Friday, October 30, 2009

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

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