Mother’s Little Helper

June 12th, 2011

There’s a gobsmacker of an article in the current New York Review of Books about the epidemic of mental illness that America is presently experiencing, or, to put it another way, the epidemic of pharmaceutical treatments for diagnosed mental disorders that America is presently financing.  It seems that the psychotropic medications we have been using in vast and ever-increasing quantities over the past fifty years, the antidepressants, antipsychotics, and antianxiety nostrums that have become the mainstay of psychiatric therapy, are no more effective than placebos.  In sum, we have been – surprise, surprise! – the victims of a massive fraud.  Moreover, the whole edifice of medical research, which rests on a foundational distinction between placebos and therapeutic agents, shows signs of crumbling.

Placebos are used when testing drugs for safety and effectiveness.  The drug is given to one group of people, and the placebo, a (supposedly) therapeutically inert substance, is given to a comparable group.  In standard “double blind” controlled tests, neither group of experimental subjects knows whether they are getting the drug or the placebo, nor do the persons administering the substances to them.  The idea is to promote objective measurement of the drug’s effects, if any, as compared to the placebo, by avoiding conscious and unconscious influences that might be caused by the subjects’ knowledge of what they are taking or the tester’s knowledge of what they are giving.

In order to be approved by the FDA for sale to the public, a drug must perform better than a placebo in double blind controlled studies.   The drug companies perform the studies and report the results to the FDA.  According to the NYReview article, if there are two positive studies, that is, two studies where the drug outperforms the placebo, that is, by having a better therapeutic effect than a substance which is assumed to have no therapeutic effect at all, the drug is considered effective.  Positive studies tend to get published, since it is in the drug companies’ interests to do so.  Negative studies, in the words of the article, “often languish unseen within the FDA, which regards them as proprietary and therefore confidential.  This practice greatly biases the medical literature, medical education and treatment decisions.”

The kicker is that when psychologist Irving Kirsch and his colleagues obtained copies of all the studies through the Freedom of Information Act, negative and positive ones alike, it turned out that, overall, the placebos were effective in almost as many cases as were the drugs, and the difference in degree of effect between the drugs and the placebos was so small as to be clinically meaningless.  But wait, there’s more.  Kirsch’s analysis of the data indicates that the reason for the already small difference in performance between the drugs and the placebos may be due to the fact that the drugs produced more side effects than the placebos, thus allowing the patients who received the drugs to perceive that they were getting a clinically active substance.   Yes, that’s right.  The drugs only appeared more effective, probably because they were benefiting from an enhanced “placebo effect”.  Data showed that when compared to a placebo that also produced side effects, antidepressants had no advantage at all!

This is not to say that antidepressants, antipsychotics, and antianxiety drugs don’t do anything.  Therapeutically, they’re about the same as “placebos.”  To put it another way, I don’t think that anyone could seriously question that our psychopharmacopia has had some positive effect.  Too many patients have experienced diminution of their symptoms for too long, for that to be in doubt.  What Kirsch’s research shows instead is that the supposed “drug effect” unique to each of the prescribed substances was actually something else, which had little if anything to do with the particular substance involved.  What we euphemistically call “side effects,” of course, are another matter.  The side effect indubitably goes with the medication.

Drug therapy for mental illness often involves a prolonged process of finding the “right” medication or combination of medications among the various alternatives, adjusting dosages up and down, changing medications when they stop working for some mysterious reason or because the side effects have become intolerable.  Kirsch’s research permits the speculation that this is less a process of making adjustments to the complex and dynamic biochemistry of the patient,  than it represents a three-way, ongoing negotiation among the therapist, the patient, and the disease.

As with most Americans, I have known people who were on antidepressants.  One interesting thing one of them told me was that the medication changed her behavior, but did not actually make her feel better. I could confirm from my own personal observation that her behaviour had changed for the better, and I was so grateful for this at the time that I didn’t think much about the other part.  Knowledgeable people have told me that this dichotomy, the patient acting better but still feeling terrible, is quite usual.  Now I wonder, if her antidepressant functioned just like a placebo, it might make sense that it touched the part of her illness that was more subject to control – her behavior.  Furthermore: the positive change in her behavior allowed her to re-establish and build upon the interpersonal connections that were the true basis of her recovery.  The drug did not cure her, but it helped open a space in which the healing could occur.

I wonder if another direction this research points, in addition to alerting us all to the massive fraud perpetrated on the public by the drug companies with the more-or-less passive collusion of the FDA and the willfully blinkered ignorance of the medical profession, is to cause us to re-examine the concept of “placebo.”  We can either abandon the notion that our psychopharmacology is effective, or we can accept that equally so are a whole range of substances that medicine has assumed to be psychopharmacologically inert.  It might be productive to say, there is no such thing as a “placebo,” at least not in this field of medicine.  Of course, to admit this would require medical science to devise a whole new research paradigm, and to proceed on the basis that all previous psychopharmacological research is valid only in that it has brought us to this point.

This entry was posted on Sunday, June 12th, 2011 at 4:02 pm and is filed under Medicine, society. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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