“Dollars For Docs” – What It Really Means

September 25, 2011

A few weeks ago I received an invitation to an October 1 symposium on Latuda, a new antipsychotic from Sunovion (formerly known as Sepracor).  Latuda (lurasidone) was released about six months ago amidst much fanfare—and very aggressive marketing—as a new atypical antipsychotic with, among other advantages, pro-cognitive properties.

I have only prescribed Latuda to three patients, so I have only limited experience with it.  (In case you’re wondering:  one success, one failure, one equivocal.)  However, I have read several papers about Latuda, and I am interested in learning more about it.  The symposium’s plenary speaker is Stephen Stahl from the Neuroscience Education Institute.  Dr Stahl has received money from Sunovion (which is obvious from his publications and disclosures) but he is also a very knowledgeable neuroscientist.  I figured he would be able to describe the differences between Latuda and the other atypical antipsychotics currently on the market.  So I accepted the invitation.

However, upon further thought, I wondered whether my attendance might represent a “payment” from the Sunovion Corporation.  I was not offered any money from Sunovion to attend this event (in fact, you can see my invitation here: page1, page2).  Nevertheless, according to the Physician Payment Sunshine Act, which was passed as part of PPACA (i.e., “Obamacare”), all pharmaceutical companies and medical device manufacturers, as of 2013, are required to report payments to physicians, including direct compensation as well as “food, entertainment, research funding, education or conference funding,” and so forth.

Despite the mandatory 2013 reporting date, several companies have already started reporting.  Other major drug firms to self-report thus far include AstraZeneca, Eli Lilly, Merck, and Pfizer.  Their reports have been widely publicized at sites such as “Dollars For Docs,” which “allows the public to search for individual physicians to see whether they’ve been on pharma’s payroll.”  Several other sites encourage patients to use this site to ask “Does your doc get money from drug companies?”

A quick search of my own name reveals that I received $306 from Pfizer in the year 2010.  Wow!  I had no idea!  What exactly does this mean?  Am I a Pfizer slave?  Did my Pfizer rep walk up to me on 12/31/10, hand me a personal check for $306 and say, “Thank you, Dr. Balt, for prescribing Geodon and Pristiq this year—here’s $306 for your work, and we look forward to more in 2011”?

The answer is no.  I received no money from Pfizer (and, to be frank, I didn’t prescribe any Pristiq last year, because it’s essentially Effexor).  As it happens, during 2010 I worked part-time at a community mental health clinic.  The clinic permitted drug reps to come to the office, bring lunch, and distribute information about their products.  We had lunches 1-2 days out of the week, consisting of modest fare:  Panera sandwiches, trays of Chinese food, or barbecued ribs.  Most of the doctors didn’t have time to eat—or if we did, we scarfed it down in between patients—but we would often talk to the reps, ask questions about their drugs, and accept product literature (which virtually always went straight into the trash), reprints, and educational materials from them.

We were visited by most of the major drug companies in 2010.  (BTW, this continued into 2011, but we are no longer allowed—under our contract with the County mental health department—to accept free samples, and we no longer accept lunches.  Interestingly, my Pfizer rep told us that payments would be reported only as of 1/1/11 and NOT earlier; obviously that was untrue.)  All of the lunches were generally the same, and consisted of inexpensive, modest food, mainly consumed by the clinic staff—secretaries, administrators, assistants—since the doctors were actually working through the lunch hour.  I have since learned that the formula for calculating doctors’ payouts was to take the full cost of the lunch (including all staff members, remember), divide it by the number of doctors in the office, and report that sum.   That’s where you get my $306.00.

[In the interest of full disclosure, in my four years of practice post-residency, I have only been offered one “material” non-food gift: about three years ago, Janssen gave me a $100 voucher for a textbook; I used it to purchase Glen Gabbard’s psychodynamic psychotherapy text.]

Anyway, back to the Latuda symposium.  Knowing what I now know about drug companies, I wouldn’t be surprised if Sunovion reports a $1000+ payout to me if I attend this half-day symposium.  (Facility rental + A/V costs + Xeroxing/handouts + coffee service + refreshments, all divided by the # of docs in attendance.)  I frankly don’t want my future patients searching my name on Dollars For Docs and finding I received a huge “payment” from Sunovion in Q3 2011.  On the other hand, I would like to learn more about Latuda and whether/how it differs from other antipsychotics on the market (including generic first-generation agents).  If possible, I would also like to question Steve Stahl directly about some of what he’s written about this drug (including his Sunovion-funded articles).  What better forum to do this than in a public symposium??

[Note: please see ADDENDUM below.]  I have contacted two different Sunovion sales reps to ask whether my attendance will be “reported” as a payment, and if so, how much.  I have not received a response.  I also called the RSVP number for the symposium.  The registration is being managed by Arbor Scientia, a medical communications company contracted by Sunovion to manage these events.  I was directed to Heather of Arbor Scientia; I left her a message but have not yet received a return call.

So at this point, I am looking forward to attending an event to learn more about a new drug—and the opportunity to challenge the experts on the advantages (if any) of this drug over others—but in doing so, I might also be reported as having “received” a large payment from Sunovion, perhaps even larger than what Pfizer reported they paid me in 2010.

Patients should recognize that sometimes the only way for their doctors to learn about new drugs is to attend such events (assuming they can remain objective, which can be hard when the wine is freely flowing!).  Admittedly, there are doctors who accept much larger sums as speakers or “key opinion leaders,” but organizations like ProPublica should differentiate those doctors (with whom I, personally, have an ethical gripe) from those who are simply workaday folks like me who want to get as much information as they can, provide effective and cost-efficient care—and maybe inhale a free sandwich every once in a while.

ADDENDUM Sept. 26:  Today I received a phone call from Arbor Scientia (from a number that is actually registered as NEI’s main number—as it turns out, they are located in the same building) to assure me that Sunovion adheres to the Physician’s Sunshine Act provision: namely, that they’ll report “payments” to doctors only after January 1, 2012.  (See also here.)  Interestingly, my local Sunovion rep had told me 1/1/11.  (This is only somewhat reassuring: my Pfizer rep had told me they would start reporting as of 1/1/11, but clearly my “payments” from 2010 were reported.)

50 Comments | antipsychotics, community mental health, marketing, psychopharmacology | Tagged: , , , , | Permalink
Posted by stevebMD

Rosenhan Redux

September 20, 2011

“If sanity and insanity exist, how shall we know them?”

Those are the opening words of a classic paper in the history of psychology, David Rosenhan’s famous “pseudopatient” study (pdf), published in the prestigious journal Science in 1973.  In his experiment, Rosenhan and seven other people—none of whom had a mental illness—went to 12 different hospitals and complained of “hearing voices.”  They explained to hospital staff that the voices said “empty,” “hollow,” and “thud.”  They reported no other symptoms.

Surprisingly, all patients were admitted.  And even though, upon admission, they denied hearing voices any longer, they all received antipsychotic medication (Rosenhan had instructed his pseudopatients to “cheek” their meds and spit them out later) and were hospitalized for anywhere from 7 to 52 days (average = 19 days).  They behaved normally, yet all of their behaviors—for example, writing notes in a notebook—were interpreted by staff as manifestations of their disease.  All were discharged with a diagnosis of “schizophrenia in remission.”

Rosenhan’s experiment was a landmark study not only for its elegance and simplicity, but for its remarkable conclusions.  Specifically, that psychiatric diagnosis often rests solely upon a patient’s words, and, conversely, that “the normal are not detectably sane.”

Would a similar experiment performed today yield different results?  Personally, I think not.  (Well, actually, admission to a psychiatric hospital these days is determined more by the availability of beds, a patient’s insurance status, and the patient’s imminent dangerousness to self or others, than by the severity or persistence of the symptoms a patient reports, so maybe we’d be a bit less likely to admit these folks.)  At any rate, I’m not so sure that our diagnostic tools are any better today, nearly 40 years later.

In a very controversial book, Opening Skinner’s Box, published in 2003, journalist Lauren Slater claimed to have replicated Rosenhan’s study by visiting nine psychiatric emergency rooms and reporting a single symptom: hearing the word “thud.”  She wrote that “almost every time” she was given a diagnosis of psychotic depression and was prescribed a total of 60 antidepressants and 25 antipsychotics (that’s an average of 9.4 medications per visit!).  But her report was widely criticized by the scientific community, and Slater even confessed in the November 2005 Journal of Nervous and Mental Disease, that “I never did such a study: it simply does not exist.”

While I’m deeply disturbed by the dishonesty exhibited by Slater, whose words had great power to change the public perception of psychiatry (and I am offended, as a professional, by the attitude she demonstrated in her response to her critics… BTW, if you want a copy of her response—for entertainment purposes only, of course—email me), I think she may have been onto something.  In fact, I would invite Slater to repeat her study.  For real, this time.

Here’s what I would like Slater to do.  Instead of visiting psychiatric ERs, I invite her to schedule appointments with a number of outpatient psychiatrists.  I would encourage her to cast a wide net:  private, cash-only practices; clinics in academic medical centers; community mental health clinics; and, if accessible, VA and HMO psychiatrists.  Perhaps she can visit a few family practice docs or internists, for good measure.

When she arrives for her appointment, she should report one of the following chief complaints:  “I feel depressed.”  “I’m under too much stress.”  “I see shadows out of the corner of my eyes sometimes.”  “My mood is constantly going from one extreme to the other, like one minute I’m okay, the next minute I’m all hyper.”  “My nerves are shot.” “I feel like lashing out at people sometimes.”  “I can’t pay attention at work [or school].” “I sometimes drink [or use drugs] to feel better.”  Or anything similar.

She will most certainly be asked some follow-up questions.  Maybe some family history.  Maybe a mental status exam.  She will, most likely, be asked whether she’s suicidal or whether she hears voices.  I encourage her to respond honestly, sticking to her initial, vague, symptom, but without reporting anything else significant.

In the vast majority of cases, she will probably receive a diagnosis, most likely an “NOS” diagnosis (NOS = “not otherwise specified,” or psychiatric shorthand for “well, it’s sort of like this disorder, but I’m not sure”).  She is also likely to be offered a prescription.  Depending on her chief complaint, it may be an antidepressant, an atypical antipsychotic, or a benzodiazepine.

I don’t encourage otherwise healthy people to play games with psychiatrists, and I don’t promote dishonesty in the examination room.  I also don’t mean to suggest that all psychiatrists arrive at diagnoses from a single statement.  But the reality is that in many practice settings, the tendency is to make a diagnosis and prescribe a drug, even if the doctor is unconvinced of the seriousness of the patient’s reported symptoms.  Sometimes the clinic can’t bill for the service without a diagnosis code, or the psychiatrist can’t keep seeing a patient unless he or she is prescribing medication.  There’s also the liability that comes with potentially “missing” a diagnosis, even if everything else seems normal.

And on the patient’s side, too, the forces are often in favor of receiving a diagnosis.  Sure, there are some patients who report symptoms solely because they seek a Xanax Rx or their Seroquel fix, and other patients who are trying to strengthen a disability case.  But an even greater number of patients are frustrated by very real stressors in their lives and/or just trying to make sense out of difficult situations in which they find themselves.  For many, it’s a relief to know that one’s troubles can be explained by a psychiatric diagnosis, and that a medication might make at least some aspect of their lives a little easier.

As Rosenhan demonstrated, doctors (and patients, often) see things through lenses that are colored by the diagnostic paradigm.  In today’s era, that’s the DSM-IV.  But even more so today than in 1973, other factors—like the pharmaceutical industry, the realities of insurance billing, shorter appointment times, and electronic medical records—all encourage us to read much more into a patient’s words and draw conclusions much more rapidly than might be appropriate.  It’s just as nonsensical as it was 40 years ago, but, unfortunately, it’s the way psychiatry works.

19 Comments | Uncategorized | Permalink
Posted by stevebMD

How Abilify Works, And Why It Matters

September 13, 2011

One lament of many in the mental health profession (psychiatrists and pharmascolds alike) is that we really don’t know enough about how our drugs work.  Sure, we have hypothetical mechanisms, like serotonin reuptake inhibition or NMDA receptor antagonism, which we can observe in a cell culture dish or (sometimes) in a PET study, but how these mechanisms translate into therapeutic effect remains essentially unknown.

As a clinician, I have noticed certain medications being used more frequently over the past few years.  One of these is Abilify (aripiprazole).  I’ve used Abilify for its approved indications—psychosis, acute mania, maintenance treatment of bipolar disorder, and adjunctive treatment of depression.  It frequently (but not always) works.  But I’ve also seen Abilify prescribed for a panoply of off-label indications: “anxiety,” “obsessive-compulsive behavior,” “anger,” “irritability,” and so forth.  Can one medication really do so much?  And if so, what does this say about psychiatry?

From a patient’s perspective, the Abilify phenomenon might best be explained by what it does not do.  If you ask patients, they’ll say that—in general—they tolerate Abilify better than other atypical antipsychotics.  It’s not as sedating as Seroquel, it doesn’t cause the same degree of weight gain as Zyprexa, and the risk of contracting uncomfortable movement disorders or elevated prolactin is lower than that of Risperdal.  To be sure, many people do experience side effects of Abilify, but as far as I can tell, it’s an acceptable drug to most people who take it.

Abilify is a unique pharmacological animal.  Like other atypical antipsychotics, it binds to several different neurotransmitter receptors; this “signature” theoretically accounts for its therapeutic efficacy and side effect profile.  But unlike others in its class, it doesn’t block dopamine (specifically, dopamine D2) or serotonin (specifically, 5-HT1A) receptors.  Rather, it’s a partial agonist at those receptors.  It can activate those receptors, but not to the full biological effect.  In lay terms, then, it can both enhance dopamine and serotonin signaling where those transmitters are deficient, and inhibit signaling where they’re in excess.

Admittedly, that’s a crude oversimplification of Abilify’s effects, and an inadequate description of how a “partial agonist” works.  Nevertheless, it’s the convenient shorthand that most psychiatrists carry around in their heads:  with respect to dopamine and serotonin (the two neurotransmitters which, at least in the current vernacular, are responsible for a significant proportion of pathological behavior and psychiatric symptomatology), Abilify is not an all-or-none drug.  It’s not an on-off switch. It’s more of a “stabilizer,” or, in the words of Stephen Stahl, a “Goldilocks drug.”

Thus, Abilify can be seen, at the same time, as both an antipsychotic, and not an antipsychotic.  It’s both an antidepressant, and not an antidepressant.  And when you have a drug that is (a) generally well tolerated, (b) seems to work by “stabilizing” two neurotransmitter systems, and (c) resists conventional classification in this way, it opens the floodgates for all sorts of potential uses in psychiatry.

Consider the following conditions, all of which are subjects of Abilify clinical trials currently in progress (thanks to clinicaltrials.gov):  psychotic depression; alcohol dependence; “aggression”; improvement of insulin sensitivity; antipsychotic-induced hyperprolactinemia; cocaine dependence; Tourette’s disorder; postpartum depression; methamphetamine dependence; obsessive-compulsive disorder (OCD); late-life bipolar disorder; post-traumatic stress disorder (PTSD); cognitive deficits in schizophrenia; alcohol dependence; autism spectrum disorders; fragile X syndrome; tardive dyskinesia; “subsyndromal bipolar disorder” (whatever that is) in children; conduct disorder; ADHD; prodromal schizophrenia; “refractory anxiety”; psychosis in Parkinson’s disease; anorexia nervosa; substance-induced psychosis; prodromal schizophrenia; trichotillomania; and Alzheimers-related psychosis.

Remember, these are the existing clinical trials of Abilify.  Each one has earned IRB approval and funding support.  In other words, they’re not simply the fantasies of a few rogue psychiatrists; they’re supported by at least some preliminary evidence, or at least a very plausible hypothesis.  The conclusion one might draw from this is that Abilify is truly a wonder drug, showing promise in nearly all of the conditions we treat as psychiatrists.  We’ll have to wait for the clinical trial results, but what we can say at this point is that a drug which works as a “stabilizer” of two very important neurotransmitter systems can be postulated to work in virtually any way a psychopharmalogist might want.

But even if these trials are negative, my prediction is that this won’t stop doctors from prescribing Abilify for each of the above conditions.  Why?  Because the mechanism of Abilify allows for such elegant explanations of pathology (“we need to tune down the dopamine signal to get rid of those flashbacks” or “the serotonin 1A effect might help with your anxiety” – yes, I’ve heard both of these in the last week), that it would be anathema, at least to current psychiatric practice, not to use it in this regard.

This fact alone should lead us to ask what this says about psychiatry as a whole.  The fact that one drug is prescribed so widely—owing to its relatively nonspecific effects and a good deal of creative psychopharmacology on the part of doctors like me—and is so broadly accepted by patients, should call into question our hypotheses about the pathophysiology of mental illness, and how psychiatric disorders are distinguished from one another.  It should challenge our theories of neurotransmitters and receptors and how their interactions underlie specific symptoms.  And it should give us reason to question whether the “stories” we tell ourselves and our patients carry more weight than the medications we prescribe.

165 Comments | antipsychotics, medications, psychopharmacology | Tagged: , , , | Permalink
Posted by stevebMD

How To Retire At Age 27

September 4, 2011

A doctor’s primary responsibility is to heal, and all of our efforts and resources should be devoted to that goal.  At times, it is impossible to restore a patient to perfect health and he or she must unfortunately deal with some degree of chronic disability.  Still other times, though, the line between “perfect health” and “disability” is blurred, and nowhere (in my opinion) is this more problematic than in psychiatry.

To illustrate, consider the following example from my practice:

Keisha (not her real name), a 27 year-old resident of a particularly impoverished and crime-ridden section of a large city, came to my office for a psychiatric intake appointment.  I reviewed her intake questionnaire; under the question “Why are you seeking help at this time?” she wrote: “bipolar schizophrenia depression mood swings bad anxiety ADHD panic attacks.”  Under “past medications,” she listed six different psychiatric drugs (from several different categories).  She had never been hospitalized.

When I first saw her, she appeared overweight but otherwise in no distress.  An interview revealed no obvious thought disorder, no evidence of hallucinations or delusions, nor did she complain of significant mood symptoms.  During the interview, she told me, “I just got my SSDI so I’m retired now.”  I asked her to elaborate.  “I’m retired now,” she said.  “I get my check every month, I just have to keep seeing a doctor.”  When I asked why she’s on disability, she replied, “I don’t know, whatever they wrote, bipolar, mood swings, panic attacks, stuff like that.”  She had been off medications for over two months (with no apparent symptoms); she said she really “didn’t notice” any effect of the drugs, except the Valium 20 mg per day, which “helped me settle down and relax.”

Keisha is a generally healthy 27 year-old.  She graduated high school (something rare in this community, actually) and took some nursing-assistant classes at a local vocational school.  She dropped out, however, because “I got stressed out.”  She tried looking for other work but then found out from a family member that she could “apply for disability.”  She applied and was denied, but then called a lawyer who specialized in disability appeals and, after about a year of resubmissions, received the good news that she can get Social Security Disability, ensuring a monthly check.

How is Keisha “disabled”?  She’s disabled because she went to see a doctor and, presumably, told that doctor that she can’t work because of “stress.”  That doctor probably asked her a series of questions like “are you unable to work because of your depressed mood?”, “Do you find it hard to deal in social situations because of your mood swings?” etc., and she answered them in the affirmative.  I’ve seen dozens—if not hundreds—of disability questionnaires, which ask the same questions.

I have no doubt that Keisha lives a stressful life.  I’ve driven through her part of town.  I’ve read about the turf wars being waged by the gangs there.  I know that her city has one of the highest murder rates in America, unemployment is high, schools are bad, and drug abuse and criminal activity are widespread.  I would be surprised if anyone from her neighborhood was not anxious, depressed, moody, irritable, or paranoid.

But I am not convinced that Keisha has a mental illness.

Lest you think that I don’t care about Keisha’s plight, I do.  Keisha may very well be struggling, but whether this is “major depression,” a true “anxiety disorder,” or simply a reaction to her stressful situation is unclear.  Unfortunately, psychiatry uses simple questions to arrive at a diagnosis—and there are no objective tests for mental illness—so a careless (or unscrupulous) provider can easily apply a label, designating Keisha’s situation as a legitimate medical problem.  When combined with the law firms eager to help people get “the government money they deserve,” and the very real fact that money and housing actually do help people like Keisha, we’ve created the illusion that mental illness is a direct consequence of poverty, and the way to treat it is to give out monthly checks.

As a physician, I see this as counter-therapeutic for a number of reasons.  With patients like Keisha, I often wonder, what exactly am I “treating”?  What constitutes success?  An improvement in symptoms?  (What symptoms?)  Or successfully getting her on the government dole?  And when a patient comes to me, already on disability after receiving a diagnosis of MDD (296.34) or panic disorder (300.21) from some other doctor or clinic, I can’t just say, “I’m sorry about your situation, but let’s see what we can do to overcome it together,” because there’s no incentive to overcome it.  (This is from someone who dealt with severe 307.51 for sixteen years, but who also had the promise of a bright future to help overcome it.)

Moreover, making diagnoses where there is no true pathology artificially inflates disease prevalence, further enlarging state and county mental health bureaucracies.  It enables massive over-prescription of expensive (e.g., atypical antipsychotics like Seroquel and Zyprexa), addictive (like stimulants and benzodiazepines), or simply ineffective (like SSRIs) medications.  And far from helping the downtrodden who claim to be its “victims,” this situation instead rewards drug companies and doctors, some of whom prefer serving this population because of the assembly-line nature of this sort of practice:  see the patient, make the diagnosis, write the script, and see them again in 3-6 months.

The bottom line is, here in America we’ve got thousands (perhaps millions?) of able-bodied people who, for one socioeconomic (i.e., not psychiatric) reason or another, can’t find work and have fallen upon psychiatric “disability” as their savior.  I’d love to help them, but, almost by definition, I cannot.  And neither can any other doctor.  Sure, they struggle and suffer, but their suffering is relieved by a steady job, financial support, and yes, direct government assistance.  These are not part of the psychiatric armamentarium.  It’s not medicine.

Psychiatry should not be a tool for social justice.  (We’ve tried that before.  It failed.)  Using psychiatric labels to help patients obtain taxpayers’ money, unless absolutely necessary and legitimate, is wasteful and dishonest.  More importantly, it harms the very souls we have pledged an oath to protect.

70 Comments | community mental health, disability, mental health | Tagged: , , , | Permalink
Posted by stevebMD

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