Weighing the Risks and Benefits - Will My Life Be Better?

"You have to weigh the risks and benefits."  That is what the doctor says.  It's your body, your decision, your responsibility.

But how do you weigh them?  There is that list of side effects.  They sound pretty scary, but the doctor assures you they are usually manageable.  Then there is the potential benefit of feeling better.  Well, that would be the gold ring, now wouldn't it?  Being able to get back to your family, your job, your life?

It's not a hard sell.  Reach out your hand and the pharmaceutical company will place in it that most precious of all commodities, hope.

Perverse little smarty pants that I am, after my hopes had been dashed six times, I started to read.  For four years I read journal articles about clinical studies.  The basic format begins with a measurement of depressive symptoms, usually the Hamilton Rating Scale for Depression, HAMD, depressed mood, suicidal ideation, sleeplessness, loss of appetite, etc.  You get points for severity.  Unlike your junior high math exam, the higher the score, the worse off you are.  In fact, if you ace this test, they will administer electric shocks to your brain (yes, I know, you will be unconscious at the time and won't feel a thing) until you forget how bad you feel and get a lower score.

So there are two groups, as alike as possible, Group A averages a HAMD score of 21.6, Group B's average is 22.1.  That's the mid range for moderately depressed, and the typical test subject score.  They don't include you in medical trials if you keep getting a high score, because now it's the medication that is being tested, and they want an audience that is easier to please.  Group A gets the medication being tried, Group B gets the placebo.  After 8 weeks, Group A's HAMD score is 8.2, Group B's score is 10.9, both in the mildly depressed range, but the difference is "statistically significant."  [That would depend on how big the sample is, and I am not doing the math.]  More people in Group A than Group B reached remission, a HAMD score of 6 or less.  A certain number dropped out because of side effects, so they don't count.  And there we have it.  The medication improves depressive symptoms by a statistically significant amount and is well tolerated, and you should get yours today.

But you know what?  That study with all its statistics did not answer your question.  Will you feel better?  Will you get your life back?  It told you what the odds are that your depressive symptoms would be reduced.  But that is not the same thing.  Not at all.

For example,the truck driver who is sad, not sleeping well, has no appetite, worries a lot and feels guilty is given Zoloft by his family practitioner.  Now he's eating better and is learning to put past sins behind him.  But he is too dizzy to drive, gets in fights with his friends and can no longer satisfy his wife, or even himself in bed.  So he decides to quit his meds.  The doctor is focused on his HAMD score and is very concerned, convinces him to try another med, then another.  But each time he gets the same side effects, and meanwhile has lost his job.

The truck driver has weighed the risks and benefits, asking is my life better? No, it isn't.  Let's hope his doctor knows that Cognitive Behavioral Therapy is often as effective as antidepressants for mild and moderately depressed people.  Ditto aerobic exercise, which could help his lose those extra pounds, improve how he feels about himself, and change the nature of what happens when they turn out the lights.

It turns out there are lots of psychological tests.  Many try to do what the HAMD does, and their inventors think that their tests do it better -- measure depressive symptoms.  But there is also a test that asks the real question: Are the lives of the people who take this medication better?  The Sheehan Disability Scale is a three question test, answered by the patient.  On a scale of 1-10, how much have the symptoms disrupted your work/school, your social life, your family/home responsibilities this past week?  It's simple.  It's easy.  It's what the people who are taking the meds want to know, will my life be better.  The people doing the research are focused on symptoms, not on the patient's life.  So that is how I read journal articles for four years and had never heard of the Sheehan Disability Scale (SDS).

For some reason, the clinical trials for Abilify decided to ask the patient's question, using the SDS.  Actually, they used seven different tests.  When the journal articles came out, they reported only one, the Montgomery-Asberg Depression Rating Scale (MADRS), a substitute for HAMD.  My September 4 post, OMG!! That's What They Said! Significant, reported its not particularly impressive, but FDA passable,  "statistically significant reduction in depressive symptoms."  The other test results disappeared.

But somebody noticed, and called them on it.  That is when I learned that the SDS even existed.  Why would they go to all the trouble of doing seven different tests, and then publish the results of only one?  Turns out that while Abilify.com says that "Clinical studies of adults with depression showed that adding ABILIFY to an antidepressant helped to significantly improve depressive symptoms compared to adults treated with an antidepressant alone," as far as the people who actually swallowed the stuff were concerned, it was a wash.  When you weigh symptoms and side effects, they reported that there was no improvement in their work/school life, a little improvement in family life.  But overall, it was a wash.

What was the author's response?  "Robert Berman from Bristol-Myers Squibb wrote... "this may be due to the lower sensitivity" of the measure."  I got that from "Abilify, Depression and the Memory Hole" at clinpsyc.blogspot.com.  Robert Berman, chief author of the research report, is not only an employee of Bristol-Myers Squibb, his compensation also includes stock options -- a little side note on how medical research is conducted in a for-profit health care system.

Okay, so the Sheehan Disability Scale is not sensitive enough to pick up what were pretty small decreases in depressive symptoms anyway.  That isn't its purpose.  What it will do is weigh your risks and benefits. Will Abilify improve my life, at work, at home, at play?  Nope.  Not if you are taking it for depression.  It won't.

What Prozac Monologues wants to know is what the Sheehan Disability Scale would tell me about Lamictal, the medication I have just added to my antidepressant instead of Abilify.  But as far as I know, nobody asked.

photo by Hans Anderson, This file is licensed under the Creative Commons Attribution ShareAlike 3.0

Taking a Break

Into the life of every over-medicated lab rat, a little downtime must fall.  Prozac Monologues is taking a bit of a break, with apologies to regular readers.  I hope to tinker with the sidebars to add some resources, while not being able to maintain my own writing standards.

Meanwhile, let me once more recommend Knowledge is Necessity for information about the Pharma/Medico/Therapeutic Industrial Complex, and occasional good clean fun. 

Photo credit: Copyleft Attitude http://artlibre.org/licence/lal/en/

To our Families

To that end, I am going to live with this disease the way Don lived with his. Openly -- I have a mental illness. Actively -- I will answer ignorance with education. Politically-- I will meet discrimination with change. And in community -- I will support and be supported by others who share this illness with me, so that we can survive it together.

I did get to say those words on Sunday night.  

This morning I made a list of all the things you would be reading about at prozacmonologues if only I were able to read more than three paragraphs at a time.  I am tempted to feel badly, especially for all my older readers, who come here expecting to find out about the relationship between nonsense and the anterior cingulate cortex, or Wyeth's research techniques in its effort to get Abilify approved for augmentation in the treatment of major depressive disorder, or "Akathisia: Stop it or Die," or my discourse on the concept of a failed suicide attempt. 

But down, damn ant! [automatic negative thought] You, dear reader, are not reading about all those things because sedation and supervision in lieu of hospitalization is working just fine.  ["Plan?  What's a plan?  Do I have to stand up?"] So I was able to speak my piece on Sunday night, the candlelight vigil that began Mental Illness Awareness Week.

Everybody thinks I am a wonderful speaker, and they told me so and the local paper quoted me, and that was very nice.  But somebody also needs to say that it was possible, not only because God was willing, but because my spouse has turned her life upside down to take care of me right now.  She is negotiating with her workplace, she is working from home, she is attending Family to Family meetings, she represents my interests, she fights my battles, she keeps my meds, she does the dishes, she walks the dog.  She is exhausted.  And she comes home from Family to Family meetings and tells me that there are other families, too.

Mental illness is a family disease.  And when I say that we survive it together, well, family is a very big word.  Some of us become family, because we choose to be.  I am so grateful for four friends who attended that sexuality talk that didn't turn out to be quite what we thought it would be, but instead has become the germ for the Loony Review, by the Not Ready for Discharge Players!  [A potential addition to next year's program?]  We are family because we choose to be, because to not choose to be wouldn't be insane, it would simply be stupid.

But some of us are family because that's how we started out, when we didn't know what it would cost.  The members who do not have the diagnosis, boy, do they still get to have the disease!  And pay the cost.

Some of us who have the diagnosis don't have the capacity or the wit to say it.  I do.  So today I will say what they would if they could.  Thank you.  We owe you our lives. We wish it didn't have to cost you so much.  Sometimes we lie to you, or are mean to you, or even desert you.  And you aren't always right.  And sometimes you DO make it worse.  But mostly we know that we owe you our lives.  Not all of us survive.  But those of us who do, we survive it together.  Thank you.

Thank you, Helen. 

photos in public domain 

Hello, my name is Willa, and I have a mental illness

I try to post more often.  The last week has been spent in a story so stereotypical that those readers who have or have tried to get disability benefits will find it banal.  And until it has an ending, I can't tell it in Prozac Monologue mode: reflections and research on the mind, the brain, depression and society. I am not reflecting yet.
So I tempt fate with the following.  Si Dios quiere, God willing -- I will say the following at the opening of Mental Illness Awareness Week Sunday, October 4, 6:30 PM, at the Anne Cleary Walkway, University of Iowa Campus, Iowa City, Iowa, a candlelight vigil to remember those who have died from mental illness and to support those who hope to survive it.

Hello, my name is Willa and I have a mental illness.

Hello, I am the Reverend Willa Marie Goodfellow, an ordained minister, an Episcopal priest who has served congregations, campus ministries, and diocesan staff in Iowa for 27 years. And I have a mental illness.

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