Big Brother in Your Medicine Cabinet

June 29, 2011

If there’s one thing I’ve learned from working as a doctor, it is that “what the doctor ordered” is not always what the patient gets.  Sure, I’ve encountered the usual obstacles—like pharmacy “benefit” (ha!) managers whose restrictive formularies don’t cover the medications ordered by their physicians—but I’ve also been amazed by the number of patients who don’t take medications as prescribed.  In psychiatry, the reasons are numerous:  patients may take their SSRI “only when I feel depressed,” they double their dose of a benzodiazepine “because I like the way it makes me feel,” they stop taking two or three of their six medications out of sheer confusion, or they take a medication for entirely different purposes than those for which it was originally prescribed.  (If I had a nickel for every patient who takes Seroquel “to help me sleep,” I’d be a very rich man.)

In the interest of full disclosure, this is not limited to my patients.  Even in my own life, I found it hard to take my antidepressant daily (it really wasn’t doing anything for me, and I was involved in other forms of treatment and lifestyle change that made a much bigger difference).  And after a tooth infection last summer, it was a real challenge to take my penicillin three times a day.  I should know better.  Didn’t I learn about this in med school??

This phenomenon used to be called “noncompliance,” a term which has been replaced by the more agreeable term, “nonadherence.”  It’s rampant.  It is estimated to cost the US health care system hundreds of billions of dollars annually.  But how serious is it to human health?  The medical community—with the full support of Big Pharma, mind you—wants you to believe that it is very serious indeed.  In fact, as the New York Times reported last week, we now have a way to calculate a “risk score” for patients who are likely to skip their medications.  Developed by the FICO company, the “Medication Adherence Score” can predict “which patients are at highest risk for skipping or incorrectly using” their medications.

FICO?  Where have you heard of them before?  Yes, that’s right, they’re the company who developed the credit score:  that three-digit number which determines whether you’re worthy of getting a credit card, a car loan, or a home mortgage.  And now they’re using their clout and influence actuarial skills to tell whether you’re likely to take your meds correctly.

To be sure, some medications are important to take regularly, such as antiretrovirals for HIV, anticoagulants, antiarrhythmics, etc, because of the risk of severe consequences after missed doses.  As a doctor, I entered this profession to improve lives—and oftentimes medications are the best way for my patients to thrive.  [Ugh, I just can’t use that word anymore… Kaiser Permanente has ruined it for me.]

But let’s consider psychiatry, shall we?  Is a patient going to suffer by skipping Prozac or Neurontin for a few days?  Or giving them up altogether to see an acupuncturist instead?  That’s debatable.

Anyway, FICO describes their score as a way to identify patients who would “benefit from follow-up phone calls, letters, and emails to encourage proper use of medication.”  But you can see where this is going, can’t you?  It’s not too much of a stretch to see the score being used to set insurance premiums and access (or lack thereof) to name-brand medications.  Hospitals and clinics might also use it to determine which patients to accept and which to avoid.

Independently (and coincidentally?), the National Consumers League inaugurated a program last month called “Script Your Future,” which asks patients to make “pledges” to do things in the future (like “walk my daughter down the aisle” or “always be there for my best friend”) that require—or so it is implied—adherence to their life-saving medications.  Not surprisingly, funds for the campaign come from a coalition including “health professional groups, chronic disease groups, health insurance plans, pharmaceutical companies, [and] business organizations.”  In other words: people who want you to take drugs.

The take-home message to consumers patients, of course, is that your doctors, drug companies, and insurers care deeply about you and truly believe that adherence to your medication regimen is the key to experiencing the joy of seeing your children graduate from college or retiring to that villa in the Bahamas.  Smile, take our drugs, and be happy.  (And don’t ask questions!)

If a patient doesn’t want to take a drug, that’s the patient’s choice—which, ultimately, must always be respected (even if ends up shortening that patient’s life).  At the same time, it’s the doctor’s responsibility to educate the patient, figure out the reasons for this “nonadherence,” identify the potential dangers, and help the patient find suitable alternatives.  Perhaps there’s a language barrier, a philosophical opposition to drugs, a lack of understanding of the risks and benefits, or an unspoken cultural resistance to Western allopathic medicine.  Each of these has its merits, and needs to be discussed with the patient.

Certainly, if there are no alternatives available, and a patient still insists on ignoring an appropriate and justifiable medical recommendation, we as a society have to address how to hold patients accountable, so as not to incur greater costs to society down the road (I’m reminded here of Anne Fadiman’s excellent book The Spirit Catches You And You Fall Down).  At the same time, though, we might compensate for those increased costs by not overprescribing, overtreating, overpathologizing, and then launching campaigns to make patients complicit in (and responsible for!) these decisions.

Giving patients a “score” to determine whether they’re going to take their meds is the antithesis of good medicine.  Good medicine requires discussion, interaction, understanding, and respect.  Penalizing patients for not following doctors’ orders creates an adversarial relationship that we can do without.

24 Comments | business, marketing, medications, psychopharmacology | Tagged: , , , , | Permalink
Posted by stevebMD

Is Weiner Really Such A Bad Guy?

June 25, 2011

I don’t use this blog as a platform for political opinions or broad social commentary, but the Anthony Weiner “sexting” fiasco has raised some issues in my mind.  And I guess, in a roundabout way, it actually does pertain to psychiatry and medicine, so I figured I’d share these thoughts.

Unless you’ve been exiled to the Gulag for the last month, you probably know that Weiner, a Democratic New York congressman, was forced to resign from his post after the outcry over lewd photographs he sent to women from his Twitter account.  He left his office in disgrace and is apparently entering rehab.  (Maybe I’ll write about the wisdom of that move in a different post.)

The thing is, Weiner was a generally well-liked Congressman and was reportedly a leading candidate to run for mayor of New York in 2013.    He had many supporters and, until the “Weinergate” scandal broke, was seen as a very capable politican.  One might argue, in fact, that his sexual exploits had no effect on his ability to legislate, despite the vociferous (and at times rabid) barbs levied upon him by pundits and critics after the scandal became public.

Now, don’t get me wrong.  I am not condoning his behavior.  I am not saying that we should ignore it because “he’s otherwise a good guy.”  In no way should we turn a blind eye to something that shows such poor taste, a profound lack of judgment, and a disregard for his relationship with his wife.

But does it require the sudden unraveling of an entire political career?  Weiner has done some bad things.  But do they make him a bad congressman?

Some of the same questions arose during the recent flurry of stories about doctors who speak for drug companies.  As ProPublica has written in its “Dollars for Docs” series, some doctors have earned tens of thousands of dollars speaking on behalf of companies when they are also expected to be fair and unbiased in their assessment of patients, or in their analysis and presentation of data from clinical trials.

This is, in my opinion, a clear conflict of interest.  However, some of the articles went one step further and pointed out that many of those doctors have been disciplined by their respective Medical Boards, or have had other blemishes on their record.  Are these conflicts of interest?  No.  To me, it seems more like muckraking.  It’s further ammunition with which critics can attack Big Pharma and the “bad” doctors who carry out its dirty work.

Now I don’t mean to say that every sin or transgression should be ignored.  If one of those doctors had been disciplined for excessive or inappropriate prescribing, or for prescription fraud, or for questionable business practices, then I can see why it might be an issue worthy of concern.  But to paint all these doctors with a broad stroke and malign them even further because of past disciplinary action (and not simply on the basis of the rather obvious financial conflicts of interest), seems unfair.

The bottom line is, sometimes good people do bad things.  And unfortunately, even when those “bad things” are unrelated to the business at hand, we sometimes ruin lives and careers in our attempts to exact justice.  Whatever happened to rehabilitation and recovery?  A second chance?  Can we evaluate doctors (and politicians) by the quality of their work and their potential current conflicts, rather than something they did ten or twenty years ago?

(By the way, there are some bad—i.e., uninformed, irresponsible—doctors out there who have no disciplinary actions and no relationships with pharmaceutical companies.  Where are the journalists and patient-advocacy groups looking into their malfeasance?)

In our society, we are quick to judge—particularly those in positions of great power and responsibility.  And those judgments stick.  They become a lens through which we see a person, and those lenses rarely come off, regardless of how hard that person has worked to overcome those characterizations.  Ask any recovered alcoholic or drug addict.  Ask any ex-felon who has cleaned up his act.  Ask any “impaired professional.”  (In the interest of full disclosure, I am one of those professionals, whose “impairments” stemmed from a longstanding mental illness [now in remission] and affected none of my patients or colleagues, but which have introduced significant obstacles to my employability for the last five years.)  And ask any politician who has had to surrender an office due to a personal failing like Weiner’s.

Come to think of it, ask any patient who has been given a psychiatric diagnosis and whose words and actions will be interpreted by her friends, family,  doctors, or boss as part of her “borderline personality” or “bipolar” or “psychosis.”  It’s hard to live that down.

When evaluations matter, we should strive to judge people by the criteria that count, instead of the criteria that strengthen our biases, confirm our misconceptions, and polarize us further.  If we are able to do so, we may make it easier for people to recover and emerge even stronger after making mistakes or missteps in their lives.  We also might get along with each other just a little better.

44 Comments | mental health, policy, society | Tagged: , , , , | Permalink
Posted by stevebMD

When Your EMR Goes Down On You

June 21, 2011

Electronic medical records (EMRs) are the way of the future.  And, for most practices, that future is today, whether we like it or not.  The federal Center for Medicare Services is paying doctors a financial incentive to switch from paper to electronic charts, and the first checks have already been cut.

It’s notable that the government has chosen to bribe doctors to switch to electronic records, when no one had to pay us (or you) to use Google or Facebook or Twitter.  Maybe it’s because EMRs don’t run like Google, Facebook, or Twitter.  Despite the tremendous potential benefits of EMRs, they remain clunky, distracting, and non-intuitive.  In their current form, their benefits are clearly limited to administrators, third-party payers, and others who are more interested in data than in the quality of care provided.  But what do I know, I’m just a doctor, and no one ever asked me.

Anyway, in the last 18 months, I’ve had the opportunity to use two different EMRs, one called Patient Care Manager by Prime Clinical (about which I can’t find much positive to say, so I’ll keep my mouth shut), and another, Practice Fusion.  I must admit I’ve been rather impressed by Practice Fusion, a free “cloud-based” EMR system with many user-customizable features and a surprisingly simple interface.

Alas, for several hours yesterday—right in the middle of a busy Monday—Practice Fusion went down.   As in:  totally unavailable.  Couldn’t log on, couldn’t view any charts, lab reports, patient correspondence, or the daily schedule.  Couldn’t even look at patient demographics.  It was as if the entire chart rooms of hundreds of doctors’ offices across America were closed for the day.

In a conventional practice with paper charts, this sort of thing is unacceptable.  To be sure, things get lost every once in a while, but to lose access to an entire chart room—and schedule—without any idea of when it will return, is a potentially very serious problem.  Doctors have been severely disciplined for losing or missing data (even in individual cases), and clinics have been penalized with significant fines for shoddy recordkeeping.

Fortunately, Practice Fusion came back up late in the day, but not until hundreds of practices across the country struggled for 5-6 hours without vital information, making for a very difficult Monday.

I should point out that (when it works) Practice Fusion is unique.  More so than any other EMR I’ve used, PF is extremely user-friendly, offering informative (and sometimes humorous and irreverent) YouTube videos, live online chat, and an attentive support team.  They even allow comments on their public Facebook page.  You might expect it to be a place for doctors to vent their outrage on a day like yesterday.  To the contrary, most of the comments were quite sympathetic.  Some direct quotes:

“I feel like I’m deaf and blind… could not pull labs or test results…. I know it happens. It could happen even to the best. But hey! It’s not the end of the world!  True, it’s very inconvenient since I’ll be spending most of my evening trying to catch up charting.  But still… Love you guys! Keep up the good work!”

“I love Practice Fusion no matter what happened today… Good job guys!!!”

“We are thankful for PF, even with the RARE problem…. Thanks to you and the team for providing us a reliable and FREE EMR.”

“If it’s going to stay this fast [after the outage] I can get over being down today though it was quite stressful!  Thank you PF staff.  You were probably stressed too.”

It’s a surprising commentary when a very significant glitch in a widely used EMR system—which, in a conventional practice situation, might have resulted in disciplinary action or heavy fines, and which most certainly resulted yesterday in lost income for a number of docs and probably more than a few adverse patient outcomes—was accepted with such grace.

Maybe I’m old-fashioned, but EMRs are not like any other piece of software.  When Netflix goes down, I can’t watch a streaming movie.  But when Practice Fusion goes down, I can’t access vital information which may make a significant impact on the well-being of the patients in my office.  It’s a very slippery slope when we “permit” EMRs to be buggy, and even worse when we providers simply “accept” it (and even give the companies a free pass) when they go down.

But then again, the future is today.  We need to get used to it.

39 Comments | computers, EMR, psychiatry | Tagged: , , , | Permalink
Posted by stevebMD

Psychopharm R&D Cutbacks: Crisis or Opportunity?

June 19, 2011

The scientific journal Nature ran an editorial this week with a rather ominous headline: “Psychopharmacology in Crisis.”  What exactly is this “crisis” they speak of?  Is it the fact that our current psychiatric drugs are only marginally effective for many patients?  Is it the fact that they can often cause side effects that some patients complain are worse than the original disease?  No, the “crisis” is that the future of psychopharmacology is in jeopardy, as pharmaceutical companies, university labs, and government funding agencies devote fewer resources to research and development in psychopharmacology.  Whether this represents a true crisis, however, is entirely in the eye of the beholder.

In 2010, the pharmaceutical powerhouses Glaxo SmithKline (GSK) and AstraZeneca closed down R&D units for a variety of CNS disorders, a story that received much attention.  They suspended their research programs because of the high cost of bringing psychiatric drugs to market, the potential for lawsuits related to adverse events, and the heavy regulatory burdens faced by drug companies in the US and Europe.  In response, organizations like the European College of Neuropsychopharmacology (ECNP) and the Institute of Medicine in the US have convened summits to determine how to address this problem.

The “problem,” of course, for pharmaceutical companies is the potential absence of a predictable revenue stream.  Over the last several years, big pharma has found it to be more profitable not to develop novel drugs, but new niches for existing agents—a decision driven by MBAs instead of MDs and PhDs.  As Steve Hyman, NIMH director, told Science magazine last June,  “It’s hardly a rich pipeline.  It suggests a sad dearth of ideas and … lots of attempts at patent extensions and new indications for old drugs.”

Indeed, when I look back at the drug approvals of the last three or four years, there really hasn’t been much to get excited about:  antidepressants (Lexapro, Pristiq, Cymbalta) that are similar in mechanism to other drugs we’ve been using for years; new antipsychotics (Saphris, Fanapt, Latuda) that are essentially me-too drugs which don’t dramatically improve upon older treatments; existing drugs (Abilify, Seroquel XR) that have received new indications for “add-on” treatment; existing drugs (Silenor, Nuedexta, Kapvay) that have been tweaked and reformulated for new indications; and new drugs (Invega, Oleptro, Invega Sustenna) whose major attraction is a fancy, novel delivery system.

Testing and approval of the above compounds undoubtedly cost billions of dollars (investments which, by the way, are being recovered in the form of higher health care costs to you and me), but the benefit to patients as a whole has been only marginal.

The true crisis, in my mind, is that with each new drug we psychiatrists are led to believe that we’re witnessing the birth of a blockbuster.  Not to mention the fact that patients expect the same, especially with the glut of persuasive direct-to-consumer advertising (“Ask your doctor if Pristiq is right for you!”).  Most third-party payers, too, are more willing to pay for medication treatment than anything else (although—thankfully—coverage of newer agents often requires the doctor to justify his or her decision), even though many turn out to be a dud.

In the meantime, this focus on drugs neglects the person behind the illness.  Not every person who walks into my office with a complaint of “depression” is a candidate for Viibryd or Seroquel XR.  Or even a candidate for antidepressants at all.  But the overwhelming bias is that another drug trial might work.  “Who knows—maybe the next drug is the ‘right’ one for this patient!”

Recently, I’ve joked with colleagues that I’d like to see a moratorium on psychiatric drug development.  Not because our current medications meet all of our needs, or that we can get by without any further research.  Not at all.  But if we had, say, five years with NO new drugs, we might be able to catch our collective breaths, figure out exactly what we’re treating after all (maybe even have a more fruitful and unbiased discussion about what to put in the new DSM-5), and, perhaps, devote resources to nonpharmacological treatments, without getting caught up in the ongoing psychopharmacology arms race that, for many patients, focuses our attention where it doesn’t belong.

So it looks like my wish might come true.  Maybe we can use the upcoming slowdown to determine where the real needs are in psychiatry.  Maybe if we devote resources to community mental health services, to drug and alcohol treatment, pay more attention to our patients’ personality traits, lifestyle issues, co-occurring medical illnesses, and respond to their goals for treatment rather than AstraZeneca’s or Pfizer’s, we can improve the care we provide and figure out where new drugs might truly pay off.  Along the way, we can spend some time following the guidelines discussed in a recent report in the Archives of Internal Medicine, and practice “conservative prescribing”—i.e., making sensible decisions about what we prescribe and why.

Sometimes, it is true that less is more.  When Big Pharma backs out of drug development, it’s not necessarily a bad thing.  In fact, it may be precisely what the doctor ordered.

22 Comments | business, marketing, medications, psychopharmacology | Tagged: , , , , , | Permalink
Posted by stevebMD

Lexapro, Hot Flashes, and Doing What Works

June 15, 2011

One of the most common—and distressing—symptoms of menopause is the “hot flash.”  As many as 85% of perimenopausal women complain of hot flashes, characterized by a sensation of intense heat, a flushed appearance, perspiration, and pressure in the head.  An effective remedy for hot flashes over the years has been hormone replacement therapy, but many women shun this treatment because of the increased risk of breast cancer, heart disease, and stroke.  In its place, antidepressants like SSRIs and SNRIs have become more commonly prescribed for hot flashes.  Many women report great improvement in symptoms, both anecdotally and in some small open-label trials, with antidepressant therapy.

But do antidepressants actually do anything at all?

Jim Edwards covers this story in a post today on bnet’s “Placebo Effect” blog. Edwards describes a study published in the Journal of the American Medical Association (JAMA) in January 2011 (PDF here).  The study showed the clear benefit of Lexapro (an SSRI made by Forest Labs) relative to placebo in a randomized clinical trial of more than 200 menopausal women with hot flashes.  However, Edwards also reports that a brand new study (which he calls “elegant”) published in the journal Menopause found NO effect of Lexapro.  This second study measured hot flashes not by patient report, but instead by a “battery-powered hot flash detector” worn by women participating in the research.

Does Edwards conclude that the first study was bogus?  Well, not quite.  Edwards argues that the integrity of the JAMA study was dubious from the start because its lead author, Ellen Freeman, received money (honoraria and research support) from Forest Labs, while the paper in Menopause was not tainted by drug company money.  (Note: he neglected to point out that the author of the second study, Robert Freedman, holds a patent, US # 60,741,376, on the “hot flash detector” used in his study.  Yeah, that’s “elegant.”)

Now, I understand that pharmaceutical company funding has a potential to bias research (sometimes a great deal), even when the researchers swear by their objectivity.  But in this case, Edwards’ axe-grinding seems to have obscured some more relevant arguments.  In his zeal to criticize Freeman for her nefarious Forest ties, he ignores the fact that patients often do report a benefit of Lexapro.  A more relevant (and convincing) argument might have been: What makes Lexapro that much better than a generic SSRI—which would be significantly cheaper—in the treatment of hot flashes?  But no, that question was overlooked.

It’s also important to consider the methods used in the Menopause study.  Freedman and his colleagues used “objective” measures of hot flashes (using a device patented by the author, remember) instead of patients’ self-report.  What did these ambulatory monitors measure?  “Humidity on the chest”—that’s it.  (Hmmm… maybe the Exmovere Corporation could build an “Exmobaby garment” for menopausal women??)  Lexapro had no significant effect on this objective measurement.

But the problem is, hot flashes are subjective experiences.  Just like depressed mood, fatigue, pain, gastrointestinal upset, and many other symptoms we treat in medicine.  There’s probably a physiological explanation, but we don’t know what it is.  I’m sorry, but it seems presumptuous (if not downright arrogant) to say that a biometric device is an “accurate” detector of hot flashes, regardless of what the woman reports.  It’s like saying that a person is depressed because his ethanolamine phosphate level is high, or that another has OCD because she has a thicker right superior parietal gyrus in an MRI scan.

Anyway, back to Edwards’ blog post:  His opening sentence, dripping with obvious sarcasm, is “Never mind the evidence; just treat patients’ complaints.”  He then proceeds to completely downplay (if not ridicule) the fact that women frequently report a benefit of Lexapro and other SSRIs.

I wonder whether Edwards has paid any attention to what we’ve been doing in psychiatry for the last several decades.  Trust me, I would love to understand the biological basis of my patients’ symptoms—whether depression, psychosis, anxiety, or hot flashes—in order to develop more “targeted” medical treatment.  But the evidence is just not there (yet?).  In the meantime, we have to use what we’ve got.  If a woman reports improvement on Lexapro without any side effects (in other words, if the benefit exceeds the risk), I’ll prescribe it.

Let me be clear.  I’m not defending Lexapro:  if there’s a cheaper generic alternative available we should use it.  Similarly, I’m not defending Ellen Freeman: pharmaceutical funding should be fully disclosed and, moreover, it does skew what gets published (or not).  And I’m not criticizing Dr Freedman’s Hot Flash Detector (why does that sound like something out of a 1920’s Sears Catalog?): objective measures of subjective complaints help us to understand complicated pathophysiology more clearly.

But if patients benefit from a treatment (and aren’t harmed by it), we owe it to them to provide it.  Arguments like “the research is biased,” “it’s not scientific enough,” or “doctors don’t know how it works anyway” are valid, and should not be ignored, but should also not keep us from prescribing treatments that alleviate our patients’ suffering.

26 Comments | biomarkers, medications, psychopharmacology | Tagged: , , , , , | Permalink
Posted by stevebMD

Biomarker Envy IV: The Exmobaby

June 12, 2011

To what lengths would you go to keep your child healthy?  Organic, non-GMO baby food?  Hypoallergenic baby lotions and shampoos?  Bisphenol-free baby bottles?  How about a battery-powered biosensor garment that transmits ECG, skin temperature, and other biometric data about your baby wirelessly to your computer or via SMS message to your smartphone in real time?

Never fear, the Exmobaby is here.  Introduced late last year (and shown in the picture above—by the way, I don’t think that’s Jeff Daniels as a paid spokesman), the Exmobaby is a sleep garment designed for babies aged 0-12 months, which contains “embedded, non-contact sensors, a battery-powered Zigbee transmitter pod, a USB Zigbee receiver dongle that plugs into a Windows PC,” and all the necessary software.  Their slogan is “We Know How Your Baby Feels.”

It sounds like science fiction, but in reality it’s just a souped-up, high-tech version of a baby monitor.  But is it an improvement upon the audio- or video baby monitors currently available?  Exmovere certainly thinks so.  And, luckily for them, there’s no shortage of worried parents who are willing to pay for peace of mind (the device starts at $1000 and goes up to $2500, plus monthly data charges). [Note: please see addendum below.]

But while this might be an example of “a fool and his money being soon parted,” Exmovere makes some claims about the product that are highly questionable.  I first learned about the Exmobaby in a post on the KevinMD website, in which Exmovere’s CEO, David Bychkov, commented that “using Exmobaby to observe and record physiological data symptomatic of emotional changes can be useful… if you are a parent of a child with autism.”

In other words, this isn’t just a fancy monitoring device, this is a high-tech way of understanding your child’s thoughts and emotions—an “emotional umbilical cord between mother and child”—and, quite possibly, a way to diagnose a psychiatric, neurodevelopmental disorder in your newborn, all in the comfort of your own home.

I surfed over to the Exmobaby web site, whose home page shows a smiling, happy infant wearing these newfangled jammies.  Cute!  And the device (?) looks harmless enough.  But the FAQ page is where it gets interesting (or scary, depending on your position).  One question asks, “how is it possible to detect emotional states using Exmobaby?”  The response sounds like pure 21st century biobehavioral mumbo jumbo:

Detection of emotion involves software that compares heart rate, delta temperature and movement data (arousal) to heart rate variability and skin temperature (valence). These data, if tracked over time, enable a system to “guess” from a series of words that could be used to describe an emotional state: anger, fatigue, depression, joy, etc….In the case of babies, Exmovere is asking its users to try something new: name states. Exmobaby software will monitor trends in vital states. Parents will be asked to name states, such as “giggly” or “grumpy,” and the system can and will alert them when the underlying readings that match those states are detected. The idea is … to create a deeper level of communication between babies and their parents at the beginning of such a critical relationship.

In plain English: they’re asking parents to correlate data from the Exmobaby software (rather than their direct observations of the baby, which is how parents used to interact with their kids) with what they consider to be the baby’s emotional state.  Thus:  “My baby’s happy because the software says he is” rather than using old-fashioned signs—you know, like smiles and giggles.

The Exmovere website also includes an article, clearly written for parents, on “Exmobaby and Autism.”  Now, autism and “autism-spectrum disorders” (ASDs) are hot topics receiving a great deal of attention these days.  ASDs currently have an estimated prevalence of 1 in 110 (and rising rapidly), with an average age of diagnosis of approximately 4 years.  Nonetheless, parents of children with ASDs begin to identify concerns by the age of 12 to 18 months, and finding a “biomarker” to enable earlier diagnosis would allay the fears and insecurities of new parents.

But is Exmovere preying on precisely these fears and insecurities?  Well, let’s first ask: is it even reasonable to think about diagnosing ASDs before the age of 12 months (when the Exmobaby garment would be worn?).  A recent study showed that ASDs could be diagnosed as early as 14 months of age, based on social and communication development (but no biometric measures).  The American Association of Pediatrics recommends ASD screening (an interview with the parents and structured observation of the child) at ages 18 and 24 months, no earlier.  And a recent article in Pediatrics remarked that there are few measures sensitive and specific enough to detect ASD before 2 years of age (and, again, no “biological” measures to speak of).

The Exmobaby handout (which I’ve uploaded here), on the other hand, is a perfect example of a drug/device manufacturer capitalizing on the fears of parents by conflating statistics, commentary, and recommendations in a way that makes their device sound like a vital necessity for healthy infant development.  It’s deceptive marketing, pure and simple.

For example, it states “One of the ‘red flags’ in early diagnosis of ASDs is a lack of response from baby to the use of their name. Parents can potentially use Exmobaby to record times when baby’s name was said so that the reports will correlate any movement or vital sign response.”  Also, “specific tests can be designed in consultation with pediatricians to use Exmobaby to assist with diagnoses of ASDs and related developmental disorders.”  Never mind that there’s nothing in the literature correlating movement or vital-sign responses with diagnosing ASDs in this age group.

Conveniently, Exmovere also included its marketing strategy on its website (available here). It’s clear they’re planning to market Exmobaby as a garment (“a $5 billion per year worldwide market”) and not as a medical device.  That’s probably a good idea.  Or is it?  Bypassing medical professionals and tapping into a wide market of “worried well” might be good for business, but what about the “downstream” impact on our health care system?

So many questions.  But I’ll have to address them some other time, because I need to go make a sandwich.  I just got a text message telling me I’m hungry.

Addendum:  After posting this article, I received an email from Exmovere’s Investor Relations Advisor who pointed out that the $1000-$2500 prices I quoted above are for Evaluation Kits, specifically for distributors, researchers, and hospitals.  Exmobaby is not available for retail purchase at this time.  They anticipate a lower cost when the device/garment is sold directly to end users.

14 Comments | biomarkers, diagnostics, mental health | Tagged: , , , , , , , , , , | Permalink
Posted by stevebMD

I Want a DSM Wiki

June 8, 2011

As most readers of this blog are well aware, the American Psychiatric Association will publish its latest version of the Diagnostic and Statistical Manual (the hallowed “DSM”) in 2013.  The next version will be version 5.  (Note, it’s “5,” not “V.”  This is so that follow-up versions can be named 5.0.1, 5.1, 5.1.1, etc.  Just like computer software.  I kid you not.)

The provisional criteria have been made public, and the APA invites anyone to comment on its website, dsm5.org.  (The full development process was not this transparent.  Allen Frances and Robert Spitzer, two dissidents, famously decried the “nondisclosure agreements” the book’s authors had to sign.  Spitzer even commented, “The intent seemed to be not to let anyone know what the hell was going on.”)

But as we get closer to the publication date, readers can have a closer look under the hood.  Anyone can surf over to their website and make comments.  Yes, now is your chance to let the leaders of the psychiatric profession know precisely what you think about the new “Somatic Symptom Disorder” diagnosis; challenge the possible removal of the “narcissistic” category; or just tell the authors that you think psychiatry is all a crock of s***.

In an interview published today on Medscape, David Kupfer, chair of APA’s DSM-5 task force, reports that this spirit of openness and flexibility will likely persist even after its publication.  He says the upcoming DSM-5 will be a “living document,” complete with an electronic version (probably online?) which will be “much easier to update and may even include links to videos and vignettes.”

That could be a big step forward.  Imagine: if you’ve never seen catatonia before, you might be able to click on the DSM-5 entry and see a video of a catatonic person.  If your patient doesn’t understand why you just diagnosed her with borderline personality, you can read her a descriptive vignette (so much more interesting than a checklist!) and she’ll get it.

My thinking is, why stop there?  Psychiatrists are already way behind the times when it comes to modern technology.  Our peers in other specialties get to use fancy doodads like MRI scanners and bypass machines and stents all day long.  We just sit around and talk to people.

And then it hit me:  the APA should create a DSM-5 wiki.

For those of you who have no idea what a “wiki” is, it’s a website developed collaboratively by users and visitors.  Any user can add content, and it’s edited in real time by other users.  Disputes are resolved by online discussion, and historical changes can be viewed by anyone.  Perhaps the most famous example of a wiki is Wikipedia, the online encyclopedia.  Those articles were not first published in a book somewhere; instead, they have been written by experts and non-experts alike, and are constantly being edited.  Wikipedia has, for better or for worse, come to replace conventional encyclopedias and is a remarkably accurate (and free) source of material.

Maybe the APA can do the same!  Let’s put the DSM-5 online and let people do whatever they want with it.

Imagine the uses.  A DSM-5 wiki would let clinicians chime in about what they think ought to be changed or added, like an interesting “subtype” of an existing disorder.  Similarly, scientists could share findings that might be relevant to diagnosis (like newly discovered biomarkers) and clinicians could share novel uses of off-label medications, therapeutic successes, and interesting case reports.

Each medication could have its own Wiki page, with complete FDA approval information and dosing.  Herbals could be included.  To be fair, pharmaceutical companies would have free access to their documents, but any changes made by industry would be flagged as such.  Users could even upload cost data to help patients find affordable generic alternatives.

But the APA needs to make an even stronger statement that we’re not just old guys sitting around smoking pipes.  We need to go balls to the wall.  We could allow users to upload videos of unique patient presentations (with the proper HIPAA safeguards in place, like black rectangles over patients’ eyes, etc), public-domain lectures by famous psychiatrists, and links to journal articles describing new and relevant findings.  We could also add references to fascinating psychiatry blogs like this one. (lol)

Patients could also upload their own experiences, in YouTube format.  Their videos would be cross-referenced to the relevant diagnoses and/or medications.  Videos with the most “hits” could win a prize.  Maybe we can link terms to their Urban Dictionary entries.

We could add clips from Hollywood movies depicting particular disease presentations.  We could add links to Amazon.com to purchase relevant books (and use the Amazon Associates revenue to help manage server costs).  We could include a Skype plug-in that would allow users to chat with other people logged on at the  same time.  We could even sell space to advertisers like Groupon (“10 sessions of psychotherapy for the price of 5 in Chicago!!”) or, for those over 21, porn sites (targeted specifically to readers of the “Paraphilias” entry).

Social media is the future, and the APA really needs to get with the program!  An animated GIF logo.  An MP3 theme playing in the background of each page.  A Flash-based interface (sorry, iPad users).  The APA could even create new, edgy slogans for itself and for the DSM.  For instance, it’s not DSM-5 anymore, it could be “D5M-ph!\/3”.  It’s not just a “living document,” it can be the most 4w3soM3 social media psychiatry destination on the planet!   OMG!!!!!!1!

Let’s do it.

30 Comments | computers, DSM-5, psychiatry | Tagged: , , | Permalink
Posted by stevebMD

How Not To Be A Difficult Patient

June 5, 2011

One of the more interesting posters at last month’s American Psychiatric Association Annual Meeting was presented by Ricardo Salazar of UT San Antonio and the South Texas Psychiatric Practice-Based Research Network (PBRN).  The topic was “the Difficult Patient in Psychiatric Practice” and it surveyed psychiatrists about which patients they considered “difficult” and why.

It might sound somewhat disrespectful (and maybe a little naïve) to label a patient as “difficult.”  However, doctors are people too, and it would be even more naïve to think that doctors don’t have their own reactions to (and opinions of) the patients they treat—something referred to in psychoanalytic theory as “countertransference.”  Let’s face it:  doctors simply don’t like dealing with some patients.  (That’s why some choose private practice, to cherry-pick those whom they do like.)

Nevertheless, I think this topic needs more attention, particularly in today’s environment.  Much of what we do in mental health (both psychopharmacologically and in therapy) has a questionable evidence base, and yet the experience of clinicians and of patients is that our interventions frequently work.  I maintain that clinical benefit often results more from the interpersonal relationship between a patient and a doctor who listens and seems to understand, than from the pill that a doctor prescribes or the specific protocol that a therapist follows.  (This is yet another reason why quick-throughput psychiatry, dictated by brain scans, blood tests, and checklists, is bound to fail for most patients.)

Anyway, Dr Salazar’s study used a scale called the “Difficult Doctor-Patient Relationship Questionnaire (DDPRQ-10),” developed by Steven Hahn and colleagues in 1994.  I had not heard of this scale before.  Here are some sample questions:

1.  How much are you looking forward to this patient’s next visit after today?
3.  How manipulative is this patient?
4.  To what extent are you frustrated by this patient’s vague complaints?
6.  Do you find yourself secretly hoping this patient will not return?
8.  How time-consuming is caring for this patient?

As a patient, I might find some of these questions mildly offensive (“does my doctor secretly hope I won’t return??”), but as a doctor I must admit that some days I look at my schedule and see a name that makes me dread that hour.  (If you’re a doctor and you’re reading this and you do not agree, you’re either fooling yourself, you’re perfect, or you’re IBM’s Watson.)  Recognizing those feelings, however, often helps me to prepare for the session—and examine my own biases and faults—and such appointments often turn out to be the most satisfying (at least for the patient).

Salazar’s study showed that, on average, psychiatrists considered approximately 15% of their patients to be “difficult.”  The most common diagnoses among the “difficult” patients were schizophrenia (32%), bipolar disorder (19%), cognitive disorder (24%), and personality disorder (32%).  Patients with depression (11%) or anxiety (9%)—and, interestingly, patients who were in psychotherapy (11%)—were considered less difficult.  Not surprisingly, patients with alcohol and substance use disorders were also labeled difficult (23%), but patients with somatization (defined in this study as “unexplained physical complaints”) were less so (10%).

A fascinating review of 94 studies published between 1979 and 2004 described four reasons why patients may be considered “difficult”:  (1) chronicity– i.e., patients fail to improve over time; (2) severe, unmet dependency needs which patients then project onto the caregiver; (3) severe character pathology (especially borderline, narcissistic, and paranoid types); and (4) an inability to “reflect” (which the authors attribute to a history of insecure attachment early in life).  The authors also described three types of difficult patients:  the “unwilling care avoider” who doesn’t see himself as sick; the “ambivalent care seeker” who is often demanding and dependent, but is frequently self-destructive and self-sabotaging; and the “demanding care claimer” who is aggressive, attention-seeking and manipulative, but who sees himself as a patient only when necessary to achieve his own goals (legal, financial, or otherwise).

Of course, every patient interaction is a two-way street.  Regarding psychiatrists, the Salazar study found that young (<40 yrs old) psychiatrists, and those working in a group practice, claimed to have more difficult patients.  Another large study published in 2006 examined 1391 physicians to identify which features of doctors underlie their perceptions of patients as “frustrating.”  They found that high frustration was associated with doctors who were younger (<40 yrs old), worked >55 hrs/week, had symptoms of depression, stress, or anxiety (yes, that’s in the doctor, not the patient), and had “a greater number of patients with psychosocial problems or substance abuse.”  Two-way street, indeed.

It’s commonly said that “there’s no such thing as a stupid question.”  By the same token, I would posit that there’s no such thing as a difficult patient.  To be sure, some patients present with difficult problems, challenging histories, poor interpersonal skills, and needs that simply can’t be met with the interventions available to the physician.  But every patient suffers in his or her own way.  Doctors bring their own baggage to the interaction, too, in the form of strong opinions, personal biases, lack of knowledge, or—conversely—the perception that we know what’s going on, when in reality we do not.

When you add in the extrinsic factors that make the interaction even more strained—shorter appointments, care that is dictated by some third party rather than the doctor or the patient, poorly designed electronic medical record systems, or financial conflicts of interest that violate the doctor-patient trust—the “difficulties” just keep piling up.

It’s important that we look at every aspect of the doctor-patient interaction in order to improve the quality and efficacy of the care we provide.  Patients should not need to worry about whether they’re perceived as “difficult” or “frustrating.”  And when these perceptions do exist, we must critically examine the impact it has on their care, and what it says about the professionals we call upon to treat them.

19 Comments | mental health, psychiatry, subjectivity | Tagged: , , , , | Permalink
Posted by stevebMD

Another Day, Another Seroquel XR Indication?

June 1, 2011

Just when you thought the antipsychotic drug Seroquel had fully penetrated doctors’ offices and patients’ medicine chests (not to mention law offices and children’s tummies) all across America, a new clinical trial is recruiting subjects for yet another indication for this ubiquitous drug.

Technically, the trial is of Seroquel XR, not Seroquel.  (Because, you know, the two are COMPLETELY different drugs, as described in this YouTube video.)  But you get the idea.  Anything to keep the money flowing for Astra-Zeneca, especially after Seroquel goes generic in 2012.

Thanks to a tip from Stephany at Soulful Sepulcher, you can read all the details of this study here.  It’s called the “Quietude Study,” a trial of Seroquel XR for the treatment of agitated depression.  Specifically, they want to compare Seroquel XR (at doses up to 150 or 300 mg/day) with Lexapro (up to 20 mg/day), and the investigators predict that Seroquel XR will be more effective in the management of depression “with prominent agitation.”

Two things caught my eye right away:  First, the name of the study (“Quietude”) is obviously a play on words, since the generic name for Seroquel is quetiapine.  How cute.  I also noticed that the study is being conducted by Roger McIntyre, MD, whom I saw just yesterday on the medical website QuantiaMD giving a blatantly obvious “infomercial” for Geodon (for Quantia members, here’s the link), a competitor’s drug.  [And for more info on QuantiaMD, see Daniel Carlat’s recent post about this site.])

But let’s get more substantive, shall we?  A look at the details of this new “Quietude” study is revealing.  For one thing, the opening statement of the study’s “Purpose” is:  “Most individuals with major depressive disorder manifest clinically significant agitation.”  Really?  I’ve certainly seen cases of agitated depression, but are “most” depressed patients agitated?  Not in my experience.  Maybe when they say “agitation” they’re including patients with akathisia, an occasional side effect of some antidepressant medication.  I understand research proposals always have to start with a statement about how widespread the problem is, but this one seems a bit of a stretch.

The inclusion and exclusion criteria are also included in the study design.  One of the inclusion criteria, along with the typical symptomatic measures (i.e., HAM-D >20 and CGI-S >4), is “significant agitation.”  That’s it.  By whose measure?  Patient report?  Clinician’s evaluation?  I’d really like to know more about how the “agitated” folks are going to be selected.

Some interesting exclusion criteria are (a) “known lack of antidepressant response to escitalopram [Lexapro]” and (b) “known lack of antidepressant response to quetiapine [Seroquel].”  So they’re enriching their population for individuals who have not already tried Lexapro or Seroquel and failed to respond to the antidepressant effect. Perhaps this isn’t a huge problem, but Seroquel XR is not the greatest antidepressant (see below), and this exclusion criterion will probably weed out the patients who gained weight on Seroquel or “felt like a zombie”—two common complaints with this medication which often lead to its discontinuation.

But what disturbs me the most about this trial is the fact that it seems entirely unnecessary.  The fact of the matter is that Seroquel XR is–for better or for worse—already used for many cases of “agitated depression.”  And it’s not even entirely off-label, because Seroquel XR is approved for bipolar depression and for the adjunctive treatment of MDD (whether it actually works as an antidepressant is another story).  As mentioned above, quetiapine is a sedating drug in many patients, so of course a psychiatrist is going to think about it for “agitated depression.”  (Unless he/she wants to take the time to determine the causes of the patient’s agitation, which, unfortunately, often does not happen.)

But there’s more.  When Seroquel XR was first introduced, with much fanfare, for the treatment of depression, I remember being somewhat skeptical and asking my local AstraZeneca sales force whether it had any “antidepressant effect” other than its well-known sedative and appetite-enhancing effects (because, after all, those are two of the symptoms of depression typically measured in clinical trials).  I was reassured that, no, no, Seroquel XR is more than that; it acts on all depressive symptoms, probably through its metabolite norquetiapine.

In fact, a year ago I emailed a local “key opinion leader” who spoke extensively for AstraZeneca and was told the following (emphasis added; BTW, if it’s too technical for you, don’t worry, go ahead and skip):

I think the concept is that quetapine at low doses (25-50-100 mg) is almost entirely anti-histaminergic and anti-muscarinic. However at the 150-300 mg doses there is significant norepinephrine transporter inhibition from the metabolite norquetapine as well as 5HT 1A agonism and 5HT2A AND 5HT2-C antagonism which all increase dopamine. Thus at the higher doses of 150-300 mg there is significant antidepressant activity but also increases in frontal, limbic and striatal dopamine which can be stimulatory (as well as having anti-depressant effects). At the 600-800 mg doses there is significant D-2 antagonism which is where the antipsychotic effect (D-2 antagonism) kicks in. Thus as the doses escalate patients go from pure sedation to antidepressant to antipsychotic effects.  At least this is the theory based on the dose related relative strength and affinities for its respective receptors.

The premise of the “Quietude” study seems to be telling us something different—even though it’s what we already knew if we only paid attention to what our patients tell us (and not necessarily to AstraZeneca): namely, that the primary advantage of intermediate-dose Seroquel XR does seem to be its sedative effect.  And this might indeed make it effective for the treatment of the “psychological and physical restlessness” associated with depression.

Anyway, because the trial is only being run in Canadian sites, I won’t have to worry about whether to refer my patients to it.  But it’s also a trial whose results I won’t exactly be anxiously awaiting.

33 Comments | antipsychotics, clinical trial, depression | Tagged: , , , , , | Permalink
Posted by stevebMD

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