“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.)


The Balance of Information

May 19, 2011

How do doctors learn about the drugs they prescribe?  It’s an important question, but one without a straightforward answer.  For doctors like me—who have been in practice for more than a few years—the information we learned in medical school may have already been replaced by something new.  We find ourselves prescribing drugs we’ve never heard of before.  How do we know whether they work?  And whom do we trust to give us this information?

I started to think about this question as I wrote my recent post on Nuedexta, a new drug for the treatment of pseudobulbar affect.  I knew nothing about the drug, so I had to do some research.  One of my internet searches led me to an active discussion on a site called studentdoctor.net (SDN).  SDN is a website for medical students, residents, and other medical professionals, and it features objective discussions of interesting cases, new medications, and career issues.  There, I found a thread devoted to Nuedexta; this thread contained several posts by someone calling himself “Doogie Howser”—and he seemed to have a lot of detailed information about this brand-new drug.

Further internet sleuthing led me to a message board on Yahoo Finance for Avanir Pharmaceuticals, the company which makes Nuedexta.  In one of the threads on this board, it was suggested that the “Doogie Howser” posts were actually written by someone I’ll call “TS.”  Judging by the other posts by this person, “TS” clearly owns stock in Avanir.  While “TS” never admitted to writing the SDN posts, there was much gloating that someone had been able to post pro-Nuedexta information on a healthcare website in a manner that sounded authoritative.

Within 24 hours of posting my article, someone posted a link to my article on the same Yahoo Finance website. I received several hundred “hits” directly from that link.  Simultaneously (and ever since), I’ve received numerous comments on that article, some of which include detailed information about Nuedexta, reminiscent of the posts written by “Doogie Howser.” Others appear to be written by “satisfied patients” taking this drug.  But I’m skeptical. I don’t know whether these were actual patients or Avanir investors (or employees); the IP address of one of the pro-Nuedexta commenters was registered to a public-relations firm in Arizona. Nevertheless, I have kept the majority of the posts on the blog, except those that contained personal attacks (and yes, I received those, too).

The interesting thing is, nothing “TS”/”Doogie Howser” said about Nuedexta was factually incorrect.  And most of the posts I received were not “wrong” either (although they have been opinionated and one-sided).  But that’s precisely what concerns me. The information was convincing, even though—if my hunch is correct—the comments were written for the sake of establishing market share, not for the sake of improving patient care.

The more worrisome issue is this: access to information seems to be lopsided.  Industry analysts (and even everyday investors) can have an extremely sophisticated understanding of new drugs on the market, more sophisticated, at times, than many physicians.  And they can use this sophistication to their advantage. Some financial websites and investor publications can read like medical journals.  Apparently, money is a good motivator to obtain such information and use it convincingly.  Quality patient outcomes? Not so much.

So what about the doctor who doesn’t have this information but must decide whether to prescribe a new medication?  Well, there are a few objective, unbiased sources of information about new drugs (The Medical Letter and The Carlat Report among them).  Doctors can also ask manufacturers for the Prescribing Information (“PI”) or do their own due diligence to learn about new treatments.  But they often don’t have the time to do this, and other resources (like the internet) are far more accessible.

However, they’re more accessible for everyone.  When the balance of information about new treatments is tipped in favor of drug manufacturers, salespeople, and investors—all of whom have financial gain as their top priority—and not in favor of doctors and patients (whose lives may be at stake), an interesting “battle of wits” is bound to ensue.  When people talk a good game, and sound very much like they know what they’re talking about, their motives must always be questioned.  Unfortunately—and especially under the anonymity of the internet—those motives can sometimes be hard to determine.  In response, we clinicians must be even more critical and objective, and not necessarily believe everything we hear.


Horizant: The Second Coming of Gabapentin

April 8, 2011

Like the religious notion of reincarnation, apparently some drugs are destined to be reborn as newly designed and re-packaged drugs for brand new indications.  I’ve written about Contrave and Silenor, for instance—two drugs with generic equivalents that have been re-tweaked, re-packaged, and renamed, for newer (and larger) markets.

This week, the FDA granted its approval to yet another “new” agent (that’s “new” with an asterisk, mind you), Horizant, developed by GlaxoSmithKline (GSK) and Xenoport.  Horizant is a name-brand version of gabapentin, which is also known as Neurontin.  While on the surface this appears to be an attempt to re-brand an existing drug, it may actually provide some advantages over the already-available alternative.  But the question is, at what cost?  And for what exactly?

Gabapentin was approved in 1994 and is marketed as Neurontin.  It’s approved for the treatment of partial seizures and post-herpetic neuralgia (although its manufacturer, Pfizer, got into some serious trouble for extensive off-label marketing of this compound—so what else is new?).  These days, it’s actually quite widely used by neurologists and psychiatrists, not just for seizures, but also for  chronic pain syndromes, anxiety, mood stabilization (where it’s not particularly effective), and even for alcohol dependence.

Gabapentin’s bioavailability—the ability of the drug to enter the bloodstream when taken as an oral dose—is rather low (and, paradoxically, decreases as the dose is increased) and the duration of its action is quite short, which means that users need to take this drug three or four times daily.  The key advantage of Horizant is that it is a “pro-drug.”  Technically it’s gabapentin enacarbil, and the “enacarbil” refers to a molecule added to the drug which allows it to be absorbed along the entire GI tract, resulting in greater blood levels.

(Interestingly, in early 2010 the FDA rejected Horizant’s first request for approval, citing a small but significant risk of cancer.  They relented, however, and approved it this year after “reconsidering the risks and benefits.”  Sound fishy?  No, I’m sure it’s all good.)

So who might use Horizant?  Well, you can bet that GSK and Xenoport hope that anyone who currently uses Neurontin (and there are a lot of them) is a potential customer patient.  Officially, though, it was approved for the treatment of restless legs syndrome (RLS).

Now, RLS is one of those “diseases that may not be diseases”—or “diseases that you didn’t know you had.”  (See the articles here and here for accusations of “disease mongering” by GSK [hey! GSK! Coincidence? I don’t think so!] when it introduced Requip, the first “treatment” for RLS.)  Hopefully it goes without saying that when you see headlines like “Disease X may affect  7-10% of the population” when, in fact, no one had even heard of Disease X ten years ago, you have to be somewhat suspect.

Nevertheless, like much else in psychiatry, there may be some reality to RLS; it may in fact be a true pathophysiological entity that responds to medication.  (Whether this entity afflicts 10% of the population is another story.)  Current treatment strategies involve dopamine replacement, in the form of Requip (ropinirole) or Mirapex (pramipexole) so maybe dopamine insufficiency is part of the process.

The symptoms of RLS are “an urge to move the limbs, which improves with activity and worsens with rest.”  That’s about it.  Which leads to yet another problem (a problem that GSK and Xenoport don’t see as a problem, that’s for sure): with such nonspecific and common symptoms (who among us hasn’t felt somewhat restless, with interrupted sleep?), a lot of people might get diagnosed with RLS when their symptoms are actually due to something else.

I thought of this a few weeks ago, when I saw that the RLS “patient page” on the National Institutes of Health (NIH) web site referred to RLS as “akathisia” (thanks to altmentalities for the link).  Akathisia (from the Greek for “not sitting still”) has long been recognized as a side effect of some—perhaps most—psychiatric medications, from antipsychotics to antidepressants.  It is often described as an “inner restlessness,” a “need to keep moving.”  Sometimes it’s associated with extreme emotional distress.  In terms of severity, it can range from a mild nuisance to—in some cases—aggressive tendencies.  (Indeed, the psychiatrist David Healy has even linked psychotropic-induced akathisia to suicide attempts and violent behavior.)

Psychiatrists really don’t know exactly what causes akathisia, and disagree on how to treat it.  It may have something to do with dopamine blockade, or something completely independent.  Treatment might consist of benzodiazepines (like Ativan or Valium), beta blockers (like propranolol), or discontinuing the drug that caused it in the first place.

Unlike RLS, which seems to bother people most when they are lying down (hence its tendency to disrupt sleep), drug-induced akathisia is worse when people are awake and moving around.  Sounds like a simple distinction.  But nothing is quite this simple, particularly when psychiatric drugs—and real people—are involved.   In fact, many psychiatric meds can cause other motor side effects, too, involving (theoretically) yet other neural pathways, such as “parkinsonian” side effects like rigidity and tremor.  (In fact, some antipsychotic drug trials show “restlessness” and “akathisia” as entirely separate side effects, and when I’ve tried to ask experts to explain the difference, I have never received a straightforward answer.)

So what does this all mean for Horizant?  I could be cynical and simply remark that GSK/Xenoport are capitalizing on the nonspecificity of symptoms, the tremendous diagnostic overlap, and the fact that motor side effects, in general, are common side effects of antipsychotics (one of the most widely prescribed drug classes worldwide).  In other words, they know that there are a lot of people out there with “restless legs” for all kinds of reasons, and lots of psychiatrists who will misdiagnose akathisia as RLS and prescribe Horizant for this purpose.  But in reality, that remark would not be all that cynical.  Remember, there is this pesky little thing called “return on investment.”

What it means for the patient (or should I say “customer”) is more confusing.  A new agent with apparently better availability and kinetics than gabapentin is now available, but approved for the treatment of something that may or may not exist (in most patients), and may or may not be more effective than gabapentin itself.  Oh, and a hefty price tag, too.  Ah, the wheels of psychopharmacology keep turning….

(NB: altmentalities has also written her point of view on the Horizant story… I suggest you check it out, too.)


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