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Latuda-Palooza: Marketing or Education?

October 2, 2011

In my last blog post, I wrote about an invitation I received to a symposium on Sunovion Pharmaceuticals’ new antipsychotic Latuda.  I was concerned that my attendance might be reported as a “payment” from Sunovion under the requirements of the Physicians Payment Sunshine Act.  I found it a bit unfair that I might be seen as a recipient of “drug money” (and all the assumptions that go along with that) when, in fact, all I wanted to do was learn about a new pharmaceutical agent.

As it turns out, Sunovion confirmed that my participation would NOT be reported (they start reporting to the feds on 1/1/12), so I was free to experience a five-hour Latuda extravaganza yesterday in San Francisco.  I was prepared for a marketing bonanza of epic proportion—a la the Viagra launch scene in “Love And Other Drugs.”  And in some ways, I got what I expected:  two outstanding and engaging speakers (Dr Stephen Stahl of NEI and Dr Jonathan Meyer of UCSD); a charismatic “emcee” (Richard Davis of Arbor Scientia); an interactive “clicker” system which allowed participants to answer questions throughout the session and check our responses in real time; full lunch & breakfast, coffee and snacks; all in a posh downtown hotel.  (No pens or mugs, though.)

The educational program consisted of a plenary lecture by Dr Stahl, followed by workshops in which we broke up into “teams” and participated in three separate activities:  first, a set of computer games (modeled after “Pyramid” and “Wheel Of Fortune”) in which we competed to answer questions about Latuda and earn points for our team; second, a “scavenger hunt” in which we had 5 minutes to find answers from posters describing Latuda’s clinical trials (sample question: “In Study 4 (229), what proportion of subjects withdrew from the Latuda 40 mg/d treatment arm due to lack of efficacy?”); and finally, a series of case studies presented by Dr Meyer which used the interactive clicker system to assess our comfort level in prescribing Latuda for a series of sample patients.  My team came in second place.

I must admit, the format was an incredibly effective way for Sunovion to teach doctors about its newest drug.  It reinforced my existing knowledge—and introduced me to a few new facts—while it was also equally accessible to physicians who had never even heard about Latuda.

Moreover, the information was presented in an unbiased fashion.  Unbiased?, you may ask.  But wasn’t the entire presentation sponsored by Sunovion?  Yes, it was, but in my opinion the symposium achieved its stated goals:  it summarized the existing data on Latuda (although see here for some valid criticism of that data); presented it in a straightforward, effective (and, at times, fun) way; and allowed us doctors to make our own decisions.  (Stahl did hint that the 20-mg dose is being studied for bipolar depression, not an FDA-approved indication, but that’s also publicly available on the clinicaltrials.gov website.)  No one told us to prescribe Latuda; no one said it was better than any other existing antipsychotic; no one taught us how to get insurance companies to cover it; and—in case any “pharmascold” is still wondering—no one promised us any kickbacks for writing prescriptions.

(Note:  I did speak with Dr Stahl personally after his lecture.  I asked him about efforts to identify patient-specific factors that might predict a more favorable response to Latuda than to other antipsychotics.  He spoke about current research in genetic testing, biomarkers, and fMRI to identify responders, but he also admitted that it’s all guesswork at this point.  “I might be entirely wrong,” he admitted, about drug mechanisms and how they correlate to clinical response, and he even remarked “I don’t believe most of what’s in my book.”  A refreshing—and surprising—revelation.)

In all honesty, I’m no more likely to prescribe Latuda today than I was last week.  But I do feel more confident in my knowledge about it.  It is as if I had spent five hours yesterday studying the Latuda clinical trials and the published Prescribing Information, except that I did it in a far more engaging forum.  As I mentioned to a few people (including Mr Davis), if all drug companies were to hold events like this when they launch new agents, rather than letting doctors decipher glossy drug ads in journals or from their drug reps, doctors would be far better educated than they are now when new drugs hit the market.

But this is a very slippery slope.  In fact, I can’t help but wonder if we may be too far down that slope already.  For better or for worse, Steve Stahl’s books have become de facto “standard” psychiatry texts, replacing classics like Kaplan & Sadock, the Oxford Textbook, and the American Psychiatric Press books.  Stahl’s concepts are easy to grasp and provide the paradigm under which most psychiatry is practiced today (despite his own misgivings—see above).  However, his industry ties are vast, and his “education” company, Neuroscience Education Institute (NEI), has close connections with medical communications companies who are basically paid mouthpieces for the pharmaceutical industry.  Case in point: Arbor Scientia, which was hired by Sunovion to organize yesterday’s symposium—and similar ones in other cities—shares its headquarters with NEI in Carlsbad, CA, and Mr Davis sits on NEI’s Board.

We may have already reached a point in psychiatry where the majority of what we consider “education” might better be described as marketing.  But where do we draw the line between the two?  And even after we answer that question, we must ask, (when) is this a bad thing?  Yesterday’s Sunovion symposium may have been an infomercial, but I still felt there was a much greater emphasis on the “info-” part than the “-mercial.”  (And it’s unfortunate that I’d be reported as a recipient of pharmaceutical money if I had attended the conference after January 1, 2012, but that’s for another blog post.)  The question is, who’s out there to make sure it stays that way?

I’ve written before that I don’t know whom to trust anymore in this field.  Seemingly “objective” sources—like lectures from my teachers in med school and residency—can be heavily biased, while “advertising” (like yesterday’s symposium) can, at times, be fair and informative.  The end result is a very awkward situation in modern psychiatry that is easy to overlook, difficult to resolve, and, unfortunately, still ripe for abuse.

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Psychopharm R&D Cutbacks II: A Response to Stahl

August 28, 2011

A lively discussion has emerged on the NEI Global blog and on Daniel Carlat’s psychiatry blog about a recent post by Stephen Stahl, NEI chairman, pop(ular) psychiatrist, and promoter of psychopharmaceuticals.  The post pertains to the exodus of pharmaceutical companies from neuroscience research (something I’ve blogged about too), and the changing face of psychiatry in the process.

Dr Stahl’s post is subtitled “Be Careful What You Ask For… You Just Might Get It” and, as one might imagine, it reads as a scathing (some might say “ranting”) reaction against several of psychiatry’s detractors: the “anti-psychiatry” crowd, the recent rules restricting pharmaceutical marketing to doctors, and those who complain about Big Pharma funding medical education.  He singles out Dr Carlat, in particular, as an antipsychiatrist, implying that Carlat believes mental illnesses are inventions of the drug industry, medications are “diabolical,” and drugs exist solely to enrich pharmaceutical companies.  [Not quite Carlat’s point of view, as  a careful reading of his book, his psychopharmacology newsletter, and, yes, his blog, would prove.]

While I do not profess to have the credentials of Stahl or Carlat, I have expressed my own opinions on this matter in my blog, and wanted to enter my opinion on the NEI post.

With respect to Dr Stahl (and I do respect him immensely), I think he must re-evaluate his influence on our profession.  It is huge, and not always in a productive way.  Case in point: for the last two months I have worked in a teaching hospital, and I can say that Stahl is seen as something of a psychiatry “god.”  He has an enormous wealth of knowledge, his writing is clear and persuasive, and the materials produced by NEI present difficult concepts in a clear way.  Stahl’s books are directly quoted—unflinchingly—by students, residents, and faculty.

But there’s the rub.  Stahl has done such a good job of presenting his (i.e., the psychopharmacology industry’s) view of things that it is rarely challenged or questioned.  The “pathways” he suggests for depression, anxiety, psychosis, cognition, insomnia, obsessions, drug addiction, medication side effects—basically everything we treat in psychiatry—are accompanied by theoretical models for how some new pharmacological agent might (or will) affect these pathways, when in fact the underlying premises or the proposed drug mechanisms—or both—may be entirely wrong.  (BTW, this is not a criticism of Stahl, this is simply a statement of fact; psychiatry as a neuroscience is decidedly still in its infancy.)

When you combine Stahl’s talent with his extensive relationships with drug companies, it makes for a potentially dangerous combination.  To cite just two examples, Stahl has written articles (in widely distributed “throwaway” journals) making compelling arguments for the use of low-dose doxepin (Silenor) and L-methylfolate (Deplin) in insomnia and depression, respectively, when the actual data suggest that their generic (or OTC) equivalents are just as effective.  Many similar Stahl productions are included as references or handouts in drug companies’ promotional materials or websites.

How can this be “dangerous”?  Isn’t Stahl just making hypotheses and letting doctors decide what to do with them?  Well, not really.  In my experience, if Stahl says something, it’s no longer a hypothesis, it becomes the truth.

I can’t tell you how many times a student (or even a professor of mine) has explained to me “Well, Stahl says drug A works this way, so it will probably work for symptom B in patient C.”  Unfortunately, we don’t have the follow-up discussion when drug A doesn’t treat symptom B; or patient C experiences some unexpected side effect (which was not predicted by Stahl’s model); or the patient improves in some way potentially unrelated to the medication.  And when we don’t get the outcome we want, we invoke yet another Stahl pathway to explain it, or to justify the addition of another agent.  And so on and so on, until something “works.”  Hey, a broken clock is still correct twice a day.

I don’t begrudge Stahl for writing his articles and books; they’re very well written, and the colorful pictures are fun to look at– it makes psychiatry almost as easy as painting by numbers.  I also (unlike Carlat) don’t get annoyed when doctors do speaking gigs to promote new drugs.  (When these paid speakers are also responsible for teaching students in an academic setting, however, that’s another issue.)  Furthermore, I accept the fact that drug companies will try to increase their profits by expanding market share and promoting their drugs aggressively to me (after all, they’re companies—what do we expect them to do??), or by showing “good will” by underwriting CME, as long as it’s independently confirmed to be without bias.

The problem, however, is that doctors often don’t ask for the data.  We don’t  ask whether Steve Stahl’s models might be wrong (or biased).  We don’t look closely at what we’re presented (either in a CME lesson or by a drug rep) to see whether it’s free from commercial influence.  And, perhaps most distressingly, we don’t listen enough to our patients to determine whether our medications actually do what Stahl tells us they’ll do.

Furthermore, our ignorance is reinforced by a diagnostic tool (the DSM) which requires us to pigeonhole patients into a small number of diagnoses that may have no biological validity; a reimbursement system that encourages a knee-jerk treatment (usually a drug) for each such diagnosis; an FDA approval process that gives the illusion that diagnoses are homogeneous and that all patients will respond the same way; and only the most basic understanding of what causes mental illness.  It creates the perfect opportunity for an authority like Stahl to come in and tell us what we need to know.  (No wonder he’s a consultant for so many pharmaceutical companies.)

As Stahl writes, the departure of Big Pharma from neuroscience research is unfortunate, as our existing medications are FAR from perfect (despite Stahl’s texts making them sound pretty darn effective).  However, this “breather” might allow us to pay more attention to our patients and think about what else—besides drugs—we can use to nurse them back to health.  Moreover, refocusing our research efforts on the underlying psychology and biology of mental illness (i.e., research untainted by the need to show a clinical drug response or to get FDA approval) might open new avenues for future drug development.

Stahl might be right that the anti-pharma pendulum has swung too far, but that doesn’t mean we can’t use this opportunity to make great strides forward in patient care.  The paychecks of some docs might suffer.  Hopefully our patients won’t.


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