Spence, a General Practitioner from Glasgow, Scotland.  He writes and blogs about “… all the stupid and bad things that medicine does.”  His recent posts include: Saying “no” to Chemotherapy; The Power of Non Intervention; and Get Big Pharma out of Post Graduate Education!

He is quoted in the Mail article as follows:

“The growth rate of antidepressant use is a major concern…We need to acknowledge they are being overused.”  Dr Spence warns that our excessive use of antidepressants is turning us into a country of pill-poppers who are unable to tackle life’s routine challenges.

And:

Dr Spence says Britain must break its dependency on antidepressants so that more people can beat the blues through self-help and therapy.  “People have always talked to others to make sense of their problems,” he says. “People’s sense of well-being isn’t in the gift of medicine — it’s in the support of friends and family.”

The second comment is by Dr. Clare Gerada, chair of the Royal College of General Practitioners.  Dr. Gerada was trained in psychiatry, and Wikipedia reports that she cites mental health and substance abuse as her main work interests.

In the Mail article she is quoted as saying:

“The rise in antidepressant use is not as high as people think, …GPs are prescribing them for longer because this has been shown to work better.”

This strikes me as typical of psychiatry’s response to any kind of criticism.  It is obvious that the use of antidepressants has been increasing, and that the increase is causing concern.  In addition, there is abundant evidence that antidepressants are nowhere near as effective as they are claimed to be (here, here, and here), and that long-term use of these drugs leads to a deteriorating long-term outcome.  It is also becoming increasingly clear that the side effects are more serious and more prevalent than pharma-psychiatry’s promotions portrayed.

Incidentally, a similar experiment was conducted in Ireland six months ago by a journalism student, with similar results.  The Irish Examiner covered the story in their article Depressing truth about treating depression in the young.

More SSRI Side Effects: Upper GI Bleeding

Earlier this month, the American Journal of Psychiatry published an article by Yen-Po Wang, M.D., et al, titled Short-Term Use of Serotonin Reuptake Inhibitors and Risk of Upper Gastrointestinal Bleeding.  [Thanks to Mad in America for the link]

The research was conducted in Taiwan.  The authors studied the records of 5,377 psychiatric inpatients with gastrointestinal bleeding between 1998 and 2009.  Study subjects served as their own controls, i.e. the incidence of bleeding in the period following the antidepressant prescription was compared with the incidence of bleeding during a period when they were not taking antidepressants.

FINDINGS

The adjusted odds ratio for the risk of upper gastrointestinal bleeding after starting an SSRI was 1.67 (after 7 days), 1.84 after 14 days, and 1.67 after 28 days.

CONCLUSIONS

“Short-term SSRI use (7–28 days) is significantly associated with upper gastrointestinal bleeding.”