1 Boring Old Man

The Inadequacy of EBM
Recently, Richardson and Doster suggested the consideration of three dimensions in the process of evidence-based decision:

1. baseline risk of poor outcomes from an index disorder without treatment
2. responsiveness to the treatment option
3. vulnerability to the adverse effects of treatment.

EBM is focused on the potential benefits that therapy may entail as to baseline risk, but it is likely to neglect the other two dimensions. A rational approach to treatment takes into account the balance between potential benefits and adverse effects applied to the individual patient. The achievement of such balance is hindered by the difficult integration of different sources of information. Guidelines tend to place emphasis on systematic reviews and meta-analyses of RCT, which are uniquely geared to highlighting benefits. The clinician needs to have a clear account of the potential benefits of a specific treatment, as well as of the predictors of responsiveness and of the potential adverse events that may be triggered by the therapeutic act. The conceptual model that has generated EBM and guidelines clashes with clinical reality and fosters a dichotomy between medical science and clinical judgment.

The example that immediately came to mind was actually a popular long-running CME Class that I had written about in December 2010 [see cme…]:

It had the reputation of being an upbeat program with a lot of What’s new? and What’s coming down the road? presentations by psychiatry’s front running KOLs. But in December 2010, it struck a discordant note to my ear. By then, the wheels were coming off of KOL Psychiatry. In June of 2008, Senator Grassley and Paul Thacker had exposed widespread unreported PHARMA income and the poster boys were Charlie Nemeroff and Alan Schatzberg [Top Psychiatrist Didn’t Report Drug Makers’ Pay, Grassley Questions Stanford Psychiatrist’s Industry Ties] with both stepping down from their chairs in the aftermath. Then in June of 2009, Allen Frances had joined Robert Spitzer in contesting the directions of the DSM-5 Revision process [A Warning Sign on the Road to DSM-V: Beware of Its Unintended Consequences], and KOL Psychiatry had become COI Psychiatry. To top things off, in November 2010, another shoe had dropped. It seems that a book by Charlie Nemeroff and Alan Schatzberg [Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care] was ghost-written, paid for by GSK [Drug Maker Hired Writing Company for Doctors’ Book, Documents Say]. So in December 2010 when I read that flyer, I would’ve thought that the Grassley cohort would be discredited. But there they were. I wrote Dr. Salzman a WTF? email and he wrote back assuring me that they were reformed and receiving no PHARMA support [which was hardly my point].

Soon thereafter, I saw two cases in quick succession that taught me an important lesson. I wrote about the first one [evidence-based medicine VI: a case…]. A longtime friend of my daughter’s had come up to see her during a visit. I heard them talking on the porch. she was saying that her Psychiatrist had "finally gotten her meds right" [I think she mumbled the word "Bipolar"]. She said she was on two medications that she named [I cringed]. A couple of months later, my daughter called from North Carolina. She’d gotten a call from her friend [in Atlanta] who was driving around crazed and suicidal. Would I call her? I tried and failed, but found out that she’d driven to a mental hospital and checked herself in. One of those medications was Abilify. She had been gaining a lot of weight so she stopped it. That episode was Abilify Withdrawal that cleared with one pill.  The second case was a Social Worker I worked with. She called me from the side of the road out of town in an agitated state saying she was going crazy. She’d been taking Effexor from her Primary Care Physician for a while. She decided that she didn’t need it anymore and took her last pill the night before. On the phone through her tears she asked, "Could that be it!" She was across the street from a pharmacy, so I called the pharmacist and got her a couple of pills. Not much later, she called back, "That was it!"

How does that get to the Harvard CME Course? I hadn’t really seen withdrawal symptoms from psychiatric meds – only heard about them. I didn’t/don’t prescribe antipsychotics to non-psychotic people. I didn’t/don’t prescribe the short-acting antidepressants like Effexor and Paxil. And I’ve always tapered all psych meds routinely. So I had no feel for the syndrome. After those cases, I started reading about withdrawal. Most of what I found was from patient reports, and from Alto’s SurvivingADs site. So I got in touch with an old friend who was serving as president of our State Association at the time to suggest a program at one of the meetings on the withdrawal syndromes. He was nice but told me that they didn’t have that kind of program. "That’s for CME," he said. He then told me that he got his yearly CME by going to the Harvard Master Class. I asked if they taught about withdrawal, and he said "no." When I got off the phone, I realized that he really didn’t know what I was talking about – about the withdrawal syndromes. And why was that interchange five years ago on my mind when I read Dr. Fava’s editorial? That one’s easy. The flyer for this year’s Harvard Master Class was already  open on my computer’s desk-top for a future post:

^{[click image for the full sized original]}

It’s five years later, and the same people are still at it! still talking about the same topics! still upbeat, still populated with the alumni from Senator Grassley’s Senate investigation – Alan Schatzberg, Charlie Nemeroff. Old standby’s Jeffrey Lieberman and Stephen Stahl are still in the house. I have no transcript, but I can guarantee that this group of speakers will do exactly what Dr. Fava was talking about – accentuate the positive, eliminate the negative, and latch on to the affirmative, but don’t mess with mister in-between. They always have.