Multi-Pronged Pharmaceutical Company Marketing Can Make "Evidenced-Based Medicine" a Joke

The above quote was taken from a talk by Ben Goldacre at the TED conference.

Of course, readers of this blog know that misleading pharmaceutical company marketing strategies and techniques are a recurring theme here. Deep sixing studies that show that their products don't work very well is just the tip of the proverbial iceberg.

One of the more impressive attributes of their marketing strategies is how multi-faceted they are. They target both physicians and the public at every possible turn, and affect every step of the process of generating the accepted “evidence base” for medical treatment in the minds of anyone potentially involved.

In a new article in the European Journal of Clinical Investigation, authors Emmanuel Stamatakis, Richard Weiler, and John P.A. Loannidis point out that just one drug, Lipitor, brought in $130 billion dollars in 14 years - an amount higher than the 2010 gross domestic product of 129 different countries.

They go on to enumerate many of the misleading marketing strategies, and describe the obvious biases that results from them. I will briefly review them here.

1.   Evidence production:

a.     Pharma designs and controls a large portion of the most influential studies.

b.    Industry-sponsored trials are more likely to compare their drug against an inactive or “straw man” comparator.

c.    They almost never compare their drugs to a variety of different possible interventions – including mere life style changes. I would add that when it comes to child psychiatry, they never compare their results to that of Supernanny-style family therapy. (Come to think of it, neither do most of the purveyors of various psychotherapy treatment paradigms).

d.   Their studies often guide the content of subsequent clinical research.

e.    Their studies are more likely to state favorable results and slyly avoid “inconvenient” findings.

f.     They raise the status of studies that they have actually writen up themselves by attaching the names of well-known academically-affiliated investigators (ghost writing) who are then paid off.

2.   Evidence synthesis

a.      Systematic reviews that they sponsor review prior studies that had asked the wrong questions to begin with.

b.     They limit access to the raw data on which their studies are based.

c.      With meta-analysis, or combining statistics from many previous studies, 100% of industry sponsored meta-analyses recommended using their drug, compared to 0% (you heard right) of independent meta-analyses, even though the actual statistics presented in both cases were quite similar. Conflicts of interest are generally not reported in meta-analyses (not that anyone would pay attention if the were).

3.   Understating risks of drugs

a.      Recent withdrawals of previously FDA-approved drugs seem to indicate that manufacturers intentionally distort the presentation of clinical trial safety data.

b.     Companies carefully train their sales representatives to tactfully avoid physician questions about the safety of their products.

4.   Cost-effectiveness evaluation

a.      Studies funded by industry are more than twice as likely to show good cost-effectiveness of their drug than independently financed studies.

b.     This is accomplished through the use of subtly biased assumptions about the intervention and its comparators.

5.   Clinical practice guidelines

     Because many of the authors of treatment guidelines produced by various medical specialty and subspecialty groups have a financial conflict of interest because they are paid by drug companies via consultancies, research support, or stock ownership, these guideline are often heavily focus on new, costly interventions and only loosely follow all of the available evidence.

6.   Healthcare professional education

a.     Gifts to medical students, which lately have been banned by many medical schools, were routinely given for decades. These are often given during “academic” presentations that are sponsored by industry and which are given by influential medical school professors.

b.   Industry-sponsored continuing medical education (CME) for practicing physicians accounted of approximately half of all CME as recently as 2010.

c.    The doctors who present CME usually use slides provided by the drug companies that manufacture the drugs prominently featured during the presentation.  Pharma also pays the presenters hefty fees.

7.    Direct influence on docs

a.    Drug sales representatives frequently visit doctors’ offices to “share” information with both the doctors and their staffs.

b.   Regular interactions with sales reps increases the chances that a company’s drug will be added to a hospital drug formulary (their list of preferred medications) by over 300%.

8.   Direct of consumer advertising

    Industry spending on TV and media adds increased from $11 billion dollars to $30 billion dollars per year over the period of 1996-2005.

Need they say more?

Defense Mechanisms, Irrational Beliefs, and Mortification

"...what makes them defense [mechanisms] is not that they protect you from pain-- they don't, clearly. They suck at doing this, look around.  The purpose of defense mechanisms is to stop you from changing." ~ The Last Psychiatrist

As originally defined by Sigmund Freud, the founder of psychoanalytic (PA) therapy, a defense mechanism is a tactic developed by a person’s ego to protect against anxiety. The ego is part of his three part model of the mind that also includes biological impulses (the id) and the learned values of the individual from his or her cultural milieu (the conscience or superego).  

Defense mechanisms were thought by the Freudians to safeguard the mind against feelings and thoughts that are too difficult for the conscious mind to cope with because of an internal conflict  (neurosis) between one’s natural impulses and one’s conscience. In some instances, defense mechanisms are thought to keep inappropriate or unwanted thoughts and impulses from entering the conscious mind at all.

For example, when someone's desire to have sexual relations with a stranger conflict with a belief in the societal convention of not having sex outside of marriage, unsatisfied feelings of anxiousness or  anxiety come to the surface. To reduce these negative feelings, the ego might employ one of the defense mechanisms.

The most common defense mechanisms are called regression, repression, reaction formation, isolation of affect, undoing, projection, introjection, turning against the self, and somatization. Some defenses are considered “primitive,” such as acting out, splitting, and dissociation.  Others are considered somewhat healthy, including sublimation and humor.  A man with repressed angry impulses might, for example, become a surgeon and get to both cut on people and do good at the same time. Some of these defenses are illustrated in the cartoon above. Interested readers that are not familiar with the various PA defense mechanisms can find definitions of almost all of them here. 

Cognitive Behavioral (CBT) therapists, as opposed to analytically oriented therapists, reject the whole concepts of the unconscious, the tripartate mind, and defense mechanisms – although they often seem to recognize their behavioral manefestations and just call them something else.  

They believe that seemingly neurotic or conflicted, Woody-Allen style behavior stems mostly from irrational beliefs.

The first cognitive therapist was Albert Ellis, who came up with his theory at least a decade before his model was hijacked by Aaron Beck.  He listed some of these irrational beliefs:

·        It is a dire necessity for adult humans to be loved or approved by virtually every significant other person in their community.

·        One absolutely must be competent, adequate and achieving in all important respects or else one is an inadequate, worthless person.

·        People absolutely must act considerately and fairly and they are damnable villains if they do not. They are their bad acts.

·        It is awful and terrible when things are not the way one would very much like them to be.

·        Emotional disturbances are mainly externally caused and people have little or no ability to increase or decrease their dysfunctional feelings and behaviors.

·        If something is or may be dangerous or fearsome, then one should be constantly and excessively concerned about it and should keep dwelling on the possibility of it occurring.

·        One cannot and must not face life's responsibilities and difficulties and it is easier to avoid them.

·        One must be quite dependent on others and need them and one cannot mainly run one's own life.

·        One's past history is an all-important determiner of one's present behavior and because something once strongly affected one's life, it should indefinitely have a similar effect.

·        Other people's disturbances are horrible and one must feel upset about them.

·        There is invariably a right, precise and perfect solution to human problems and it is awful if this perfect solution is not found.

These irrational beliefs cause people to do irrational things like overgeneralize, catastrophize, awfulize, or musterbate/should all over themselves – and this leads to low-frustration tolerance, self-pity, anger, depression, and to behaviors such as procrastination, avoidance, and inaction. To a musterbater who feels a failure because he came in second at something, Ellis might reply, “What JEHOVIAN MANDATE says that you MUST come in first?”

Cognitive behavioral therapists are beginning to grudging admit that these irrational beliefs are often tied into one’s upbringing as a child. They originally believed, and many still do, that they only occur because people are fundamentally and innately irrational.

So who’s right, the CBT folks or the PA folks? Well, of course, both are right. And both are also wrong!  Let me explain.

When I first learned psychoanalytically-oriented psychotherapy, I began to notice what the Last Psychiatrist mentioned in the quote at the beginning of the post. Defense mechanisms were envisioned by Freud as protecting the self against anxiety, but neurotic people were the most anxious people out there! Yes, indeed defense mechanism suck at preventing anxiety. So what do they do? 

What defense mechanisms do, from my unified therapy (UT) prospective, is to block a person's expression of innate thoughts and desires that run counter to the roles they feel they must play to maintain homeostasis in their family of origin. If a belief or a desire conflicts with that role, it has to be blocked so that the person does not change from their role behavior. This specifically is the “change” that is blocked. People literally try to kill off parts of themselves that are incompatible with their social role (I call this mortification). 

If this is the case, it becomes easy to see that the irrational beliefs listed by the CBT’ers also come in handy. People use these beliefs to discourage themselves from indulging in certain behaviors that they might otherwise want to do if they became self-actualized and stopped playing their role.  

For example, a woman with a gender role conflict who secretly wants to be a singer instead of a housewife as her sexist family demands will stop herself from ever being a successful singer if she thinks, overgeneralizing, that having failed one audition invariable means that she will never pass one in the future. That being the case, why bother to try? 

In other words, the irrational beliefs listed by Beck and Ellis serve the same function as defense mechanisms.  One could say, in fact, that they are defense mechanisms!

I once suggested to Albert Ellis during a Q and A at a therapy conference that perhaps irrational beliefs and defense mechanisms serve the same purpose. He naturally launched into a sarcastic tirade at me for daring to even think something like that. Too bad.

Clinical Wisdom – Who Needs It?

In the March/April Issue of the Psychotherapy Networker, the question of whether clinical wisdom - knowledge and intuition that a therapist gains over years of experience - has any place in today’s culture. As the magazine’s editor, Richard Simon, puts it: “The search for wisdom is out of sync with our entire culture, which much of the time is one of hurry and distraction, shallow questions and quick answers, short attention spans, and chronic restlessness.” 

He adds that the pioneers in the field of psychotherapy knew that good therapists were not just technique dispensing machines. They knew that being a good therapist required genuine insight into what it means to be a human being. Today, however, the emphasis is on quick fixes, and “short term, empirically supported manualized and medicalized therapy,” not to mention a pill for every ill. And too often, the “empirically supported” therapy treatments are based on poorly constructed, symptom counting studies that neglect underlying personality. Not to mention our relationships!

People who dismiss all widespread clinical experience and wisdom as "anecdotal" probably think it necessary to devise a scientific experiment to actually prove that the sky appears blue to the human eye at noon local time on a cloudless sunny day on the equator.

Simon comments that for therapists there are marketing plans to revise, website statistics to crunch, and referral sources to cultivate. Who has time to be wise?

This is a horrific trend, and as I have pointed out several times in this blog, it is not just biological psychiatrists and managed care insurance companies that push for it. The culture at large demands it more and more. And yet we wonder why so many people feel that their lives are empty, and fill their time with narcissistic pursuits or crass materialism.

In the lead article of the magazine, psychologist Ronald Siegel makes the following valuable points. We in the profession all need to keep making them, both to our fellow mental health professionals and to the public at large. Unfortunately, too many people in our fields are, when one gets right down to it, wimps. When managed care insurance companies say, “Jump,” they ask, “How high?"

• Even though the therapy literature, modeled after double-blind drug research, has tried to eliminate the person of the therapist as a variable, studies consistently show that the most important variable in therapy success is the patient’s relationship with the therapist. It has proven far more important than any therapy technique.

•  Patients do need to feel deeply understood by their therapist, and for the therapist to really be there with them, in order for them to be helped to find a way to overcome suffering and lead a fulfilling life.

• Sometimes when patients' despair seems to be increasing rather than decreasing, it is actually a sign that they are finally beginning to grapple with their most troubling issues. It can therefore be a sign of progress rather than that therapy is going in the wrong direction. A wise therapist will know, in a given instance, which of these two possibilities is occuring.

• It should be OK for the therapist to not immediately know what to do with a patient during a session. Sometimes it takes a lot of time to figure things out. People are complicated. Managed care insurance does not want clinicians to ever acknowledge this fact to their patients, especially when that would involve longer treatment. 

I would add: a very troubling manifestation of this problem is that, a long time ago when I first trained, we would write down our conclusion after taking an initial history and doing an examination as a diagnostic impression, rather than as “the” diagnosis - just in case later information changed the apparent clinical picture. This was true in all of medicine, not just psychiatry. Now, the insurance companies demand a diagnosis right off the bat, or they will not pay the insurance claim. The initial diagnosis then stays in the patient’s insurance records even if it is later changed to something entirely different by the clinician, and gets listed as a “pre-existing condition.” Therefore, patients buying a new policy are refused future coverage for a condition that they never even had!

• When therapists are stuck with a particular treatment ideology, they often ignore information that does not fit with their preconceived model, and elaborate on any information that supports their ideas. Of course we all do that to some extent, but therapists do need to be aware of this tendency. When I was in training, some of my supervisors used to refer to the “Procrustean bed” when discussing any “one size fits all" model. Having never actually read the myth, I missed the nuances of what the phrase meant. Procrustes lived on busy road and invited travelers to spend the night on his grand iron bed. If the traveler was too tall for the bed, he would cut off their feet. If they were too short, he would stretch them to fit!

• The symptom-focused approach leads therapists to focus solely on the “problem du jour,” and miss the larger problem of dealing with the many ways a given patient clings to behaviors that seems to bring on his or her own difficulties.

• People who learn how to be introspective are much likelier to do well in therapy than those who do not.  Siegel adds, “Our clients are themselves discouraged from introspection by the pharmaceutical industry, which offers images of unbalanced neurotransmitters to explain their difficulties (the ads neglect to list ‘may lead to an unexamined life’ among possible side effects).”

 Now that’s wisdom.

Just Another Manic Mom Day

So mental illness is a myth, huh? 

"How do You Grab a Naked Lady" is a gripping memoir by Sharon L. Hicks that is hard to put down. It mostly centers around her crazy-making relationship with her legitimately bipolar mother, particularly during the mother’s manic episodes. Her mother certainly did not have bipolar, myass disorder, or bipolar “spectrum” disorder (B.S.).

Of course, having a parent with a severe mental illness can itself lead to severe family dysfunction that adversely affects other, completely normal family members, particularly children. What follows are a couple of examples of Mom’s behavior while in the manic state. Ask yourself how you might turn out if your mother routinely did things like this in front of you - and often in public:

"Sharon, are you listening to me? I had a 24K gold necklace made for me with the letters   F-U-C-K to dangle across my chest. It cost me $15,000. Let's go pick it up."...
"I'm sorry Mrs. Hicks, but management would not allow us to make the necklace." 
"Oh yeah, well fuck you!...Mother spun around and headed for the escalator or the 2nd floor...In one fluid motion, Mother pulled her muumuu over her head..
"Yes, sir, completely naked."
...As she paraded down the escalator, she yelled, "You're all a bunch of shitheads."

Or another time: “I’m calling President Kennedy. He absolutely must take these pills! And I’m calling everyone I know to tell them about the divorce [from the author’s dad]…And the flies on the wall agree with me…I know because they are fluttering their wings. That’s how they talk to me…I’m the only one who understands how they communicate…they have names. I’ve named them all. They really like their names. They told me so.”

And no, people with personality problems do not act like that, or seriously say things like that. Seriously.

The patient’s childhood was further complicated by the mother’s behavior when the mother was in the euthymic state (neither manic or depressed). In the euthymic state, bipolar patients are just like everyone else. Their moods completely span the normal range. They can have the same problems as anyone else. They can be very functional, or they can have severe personality problems. They can also react poorly to the consequences of their own crazy behavior when they had been in the manic state.

In the case of the author, her mother is described as having been very narcissistic and self centered while euthymic, and as having rarely asked her daughter how the daughter felt about anything. Furthermore, Mom seemed to love being in the manic state, even though it frequently led to her being arrested or thrown into a mental hospital and given electroshock treatments. (This was during the 1940’s, 1950’s, and early 1960’s when patients had few rights, and there were few effective medications).  

But later, when there were effective medications, the mother would refuse to take them. She seemed to feel that even the depressed episodes were worth it, because there would also be those exciting manic highs. While manic, she particularly liked the hypersexuality that came with the territory, even when that meant running naked in public.

At times, the author felt that maybe mother really had control of her behavior even while manic, and was using it to get what she wanted. She read Thomas Szasz, who wrote about how mental illness was a myth. For a short time, she considered it. 

Naaah! She knew her mom was just crazy during manic episodes.

Another factor that affects both the way diseases like bipolar disorder present themselves as well as their effects on other family members is the ambient culture. This idea in no way diminishes the FACT that psychosis is a brain dysfunction. 

The author was born at a time during which gender role stereotypy was the norm. The dream of the author’s father was that she would marry a professional man who made a lot of money, move into the suburbs, and have lots of children. Sort of what her mother did, although she complained about it her whole life. She loved telling her husband what a sh*thead he was.

The author actually didn’t really like the whole sexist white picket fence fairy tale, wanting rather to get her doctorate in philosophy and do great things. On the other hand, she did not want to be anything like her mother. Yet somehow she spent most of her life living out the worst of the two worlds. Her career aspirations were halted when she got pregnant - several times - and married two men whom she did not love but who provided the picture perfect world that her father wanted for her. 

In this world, even men who appeared to be supportive of women's careers nonetheless saw them as lesser beings. When the author had to quit the graduate philosophy program (because she "accidentally" allowed herself to become pregnant, of course), the department chair said, "We need women like you to become professors. So the men can do the research."

In line with the family dynamics of someone without a psychotic parent, the author allowed her husbands and even her son to verbally abuse her, much like her mother frequently did whenever the author had to rescue Mom from her manic escapades. Between husbands, the author became somewhat hypersexual herself, though not nearly in the same way that her mother did during mania. After spending much of her life trying – and failing for the most part, even while not being mentally ill herself in the least - to be everything her mother was not, she came to realize that she admired her mother’s free spirit.

As she struggled to break free from her sexist upbringing, the author brilliantly describes the existential terror that results when someone tries to do something like that: “…might strip away a lifetime of beliefs about who I was, who I was supposed to be. Then what?  What happened after that? That’s the part they didn’t tell you. What happened when you didn’t recognize your life or even yourself any more? When there was only a smoldering void where familiarity used to live?”

So are all of the people society labels mentally ill just eccentric folks who just do not fit in with society?  During her many trips to mental hospitals to visit her mother, the author relates the following conversation with another patient:

“Don’t eat the food,” he told me.

“Why not?”

“Because it’s poisoned.”

“How do you know?”

“The aliens told me. They communicate with me through the fillings in my teeth.”

“Thanks for the advice.”

The thoughts of a functioning normal brain?  Yeah, right.

Headline: CDC Reports Rise in Autism Diagnosis

USA Today on 3/20/13 reported, "Rates of all forms of autism in the U.S. may be substantially higher than previously estimated, according to a new government report that found that 1 out of every 50 school-age children - roughly one on every school bus - has the condition." This is significantly higher than the 1-in-88 figure reported by a different government agency last year. 

According the article, study author Stephen J. Blumberg, a senior scientist at the National Center for Health Statistics, explained "The fact that the new study found such high rates implies that 'there will likely be more demand for (autism-related) services than we had previously thought.'" The higher figures "recorded in the new study suggest that officials are getting better at counting kids with autism - not that more have the condition, several experts said."

Getting better at counting kids with autism? Well, I suppose that would be one explanation.  But a curious one. Autism used to mean a very unsubtle and obvious condition in which a child has severe language, intellectual and social impairments and unusual, repetitious behaviors. Somehow, like bipolar disorder, the definition has gradually expanded like a hot air balloon, and now includes "milder, related conditions."

Whenever there is a major increase in “diagnosed” cases of any psychiatric disorder, there are a number of possible explanations for why this has occurred.  The condition supposedly being a genetic disease is never one of them, as the gene pool does not change radically in even 100 years, let alone 10 or 15 – Unless, of course, there is a widespread selective breeding program. I don’t think I’ve heard of anything like that going on, even in North Korea.

So what are the other possibilities? 

One is indeed that the disorder was not recognized as a separate entity for some reason. This actually happened with panic disorder, which is as real as the earth and the moon, and which is fairly common. Common, but for some reasons many psychiatrists even now don't ask patients if they have the symptoms. That phenomenon is rampant in the Veterans Administration Hospital.

For decades, patients would show up at hospital emergency rooms complaining that they were having a heart attack. Multiple tests would be performed including physical exams, EKG’s, and cardiac enzymes (proteins associated with the heart that increase when there is heart tissue damage). All the tests would come out completely negative for a myocardial infarction. 

Still, hardly anyone in psychiatry seemed to mention this until the 1970’s, and panic disorder did not become part of the diagnostic manual, the DSM, until the DSM-III in 1980. Perhaps it was because sufferers were quite sure that they had a physical abnormality and did not consult psychiatrists, and because ER doctors were too afraid to tell patients they might have a psychiatric problem for fear of being accused of thinking the symptoms were “all in the patient’s head.”

Possibility #2 is that there is a new environmental pathogen - a disease causing germ or pollutant in the food or in the air. AIDS comes to mind as an example – the virus did not spread from monkeys to humans until the middle of the last century in all likelihoond, and did not become commonplace in people, especially in the United States, until the early 1980’s.

A lot of people thought that the sudden explosion of ADHD in the States was due to new food additives. There turned out to be no convincing evidence of this, but a lot of people still believe it.

The third possibility is that there have been major shifts in the ambient culture which lead to conflict and confusion in families and which can, unlike the gene pool, change in relatively short periods of time. A good example is borderline personality disorder (BPD), a disorder of such magnitude and obvious psychiatric distress that it would have been nigh impossible for psychiatrists to miss. This is especially true because when it first began to show up in large numbers in the 1970’s, most psychiatrists were psychoanalysts with a major interest in personality.  

And yet the incidence of BPD exploded. Readers of this blog know that I have seen major changes in parenting styles and gender role functioning that I believe account for the disorder, with genetic make-up playing a decidedly minor role.

The last possibility is the one that I think is occurring here with autism, and it again will be quite familiar to those familiar with this blog. 

I must add the disclaimer that I do not treat children or autism myself, so admittedly I have no direct knowledge of what’s going on. But still I have seen some evidence.

The last possibility is that of disease mongering by pharmaceutical companies and mental health professionals, combined with parents looking for “biological” explanations for their acting-out children rather than face what might be going on at home within their family.

The main theme of this blog is that together these separate interests groups synergistically increase the rate of false diagnoses – the emergence of so called “spectrum” disorders which, the reasoning goes, simply must exist because some behavior being seen seems superficially similar to some aspect of a real disorder. That way mental health professionals get more business, drug companies sell more sedating drugs, and parents don’t have to look at their own behavior.

Another significant aspect of this process is indirect financial incentives: 1. Government officials looking at how common an illness or disorder is when weighing how to spend limited public health and research funds. This provides a financial incentive for researchers to find more “cases.”  2. People looking to get their kids on disability in order to receive government money have more behavior that they can coach their children to manifest in order to get their “crazy checks.”

So what’s the evidence that this might be happening with autism "spectrum"? Well first of all, the research on which the headline is based has a basic flaw. The data was collected from a phone survey of parents in 2011 and 2012, of which "Less than a quarter of the parents contacted agreed to answer questions." That 25% sample of parents might not be representative of the entire group of parents with children.  

Furthermore, if my speculation has validity, parents who did agree to participate might just have a strong desire to prove that their children have it by exaggerating their children’s behavior. Just sayin’.

Even more curious is that the biggest increase in autism diagnoses was in boys and adolescents aged 14 to 17. This is well beyond the age at which real autism should have been clearly noticeable. To me, this reeks of an increase in the prevalence of behavior problems, not an increase in the prevalence of a serious mental disease like autism.