Big Brother Is Watching You (Sort Of)

February 17, 2012

I practice in California, which, like most (but not all) states has a service by which I can review my patients’ controlled-substance prescriptions.  “Controlled” substances are those drugs with a high potential for abuse, such as narcotic pain meds (e.g., Vicodin, Norco, OxyContin) or benzodiazepines (e.g., Xanax, Valium, Klonopin).  The thinking is that if we can follow patients who use high amounts of these drugs, we can prevent substance abuse or the illicit sale of these medications on the street or black market.

Unfortunately, California’s program may be on the chopping block.  Due to budget constraints, Governor Jerry Brown is threatening to close the Bureau of Narcotic Enforcement (BNE), the agency which tracks pharmacy data.  At present, the program is being supported by grant money—which could run out at any time—and there’s only one full-time staff member managing it.  Thus, while other states (even Florida, despite the opposition of Governor Rick Scott) are scrambling to implement programs like this one, it’s a travesty that we in California might lose ours.

Physicians (and the DEA) argue that these programs are valuable for detecting “doctor shoppers”—i.e., those who go from office to office trying to obtain Rx’es for powerful opioids with street value or addictive potential.  Some have even argued that there should be a nationwide database, which could help us identify people involved in interstate drug-smuggling rings like the famous “OxyContin Express” between rural Appalachia and Florida.

But I would say that the drug-monitoring programs should be preserved for an entirely different reason: namely, that they help to improve patient care.  I frequently check the prescription histories of my patients.  I’m not “playing detective,” seeking to bust a patient who might be abusing or selling their pills.  Rather, I do it to get a more accurate picture of a patient’s recent history.  Patients may come to me, for example, with complaints of anxiety while the database shows they’re already taking large amounts of Xanax or Ativan, occasionally from multiple providers.  Similarly, I might see high doses of pain medications, which (if prescribed & taken legitimately) cues me in to the possibility that pain management may be an important aspect of treating their psychiatric concerns, or vice versa.

I see no reason whatsoever that this system couldn’t be extended to non-controlled medications.  In fact, it’s just a logical extension of what’s already possible.  Most of my patients don’t recognize that I can call every single pharmacy in town and ask for a list of all their medications.  All I need is the patient’s name and birthdate.  Of course, there’s no way in the world I would do this, because I don’t have enough time to call every pharmacy in town.  So instead, I rely largely on what the patient tells me.  But sometimes there’s a huge discrepancy between what patients say they’re taking and what the pharmacy actually dispenses, owing to confusion, forgetfulness, language barriers, or deliberate obfuscation.

So why don’t we have a centralized, comprehensive database of patient med lists?

Some would argue it’s a matter of privacy.  Patients might not want to disclose that they’re taking Viagra or Propecia or an STD treatment (or methadone—for some reasons patients frequently omit that opioid).  But that argument doesn’t hold much water, because in practice, as I wrote above, I could, in theory, call every pharmacy in one’s town (or state) and find that out.

Another argument is that it would be too complicated to gather data from multiple pharmacies and correlate medication lists with patient names.  I don’t buy this argument either.  Consider “data mining.”  This widespread practice allows pharmaceutical companies to get incredibly detailed descriptions of all medications prescribed by each licensed doctor.  The key difference here, of course, is that the data are linked to doctors, not to patients, so patient privacy is not a concern.  (The privacy of patients is sacred, that of doctors, not so much; the Supreme Court even said so.)  Nevertheless, when my Latuda representative knows exactly how much Abilify, Seroquel, and Zyprexa I’ve prescribed in the last 6 months, and knows more about my practice than I do (unless I’ve decided to opt out of this system), then a comprehensive database is clearly feasible.

Finally, some would argue that a database would be far too expensive, given the costs of collecting data, hiring people to manage it, etc.  Maybe if it’s run by government bureaucrats, yes, but I believe this argument is out of touch with the times.  Why can’t we find some out-of-work Silicon Valley engineers, give them a small grant, and ask them to build a database that would collect info from pharmacy chains across the state, along with patient names & birthdates, which could be searched through an online portal by any verified physician?  And set it up so that it’s updated in real time.  Maintenance would probably require just a few people, tops.

Not only does such a proposal sound eminently doable, it actually sounds like it might be easy (and maybe even fun) to create.  If a group of code warriors & college dropouts can set up microblogging platforms, social networking sites, and online payment sites, fueled by nothing more than enthusiasm and Mountain Dew, then a statewide prescription database could be a piece of cake.

Alas, there are just too many hurdles to overcome.  Although it may seem easy to an IT professional, and may seem like just plain good medicine to a doc like me, history has a way of showing that what makes the best sense just doesn’t happen (especially when government agencies are involved).  Until this changes, I’ll keep bothering my local pharmacists by phone to get the information that would be nice to have at my fingertips already.

11 Comments | addiction, computers, medications | Tagged: , , , , , , | Permalink
Posted by stevebMD

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

Off-Label Meds: Caveat Prescriptor

March 13, 2011

In medicine we say that a drug is “indicated” for a given disorder when it has gone through rigorous testing for that condition. Typically, a drug company will perform clinical trials in which they select patients with the condition, give them the new drug, and compare them with similar patients who are given a placebo (or an established drug which is already used to treat the disease). In the US, when the FDA approves a drug, the drug company is then permitted to advertise it in magazines, journals, TV, the internet, and directly to doctors, but they must specify its “approved” use.

In the past few years, several drug companies have found themselves in trouble after accusations of marketing their drugs for off-label indications. Total fines have reached into the billions, and many companies have vowed to change their marketing practices in response.

It should be emphasized, however, that doctors use drugs off-label very frequently. This is particularly true in psychiatry, where an estimated 31% of all prescriptions are off-label. Some familiar examples include trazodone (an antidepressant) for insomnia or beta blockers (originally approved for hypertension and heart failure) for anxiety. Furthermore, some very common symptoms and conditions, such as personality disorders, impulsivity, nightmares, eating disorders, and PTSD, have no (or few) “indicated” medications, and yet we often treat them with medications, sometimes with great success. And since the FDA restricts its approvals to medications and devices, even psychotherapy—something we routinely recommend and “prescribe” to patients—is, technically, off-label.

One colleague took this one step further and explained that virtually any psychiatric drug which has been prescribed for more than 8 or 12 weeks is being used “off-label” since the studies to obtain FDA approval are generally no longer than that. Admittedly, that’s nitpicking, but it does demonstrate how the FDA approval process works with a very limited amount of clinical data.

Drug companies that deliberately market their drugs for off-label indications are indeed guilty of misrepresenting their products and deceiving doctors and consumers. But to blame them for bad patient outcomes conveniently ignores the one missing link in the process: the doctor who decided to prescribe the drug in the first place. Whether we like it or not, drug companies are businesses, they sell products, and as with everything else in our consumerist society, the buyer (in this case the doctor) must beware.

Here’s an example. A new drug came to market in February called Latuda, which has been FDA approved for the treatment of schizophrenia. Before a few months ago, most community psychiatrists (like me) knew absolutely nothing about this drug.

If a sales rep visits my office tomorrow and tells me that it’s approved for schizophrenia and for bipolar disorder, she is obviously giving me false information. This is not good. But how I choose to use the drug is up to me. It’s my responsibility—and my duty, frankly—to look at the data for schizophrenia (which exists, and which is available on the Latuda web site and in a few articles in the literature). If I look for data on bipolar disorder, I’ll find that it doesn’t exist.

That’s just due diligence. After reviewing the data, I may conclude that Latuda looks like a lousy drug for schizophrenia (I’ll save those comments for later). However, I might find that it may have some benefit in bipolar disorder, maybe on particular symptoms or in a certain subgroup of patients. Or, I might find some completely unrelated condition in which it might be effective. If so, I should be able to go ahead and use it—assuming I’ve exhausted the established, accepted, and less costly treatments already. Convincing my patient’s insurance company to pay for it would be another story… but I digress.

I don’t mean to imply that marketing has no place in medicine and that all decisions should be made by the physician with the “purity” of data alone. In fact, for a new drug like Latuda, sales reps and advertising materials are effective vehicles for disseminating information to physicians, and most of the time it is done responsibly. I just think doctors need to evaluate the messages more critically (isn’t that something we all learned to do in med school?). Fortunately, most sales reps are willing to engage doctors in that dialogue and help us to obtain hard data if we request it.

The bottom line is this: psychiatric disorders are complicated entities, and medications may have potential far beyond their “approved” indications. While I agree that pharmaceutical marketing should stick to proven data and not anecdotal evidence or hearsay, doctors should be permitted to use drugs in the ways they see fit, regardless of marketing. But—and this is critical—doctors have a responsibility to evaluate the data for both unapproved and approved indications, and should be able to defend their treatment decisions. Pleading ignorance, or crying “the rep told me so,” is just thoughtless medicine.

7 Comments | clinical trial, FDA, marketing, medications | Tagged: , , , , , | Permalink
Posted by stevebMD

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