Physicians as Unwitting Research Subjects

"We'd like to invite you to join your colleagues and thought leaders in the field for a discussion concerning a new treatment for major depression."

This sounds like something that a busy physician, trying to keep up with the latest developments in the field, might really benefit from.  I continue to get invitations that sound just like this one.  The group sponsoring such discussion groups is not usually identified clearly in the invitation, but if it is mentioned the name usually contains words like "medical education."  Of course, the sponsor does not formally offer the kind of Continuing Medical Education most physicians require for keeping their medical licenses.

When I was a young and somewhat naive psychiatrist back in the early 1980's, I responded to one of these invitations to learn about a new antidepressant called Desyrel (generic name: trazodone).  This medicine is used today primarily in low doses (25 -  150 mg.) as a non-addictive sleep medication because many people find it extremely sedating.  The anti-depressant dose, rarely prescribed because many people taking it have trouble staying awake, is 400 to 600 mg per day.  Consequently, many doctors don't think it is an effective antidepressant because they never prescribe anywhere near that much.

Desyrel came out in the years before the SSRI antidepressants like Prozac and Paxil were on the market, and many docs were looking for alternatives to tricyclics like Elavil or imipramine, and MAO inhibitors like Nardil, since those medications often cause a lot of side effects and are also fatal if taken in overdose.  The real sponsor of the discussion group - the pharmaceutical company making Desyrel - was well aware of this and was looking for the best ways to take advantage of this situation in order to increase the number of prescriptions being written for its new drug. 

And not just by having doctors learn about the drug.

In fact, the real and covert reason for sponsering such discussion groups in the first place is to study physician behavior.  Of course, I did not know that at the time.  The drug companies were putting doctors under the microscope to determine the best ways of marketing their products.  They still do this, and they are very good at it.

Looking back, I remember the "leader" of the discussion asking the panel, "If I told you that Desyrel works much faster than tricyclics, would that be something that would be important to you?"  Since anti-depressants, when they work for Major Depressive Disorder, do not begin to kick in for about two weeks, and do not provide their full benefits until five to six weeks have elapsed, this would indeed be a fine selling point.

"Of course," most of the members of the now quite excited discussion group replied.

Since then, almost every new antidepressant, up to and including the latest one called Viibyrd, has made the claim that it has an earlier onset of action than all the others. 

For the record, none of them actually does.

The pharmaceutical industry shows particular interest in discussion group members who seem reluctant to endorse their new product.  These folks become objects of more intense study.  The group leaders probe these persons to find out exactly what might convince them to prescribe the new pill.  How can they best appeal to them?  Feed their ego in some way?  Preach patient convenience?  Which side effects are they most concerned about? 

The answers to these questions are not only used to develop overall strategies for pharmaceutical sales reps to use with reluctant prescribers, but are also used to compile information on individual physicians in the area, so sales reps can prepare themselves with a plan that is highly tailored to each physician. The plan is then used on the unsuspecting practitioner to help increase the number of prescriptions for their drug that that doctor writes.

The success of the reps is then monitored by the company by studying the prescribing practices of the given physician.  This information is readily available from local pharmacies unless the physician knows that he or she can opt out of allowing pharmacies to sell their information, as I described in a previous post.

WSJ Redux Lets Talk Research

I need to apologize right now for the length of this post. And maybe the topic. I really didn't intend to respond to Meghan Cox Gurdon's most recent opinion piece in the Wall Street Journal. I responded to her first one, and, in general, I am truly uninterested in debates in which the opposing parties repeat the same arguments, only louder.

But then I read the thing (and was asked about it on Twitter), and ... oh, she (sort of) cited some research:

There are real-world reasons for caution. For years, federal researchers could not understand why drug- and tobacco-prevention programs seemed to be associated with greater drug and tobacco use. It turned out that children, while grasping the idea that drugs were bad, also absorbed the meta-message that adults expected teens to take drugs. Well-intentioned messages, in other words, can have the unintended consequence of opening the door to expectations and behaviors that might otherwise remain closed.

Wow. That is a mighty strong claim. Allow me to unpack it for you. If you're wondering (I know I was, since she didn't cite any specific studies), I believe she's referring to research on Drug Abuse and Resistance Education (DARE) and a few similar programs.

A few bits of contextual information:

1. DARE is a zero-tolerance program that involves police officers teaching the anti-drug curriculum to kids--starting when they're in elementary school. Researchers' explanations of why DARE isn't effective include limited opportunity to practice social skills involved in drug refusal, as well as presenting material and concepts to kids who are too young to understand it (the Surgeon General's report is here).
2. Although Mrs. Gurdon makes it sound like prevention programs definitely lead to an increase in substance use in kids, and there are a few studies that found increased risk for substance use associated with DARE, the bulk of the evidence suggests DARE is mostly just ineffective. It has some positive effects that decay over time, and overall, results show that kids who've gone through the program are no less likely to use substances than kids who haven't had DARE.
3. Numerous other substance abuse prevention programs have been found to be effective, specifically, those that involve practicing social skills related to refusal, making the interventions developmentally appropriate, and dissemination of accurate information regarding social norms related to drug and alcohol use. If you're curious, go to this incredibly useful site and click "substance abuse prevention" to find a comprehensive listing of evidence-based programs.

This is your brain on YA.

That social norm bit up there is the link. In her attempt to support her point about YA books "normalizing" stuff like self-mutilation, drug use, killing reapers with Khopesh swords, and kissing vampires, I *think* Mrs. Gurdon is alluding to the research on social norms that indicates that, if you give people information about how their peers behave, they're more likely to conform to that standard. That's the social learning theory I mentioned in my response to her first opinion piece. And you know what? That shouldn't be dismissed. Peer pressure is not just a kid standing next to you, whispering "do it do it do it ..." If you believe everyone around you is doing something, you're more likely to do it, even if no one tells you to do it.

This is what fuels the bandwagon effect. It's real. If YA books make teens believe that nearly everybody's engaging in self-harm, that could be a problem. Perhaps we could actually do some research before we assume that's how teens think when they read a book like Cheryl Rainfield's SCARS, though?

In addition, Gurdon's argument about YA is strikingly narrow. It doesn't hold up for other mental illnesses, trauma, and membership in minority cultural/ethnic/sexual/gender-identity groups. Reading about someone with OCD won't give you OCD, for example. Reading about this stuff *might*, however, help you see individuals who are different from you as worthy of respect, kindness, and equality. But if her concern is that kids will understand that one in five of their classmates is struggling with a mental illness, or if it helps them avoid assumptions about the preferences and backgrounds of their peers, or if it helps them realize they're not the only one having those feelings ... er, wait. Is that a problem?

Please consider a few other things as well. First, inaccurate social norming is not the primary criticism of those substance abuse prevention programs. It's one of them, but note it's not the only one. My concern about Mrs. Gurdon's quote is that she seems to be saying that substance abuse prevention programs are BAD because adults are talking about these issues with kids, or, at least, providing them with information, and OMG THAT'S SO WRONG.

We have a decent amount of evidence to suggest that when adults take a ZERO-tolerance, highly restrictive approach to just about anything, kids are not going to automatically fall into line. There's research to show that using scare tactics to keep kids on the straight and narrow does NOT work. And--withholding information from kids might be harmful. That's certainly what one study seemed to indicate when it showed that kids who received abstinence-only sex education were just as likely to have sex as their peers--but they were less likely to use protection. That's in contrast to the kids who received comprehensive sex education (which includes abstinence). To read a review of research on both types of programs (from the Journal of Adolescent Health), go here.

Second, is the information kids get through music, video games, television programs, movies, and social networking sites the same as information delivered via literature? I'm not sure, but IF you were to do a survey of where and how kids get their information about self-mutilation, substance use, and sexual behaviors, my guess is ... it isn't from a YA book.

Third, and just for fun, the idea of books as therapeutic is far from new. And also: more time spent reading is associated with lower levels of depression (note I'm not claiming reading causes those lower levels, but interestingly, the opposite is true of time spent listening to music).

And finally, let me tell you, the mechanisms surrounding the emergence of mental illness in young people are complex, varied, and far more fundamental roots than the YA books kids read (for those who do read ...).

The big-bang-for-your-buck variables (apart from genetics)? Parenting. Social environment. Trauma.

Part of me sort of wants to scream WHY ARE WE WASTING TIME TALKING ABOUT THIS instead of supporting parents to really engage with their kids, become educated and empowered consumers of both research and literature, and make good decisions about how to guide their teens? How about we talk about how to get more teens to read? Oh, heck, why don't we all go and work on our WIPs?

Once again, I'm done. Your turn.

Did you bother to read Mrs. Gurdon's second opinion piece? Did you find it more convincing than the first? Are you swayed when people cite research results? How do you judge the accuracy of that information and whether it is being used appropriately? [If anyone's ever interested, I have tons of information on this subject and would be happy to do a blog post--I've taught a short course for mental health professionals on how to be smart consumers of research.]

Performance versus Ability Another Issue Frequently Ignored in Psychiatry Research

In previous posts, I have discussed some bizarre assumptions made in psychiatry research papers when the data is analyzed. I wrote about how, for example, differences in brain area size and functioning between different groups on fMRI scans are automatically interpreted as abnormalities.

Nassir Ghaemi, a blogger on Medscape with whom I have had some strong disagreements about borderline personality disorder and bipolar disorder, nonetheless had a great quote on this with which I wholeheartedly agree:
             

"All things biological are not disease, even though we can define disease in such a way that all diseases are biological. This matter is obvious once pointed out. A few assumptions,  which seem either patently true or very likely: all human psychological experience is mediated by the brain; each person only has one brain; therefore the brain will always be biologically changing as we have psychological experiences. Reading a blog post about the brain is a psychological experience. Having delusions from schizophrenia is a psychological experience. The first brain change does not reflect disease; the second does. So showing MRI changes with adult ADHD or borderline personality does nothing to demonstrate that those conditions are diseases. If you watch TV and play video games inordinately, you will have changes in your brain, and you might also develop clinical symptoms of ADHD. If you are repeatedly sexually abused, you will have changes in the brain, and you might also develop clinical symptoms of borderline personality. But those changes in the brain do not have the same causal role as the neuronal atrophy that happens with trisomy 21, or with schizophrenia, or bipolar illness..."

Another major nonsensical assumption that litters the psychiatric literature (the literature littering alliteration?) is that one can totally disregard the motivations of research subjects as well their past experiences and the environmental context in which they live when evaluating their performance on psychological tests. 

I mentioned an example of how this is utter nonsense in a previous post: The performance of African-Americans on IQ tests just might be related to the fact that for several generations Blacks who looked too smart were at high risk of being lynched. Do you think they are just as motivated as other folks to want to look smart on an IQ test which is being administered by White researchers?

What I have seen more and more lately, particular in the personality disorders literature, are studies that look at differences between various diagnostic groups on such issues as how much "impulsive aggression" they show, or how and how well they read the emotional state of ambiguous faces of strangers in photographs. When differences are found, once again the "lower" performing groups are just assumed to be "impaired" or "abnormal."

This, of course, confuses performance with ability. Without knowing anything about what the subjects in the experiments are motivated to do in their daily lives on any particular dimension for whatever reason, or what environmental contingencies they are worried about that may relate to the task at hand, it is literally impossible to say for sure whether any difference in their performance is related to what they would be able to do if those other issues were not operative.

Patients with borderline personality disorder, for example, grow up in families in which double messages are flying in all directions, and with parents who can switch from being over-involved to neglectful at the drop of hat. They are bound to have a higher index of suspicion about what facial expressions on strangers might mean than someone who grew up in a more consistent and predictable environment. If they did not, they would be morons.

Another major issue ignored in the literature is the difference between a research subject's real self versus their persona or false self in certain social situations. We all present different "faces" to the outside world depending on social context. Researchers who do not consider this must think that men, for example, present themselves exactly the same way around their children, their bosses, and their mistresses. Really?

With personality disorders, as I described in several previous posts, people play social roles designed to stabilize family homeostasis. These roles are merely a much more pervasive version of the different roles played by the above "normal" man interacting with different people. So someone with antisocial tendencies, for example, which are part of the role of avenger, are motivated to show more impulsive aggression than other people - on purpose - and have literally trained themselves to be like that. They do so habitually, automatically, and without thinking. Of course they will show more impulsive aggression in the experiment! Why wouldn't they? 

In fact, showing a lot of impulsive aggression might be considered to be part of the definition of antisocial behavior. The experiments therefore do nothing more than prove that anti-social people act habitually in an anti-social manner. Like, duh!

These types of results in no way indicate any "deficits," "deficiencies," or "abnormalities." One wonders how people who make these ludicrous assumptions ever manage to get through medical or graduate school.