Plausible Deniability

Once rockets go up

Who cares where they come down?

That's not my department

Says Wernher von Braun

                                                  ~Tom Lehrer

Pharmaceutical companies and their marketing departments have been studying the psychology and the behavior of physicians for decades and have become masters of the subtle con job.  The goal of the con job is to convince physicians to prescribe new and expensive drugs when old generics will do the job better, much more cheaply, and sometimes with fewer side effects.

This con job often involves multiple components that seem to be acting independently but are being co-ordinated behind the scenes, and employs very subtle mind tricks to shape the thinking of the physician.  The influence techniques are also taught to their army of pharmaceutical representatives who visit doctors in their offices, and who also learn how to ingratiate themselves with the physician.

This post will focus on one of their techniques that I refer to plausible deniability.  Plausible deniability is defined as the believable denial of a fact or allegation, or of previous knowledge of a fact. The term most often refers to the denial of blame for wrongdoing. In the case that illegal or otherwise disreputable and unpopular activities become public, high-ranking officials and academic physicians alike may deny any awareness of such acts or any connection to the agents used to carry out such acts.

The term became notorious during the arms-for-hostages Iran-Contra scandal in 1986.  I use it here, however, to describe a strategy in which psychiatric "experts" who are paid directly by pharmaceutical companies advocate for non-FDA approved indications for brand-named drugs (the doing of which is supposed to be illegal) in such a way that they can deny that they are doing exactly that.

In my book, How Dysfunctional Families Spur Mental Disorders, I strongly critique the presentation of one particular study that purported to show that antidepressant medications, which are almost all going or have gone generic, are not effective in manic-depressive patients who are in the midst of a depressive episode.  The study seemed to me to have mainly used subjects who had already failed at least one and perhaps two or three other antidepressant medications, making it far less likely that they would respond to the drugs used in the study.

Nowhere in the journal article describing the study does it say that it is a study of treatment-resistant bipolar depression, as opposed to a study of garden-variety bipolar depression.  I figured it out by reading between the lines.  Even though the study itself was not rigged, any experienced clinician could have easily predicted that the chances were excellent that it would turn out exactly the way it did. The journal article was extremely misleading because it did not disclose the true nature of the subject sample. 

If antidepressants do not work in bipolar depression as the drug companies want doctors to believe, the doctors will instead prescribe brand named anti-psychotic medications, which in my clinical experience have very limited effectiveness in any clinical depression.

Of course, the authors of the study clearly did not recommend that the expensive brand-named atypical antipsychotics be used instead of antidepressants.  They did not need to. The drug companies have other people who do that job for them.  In fact, it is better for the researchers and for PhARMA if researchers do not recommend the other drugs, in order to maintain plausible deniability in case someone like me notices that the study is not what it says it is.

I got into a discussion with a nationally known psychiatrist, Dr. William Glazer, on LinkedIn about whether or not studies can be rigged, and he wanted me to provide an example of one that I thought had been.  I brought up the article in question.  It turns out that Dr. Glazer knew the lead author of the study, Dr. Gary Sachs, as they both had worked at Harvard, and he asked him about what I wrote. 

The language that the two of them used provides an extremely good illustration of plausible deniability as used by PhARMA-influenced experts.

This is a long post and I apologize for that, but I want readers to appreciate the sophistication of how this is done.

I will include some of the exchanges we had, along with additional commentary describing what I suspect might be going on.  These comments were not part of the original exchange, and are in brackets and italics.  Some lay explanations for technical terms are also included in that format.

The original topic of the conversation was a recent article in the New York times by a Pharma critic, Dr. Marcia Angell.  She had been a hero of mine before, but both Dr. Glazer and I agreed that she went far beyond her expertise in this particular article. Here is the conversation:

William Glazer, M.D.

David Allen • Many of today's RCT's [randomized controlled drug studies] do in fact suck because of rigging by big PhARMA, and a tremendous quantity of mis- and overdiagnosis of mental disorders (e.g. bipolar disorder by doctors who completely disregard the requirements for duration and pervasiveness) is going on because doctors are paid more for medication checks than therapy. On the other hand, some mental illnesses respond better to meds than a lot of the conditions in internal medicine. It is a shame that Dr. Angell has apparently never treated, say, a melancholic depression. To discount widespread clinical experience because some psychiatrists are corrupt or incompetent is shameful.

William Glazer MD • ...No matter how hard you try, it is impossible to "rig" a study to show that an ineffective drug is effective. Pharma studies might show statistical differences that don't have much clinical meaning (because they include large numbers of subjects), but they can't "rig" a study to show something that isn't there. The FDA requires that an antidepressant demonstrate statistical superiority to placebo in 2 separate studies. Over 30 antidepressants have run through that requirement and most of them are available today to help us treat patients.

Marcia Angell and the authors of the books she reviewed are capitalizing on the media and political attention that has come out of law suits (most of them settled) against pharmaceutical companies. With only one exception, these authors have not treated patients (as is mentioned in previous comments on this blog). These authors are utilizing media style, not scientific style to make their points. And they are doing some damage if ONE patient stops antidepressants after reading this misinformation and gets hospitalized, loses a job or commits suicide. And from what I hear, this is happening. If anyone has a patient who was influenced by this misinformation, I would appreciate hearing about it at [his e-mail address].

David Allen • I pretty much agree with all the points made in these comments, and I am extremely disappointed in Angell, because she has in the past discussed what is going on between Pharma and academia and raised many valid points. When it comes to psychiatry, though, she knows nothing. Antidepressants are among the most effective drugs in all of medicine.

I do have to take exception on one point made by Bill Glazer, though: the question of whether Pharma can rig studies. If they can't, why is it that 90% of head to head comparisons between me-too drugs [New medications that are almost the same as older medications and do the same thing] come out in favor of the sponsor's drug? Also, if the authors of a study - say on medication for supposed bipolar disorder in children - mix in subjects with "bipolar NOS" because they do not believe in the duration criteria, and also do not take into account that they may be just sedating acting-out children, then the drugs will look "effective." But effective for exactly what?

William Glazer MD • David your question is a good one, and fortunately, we have the time and space here to air it.

To me, the term "rig" has a ring of the sinister. It implies that the drug studies have hidden elements in their designs in order to dupe reviewers like the FDA, independent clinicians and a wide readership of practitioners into thinking that the drug in question is something that it is not. If that is what you mean by "rig", then I need to ask you to provide a substantive example or two.

If by "rig" you mean that the drug companies select design elements that will bring out the advantages of the particular agent in question, then that is a very different story. Having been involved in clinical research, I have observed that ALL studies are "rigged" in this context of the word regardless of who is funding the project. You have a hypothesis, you set out to prove your hypothesis to be true. You live and die by your findings. A faculty member conducting a line of investigation completely funded by NIMH will not get his/her papers published if he/she does not have positive results.

This kind of "rigged" is how the scientific process works. As far as I am concerned, it is a legitimate process because it is open to scrutiny via peer review, FDA review (which is far more stringent than any peer review conducted by journal) and reader review. As an aside, note that no manufacturer has won a claim status for superiority of its antidepressant over another one. That's because no study has definitively shown the superiority of one antidepressant over another.

If Company A designs a study comparing their antidepressant to Company B's and they choose for example, an advantageous dose for its product, anyone is able to read the detail and see what they did. [How is under-dosing a comparator drug not rigging the study even if it’s done openly?] That is our responsibility as clinicians to do. The results can be questioned - and they usually are by the manufacturer of the competing antidepressant, and we all can follow that dialogue.

Final point for now: What CAN happen (and does happen) is that Company A proceeds to market a study comparing antidepressants by "spinning" the results. At the end of the day, it is our fault if we buy it, and the company should be held liable for being irresponsible in its communications. I'd say the same for companies that hold back evidence of side effects - that is unacceptable and irresponsible.

So, David, I would be interested to see an example of "rigged" in the first context that I described above. I think that we should be careful about making generalizations about Pharma funded studies. They often bring in new information, and ultimately, innovation. They should not be thrown out wholesale - we'd end up going back to the stone age.

David Allen • Bill, thanks for your thoughtful response. First, I want to make clear that I am not advocating against industry sponsored studies. Of course they bring in new information. Second, I absolutely agree that physicians need to read the studies to see what was done, and it is ultimately up to the doctor to make an informed decision.

Unfortunately, most docs only read the abstracts - if that - which as you know, do not include the weaknesses of the study described in the discussion session.  [Note as we proceed that Dr. Glazer does not address this point].

You are right about competing companes exposing the weaknesses of their competitors' brand-named drugs, but who is doing that as much for generics? [He does not address this point, either].

In the past drug companies have deep sixed studies with negative results and only presented the positive ones to the FDA and the public. Thankfully, I think this practice has been stopped. Replication of course is essential. [Ditto; this point is never addressed].

IMO, most of the studies of Lamictal may not be "rigged" but they are highly misleading. The outcome measure "time to next affective disorder episode" over [a period of] 18 months is almost meaningless. If a drug is prophylactic like lithium, then there wouldn't be many relapses at all in that period. If just 1% of the subjects actually responded to lamictal, it would beat placebo since the time to next episode would be over 18 months. This all could mean that we have much better drugs. But I've never seen this discussed in the articles.

I don't think it's a coincidence that we are hearing all this negative stuff about anti-depressants just as they are almost all going generic. I cannot prove it, but I suspect the drug companies are demonizing them hoping that doctors will prescribe atypicals instead. And that is exactly what I am seeing in patients referred to my residents' clinics. Interesting that the manufacturers of Paxil suddenly seemed to "discover" that they had strong evidence of teratogenicity [the drug may cause some birth defects in babies born to mothers taking the medication] from decades ago.

I believe the drug companies demonized benzo's after they went generic by wildly exaggerating their addictive potential. Whenever and wherever you see references to benzo's in the professional literature, there is an accompanying phrase to the effect that, "but of course they are addictive." I don't see any references to Atypicals that add, "but of course they can cause diabetes." And frankly, if I had to choose, I'd rather be addicted to a benzo than to insulin.

There is a widely-quoted study by Sachs et al in the NEJM claiming antidepressants don't work in bipolar patients, when any clinician who has used lithium for mania prophylaxis knows that they work wonderfully for bipolar depression as long as you have a mood stabilizer on board to prevent switching [from depression straight into a manic high]. The study does not say what percentage of the subjects had already failed other antidepressants, but the subjects were all referred by clinicians and were already on a mood stabilizer, and in the midst of an active episode of bipolar depression [meaning they were all being treated already but were not getting better, so they were referred for the study].

Only patients who had failed the two antidepressants used in the study were excluded; none of the patients who failed the multitude of other antidepressants were excluded. The article says some patients were tapered off of their other meds, but does not say what meds those were.

Furthermore, when some atypicals [antipsychotics like Abilify] became FDA approved for mania, patients on those meds were brought in as well as being on a "mood stabilizer." What all this means is that a significant percentage of the subjects in the study had failed at least one trial of an antidepressant, and perhaps two or three! And some also failed an atypical, which are being touted as anti-depressants these days. In other words, they used a treatment-resistant population and never said so, and shock of shock, placebo outperformed the antidepressants. I wrote e-mails to both of Dr. Sachs' email addresses nicely asking what percentage of the subjects in the study had failed other antidepressants. I never heard back.

That sounds like a rigged study to me.

William Glazer MD • Thanks David. Most of the examples that you refer to are ones in which there is transparency - you may question the authors' interpretation (or non-interpretation) of the data, but the reader is able to see from the details of the study what is going on. [Pharma knows jolly well that most psychiatrists are not going to question a bad outcome measure that sounds reasonable, although technically the study is not “rigged”]. I am currently pursuing your reference to the Sachs et al paper in the NEJM because you seem to feel that there is "rigging" in the first sense of the term as I discussed it above. I'll get back to you on that.

It's interesting how both you and I have our own preferred conspiracy theories about the attack on antidepressants. I seem to be blaming the psychologists and you are blaming the pharmaceutical industry (of course I am being overly dramatic here). But we certainly seem to be in a "fight or flight" response. We are both probably a little paranoid. :-)

David Allen • Bill, we may both be reacting to the attack on antidepressants because we both know they are damn good medications. It's OK to be paranoid when they are after you!!

Gary Sachs, M.D.

William Glazer MD • David - getting back to the issues that you raised, I followed up on the NEJM article by Gary Sachs reporting the results of the STEP-BD study (Sachs et al: Effectiveness of Adjunctive Antidepressant Treatment for Bipolar Depression N Engl J Med 2007; 356:1711-1722 April 26, 2007). I spoke directly with Gary and shared your concerns with him. This is what he said, and he was happy to have me convey it through this medium. I hope it helps:

"In regard to the STEP-BD finding, the suggesting that it was somehow "rigged" surprises me. The study was an NIMH funded treatment effectiveness study. It sought to enroll a sample representative of treatment seeking patients. By all measures it did exactly that. If Dr Allen wants to say that our results may not generalize to treatment naive patients [patients who had never been exposed to any medications], he is correct. If he wants to say that treatment refractory patients are the one most likely to be seeking treatment, he may be right about that too. [These last two statements are an implicit admission that my primary concern about the study was spot-on correct - that most of the subjects were in fact treatment-resistant. 

However, notice how this specific wording, or a reasonable facimile thereof, is never clearly used.  And he still does not answer the basic question about what percentage of the subjects in the study had failed one or more previous antidepressants.  Nor does he address the rather blatant omission of a key descriptor of the subject population in the journal article describing the study].  While treatment responders would have little motivation to enter a usual RCT, STEP-BD also enrolled euthymic patients, Of course if patients stayed well, they would never have been eligible to the randomized acute depression study.

[This is an excellent discussion of why studies of antidepressants are so notoriously difficult to do, but it is in no way a discussion of whether his journal article was misleading.  Note also he uses the words “treatment-naïve” or “treatment-refractory” instead of the current psychiatric buzzword, “treatment-resistant.” This may seem like a trivial point, but many practitioner just lightly scan articles and discussions like this. Using the buzz word might get their attention more than the alternatives. It makes a difference!].

I also agree there are many bipolar patients that apparently respond to standard antidepressants in clinical practice. The problem is that this has never been demonstrated in an adequately powered clinical trial. [True. Just as Glazer had pointed out, he did not know with certainty how this study would come out until he did it. On the other hand, as I mentioned in the intro to this exchange, any experienced clinician would have predicted that it was extremely likely that this study would in fact come out just as it did. If it had not, one might suspect that it was poorly designed. This was a well-designed study of antidepressant response in treatment resistant patients].

Furthermore, placebo did not beat the standard antidepressant in STEP-BD. [Here he is talking about a completely unrelated part of the STEP-BD study. A sly diversion from the topic at hand]. However, since the psychosocial interventions, did beat the control condition, it is hard to argue that the study was "rigged" to favor patent medicines.  [I wonder: how many psychotherapists read about drug studies in the New England Journal of Medicine?  Dr. Sachs and PhARMA can rest assured that this point would not be widely reported.  Also, speaking as a practitioner and strong advocate of psychotherapy, doing psychotherapy with a patient in a real bipolar depression is a complete and utter waste of time.  As we all know, having zero energy, thinking at a snail’s pace, being totally overcome with an all-encompassing sense of helplessness and hopelessness, and a blanket sense of the utter futility of everything is a perfect recipe for a successful course of psychotherapy.  If subjects in the STEP-BD sample responded to it, I would have to question the diagnoses of the subjects.


My guess is that they may not have been, at the time of the study, in a bipolar depression at all but were reacting to purely environmental problems. 


Also, throwing a bone to psychotherapy is another frequent PhARMA speaker's tactic so they can claim a presentation was fair and balanced, even though it is done in such a way that most of an audience will ignore it.].

I wish I could have responded to every email about the STEP-BD results. I did the best I could but may have missed his inquiry."  [How convenient. All I asked in my TWO e-mails was, in a very pleasant and professional tone, what percentage of the subjects in the study had failed previous antidepressants.  I also signed it with my title, Professor of Psychiatry at UT, so it just was not just any old inquiry.  Guess he just missed them].

David Allen • Bill, that defense is completely inadequate. Why did the article not say what percentage of the sample had failed a previous antidepressant? We know from the STAR-D study that there is diminishing returns when a second and third antidepressant are tried. I guess you could say that the article was transparent, as Dr. Sachs seems to be arguing, because I could read between the lines and see what they did. Perhaps not including this statistic was an innocent oversite, but it sounds like when you talked to him he still did not answer the question. The line between rigging and being extremely misleading is what we seem to disagree about, but that's just semantics. "Opinion leaders" and throw away journals are already treating the idea that bipolar depression does not respond to antidepressants as an established fact, when it is obviously complete baloney.

William Glazer MD • With all due respect David, you are not creating a fertile ground for an academic discussion about the NEJM STEP-BD study by Dr Sachs and colleagues. [Gee, was I being too mean?]. Dr Sachs read your last comment and respectfully declined to continue the dialogue because he flet that you sounded like you had your mind made up and there was no room for productive collegial debate. [Why would I change my mind when he confirmed that my suspicions were correct? And he was still refusing to answer my central question].  

I re-read the Sachs article and I think that your focus in on the narrow question of the effect of the history of antidepressant exposure on the outcome is interesting, but it hardly succeeds in establishing that this NIMH funded study was "rigged".

First, and most importantly, this was a randomized trial. This means, as I know you know, that it is likely that patients who failed on previous antidepressants were equally exposed to one of the two study conditions: antidepressant or placebo. Second, the authors do report on the history of depressive episodes in the patients assigned to drug versus placebo. And there was not the slightest hint of a difference in the randomization. [All true, and completely irrelevant to the question I was asking and the issue at hand about the deception in the presentation of the data]. 

Third, Dr Sachs and colleagues IN THE ABSTRACT did not say that they had proven that antidepressants were ineffective in bipolar depression. The reported their finding and immediately called for additional long-term well designed studies. [Pharma does not need for Dr. Sachs to say that, and probably would not want him to.  Sachs was just a cog in the machine.  Pharma has a lot of other paid lackeys out to “spread the word,” and they will be the ones recommending atypicals as an alternative.  This is exactly what I mean: Dr. Sachs has plausible deniability].

I don't know what thought leaders or throw away journals you are referring to, but if you go to the original source - the Sachs et al NEJM article, I think you find a well-designed, study that adds incrementally to our knowledge. [Is he just playing dumb here?  He was featured in a whole series of CME tapes sponsored by drug companies called PsychLink.  Does he really not know that “opinion leaders” is the term big Pharma uses to describe their paid-off “experts?”  And if he hasn’t seen the idea that antidepressants don’t work in bipolar depression anywhere else, then he has his head in the psychiatric sand]. A casual read of that paper makes it evident that it does not recommend a practice policy. [Of course not.  It doesn’t have to.  See my commentary at the end of the last paragraph]. 

It is a fine piece of work that has no evidence of being "rigged" in the first sense of the term discussed above. How others interpret and spin this study may be grist for our mill here [MAY be??], but we are talking about high quality research. [It was high quality research that was presented in an extremely misleading way]. We certainly need to know more, and perhaps you can interest someone to design a study that specifically tests your hypothesis. [Sachs and Glazer’s responses in fact tested my hypothesis, and my hypothesis won]. 

David Allen • Also with all due respect, Bill, I do not understand how you can say that omitting from the journal article the highly relevant fact that the subjects in the study were mostly treatment-resistant patients - some probably highly so - is defensable. I'm asking a very simple and highly relevant question of Dr. Sachs about the journal article's presentation of the study, NOT the relative merits of the study itself. If he doesn't want to answer it, I think that speaks to the validity of my argument that the presentation was purposely misleading. I doubt his refusal to answer is because of my attitude. And do you mean to suggest that he doesn't know how his conclusions are being used in the field? Please.
[A Third Party] • Dr Allen's comments make sense to me..... Am I missing something???
William Glazer MD • Sorry [third party], but I have taken it as far as I can take it. [He could not take it any further because he had lost the argument].

Ve Have Vays of Making You Talk, Part IV: Fatalism

In Part I of this post, I discussed why family members hate to discuss their chronic repetitive ongoing interpersonal difficulties with each other (metacommunication), and the problems that usually ensue whenever they try.
I discussed the most common avoidance strategy - merely changing the subject (#1) - and suggested effective countermoves to keep a constructive conversation on track. In Part II, I discussed strategies #2 and #3, nitpicking and accusations of overgeneralizing respectively. In Part III, I discussed strategy #4, blame shifting.  Now I move on to strategy #5.

To review once again, the goal of metacommunication is effective and empathic problem solving. In this post, I will discuss an avoidance strategy called fatalism, and describe appropriate counter-strategies to get past it.

As with all counter-strategies, maintaining empathy for the Other and persistence are key.

Strategy #5: Fatalism

Fatalism is a doctrine that advances the idea that almost all events are fixed in advance so that human beings are powerless to change them. It is commonly used to refer to an attitude of helplessness and resignation in the face of some ongoing events which are thought to be unalterable, or in the face of some future event or events which are thought to be inevitable.

In metacommunication, fatalism is most commonly invoked in order to resist and discourage further attempts at solving family problems whenever somebody tries. When one family member wants to bring up a highly emotionally salient past event that has led to unresolved feelings, for example, a second family member protests, "Why are you bringing this up again? You cannot change the past."

Well of course you cannot change the past.  At least not as far as we know, anyway.  The past seems to be rather fixed, does it not? No one denies that. Perhaps there is an alternate universe out there somewhere, but if so, we have no access to it. 

The fallacy here, however, is the implication that the past is no longer having any effect on the present, nor will it have any continuing effect on the future. It implies that people are not affected by memories in the here and now, and that they do not use past events in order to predict future ones.   It almost seems to be arguing that every moment in the present is entirely independent and disconnected from every previous moment.

Fatalism is unfortunately a significant component of the be­lief systems of many cultural groups that have emigrated to the United States. Many times, patients who attempt to metacommunicate about family problems so that they can be solved are accused of being troublemakers.

Another accusation based on a belief in fatalism is the charge that patients who are known to be in therapy are inappropriately trying to be psychiatrists themselves. "Quit trying to analyze everything!" is a frequent family rallying cry.

Fatalism-implying accusations can, however, be used to pave the way for individual family members to question, rather than perpetuate, established fatalistic family belief sys­tems. Individuals can empathize with fatalistic family members by admitting that they themselves used to think just as the family does.  However, they then go on to add that they now have developed real doubts about those ideas.

Why shouldn't they try to analyze a situation? Understanding a problem is benefi­cial for figuring out a way to solve it.  People in the family may disagree, but only because they feel helpless about changing their future. These feelings of helplessness often stem from past experiences or catastrophes that befell their forefathers.  That anxiety has been passed down from one generation to the next, often with the source of the original anxiety becoming lost. Times have changed for the better, but the family continues to act as if these somewhat ancient horrors are still in operation.

In response to the accusation that they are dwelling on the past, individuals can point out how those past situations are continuing to affect the family's present situation. They can say that they are bringing them up because they want to have better relationships with the family. The old problems are creating distance, and they want to be closer.

In response to the charge that they are being troublemakers and creating dissonance in the family, individuals can reply that the dissonance already exists, and they are trying to reduce it by discussing its causes. They can add that if the bad feelings can be reduced, then the whole family will wind up feeling happier and warmer with one another.

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The Impact of Intervention in Addiction Through an Amy Winehouse Scope

Today's post in a guest post courtesy of Allison Gamble, a writer for psychologydegree.net. 

“They tried to make me go to rehab, I said, "No, no, no"

Yes, I've been black but when I come back you'll know, know, know

I ain't got the time and if my daddy thinks I'm fine

He's tried to make me go to rehab, I won't go, go, go”

           ~ "Rehab" Amy Winehouse

The late singer Amy Winehouse released “Rehab” in 2007, a now haunting song that revealed her struggles with drug and alcohol abuse, her reluctance to seek help, and the role her family and friends played in her life. Some attempted to push her towards treatment, while others seemed to enable Winehouse's destructive behavior and ignored warning signs that may have caused her sudden death. While Winehouse’s plight has gained media attention, her celebrity is one of the only factors that separated her situation from the problems that many individuals who abuse drugs and alcohol deal with every day.

Like many other families who have loved ones with a substance abuse problem, Amy’s family is placing fault on others for her sad demise. It doesn’t take a degree in psychology to smell the denial in the air. Interviews with her parents show they lay blame for her death on detox methods instead of also looking at both their behavior and having not intervened in time to possibly help Amy.  Of course, losing a child is awful enough, but they are likely also feeling tremendous guilt that they had not taken more steps to try to protect her from a fate no one wanted to believe would come to fruition.

In American and the UK alike, due to the absence or failure of family members and friends intervening, many addicts like Amy are left to cycle through pricey rehab clinics and wind up taking endless supplies of anti-psychotics, anti-depressants, anti-anxiety meds and more. Gaining the approval of doctors, rehab clinics and pharmaceutical companies, families are held harmless as they look at addiction as a disease. With this medical model, the one loser winds up being the addict.

While little has been revealed about Winehouse’s upbringing, it is known that her parents separated when she was 9 years old. Father, Mitch Winehouse, claimed in a 2008 interview, titled “How my affair made Amy suffer,” with British newspaper The Daily Mail, that a longstanding affair with a colleague was an open secret in their home. Winehouse’s paramour was even known by Amy and her siblings as “Daddy’s work wife.” Mitch Wineshouse claims he never realized that their family’s dysfunction had impacted Amy so negatively until years later when he heard her song “What it is About Men” that the line “all the shit my mother went through” referred to his deception.

Amy’s mother Janis claims her Amy had always been a rebel but that her defiant streak intensified when Amy became a teenager. In an unusual move by Janis, Amy was allowed to leave home to live with a friend at the age of 15. "It would have been fine but she moved out for her own convenience. She wanted to live with a friend. Perhaps she wanted her mum to fight to make her stay. But I felt she had grown up by then,” her mother said in a January 2008 interview, eerily titled “Amy Winehouse’s mum says she’ll be dead in a year,” with the Sunday Mirror. This is not to say that Janis is solely responsible - there are surely hundreds of children who move out early without overdosing at 27. But could a firmer hand have helped steady the wheel? We’ll never know.

Janis went on to say that she while she doesn’t feel responsible for Amy’s decline into drugs, she reveals being lackadaisical when Amy started running into trouble. "Amy was never an easy child and she was always open to any new bad influence. Her life became a bit muddled when she left home. She started smoking marijuana and got her first tattoo - a Betty Boop on her back. I just said, 'Oh well.’”

Amy’s family always seemed to have a disturbing dynamic. Janis was unhappy; Amy was rebellious, but always trying to please her out-of-the-picture father Mitch. "I don't do happy. [Amy] doesn't, it seems, do emotion either. But it's just her way of coping,” Janis explained.

As a Amy became an adult, her family unit added another dysfunctional member: ex-husband Blake Fielder-Civil. A self-admitted addict, Blake claims to have introduced Amy to narcotics usage. “I’m not trying to defend his behavior and I know him for what he is: he’s an addict and he has done some terrible things. He feels enormous grief and responsibility for some of the things that have happened, as well he should,” Fielder-Civil’s mother, Georgette, told the Daily Mail in “Don’t blame my son for Amy’s death: Blake Fielder-Civil's mother's plea as she insists the couple were still in love.”

Although some families shift the blame for a substance abuse problem on medical issues, they are often the ones who have, perhaps unwittingly, facilitated the problem to a significant degree. In 1991, The Journal of the Academy of Child and Adolescent Psychiatry reported that researcher James R. McKay and colleagues had studied adolescent substance abusers and confirmed what we know anecdotally: that greater perceived degrees of dysfunction were linked to increased levels of substance abuse prior to hospitalization.

With modern medicine focusing on the disease model of addiction, pharmaceutical companies have been instrumental in keeping substance abusers like Amy addicted by flooding the market with painkillers and psychoactive meds, while also profiting from drugs to counter addiction.

In July 2011, financial website This is Money reported that one such company, Reckitt Benckiser Pharmaceuticals, was delighted to announce that its newest delivery system for the heroin addiction drug, Suboxone, would now be a big moneymaker. “As is well known, our Suboxone tablets can become subject to generic competition in the U.S. at any time, and moving more of our business into the film remains a key priority. At the end of June 2011, the Suboxone film had captured a 41 per cent volume share of the U.S. market,” he said.

Talk show host and former journalist Piers Morgan knew Winehouse and told Entertainment Tonight in “Piers Morgan hits out at Amy Winehouse’s record company after singer’s death,” that while the troubled singer ultimately succumbed due to her own addictive behavior, others in her life failed to take responsibility. Echoing a common question, Morgan wanted to know where everyone was when she needed help. He stated, “I do blame people. Where were all the people making money out of her when it mattered? Really, where were they? You know, it's just not good enough that they're all going to make millions out of it now she’s dead.”

Blake Fielder-Civil’s mother seems to agree. “We all played our part in what happened to her. I have had to look deep into my heart and wonder if I could have helped, done things differently,” she said.

While we may never know what caused Amy's death, ultimately she was responsible for her actions. However, family members, “friends,” doctors, rehab centers and pharmaceutical companies must also accept responsibility for the role they played in her destruction. We need to move towards a more cohesive model that merges psychology and psychiatry to prevent more parents from losing their daughters.

More Bipolar Disease Mongering in a Respected Journal.

“The drug companies learned a while back that the best way to sell drugs was to sell diagnoses… selling the diagnosis is a way of opening up the new market. New diagnoses are as dangerous as new drugs, at least in psychiatry.”~ Dr Allen Frances, chair of DSM IV task force - Selling Sickness conference, 2011.

One of the main themes of both my book How Dysfunctional Families Spur Mental Disorders and this blog has been the incredible expansion of the bipolar diagnosis to anyone who is moody, chronically depressed and irritable, or chronically agitated. 

This has been done predominantly by some egocentric blowhard psychiatrists trying to make a name for themselves in conjunction with a well-documented and highly successful plan by several pharmaceutical companies to enlarge the market for their brand named, so-called atypical antipsychotics.  This marketing plan was documented with the release of Eli Lilly's own company marketing memos as part of a US Justice Department investigation - the so called Zyprexa Documents. These medicines are potentially toxic and do nothing to solve the interpersonal and psychological problems of many of the mental health patients to whom they are prescribed.

My colleague in Australia, Peter Parry, told me,  "Our director of training for psychiatry in our state quipped sarcastically that we may as well subsitute “mental disorder” with “bipolar disorder” and have the “DSM of Bipolar Disorders” and then recategorise subtypes like ‘adjustment bipolar disorder,’‘personality-based bipolar’ etc."  With some of the psychiatrists I know personally, this would actually be considered a good idea!

Many of the adults misdiagnosed with bipolar actually carry the diagnosis of borderline personality disorder and not bipolar. While medication can help these folks with some symptoms, most of these patients are in dire need of good psychotherapy.  Unfortunately, a lot of therapists do not like to work with them, so many end up seeing psychiatrists who use antipsychotics basically to shut them up.

"Disease mongering" is a term used for marketing techniques designed to accomplish what Dr. Frances alluded to at the top of this post.  The ongoing mongering of bipolar disorder by the pharmaceutical companies uses many tricks.  Often so-called researchers and practitioners alike do totally inadequate diagnostic evaluations using highly inaccurate and misleading symptom checklists; others employ the completely unvalidated concept of bipolar spectrum, or b.s. as I like to call it.

Bipolar ver. 4.1

A highly transparent example of disease-mongering was just published in a respected psychiatric journal, the Archives of General Psychiatry.  521 hospital-based or community psychiatrists in 18 countries in Asia, Europe, and Africa between April 1, 2008, and April 30, 2009 were involved in a “research” project which was designed to shape their thinking and diagnosing, and altering diagnostic paradigms in those countries.



The article is titled “Prevalence and Characteristics of Undiagnosed Bipolar Disorders in Patients With a Major Depressive Episode” and was “designed, conducted and prepared” by Sanofi-Aventis. Sanofi-Aventis markets an atypical antipsychotic named Solian, which is the brand name of the drug amisulpride.  It is not FDA-approved in the United States, which is probably one reason why this study was done overseas.

The supposed "results" of the study:

“These results are from a large, 3-continent, culturally generalizable study conducted by practicing psychiatrists. The data indicate that, whereas with application of the DSM-IV-TR criteria, 16.1% of patients with Major Depressive Episodes met criteria for either bipolar I or bipolar II disorder, this rate rose to 47% with application of the bipolarity-specifier criteria.

These results suggest that bipolar features are more frequent in patients with MDE than indicated by DSM-IV-TR criteria. Almost half of the entire 5098 cohort presented the core symptoms of bipolarity (elevated mood, irritable mood, or increased activity), and these symptoms led to unequivocal changes in behavior that were observable by others in a similar proportion of patients.”

What this means is that, if this were true, half of patients who exhibit Major Depressive Episodes are actually bipolar and should  be taking “mood stabilizers.” Not lithium, I suppose, but antipsychotics. 

The article  goes on to state: “Major depressive disorder, the most common psychiatric illness, is often chronic and a major cause of disability. Many patients with major depressive episodes who have an underlying but unrecognized bipolar disorder receive pharmacologic treatment with ineffective regimens that do not include mood stabilizers.”

All of the "researchers" recruited received fees, on a per patient basis, from Sanofi-Aventis in recognition of their participation in the study. The key lead authors, all with significant Pharma connections, did not disclose their personal ties. Quite a transparent example of how cultural beliefs are manufactured, and how direct involvement with Pharma is normalised.

So what's wrong with the study?  Well that hinges on the meaning of the term "bipolarity specifier" that was added to the usual, DSM criteria for bipolar disorder.  This assumes that this additional test has been validated as being predictive of actual bipolar disorder, which is a "fact" not in evidence.  It sounds in the study as if this were an established and valid measure.

Here's the defintion:

“This bipolarity specifier attributes a diagnosis of bipolar disorder in patients who experienced an episode of elevated mood, an episode of irritable mood, or an episode of increased activity with at least 3 of the symptoms listed under Criterion B of the DSM-IV-TR associated with at least 1 of the 3 following consequences: (1) unequivocal and observable change in functioning uncharacteristic of the person’s usual behavior, (2) marked impairment in social or occupational functioning observable by others, or (3) requiring hospitalization or outpatient treatment. No minimum duration of symptoms was required and no exclusion criteria were applied.”

People sleeping less, talking more, and doing more. This is how mental illness is now being defined in psychiatry’s leading journal.

One of the dead giveaways that this article is bipolar diseases mongering is the sentence:
“No minimum duration of symptoms was required and no exclusion criteria were applied.”
This means that any person who has a suddenly angry, agitated, or elated response to an environmental trigger (like a big fight with a family member or winning the lottery) could be labeled bipolar.

This would also mean that if they had an episode of emotional dysregulation for the same reason, the reaction would be labeled a bipolar episode. This makes almost anyone who has borderline personality disorder suddenly bipolar.

23.2% of their subjects had experienced episodes of elevated or irritable mood triggered by antidepressants and were also defined as bipolar.  This is almost comical. Irritibility is a common side effect of drugs like prozac and has absolutely nothing to do with bipolar disorder (unless tranquilizers cure mania, because they sure do cure that side effect). This incredible nonsense is straight out of Hagop Akiskal’s dishonest playbook. I heard him say once that if someone who is depressed gets agitated on an SSRI, he just “knows” that person is bipolar.

The word bipolar, in the sense advocated by this piece-of-you-know-what study, is showing up in common discourse everywhere, particularly among young people describing their unpredictable and volatile classmates.  You can even hear the word in pop songs used as a synonym for moody (e.g. “Hot and Cold” by Katy Perry).

Someone... call the doctor
Got a case of love bi-polar

The drug companies have really done a masterful job in bastardizing the diagnosis of real bipolar disorder, which is a serious mental illness.  The harm to both the field and to patients alike has been staggeringly immense.

'Fess Up



In my blog post of June 2, 2010, Step Up to the Plate, I encouraged members of families plagued by repetitive troublesome interactions, as well as histories of domestic abuse and child abuse, to quit beating themselves up about it and do something to fix their family relationships in the present.  No matter how terrible what you did was, you can make things better for yourself and everyone else from this point in time forward. 

As I said in that post, "Hating yourself and/or feeling guilty about everything not only makes you miserable, it makes the rest of your family miserable as well, and can cause problematic, repetitive family behavior patterns to be passed down from one generation to another."

Nowhere is this more important than for parents who had physically, verbally, or sexually abused their children, or severely neglected them, when they were growing up.  You know who you are.  All the denial in the world will not change the fact that both you and the person or persons you abused know exactly what you did. 

Parents who push their adult children away through cruel or unpleasant behavior (because of a sense that their children are better off without them), not only punish themselves, but do their children no favors either. By the same token, trying to make your children hate you through constantly accusing them of lying or by minimizing the significance of what you did will not make them feel better, but far worse. It accomplishes nothing but making them feel invalid and almost subhuman.

And you know, down deep, how much you really want them to love you and forgive you. And your children really do, deep down, want to forgive you. Please let them.

'Fess up to what you did directly to them and stop making excuses. Tell them how sorry you are even if that seems to make them angry or if they refuse to accept your apology. Tell them that you would like them to forgive you but you know you may not deserve it and you will certainly understand if they feel they cannot do so.   

Try to explain to them the experiences that you had growing up that may have led you to do the foul deeds, but without using those explanations as a justification for your actions. There is no justification. Perhaps, in order to do this right, you will need a therapist to act as an arbiter between you and your adult children.

You always have three choices. First, you can deny what you did and continue to lie to everyone including yourself, but you will always know that it is true. Second, you can continually beat yourself up about it as if your shortcomings are written in stone and any harm you may have inflicted on your children is unforgivable and irreversible. The result of this course of self-damning action is continued guilt, which leads to more and more unpleasant feelings, which in turn lead to desperation, despair, and hopelessness.

Those two choices will not only make you feel worse, they will not help your children feel any better about you, your relationship with them, or their childhood. As I mentioned, it usually makes them feel much worse. If they have children themselves, the after-effects of what happened to them as children will continue to poison, in one way or another, their relationship with their own kids.

A much better course of action is to forgive yourself for your human frailties, learn from your mistakes so that you do not repeat them, and talk openly with your offspring as best you know how about what had happened and why you felt and acted the way that you did.

It's time to 'fess up. If you decide to do this, do not procrastinate. You might change your mind. There will never be a better time than right now. The transmission of dysfunctional family patterns from one generation to the next can be stopped.