Words That Work in Deceptive Drug Company Advertising to Physicians

"It depends upon what the meaning of the word 'is' is." ~ Bill Clinton

I recently came across a rather humorous document from a legal action that was taken way back in 2008 against the drug company giant AstraZenica (AZ) in litigation over marketing issues with its antipsychotic drug, Seroquel (Quetiapine). I thought it would be fun to share with my readers.

It came from the United States District Court, Middle District of Florida, Orlando division in the matter of Seroquel products liability litigation, Case # 6:06-md-01769-ACC-DAB, on April 24, 2008.

It was a Q&A between a lawyer and the AZ executive who was involved in organizing the slides used in promotional talks given to physicians. It concerned the use of the term "unsurpassed" in slides used to market the drug.

Seroquel was one of the newer "atypical" antipsychotic medications. They were called that to distinguish them from the old, "typical" antipsychotics like Haldol. The old drugs were notorious for causing acute neurological side effects such as a Parkinson's disease-like tremors and muscle spasms (which can be easily countered with another class of drugs), as well as a long term one called tardive dyskinesia (TD) that could become permanent. 

To see what TD looks like, watch the Batman Movie The Dark Knight with Heath Ledger playing the Joker, who I guess was supposed to have been an ex mental patient, and was portrayed as having the mouth movements typical of TD.

The new '"atypical" drugs are much less likely to cause these neurological problems, but instead are far more likely to cause metabolic syndrome - weight gain, increased cholesterol, and even diabetes. (Recently released ones in the last few years are better on this score as well, but Seroquel is one of the worst offenders in this regard). Pick your poison. Atypicals have never been shown to be more effective than the typicals for the hallucinations and delusions characteristic of psychotic disorders.

In fact, AZ's own documents showed that the company analyzed 10 studies, and found that none of them showed that Seroquel was superior to any other antipsychotic drug.

So how did AZ spin this in its sales presentation to doctors? Their slides said the drug was "unsurpassed" in efficacy the treatment of schizophrenia. They found that this word was one that worked.

This is funny because there are two different definitions of "unsurpassed." The definition most people think of is "superior in achievement or excellence to any other." In other words, most people would think that the slide indicated that Seroquel was the most effective antipsychotic drug available.

The more literal definition, however, is "as good as or better than any other." This means that other drugs can be equally as good. Obviously, that wasn't the message that the slides were meant to convey to the doctors, but because the lesser known definition exists, this gave the company plausible deniability against the charge that it was making claims unsubstantiated by any research - even though that was the take home message most people would take home. Pretty sneaky!

The company man responded to questions about this with mental sommersaults, some of which - as my friend Peter Parry points out - are cringe-worthy. So here it is (minus some objections by the involved lawyers):

Q. Let me just read the conclusion to the jury and then ask you a question about it. "Conclusions. The intended claim of 'superiority versus Haloperidol' is highly unlikely using these data, however 'a claim of equivalence is not ruled out.' Did I read that correctly?

A. Yes, you did.

Q. Were you ever informed of that Technical Document No. 5 or its conclusions?

A. I have told you twice already no.

Q. Okay. Do you think you maybe should have been informed of this information before you Went around making claims of unsurpassed efficacy?

A. No, because I took my guidance from the head of clinical, the disclosure committee, and the SERM group. By the way, how is

equivalence different from unsurpassed?

Q. Do you really think you get to ask me questions? Is that what you think this process involves, that you get to ask me questions and I give you answers?

A: I'm trying to answer your question.

Q. Well, let me ask, since you asked me a question, let me ask you a

question: "Unsurpassed," "unsurpassed,"- what does that mean?

A. It means --

Q. Nobody is better; right?

A. It means equivalent.

Q. So if I really -- I'm trying to think of something. If I tell

somebody that I went to a track meet and I saw an athlete that has been

unsurpassed, I mean he was -- her, let's say her. Her ability to do the broad jump and the high jump and the relays were unsurpassed, and I was just so impressed and I go and tell you it was unsurpassed, you believe that means I'm saying she was equivalent to everybody else at the meet?

A. Possibly, yes. That's the correct grammar. Possibly, yes. She

was possibly better; she was possibly equivalent.

Q. And if I come home and --your child, you said, is 5 years old?

A. I have got two.

Q. How old are they? Mine are 22, 20, and 17. How old are yours?

A. 3 and 5.

Q. When your child comes home from school let's say from first grade

and says, "Daddy, I" -- well, I don't think first grade. And your child may be smart because you are smart. So let's just go to fifth grade. Go to

fifth grade. "Daddy, my grade in my English class was unsurpassed." What

are you going to say, "Congratulations.You made the same grade as everybody else"? Is that what you are telling this jury, is "unsurpassed" means the same?

A. Yes, it does, it means the same as or better. That's exactly what it means.

Q. So -- that's exactly what it means. So when AstraZeneca -- I'm glad to know this. This is interesting and I'm glad we're getting this out here. So when AstraZeneca made the claims of unsurpassed efficacy in regard to Seroquel, what they were meaning to say was, "We are just the same as everybody else"; is that right?

A. No, but I think we were incredibly careful with the use of grammar to depict what the clinical studies showed and concluded.

Q. You were trying to be tricky?

A. No. We were being incredibly precise and using the correct language. Of course, the language varied from country to country and label to label. The global impression from the safety and efficacy review group was our efficacy was unsurpassed.

Q. And you said in order to use that language, using your words, you were being incredibly careful; is that right?

A. No, I didn't. I said "incredibly precise."

Q. "Incredibly precise"; is that right?

A. Yes.

Q. All right. So if somebody understood the term "unsurpassed efficacy" to mean that you were better than others, they were just being incredibly what, dumb?

A. No. We would never make a claim without showing supporting documentation. So, for example, in the U.S., the doctor could read the label,he could read the FDA approval, and he could see the total span of facts.

Q. I'm not asking about the label and I'm not talking about the FDA

approval. I'm talking about what you've called at various points during this deposition a slogan or a phrase used in regard to Seroquel, and that was unsurpassed efficacy. Are you telling this jury honestly under oath that you were being so incredibly precise in the marketing of Seroquel that "unsurpassed efficacy" really meant that "We were the

same as everybody else"? Is that what you're telling this jury?

A. No. I'm saying that we chose that word to explain the fact that in the studies that we had done, our efficacy was unsurpassed when used in the right patients in the right dose in the right population. You can read a document like this without the context and it would be easy to be misunderstood about the total conclusion for what we say about Seroquel. 

Antipsychotics Are For Psychosis, Not Insomnia Redux



In my post of February 16 of this year, Antipsychotics Are For Psychosis, Not Insomnia, I reported on the increasing off-label (non FDA-approved) prescription of so-called atypical antipsychotic medication for insomnia and anxiety, despite the risk these drugs pose of causing metabolic syndrome (diabetes, obesity, and increased blood cholesterol and triglycerides [blood fats]) as well as an irreversible neurological problem called tardive dyskinesia. 

Somehow doctors - mostly primary practitioners but many psychiatrists as well - have been brainwashed into thinking that this risk is somehow much less than the risks posed by addiction from sedatives and hypnotics  - the old fashioned tranquilizers and sleeping pills. (Tranquilizers and sleeping pills are actually one and the same thing, by the way.  What's the difference?  Marketing.  Some of these drugs are marketed for sleep and some for anxiety, but they all do both of these things).

Anyway, a class of drugs called benzodiazepines are the most commonly used drugs indicated for insomnia and anxiety.  These include drugs like Valium, Librium, Ativan, Klonopin, Dalmane, Restoril, and Xanax.  They replaced the far more addictive and dangerous barbiturates several decades ago.

A newer (and of course much more expensive) group of drugs (Ambien, Lunesta and Sonata) were marketed as being "different" from the other benzodiazepines, so many doctors are much less afraid of prescribing them than the old drugs. 

In truth, these drugs work almost exactly the same way as the older benzo's.  They also cause sleepwalking. And they are every bit as addictive.  In fact, according to my prime source for all things concerning drug abuse, Rolling Stone magazine, the latest fad in D.C. is staying awake while on Ambien. Apparently, you can get really high if you do that. (Now that you know, please don't go out and do it!)

Of course, mild and moderate anxiety and insomnia can often be treated without any medication at all, but don't even get me started on that.

Actually, benzo's (with the possible exception of Xanax, which is very short acting), are not abused by themselves very much at all by addicts.  When was the last time you read a horror story in the news about valium addiction? It is also almost impossible to die from a benzo overdose if no other drugs are taken with them.

The drugs can create trouble, however, when they are combined with opiates - in which case one can overdose on the combination and die.  Unfortunately, this has been happening with increasing frequency lately.  But I digress.

Not only are benzo's by themselves pretty safe, but they have almost no side effects at all except in the elderly.  Compare their risks with the risks of atypical antipsychotics, and it is absolutely no contest at all.  Personally, if I had to choose, I would much prefer to be addicted to a benzo than be addicted to insulin shots!

Despite this obvious discrepancy in the risks, the problem of the misuse of prescriptions for antipsychotics by physicians to treat insomnia and anxiety continues to worsen.  In the September 2, 2011 issue of Psychiatric News, an American Psychiatric Association newspaper, there were two headlines side by side:  "Antipsychotics Increasingly Prescribed for Anxiety" and "Concern Raised Over Antipsychotic Use for Sleep Problems."

Even well known drug company apologist Charles Nemeroff was quoted as bemoaning the use of antipsychotics for anxiety disorders like panic disorder.

For insomnia, the biggest seller is the drug Seroquel (Quetiapine), which is second only to Zyprexa (Olanzepine) in causing metabolic syndrome.  Indeed, Seroquel is probably the most sedating atypical.  The article in the paper pointed out that a lot of physicians who prescribe this medication do not even bother to monitor the patient for increases in weight, blood sugar, and serum fats. 

The article about insomnia was prompted a large increase in prescriptions for this drug for insomnia in military personel.  According to the Department of Defense, in 2001 20-30 soldiers per ten thousand were treated for insomnia.  By 2009, the figure had soared to 226 per ten thousand. 57% of all prescriptions of Seroquel were for insomnia! 

Soldiers reported gaining an average of 6.3 pounds each on the drug.  Only 61% had a check of their blood sugar within six months of starting the medication.  Fortunately, no actual cases of diabetes were found.  The author of the study that generated these statistics agreed with my theory that these drugs were being used by physicians instead of benzo's because of fear of addiction.

That reasoning is a bit like the reasoning of people who will not fly in a commercial airplane for fear of a crash, but refuse to use seatbelts when they ride in a car.  These doctors apparently are completely clueless when it comes to evaluating relative risks.

Psychiatric Drugs

Some people who read my blog may get the wrong idea about where I stand on the issue of the use of psychiatric medications, so I want to make something perfectly clear: I am an advocate of the proper use of psychiatric medications, and I think that when used correctly, they are highly effective. I prescribe them to almost all of the patients I treat, including my psychotherapy patients. If fact, my patients who exhibit signs and symptoms of borderline personality disorder would not be able to engage in the type of therapy I do if their high emotional reactivity were not partially controlled on meds.

I even prescribe atypical antipsychotics, even though they can have toxic side effects. I monitor my psychotic patients' for the emergence of metabolic syndrome by checking their blood sugar, cholesterol, and triglycerides (fat). I watch them closely for the emergence of tardive dyskinesia, a neurological side effect that may emerge after long-term treatment with antipsychotic medications. (If you saw the movie "The Dark Knight," Heath Ledger's Joker character's mouth movements look a lot like this syndrome).

Without antipsychotics, many more patients would be living out on the street in cardboard boxes. Additionally, sometimes the atypicals are the only medications that stop certain patients with borderline personality disorder from severely mutilating themselves. They are not my first choice for that, but they are sometimes necessary.

On the basis of my obvious disgust with pharmaceutical companies' disease mongering and the sloppy use of diagnostic terms by many psychiatrists, I hope no one lumps me together in the same camp as Peter Breggin or Robert Whitaker, who grossly exaggerate the dangers of psychiatric medication and distort the studies in a fashion precisely opposite to the way the drug companies do. Nor I am a fan of Tom Ssazz or R.D. Liang, who think that there is no such thing as a psychiatric disease.

BTW, Dan Carlat posted on his blog an excellent description of PhARMA disease mongering by Adriane Fugh-Berman, available at http://bostonreview.net/BR35.3/fugh-berman.php.

One of the drug company strategies that is not described in this article is to label their critics as members of Scientology. Just so you know for certain, I think the idea that mental illness is caused by a volcano god (Xenu) and space aliens (body thetans) is just a wee bit ludicrous, and that Scientology is a dangerous cult. I remember when I was a resident receiving a mailing from them asking me to come and confess my sins. Clever.

I find that doctors who buy into disease mongering are usually well-meaning but incompetent. Some, however, are predators. On an earlier post, I mentioned something called sensory integration dysfunction. I said it was a "mysterious illness" which might have caused confusion to some readers. This "dysfunction" is not recognized as a disorder by the DSM or the International Classification of Diseases, and its descriptions in the literature are highly dubious. There are no adults who are diagnosed with it. Even if it does exist as a syndrome, it is could easily be something that is due to other factors like anxiety. Yet there are doctors who prescribe expensive "treatments" for it to the children of unsuspecting and naive parents. This is shameful.