Assuming Facts Not in Evidence II - Sleeping Medications


As I described in my post of January 31:

One marketing technique used by big Pharma to misleadphysicians is theengineering of a journey of ideas that have never been proven into the clinicallore as if they were established facts. So-called experts who are paid off by drug companies make presentationsat continuing medical education conferences or write "review"articles for medical newspapers or throwaway journals in which they mentionthese so-called "facts."

In these situations, conditional phrases are said or written as aquick aside in order to leave the speakers and writers a loophole just in casea member of the audience challenges them about overstating their case. Shouldthis happen, the speakers are then able to point to the conditional languagethey used and “remind” the audience that their use of this language indicatesthat they are not making spurious claims.  


Most of the time, however, noone in the audience will make such a challenge. The audience is left with adangling implication that the statement is an established fact. Thenon-discerning physician comes away with the “take home lesson” that theassertion is true.  Research has shown that most people only rememberone or two salient points from apaper or an oral presentation anyway.


I have alsowritten about how I suspect (but cannot prove), that drug companies begin toactively spread negative information and even disinformation about drugs as soon as most brand-named drugs ina certain class become available generically. As I wrote in my post of October 19, 2011:

Pharma-inspired or paid-off writers denigratehighly-effective drugs (antidepressants and benzodiazepines) that just happento have gone generic, in hopes that doctors will prescribe more expensive,potentially more toxic, and less effective brand-named drugs (particularlyatypical antipsychotics). 

It amazes me howdrug companies have only now been releasing negative information (that had apparently been held back from the public previously) aboutSSRI anti-depressants -since they have been available since the mid-1980’s.

I had seen thissort of thing done before to a class of drugs called benzodiazepines, which aredemonized as being far more addictive than they actually are.  Interestingly, this demonization of the drugsstarted anew with the introduction of three new sleeping medications (Ambien,Lunesta, and Sonata) that, although slightly different in chemical structurethan benzodiazepines, do exactly the same thing in the brain.  (Ambien has gone generic, but Pharma sells adelayed-release version that is still brand named.  As we shall see shortly, this type offormulation directly undermines one of their claims - that the new drugs are safer than the old ones).

Benzodiazepines include such popular drugs asValium, Librium, Klonopin, Ativan, Xanax, Dalmane, and Restoril.  Ambien, Lunesta, and Sonata  are technically not benzodiazepines, but theymight as well be.  They are called non-benzodiazepine benzodiazepine receptoragonists.  Loosely translated, thismeans that they affect the same nerve cells in exactly the same way as benzodiazepine benzodiazepine receptoragonists.   

They offer no advantage in terms of addictivepotential, side effects, or efficacy.  Infact, they offer some real disadvantages. They are far more likely than the old benzo’s to cause people to dothings in their sleep that they do not remember the next day, including cookinglarge meals and even driving significant distances!  Also, if you take Ambien and force yourselfto stay awake, you get really high.

As an aside, most of the public, and manyphysicians who should know better, believe that some benzodiazepines aretranquilizers, while others are sleeping pills. An old joke asks, “What is the difference between a tranquilizer and asleeping pill?”  The answer: marketing. 

Mostoutrageously, the drug companies successfully lobbied the government to havebenzodiazepines excluded from the Medicare drug benefit program – the onlymajor class of drug so excluded – while not excluding the new, more expensivebrand named sleepers!  This law hasfinally been changed to allow for the old drugs, but that change will not takeplace for some time.

Pharma shills havefanned out to convince everyone that the new drugs are both safer and moreeffective than the old ones.  Withsuccess. I frequently see physicians who seem to think that benzodiazepines arethe scourge of the earth due to their addictive potential prescribing the newdrugs with abandon (not to mention prescribing much more serious drugs of abuse such asstimulants).


Now, that the newdrugs are better and safer is one of the widely-disseminated “establishedfacts” that are not really facts at all. Again, I am going to pick on an article in the psychiatrist newspaper,the Psychiatric Times.  I do so reluctantly because this publication often prints more balanced articles, but lately it has been just feeding me blatant examples of points I’mtrying to make in this blog.


The article inquestion appeared in the January 2012 edition of the paper and was entitled,“Treatment of Insomnia in Anxiety Disorders.” It was written by Gregory Asnis, Elishka Caneva, and Margaret Henderson.


In discussingpharmacological treatment of insomnia, they say, and I quote, “Not only are thenon-benzodiazepines effective [that partis true], but there is a notion that they are safer than benzodiazepines.”  They give two reference here I will discussshortly.


A notion? Notice they are not actually saying here that the drugs are safer.  As I mentioned above, they do try toleave themselves an out.  However, theauthors go on to make a stronger statement: “Although head to head studiescomparing these classes of hypnotics have been minimal [If that’s true, than how can they draw conclusions], a recentmetanalysis supports the findings of reduced adverse effects for thenon-benzodiazepines.”  They give a thirdreference.


They explain thatthe new drugs have a shorter half-life, and therefore cause less residual daytimesedation, and “other  [unnamed] adverse effects."


Without evenlooking at the reference, they are already spouting complete bullsh*t here thatstrongly suggests that the new drugs are better.  So what about half-lives of the drug?  Half life is the number of hours it takes forthe body to excrete 50% of an ingested drug from the body.  In truth, the different old benzodiazepines onthe market have a wide variety of different half lives. 


Some of them such as Xanax have a very short or even shorter half life than the new drugs.   Some have a mid-range half life such as Tranxene. Some have a very long half life like Klonopinand Valium.  If daytime sedation is aproblem, the doctor can either reduce the dose, or prescribe a shorter actingdrug!  There is no need for the moreexpensive alternative.  If you take adelayed release preparation so you sleep through the night, then you would face just as much daytime sedation as if you took a benzo with a longer half life!


Not only that,but the shorter the half life of a sedative, the more addictive it is.  Furthermore,the shorter the half-life, the more the drugs are likely to cause “rebound”insomnia if suddenly discontinued. So, if the authors of this article are touting theimportance of short half lives, perhaps they should also mention these facts,which are well known among addictionologists. Funny that they did not, isn’t it?


So what about themeta-analysis?   I’m glad you asked, since I found it and read it.  It says quite clearly that, in the studies they are pooling, the drugs were analyzed irrespective of their differences inhalf life, potency (how the drugs compare in strength milligram to milligram)or dosages.  


There were noindications in direct comparisons indicating that the new drugs weresafer.  There were some “indirectcomparisons” (whatever those are) that were made that seemed to indicate thatthe new drugs were slightly safer, but again, since half life, potency anddosage were not considered, what the hell does that even mean?

Also noteworthyis that the studies meta-analyzed were in people who did not also have ananxiety disorder.

As for the othertwo “references,” one of them clearly attributes the results of studies that showedfewer side effects in the new drugs to their shorter half-lives.  The other never really clearly states thatthe new drugs are preferable to the old benzodiazepines at all, although italso discussed issues concerning drug half lives.

Let the buyerbeware, baby.

 
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