Tag Archives: neuroleptics

Psychiatry Misusing the Political Process

On March 27, the US House of Representatives approved by a voice vote with no debate a Medicare bill, HR 4302, Protecting Access to Medicare Act of 2014.  The purpose of the bill is to avoid cutting Medicare payments to physicians, and there was, and is, general agreement on both side of the aisle that the bill needed to pass.

However, tacked onto the bill was a rider which authorized $60 million to expand involuntary outpatient commitment (IOC) in states that already have provision for commitments of this sort.

Involuntary Outpatient Commitment is widely advocated by organized psychiatry.  Their general position is that people who are seriously “mentally ill” are often incapable of making prudent decisions, particularly with regards to the ingestion of neuroleptic drugs.  For this reason, they contend, there needs to be legal compulsion to ensure “treatment” adherence, which usually means forced ingestion of neuroleptic drugs (sometimes in long-lasting injectable form.).

In this debate, psychiatry routinely ignores the truly devastating side effects of these products and the fact that their long-term use is associated with increased neurological damage, deterioration in quality of life, and reduced life expectancy.  They also ignore the well-established fact that forced treatment is simply not effective.

There are also some very obvious civil rights issues involved.

The National Coalition for Mental Health Recovery has taken a strong position on this bill and have posted a press release.

The Senate is due to vote on this bill tomorrow (March 31).  If you oppose this rider to the bill, please ask your Senators to reject this counter-productive amendment.  You can contact your Senators through this link.

The APA has been developing their political lobbying machine in recent years.  On their website you will find the following tabs: Congressional Action Network; Government Relations; State Relations; and Legislative Action Center.  Obviously they’re taking this seriously.  Psychiatry has received a good deal of criticism in recent years, but have consistently refused to take any of this on board.  Instead, they have relied on spin, tawdry PR promotions, and now stealth legislation to promote their expansionist and destructive agenda.

Please contact your Senators today.

Involuntary Mental Health Commitments

The recent publicity surrounding the Justina Pelletier case has focused attention, not only on the spurious and arbitrary nature of psychiatric diagnoses, but also on the legitimacy and appropriateness of mental health commitments.  It is being widely asserted that these archaic statutes are fundamentally incompatible with current civil rights standards, and the question “should mental health commitments be abolished?” is being raised in a variety of contexts.

CRITERIA

Here in the US, each state has its own laws and procedures for pursuing a mental health commitment.  Some states allow outpatient commitment as well as inpatient.  There is wording variation from state to state, but in most jurisdictions there is provision to commit a person involuntarily for psychiatric treatment if there is convincing evidence that the person has a “mental illness” and as a result of such “mental illness” is a danger to himself or others, or is gravely disabled.  The term gravely disabled is generally defined along the lines of being unable to care for oneself or provide for one’s basic needs. In recent years some states have expanded these criteria to embrace:

  1. Individuals who have a psychiatric history and are on a “deteriorating course.”
  2. Individuals who are being cared for by a family member, and this care is about to be terminated.

SHORT-TERM EVALUATION HOLD (72 hours)

Here again, the procedures vary from place to place, but in most cases the mental health center is involved.  Typically the police bring the individual to the mental health center to be evaluated by a mental health professional.  The professional evaluates the individual to determine if the legal criteria are met.  If they are, he fills out the necessary forms, swears to their accuracy in front of a judge, who , if he agrees with the assessment, signs the hold order.  The individual is then taken to the state hospital, or an alternative approved facility, by a police officer.

THREE-MONTH HOLD

Before the expiration of the 72-hour hold, the hospital personnel decide whether to allow the individual to convert to voluntary status (which he can do by signing the appropriate forms) or pursue a longer-term commitment.  The latter usually involves a formal hearing conducted in the local courthouse, or more usually, in a room at the state hospital.  A judge presides, and both hospital and client are represented by lawyers.  The hospital calls as witnesses psychiatrists and other staff who have worked with the client.  Clients may also call witnesses, but seldom do.

DISCUSSION

The fundamental premise underlying all mental health commitment legislation is that mental illnesses exist, and that these putative illnesses cause people to think, feel, and behave in a problematic, and sometimes dangerous, manner.

It is my position that this premise is spurious.  I have developed this theme throughout the website, and the details need not be repeated here.

It is also my position that psychiatric treatments, which almost always mean psycho-pharma drugs, and/or shock treatment, are for the most part unhelpful and disempowering, and usually damaging, especially in the long term!  They generally reduce, at least somewhat, an individual’s level of agitation, aggression, and/or disruption, and this is the essential justification for their use in these situations.  The notion that they are medications and are being used to treat illnesses is false.  The stark reality is that the individuals are being forcibly drugged into quietude, and this is being done under the guise of providing “treatment” for an “illness.”

If the treatments that individuals received at state hospitals and other approved facilities were extremely beneficial, then one might be posed with an ethical dilemma.  To illustrate this, consider the case of a person who has, say, a gangrenous finger, but is refusing treatment.  The treatment would involve losing the finger, but saving his life.  Refusing treatment will result in death.  One could certainly make a case for enforced treatment, especially if his family, friends, etc., were petitioning the courts in this regard.  But in fact, in the US, the general principle is that such an individual is legally entitled to refuse treatment, and die from his illness if he so chooses.

But mental health commitments are entirely different.  Individuals get committed to state hospitals, not because they are sick in any conventional sense of the term, but because they are agitated, and/or aggressive, often as a result of conflict with family members, neighbors, local officials, etc…  Usually they are people who have been committed previously, sometimes very frequently, and their social and other abilities have been severely compromised by a history of ingesting psychiatric drugs.  Often their agitation/aggression at the time of the commitment is caused by withdrawal from psychiatric drugs that they had previously taken.  In most cases they have received large quantities of neuroleptic drugs, over extended periods, the devastating side effects of which are all too obvious, and contribute to the perception that they are “different” and need to be locked up.

Because the agitation/aggression is conceptualized as a “symptom” of the putative illness, little or no attempt is made by the police or by the mental health staff to explore the reasons for the agitated, problematic behavior, or what remedies might be available.  The individual is deemed to be “mentally ill,” and it is assumed that attempts at discussion or dialogue would be pointless.  It is also assumed that the individual has zero credibility.

So the kind of ethical dilemma that might exist in the case of the man with the gangrenous finger, doesn’t arise here.  We’re not having to choose between respecting the person’s civil rights vs. saving his life.  We’re choosing between respecting his civil rights vs. forcing him to undergo procedures that will damage him further and will likely cause further deterioration in his relationships with family and other members of the community.

“KANGAROO” COURTS

The Fifth Amendment to the US Constitution states:

“…nor shall any person…be deprived of life, liberty, or property without due process of law…”

The Fourteenth Amendment states:

“…nor shall any State deprive any person of life, liberty, or property without due process of law…”

In practice, the procedures outlined above for the 72-hour hold and for the 3-month committal are considered to be due process of law.  Strictly speaking this is true, because they reflect the law as enacted by the particular state legislature.

The more fundamental question, however, is:  do these procedures provide adequate protection for the civil rights of the individual who is being committed?  In my view, the answer to this question is no, for the following reasons.

1.  In practice, the 72-hour hold is decided by the mental health worker, often a fairly junior intake worker, who in many cases has been trained to think of involuntary commitment as the only reasonable response to a crisis.  Even in cases where a judge’s signature is required, it is extremely rare to find a judge who will attempt to second-guess the mental health professional.  The unspoken ethos here is that “crazy” people are fundamentally different from “ordinary” people; that they can only be understood by trained professionals; and that interference from non-professionals is likely to be counterproductive.  This ethos, incidentally, is actively promoted by organized psychiatry.  Indeed, I would suggest that it constitutes one of the fundamental pillars of psychiatric “treatment.”  It is also false.  People who are “crazy,” or despondent, or agitated are not fundamentally different from “ordinary” people.  Their craziness, despondency, and/or agitation are usually understandable if one is willing to listen attentively and respectfully and patiently.

2.  In practice the judge’s signature tends to be a rubber stamp, and there is no attorney present to argue for the client.  There is usually not even a requirement that the client be present at the initial meeting between the mental health worker and the judge.

3.  Although danger to self or others or grave disability is usually required by the statute, in practice a 72-hour hold can be obtained in situations that don’t actually rise to this standard.  In most cases, if a client has come off his “meds,” and is agitated, a 72-hour hold will be granted even if his agitation is for some legitimate reason and is perfectly understandable, and even if he poses no particular threat to self or others.  The tacit, and incidentally false, assumption is that his agitation/aggression will inevitably escalate unless he is sent to the state hospital for “stabilization.”

4.  Once the 72-hour hold has been activated, the process is very difficult to reverse.  The client is taken to the state hospital and is often “persuaded” to convert to voluntary status.  The persuasion usually entails the threat that if he doesn’t convert, he will be committed.  I suggest that this kind of tactic makes a mockery of the term “voluntary.”

5.  If the client refuses to convert to voluntary status, he can be brought before a formal mental health hearing.

6.  This is an improvement over the 72-hour hold procedure, but in my view, the individual’s rights are not adequately protected.  As mentioned earlier, the hearing is often (perhaps usually) held in the hospital. This confers clear advantage to the psychiatrists.  They can call all the witnesses they want.  They’re on the payroll and just a few steps away.  The client is at a marked disadvantage, in that any witnesses he might want to call are likely to be in his home area (usually hours away), and at work.  The client is often unfamiliar with the procedure, and has had little opportunity to prepare his case.  Usually he gets to meet his defending attorney for only a few minutes prior to the hearing, and, in some cases, his cognitive ability has been compromised by prior “treatments.”  I recently received an email from a woman who has been through this kind of proceeding.  She pointed out that: 

“…having a patient address her involuntary status at a Review Panel while drugged and wearing hospital pajamas does tend to work against her.  If you’ve decided that someone’s incompetent, that’s pretty much what you’ll see.”

7.  If the client expresses the belief that he is not ill, and that he doesn’t need treatment, this will be interpreted (and sworn to by the psychiatrists) as convincing evidence that he is ill, and that he does need treatment.  Imagine, in a criminal trial, if a plea of not guilty were routinely construed as evidence of guilt!

8.  There is usually a great reluctance on the part of the defending attorney to challenge the psychiatrists and other professional witnesses, and in most cases the hearing endorses the psychiatrists’ recommendation – which is usually:  keep him here until we say it’s OK to let him go.

9.  Eventually, even the most heavily-drugged client realizes that the only way he’s going to get out of the hospital is to cooperate with the psychiatrists and staff.  This entails saying things like:  “I was a fool to go off my medication;” “I realize now that you people are just trying to help me;” “I’m my own worst enemy;” “I need to stay here until you people say it’s OK for me to go.”  If he can keep this up for a week or so, he’ll probably be released.

So to get back to the original question:  should this kind of practice cease? The answer is obviously yes.  The recent Justina Pelletier case has drawn much-needed attention to the abuses inherent in the psychiatric commitment system.  In particular, this case has highlighted the fact that psychiatry is a closed system that routinely rejects, marginalizes, and even pathologizes any attempt to challenge or even question its pronouncements.  Such a system has no place in a democratic, transparent society.

THE WAY FORWARD

The most significant step forward at this juncture would be the removal of the concept and term “mental illness” from all statutes.  The term has no explanatory significance, and no clear meaning.  In the area of civil commitment, it serves merely as justification of enforced drugging for individuals who are agitated or aggressive or otherwise disruptive.  It also serves as justification for denying these individuals some very basic civil rights.

Commitment is essentially a form of imprisonment.  But it goes beyond ordinary imprisonment, in that it entails the forced administration of neurotoxic chemicals and electrically-induced seizures.  What happens in practice is that the individual takes the drugs under duress in the facility, then semi-voluntarily in the community for a few weeks or even months.  He then stops taking them, or tapers himself off, until the next bout of agitation or aggressiveness.  This precipitates another trip to the state hospital, and this revolving-door travesty continues until he is too brain-damaged to live in the community.  He then goes to a nursing home, where his “medication” is dutifully administered every day, until he succumbs to a premature death. 

If “mental illness” commitments were abolished, there would be a need for a non-psychiatric crisis response team in each county/jurisdiction.  How such a team would be structured and organized is a huge topic, beyond the scope of the present article.  From a practical perspective, it needs to be noted that any non-psychiatric crisis response system will be resisted vigorously by vested interests and will not happen overnight.  What we should focus on in the meantime are those parts of the present system that are particularly unjust or particularly destructive.  These include:

1.  Doing away with the 72-hour hold and replacing it with a formal hearing with mandatory legal representation in front of a judge. 

2.  Providing training to lawyers concerning the spuriousness of psychiatric concepts and the destructiveness of psychiatric treatments.  This training should be geared towards empowering them to challenge mental health testimony in commitment hearings with the same force and vigor that they do in criminal proceedings.  In particular, they should be knowledgeable, or have ready access to knowledge, of the adverse effects of the various psychiatric drugs in common use, and the abysmally poor long-term outcomes for individuals who have been repeatedly committed over a period of years.

3.  Recruitment and training of non-psychiatric “talk-down” teams in every county.  These could be part of the sheriff’s department or, preferably, separate departments in their own right.

4.  Continuing to expose psychiatry as the spurious, destructive, and pharmaceutically-corrupted activity that it is.  The major need in this matter is to expose the damage that psychiatry routinely perpetrates against those entrusted to its care, and the impact that this has on life expectancy. 

5.  Encouraging mental health centers to hire psychiatric survivors, especially those who don’t support the bio-medical model.  A requirement of survivor representation on governing boards would also be helpful.

6.  Requiring mental health centers to seriously review drug dosages on all clients monthly, and either reduce these dosages or explain why this can’t be done.

7.  Requiring mental health centers to provide active training in social skills to all clients who have ever been committed to a psychiatric hospital.

Neuroleptics and Tardive Dyskinesia in Children

There’s an interesting February 11, 2014, article on Peter Breggin’s website:  $1.5 Million Award in Child Tardive Dyskinesia MalpracticeThanks to Mad in America for the link.

Here’s the opening paragraph:

“On February 11, 2014 a Chicago jury awarded $1.5 million to an autistic child who developed a severe case of tardive dyskinesia and tardive akathisia while being treated by psychiatrists with Risperdal and then Zyprexa between 2002 and 2007. The drug-induced disorder was diagnosed when he was fifteen years old and by then had become disabling and irreversible.”

Tardive dyskinesia is a movement disorder characterized by repetitive, involuntary movements, including:  grimacing, tongue movements, chewing, lip smacking, puckering of the lips, purposeless limb and body movements, etc…  The movements are sometimes described as Parkinsonian-like.

Tardive akathisia involves feelings of inner restlessness that can range from a mild sense of inner discomfort to an almost unbearable feeling of generalized tension. Victims of this condition can seldom sit still.  They usually pace a great deal, sometimes for hours on end, and even when they sit or lie down, their limbs are in more or less constant motion.

Apparently the individual in Dr. Breggin’s paper was diagnosed with autism as a child and was prescribed SSRI’s before the age of seven.  The SSRI’s caused some deterioration in the child’s behavior and mental condition, to combat which his first psychiatrist prescribed Risperdal (risperidone).  Subsequently a second psychiatrist added Zyprexa (olanzapine) to the cocktail.  Both Risperdal and Zyprexa are neuroleptics (euphemistically known in psychiatric circles as antipsychotics), and are known to cause tardive dyskinesia.

On the face of it, one would think that this would be a big story.  One can picture the headline:  “Psychiatrists Destroy Child’s Brain.”  But in fact, the only references to this case that I’ve been able to find are the present article on Peter Breggin’s site, and links to Dr. Breggin’s article on Mad in America and Carl Elliott’s blog (Fear and Loathing in Bioethics).  Pharma’s stranglehold on the media is as effective as a government security blackout.

The truly tragic aspect of all this is that the neurotoxic effects of SSRI’s and neuroleptics are well known.  It’s not like the thalidomide tragedy of the early 1960’s, in which the teratogenic effects weren’t known until it was too late.  At which point, incidentally, the drug was taken off the market.

In the case of neuroleptics, or major tranquilizers as they used to be called, the link to tardive dyskinesia has been known for decades.  In fact, Jean Delay and Pierre Deniker, French psychiatrists who are generally “credited” with introducing neuroleptics into psychiatry in the early 1950’s, promoted the notion that the dyskinesic effect was linked to the putative therapeutic effect.  For this reason, they routinely raised the dose until this produced noticeable dyskinesia.

As the second generation neuroleptics became available, it was widely touted by pharma and by psychiatrists that these new drugs would not cause tardive dyskinesia.  That claim is now discredited.  The second generation neuroleptics do cause tardive dyskinesia, though perhaps at a slower rate than the earlier drugs. [CATIE Study]

The incidence of tardive dyskinesia among people who take neuroleptics is high.  The risk generally increases with higher doses and longer duration.  Psychiatrists justify this neurotoxification on the grounds of the “benefit” outweighing the risk, but it is truly difficult to imagine what benefit the individual in this case derived from these drugs that would outweigh his present plight.

Another argument that psychiatrists use in this area is that through careful observation, they can spot tardive dyskinesia in its very early stages, and by stopping the drug at that point, can arrest the problem.  The argument is specious, however, on two grounds.  Firstly, although the drugs cause this problem, they also mask its manifestation.  By the time the problem is sufficiently pronounced to break through the masking effect, it has already reached an advanced stage.  Secondly, the tardive dyskinesia is not only a disabling and disfiguring movement disorder, it is also an indication of more generalized neurological damage.  Here’s a quote from Joseph Glenmullen’s book Prozac Backlash (2000):

“We still do not fully understand how tics reflecting permanent brain damage develop with major tranquilizers.  But when one looks at the symptoms, the best model to explain them is that the appearance of noticeable tics is merely the final stage in a process of slow, progressive damage.” (p 57) [Emphasis added]

For readers who are not familiar with tardive dyskinesia, there are videos herehere, and here.  If you do a Google search, you can find others.

In my experience, there is a widespread belief among the general public that tardive dyskinesia is a “symptom” of the condition known as schizophrenia.  Almost everybody over the age of 40 who has been “diagnosed” as “schizophrenic” has been prescribed neuroleptics, and most of these people have tardive dyskinesia, so it’s not surprising that the public is confused.  Tardive dyskinesia is extraordinarily disfiguring and disabling, and serves to confirm the popular view – avidly promoted by psychiatrists – that “schizophrenia” is a progressive brain disease.  This is even more the case in that, as the victims of this neurotoxic assault continue to ingest these drugs, their presentation becomes steadily more disfiguring and more stigmatizing – “confirming” that “schizophrenia” is a progressive condition.

Organized psychiatry routinely claims that it is working hard to reduce the stigma associated with “mental illness,” and they castigate us “mental illness deniers” for allegedly increasing this stigma.  If psychiatry were seriously interested in destigmatizing these individuals, they would take some of the money that they are currently using to promote their profession, and use it to tell the public the truth:  that tardive dyskinesia is caused by psychoactive drugs!; that tardive dyskinesia is caused by psychiatrists and is entirely preventable.  But apparently the APA feel that they have better things to do with their money.

Psychiatry in America today is little more than a marketing arm for pharma.  Neuroleptics are neurotoxic drugs that, at least initially, have a controlling and dampening effect on agitated, aggressive behavior.  In the long term – and psychiatry routinely promotes them as long-term treatments – they are fraught with truly horrendous adverse potential.

Whatever might be argued about their use for consenting adults (and I recognize psychiatry’s creative understanding of the word “consent”), it’s difficult to even imagine how practitioners can foist these products onto children, whose brains are still developing.  By what kind of mental gymnastics can a psychiatrist prescribe these products to a child, and at the same time maintain even a semblance of self-esteem?

How much more destruction and how many more lawsuits is it going to take before psychiatrists recognize the obvious truth:  that you can’t help people by damaging their brains?  What is it about psychiatry that renders its adherents so narcissistically unreceptive to this patently clear reality?

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.

As one can see, the most frequent use of these products for children of all ages, but especially for those under the age of 14, is disruptive behavior disorders.  In other words, the drugs are being used to control misbehavior.

On September 24, 2012, an article by Richard Friedman, MD, psychiatrist, appeared in the New York Times.  The article was titled A Call for Caution on Antipsychotic DrugsHere’s a quote:

“…there has been a vast expansion in the use of these second-generation antipsychotic drugs in patients of all ages, particularly young people. Until recently, these drugs were used to treat a few serious psychiatric disorders. But now, unbelievably, these powerful medications are prescribed for conditions as varied as very mild mood disorders, everyday anxiety, insomnia and even mild emotional discomfort.”

There is nothing to suggest that Dr. Friedman’s call for caution has been heeded.  In fact, according to Drugs.com, Abilify (aripiprazole), a second generation neuroleptic, was the best-selling drug in the US for all four quarters of 2013. (Q1, Q2, Q3, and Q4.)  Not just the best-selling psychiatric drug – the best selling drug, period!

Psychiatry is not something good that needs some minor corrections.  Psychiatry is something fundamentally flawed and rotten.  Organized psychiatry is so intoxicated by its own self-congratulatory rhetoric, that it has rendered itself blind to the reality – that it is destroying people’s brains.

Psychiatry’s Over Reliance On Pharma

I recently read The NIMH-CATIE Schizophrenia Study: What Did We Learn? by Jeffrey Lieberman, MD, and T. Scott Stroup, MD, MPH.  The article was published in the American Journal of Psychiatry 168:8, August 2011.  

Here are two quotes:

“When the CATIE study was designed in 1999-2000, the prevailing opinion of researchers and clinicians alike was that the newer (second-generation) antipsychotic drugs were vastly superior to the older (first-generation) antipsychotic drugs in efficacy and safety. This largely reflected the results of studies sponsored by the manufacturers of the new drugs…, marketing messages of pharmaceutical companies and the hopes of many who wanted better treatments.”

“CATIE helped to demonstrate that, although the introduction of second-generation antipsychotic drugs brought new options for treatment of psychosis, the major advance many had hoped for remains elusive.”

Let’s take a look at the first passage.  Essentially what’s being said is that by about the year 2000, psychiatric researchers and practitioners believed that the second-generation neuroleptics were vastly superior to the older drugs in effectiveness and safety.

The CATIE study debunked these beliefs, as is acknowledged clearly in the second quote.

EFFECTIVENESS AND SAFETY

Here is a list of the second-generation neuroleptics introduced prior to the year 2000 with the main adverse effects associated with the use of each drug as listed in the 2001 PDR.

  • Clozapine, Clozaril (1989).  Adverse effects:  agranulocytosis (black box); seizures (black box); orthostatic hypotension (black box); neuroleptic malignant syndrome; tardive dyskinesia; akathisia, etc… 
  • Risperidone, Risperdol (1994).  Adverse effects:  extrapyramidal disorders; akathisia; aggressive reaction; joint pain; weight gain, etc… 
  • Olanzapine, Zyprexa (1996).  Adverse effects:  neuroleptic malignant syndrome; tardive dyskinesia; akathisia; weight gain; postural hypotension; joint pain; extremity pain, etc… 
  • Quetiapine, Seroquel (1997).  Adverse effects:  neuroleptic malignant syndrome; tardive dyskinesia; orthostatic hypotension; seizures; hypothyroidism; cholesterol and triglyceride elevations; etc… 

Each entry in the PDR is a verbatim copy of the manufacturer’s FDA-approved labeling information and is updated annually.  It is clear, from the adverse effects listed with each of these products, that the respective manufacturer acknowledged clearly that there was a real danger of serious and potentially irreversible adverse effects.

With the exception of clozapine, the manufacturers also acknowledged that their efficacy data was based on very short-term trials.

  • risperidone                  3 weeks
  • olanzapine                   6 weeks
  • quetiapine                    6 weeks 

The entry for olanzapine (Zyprexa) stated explicitly:

“The efficacy of ZYPREXA was established in short-term (6-week) controlled trials of schizophrenic inpatients…

The effectiveness of ZYPREXA in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.  Therefore, the physician who elects to use ZYPREZA for extended periods should periodically re-evaluate the long-term usefulness of the drug for this individual patient… [emphasis added]

ZYPREXA is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.

The efficacy of ZYPREXA was established in two placebo –controlled trials (one 3-week and one 4-week), with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or, without psychotic features…

The effectiveness of ZYPREXA for longer-term use, that is, for more than 4 weeks treatment of an acute episode, and for prophylactic use in mania, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use ZYPREXA for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient…” [emphasis added]

Against this background, it’s difficult to afford much credence to the assertion of Drs. Lieberman and Stroup that the responsibility for psychiatrists’ false beliefs that these products were vastly superior to the old drugs in efficacy and safety can be laid at the feet of pharma.

It is noteworthy that Drs. Lieberman and Stroup mention not only industry sponsored studies, but also pharma’s “marketing messages.” [emphasis added]

This strikes me as an extraordinary admission.  America is the birthplace of aggressive marketing, and we all know how successful it can be in the selling of cars, vacuum cleaners, etc…  But for a group of people, who routinely claim that they are a bona fide medical profession, to admit that they were duped by tawdry marketing ploys raises serious concerns about their credibility and competence.

Drs. Lieberman and Stroup are defending psychiatry’s overly zealous adoption of the newer drugs by blaming the pharmaceutical companies’ misleading research and commercials.  But the much more fundamental issue is:  why did psychiatrists believe these messages despite the fact that the PDR entries for the drugs in question provided abundant justification for caution and restraint?

It’s difficult to avoid the suspicion that the various largesse showered on psychiatry by the pharma industry might have played some part.

It’s also clear that psychiatrists’ love affair with these drugs and their vulnerability to pharma marketing continue to this day.

In the third quarter of 2013, the second-generation neuroleptic Abilify (aripiprazole), with over $1.5 billion in sales, was not only the best selling neuroleptic drug in the US, it was the highest grossing of all prescription drugs.  It was also the most heavily promoted neuroleptic in 2011 (the last year for which I can find data), and accounted for 38% of neuroleptic promotional spending.

However, there is nothing in the current PDR entry, which is available online, to suggest that it is any safer than the other products.  All the usual second-generation neuroleptic adverse effects are listed, including tardive dyskinesia, akathisia, weight gain, metabolic problems, neuroleptic malignant syndrome, etc…  There are also two black box warnings:  increased mortality in dementia-related psychosis; and increased suicide risk in children and young adults.

In addition, efficacy studies were limited to 6 weeks.

SUMMARY

So in 2011, we had Drs. Lieberman and Stroup blaming pharma advertizing for psychiatry’s misplaced enthusiasm for the newer neuroleptics, while side-stepping the obvious corollary:  that psychiatrists were taken in by these promotions.  Now, two years later, the problem is still with us.  Psychiatrists apparently are still responding positively to the marketing messages; and neuroleptic drugs, which in former times were barely a blip on the sales charts, are now acquiring blockbuster status.

Psychiatric Dogmatism

In November, Joanna Moncrieff, MD, a British psychiatrist who works as a Senior Lecturer in psychiatry at University College London and a practicing consultant psychiatrist, started her own blog.  What’s remarkable about this blog is that it is highly critical of psychiatry.  Dr. Moncrieff marshals important facts and arguments in this area, and it is probably safe to say that her popularity among her peers is in decline.

The facts that she adduces, however, are indisputable, and her qualities of honesty, courage, and integrity are evident in everything she writes.

So far, she has written six posts. The central theme of three of these posts is antipsychotic (or as I prefer to say, neuroleptic) drugs.

Psychiatry has its head in the sand: Royal College of Psychiatrists rejects discussion of crucial research on antipsychotics (Dec 20)  Quote:

“It seems not to be interested in discussing the serious harm its drugs can do to both physical and mental health, and in taking the steps necessary to minimise this harm. The profession appears to believe that if it keeps quiet about these inconvenient findings, and discusses them as little as possible, the fuss will blow over and nothing need change.” 

Antipsychotics and brain shrinkage: an update (Dec 13)  Quote:

“People need to know about this research because it indicates that antipsychotics are not the innocuous substances that they have frequently been portrayed as. We still have no conclusive evidence that the disorders labelled as schizophrenia or psychosis are associated with any underlying abnormalities of the brain, but we do have strong evidence that the drugs we use to treat these conditions cause brain changes. This does not mean that taking antipsychotics is not sometimes useful and worthwhile, despite these effects, but it does mean we have to be very cautious indeed about using them.”

Long-term Antipsychotics – making sense of the evidence (Dec 9)  Quote:

“This study [Wunderink et al] should fundamentally change the way antipsychotics are used. These are not innocuous drugs, and people should be given the opportunity to see if they can manage without them, both during an acute psychotic episode and after recovery from one. If psychiatrists had not forgotten the lessons of the past, and if they had been prepared to acknowledge what they saw the drugs doing with their own eyes, this would have come about long ago.”

Whilst all of Dr. Moncrieff’s writing is compelling, it was this last quote that particularly caught my attention, and caused me to articulate the following questions:

  • Why have psychiatrists not acknowledged what they saw the drugs doing with their own eyes?
  • How did it come to be that highly educated and intelligent people became so enamored of their professional dogma that they failed to recognize the damage that neuroleptic drugs were doing and continue to do?
  • And, with particular reference to the last decade or so, how have they been able  to participate, apparently with clear consciences, in the huge increase in the use of these products, even to children as young as 2 years? 

In my view the answers to these questions fall into two general categories:  self-interest and fear.

SELF-INTEREST

For the past fifty or sixty years, the prescribing of psychopharmaceutical products has brought considerable benefit to the psychiatric profession.  Firstly, it has provided them a good living ($190,000 per annum in the US) for relatively non-taxing work (15- minute med checks).  Secondly, it has boosted their perceived status in the eyes of other medical practitioners.

It’s largely forgotten now, but during the 60’s and even into the 70’s, psychiatrists were widely regarded by the medical community as a coterie of quacks who delved endlessly and pointlessly into such chimerical abstractions as unconscious impulses, Oedipus complexes, ids, etc…  Today psychiatrists prescribe drugs, have their own medical journals which often have pictures of brain scans, and conduct randomized controlled trials.  They’ve become “respectable,” or at least somewhat respectable, and they recognize that this respectability is intrinsically dependent on their symbiotic relationship with pharma.

FEAR

The kind of fear that I’m talking about here might more correctly be termed peer pressure – the fear of being ostracized or marginalized by one’s professional colleagues.  In my interactions with psychiatrists during my career, I gained the impression that in medical colleges there’s relatively little emphasis placed on discussion and opinions, and relatively high emphasis on absorbing the facts as passed down by the academics.  Other disciplines stress discourse and debate, especially at doctoral level, but medicine leans towards a traditional didactic model and conformity to orthodoxy.  I’m not saying that this is necessarily a bad thing.  Four years of medical school passes quickly, and there’s a lot of factual material to be learned.  But the inevitable result is that medical practitioners tend to be followers of orthodoxy rather than innovators.  The rationale is that the academic researchers will pursue the innovations, and the toilers in the field will follow protocol.

In and of itself this isn’t a bad model.  Similar dynamics occur in engineering.  But – and this is crucial – for the past 40 years or so academic psychiatry has been hijacked by pharma!  The only innovation that’s allowed to occur is:  more drugs for more people.

In this kind of context it’s almost impossible for a junior psychiatrist in a hospital or a mental health center to challenge the standard philosophy.  And as the years pass, it becomes even more difficult, because any challenge of this sort inevitably involves a critical review of one’s own career.

It’s almost as if there’s a macabre conspiracy of silence among psychiatrists concerning the spuriousness of their concepts and the damage they inflict on their clients.  In their “hearts” they all know that it’s there, and that it’s enormous, but no one is allowed to talk about it.  No one is allowed to wake the monster, because they intuitively know that the monster will devour them all.

 

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.

 

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.

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.

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.

Second Generation Neuroleptics, Tardive Dyskinesia, and the Law

There’s an interesting article on Harvard Law Petrie-Flom Center’s blog titled Daubert as a Problem for Psychiatrists.  It was written by Alex Stein and is dated September 19.  [Thanks to Dustin Salzedo for drawing my attention to this in a comment on an earlier post.]

The article deals with the legal rules governing the admission of expert testimony.  Apparently there are two different sets of rules in this area, known respectively as Frye and Daubert.

Under the Frye rules, expert testimony can be admitted only if its validity is generally recognized and accepted by the “relevant community of experts.”

Under the Daubert rules, testimony can be admitted if it is scientifically grounded and can be explained to a jury, even though it may still be controversial.

The importance of the distinction was highlighted in a recent United States District Court case – Patteson v Malloy.  In this case, Kay Patteson, plaintiff, had filed suit against her psychiatrist, John Maloney, MD, on the grounds that the Seroquel he prescribed her for insomnia had caused tardive dyskinesia.  Seroquel is a second-generation neuroleptic.  Tardive dyskinesia is an irreversible movement disorder involving disability and disfiguring involuntary movements.

When the second-generation neuroleptics first came on the market, it was claimed that they didn’t cause tardive dyskinesia, but the spuriousness of this claim was quickly recognized.  I certainly wasn’t aware that there was any residual controversy or doubt on this matter, but apparently there is – at least as far as Dr. Maloney is concerned.

In the court case, Dr. Maloney’s lawyers sought to have all testimony linking Seroquel to tardive dyskinesia excluded on the grounds that Ms. Patteson’s expert testimony was unreliable.  To support this position, Dr. Maloney produced his own expert whose study showed no link between Seroquel and Ms. Patteson’s tardive dyskinesia.  Dr. Maloney also contended that his expert’s study was sounder than the plaintiff’s.

Dr. Maloney, according to court documents, has contended that “…no scientific methodology has attributed Seroquel to causing tardive dyskinesia.”  He has also indicated that the study his expert witness will present is a “…– a clinical trial conducted by AstraZeneca…” (the manufacturer and marketer of Seroquel).  Dr. Maloney’s expert witness is Thor W. Rak, MD.

I can find no information on the Internet about Dr. Rak.  Nor have I been able to identify the particular AstraZeneca trial.

On September 16, 2013, the judge ruled that the scientific evidence linking Seroquel to tardive dyskinesia is solid enough to be presented to a jury.  The judge also allowed testimony on differential diagnosis to be admitted.  This involves systematically ruling out other possible causes of the tardive dyskinesia, leaving only Seroquel as the remaining causative agent.

It is unlikely that these rulings would have been made under the Frye rules.

Back to Alex Stein’s article.

“The consequent liability risk for psychiatrists is obvious, given the frequency of tardive dyskinesia among psychiatric patients. Antipsychotic drug prescriptions follow the trial and error method. This method involves patient-specific observations, tradeoffs and adjustments that rely on the psychiatrist’s intuition. There are no hard-and-fast rules and protocols similar to those that provide legal ‘safe harbors’ for other doctors…As a result, plaintiffs’ experts would often be able to second-guess the psychiatrist’s drug prescription and plausibly describe it as negligent.”

Dr. Stein goes on to point out that the increased liability risk for psychiatrists will now apply in state and federal courts that use the Daubert rules.  Dr. Stein points out that psychiatrists, before prescribing neuroleptics, can protect themselves from this liability by having their clients sign an informed consent document that explains the risk of tardive dyskinesia.

DISCUSSION

It is a general theme of this website that psychiatric drugs are not medications in any proper sense of the word.  Rather, they are neurotoxic chemicals with a wide range of negative effects.

One of these effects, that in my opinion is particularly devastating, is tardive dyskinesia. If you’re not familiar with this condition, you can see some video footage here.  If you do a Google search, you will find more videos.  It has been known for decades that neuroleptic drugs (i.e. the class of drugs used to “treat” the so-called psychotic disorders) cause tardive dyskinesia.  As mentioned earlier, this includes the second-generation neuroleptics.

I have always been troubled by the ease with which psychiatrists prescribe these products and the vehemence with which they defend these practices.  In recent decades, I have been frankly appalled by the fact that psychiatry has been systematically expanding the range of problems for which they prescribe these drugs, even to the point of administering them to toddlers to control temper tantrums, and elderly dementia patients to control agitation and aggression.

These expansions have attracted a good measure of criticism, which psychiatry routinely ignores, though in very recent months there have been some indications of retreat.  (See the APA’s news release List of Common Uses of Psychiatric Medications to Question.)

But of its own accord, psychiatry seldom takes note of the damage that it does.  With the easing of the rules on evidence admission, it may be that successful malpractice suits will prevail where considerations of “do no harm” have failed.