The Big Lie and Pharmaceutical Marketing

Yet in actuality this was yet another repetition of the same old big lie technique.  Looking at the abstract of the article more closely, the conclusion was a little different: that the results of a symptom rating instrument, the Young Rating Mania Scale (YMRS), showed this, not a complete and comprehensive diagnostic evaluation of the subjects in question: “In age-grouped YMRS item assessments of bipolar mania, anger dyscontrol was most prominent for youth, whereas disordered thought content was paramount for adults.”

Notice how the authors cannot be accused of lying, since this is in fact what their study actually showed.  The “take home message,” however, is that this means that these symptoms are in fact valid symptoms of bipolar disorder in kids.

So let’s take a closer look at the study and the YMRS.  The study was based on a review of the literature describing several other studies, and the other studies that were chosen for review were “… studies reporting age group differences in total YMRS scores that included individual baseline item scores.”  So this study reviewed other studies that used what I will soon show is a highly suspect test. 

Symptom rating instruments like the YMRS are meant for two purposes: 

1. To be screen out patients who for sure do NOT have the diagnosis and make sure that anyone who might have the diagnosis is included for evaluation. In other words, the tests are designed to have a lot of false positives, that is, people who score positively on the test but do not in fact, have the disorder.

The authors of this review clearly know that the YMRS is a screening instrument:  “These outpatient studies required a minimum YMRS total baseline score of 20 for inclusion and achieved total baseline YMRS scores of 28 to 33 indicating at least moderate manic symptoms [20,22,23,25]. In these clinical trials sponsored by industry, trained raters did the YMRS item scoring at baseline. The subjects who met full research criteria for mania were subsequently randomized into placebo and medication treatment groups.”

2.  To measure changes in symptoms over time in patients who have already been diagnosed correctly by other means. The other means that are used usually consist of research diagnostic clinical interviews, but we have no way of knowing how well the clinical interviews were done – particularly whether the duration and pervasiveness criteria of the symptoms were applied correctly, since this is frequently not done by drug company shills. 

But even using a symptom rating scale to measure changes in symptoms is frought with difficulty, particularly in the case of the YMRS, which completely ignores the issue of symptom pervasiveness and duration.

The problem with tests that ask patients to rate their own symptoms was described succinctly by one patient, who purportedly said about a psychiatrist who used a self report question as the entire basis for prescribing drugs, “The question is always the same. He asks me, ‘On a scale of 1 to 10, rate your mood.’ I answer, but you know, in 6 hours I might have a different answer.”   

Many of these rating scales uses what is called a Likert Scale.  Likert Scales generally ask a patient or a researcher to rate the severity of a given symptom on a 4 to 7 point scale.  A big issue with Likert Scales in self-report instruments is that when they ask whether a symptom is mild or severe is that they do not indicate the answer to the question, compared to what?  Compared to a patient with a clinical disorder, or compared to the symptoms as they have been experienced by the patients themselves?  When someone is very sad but has never been clinically depressed, he might rate the sadness as severe.  Having perhaps never seen another person with a severe clinical depression, he has no external reference point that would distinguish a normal mood from a highly abnormal mood.

Now for the YMRS. The YMRS asks a clinician to rate the patient’s symptom based on what the patient looks like or says at the time of the interview. Let’s look at item number 5 on the YMRS scale, irritibility.  The interviewer is asked to rate it on a 5 point scale based on observations during administration of the test.  0 = absent, 1 = subjectively increased, 2 = irritable at times dring the interview, or recent episodes of anger or annoyance on the ward, 3 = frequently irritable during the interview: short, curt throughout, and 4 = hostile, uncooperative, interview impossible.

Notice that there is no requirement than an effort be made to find out why the patient presents with irritability during the interview.  It just assumes that it is due to the underlying mania.  But how long has it been going on?  Just today?  How do we know the patient is not acting irritable because he had been having a really bad day, or because the interviewer was perceived as condescending? We don’t.  

Or take item #6, rate and amount of speech.  Manic patients have what we called pressured speech – they talk and talk and no one can get a word in edgewise.  This is present regardless of external circumstances.  If a patient exhibits very fast speech in the YMRS interview, on the other hand, the symptom could conceivably be present because the patient is in a big hurry to leave on that particular day, but characterologically likes to make sure the doctor gets a very precise answer with all its myriad details to any question.  

Without this additional information, the answers to the questions are meaningless!  In children, aggression and irritability have hundreds of potential causes besides their supposedly being symptoms of bipolar disorder.

But the mantra that they are indeed symptoms of bipolar disorder in children is once again subtly repeated.  Over and over and over again: the big lie technique in operation.

2012-08-07 06:45:37

Source: http://davidmallenmd.blogspot.com/2012/08/the-big-lie-and-pharmaceutical-marketing.html