Rerun - Meds Compliance: The Problem Clinician

This from April ...

Yesterday, I raised the topic of physicians turning a deaf ear to our complaints about meds side effects. The obvious conclusion to draw is that patients will simply stop taking their meds. You don’t need a medical degree to understand that. In fact, it helps if you don’t have one.

Two and a half years ago, a psychiatrist who practices in Princeton, NJ (I used to live just outside Princeton) invited me to deliver a grand rounds to a psychiatric facility there. I was very hesitant. I’m a journalist, I explained. It’s not my place to tell others how to do their jobs.

But I had been doing my own research into meds compliance. Perhaps it would be okay, I suggested, if I were to report on my research from the perspective of a patient. The psychiatrist loved the idea, and we booked a date.

How controversial can meds compliance be, right? I mean, no one is against meds compliance. So I went back over my old research, then did some more, and started connecting the dots. Suddenly, I realized I was in big trouble. Psychiatrists came out looking worse than the patients. A lot worse.

There’s no way I can sugar-coat this, I confided to my friends. They’re going to run me out of town on a rail.

The first part of my talk - “The Problem Patient” - went over reasonably well. But I started sinking fast when I got into “Problem Meds.” Then “The Problem Clinician” went up on my PowerPoint.

Frozen silence. We’re not talking ordinary frozen silence, as in “stony cold” frozen silence. We’re talking zero degrees Kelvin silence, as in utter cessation of all molecular motion frozen silence.

What’s totally weird is they should have been rolling in the aisles. My PowerPoint slide featured a photo of Hugh Laurie from the TV series “House” snapping on a latex glove. “House” is set in Princeton. Surely, my audience would at least chuckle in knowing appreciation.

Silence. Zero degrees Kelvin silence. 

Up went a slide of Heidi Klum. “Have you ever noticed how many drug reps look like Heidi Klum?” I asked. Or Russell Crowe?

To paraphrase George Bush, I “misunderestimated” my audience.

Let’s take a look at some of the hard cold facts from my PowerPoint:

• According to a 2002 study by Scott and Pope, 50% of  bipolar patients on mood stabilizers acknowledged some degree of medication nonadherence in the previous 2 years.
• According to a 2007 Swedish study, 25 percent stopped taking their lithium in 45 days. The median time to discontinuation of lithium was 181 days.
• In one of the NIMH-underwritten CATIE schizophrenia trials, no one completed the study.
• In a 2006 long-term Zyprexa trial, nearly 80 percent of the patients on the drug dropped out.
• A 2005 Medscape article reported that only 28% complied with their SSRIs at 6 months.

I asked the clinicians in the audience if these non-compliance rates were higher than they thought, and managed to coax out some reluctantly nodding responses.

Sending patients out the door with just a prescription is not treatment, I reminded them. (They positively hated hearing that.)

Obviously, I went on to say, a clear psychiatric disconnect exists. According to another study by Scott and Pope, clinicians felt their patients quit lithium owing to "missing highs." Patients who quit, on the other hand, cited other reasons.

At the 2006 national NAMI convention, Stephen Goldfinger MD of SUNY told his audience: “Patients will be adherent if the meds do their real job.”

I did my initial research into meds noncompliance about eight years ago when I came across a Kirsch meta-analysis (summarized in a recent piece) that revealed, amongst other things, that only 63 percent of the patients in antidepressant drug trials completed the four to six weeks these trials ran.

Curious, I began checking if these drop-out rates applied across the rest of medicine, such as cancer. So I picked a cancer med at random, Nolvadex (tamoxifen) and read that AstraZeneca had stopped a 1997 study due to 26 percent of patients quitting after one year.

Hmm, I thought. A 74 percent completion rate over one year, significantly higher than the antidepressant completion rate over a mere six weeks. Yet, this was totally unacceptable in the field of cancer. I remember reporting in a Newsletter at the time that a drug company would be touting the exact same completion rate for an antidepressant as a stunning success. Indeed, two weeks later, Lundbeck proved me right by publishing a one-year Lexapro trial that highlighted a mere 26 percent of patients dropping out of the study.

I didn’t bring this up this in my talk. What I did note was that the 26 percent Nolvadex drop-out rate almost exactly corresponded to the 21 percent Zyprexa completion rate.

Psychiatry and oncology clearly have different standards. So, are oncologists telling their patients something different? My guess is they are. I acknowledged to my audience I was speculating, but I managed to get them to sign off on this PowerPoint:

What oncologists may be telling their patients:

It's going to be hell, but there is an excellent chance your cancer will go away.

Then I showed them this PowerPoint:

What I know too many psychiatrists tell their patients:

What are you complaining about? These meds work. Something must be wrong with you. You're much better off than you were before. You need to stay on these drugs the rest of your life.

What I’m guessing the cancer patient may be thinking is this: One year of hell - if that's what it takes to get my old life back, I'm willing to put up with that.

What I know the psychiatric patient is thinking is this: This is the best you can do? You mean I'm going to have to spend the rest of my life - like this?

As Ross Baldessarini MD of Harvard told a 2006 American Psychiatric Association annual meeting: "We need to be a lot more sensitive to minor complaints."  Otherwise, "we will drive patients out of treatment."

So maybe psychiatrists need to be working off a bad news/good news script. First the bad news:

Your meds are only part of the equation. You are unique. It may take time to find the right meds and doses that work right for you. Until we dial in your meds just right, you may have to put up with significant side effects. You may also not feel like yourself. You may feel you want to quit altogether.

Now the good news:

We are going to work together on your recovery. As your knowledge and skills improve, I will be in a better position to help you. You will also be in a better position to help yourself. Trust me, there is light at the end of this tunnel.

I wrapped up my talk a few minutes later. The audience, composed entirely of clinicians, showed their appreciation by stampeding for the exits the second my lips stopped moving.

Meds Compliance: The Problem Clinician

Yesterday, I raised the topic of physicians turning a deaf ear to our complaints about meds side effects. The obvious conclusion to draw is that patients will simply stop taking their meds. You don’t need a medical degree to understand that. In fact, it helps if you don’t have one.

Two and a half years ago, a psychiatrist who practices in Princeton, NJ (I used to live just outside Princeton) invited me to deliver a grand rounds to a psychiatric facility there. I was very hesitant. I’m a journalist, I explained. It’s not my place to tell others how to do their jobs.

But I had been doing my own research into meds compliance. Perhaps it would be okay, I suggested, if I were to report on my research from the perspective of a patient. The psychiatrist loved the idea, and we booked a date.

How controversial can meds compliance be, right? I mean, no one is against meds compliance. So I went back over my old research, then did some more, and started connecting the dots. Suddenly, I realized I was in big trouble. Psychiatrists came out looking worse than the patients. A lot worse.

There’s no way I can sugar-coat this, I confided to my friends. They’re going to run me out of town on a rail.

The first part of my talk - “The Problem Patient” - went over reasonably well. But I started sinking fast when I got into “Problem Meds.” Then “The Problem Clinician” went up on my PowerPoint.

Frozen silence. We’re not talking ordinary frozen silence, as in “stony cold” frozen silence. We’re talking zero degrees Kelvin silence, as in utter cessation of all molecular motion frozen silence.

What’s totally weird is they should have been rolling in the aisles. My PowerPoint slide featured a photo of Hugh Laurie from the TV series “House” snapping on a latex glove. “House” is set in Princeton. Surely, my audience would at least chuckle in knowing appreciation.

Silence. Zero degrees Kelvin silence. 

Up went a slide of Heidi Klum. “Have you ever noticed how many drug reps look like Heidi Klum?” I asked. Or Russell Crowe?

To paraphrase George Bush, I “misunderestimated” my audience.

Let’s take a look at some of the hard cold facts from my PowerPoint:

• According to a 2002 study by Scott and Pope, 50% of  bipolar patients on mood stabilizers acknowledged some degree of medication nonadherence in the previous 2 years.
• According to a 2007 Swedish study, 25 percent stopped taking their lithium in 45 days. The median time to discontinuation of lithium was 181 days.
• In one of the NIMH-underwritten CATIE schizophrenia trials, no one completed the study.
• In a 2006 long-term Zyprexa trial, nearly 80 percent of the patients on the drug dropped out.
• A 2005 Medscape article reported that only 28% complied with their SSRIs at 6 months.

I asked the clinicians in the audience if these non-compliance rates were higher than they thought, and managed to coax out some reluctantly nodding responses.

Sending patients out the door with just a prescription is not treatment, I reminded them. (They positively hated hearing that.)

Obviously, I went on to say, a clear psychiatric disconnect exists. According to another study by Scott and Pope, clinicians felt their patients quit lithium owing to "missing highs." Patients who quit, on the other hand, cited other reasons.

At the 2006 national NAMI convention, Stephen Goldfinger MD of SUNY told his audience: “Patients will be adherent if the meds do their real job.”

I did my initial research into meds noncompliance about eight years ago when I came across a Kirsch meta-analysis (summarized in a recent piece) that revealed, amongst other things, that only 63 percent of the patients in antidepressant drug trials completed the four to six weeks these trials ran.

Curious, I began checking if these drop-out rates applied across the rest of medicine, such as cancer. So I picked a cancer med at random, Nolvadex (tamoxifen) and read that AstraZeneca had stopped a 1997 study due to 26 percent of patients quitting after one year.

Hmm, I thought. A 74 percent completion rate over one year, significantly higher than the antidepressant completion rate over a mere six weeks. Yet, this was totally unacceptable in the field of cancer. I remember reporting in a Newsletter at the time that a drug company would be touting the exact same completion rate for an antidepressant as a stunning success. Indeed, two weeks later, Lundbeck proved me right by publishing a one-year Lexapro trial that highlighted a mere 26 percent of patients dropping out of the study.

I didn’t bring this up this in my talk. What I did note was that the 26 percent Nolvadex drop-out rate almost exactly corresponded to the 21 percent Zyprexa completion rate.

Psychiatry and oncology clearly have different standards. So, are oncologists telling their patients something different? My guess is they are. I acknowledged to my audience I was speculating, but I managed to get them to sign off on this PowerPoint:

What oncologists may be telling their patients:

It's going to be hell, but there is an excellent chance your cancer will go away.

Then I showed them this PowerPoint:

What I know too many psychiatrists tell their patients:

What are you complaining about? These meds work. Something must be wrong with you. You're much better off than you were before. You need to stay on these drugs the rest of your life.

What I’m guessing the cancer patient may be thinking is this: One year of hell - if that's what it takes to get my old life back, I'm willing to put up with that.

What I know the psychiatric patient is thinking is this: This is the best you can do? You mean I'm going to have to spend the rest of my life - like this?

As Ross Baldessarini MD of Harvard told a 2006 American Psychiatric Association annual meeting: "We need to be a lot more sensitive to minor complaints."  Otherwise, "we will drive patients out of treatment."

So maybe psychiatrists need to be working off a bad news/good news script. First the bad news:

Your meds are only part of the equation. You are unique. It may take time to find the right meds and doses that work right for you. Until we dial in your meds just right, you may have to put up with significant side effects. You may also not feel like yourself. You may feel you want to quit altogether.

Now the good news:

We are going to work together on your recovery. As your knowledge and skills improve, I will be in a better position to help you. You will also be in a better position to help yourself. Trust me, there is light at the end of this tunnel.

I wrapped up my talk a few minutes later. The audience, composed entirely of clinicians, showed their appreciation by stampeding for the exits the second my lips stopped moving.

Noncompliance - Time for Psychiatrists to Practice Real Medicine

In my most recent blog, I mentioned a grand rounds lecture I delivered last year to a psychiatric facility on meds compliance. In the talk, I made two comparisons: 1) A psychiatric drug trial to a cancer drug trial, and 2) A hypothetical oncologist appointment to a psychiatric appointment.

The first clinical trial was an Eli Lilly trial of bipolar patients on the antipsychotic Zyprexa. These were patients who responded well to the med in the initial going. Despite that, 79 percent dropped out of the study after 48 weeks. Believe it or not, Eli Lilly actually found a way to put a positive spin on the findings.

This study is all too typical of long term studies on virtually all classes of psychiatric meds, with drop-out/noncompliance rates averaging about 70-80 percent. In one trial, 100 percent of the patients dropped out. In other words, no one finished the study.

The second trial I referred to was an AstraZeneca study of breast cancer patients on tamoxifen. In that study, 26 percent dropped out after one year, almost the exact inverse of the Zyprexa study. But rather than put a positive spin on the finding, AstraZeneca was so alarmed by the high drop-out rate that they stopped the study.

What is going on? Both drugs have horrible side effects, but one group of patients is obviously buying into long term treatment and the other isn't. Could the difference lie in what doctors are telling their patients?

Consider the gist of the message the oncologist gives to a patient:

"It's going to be hell, but there's an excellent chance your cancer will go away."

I made sure all the heads in the room were nodding on that point before proceeding to my next PowerPoint. Now here's what I know too many psychiatrists are telling their patients, I said:

"What are you complaining about? These meds work. Something must be wrong with you. You're much better off than you were before. You need to stay on these drugs for the rest of your life."

I sensed the hackles in the room rising, but plowed straight into my next PowerPoint:

"What the cancer patient may be thinking: One year of hell - if that's what it takes to get my old life back, I'm willing to put up with that.

"What I know the psychiatric patient is thinking: This is the best you can do? You mean I am going to have to spend the rest of my life - like this?"

By now, my audience of clinicians was turning into a lynch mob. But it was only going to get worse. Up until now, I had only been presenting the facts. Now I was about to tell this group of highly-educated and highly-experienced clinicians how to do their jobs:

There is the crucial "window of opportunity" phase in the doctor-patient relationship, I said. The patient has been brought out of crisis and has been reasonably stabilized, but is clearly not well. For many patients, a long hard road lies ahead. You have one chance to get your patient to buy into long-term treatment, and you need to be brutally frank about presenting the bad news along with the good.

First the bad news: These meds are not magic bullets. You may have to put up with significant side effects in the short term. It may take time to dial in your meds just right. You may not feel like yourself. You may want to quit altogether.

Now the good news: I am going to work with you on your recovery. As your knowledge and skills improve, I will be in a better position to help you. You will also be in a better position to help yourself. Trust me, there is light at the end of this tunnel.

So how did this go over? No sooner did I wrap up my talk than I was looking at empty chairs. Literally, it was as if the fire alarm had gone off.

I rest my case ...