What Does a Diet Drug Have in Common With a Swiffer?

February 8, 2011

What does the new anti-obesity drug Contrave have in common with the Swiffer?

Yes, I’m talking about that Swiffer, the cleaning tool that is essentially a dry mop with disposable dusters that attach to a dispensible handle.

When the Swiffer was first introduced, it was a revolutionary product.  And it remains a top seller for Procter & Gamble, its manufacturer.  But in reality, it’s not exactly a revolutionary idea.  In fact, my mother, in fact (an expert cleaner in her own right, much to my childhood chagrin) used to remark that she could have become a millionaire if she had marketed her own idea for a “homemade Swiffer”:  wet paper towels or dryer sheets wrapped around a broom head.  The Swiffer is one of those miracles of “good design”— an idea that is elegant in its simplicity but surprisingly effective in its application, and I’m sure it has led thousands of housewives (okay, and househusbands, too) to lament, “why didn’t I think of that?”

Enter Contrave.  What exactly is Contrave?  It’s a weight loss drug being developed by Orexigen Pharmaceuticals, Inc.  It’s not available yet, but you may have read about it in the business pages a few weeks ago, when Orexigen’s stock price (symbol: OREX) took a 72% nose dive in a single day after the FDA rejected it, recommending further study of the drug to rule out cardiac toxicity.

Like the Swiffer, Contrave is nothing terribly new; it’s a re-packaged “combination drug” consisting of two commonly used medications that psychiatrists and other doctors have been prescribing for years:  bupropion and naltrexone.  Bupropion (more commonly known as Wellbutrin or Zyban) is frequently used for the treatment of depression (and has been shown to cause some weight loss on its own).  Naltrexone (ReVia or Vivitrol) is an opiate antagonist and has been used in the treatment of alcoholism, opiate dependence, and impulse-control disorders.

In a clincial trial published last year, the combination of 360 mg bupropion (a respectable dose for depression, although not a dose most doctors would start with, right out of the gate) and either 16 or 32 mg naltrexone (a slightly lower dose than we use in alcohol dependence), was associated with an average 5.0% or 6.1% weight loss, respectively, over a one-year period (vs. 1.3% in the placebo group).  A related study, whose results were submitted for FDA approval, used similar doses and found that half of the patients taking Contrave lost >5% of their body weight.

So here we have a novel agent that shows some efficacy in a notoriously hard-to-treat condition, but which is not really a novel agent at all.  Just like the Swiffer is a “gee-whiz” product that is clever, remarkably useful, but conceptually quite simple.

But this is where (in my opinion) the similarities should end.  Very few people would blame Procter & Gamble for developing a product that fills a niche but is really an overpriced combination of some readily available (and much cheaper) materials.  Frugal consumers can pass on the Swiffer and make their own, while plenty of others are willing to pay the premium for the convenience of the name-brand product.  And I think we’d all agree that people can spend their money on household cleaning supplies in whatever way they see fit.

But in medicine things are different.  When a product receives FDA approval for a given indication (especially a disease as prevalent as obesity), it’s an automatic market; plenty of doctors will prescribe it, and insurance companies & public insurers like Medicaid will cover it.  Simultaneously, you can bet that a well-orchestrated promotional campaign will rally millions of customers to “ask their doctor” about this “brand new diet drug” they saw on TV.  And Orexigen will most certainly charge a hefty premium over the component costs of bupropion and naltrexone alone, to recover the costs of clinical trials and to return a profit to its shareholders.  To be sure, as doctors learn that Contrave is actually a combo of two cheaper drugs they can easily prescribe, they might prescribe less of it, but not before a huge market is created and exploited.

Ingenuity is a wonderful thing, especially when it’s brought to bear on problems that are notoriously difficult to solve, whether it’s the obesity epidemic or that mess on your kitchen floor.  However, when a manufacturer repackages old products under a new name and charges a hefty premium for it, we need to be aware of this, and make decisions accordingly.  While most consumers don’t mind paying an extra few bucks for the convenience of a Swiffer, we should think twice about allowing our cash-strapped medical system to shell out the billions for a “blockbuster” drug like Contrave.

Is a Good Doctor Like a Good Teacher?

February 7, 2011

The Huffington Post published an interesting and thought-provoking article two weeks ago, entitled “What If We Treated Doctors The Way We Treat Teachers?” The author, an assistant professor of education at Towson University, suggests that, since doctors and teachers both provide a vital service to society (and, importantly, to all members of society, not just those who care about whether they might develop diabetes in 30 years, or whether they can get into a good college), doctors and teachers should be evaluated by similar measures.

In particular, he writes, doctors and others involved in patient care should be evaluated by their patient outcomes, for example, whether a doctor’s patients meet certain standards of general health, whether a community’s specific health care needs are being met, and whether medical schools produce competent physicians.  This emphasis on “outcomes” is in parallel with the education system’s emphasis on measuring student performance as a way to assess the effectiveness of teachers.

Even though his article was not meant to be taken literally, I believe that most of his proposals are quite sound.  No one would argue that it is NOT the responsibility of the medical profession to make sure that people are healthy, that underserved communities get the care they need, that hospitals are available to take care of the sick, and so forth.  And since we know the underlying causes of many diseases, and public health has identified numerous strategies that can prevent or delay the development of common conditions, one would think that we would welcome “outcome measures” as a way to demonstrate and prove how effective our interventions are.

[One underlying message of the article, however, which I won’t detail here, is that the same cannot be said for education; there are widely divergent opinions on the “right” way to educate a child, and even if there was one “right” way, the educational system (much less an individual teacher) absolutely cannot control what happens in the child’s home that may have a profound impact on how he or she learns.]

So why don’t we evaluate doctors on these measures?  Well, for one thing, how do we measure “success” or “health”?  When people are sick, they have abnormalities or lesions that we can see, measure, and fix.  We can remove the tumor or help the blood pressure get back to normal, but is that the right measure of “health”?  Another reason doctors aren’t subject to outcome measures is because it’s far easier to assess doctors on other measures that have little to do with patient care but serve some other special interest.  For instance, I’m evaluated by various parties on how many prescriptions I write, how many days my patients stay in the hospital, how completely I fill out the mental status exam form in my patient charts, how many buttons I click in my electronic medical record system, and so on.  Everything EXCEPT how well my patients do.

And then, of course, there’s the fact that so many other factors which are beyond the control of the physician (and usually outside of the patient’s control, too) prevent positive outcomes:  insurance companies refuse to cover the cost of effective drugs and other treatments; direct-to-consumer advertising leads patients to demand medications that may not be helpful (and which might actually cause harm); and the lack of accessible and affordable primary care treatment, or other services such as therapy or rehab prevents patients from accessing vital components of effective care.

I’ll go on record to say that doctors ought to be evaluated on how healthy their patients are.  After all, that’s why we do what we do.  But before we start measuring patient outcomes, let’s first decide what we want to measure, and whether it’s valid.  Simple measurements like blood pressure or cholesterol level are a start, but don’t tell the whole story; neither do “patient satisfaction scores,” as sometimes the best medical advice is something patients don’t want to hear.  Second, let’s make sure patients and doctors have access to the resources that would promote positive outcomes.  We know the elements of wise, cost-effective, preventive care, so we should implement them.  Finally, if we are to measure patient outcomes, then let’s stop assessing and rewarding physicians on other measures that have nothing to do with patient care.

All doctors want to treat patients, just as all teachers want to educate students.  Measuring outcomes—i.e., how effectively do we do what we set out to do—is one way to ensure good doctors and good teachers, but let’s make sure we’re measuring the right things, we have access to the tools we need to do the job, and we remove all the other obligations that interfere with the job we have undertaken.  Whether that can be done (in medicine or in education) is anybody’s guess.

When Does Treatment End?

February 5, 2011

When is it okay to discontinue psychiatric treatment?  Is a patient ever “cured” of a psychiatric illness?  It sounds like a straightforward question, but it’s also one that is rarely asked, at least by psychiatrists.

To be honest, I hadn’t really given it much thought myself, until recently.  A large proportion of my patients actually improve with treatment (thank goodness!), and sometimes I ask myself, “Does he need to see me anymore?”  And isn’t that the goal of medicine?  To cure someone?  To rehabilitate him?  To “fix” him?  To be able to say to someone, “Congratulations, you’re cured!”  Sure, I can decrease the frequency of his office visits because he seems “stable,” but why can’t I let go completely?

We don’t do that often enough in psychiatry, and I can’t figure out why.  The “bio-psycho-social” model of psychiatry, the three-tiered foundation on which modern psychiatric care is built (although not immune to criticism), incorporates psychological and social components, two factors which are often amenable to change, especially with a motivated patient.  Do we not believe that we can cause biological change, too?  And perhaps reach the point where we’ve corrected whatever biological defect we identified, and let our patient go forth and be happy, in the absence of psychiatric medication?  Or do we honestly believe that the biological defect is so tenacious, so permanent, that we must continue to medicate indefinitely?

To be sure, there are cases of chronic mental illness in which ongoing, life-long medication management is necessary to guarantee the safety and well-being of a patient.  There are also cases in which short-term treatment is the rule.  In my practice, for instance, I do not initiate treatment with a medication like a benzodiazepine or Suboxone without some discussion of how and when the medication will be discontinued—sort of an “exit strategy,” so to speak.

But there are countless other patients who reach a sort of therapeutic “plateau”:  they feel overwhelmingly better than they did when they first presented for care, they’ve “responded to treatment,” and while they may not have eliminated 100% of their symptoms or solved all of their presenting problems, they feel well enough that they can be trusted to move onward.  Is another six months on antidepressants really going to make a difference in this patient?  Is a psychostimulant really necessary now that this patient has developed new organization and study skills?  Has this patient adopted new ways to cope with his aggression or obsessiveness such that medications are no longer necessary?  These are the questions that we really ought to be asking more frequently than we do.

Most psychopharmacologists would argue that therapeutic success is not only the result of medication management, but, significantly, the justification for continuing with medication management. In other words, a patient achieves remission from depression because of the medication, not because of the steps he has taken to improve his lifestyle, his self-esteem, his relationships, etc.  (Or, to be more accurate, the medication permits him to make—and maintain—the lifestyle changes that helped to emerge from his illness.)  Stopping medication and discharging a patient is a breach of the therapeutic contract.  Aren’t we taught that relapse is a part of this disease?  Yes, it is, for some patients.  But how do we determine which ones?

Psychologists and psychotherapists receive extensive training in ending the therapeutic relationship with a client —a process they refer to as “termination.” A key component is determining whether a client is appropriate for termination, and whether the original treatment goals have been met.  The process of termination celebrates the success of the therapy and, symbolically and practically, awards the client with a new identity, granting him or her with the newfound ability—and responsibility—to face obstacles that initially seemed insurmountable.  Why we don’t challenge ourselves to do the same thing in psychiatry is a mystery to me.

The American Psychiatric Association recently published its revised treatment guidelines for major depression.  In the entire 100-page document, the section on “Discontinuation” is only one paragraph, on page 20.  It says nothing about when to discontinue, how to discontinue, or which patients are the best candidates for discontinuation.  Instead, it simply advises the doctor to inform the patient “of the potential for a depressive relapse and [establishing] a plan for seeking treatment in the event of recurrent symptoms.”  Good advice, but it says nothing about what constitutes success.

Perhaps we continue care indefinitely because we believe lifelong pharmacotherapy is essential to correct the abnormality that exists in the brain.  Unfortunately, with few exceptions, science really hasn’t been able to make that connection.  Perhaps we continue care because we don’t believe in our patients’ ability to maintain the gains they have achieved without our help.  This, too, is unfortunate, as it inherently denies the patient’s own capacity for improvement and change.

Whatever the reason, it’s time for our field to think seriously about how we “end” care.  Not to admit failure—on the contrary, to refocus our efforts on achieving a successful outcome for the patient while preserving the patient’s autonomy and independence whenever possible.  It’s respectful, responsible, and the right thing to do.

Lessons of Rebecca Riley

February 2, 2011

I’ve been following the Rebecca Riley case in Massachusetts, although not as closely as I would like to, since I find the details so incredibly disturbing.  For those of you who aren’t familiar with it, four year-old Rebecca died in 2006 after an overdose of the psychotropic medications clonidine, Depakote, and Seroquel.  Her parents were convicted of murder in 2010 even though they argued that they were simply “following the instructions” of Rebecca’s child psychiatrist, Dr Kiyoko Kifuji of Tufts Medical Center.  Dr Kifuji had diagnosed Rebecca with bipolar disorder and prescribed three powerful medications to her, starting at the age of 2.

It has also come to light that Rebecca’s parents had exploited the social service system to obtain federal disability benefits for their three children– Rebecca and two older siblings, who were also diagnosed with bipolar disorder and ADHD by Dr Kifuji.  Also, Dr Kifuji’s medical license was suspended for two years after Rebecca’s death, although she eventually returned to practice medicine at Tufts, where she still sees patients.  Finally, Tufts settled a malpractice suit with the family last week for $2.5 million.

Many news stories disturb me, but this one makes me particularly angry, because all parties share part of the blame.  Obviously, I did not evaluate Rebecca myself (and, in the interest of full disclosure, I am not a child psychiatrist, nor have I even raised a two-year-old of my own), but the facts of the case, as I understand them, fill me with contempt for just about everyone involved.  Everyone that is, except for Rebecca.

The objects of my rage?  Let’s go down my list, one at a time:

  • Dr Kiyoko Kifuji – Even if we grant the possibility that bipolar disorder can be diagnosed in a two year-old (a questionable premise, even according to the experts), the evidence suggests that Dr Kifuji permitted Rebecca’s parents to give the medications as they saw fit (and agreed with their decisions to increase doses), authorized prescriptions over the phone without evaluating Rebecca, and was cautioned by pharmacies that Rebecca’s parents were going through meds more quickly than expected.  Social workers and a school nurse also alerted Dr Kifuji to the fact that Rebecca seemed oversedated and “like a floppy doll,” but Dr Kifuji allegedly made no adjustments to Rebecca’s treatment plan.
  • Michael and Carolyn Riley (Rebecca’s parents) – Seven abuse and neglect complaints were filed with the Massachusetts Dept of Children and Families, starting in 2002, alleging that the Rileys seemed unable to care for their children; apparently they, too, were also taking doses of medications that, at times, impaired their judgment.  Furthermore, it has come to light that everyone in the Riley family (except Rebecca) had applied for, and received, federal disability payments, in what appears to be a deliberate attempt to defraud the system to earn extra income.  They had filed an application for Rebecca, which was denied, but the Rileys appealed the decision.  However, after Rebecca’s death, in a jailhouse interview in September 2007, Carolyn Riley confessed to Katie Couric that she was not sure whether Rebecca had bipolar disorder after all: “maybe she was just hyper for her age.”
  • Massachusetts Department of Children and Families– While not directly responsible for Rebecca’s death, the warning signs were clearly visible that the Rileys were unfit to care for their children, including the abuse and neglect complaints noted above, as well as specific complaints from Rebecca’s therapist that, on a home visit, Carolyn Riley seemed “drugged and unable to care for [her] children.”  Agencies like this are incredibly overburdened and underfunded, but when they drop the ball, as they did in this case, lives may be at stake.
  • The psychiatric profession – As I’ve written on this blog, we as a discipline have not only expanded diagnostic criteria for mental illness (and are continuing to do so), but sometimes err on the side of over-diagnosis and over-treatment, rather than exploring alternate explanations for behavior or less potent treatment options.  One may argue that Dr Kifuji was practicing within the accepted standard of care.  Because I am not a child psychiatrist, I cannot comment on that, but there has been a 40-fold increase in diagnosis of childhood bipolar disorer from 1994 to 2003, which only a few in our profession have questioned or challenged.
  • The pharmaceutical industry – Drug companies are easy targets for frustration and rage, but in this case it could be argued that it was the inappropriate use of three commonly used (and frequently effective) medications which led to Rebecca’s death.  Two of the three medications she was taking (clonidine and valproic acid) are off-patent, so no one can accuse a drug company of “pushing” a medication on Rebecca for the sake of profit.  Nevertheless, efforts by Big Pharma to promote and expand the use of their medications can unfortunately bias some providers to overuse their agents, and the promotion of drugs while downplaying the risk of adverse effects is inexcusable.  (Even so, in my opinion, we doctors need to be held responsible for what we prescribe and why.)
  • Massachusetts Board of Registration of Medicine – Dr Kifuji entered a “voluntary agreement” to stop practicing psychiatry from February 2007 to September 2009.  The Board conducted an investigation into the case but “closed the complaint against Dr Kifuji without discipline.”  She has since returned to practice.  In my experience, I have seen state medical boards revoke licenses from doctors whose misbehaviors were not nearly as (allegedly) egregious as Dr Kifuji’s, or which involved only their personal lives and not patient care.  When I see the reports of this case and recognize that Dr Kifuji still practices psychiatry (in the same location and with the same patient population) I am concerned about the double standard being practiced by licensing bodies.
  • Tufts Medical Center – Obviously, Kifuji’s care was provided by an institution that also shares some responsibility for the ethical and beneficent provision of medical care. At the same time, it is shocking that Kifuji has retained her faculty position at Tufts.  Again, in my experience, hospitals and other institutions tend to be overly conservative when there is even the question of inappropriate behavior by one of their providers, if only to maintain good public relations.  Perhaps her employment will be terminated or limited now that a malpractice settlement has been reached, but it does strike me as one of those cases in which I see nothing that Tufts could gain by Dr Kifuji’s continued employment.
  • Malpractice Attorneys – Another easy (but valid) target.  Even assuming that malpractice was committed and the charges were valid, the fear of cases of this magnitude may make doctors less likely to treat the cases which actually do require aggressive care (and also contributes to defensive medicine, resulting in greater health care costs).  One might ask, however, whether the case, brought on behalf of Rebecca’s estate, had any merit, since her parents had already been convicted of her murder.  But as with most things in life, where there’s an opportunity for a payout, there are those who will spring into action:  A settlement of $2.5 million at 35% contingency fee, plus other expenses = $875K +.  And maybe the lawyer will be the guardian of funds, or set up a trust for Rebecca’s siblings, for an additional fee.  As a doctor wrote on a different website, “Three years of law school suddenly sounds like a better investment than medical school, internship, residency, and fellowship training.”

So many opportunities for Rebecca’s life to have turned out differently.  And so much blame to go around.  Unfortunately, the only one without any culpability at all is Rebecca herself.

%d bloggers like this: