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This phenomenon used to be called “noncompliance,” a term which has been replaced by the more agreeable term, “nonadherence.”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.


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.


How Much Should Addiction Treatment Cost?

May 22, 2011

Drug and alcohol abuse are widespread social, behavioral, and—if we are to believe the National Institutes of Health and most addiction professionals—medical problems.  In fact, addiction medicine has evolved into its own specialty, and a large number of other allied health professionals have become engaged in the treatment of substance abuse and dependence.

If addiction is a disease, then we should be able to develop ways to treat addictions effectively, and the costs of accepted treatments can be used to determine how we provide (and reimburse for) these services.  Unfortunately, unlike virtually every other (non-psychiatric) disease process—and despite tremendous efforts to develop ways to treat addictions effectively—there are still no universally accepted approaches for management of addictive disorders.  And the costs of treating an addict can range from zero to tens (or hundreds) of thousands of dollars.

I started thinking of this issue after reading a recent article on abcnews.com, in which addiction psychiatrist Stefan Kruszewski, MD, criticized addiction treatment programs for their tendency to take people off one addictive substance and replace it with another one (e.g., from heroin to Suboxone; or from alcohol to a combination of a benzodiazepine, an antidepressant, and an antipsychotic), often at a very high cost.  When seen through the eyes of a utilization reviewer, this seems unwise, expensive, and wasteful.

I agree with Dr Kruszewski, but for a slightly different reason.  To me, current treatment approaches falsely “medicalize” addiction and avoid the more significant psychological (or even spiritual) meaning of our patients’ addictive behaviors.  [See my posts “Misplaced Priorities in Addiction Treatment” and “When Does Treatment End.”]  They also cost a lot of money:  Suboxone induction, for instance, can cost hundreds of dollars, and the medication itself can cost several hundred more per month.  Likewise, the amounts being spent to develop new pharmacotherapies for cocaine and stimulant addiction are very high indeed.

Residential treatment programs—particularly the famous ones like Cirque Lodge, Sierra Tucson, and The Meadows—are also extremely expensive.  I, myself, worked for a time as a psychiatrist for a long-term residential drug and alcohol treatment program.  Even though we tried to err on the side of avoiding medications unless absolutely necessary (and virtually never discharged patients on long-term treatments like Suboxone or methadone), our services were quite costly:  upwards of $30,000 for a four-month stay, plus $5000/month for “aftercare” services.  (NB:  Since my departure, the center has closed, due in part to financial concerns.)

There are cheaper programs, like state- and county-sponsored detox centers for those with no ability to pay, as well as free or low-cost longer-term programs like the Salvation Army.  There are also programs like Phoenix House, a nonprofit network of addiction treatment programs with a variety of services—most of which are based on the “therapeutic community” approach—which are free to participants, paid for by public and private funding.

And then, of course, are the addicts who quit “cold turkey”—sometimes with little or no support at all—and those who immerse themselves in a mutual support program like Alcoholics Anonymous (AA).  AA meetings can be found almost everywhere, and they’re free.  Even though the success rate of AA is probably quite low (probably less than 10%, although official numbers don’t exist), the fact of the matter is that some people do recover completely without paying a dime.

How to explain this discrepancy?  The treatment “industry,” when challenged on this point, will argue that the success rate of AA alone is abysmal, and without adequate long-term care (usually in a group setting), relapse is likely, if not guaranteed.  This may in fact be partially true; it has been shown, for instance, that the likelihood of long-term sobriety does correlate with duration of treatment.

But at what cost?  Why should anyone pay $20,000 to $50,000 for a month at a premiere treatment center like Cirque Lodge or Promises Malibu?  Lindsay Lohan and Britney Spears can afford it, but few else—and virtually no insurance plans—can.

And the services offered by these “premiere” treatment programs sound like a spa menu, rather than a treatment protocol:  acupuncture, biofeedback, equine therapy, massage, chiropractic, art therapy, nature hikes, helicopter rides, gourmet meals or private chef services, “light and sound neurotherapy,” EMDR, craniosacral therapy, reiki training, tai chi, and many others.

Unfortunately, the evidence that any one of these services improves a patient’s chance of long-term sobriety is essentially nil.  Moreover, if addiction is purely a medical illness, then learning how to ride a horse should do absolutely nothing to help someone kick a cocaine habit.  Furthermore, medical insurance should not pay for those services (or, for that matter, for group therapy or a therapeutic-community approach).

Nevertheless, some recovering addicts may genuinely claim that they owe their sobriety to some of these experiences:  trauma recovery treatment, experiential therapy, “male bonding” activities (hat tip to the Prescott House), and yes, even the helicopter rides.

The bottom line is, we still don’t know how to treat addiction, or even what it really is in the first place.  Experts have their own ideas, and those in recovery have their own explanations.  My opinion is that, in the end, treatment must be individualized.  For every alcoholic who gets sober by attending daily AA meetings, or through religious conversion, there’s another addict who has tried and failed AA numerous times, and who must enroll in multiple programs (costing tens of thousands of dollars) to achieve remission.

What are we as a society willing to pay for?  Or should we simply maintain the free-market status quo, in which some can pay big bucks to sober up with celebrities on the beaches of Malibu, while others must detox on the bathroom floor and stagger to the AA meetings down the street?  Until we determine how best to tailor treatment to the individual, there’s no shortage of people who are willing to try just about anything to get help—and a lot of money to be made (and spent) along the way.


FDA approval of psych meds – an alternative

January 17, 2011

The FDA’s approval process for new psychiatric drugs is broken.  It is time-consuming and costly, and benefits no one—patients, physicians, pharmaceutical companies, managed care organizations, or other payers.

To bring a new compound to market, pharmaceutical companies and academic labs invest years (and millions of dollars) in basic research.  When a compound appears promising, it enters “Phase I” testing, to assess the drug’s basic properties and safety profile in healthy human subjects; this phase may take one to two years.  If successful, the drug enters “Phase II” testing, which measures responses to the drug in a small target population of patients.  After this step comes “Phase III” testing, usually the most expensive and prolonged phase, in which the drug is tested (usually against a placebo) to determine its safety and efficacy for a given indication.  This may take many more years, and many more millions of dollars, to complete.

For psychiatric drugs, this process is somewhat of an anachronism.  There is extensive overlap among psychiatric diagnoses (and the changes on the horizon with DSM-5 won’t make things any clearer), so it makes little sense to focus on a drug’s efficacy for a single indication (e.g., generalized anxiety disorder) when it could prove quite helpful in another (e.g., major depression).  The end result is that doctors think about patients in terms of diagnoses (and assign diagnoses that are sometimes inaccurate) rather than about the symptoms (or the patients) they are treating.  Managed care companies, too, force us to pigeonhole patients into a given diagnosis in order for them to pay for a medication.  Finally, pharmaceutical companies must conduct expensive, prolonged Phase III trials for each indication they wish to receive (driving up costs of all medications), and are subject to significant penalties when they even suggest that their drug might be used in a slightly different population.

Here is one way the drug approval process could be improved for all involved.  Rather than recruit a uniform population of subjects with a given diagnosis (which does not resemble the “real world” in any way), we can require drug companies to test the drug to a large number of subjects with a broad range of psychiatric conditions (as well as normal controls), perform a much more extensive battery of tests on each subject, release all the data, and then allow doctors to determine how to use the drugs.

For instance, let’s say a company believes, on the basis of its research, that “olanzidone” might be an effective antipsychotic.  So they recruit several hundred subjects—some with schizophrenia, some with depression, some with bipolar disorder, some with a personality disorder, some with multiple disorders, and so on, and some with no psychiatric diagnosis at all—and subject them to a battery of baseline tests:  a physical exam; comprehensive laboratory measures; genetic screens; cognitive tests; personality tests; tests of anxiety, depression, OCD symptoms, panic symptoms, PTSD symptoms, and so on; as well as a full diagnostic clinical interview.  They administer olanzidone at a range of doses (determined to be safe on the basis of phase I testing) and over a range of time periods, then perform the same battery of tests after the trial.  All results are then published and made available to clinicians.

The results might show that olanzidone is an effective antipsychotic, but only in patients with a concurrent mood disorder.  They might show that olanzidone worsens anxiety.  They might show that olanzidone causes weight gain, but only in patients with the HTR2C -759C/T polymorphism.  They might show that olanzidone worsens negative symptoms of psychosis, but improve cognitive abilities.  Get the picture?

It sounds, at first, like this alternative would be just as complex and time-consuming as the current way of doing things.  But I don’t think so.  For one thing, drug companies wouldn’t have to spend as much time and money finding the “perfect” subject population, and can test a drug’s safety profile in a diverse group of subjects.  Also, companies wouldn’t have to invest millions of R&D dollars to obtain each new indication.  Furthermore, they would be required to make all data public, preventing them from hiding data which don’t support a medication’s proposed indication.  Finally, this proposal would allow doctors to make medication decisions based on a much more extensive and accuate data set, rather than the information that is offered to them in glossy drug-company brochures.

The drawbacks?  We might end up with far more compounds on the market, some of questionable efficacy.  But drug companies would most likely invest their efforts in developing compounds that have some chance of improving what’s on the market (instead of just finding a new “niche” indication).  Drug companies may also fear the loss of market share or the costs of testing drugs on larger populations of patients.  But, in reality, this may actually create new markets for drugs and would obviate the need to push for new indications every few years.

This change would also make for more truthful (and informative) marketing material.  Instead of an ad proclaiming “Olanzidone newly approved for the treatment of schizophrenia!!” (which doesn’t mean very much, frankly), I might read an ad explaining “Olanzidone shows a 30% decrease in average PANSS score; no effect on mood symptoms; a significant improvement in executive function but not memory; a modest decrease in Beck Anxiety Inventory score; and a significant improvement in Pittsburgh Sleep Quality Index.”  Not quite as sexy, but certainly more helpful in my practice.

This will, of course, never happen, because there are simply too many vested interests in the status quo.  But now is the time to start thinking of ways to make the approval process more transparent to the public, and to help doctors (as well as patients and payers) make more informed decisions about the drugs we use.


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