Tag Archives: research corruption

The FDA:  The Fox Guards the Hen House

In their Fall 2013 issue, the Journal of Law, Medicine, and Ethics published a symposium of papers by members of the Harvard’s Edmond J. Safra Center for Ethics.  The symposium was called Institutional Corruption and Pharmaceutical Policy.

The symposium focuses on pharmaceutical products generally, but all the material is relevant and important in the context of psychiatric drugs.

In this post I will highlight one of these papers:  Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs, by Donald W. Light, Joel Lexchin, and Jonathan J. Darrow.

Here are some quotes:

“An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians…”

“It is our thesis that institutional corruption has occurred at three levels.  First, through large-scale lobbying and political contributions, the pharmaceutical industry has influenced Congress to pass legislation that has compromised the mission of the Food and Drug Administration (FDA).  Second, largely as a result of industry pressure, Congress has underfunded FDA enforcement capacities since 1906, and turning to industry-paid ‘user fees’ since 1992 has biased funding to limit the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages.  Finally, industry has commercialized the role of physicians and undermined their position as independent, trusted advisers to patients.”

“Despite the small number of clinically superior drugs, sales and profits have soared as successful marketing persuades physicians to prescribe the much more costly new products that are at best therapeutically equivalent to established drugs…  Both an American and a Canadian study found that 80 percent of the increase in drug expenditures went to paying for these minor-variation new drugs, not for important advances…  Companies claim that R&D costs are ‘unsustainable.’  But over the past 15 years, revenues have increased six times faster than has investment in R&D.…”

“…allowing companies to test their own products has led them – as rational economic actors – to design trials in ways that minimize detection and reporting of harms and maximize evidence of benefits…”

“…companies have created what can be characterized as the trial-journal pipeline because companies treat trials and journals as marketing vehicles.”

“Furthermore, companies are much less likely to publish negative results, and they have threatened researchers who break the code of secrecy and confidentiality about those results… Positive results are sometimes published twice – or even more often – under different guises.  This further biases meta-analyses – a method of statistically combining the results of multiple studies – and clinical guidelines used for prescribing.  The result is ‘a massive distortion of the clinical evidence… For decades the FDA has kept silent about these practices and about the discrepancies between the data submitted to the FDA by companies and the findings published in journal articles, to the detriment of patients but much to the benefit of the companies.”

The authors offer five suggestions for restoring institutional integrity in this field.

  1. “…while research companies play important roles in discovering and developing superior drugs, they should play no role in testing them.”
  2. “…the FDA needs new leadership to restore public trust and build a new culture focused on safety through enforcement of its existing rules.”
  3. “…user fees must end, and the FDA must be entirely funded by taxpayers-as-consumers. The FDA should be entirely clear about whom it serves.”
  4. “…while approval criteria should allow for a sufficient number of therapeutically equivalent drugs in a class to give clinicians a range of choices…they should also require patient-relevant evidence of superiority.”
  5. “…Congress needs to restore trust by creating a National Drug Safety Board with adequate powers, funds, and mandates to independently investigate and report on drug safety issues.”

This is a meticulously written and well-referenced article.  I urge readers to take a look.  The authors have pulled together all the compelling issues in this matter, and have presented them in a cogent and condensed format.  The article provides excellent material for developing responses to psychiatry’s exaggerated claims, and for lobbying politicians with regards to the obviously much-needed reforms.

According to OpenSecrets.org, the pharmaceutical/health products industry spent $226 million lobbying US politicians in 2013.  By contrast, the defense aerospace industry, popularly regards as a heavy lobbyer, spent $58 million.

Sluggish Cognitive Tempo – A New Diagnosis?

On April 11, 2014, journalist Alan Schwarz (brief bio here) published an article in the New York Times on this topic, titled Idea of New attention Disorder Spurs Research, and Debate.  Alan has written extensively on the rising rates of the condition known as ADHD, and on the abuse of the drugs that are used to “treat” this condition. He has drawn a good deal of criticism from psychiatry’s believers.

In the NY Times article Alan draws attention to the fact that sluggish cognitive tempo (SCT) is being promoted as a new disorder  “… characterized by lethargy, daydreaming and slow mental processing.”  He makes the obviously valid point, that the formalization of such an entity  “… could vastly expand the ranks of young people treated for attention problems.”

The NY Times article was prompted by the fact that the Journal of Abnormal Psychology featured this emerging “diagnosis” in its January 2014 issue.  The issue contained eleven articles on the topic.  These articles addressed questions like:

  • Is SCT a sub-domain of ADHD?
  • Is SCT a disorder in its own right?
  • What are the symptoms of SCT?
  • What are SCT’s co-morbidities?
  • In what ways does SCT differ from ADHD, inattention type?
  • How does SCT differ from depression and anxiety, etc.?

It is a central theme of this website that mental illnesses/disorders, including ADHD and SCT, have no ontological or explanatory significance, are not a helpful way to conceptualize human existence, and in fact are intrinsically disempowering and stigmatizing.  The fact that these so-called illnesses are adduced by their psychiatric inventors to legitimize toxic treatments adds to their destructiveness.  The details of these critiques need not be repeated here.

HISTORY OF SCT

Sluggish cognitive tempo is not a new concept.  ADHD has long been criticized, even by psychiatrists, as embracing two very different kinds of presentations:  inattentiveness, on the one hand, and hyperactivity/impulsivity on the other.  DSM-III-R (1987) acknowledged this problem and created the new “diagnosis” 314.00 Undifferentiated Attention-Deficit Disorder (p 95).  The manual describes this condition as follows:

“This is a residual category for disturbances in which the predominant feature is the persistence of developmentally inappropriate and marked inattention that is not a symptom of another disorder, such as Mental Retardation or Attention-deficit Hyperactivity Disorder, or of a disorganized and chaotic environment.” [Emphasis added]

DSM-IV (1994) also acknowledged this issue, and split ADHD into three distinct “diagnoses.”

  • ADHD Combined type
  • ADHD Predominantly inattentive type
  • ADHD Predominantly hyperactive-impulsive type

DSM-IV-TR (2000) created the “diagnosis” 314.9  Attention –Deficit/Hyperactivity Disorder Not Otherwise Specified

“This category is for disorders with prominent symptoms of inattention or hyperactivity-impulsivity that do not meet criteria for Attention-Deficit/Hyperactivity Disorder.  Examples include:

1.  Individuals whose symptoms and impairment meet the criteria for Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type but whose age at onset is 7 years or after.

2. Individuals with clinically significant impairment who present with inattention and whose symptom pattern does not meet the full criteria of the disorder but have a behavioral pattern marked by sluggishness, daydreaming, and hypoactivity.” [Emphasis added]

DSM-5 has two residual categories in this area:

  • Other Specified ADHD (314.01)
  • Unspecified ADHD (314.01)

These “diagnoses” do not mention sluggishness, daydreaming and hypoactivity specifically, but these attributes are clearly embraced by the definitions.  This is particularly the case in that practitioners working with DSM-IV-TR would have become accustomed to conceptualizing this particular presentation as a “sub-diagnosis” of ADHD and, in addition, DSM-5 did not repudiate the SCT example given in DSM-IV-TR.  DSM-5 offers no examples of the residual diagnoses, the most reasonable interpretation of which is that the older examples are still to be considered valid as well as any others that individual practitioners encounter/invent as they go about their work.

It is noteworthy also that the DSM-5 main entry on ADHD contains the phrases: “mind seems elsewhere” and “may include unrelated thoughts.”  These phrases did not occur in the DSM-IV-TR main entry, and are clearly intended to embrace the notion of daydreaming.

So it is clear that the APA’s notion of ADHD (predominantly inattentive type) has long embraced daydreaming and lethargy, and it was probably inevitable that psychiatry, with its ever-expanding agenda, would eventually begin to conceptualize this as a distinct “illness.”  So today we have sluggish cognitive tempo emerging as a “diagnosis” in its own right, and attracting comment and attention.

CURRENT STATUS OF SCT

Earlier this year, Catherine Saxbe MD, a psychiatrist, and Russell Barkley PhD, a psychologist, wrote a paper reviewing the history of research on sluggish cognitive tempo.  The paper, The second attention disorder? Sluggish cognitive tempo vs. attention-deficit/hyperactivity disorder: update for clinicians, was published in the Journal of Psychiatric Practice.  Here’s a quote:

“Sluggish cognitive tempo (SCT) refers to an impairment of attention in hypoactive-appearing individuals that first presents in childhood. At this time, it exists only as a research entity that has yet to debut in official diagnostic taxonomies. However, it seems likely that a constellation of characteristic features of SCT may form the criteria for a newly defined childhood disorder in the foreseeable future, provided limitations in the extant findings can be addressed by future research.”

The authors expressed the belief that sluggish cognitive tempo is an unfortunate name for the disorder  “…since the term sluggish is associated with connotations of being retarded, slow-witted or just plain lazy.”  They remind us that

“More than semantics is at stake here.  The nosology reflects the way we conceptualize a disorder, view our patients, and how they understand themselves.”

They suggest that “concentration deficit disorder” or “developmental concentration disorder” or “focused attention disorder” would be better names for the problem, and appear to be entirely blind to the fact that the negative effects of referring to a child as “sluggish” pale to nothing compared with the stigma and disempowerment inherent in the notion that he is a “patient” with a “mental illness” (regardless of the name given to this illness).  In addition to which, of course, must be reckoned the destructive effects of the “treatments.”

Here are some more quotes from the Saxbe and Barkley article:

“No large-scale medication trials have examined response to stimulants specifically in SCT, but one recent investigation shows promise for the potential use of atomoxetine.”

and

“This is an exciting finding and warrants further investigation as it is the first published report to show improvement in SCT with any medication.”

and

“Given the overlap of SCT with anxiety and depression, perhaps selective serotonin reuptake inhibitors (SSRIs) might be [another] possible treatment.”

The study in question is Wietecha L. et al., titled Atomoxetine improved attention in children and adolescents with attention-deficit/hyperactivity disorder and dyslexia in a 16 week, acute, randomized, double-blind trial.  This appeared in the November 2013 issue of Journal of Child and Adolescent Psychopharmacology.  The paper is a study of the efficacy of atomoxetine in the “treatment” of various attention problems including SCT.  Atomoxetine is a selective norepinephrine reuptake inhibitor (NRI) marketed as Strattera by Eli Lilly.  The study (Wietecha et al.) found that:

“The atomoxetine-treated ADHD-only subjects significantly improved from baseline to Week 32 on…all K-SCT [Kiddie-Sluggish Cognitive Tempo Interview] subscales…”

and

“This is the first study to report significant effects of any medication on SCT.”

All of this is particularly interesting because:

  1. Ritalin, which is now off patent, and other stimulants, are reportedly ineffective in the “treatment” of SCT “symptoms.” (Saxbe and Barkley, 2014, p. 47)
  2. Atomoxetine, which is still on-patent, is now “proven” effective in this area.
  3. Linda Wietecha works as a Clinical Research Scientist for Lilly USA, LLC
  4. According to Dollars for Docs, the following co-authors on the study have also received money from Eli Lilly in the period 2009-2012: Bennett Shaywitz, MD, $963,003; Stephen Hooper, PhD, $16,540; David Dunn, MD, $56,886; and Keith McBurnett, PhD, $5,000.
  5. Russell Barkley, PhD, co-author of the article cited earlier, received $120,283 from Eli Lilly for consulting, speaking, and travel between 2009 and 2012 (Dollars for Docs), and as recently as February of this year gave a lecture tour in Japan sponsored by Eli Lilly.

All of which raises the interesting question:  is SCT disorder being promoted at the present time by Eli Lilly’s paid hacks as a way of increasing sales of atomoxetine (Strattera) while it is still on patent?

PSYCHIATRIC CREDIBILITY

Interestingly, and sadly, most of the research and promotion of SCT has been done by psychologists rather than psychiatrists.  This fact prompted Jeffrey Lieberman, MD, President of the APA, and very eminent psychiatrist to  tweet on April 11 “no credible psychiatrist takes this [SCT] seriously” in response to Alan Schwartz’s article in the New York Times.  Dr. Lieberman seems to be unaware that in DSM-IV-TR (2000), the APA created a specific “diagnosis” for the sluggishness/daydreaming/hypoactivity presentation (using those exact words), and that this “diagnosis” has been clearly retained in DSM-5 (though without those specific words).  I’ve never been aware of any great outcry from organized psychiatry, or from individual practitioners, on this matter.  So, if we are to take Dr. Lieberman at his word (and why would we not do that?), there must be an enormous dearth of “credible psychiatrists” within the APA’s ranks.

In this context, it is also noteworthy that the Wietecha et al. article was published in the Journal of Child and Adolescent Psychopharmacology, which suggests – at least to me – that the journal takes SCT seriously.  The editor-in-chief is Harold Koplewicz, MD, psychiatrist, founding member and President of the Child Mind Institute.  Dr. Koplewicz has held many prestigious positions, and has received numerous awards, including the 2009 American Psychiatric Association McGavin Award for lifetime contributions to child psychiatry.  But alas, he must now be considered a psychiatrist with no credibility.

And

The Saxbe and Barkley article was published by the Journal of Psychiatric Practice, the editor of which is John Oldham, MD, Senior VP and Chief of Staff at the Menninger Clinic, and a psychiatry professor at Baylor College of Medicine.  Dr. Oldham is a past President of the APA (2010-2011), and of the American College of Psychiatrists (2010-2011).  He has also been President of the International Society for the Study of Personality Disorders, and was a member of the DSM-5 Personality Disorders workgroup.  But, here again, no credibility!

The general point here is that psychiatry has embraced the concept of medicalizing daydreaming. Dr. Lieberman either doesn’t realize this, or is trying to conceal the fact.

DISCUSSION

It would be easy to get distracted by this recent attempt to promote childhood daydreaming as a mental illness.  As mentioned earlier, daydreaming, or to use psychiatric terminology, “the persistence of developmentally inappropriate and marked inattention,” has been a specific “mental illness” since DSM-III-R, 1987, (p 95).

The fact is that any human presentation can be considered a mental illness.  All that is needed is the APA’s say so.  And the APA made their position absolutely clear in the foreword to DSM-II (1968).  In the paragraph where they discuss what “diagnoses” should be included in the manual, they state:

“The Committee has attempted to put down what it judges to be generally agreed upon by well-informed psychiatrists today.” (p viii)

In other words:  if we say it’s a mental illness, then it’s a mental illness!

In subsequent editions of the manual, they offer a definition of a mental disorder, which when stripped of verbiage boils down to:  any significant problem of thinking, feeling, and/or behaving.  And who decides something is a problem?  A psychiatrist, of course.

Sluggish Cognitive Tempo (or concentration deficit disorder, as Drs. Barkley and Saxbe would prefer to call it) is more psychiatric nonsense.  But that’s all it is – more of the same; another inevitable result of psychiatry’s fundamentally flawed, spurious, and destructive medicalization of human existence.  Psychiatry continues to expand its net of entrapment into all aspects of life and into every corner of the globe.

By all means let’s speak out against this latest encroachment, but let us not lose sight of the corrupt and spurious engine that has been driving this endeavor since the 1950’s, or of the trail of human suffering and destruction that it has left, and continues to leave, in its wake.

Nor let use lose sight of the fact that many of the greatest writers, scientists, and artists were chronic daydreamers.  We can only imagine how much better the world would be today if these individuals had received the benefits of modern psychiatric treatment. We can also look forward to a better future – a future where daydreaming will be routinely recognized as the illness that it is, it’s victims will be “treated” appropriately with psychiatric drugs, and this plague, that has beset humanity since pre-historic times, will finally be eradicated.

* * * * * * * * *

There is absolutely no facet of human existence that psychiatry will not pathologize in the pursuit of its own self-serving agenda.

Revitalizing Psychiatric Therapeutics?

In January of this year, Steven Hyman MD, former Director of NIMH and currently a leading psychiatric researcher at MIT and Harvard, published Revitalizing Psychiatric Therapeutics in Neuropsychopharmacology.  The article is in the journal’s commentary section and is essentially an opinion piece.  Here’s Dr. Hyman’s summary:

“Despite high prevalence and enormous unmet medical need, the pharmaceutical industry has recently de-emphasized neuropsychiatric disorders as ‘too difficult’ a challenge to warrant major investment.  Here I describe major obstacles to drug discovery and development including a lack of new molecular targets, shortcomings of current animal models, and the lack of biomarkers for clinical trials.  My major focus, however, is on new technologies and scientific approaches to neuropsychiatric disorders that give promise for revitalizing therapeutics and may thus answer industry’s concerns.”

Dr. Hyman is a key figure in the promotion of bio-psychiatry.  His opinions carry weight, and I thought it might be useful to examine what he has written.

Dr. Hyman begins with a brief look at the psychopharmacological “revolution” of 1949-1957, during which lithium, chlorpromazine, iproniazid and imipramine were introduced.

“These serendipitously recognized drugs gave rise to a large number of related compounds in each therapeutic class that in aggregate produced enormous benefit to patients while fundamentally changing the scientific and clinical landscape of psychiatry.”

and

“Later, beginning with clomipramine, serotonin-selective antidepressants were found to exhibit a degree of efficacy for obsessive-compulsive disorder.  These discoveries not only improved many lives but also motivated significant advances in both basic science and clinical investigation.”

Dr. Hyman’s enthusiasm for the drug revolution in psychiatry is clearly evident, and there’s little or no recognition that the drugs he mentions may have done, on balance, more harm than good.  He does concede some toxicity concerns but assures us that the drugs developed in the last 50 years are less toxic than their forerunners.  He acknowledges, however, that they are no more effective.

“What has not happened for five decades across the range of psychiatric drug classes is any significant improvement in efficacy.”

Dr. Hyman attributes this lack of improvement in efficacy to the fact that

“…the molecular targets of all of today’s widely used psychiatric medications are the same as the targets of their 1950s prototypes.”

Dr. Hyman notes that

“…the past 4 years have seen the industry significantly decreasing its investment in psychiatric disorders while investing in other areas.”

He attributes this reduction in investment to pharma’s perception that the “scientific underpinnings” of psychiatry are “less mature” than in other medical fields.

This, he tells us, has “enormous negative consequences for patients with psychiatric disorders and their families” because “…discoveries that may come from academic labs in the near term…” will not result in marketable products without pharmaceutical funding.

So, according to Dr. Hyman, pharma is distancing itself from psychiatry because psychiatry’s scientific underpinnings are less mature than other fields.  Specifically, Dr. Hyman mentions:

1.  “poor understanding of disease mechanisms”
2.  “significant disillusionment with animal models”
3.  “a phenomenological diagnostic system and a lack of biomarkers for diagnosis or ascertainment of treatment response”

With regards to the third item, Dr. Hyman is fairly blunt about psychiatry’s current diagnostic categories.

“Newer technologies combined with growing momentum for a ‘cognitive jailbreak’ from the fictive DSM categories that have captured grant making, journal editing, and regulatory decisions for the past several decades suggest that progress may be in the offing for biomarkers as well.” 

The general theme of the rest of the article is that great breakthroughs are at hand – maybe.

“Because of advances in genomic technologies, psychiatry is at the threshold of gaining information about molecular mechanisms of disease.  That said, putting genetic findings to work in the service of understanding the pathogenesis on psychiatric disorders and revitalizing therapeutics poses very difficult challenges.”

SUMMARY

Dr. Hyman’s article is interesting from a number of perspectives.

Firstly, he is clearly wedded to the bio-psychiatric approach and to the notion that psychiatric “patients” have gene-linked neural defects, the identification and remediation of which should be the primary focus of research.

Secondly, he is optimistic that breakthroughs in this area will occur, and that the pharma industry will resume its financial support of psychiatric research.

“The pace of technology development seems only to be accelerating, and should thus give us hope.  Despite the challenges, there is a substantial opportunity to win back industry and to revitalize psychiatric therapeutics by embracing clear thinking and by putting technologies to work.”

But of greatest interest is Dr. Hyman’s claim that pharma is abandoning psychiatric research because the latter has failed to identify precise “disease mechanisms” or biomarkers.

Pharma had been a staunch supporter of psychiatric research for five decades, during which time there were no identified disease mechanisms or biomarkers.  There were hypotheses, of course (e.g. the biogenic amine theory of depression, the serotonin theory of depression, the dopamine theory of schizophrenia, etc.), and these theories were promoted, both by psychiatry and by pharma, with more enthusiasm and vigor than their merits warranted.

It is also the case that psychiatry’s relationship with pharma was riddled with corruption at all levels of the profession, but especially among its leadership.

One facet of this corruption was the routine over-statement of psychiatry’s effectiveness, and, equally routine, under-statement of adverse effects.

And through all of this, psychiatry and pharma remained blissfully hand in glove.

What has changed in recent years is simply that the bubble of deception and profiteering has burst.  The spurious concepts and the destructive practices have been exposed; there is an active, growing, and outspoken survivor movement; and we’re seeing an increasing number of successful lawsuits.

In addition, there is a growing sense that it is only a matter of time before a definite link between psycho-pharma products and the school shootings will be established.

Pharma’s decision to hitch its wagon to psychiatry was never driven by science.  It was driven by business considerations.  Likewise, the decision to unhitch has nothing to do with science.  It’s because the cost of doing business with psychiatry has become unacceptably high.

CAFÉ Study: Real Science or Marketing Exercise?

BACKGROUND

On December 8,  I received the following question from a reader:  (The subject matter is the controversial CAFÉ – Comparisons of Atypicals in First Episode of Psychosis – study.  This was the study in which Dan Markingson committed suicide.)

“It appears that there was no head-to-head with a control group taking a placebo pill. Nor was there a control group featuring ‘old’ types of ‘antipsychotic’. If that was the case then it is very poor study. If you are just looking at 3 ‘new’ subtypes of a ‘new’ class – then what on earth can you hope to show from the data.”

I started to write a response, but the subject is complex, and my response became the following article.

******************************

Any discussion of CAFÉ must begin with a review of CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness).

CATIE was a randomized trial funded by the US government (NIMH).  It was written up in three phases:  Phase 1 (Lieberman J et al, 2005); Phase 2 Part a (McEvoy JP et al, 2006) and Phase 2 Part b (Stroup TS et al, 2006);  and CATIE Phase 3 (Stroup TS et al, 2009).  CATIE’s purpose was to compare old neuroleptics with new neuroleptics.  There was no placebo.  This reflected the belief/assumption that the efficacy of neuroleptics generally had already been established.  The researchers compared the old drug perphenazine with the second generation neuroleptics olanzapine, quetiapine, risperidone, and ziprasidone.  The conclusion:

“Olanzapine was the most effective in terms of the rates of discontinuation, and the efficacy of the conventional antipsychotic agent perphenazine appeared similar to that of quetiapine, risperidone, and ziprasidone.  Olanzapine was associated with greater weight gain and increases in measurers of glucose and lipid metabolism.” (Phase 1, p 1209)

So, a kind of mixed result; but notice that quetiapine was shown to be no better than the old drug.

In CATIE phase 2, clozapine was introduced.  One of the findings was:

“At 3-month assessments, Positive and Negative Syndrome Scale total scores had decreased more in patients treated with clozapine than in patients treated with quetiapine or risperidone but not olanzapine.” ( Part a, p 600)

and

“…risperidone and olanzapine were more effective than quetiapine and ziprasidone as reflected by longer time until discontinuation for any reason.” (Part b, p 611)

Again, a mixed result.  Clozapine is most effective but known to have even more serious adverse effects than other neuroleptics.  But notice again that quetiapine isn’t looking too good.

CATIE also had a placebo-controlled arm that addressed the use of neuroleptics in “treating” aggression and agitation in patients with Alzheimer’s Disease (CATIE-AD, Schenider et al 2006).  Even here, quetiapine didn’t do so well.  It had the lowest “improvement” rate, though the differences were not statistically significant.  The researchers also noted that:

“Adverse effects offset advantages in the efficacy of atypical antipsychotic drugs for the treatment of psychosis, aggression, or agitation in patients with Alzheimer’s disease.” (p 1525)

It was also found in CATIE Phase 1 that the individuals who had received quetiapine had the highest rate of hospitalization during the study.  The comparative figures were:

Olanzapine –    11%
Quetiapine –    20%
Risperidone –   15%
Perphenazine – 16%
Ziprasidone –   18%
(Table 3, p 1220)

These differences were statistically significant at the 0.001 level (i.e. there’s less than one chance in a thousand that the differences could have occurred by chance).

CAFÉ

Which brings us to CAFÉ, a multi-site study of neuroleptic treatment of first episode psychosis, funded by AstraZeneca, manufacturer of quetiapine (Seroquel).  CAFÉ was written up in two parts in the American Journal of Psychiatry.  CAFÉ has been criticized as little more than a marketing ploy by AstraZeneca to rescue their baby from the CATIE fall-out.

There were two main hypotheses:

“…that quetiapine was not inferior to olanzapine or risperidone in the rate of all cause treatment discontinuation in early psychosis patients.” (p 1050)

and

“…that the three agents would be equivalent in their effects on various neurocognitive measures.” (p 1061)

The researchers concluded:

“Olanzapine, quetiapine, and risperidone demonstrated comparable effectiveness in early-psychosis patients, as indicated by similar rates of all-cause treatment discontinuation.” (p 1050)

and

“Olanzapine, quetiapine, and risperidone all produced significant improvement in neurocognition in early-psychosis patients.  Although cognitive improvements were modest, their clinical importance was suggested by relationships with improvements in functional outcome.” (p 1061)

So, quetiapine is just as good, as measured by rates of treatment discontinuation, in early stage psychosis as the other second-generation neuroleptics.  The rate of treatment discontinuation, however, is a fairly minimal outcome criterion.  The usual rationale for using it in these kinds of studies is the assumption that it is inevitably associated with poor outcome generally.  This assumption has been critiqued widely in recent years, but is still generally accepted by psychiatrists.

But the most serious critique launched against CAFÉ is that the researchers administered the rival drugs at reduced dosages.  Olanzapine and risperidone were administered at about 60% of the CATIE dose, while quetiapine was administered at about 90% of the CATIE dose.  Here’s what the researchers wrote:

“Previous studies suggesting that first-episode patients receive therapeutic benefit from antipsychotic doses lower than those required for chronic patients and that first-episode patients develop unnecessary extrapyramidal side effects at higher doses led us to use lower dose ranges of olanzapine and risperidone in this study than those used in the Clinical Antipsychotic Trials of Intervention effectiveness (CATIE). However, given quetiapine’s low extrapyramidal side effects liability, we expected that the quetiapine doses used in CATIE would be tolerable in our study population.” (p 1058)

This seems questionable.  Neuroleptics, at least initially, reduce agitated thoughts and behavior.  And the higher the dose, the greater the “improvement.”  The authors themselves acknowledged this interpretation:

“This may have been a factor in the comparable effectiveness demonstrated by quetiapine.  In the CATIE phase 1 and phase 2 schizophrenia trials…higher mean modal doses of olanzapine and risperidone but similar mean modal doses of quetiapine were used; in these trials, olanzapine and less consistently risperidone proved to be more effective than quetiapine.  It remains an empirical question whether higher doses will improve the relative effectiveness of quetiapine in chronic patients.” (p 1058)

But this is buried in the text of a 20-page article.  As mentioned earlier, the article is written up in two parts in the American Journal of Psychiatry, 2007 (p 1050-1060 and p 1060-1071).  The above quotes appear on page 1058, but are not reflected in the conclusions.

The authors’ assertion of “low extrapyramidal side effect liability” for quetiapine is also of interest.  Firstly, they cite no reference in support of this assertion.  Secondly, CATIE had reported the following percentages for extrapyramidal effects: olanzapine 2%; quetiapine 3%; risperidone 3%; ziprasidone 4%.  The actual numbers are too small to draw firm conclusions, but there is nothing to suggest that quetiapine has a particularly low liability.

Another item of interest that was buried in the text, but did not appear in the conclusions, was:

“A total of 18 serious adverse events occurred, four in the olanzapine group and seven each in the quetiapine and risperidone groups.  These events included two suicide attempts and one alleged homicide in the olanzapine group, two completed suicides and one case of suicidal ideation in the quetiapine group, and one suicide attempt in the risperidone group.” (p 1057)

Further indications of the researchers’ agenda are suggested by the following quote:

“Our findings in this study suggest that the effect of quetiapine on cognition may be as beneficial as that of olanzapine or risperidone, and thus this agent may be another evidenced-based alternative for clinicians who focus on cognitive outcomes. (p 1069)

Even one of the primary conclusions was tenuous.  In the second part of the write-up, as mentioned earlier, the authors had concluded:

“Olanzapine, quetiapine and risperidone all produced significant improvements in neurocognition in early-psychosis patients.” (p 1061)

Buried in the text, however, on page 1069-1070, they wrote:

“In this study, patients with early psychosis who demonstrated cognitive improvement at 52 weeks also demonstrated functional benefit in social and occupational domains, which suggests a functional relevance for cognitive improvement.  One caveat to this promising conclusion is that given the high dropout rate in this study, these data apply only to the patients who were able to stay in treatment and complete comprehensive assessments for 52 weeks, a group that comprised only 20% of the original sample.” [emphasis added]

MEASURES OF EFFECTIVENESS

As mentioned earlier, the outcome criteria that were highlighted in the conclusions sections of the two papers were:  rate of treatment discontinuation and improvements in neurocognition.

However, various other items were assessed during CAFÉ that might usefully have been included in the papers’ conclusions.  In fact, the authors stated:

“Efficacy was measured in two domains:  1) psychopathology and 2) social and occupational functioning.  Psychopathology was assessed by the PANSS, the CGI, and the Calgary Depression Scale for Schizophrenia….  Social and occupational functioning was assessed with the Heinrichs-Carpenter Quality of Life Scale….” (p 1053)

Measurements on these scales were taken before the study began, and at 12 and 52 weeks.  The results are presented in Table 2 (p 1052).    (Click on the image below to see the full-size table.)  This is a rather complex table, and comparisons across the three drugs are not easy.  For this reason, I restructured and graphed the data below.

Table 2 from CAFE Study

 

 

 

 

In Table 2, an improvement in some of the scales is indicated by a negative number, in other scales by a positive number.  For ease of comparison, I eliminated the signs and focused only on the magnitude of change from the baseline value.  In each graph the direction upwards on the page indicates more improvement from baseline.  As can be readily seen, the level of improvement with quetiapine is lower (at both 12 and 52 weeks) than with olanzapine or risperidone in 6 of the 7 scales.  This difference is marginal in the CGI Severity Scale, and only reached statistical significance with the PANSS positive symptoms scores (and this was mentioned in the abstract), but the fact that quetiapine fared worse on 6 of the 7 variables seems noteworthy.

This is especially true in that the six scales addressed here are precisely the measures that would be of particular interest in the assessment of treatment effectiveness for psychotic thoughts/behaviors.  In fact, CATIE used the PANSS positive and negative scales to assess effectiveness.  Since the entire purpose of the study was to compare the relative effectiveness  of these drugs, it’s difficult to find a valid reason for not presenting the relative effectiveness data more clearly

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DISCUSSION

The big question is:  was CAFÉ a piece of genuine scientific research; or was it a marketing exercise bought and paid for by AstraZeneca in an attempt to rehabilitate their drug quetiapine (Seroquel)?  Obviously arguments can be made on both sides, but here are two factors that may have some bearing.

1.  AstraZeneca funded the study.

2.  There were a total of twelve authors listed on the two write-ups.  All but three declared a history of financial ties to AstraZeneca.  Of these three, Dr. Lieberman acknowledged that he had worked for AstraZeneca as an unremunerated consultant.  Dr. Sweeney declared only the funding for the present study (he was lead investigator), and Dr. Gu declared no ties.  Two of the authors, Dr. Lazarus and Dr. Sweitzer were employees of AstraZeneca, and both held stock options. (p 1059 and 1070)

The importance of these kinds of funding issues was highlighted in a study of head-to-head comparisons of second generation neuroleptics by Heres et al (Amer Jour Psych 2006).  These researchers found:

“In 90.0% of the studies, the reported overall outcome was in favor of the sponsor’s drug….Potential sources of bias occurred in the areas of doses and dose escalation, study entry criteria and study populations, statistics and methods, and reporting of results and wording of findings.”

DAN MARKINGSON

There were two completed suicides in the study, both in the quetiapine group.  One of these was Dan Markingson.  Dan’s inclusion in the study has been the subject of considerable controversy.  His mother, Mary Weiss, stated that she saw his condition deteriorate markedly during the period in question, and that she made repeated attempts to have him removed from the study and taken off the drug.  It is also reported that she alerted the study coordinator to the danger of homicide or suicide.  Her protests were not heeded.  Recently, thanks largely to the persistent efforts of Carl Elliott, the Faculty Senate of the University of Minnesota has voted to commission an independent inquiry into the circumstances of Dan’s death.  However, on December 11, Eric Kaler, President of the university stated in a press interview that the inquiry will only be looking into the university’s review procedures and that it will not be a review of Dan Markingson’s death.  This announcement, predictably, has re-opened the controversy (subsequent letter from University of Toronto).

THE BIG QUESTIONS

Why did the research team at the University of Minnesota’s Department of Psychiatry not take protective action in response to Mary Weiss’s warnings concerning her son Dan?

Did they discuss these concerns, and, if so, is there a record of these discussions?

Was an assessment made of Dan’s suicide potential in response to Mary’s expressions of concern?  If so, what was the result of that assessment?

On which site(s) did the other suicide and the three suicide attempts occur?

Was the decision-making concerning Dan influenced by the desire to portray quetiapine in as favorable a light as possible?  In particular, was the decision not to hospitalize Dan influenced by the fact that quetiapine had fared so poorly in CATIE on the hospitalization measure?

With regards to this last point, there is, I suggest, a pressing need to separate and publish CAFÉ’s relative hospitalization rates for the three drugs.  This information was not published in the study write-up, but presumably would still be available in the research files.

It is also important to investigate the question of informed consent.  In the study write-up, the authors state that:

“…written informed consent was obtained from the patients or their legally authorized representatives.” (p 1051)

It has been suggested that Dan Markingson was incapable of providing informed consent at the time of his enrollment.  Carl Elliott has written:

“When Mary found out that Dan had been recruited into the CAFE study, she was stunned. “I do not want him in a clinical study,” she told Olson [Stephen C. Olson, MD, one of the researchers]. Just a few days earlier, Olson indicated in a petition to the court that Dan was both dangerous and mentally incapable of consenting to antipsychotic medication. How could he now be capable of consenting to a research study with the very same antipsychotics—especially when the alternative was commitment to a state mental institution?”

A complicating factor here is that AstraZeneca paid the University of Minnesota $15,648 for each person they enrolled in CAFÉ, and it has been suggested that this financial incentive might have clouded the researchers’ judgment with regards to the ability to provide informed consent.

At the very least there are unanswered questions.  Was Dan capable of giving informed consent?  Was his “consent” coerced in any way?

It is now over nine years since Dan’s death.  It is high time that these questions were addressed in a serious and impartial manner.

 

U of Minnesota Faculty Senate Vote To Review Dan Markingson’s Death

In 2004, 26-year-old Dan Markingson committed suicide.  Since then, numerous concerns have been expressed about the events that led up to his death.  In particular, it has been claimed that he was coerced into the CAFE study, and that he was too delusional to understand what was involved.  It has also been reported widely that his mother, Mary Weiss, saw his condition deteriorate while he was taking the study drug – Seroquel (quetiapine) – and that she made numerous unsuccessful requests to the researchers to have him removed from the study.

Carl Elliott, PhD, Bioethics Professor at the university, has been calling, repeatedly, for an independent inquiry on this matter.  His requests have been consistently resisted by the psychiatrists who conducted the study as well as the university administration, but yesterday, the University Faculty Senate voted 67-23 to reopen the matter and conduct an independent inquiry.

In my view, there are three immediate lessons to be learned:

1.  Never give up.  Carl Elliott has been hammering away at this door for years.

2.  Individuals can make a difference.  I’m sure there were times when Carl felt that he was getting nowhere, that pharma/psychiatry’s forces were too strong, and that he was just one voice crying in the wilderness.  Each of us is just one voice, but collectively we are having an impact.

3.  Psychiatry at its core is rotten.  It can’t abide scrutiny, and will continue to resist attempts to expose its spurious and destructive practices.  There has been no change of heart in psychiatry.  They continue to expand their “diagnostic” net and to prescribe more dangerous drugs to more people.  They avail of every opportunity to promote their stigmatizing and disempowering agenda.  Psychiatry has no internal control mechanism that might limit this predatory, self-serving expansion. There are a few dissenting voices within psychiatry, and they are to be commended, but there is no groundswell of protest from the APA membership.  Psychiatry will not stop destroying lives until it is stopped by outside forces.

That is why it is so important that we keep writing – keep passing the word.  There have been thousands and thousands of Dan Markingsons.  And there will be thousands more.

 

Neuroleptics for Children: Harvard’s Shame

In December 2012, Mark Olfson, MD, et al, published an article in the Archives of General Psychiatry.  The title is National Trends in the Office-Based Treatment of Children, Adolescents, and Adults with AntipsychoticsThe authors collected data from the National Ambulatory Medical Care Surveys for the period 1993-2009, and looked for trends in antipsychotic prescribing for children, adolescents, and adults in outpatient visits.  Here are the results:

Age Increase in no. of antipsychotic prescriptions per 100 population (1993-2009)
0-13 0.24-1.83 (almost 8-fold)
14-20 0.78-3.76 (almost 5-fold)
21+ 3.25-6.18 (almost 2-fold)

 

The authors provide a breakdown of the diagnoses assigned to the children and adolescents during the antipsychotic visits.

Diagnosis Visits %
Children
(0-13)
Adolescents
(14-20)
Schrizophrenia 6.0 8.1
Bipolar 12.2 28.8
Depression 11.2 20.9
Anxiety 15.9 14.4
Dev Disorders 13.1 5.0
Disruptive Behavior Disorders 63.0 33.7
Other Dx’s 18.0 16.8

 

Percentages do not total 100, because some individuals were assigned more than one diagnosis.

It is clear that disruptive behavior disorders are the most common diagnoses used in antipsychotic visits for both children and adolescents.

Thirty years ago, the prescription of neuroleptic drugs to children under 14 years of age was almost unheard of.  It was rare in adolescents, and even in adults was largely confined to individuals who had been given the label schizophrenic or bipolar.

By 1993, the first year of the Olfson et al study, about a quarter of 1% of the national childhood population were receiving antipsychotic prescriptions during office visits.  The percentage for adolescents was about three quarters of 1%.  By 2009, these figures had increased to 1.83% and 3.76% respectively.

The devastating effects of these neurotoxic drugs are well known, and it is natural to wonder what forces might be driving this trend.  The authors suggest that:

“Increasing clinical acceptance of antipsychotics for problematic aggression in disruptive behavior disorders may have increased the number of children and adolescents (especially male youths and ethnic/racial minorities) being prescribed antipsychotics.  The increase in the number of clinical diagnoses of bipolar disorder and autistic spectrum disorders among children and adolescents may have further increased antipsychotic use by youths, particularly by boys.”

They also note that:

“The trend in the prescribing of antipsychotics to youths occurred within the context of a dramatic increase in the clinical diagnoses of bipolar disorder among young people.”

The notion that the increase in the prescription of neuroleptics for children is driven by increased use of the bipolar diagnosis is supported by another study:  Most Frequent Conditions in U.S. Hospitals, 2010,  by Plunter et al, January 2013, published by the Agency for Healthcare Research and Quality (a division of the US Department of Health and Human Services).  This study, which analyzed hospital admission data from 1997 to 2010, found that mood disorder, which in 1997 had been in the fourth place (behind asthma, pneumonia, and appendicitis) was by 2010 the most common diagnosis for children aged 1-17.  In the 13-year period admissions for mood disorders had increased 80%, while admissions for asthma and pneumonia had decreased by 30% and 16% respectively.

Most of the increase in mood disorder frequency was for bipolar disorder.  In the period studied, admissions for children for depression rose 12%, but admissions for bipolar disorder rose 434% (from 1.5 per 100,000 population to 8.2).  For children in the age group 5-9, the increase was 696%! – a seven-fold increase.

So, over the last decade or two, we’ve seen a huge increase in the number of children being hospitalized for bipolar disorder and in the number of children being prescribed neuroleptics in office visits.

HOW DID THIS HAPPEN?

Neuroleptics are probably the most damaging drugs used in psychiatry.  The adverse effects, including permanent and extensive brain damage, are devastating, and occur in virtually all of cases where use is prolonged (Breggin, 2011, p 197).  In former decades, their use was confined mainly to adults who had been labeled schizophrenic or bipolar.  It was routinely claimed by psychiatrists that their benefits outweighed the risks, though this contention is not standing up to the increasing scrutiny that has occurred in the past decade or so.

The increase in the prescription of neuroleptic drugs for children is a direct consequence of the increased use of the bipolar label in that population.  And most of the responsibility for that increase can, in my view, be laid at the door of one person:  Joseph Biederman, MD, of Harvard Medical School and Massachusetts General Hospital.  Dr. Biederman will go down in history as the inventor of pediatric bipolar disorder.

DSM-III-R was published in 1987.  It makes no reference to the existence of childhood bipolar disorder.  The total entry under Prevalence is:

“It is estimated that 0.4% to 1.2% of the adult population have had bipolar disorder.” [emphasis added]

DSM-IV, published in 1994, greatly expanded the concept of bipolar disorder, essentially by removing the requirement of a manic episode or a mixed (manic-depressive) episode.  References to age are vague – e.g.:

“Approximately 10%-15% of adolescents with recurrent Major Depressive Episodes will go on to develop Bipolar I disorder.”

It is not clear whether this “development” might occur in late adolescence or in adulthood. There is no suggestion that bipolar disorder can occur in a pre-adolescent child.

By 1996, however, Dr. Biederman and his colleagues at Harvard were promoting childhood bipolar disorder as an accepted psychiatric diagnosis that needed to be treated with pharmaceutical products, including neuroleptics.  This was accomplished primarily by selling the notion that childhood temper tantrums could legitimately be regarded as symptoms of mania.  This blatant distortion of the traditional concept of mania was facilitated by the “not otherwise specified” (NOS) qualifier which has been a component of almost all diagnostic categories since DSM-III.  The purpose of the NOS diagnoses is to enable psychiatrists to assign the diagnosis in question to an individual even though he doesn’t actually meet the criteria.  The fact that this renders the criteria somewhat pointless is generally lost on psychiatrists, but that’s a different story.

What the Bipolar Disorder NOS diagnosis enabled Dr. Biederman and his colleagues to say was essentially this:

We know that temper tantrums aren’t really an integral component of bipolar disorder as it is traditionally conceived.  But we believe that that’s how bipolar disorder presents itself in young children, and so that’s what we’re going to call it.

This is on a par with dermatologists deciding that pattern baldness is a symptom of psoriasis!  In real medicine, this isn’t how it’s done, but in psychiatry it’s the norm.  The “diagnoses” are fictitious.  They can be created, modified, and eliminated with strokes of a pen.  This is what Dr. Biederman and his Harvard colleagues did, and American psychiatry followed.  The neuroleptics-for-children spigot was opened, and is running freely to this day.

The creation and promotion of pediatric bipolar disorder has been described and critiqued by several writers.  Joanna Moncrieff, a British psychiatrist, provides an excellent account in her book The Bitterest Pills (2013 , p 200-205).  Here are some quotes:

“Although it is the adult market that accounts for the bulk of sales of atypical antipsychotics, it is the use of these drugs in children alongside the emergence of the diagnosis of paediatric bipolar disorder that best illustrated the way in which a severe mental disorder can be morphed into a label for common or garden difficulties, as well as the role that money plays in this process.”

“Moreover, by locating the problem in the brain of the child, it seemingly detaches it from the situation within the family.”

“Academic psychiatry fuelled this craze, with added financial incentive from the pharmaceutical industry…”

“In the 1990s, a group led by child psychiatrist Joseph Biederman, who was based at Massachusetts General Hospital and the prestigious Harvard Medical School, started to suggest that children could manifest ‘mania’ or bipolar disorder, but that it was frequently missed because it was often co-existent with other childhood problems like ADHD and ‘antisocial’ behaviour…  In a paper published in 1996 the group suggested that 21% of children attending their clinics with ADHD also exhibited ‘mania’, which was diagnosed on the basis of symptoms such as over-activity, irritability and sleep difficulties…  A year later the group were referring to bipolar disorder in children as if it were a regular, undisputed condition, and emphasized the need for ‘an aggressive medication regime’ for children with the diagnosis…”

“Neither Harvard nor Massachusetts General Hospital nor any other psychiatric or medical institution has commented on the fact that prominent academics were found to be enriching themselves to the tune of millions of dollars through researching and promoting the use of dangerous and unlicensed drugs in children and young people.  Although some individual psychiatrists have expressed misgivings…academic papers continue to discuss the diagnosis, treatment and outcome of bipolar disorder in children as if no controversy existed, with more than 100 papers on the subject published in Medline-listed journals between 2010 and 2012.  Notwithstanding…the disgrace of Joseph Biederman, the practice of diagnosing children with bipolar disorder and treating them with antipsychotics remains alive and kicking.”

The spurious creation of childhood bipolar disorder has been critiqued also by Mickey Nardo, MD, a retired psychiatrist who blogs under the name 1 Boring Old Man (which, incidentally, he isn’t).  On July 2, 2011, he published a post called bipolar kids: an all too familiar lingo…  Here are some quotes:

“What happened in that second half of the 1990s is that they created a new diagnosis – Pediatric Bipolar Disorder. Looking at these articles…or at the COBY Study [started right around this time], Bipolar Disorder in children was becoming a common diagnostic term, but the diagnostic criteria bore little resemblance to the familiar symptom complexes from the Manic Depressive Illness of old. It was something new masquerading as something old [or vice versa]. These kids weren’t euphoric, they were irritable.”

“…the Biederman-led movement to broaden the category to call all kinds of difficult and disruptive children Bipolar had little to no scientific basis. It felt like a rationalization to use the new atypical antipsychotics to control difficult behavior-disordered kids – a trick.”

“And even without knowing what we know today about what happened, at the turn of the last century there was plenty of reason to smell a rat [named pharma]. The articles had all the tell-tale phrases – “urgent public health problem” “emerging new treatments” “need for more research” – an all too familiar lingo that pointed down a well-traveled yellow brick road. And this time it didn’t lead to Oz, it lead to Harvard University. And the guy behind the curtain was Joseph Biederman …”

Ultimately Dr. Biederman was disgraced – not for the spurious expansion of a diagnostic category.  Diagnostic expansion has been psychiatry’s primary agenda for the past 60 years.  A small minority of psychiatrists might have had reservations concerning Dr. Biederman’s work, but the mainstream psychiatry-pharma alliance embraced the new development with their customary zeal and self-serving enthusiasm.

Nor was Dr. Biederman disgraced because he had deliberately encouraged the exposure of thousands of children to neurotoxic chemicals.  Again, that’s just business as usual.  And in fact, he received awards and accolades for drawing attention to the plight of these tragically “underserved” children.  Here are some of the awards and honors he has received since his ground-breaking work on childhood bipolar disorder:

  • NAMI Exemplary Psychiatrist Award
  • NARSAD Senior Investigator Award
  • ADHD Chair of World Psychiatric Association
  • Outstanding Psychiatrist Award, Massachusetts Psychiatric Society
  • Excellence in Research Award, New England Council of Child and Adolescent Psychiatry
  • Mentorship Award, Psychiatry Department, Massachusetts General Hospital
  • William A. Schonfeld Award for outstanding achievement and dedication
  • Distinguished Service Award, MGH/McLean Child and Adolescent Psychiatry Residency

He was disgraced for under-reporting to his employers at MGH and Harvard the amount of money he was receiving from the pharmaceutical industry for conducting research that was used to promote their products.  Here again, there was nothing particularly unusual in this.  The so-called Key Opinion Leaders (KOL’s) in psychiatry have been awash in pharma money for decades.  But Dr. Biederman’s take ($1.6 million) was on the high side, and came to light at a time when the corrupt psychiatry-pharma alliance was being exposed nationally, largely through the efforts of Iowa Senator Charles Grassley.

Dr. Biederman was also criticized for promising Johnson & Johnson a positive result for their neuroleptic drug risperidone in pre-school children before he had actually conducted the research.  Obviously this makes a mockery of the research, but psychiatric research was hijacked by pharma marketing decades ago.  It has long since ceased to be a source of genuine scientific information, and much of it instead is little more than marketing material bought and paid for by the pharmaceutical industry.  Dr. Biederman’s error in this area was that he committed his promises to writing (in the form of slides that he presented to Johnson & Johnson executives), and these slides and other correspondence came to light during lawsuits against Johnson & Johnson for fraudulent marketing of their products.  These are the same lawsuits that Johnson & Johnson recently settled for $2.2 billion.

The great irony with regard to Dr. Biederman’s premature promise of a positive result for Johnson & Johnson is that he was absolutely correct!  If you give a neuroleptic drug to a misbehaved child, the incidence of misbehavior will indeed decrease.  If you give him enough, he’ll go to sleep and won’t misbehave at all!  That’s why these drugs used to be called major tranquilizers.  Dr. Biederman could accurately predict this result in advance because that’s what major tranquilizers do.  If you conduct a study to see if alcohol will make people drunk you’ll get a positive result.  If you conduct a study to see if major tranquilizers subdue childhood temper tantrums, you’ll get a positive result.  Dr. Biederman couldn’t use this defense, however, because he, like psychiatrists in general, has to play along with the big fiction:  that childhood temper tantrums are a symptom of an illness, and that the drugs are medicines targeting specific faults in neural circuitry or chemical imbalances or whatever.  Dr. Biederman’s proposed study would have produced a positive results for Risperdal in the same way that most industry-sponsored studies obtain positive results:  by limiting outcome criteria to the known effects of the drug, by keeping follow-up times short, and by ignoring adverse effects.

Dr. Biederman’s ethical lapses were thoroughly investigated (for three years) by his bosses at MGH and Harvard, and in 2011 they gave him and two of his colleagues (Thomas Spencer – total take:  $1.0 M, and Timothy Wilens – total take:  $1.6 M) very, very severe slaps on the wrists.  The Boston Globe covered this story.  Here’s a quote:

“The three psychiatrists apologized in their letter for the ‘unfavorable attention that this matter has brought to these two institutions.’  They called their mistakes ‘honest ones’ but said they ‘now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.’

They said the institutions imposed remedial actions, requiring them to refrain from all paid industry-sponsored outside activities for one year, with an additional two-year monitoring period during which they must obtain approval before engaging in paid activities. They were also required to undergo unspecified additional training and suffer ‘a delay of consideration for promotion or advancement.'”

The notion that the ethical lapses of these three psychiatrists were “honest mistakes” is a little hard to credit, given that the total dollar amount was more than $4 M!

Today Dr. Biederman is fully rehabilitated and is back in business. He’s receiving research funding from ElMindA, Janssen, McNeil, and Shire, and is once again churning out research papers on topics such as ADHD and, guess what? – pediatric bipolar disorder.

THE BIG QUESTIONS

The two big questions in all of this are:

1.  Why do Harvard and Massachusetts General Hospital stand for this kind of blatant corruption and deception in the upper echelons of their psychiatry department?

2.  Why does the APA not take a stand against the medicalization and drugging of childhood temper tantrums – a problem that parents of previous generations simply took in their stride as an integral part of normal childrearing?

With regards to the APA, it’s really not much of a question.  Their agenda has always been: more psychiatric drugs for more people, and the neuroleptics-for-children development is really just business as usual.  They have dulled their ethical sensibilities through decades of prescribing benzodiazepines, SSRI’s, methylphenidate, and various other neurotoxins for an ever-widening range of human problems, and prescribing a neuroleptic to a 1½ year old for temper tantrums is a short step.

The APA, however, did express some mild concern about the spurious extension of the bipolar label to children.  In DSM 5 (p 132) they state:

“In individuals with severe irritability, particularly children and adolescents, care must be taken to apply the diagnosis of bipolar disorder only to those who have had a clear episode of mania or hypomania – that is, a distinct time period, of the required duration, during which the irritability was clearly different from the individual’s baseline and was accompanied by the onset of Criterion B symptoms.”

But rather than risk losing the pediatric business, hard-won by Harvard’s psychiatrists, they created a new diagnosis:

“When a child’s irritability is persistent and particularly severe, the diagnosis of disruptive mood dysregulation disorder would be more appropriate.”

The effect of all this is that psychiatrists can go on prescribing drugs for childhood temper tantrums, but instead of calling them bipolar disorder, they should use the new label:  disruptive mood dysregulation disorder – but they can continue to use the bipolar diagnosis also, with a few caveats, couched in the APA’s characteristically vague language.

Harvard’s stance on the scandals is a little harder to fathom.  After all, Harvard is hallowed ground – America’s Oxbridge.  It has acquired an image as a center of learning where educational and research standards eclipse all other considerations.

And in fact, there are legal and medical ethicists at Harvard who clearly recognize the implications of the psychiatric scandals.

Earlier this year, the Journal of Law, Medicine & Ethics (Vol 41, Issue 3) published a symposium of 17 papers written by members of Harvard’s Edmond J. Safra Center for Ethics.  Here are some of the titles:

Here are some quotes:

“The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created.” (Light et al)

“In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests.” (Cosgrove and Wheeler)

“Pharmaceutical and medical device companies apply social psychology to influence physicians’ prescribing behavior and decision-making.” (Sah and Fugh-Berman)

Clearly these papers are addressing important and relevant topics.  But what’s particularly noteworthy, from the present perspective, is that they originated in Harvard – the same institution in which senior psychiatry faculty members were hand-in-glove with pharma in the production of fraudulent research and advertizing.  How are we to understand this contradiction?  How are we to understand the minimal response from Harvard’s management, and incidentally from the other academic departments, given that such a wealth of ethical resources was there on their own campus, presumably available and willing to be consulted on these kinds of matters.

BUSINESS ETHICS VS UNIVERSITY ETHICS

In America, it is becoming increasingly recognized, and even accepted, that big businesses are frequently amoral.  Considerations of right and wrong are routinely subordinated to bottom line accounting.  Many big pharmaceutical companies are perceived in this light.  Indeed, the recent $2.2 B  penalty levied against Johnson & Johnson was discussed in some media outlets quite simply as a “cost of doing business.”  The question of whether it is a good thing to promote the use of neuroleptics for children doesn’t even come on the radar.  The perverse calculus is reduced to the difference between the projected profits from the drugs sales, and the fines and lawsuit settlements that might ensue.

Has Harvard’s Psychiatry Department, in concert with their pharmaceutical allies, crossed this line?  Have they now, implicitly or explicitly, adopted the ethical standards of the business world?  Have they subordinated their sense of decency and shame to considerations of prestige and revenue?

And what of the MGH/Harvard leadership?  Do they actually believe that the sanctions imposed on Dr. Biederman and his colleagues are adequate?  Or do they reckon that the years of past and future pharma revenue are worth the cost?  Have they crossed the line into the shady realm of business ethics?

And as we ponder these thorny questions, let’s not forget that the Johnson & Johnson lawsuit listed psychiatric researchers at other renowned universities, including Johns Hopkins, Stanford, UCLA, University of Illinois at Chicago, University of Texas at Austin, Georgia Regents, University of Toronto, and Dalhousie University.

Meanwhile the destructive prescribing continues, and Dr. Biederman is still at MGH, where he is Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, and at Harvard, where he is a full Professor of Psychiatry, a position, which, by his own account, ranks just below God!

Psychiatry’s primary agenda for the past 60 years has been the expansion of their diagnostic net to embrace an increasing range of ordinary human problems, and the unscrupulous prescribing of more and more psycho-pharmaceutical products to more and more people.  In the final analysis, Dr. Biederman’s problem was that he was particularly good at this job.  He was, in effect, a Model Psychiatrist – the perfect embodiment of everything that the APA stands for.

CLARIFICATION OF TERMINOLOGY

My frequent use of the term bipolar disorder in this article should not be interpreted as an endorsement on my part of the ontological validity of this expression, much less its status as an illness or disease.  I use the term bipolar disorder (and the various other so-called diagnoses) for the sake of readability and linguistic convenience.  What I mean by “bipolar disorder” is:  the vaguely defined and loosely clustered behaviors, thoughts, and feelings that psychiatrists call bipolar disorder.

Jon Rappoport’s Blog

If you haven’t seen Jon Rappoport’s blog, please take a look.  Here are two quotes from his September 22 post, Psychiatry targets college students for destruction:

“The concept called ‘mental disorder’ is a sales pitch backed up by extraordinary PR, money, academic gibberish, and government-granted official status.”

“People need to wake up to the fact that the whole panoply of human suffering has been co-opted, taken over, redefined, re-translated into a lexicon of pseudoscience.”

And another quote from his September 28 post, Alexis, Lanza, Holmes and the Psychiatric State:

“Close to 50 years ago, psychiatry was dying out as a profession. Fewer and fewer people wanted to see a psychiatrist for help, for talk therapy. All sorts of new therapies were popping up. The competition was leaving medical psychiatry in the dust.

As Dr. Peter Breggin describes it in his landmark book, Toxic Psychiatry, a deal was struck. Drug companies would bankroll psychiatry and rescue it. These companies would pour money into professional conferences, journals, research. In return, they wanted ‘science’ that would promote mental disease as a biological fact, a gateway into the drugs. Everyone would win—except the patient.

So the studies were rolled out, and the list of mental disorders expanded. The FDA was in on the deal as well, as evidenced by their drug ‘safety’ approvals, in the face of the obvious damage these drugs were doing.

So this is how we arrived at where we are. This was the plan, and it worked.

Under the cover story, it was all fraud all the time. Without much of a stretch, you could say psychiatry has been the most widespread profiling operation in the history of the human race. Its goal has been to bring humans everywhere into its system. It hardly matters which label a person is painted with, as long as it adds up to a diagnosis and a prescription of drugs.”

Jon addresses the spurious and destructive nature of psychiatry in no-nonsense, hard-hitting language.  His material is relevant and current, and very much worth reading.

Thanks to Tallaght Trialogue on Twitter for the link to this blog.

Pharma Mobilizing Consumer Groups Over Drug Trials Data

There was an interesting article Big pharma mobilising patients in battle over drugs trials data in last Sunday’s Guardian, a UK newspaper.  It was written by Ian Sample, the Guardian’s science correspondent.  Here are the two opening sentences:

“The pharmaceutical industry has ‘mobilised’ an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.”

“Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies’ claims about the safety and efficacy of drugs.”

In political circles in Europe, there is growing momentum towards legislation that would compel drug companies to release all their research data on a particular drug, including results that show negative outcomes and/or adverse side effects.

This movement, which incidentally exists here in the US also, is important because psycho-pharmaceutical companies typically “cherry pick” their in-house data and publish only the results that cast their product in a favorable light.

This is a particular problem because it is very easy to “massage” data to produce the result one wants.  It is noteworthy in this context that 90% of industry-funded research “finds” in favor of the product of the funding company.  (Heres et al, 2006)

For instance, suppose I believe, with a deep and heartfelt conviction, that people of Irish ancestry are lazy wastrels.  (I’m allowed to say things like this because I am myself Irish, so no hate mail, please!)

So I decide to do a piece of research to prove my point.  I go through the Baltimore, Maryland phone book noting each Irish name I come across, and also noting the next non-Irish name, until I have, say, 5,000 of each.  Then I call all these individuals and ask them three questions:

  • Age
  • Gender
  • Employed or not employed

And because I’m charming and persuasive, and I don’t call in the middle of dinner, they all answer cooperatively, and I get the following results.

Age(mean) Male Female Emp Unemp
Irish names 42.5 2470 2530 4000 1000
Other names 41.7 2510 2490 4007 973

 

It’s obvious that there is no appreciable difference between the two groups in terms of employment status.  But because I have asked two other questions, (besides employment status), I actually can examine the data in several ways.  Here’s how it works:

I can break the survey groups down into smaller categories:

Irish names, Male, 20-25 vs. other names, Male, 20-25;
Irish names, Male, 25-30 vs. other names, Male, 25-30;
Irish names, Male, 30-35 vs. other names, Male, 30-35;
Etc…

and check the employment/unemployment rates for each sub-category.

By breaking down the data in this way, I have converted my single survey into 20 different surveys (10 for males and 10 for females).  There’s a very good chance that at least one of these will yield a result consistent with my prejudice.

For instance, I might find the following:

Employed Unemployed % UE
Irish names, Male, 35-40 120 180 60%
Other names, Male, 35-40 170 130 43%

 

Now I can publish my results: Males of Irish ancestry aged 35-40 have a 60% unemployed rate vs. 43% for controls.  I make no mention of the fact that I cherry-picked this survey from my original data.  This is a critical omission, because whenever data is sub-divided in this way, the percentages in the sub-divisions never mirror the original result perfectly.  There’s always a measure of scatter.

This is why it’s so important that the psycho-pharmaceutical companies be required to show all their data – so that independent researchers can check for data massaging of this kind.  Incidentally, the example I gave is simplistic.  In practice, there are a great many ways to massage data, some of which are quite sophisticated.

Getting back to the Guardian’s article, it is reported that the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have drawn up a strategy to combat the push for transparency.  A memo from Richard Bergstöm, director of EFPIA, outlining this strategy, was sent to many pharmaceutical companies, and was leaked by a drug company employee.  The memo mentions “…mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data.”

Here in America it has been obvious for decades that the National Alliance on Mental Illness (NAMI) has been funded by pharma, and has been their willing mouthpiece with regards to the spurious medicalization of human problems and the pill-for-every-problem solutions peddled by psychiatry.  (There has been some talk recently of NAMI distancing themselves from pharma, but I have seen no clear indications of this yet.)

I’m not familiar with the patient groups in Europe, but it sounds like similar dynamics are at work there.

What strikes me most markedly about these kinds of activities is the self-serving cynicism of the pharmaceutical groups. Their basic objective, of course, is to sell drugs by getting their psychiatry friends to invent more and more “illnesses,” with lower and lower thresholds.  They get psychiatrists to do this in the old-fashioned way – by giving them big bundles of money.

That’s bad enough.  But they then have the gall to cozy up to the victims of their neurotoxic chemicals, convince these victims that they are their friends, and recruit them to promote the pharma-for-all message.  This also is achieved with big bundles of money.  It’s very difficult for a cash-strapped, grass-roots organization to resist the overtures of a smiling, highly-trained drug rep with an open checkbook.

The fact that the director of EFPIA felt sufficient confidence in his association’s relationships with patient groups to instruct his member companies to “mobilize” them, speaks volumes.

We already know, from the corrupted research, and the ghost-writing, that pharma routinely subordinates client welfare to corporate profits.

But the notion that patient groups would join them in their fight against research transparency suggests that they view the members and leaders of these groups as little more than mindless minions.  How could increased transparency pose any kind of a threat to client welfare or public health?  How could pharma imagine that patient groups would buy this garbage?

But wait?  Psychiatrists have been buying the same garbage for decades.  As Julie Andrews almost said:  “A spoonful of money helps the medicine go down.”

And let’s not forget, if the memo had not been leaked, this “mobilization” would be going on right now, right under our noses.

Pharma-psychiatry is something flawed and rotten.

The CAFE Study: Dr. Lieberman’s High Moral Ground

BACKGROUND

The CAFE Study, conducted by Jeffrey Lieberman, MD, et al between 2002 and 2005, has been the subject of much comment.  Carl Elliott, in particular, has written extensively on the matter, including his article The Deadly Corruption of Clinical Trials in Mother Jones.

In order to address the issues involved in the CAFE study, we must first take a brief look at the CATIE study.  This was also conducted by Dr. Lieberman et al (not the same et al as CAFE, but with some overlap).  CATIE was conducted between 2001 and 2004.

CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) has been written up in the New England Journal of Medicine.

CAFE (Comparison of Atypicals in First Episode of Psychosis) has been written up in two parts in the American Journal of Psychiatry, here and here.

CATIE was funded by the NIMH.  CAFE was funded by Astra Zeneca, the manufacturer of quetiapine (Seroquel).

SUMMARY OF CATIE

CATIE was a double-blind randomized trial of the tolerability and effectiveness of five neuroleptic drugs.  Four of these drugs were second-generation neuroleptics.  The fifth was an older, first-generation neuroleptic.  The specific drugs compared were:

New:
olanzapine (Zyprexa)
quetiapine (Seroquel)
risperidone (Risperdal)
ziprasidone (Geodon)

Old:
perphenazine (Trilafon)

1493 participants were followed for 18 months, and the study was conducted in three phases.

The National Institute of Health (of which NIMH is a section) issued a summary of CATIE’s phase 1 results in September 2005.  Here are some quotes:

“Overall, the medications were comparably effective but were associated with high rates of discontinuation due to intolerable side effects or failure to adequately control symptoms. One new medication, olanzapine, was slightly better than the other drugs but also was associated with significant weight-gain as a side-effect. Surprisingly, the older, less expensive medication (perphenazine) used in the study generally performed as well as the four newer medications.”

“Contrary to expectations, movement side effects (rigidity, stiff movements, tremor, and muscle restlessness) primarily associated with the older medications were not seen more frequently with perphenazine than with the newer drugs. The advantages of olanzapine — in symptom reduction and duration of treatment — over perphenazine were modest and must be weighed against the increased side effects of olanzapine.”

“Thus, taken as a whole, the newer medications have no substantial advantage over the older medication used in this study.”

This result is particularly important in the light of two contextual factors.  Firstly, the newer neuroleptics are a good deal more expensive than the older drugs.  Secondly, for years psychiatrists and their pharmaceutical allies had been promoting the falsehood that the side-effects with the newer drugs were not as severe.

CATIE phase 2 results:

Results: The time to treatment discontinuation was longer for patients treated with risperidone (median: 7.0 months) and olanzapine (6.3 months) than with quetiapine (4.0 months) and ziprasidone (2.8 months). Among patients who discontinued their previous  antipsychotic because of inefficacy (N=184), olanzapine was more effective than  quetiapine and ziprasidone, and risperidone was more effective than quetiapine. There were no significant differences between antipsychotics among those who discontinued their previous treatment because of intolerability (N=168).”

Conclusions: Among this group of patients with chronic schizophrenia who had just discontinued treatment with an atypical antipsychotic, risperidone and olanzapine were more effective than quetiapine and ziprasidone as reflected by longer time until discontinuation for any reason.”

CATIE phase 3 results:

Results: Time until treatment discontinuation for any reason was significantly longer for clozapine … than for quetiapine … or risperidone … but not for olanzapine …. Time to  discontinuation because of inadequate therapeutic effect was significantly longer for clozapine than for olanzapine, quetiapine, or risperidone. At 3-month  assessments, Positive and Negative Syndrome Scale total scores had decreased more in patients treated with clozapine than in patients treated with quetiapine or risperidone but not olanzapine. One patient treated with clozapine developed agranulocytosis, and another developed eosinophilia; both required treatment discontinuation.”

Conclusions: For these patients with schizophrenia who prospectively failed to improve with an atypical antipsychotic, clozapine was more effective than switching to another newer atypical antipsychotic. Safety monitoring is necessary to detect and manage clozapine’s serious side effects.”

I realize that this makes somewhat tortuous reading, and readers might want to refer back to the journal articles for clarification.  But the bottom line, for our present purposes, is that the newer neuroleptics showed no advantage over the older, and that within the newer group, clozapine (the first of the newer drugs) outperformed the more recent products.  And quetiapine (Seroquel) did particularly poorly.

SUMMARY OF CAFE

The stated purpose of CAFE was to compare the effectiveness and tolerability of three second-generation neuroleptics in individuals with early psychosis.  The three drugs compared were:

olanzapine (Zyprexa)
quetiapine (Seroquel)
risperidone (Risperdal)

These are three of the four newer neuroleptics that were compared in the CATIE study.

CAFE was a randomized, double-blind trial.  400 participants were followed for one year, and the study was written up in two parts.

The conclusions of the authors, as published in the American Journal of Psychiatry, were as follows:

“Olanzapine, quetiapine, and risperidone all produced significant improvements in neurocognition in early-psychosis patients. Although cognitive improvements were modest, their clinical importance was suggested by relationships with improvements in functional outcome.” (here)

“Olanzapine, quetiapine, and risperidone demonstrated comparable effectiveness in early-psychosis patients, as indicated by similar rates of all-cause treatment discontinuation.” (here)

COMMENT

So quetiapine’s poor performance in the CATIE study is essentially overturned in the CAFE study.  Quetiapine apparently is just as effective as olanzapine and risperidone.

However…if you wade through the actual text of CAFE, you’ll find this interesting disclaimer on p 1058:

“Previous studies suggesting that first-episode patients receive therapeutic benefit from antipsychotic doses lower than those required for chronic patients and that first-episode patients develop unnecessary extrapyramidal side effects at higher doses led us to use lower dose ranges of olanzapine and risperidone in this study than those used in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE). However, given quetiapine’s low extrapyramidal side effects liability, we expected that the quetiapine doses used in CATIE would be tolerable in our study population. This may have been a factor in the comparable effectiveness demonstrated by quetiapine. In the CATIE phase 1 and phase 2 schizophrenia trials…higher mean modal doses of olanzapine and risperidone but similar mean modal doses of quetiapine were used; in these trials, olanzapine and, less consistently, risperidone proved to be more effective than quetiapine.” [Emphasis added]

In other words, CATIE compared olanzapine, quetiapine, and risperidone, and found that quetiapine did poorly.  CAFE compared olanzapine, quetiapine, and risperidone, and found that they did equally well.  But they reduced the dose of olanzapine and risperidone.

All of these products act as major tranquilizers in the early stages of their use.  They reduce psychotic thinking because they reduce all cognitive activity.  And the more a person takes, the greater the tranquilizing effect.

In the quotation above, CATIE’s authors justify the dosage discrepancy on the grounds that higher doses of olanzapine and risperidone would have placed first episode individuals at higher risk of extrapyramidal side effects (e.g. tardive dyskinesia).  Quetiapine, however, we are told, does not pose such a risk because of “…its low extrapyramidal side effects liability.”  But the CATIE study had found no difference in these products with regards to this risk.  And the CAFE authors don’t quote any references to support this claim.

Given that the study was funded by Astra Zeneca (the manufacturer of quetiapine), it is very difficult to avoid the conclusion that the purpose of CAFE was simply to rescue Astra Zeneca’s product from the negative findings of CATIE.  It looks more like marketing than research.

In this regard, it is perhaps worth noting that in 90% of drug trials that are funded by a pharmaceutical company, the sponsor’s product is found to be superior to the competitor’s product. (Heres et al 2006)

The notion that the CAFE study reflects sponsor contamination has been addressed by other writers.  Bernard Carroll, MD, PhD, past chairman of the FDA psychopharmacologic drugs advisory committee, and past chair of the Department of Psychiatry at Duke University, has written a lengthy comment on the The Carlat Psychiatry Blog on a post concerning the CAFE study..  He offers eleven separate criticisms of the CAFE study, and draws the following conclusions:  “…the entanglement with a commercial entity has influenced the scientific agenda of these academic investigators.”

And, of course, Carl Elliott has been an outspoken critic of the CAFE study for several years.

Two of CAFE’s participants committed suicide during the study period.  Both had been randomly assigned to the quetiapine treatment.  There are very strong indications that one of these individuals – Dan Markingson – was coerced into the study and, because of his psychotic state, was incapable of giving informed consent anyway.  His mother, Mary Weiss, made repeated attempts to have him withdrawn from the study but without success.  (The Department of Psychiatry at the University of Minnesota earned $15,648 for each study participant who completed the treatment course.)  You can find a detailed account of this matter in the Carl Elliott article mentioned earlier: The Deadly Corruption of Clinical Trials.

For a drug company to promote its product is, I suppose, understandable.  It’s what they do, though their tactics are often questionable.

But for psychiatrists – including an eminent psychiatrist such as Dr. Lieberman, currently president of the APA – to lend their names and their reputations to this kind of thing is reprehensible.  And this, incidentally, is the same Dr. Lieberman who on June 18 of this year, told us that psychiatry has the moral high ground, and that he plans to respond to psychiatry’s critics by assuring us that he and his colleagues are planning to rededicate themselves to their Distinguished Fellow pledge!  So that will make everything OK.

BY THE WAY

To guard against any misapprehension, it is my view that the drugs referred to in these studies as anti-psychotics are more correctly described as neurotoxic tranquilizers with devastating side effects, including tardive dyskinesia, akathisia, and significantly reduced life expectancy.  Comparing the efficacy of these products seems to me a little bit like asking: which is better for your health, a tornado, a hurricane, or a plane crash?

Pharma Payments to Psychiatrists

On March 12 of this year, the Los Angeles Daily News ran an article by Susan Abram titled:  Doctors report big pharma payouts for drug endorsements.  It discusses the financial ties between physicians and drug companies in California.

Here are some quotes:

“In fact, hundreds of physicians, psychiatrists, and medical school faculty members across California are on the payroll of major drug companies, earning tens of thousands of dollars for speaking to other medical professionals at events held by industry leaders that make drugs such as Advair, Cymbalta, Viagra and Zoloft.”

“From 2009 to 2012, California doctors who participated were paid $242 million – the highest in the nation – by major drug companies for research, speaking, consulting, trips and meals, according to a new database released Monday by ProPublica, an independent, nonprofit news organization.”

“The database also shows that about half of the top earners are from a single specialty: psychiatry, according to findings by ProPublica.”

No surprises in any of that.  But this surprised me:

“‘It boggles my mind,’ Dr. James H. Scully Jr., chief executive of the American Psychiatric Association, told a reporter from ProPublica, referring to the big money paid to some psychiatrists for what are billed as educational talks.

“Paid speaking ‘is perfectly legal, and if people want to work for drug companies, this is America,’ said Scully, whose specialty has often been criticized for its over-reliance on medications.’ But everybody needs to be clear – this is marketing.'”

That’s Dr. Scully, the CEO of the APA.  Refreshingly honest.  But will the APA take a position on the conflicts of interest that this kind of marketing inevitably entails?

They haven’t so far.