Treatment

MEDS COMPLIANCE - OPPORTUNITY LOST

 

THIS IS THE THIRD in my series of three articles on meds compliance ...

We pick up on the action from a grand rounds I delivered to a facility in Princeton in 2008, where I was accorded the same level of affection as Bill Gates at an Apple convention. Really, it went over that well ...

I clicked my PowerPoint. "The concept of maintenance is fundamentally flawed," read the slide.

Frozen Kelvin grade silence. Oh, shit, now what?

I had already told the 50 or 60 clinicians in the audience that simply sending a patient out the door with just a prescription is not treatment, that we don't want to be like them, that from where I stand they all have flat affect, that there is a reason that all the pharm reps who visit them look like Heidi Klum or Russell Crowe, and that when their patients complain to them about feeling like fat stupid zombie eunuchs on the meds they prescribe and overprescribe we are not doing this to ruin their day.

Geesh. It wasn't like I was accusing them of something major, such as dancing like a white man. Okay, maybe they read that into my flat affect observation.

We're Stable, What Next?

By way of background, treatment roughly divides into two categories: Acute and maintenance. There is a further distinction involving maintenance vs continuation treatment, but we won't go into that.

Acute treatment is short term. Typically, we are in a state of crisis. Psychiatry is very good at getting us out of crisis and into a state of stability. What I would call a state of undepression, unpsychosis, unmania, unanxiety, and so on. But then what?

Maintenance treatment seems based on keeping us in this stable state. But here's the catch, I explained. We're stable, but not well. The confusion seems to stem over the definition of remission. Up went a PowerPoint slide from Dorland's Medical Dictionary with this old world view:

Diminution or abatement of the symptoms of a disease.

But back in 2002, I came across this, from the American Psychiatric Association Bipolar Treatment Guideline issued that year:

Complete return to baseline level of functioning and a virtual lack of symptoms.

Here's how the APA links treatment to remission:

Treatment is aimed at stabilization of the episode with the goal of achieving remission, defined as a complete return to baseline level of functioning and a virtual lack of symptoms.

In other words, it's not good enough for our clinicians to have us feeling merely less miserable than before. You can also read into this that any trade-off between reducing symptoms and major side-effects is totally unacceptable. After all, how can we lead satisfying (ie functioning) lives when the thinking and feeling parts of our brains are off-line, not to mention what's going on elsewhere with us?

Thus, contrary to popular belief, there is no distinction between the medical model and the recovery model. The APA nailed "recovery" in their 2002 Guideline. In theory, we are all on the same page. But this principle has yet to percolate throughout psychiatry.

Up went this PowerPoint:

Instead of "acute" and "maintenance," I choose to distinguish between the crisis, stabilization, and recovery phases of our illness. During the early phases, with our illness at its worst and our knowledge and insight at its least, we are nearly totally dependent on psychiatry and medications, and we would be fools to believe otherwise. Then, in a best case scenario, as our skills and insight improve, we become less reliant on psychiatry and medications and become more active in our own recovery.

Stable Is Not Our Goal

The stabilization phase is where the doctor-patient relationship begins to change. The patient is out of crisis, with significantly reduced symptoms, but is merely better and not well. Moreover, he or she is likely contending with serious meds side effects. Nevertheless, the patient is in a position to intelligently discuss his or her illness and treatment options, and wants to move on to being well.

So, here's the deal: Getting patients from crisis (acute phase) to stabilization (maintenance phase) is only half the battle, the easy half at that. The real work lies just ahead. Up went this PowerPoint, from a 2004 international bipolar treatment guideline:

The real key to treatment of bipolar disorder is successful maintenance treatment.

 

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The catch is there is no reliable evidence base for maintenance treatment. Virtually all psychiatric meds studies focus on short-term treatment for patients in the acute (crisis) stage. This from the Depakote product labeling:

The effectiveness of Depakote ER for long-term use in mania, i.e. for more than 3 weeks, has not been systematically evaluated in controlled clinical trials.

Now had I really wanted to insult my audience, I would have asked them why the friggin' hell are you treating us at this stage with industrial-strength doses as if we're 911 cases bouncing off the ceiling when maybe all we need right now is just a teensy bit to take the edge off.

Think about it: If you have a broken leg, you don't wear a cast the rest of your life. But I spared my audience all this. See, I do exercise restraint. Then I had to ruin it all by clicking on my infamous slide:

The concept of maintenance is fundamentally flawed.

All the maintenance studies that I am aware of use as their measure of success relapse prevention, often expressed as time to relapse. So, here we are - stuck - unable to move forward, like a paleolithic hunter entombed in a glacial ice sheet, and psychiatry is celebrating because we're not back where we started. But actually the opposite is true. In virtually all these studies the relapse rates are horrendous.

Here's how Eli Lilly spun a 2006 Zyprexa maintenance study result:

Compared to placebo, olanzapine delays relapse into subsequent mood episodes ...

This appeared as an abstract in the leading psychiatric journal, the American Journal of Psychiatry, which means it turned up as the opening to the article and in all the various medical databases such as PubMed. Who, after all, reads entire journal articles?

What really happened was that eight in ten of the Zyprexa patients dropped out of the study.

"Does everyone agree this is highly deceiving?" I asked my audience. Thankfully, every head in the room bobbed up and down.

"I would go further," I replied. "I would call it immoral."

Kelvin grade frozen silence. Seems I just can't keep my mouth shut.

Previous two pieces:

Meds Compliance - The Problem Clinician

Meds Compliance - Problem Patients,Problem Meds

Reviewed July 5, 2016

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