Weighing the Costs and Benefits Part III -- How to Measure Costs

The doctor said, You have to weigh your costs and benefits.  Today we continue to figure out how to do that, based on more than gut feeling and desperation.  We are building an algorithm, logical rules applied to objective data to solve a specific problem -- in this case, do you want to put these chemicals inside your body?

On August 19 I listed the factors to consideration, benefits, costs, and other issues that affect how these are calculated.  On September 2 I listed the immediate benefits of medication, and gave you a Down and Dirty way to calculate them.  I call it Down and Dirty, because it leaves out long term benefits.  Your psychiatrist will consider this a serious omission.  But we have to start somewhere.  And desperate people have to start with a time frame they can imagine surviving.  Think about the long term benefits once you feel better, and are thinking about quitting.

Today we turn to down and dirty costs.  This is more difficult to calculate, because the research on costs is filtered through the lens of noncompliance.

When you weigh your costs and benefits, if you should happen to decide the costs outweigh the benefits, it would seem logical to give the medication a pass.  On the other hand, if the doctor recommended the medication, it was because he/she has prejudged the matter and considers the benefits to outweigh the costs.

Yesterday the pharmacy attached a piece of paper to my refill.  Every single prescribing information sheet attached to any prescription I have ever received has said the exact same words.  They come in the section on side effects.  Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.

Evidently the you in you have to weigh the cost and benefits refers to the doctor, not to you.  If your opinion differs from your doctor's, then you are noncompliant.

The Filter of Noncompliance Distorts Research

The information available about costs is filtered through this concept of noncompliance, the assumption that the doctor knows better than you.  So when they do research about costs, they are asking, Why do patients fail to comply with the doctor's more educated judgment?  The purpose of the research is to find strategies to get you to comply.

Our algorithm, on the other hand, asks a different question -- I believe a more neutral question.  How do the reasons to take the medication stack up against the reasons not to?  I do not presume an outcome, do not make any judgment, and certainly do not presume your decision.  While I am critical of the oversell, remember, I am currently conducting my own thirteenth trial!  But I have to get my information from people who have already made up their minds.

And they call themselves scientists.

Nancy Andreasen, a National Medal of Science Award winner and one of the world's leading experts on schizophrenia is studying creativity and mental illness.  Her first book on the subject is The Creating Brain: The Neuroscience of Genius.  Her initial hypothesis was that writers generally would not have mental illnesses, but that some family member would.

Andreasen's research proved her hypothesis wrong, at least the part about the writers themselves.  80% of writers have a mental illness, mood disorders being the most common.  This is called a robust finding, which means way more than might occur by coincidence.  And it goes some distance to explain the blogosphere, dontcha think?!  The way she puts it, when the data proves your hypothesis wrong, then you know you are on to something.  In other words, your presupposed ideas have not distorted the interpretation of your data.  This disproved hypothesis put her on a track that led to unexpected, new findings.

Nancy Andreasen is a real scientist.

If scientists started out asking Why don't patients take our good advice? and discovered, Because sometimes patients make better decisions, then they would be on to something.  They might even find a new track that would lead to new findings.

Why Use Noncompliance Rates Instead Of Research Results As A Measure of Costs?

Once you put the pill in your mouth, you are no longer playing the odds.  You are getting results.  Other people have preceded you in this chemistry experiment, first in small numbers in the clinical trials, and then in large numbers in the real world.

The clinical trials yield some information.  What happens in the first 6-8 weeks?  How many people experience fewer symptoms of depression?  How many people go into remission?  How many people get what sort of side effects?  How many people quit before the end of the trial, because the side effects are unbearable?  How do all of these results measure up against placebo?

The clinical trials also take place under circumstances that influence the results.  Three lead to a difference between their results and the results that people in the real world experience.

First, the trial subjects (the word for people who put the chemicals inside their bodies) may be cherry-picked.  This means they are people most inclined to get good results.  Researchers try to recruit subjects who have not tried more than one antidepressant already.  Remember, half of those who are experiencing depression for the first time recover and never get it again.  People who do not recover quickly take more medications, and get worse results with each one.

In the STAR*D study, one of the selection criteria was that the subjects had not already tried any of the meds to be tested.  Those for whom the medication had already been shown ineffective were eliminated.  Which kind of stacked the deck, dontcha think?  Other scientists do.

Second, subjects receive extensive support throughout the trial.  Monitoring itself inevitably influences the results.  When depressed people get to talk about their symptoms, it reduces their isolation and eases the pain that is part of depression.  Even if those administering the medication are trained to be neutral, subjects get better, just because somebody cares enough to ask.

Third, and most significant for our purposes, is that trial subjects receive encouragement, intense encouragement, to endure side effects and finish the trial. 

Your Results May Vary

First, in the real world, even if two antidepressants do not work, consumers are urged to keep trying.  And each subsequent trial reduces the odds that the next one will be effective.

Second, in the real world, consumers are not so carefully monitored.  They are handed a prescription and sent out the door.  Subsequent appointments get briefer and briefer.

Third, in the real world, consumers are less willing to consume chemicals that make them feel worse.  We have jobs, families, lives to live, as best we can.  Nausea, dizziness, blurred vision, anxiety, insomnia... these things make living our lives difficult.

Noncompliance rates over the course of a year measure results the real world.  My guess is that is where you live.

So, how many people have weighed the costs and benefits they experience inside their own test tubes, results, not odds, and run screaming from the door?  Or more likely, tiptoe out to exercise not overt, but covert noncompliance.

What Are Those Noncompliance Numbers Again? 

10% of those prescribed antidepressants never show up at the pharmacy at all.

28% quit within the first month.

50% quit within 60 days.

72% are outta there at six months, 78% within the year.

There are problems with these numbers for our purposes.  All the different reasons for discontinuation are lumped together.  As well, different meds have different rates of discontinuation.  For example, again with the STAR*D study, 16.3% quit Celexa in the first 60 day trial, while 45.5% quit a Lithium/Zoloft combo in the third trial.

Somebody needs to be collecting this data.  Some consumer group, looking at real world data, not the guys seeking permission to sell pills. 

And Why Don't Consumers Consume?

Regarding those first 10%, we just don't know.  We can have some fun guessing.  Top ten list, that sort of thing.  But these guesses do not add to our knowledge.  This is missing data, and we will have to work around it. 

Another 44% say they quit because the medication wasn't effective.

Here we run into a problem.  It takes a while for most of these meds to work.  We don't know how many who quit in the first four weeks could tolerate the medication, but did not give it an adequate trial.

Both providers and consumers have an interest in figuring out this number.  From the provider perspective, these early quitters might respond to a better sales job.  For our purposes, the early quitters fail to give us the information we seek to figure our own odds.

Our algorithm will have to assume that further research will provide the numbers.  Once somebody funds that consumer group.

44% consumers who discontinue medication before their providers would like (the research calls it prematurely) say they did so because it made them sick.  According to the clinical trials, the most common reasons are nausea, headache, drowsiness, and increased anxiety.  These side effects are more common in the 6-8 week time frame.  Eventually, consumers cite weight gain and sexual side effects as the most significant side effects.

These are the types of numbers we will crunch to create our algorithm.  Sketchy as they are, they will be used for illustration purposes, not actual calculations.

But I need another recess -- something fun next week.

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OMGThat'sWhatTheySaid -- Noncompliance

Before I move to the costs side of Weighing the Costs and Benefits, I pause to consider the concept of noncompliance.

Noncompliance is not one of the best candidates for the OMG! Award, because I cannot point to specific usage -- it is ubiquitous.  On the other hand, it is precisely what this award is about, going to the heart of how language frames thought.  In this case, the word simultaneously names and creates a relationship between consumer and provider.

I don't particularly care for the terms consumer and provider when it comes to health care.  But I use them here, where they distinguish those who consume, literally put pills inside our mouths, from those who fill out those little slips of paper that provide the pills.  Providers replaces pushers, a term I used in a fit of pique last week.  This week, I have resolved to be more polite.

Consumers are told to weigh our costs and benefits.  When we comply with these instructions and, having done so, decide that the costs exceed the benefits, and therefore decide not to consume, then providers call us noncompliant.  What exactly is communicated here?

What is noncompliance, anyway?

I went to the dictionaries.

According to Webster's New World College Dictionary, noncompliant means failure to comply; refusal to yield, agree, etc.

MedicalNet.com puts it this way: Noncompliance: The failure or refusal to comply: the failure or refusal to conform and adapt one's actions to a rule or to necessity.

Don't you hate it when one word is defined by another word that still needs to be defined?  I went back to Webster's, and got these alternatives. 

COMPLIANCE

1: a -- the act or process of complying to a desire, demand, proposal or regimen, or to coercion; b -- conformity in fulfilling official requirements;

2 : a disposition to yield to others;

3 : the ability of an object to yield elastically when a force is applied.

So.  One has a desire, demand, proposal, regimen or official requirements, and may have access to force or coercion.  The other fails, refuses, or does not yield.  I wonder which is which? 

Scientists Study Noncompliance

Providers are disconcerted when consumers fail to consume, and spend a lot of time trying to figure out why.  By the way, this link goes to a review of literature by Alex J. Mitchell, a consultant and senior lecturer in liaison psychiatry at the Leicester Royal Infirmary in the United Kingdom, who receives no compensation from pharmaceutical companies.  I often link to reviews of literature.  Their authors read a jillion studies, including ones to which I do not have access.  Then they summarize the highlights of whatever consensus may have come from these studies.  Reviews of literature put a lot of information in one place.  Mitchell has 59 footnotes (okay, not a jillion -- I exaggerated), in case you want to look up the research behind a particular point.

So scientists speculate, do research, write articles, hold conferences and  train residents, all in efforts to increase compliance.  Their hypotheses about the causes of this behavior include inaccurate beliefs about medication, lack of insight into ones illness, lack of education in general, cognitive impairment, weight gain, sexual dysfunction, and poor patient/doctor relationship.

Mitchell even developed a flow chart to categorize the behaviors of patients: full, partial and excess adherence, intentional and unintentional non-adherence, for external or internal reasons, and various combinations of these.  Not telling your doctor that you have stopped taking your medication is called covert discontinuation, and in other places, covert noncompliance -- that word again, this time with the naughtiness of covert.

A friend noticed that Mitchell missed a category on his flow chart, the consumer who is compliant with other medications, but consistently, though inadvertently, forgets one particular medication that she thinks is the source of uncomfortable side effects.  That could be covert internal unintentional partial non-adherence.  Or would it be covert internal intentional partial non-adherence, covert here meaning that her intention is undisclosed to herself?  The flow chart matters, because having divided noncompliant consumers into subgroups, then they test different strategies to bring different subgroups back into compliance.

Some notice the non-PC nature of the word noncompliance.  While most articles I found use the term, occasionally, as in Mitchell, I come across non-adherence.  Non-adherence is supposed to imply a mutual agreement between two parties about what the treatment regimen will be.  Other articles use the terms interchangeably, recognizing a fig leaf for a fig leaf.  After all, presumably the consumer and the provider have agreed together about the regimen to which the consumer will adhere.  Only notice, if the consumer does not adhere, then he/she has violated an agreement, or broken a promise.  Still naughty.

Matthew Keene, who serves as an adviser or consultant to GlaxoSmithKline, Cephalon and Pfizer, might have merited the OMG Award on his own, for Confusion and Complaints: The True Cost of Noncompliance in Antidepressant Therapy.  But why pick on just him, because, like I said, this language and weltangshauung (as they say in philosophy -- it means world view) permeates the literature?

Why Don't Consumers Consume Their Antidepressants? -- What the Providers Say

Mitchell cites a study indicating that 10% of those prescribed antidepressants never show up at the pharmacy at all.  Keene's figures are that 28% quit within the first month, 50% within 60 days, and only 28% are still in compliance at six months.  Keene asks, Why do patients prematurely discontinue antidepressants, medications that may improve and perhaps even save their lives?  His answer -- one of the 3 C's of noncompliance: confusion, costs, and complaints. 

Confusion, costs and complaints.  Notice that each of these is patient-centered.  He didn't say incoherent, financially foolish and picky.  But they are implied in the rest of the article.  Notice also that he did not describe the phenomenon from the patients' perspective.  He could have said inadequate communication, ineffective or intolerable medications and inaccessible health care and still preserved his clever alliteration.

Why Don't Consumers Consume Their Antidepressants? -- What the Consumers Say

What if patients wrote these articles, or were even consulted?  Actually, they have been consulted.

44% consumers who discontinue medication before their providers would like (the research calls it prematurely) say they did so because it made them sick, most commonly nausea, headache, drowsiness, and increased anxiety.  Well, duh.

I don't know.  Has it occurred to anybody besides me that we could solve this puzzle and put all that research time and money to better use if we gave the scientists a turn as the lab rats?

Another 44% consumers report that they discontinue because the medication is not effective.

That leaves 16% unexplained.  I will get back to them when I discuss costs more thoroughly.

I sorted through lots of these studies before it finally occurred to me to compare rates and reasons.  Noncompliance at six months is 72%.  Back to NIMH's STAR*D study, when trial subjects received compensation, free medical care, extensive information and regular support, antidepressants were ineffective for 50% of those who took them and intolerable for 16%, a total of 66%. -- That was the first trial.  By the third trial, medications were ineffective for 83% and intolerable for 26%, more even than the total.

What I want to know is just how many people take antidepressants when they make them sick and/or don't work anyway?  I personally know three.  Consistent with research findings, that better educated consumers are more compliant, these three have among them a BA, a Masters and a PhD.

Is there something going on here that is not about good medicine?

Rethinking Consumer Noncompliance

Psychiatrist Allan Showalter, Rethinking Patient Noncompliance, challenges the premises behind repeated and repeated research on noncompliance, a behavior which found across other diagnoses, not to mention life issues ranging from flossing to portfolio diversification, as well.  Here is the video of an Iowa Hawkeye football player on a motorcycle, one week before the game with our biggest rival.  A football player.  No helmet.  Despite repeated pleas of Kirk Ferentz, the Hawkeye coach.

I do recommend that you follow Showater's link for the novelty of his thinking.  One example: Nothing in [the definition of noncompliance] implies a moral obligation on the part of the patient to follow those recommendations or to the clinician who makes those recommendations to enforce them.

Countertransference

Yuval Melamed and Henri Szor, The Therapist and the Patient: Coping With Noncompliance, focus on the relationship between the patient and therapist as the source of noncompliance, rather than taking patients at their word.  On the other hand, they use a word that I did not find in any other article.

Countertransference.  Okay, ignoring the definition that includes the word transference, [again -- so irritating when dictionaries do that], Webster's defines countertransference as the complex feelings of the psychotherapist toward the patient.

Melamed and Szor think that noncompliance arouses reactions in therapists who feel that this behavior exemplifies a lack of trust in them and in the corpus of knowledge they represent.  I think that takes us part way there.

It is the therapist's job to manage the dynamics of countertransference in what is an unequal power relationship. That management would include not allowing the therapist's feelings toward the patient to misinterpret the patient's experience as hostility and thus misdirect the intervention.

I have not found evidence that providers of medication ever explore the impact of their own feelings on their treatment of consumers, at least in the arena of noncompliance.  Countertransference is a regular part of psychotherapists' training.  If it is ever mentioned in medical school, none of the literature gives evidence that the lesson sticks.

Weighing the Costs and Benefits -- Progress Report

Sorry about all the numbers in this post.  I have not found in the research any effort to measure the costs side of you have to weigh the costs and benefits that is not filtered through the concept of noncompliance.  So the algorithm will suffer from research that is compromised by its initial assumptions.  Thta is why we had to start with the OMG Award.

Next week, the Muppets will give us a break, while my brain does a bunch of number crunching.

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Weighing Costs and Benefits Part II: Benefits

Today the Free Range Lab Rat, yours truly, continues my extended series on the Chemistry Experiment, that effort to find the chemicals that will make a dent in the suffering of those with mood disorders.

I asked, Will it work for me?

And the doctor answered, We won't know until you try it. 

THAT is the Chemistry Experiment. 

So three weeks ago I published my

Manifesto

If I am a lab rat, I will be a free-range lab rat.

Because I am a free-range rat, I decide which experiments I am willing to try.

Of course I do.  The doctor expects me to decide.  Why else did she say,

You have to weigh the costs and benefits. 

Only -- there is no scale.  Which led me, two weeks ago to continue my manifesto.

I now insist that I contribute more to this enterprise than my body.

So I have decided to create the scale.  I call it an Algorithm.  Algorithm is science-speak for a set of logical rules applied to objective data to solve a problem.  The problem to be solved is 

Do I Want To Put These Chemicals Inside My Body?

It turns out there are lots and lots of these costs and benefits to weigh.  The numbers you get in your fifteen minute med check are abbreviated and oversimplified to the point of useless.  So this is going to take a few weeks.  I am breaking it down, one step at a time.  Like I said, a set of logical rules applied to objective data to solve a problem.  I promise as few numbers and as many pictures as possible.  Plus another musical interlude.

Two weeks ago, I made a list of factors, all the things that go into the scale.  Today we look at the good side, what the doctor calls BENEFITS.

Here goes. 

Effectiveness Rate

Weighing the Costs and Benefits Part I -- What Counts?

Manifesto

If I am a lab rat, I will be a free-range lab rat.

There.  I feel better already.

To recap from last week:

You Have to Weigh The Costs and Benefits

That is what the doctor says.

Last week I promised I would develop a way to do that.  So this week we play math games.  For the next few weeks, actually.

Now, don't freak out.  I am not going to ask you to do math.  I am going to make up some rules.  You are along for the ride.  Though do feel free to suggest better rules.  Plus, I promise lots of pictures.  And a musical interlude.

I am a rat.  I live in a laboratory, where I participate in the Chemistry Experiment.  Along with other scientists, I am trying to find the chemicals that will make a dent in my mood disorder.  Not theirs.  Mine.  Which is how I got the rat end of this job.  But because I am a free-range rat, I get to decide which experiments I am willing to try.

I now insist that I contribute more to this enterprise than my body.

Manifesto of a Lab Rat -- Weighing the Costs and Benefits Part I

I Am A Lab Rat.  Yes, I am.

Here is the deal.  I was lucky enough, and you were lucky enough to be born after the discovery of penicillin (1928).  Well, I don't know when you were born.  But evidently penicillin was discovered before it became a life or death issue for either of us, or I wouldn't be writing and/or you wouldn't be reading Prozac Monologues.  This is good.

In another age, my ruptured appendix might have been treated with leeches.  That would not have been good.

As far as my more immediate health challenge goes, we are barely out of the leech stage.  Okay, that's a bummer, the timing of my life, that is.  But like I said, ruptured appendix, penicillin.  It could have been worse.

Research Into Mental Illness -- Rats

In the treatment of mental illness, they have figured out that leeches don't work.  They think chemicals might. They just haven't figured out which ones.  They are working on it.  They have lab rats, rattus norvegicus to be specific, who do the heavy lifting in this Chemistry Experiment.  Some people question the ethics of what gets done to these poor rattus norvegicuses who participate with not a single informed consent form in sight.  But that not only is another post, it is another blog.

Mood Disorders -- Tolerable, Bad and Downright Ugly, Part I

A friend recently asked me for a short description of the difference between Major Depressive Disorder and Bipolar II. I didn't keep it short.  This will not surprise my regular readers, and warn my newer ones.

But here is the short answer.  Normal mood cycles within a normal range, sad/okay/glad.  Major depression has bigger distances, between normal and really sad.  Bipolar has the biggest distances.  Bipolar I ranges from really sad to really really up, with more time spend down than up.  Bipolar II moves the base line down from bipolar I.  It goes up, though not so far, and way, way down, lower than the others.

There are other aspects to mood disorders, affecting thought, desire, motivation, energy, sleep, digestion, appetite and even physical pain.  But this astonishingly short answer says way more than your common perception that depression means you are sad; bipolar means you are crazy.

Since I regularly write about these and the other mood disorders in Prozac Monologues, it may be helpful to give the longer answer here.  So today begins another three-part series.  I do seem to like these three-part series.  Things stretch out when I want to make Prozac Monologues both clear and entertaining -- though I suspect that it's mostly people with diagnoses who get the entertaining part.

PTSD: The State of Treatment

This is the second part of a series on Post Traumatic Brain Syndrome.  Let me recap last week and expand on what we know about the neurobiological mechanisms (how the brain works) of PTSD, and then discuss treatment strategies.

When something stressful happens, the brain prepares the body for action.  The hypothalamus, pituitary gland, amygdala, locus ceruleus and opioid system all release hormones to speed up respiration, raise blood pressure, reduce sensitivity to pain, all useful conditions for the proverbial fight or flight.

Under normal stressors, as soon as these hormones are released, feedback systems go into operation.  The hypothalamus tells everybody else that their job is done and they can back off.

These hormones, especially cortisol, damage brain structures, notably the hippocampus, whose job is to regulate emotion and to perform the "that was then, this is now" function.  I named it that, and am very proud of it.  My own brain has almost no "that was then, this is now" function.  Pretty much zip.

DSM 5 and Mood Disorders, Part III -- The Way Forward

 

Lost Creek Wilderness 

I have been writing about the newly released draft of the Diagnostic and Statistical Manual -- DSM V for the last few weeks.  Let's recap:

The DSM V -- What's at Stake: The pharmaceutical and health insurance industries have a huge financial stake in who gets diagnosed with what in the mood disorder section of the Diagnostic and Statistical Manual.  This stake has skewed the new draft version of the DSM to support the status quo/current market conditions.

The DSM V made almost no changes in the Mood Disorders section.  (Well, a few, not so minor for children and the bereaved.)  This despite the evidence that the current criteria for bipolar II exclude people who are instead diagnosed with recurrent unipolar depression, but who get much worse when treated as though they had recurrent unipolar depression, and who eventually are diagnosed with bipolar II anyway, if they are still alive.  Women spend eleven years on average before being diagnosed correctly.  That's eleven years of a lot of suffering on a lot of antidepressants.  One helpful modification in the bipolar II area will become important below.

The Draft DSM V -- How Did We Get Here?: Advances in the treatment of  depression have come about by serendipitous discoveries, followed by pharaceutical companies' desires to improve their own market share.  These have been genuine advances.  However, their manipulation of research to support their products is a national disgrace.  The AMA is finally embarrassed by it.

That is where last week's post left us, at Mile Marker #3 in "Up a Creek Wilderness" -- the sorry state of research on this map that is owned by the pharmaceutical companies.

So now we have arrived at:

Goose Creek Trailhead

Mile Marker #4 -- Their goose is cooked.  They have run out of product.  There are lots of ideas out there besides the tired old "chemical imbalance/neurotransmitter" fixation on one aspect of depression.  And research is being done on other neurological mechanisms of depression.  But Big Pharma got lazy and has been slow to develop these ideas into useful medications.

Patents have expired on almost all the antidepressants on the market today.  The sleight of hand trick is to repackage the same medication by altering its formulation a little bit (Celexa/Lexapro, Effexor/Pristiq) or by doing a time-release version to add a few years to the patent (Paxil CR, Wellbutrin XL).  But that strategy has a time limit, and lack of development has caught up with these companies.

I think Eli Lilly's new product Symbyax is the ultimate in failed strategies, combining the patent-expired Prozac/fluoxetine (originally used for major depression) with the newer and controversial Zyprexa (originally used for psychosis and lately the subject of successful lawsuits).  If it really were a good idea, you could get the same results with two prescriptions, the antidepressant that worked best and an antipsychotic less dangerous than Zyprexa, instead of the two products owned by Eli Lilly.  With the combination package, you get the side effects of both: sexual dysfunction, agitation, akathisia, insomnia, etc. for Prozac and ballooning weight gain, high blood sugar, risk of diabetes, high cholesterol, tardive dyskinesia, etc. for Zyprexa.

Nevertheless Symbyox will make Eli Lilly a bit of money for a while, because it has widened the market for Zyprexa.  They need another market since that successful lawsuit reduced its use among older people with psychosis (who experience a rather nasty side effect of death from Zyprexa's off-label use for dementia.)  Symbyax now is also indicated for people with treatment-resistant depression, whose doctors need to keep coming up with something new to give them. God forbid they should reexamine the diagnosis, or that the DSM V should encourage them to do so.  People with treatment-resistant depression account for half of the depression market, the half that stays on the market, because they "keep trying," like everybody tells them they should.  So good luck, Lilly.  I hope you are in court again soon.

That's Mile Marker #4.  And it makes me as depressed as Mile Marker #3 makes me mad.

Mile Marker #5 -- It turns out that we have been traveling in a circle, and now looped back to the beginning.  This is where I find the good news.

We have another serendipitous discovery!  Lamictal was first used as an anti-convulsant.  Following the pattern of other advances in the treatment of depression, Lamictal's mood-related effects first became apparent in people with epilepsy.  Happy seizures. -- Though unlike previous medications, Lamictal works just fine for its original purpose, as well.

Lamictal (generic name lamotrigine) is now approved for use in managing seizures and bipolar I.  Its off-label uses include bipolar II and treatment-resistant unipolar depression.  (When a doctor prescribes a medication for something that it hasn't been approved for, that's called "off-label" use.)

This "off-label" use issue is critical here to advance the treatment of depression, especially for those who are misdiagnosed (using DSM V guidelines) with unipolar depression.

The rules regarding marketing of off-label use are in flux.  Currently, sales representatives may not recommend their products for off-label use, but they may direct doctors to research about such use. They may not, however, pay doctors to tell other doctors about their experiences with off-label use, at continuing education conferences and the like.  That's what got Pfizer busted, for their marketing of Geodon, another anti-psychotic like Zyprexa, while searching for their market share of dementia and depression.  The money in these cases generally goes to Medicaid and Medicare, who paid for the prescriptions.

See, there's a swamp out there between Mile Marker #5, the next serendipitous discovery and:

Mile Marker #6: Ca-ching! Ca-ching! -- that huge new money-making machine.

Doctors prescribe medications for off-label use all the time.  Drugs that have been tested and approved only for adults are tried on children.  Otherwise, there wouldn't be anything they could give to kids, because who wants to risk clinical trials on kids?  Drugs approved for one type of cancer are tried for another, because who wants to say "no" to somebody whose cancer has metastasized?

Off-label use gets turned into approved use if it works out in new clinical trials.  If it doesn't work out, it goes away.  That's the way it's supposed to work.  But if the trials don't work out, and the drug companies fudge the data and market the medication anyway, then they get sued.

My doctor told me that Lamictal is the "go-to drug" for bipolar II, evidently very common off-label use.  I don't know how she knows, whether she read the research, whether the medical journals have been flooded with articles commissioned (or maybe not) by GlaxoSmithKline, whether she heard about it from other doctors who are on (or maybe not on) GlaxcoSmithKline's payroll, or whatever.  It is also on the top of her list for treatment-resistant unipolar depression.  I am not expressing doubt about Lamictal's effectiveness.  I am simply explaining how off-label use works in clinical practice.

So we are currently at Mile Marker #5.  Now we start climbing that hill to #6.  Just like they did with tricyclics and SSRIs, everybody is asking, "How does Lamictal work?"  They think it has something to do with calcium, but I won't go into that here.

The answer to the "how" question is particularly important to the other pharmaceutical companies, because they will use the answer for a grab at their market share, by trying to improve on the side effect profile.

Lamictal's side effect profile isn't so bad, as far as mood stabilizers go.  It is light years better than Lithium, which is beyond nasty, but desperate people take it, because it has been their only relief.  Lamictal also is not so bad compared to antidepressants.  It causes fatigue, headaches, muscle pain, but not in as many people.  Its big drawback is this pesky rare (but potentially fatal) skin rash.

Potentially fatal.  Wow.  Now, one in 500 people get this rash, and all you have to do to get rid of it is stop taking the drug.  I am not sure why this rash is the major concern about the medication.  Except there is no denying the cause.  Antidepressants cause suicidal ideation and behavior at a much higher rate than Lamictal causes rash.  But try to prove it in your case.  You already have a disease that carries a risk of suicide.  And even on the antidepressant in question, it might be that your disease is simply progressing.  You are as likely to get your dose increased as discontinued.  And you will not get your day in court.  Lamictal causes some kind of rash in 1 of 10.  But even if your rash is caused by the new soap you are using, looks nothing like the bad rash, and even if you are free from suicidal thoughts for the first time in a decade, you get yanked off Lamictal.

So here is an excellent opening for other companies, to come up with something with no rash, or even a rash that only one in 1000 get.  We can expect other mood-stabilizers to reach clinical trial stage in the near future.  Ca-ching!  Ca-ching!

Mile Marker #7:  At that point, interests will align, of the pharmaceutical companies and those who have been misdiagnosed because of the not-yet-published but already dated DSM V.  The pharmaceutical companies are looking for Ca-Ching! Ca-Ching.  And depressed people are looking for better medications.  We finally reach the operation of the free market system.  This is the United States of America.  Fortunately for depressed people, there are enough of us to make it profitable to treat us.

The fly in the ointment is the DSM V.  It does loosen restrictions on the diagnosis of bipolar II a bit.  The DSM IV said that a hypomanic episode brought on by antidepressant use does not count as a real hypomanic episode, and the person has unipolar depression -- suggesting to more conservative doctors that they keep looking for a better antidepressant.  The DSM V says that an episode brought on by antidepressant use is a real hypomanic episode, with a diagnosis of bipolar II -- pointing doctors toward mood-stabilizers.

So the task of the drug reps will be to direct doctors to the research demonstrating:

• more than half of those with severe depression eventually are diagnosed on the bipolar spectrum;
• incredible harm is done to these patients when given antidepressants;
• therefore these depressed patients might benefit from receiving a mood-stabilizer from the very beginning of treatment, particularly the mood-stabilizer of which the drug rep happens to have samples.  

The true conservative treatment course might be to treat all depressive people with mood stabilizers, unless the doctor has time to sort between those with genuine unipolar depression (presenting their first episode and no history of anything that looks even slightly like hypomania) and those who have recurrent depression (or "cycling" depression), especially when Lamictal and future mood-stabilizers have better side effect profiles.  First do no harm.

Never mind what the DSM V says.

If the meds work, if they increase their makers' market share, then the pharmaceutical companies will continue to find ways to do their own education of doctors, including education in how out of touch the DSM V is with clinical practice.  These same market forces will make irrelevant the DSM's refusal to define a diagnosis for pediatric bipolar.  If the meds work, children may receive a nonsensical diagnosis, but they will also receive the appropriate medication.

Mile Marker #8:  Now all hell breaks loose with health insurance and HMOs.  They depend on the DSM for billing.  But the gap between the DSM and clinical practice in mood disorders will be so wide that case reviews and billing procedures will fall apart.  Doctors will either code according to the DSM and treat according to reality, or code according to reality and ignore DSM criteria.

But our health care delivery system is already broken, and will collapse anyway, long before we reach Mile Marker #8.

 

sign at Goose Creek Trailhead photographed by Steven Bernard

in public domain

photo of Lamictal by Parhamr and in the public domain

money bag from Microsoft clipart

"Book Burning" is licensed under the  Creative Commons Attribution 2.0 Generic license.

DSM 5 and Mood Disorders, Part II -- How Did We Get Here?

 

Lost Creek Wilderness

Starting point -- Okay, the only way we get anywhere is if we understand very clearly who owns this map.  The pharmaceutical companies do.  It's their map.  Get over it.  This knowledge will help us steer a course, or maybe give them a nudge, or at least anticipate where they are taking us.

For the longest time, depression got no respect.  When they started using medication for schizophrenia, depression was still lost in the la-la-land of Freud's neurosis.  You could either talk it out over years on the couch, or you could snap out of it.   Medical advances in the treatment of depression came about by accident.

So back in the 1950's, Smith Kline and French (today GlaxoSmithKline) were making a killing on thorazine, the first med to treat schizophrenia.  It worked, but thorazine has so many side effects they list them alphabetically.  Other drug companies wanted a piece of the action.  Seeking to improve the side effect profile, they came up with the first tricyclics.  Tricyclics (Elavil, et al.) were a bust, as far as psychosis goes.  But they had an interesting new side effect -- mania.  Happy psychotics.  

Same time frame, different illness, MAOIs were developed to treat tuberculosis.  Again, not so effective against tuberculosis.  But suddenly sullen patients were skipping down the hallways and creating "discipline problems." Happy coughers.

Mile Marker #1 -- We have a whole new market for psychotropic medications -- depression.

These accidental discoveries drove research into the neurological mechanisms of depression, posing not the question, "What causes depression," but rather, "How come antidepressants work?"  Well, one of the consequences of taking these medications is an increase in the presence of neurotransmitters, serotonin et. al.

Mile marker #2 -- We have a simple, catchy sales pitch.  Depression isn't a rich lady's neurosis, after all.  It's a "chemical imbalance in the brain" -- just as diabetes is an imbalance of insulin.  Well, that's not an issue of character, as depression was thought to be.  (And still is, you will find out if you don't get better.)  It can happen to anybody.  And it can be fixed, too.  Take a pill, just as diabetics take insulin, and you fix the imbalance.

At this point, the neurotransmitter hypothesis takes us deep into our map.  Prozac and other SSRIs (Celexa, Zoloft...) were developed by tinkering with the basic concept behind tricyclics, again as attempts to improve market share by improving the side effect profile.  But SSRIs didn't really work as well as the sales pitch did.  The market share threatened to drop as "treatment refractory" patients ran out of new meds to try.  Meanwhile, pharmaceutical companies were running out of patent protections.  Along came SNRIs (Cymbalta, Effexor...), more tinkering.

By now marketing drove/drives the research.  The pharmaceutical companies were not interested in figuring out what is happening inside the depressed brain -- they thought they already knew.  Instead, they funded research into a jillion examinations of the same "chemical imbalance" and what their own medications do for it.

Mile Marker #3 -- The pharmaceutical companies, with their already developed products to market, take over research departments of universities and medical schools.  Research departments fund their way having their top scientists sign on to reports that they have not written.  A scientist will sign more reports than he or she has time to read, much less write.  The practice is called "guest authorship."  (In other academic departments, this is called "plagarism.")  Often the pharmaceutical companies contract out the writing or do it themselves, called "ghost authorship."  They write slightly altered reports of the same clinical studies, and flood the medical journals, who publish the seemingly different reports, neglecting their own publishing standards that call for disclosure of these practices and conflicts of interest.  

No, really. The ethics of medical journal publishing has become so problematic that the AMA (American Medical Association) convened a special forum five months ago to examine the issue.  The results of study after study on various practices in authorship and publishing demonstrate that this problem has not improved since it was raised in the mid-1990's and standards were developed.

What are the prospects for improvement in publishing?  I find particularly amusing/astounding/discouraging the report on Background, Training, and Familiarity With Ethical Standards of Editors of Major Medical Journals. "Although 86% of respondents were “confident” or “very confident” in their knowledge of scientific publication ethics when they began the survey, this number dropped to 71% by the end."  Indeed.  Because: "Performance on the editorial scenarios was poor; correct answers were given by 18% to the question on plagiarism, 30% to authorship, 15% to conflicts of interest, and 16% to peer review."

These are failing grades received by the editors of medical journals.  These are the people who decide which studies get published, what information is available to my doctor and yours.  Why does this matter?  Because reading journals is how my doctor and yours keep up to date, their continuing education after medical school.

So the science has gotten pretty bad.

And in the field of mental health, the pharmaceutical companies own it.  There is one sales representative for every five doctors.  This is the United States of America.

(You get better science, and different results, if you read the journals from Europe.)

Okay, getting us into this map has made for a long enough blog post.  Next week -- Mile Marker #4, and onward.

map of Lost Creek Wilderness made by David Benbennick

in public domain

DSM 5 and Mood Disorders, Part I -- What's at Stake

Earlier this month, the American Psychiatric Association released the long awaited proposed revision of their Diagnostic and Statistical Manual of Mental Disorders (DSM-5).  It is available now for public comment, with an anticipated publication date for the final version in May 2013.  To call this the Bible of Mental Illness is to overestimate the significance of the Bible.


The DSM was first written to give clinicians and researchers a common vocabulary and a common understanding of the various diagnoses of mental illness.  John McManamy has related this history on his blog Knowledge is Necessity.  I refer you to his thorough account, found in the links at the bottom of his post. -- [Hey, John -- I recognized your image for "Few Surprises."  It was one that I considered for this post!]

The way the DSM works always reminds me of a Chinese menu.  For example, if you have one symptom from Column A and at least five from columns A and B, for over two weeks, you have Major Depressive Disorder.  You can upgrade your core diagnosis with specials offered alongside the basic menu.  These lists of symptoms provide a common vocabulary and simplify diagnosis, so that family practitioners commonly diagnose depression and prescribe antidepressants, without referral to psychiatrists.  This practice provides a boon to the pharmaceutical industry, which markets heavily to family practitioners.  If patients had to see a psychiatrist to get a prescription, fewer people would take antidepressants, since there is greater stigma attached to treatment by a psychiatrist, psychiatrists are in short supply in many parts of the country anyway, and health insurance plans provide inadequate coverage for psychiatric care. So family practitioners prescribing for depression sells more antidepressants.  Big Pharma wants to keep the DSM simple.

Over time, even as therapists have become more eclectic in their therapies, the sequence of DSMs has more narrowly defined the illnesses which therapists treat, adding more specificity.  The DSM gives a numerical identifier for each diagnosis, along with decimal points after the numbers to indicate variations and severity.  Health insurance companies rely on the DSM to determine coverage.  If you don't have a number, you don't get reimbursed.  But they have become concerned about the multiplication of diagnoses, raising the number of claims.  Health insurance companies want to limit the number of diagnoses and limit the number of people diagnosed.

Release the Kraken!!

Well, it's one of those weeks in a remitting/recurring disease. "Release the Kraken!" -- my favorite line from Clash of the Titans, a 1981 movie to be remade and released this summer.  Oh, you gotta check out that link to the trailer!

My apologies to regular readers who are looking for a new post.  It's an interesting one, Shadows.  Maybe I will be able to write it next week.  Come to think of it, the image on the right would fit that post, too. (Anonymous, in the public domain for copywrite expiration). For now, here is a reprint from last July:

What is Depression, Anyway?

When I thought the meds would work, I didn't ask this question (referring to the title, not the caption!) Depression is a disease of the brain and also of the mind. The best results are obtained by working on both fronts. Take your meds. Talk to your therapist. Simple.

Then I discovered that the meds made me worse. Whenever I say that, I rush to say that, my experience notwithstanding, for most people they work. They can save your life. And then I rush to say, but not for everybody. If you think they make you worse, you might be right.

The rhetoric keeps shifting on this point, depending on what the speaker is selling. I think the current prevailing stats are that the meds help half of us, harm a quarter of us, and for another quarter, they just don't work. And for most of us in any of those groups, the disease does go away on its own anyway, though it leaves its wreckage behind. But that is what I am gleaning from the research. Nobody in the scientific community has summed it up so simply.

Prozac is Talking -- Anybody Listening?

Anybody know this story?  You get a new prescription.  Responsible consumer that you are, you read carefully the PI [prescribing information] sheet.  It says, "If xx happens, call your doctor immediately."  Sure enough, xx happens.  You call your doctor, who does not call back.  After persistent calling over several days, the doc says, "Really?  We'll keep an eye on it."

The other day, I had a nosebleed that wouldn't stop.  The PI sheet says my new med can interfere with platelets, admittedly not very high on the list of side effects.  But I contacted the doc.  "Really?"  she said, "Where did you hear that was a side effect?"  My answer, "On the PI sheet you gave me."  It turned out, my blood work was fine, and the humidifier took care of the nosebleeds.

No harm done.  Right?

On the other hand, five years ago my GP had me on Prozac.  After a couple months, I couldn't sleep, was irritated, agitated, couldn't concentrate, had thoughts of harming myself and others.  The PI sheet said I should tell my doctor.  My doctor increased the dose.

Thus began a series of antidepressants, and a downward spiral that has ended with disability.

OMGThat'sWhatTheySaid! -- Stigma

On November 26th, the New York Times published an article about the presidential policy not to write letters of condolence to the families of service men and women who commit suicide in a war zone.  These letters of condolence have gone out since Abraham Lincoln started writing them during the Civil War.  Given the upswing of suicides in the Armed Services lately and the attendant publicity, this policy of silence, which began in the Clinton era, is coming under scrutiny and challenge.

In response to this article, psychiatrist Dr. Paul Steinberg wrote an Op-Ed commentary titled "Obama's Condolence Problem," winning him this month's OMG Award for -- oh, it's hard to choose.  There are so many prize-worthy lines.  But let's call it for: Indeed, there is nothing wrong with stigmatizing suicide while doing everything possible to de-stigmatize the help soldiers need in dealing with post-traumatic stress and suicidal thoughts. I will deconstruct this sentence after putting it in context.

Dr. Steinberg is concerned that any recognition of suicide, even the reporting of it, glorifies it and makes the taking of one’s life a more viable option. If suicide appears to be a more reasonable way of handling life’s stresses than seeking help, then suicide rates increase.

Dr. Steinberg is clearly in the voluntarist camp, believing that people make a conscious, reasoned choice to kill themselves.  Suicide, in his view, is an option, a way of handling life's stresses.  He is in, if not good, then plentiful company, who believe that even while the thought processes of those who commit suicide are impaired, their will is not. They remain responsible for their choice.

Regular Prozac Monologues readers know that I am not in the same company.  Dr. David L. Conroy gave me the words.  From Out of the Nightmare: Recovery from Depression and Suicidal Pain, "Suicide is not chosen; it happens when pain exceeds resources for coping with pain."

Conroy describes the many ways that people who are suicidal attempt to reduce their pain and save their own lives.  Those who are suicidal sometimes use the language of choice and reason.  Conroy, who speaks from personal experience, says it is terrifying to have such little control over our own emotional state that it can shove us headlong over the abyss.  This lack of control is part of, and adds to suicidal pain.  To claim that we have considered the options and are making a reasoned decision is a grasping for the image of control; it is an effort to relieve pain.

Steinberg asserts that choosing suicide over treatment is deserving of shame.  Now that first-rate treatments for depression and post-traumatic stress have evolved and are readily available, and people with emotional problems do not have to suffer quietly, are we taking away the shame of suicide?  When he decribes depression treatments as first-rate, he parts company with the National Institute of Mental Health and many doing research in the field, who acknowledge the true state of treatment.  At least a third of those who seek treatment are not able to find a medication that is effective and tolerable.  Meanwhile, certain side effects of these first-rate treatments themselves increase the risk of suicide, doubling it in the case of insomnia, a frequent side effect of SSRI's and SNRI's.  Akathesia (called "inner restlessness" on prescribing information sheets) is one of the most under-reported side effects, due to euphemisms, and among the five top risk factors for suicide among hospitalized patients.  [Side note: when you read "inner restlessness" on your prescribing sheet, did you realize that "inner restlessness" could significantly raise your risk of suicide?]

Steinberg believes that letters of condolence to family members could be an inadvertent incentive to suicide.  In light of the condolence-letter controversy, the administration is appropriately reviewing the policy that has been in place for at least 17 years — and may indeed want to consider leaving it as it is. But as a country, let’s focus our energies on doing everything we can to diminish inadvertent incentives that might increase self-inflicted deaths.  And elsewhere: We need to find the right balance between concern for the spouses, children and parents left behind, and any efforts to prevent subsequent suicides in the military.

I feel downright silly answering this argument.  But here it is:

First, the shaming of suicide is indeed one of the resources that we possess against it.  But it is an even more significant reason why people do not acknowledge and seek help for thoughts of doing it.  Shame interferes with willingness to report symptoms.  And failure to report symptoms is a significant factor in failure to recover.  To think that we can shame suicide and prevent it at the same time is fanciful. There is no balance to be found here.

Second, it is well known that surviving family members are themselves at greater risk of suicide.  Shame increases their pain, including their suicidal pain.  It is a barrier that prevents them from seeking support and prevents friends from offering it.  A letter from the President could go some distance in reducing the shame of family members and providing comfort in the midst of their pain.  If prevention of suicide is the goal, here is the most direct intervention the President could make.

Now back to the beginning.  Indeed, there is nothing wrong with stigmatizing suicide while doing everything possible to de-stigmatize the help soldiers need in dealing with post-traumatic stress and suicidal thoughts.  Putting to one side the impossibility of de-stigmatizing the second while stigmatizing the first, let's take a closer look at what Dr. Steinberg wants to de-stigmatize -- the help soldiers need.  What help would that be?  Psychiatry, leading the mental health professionals.

Steinberg wants to stigmatize suicide and de-stigmatize himself.  That's natural enough.  Nobody likes to be the object of stigma.  People who experience suicidal pain can identify with him in his desire. But I took a fanciful direction upon reading this op-ed piece.  I imagined Dr. Steinberg as a chaplain taking a course in Clinical Pastoral Education.  Are my clergy readers following me here?  Think back to your CPE experience.  Imagine the conversation in group after Dr. Steinberg says Indeed, there is nothing wrong with stigmatizing suicide while doing everything possible to de-stigmatize the help soldiers need in dealing with post-traumatic stress and suicidal thoughts.  Somebody from my CPE group would surely have asked, "How does it feel to be the object of stigma?"  And if he returned the question with a quizzical look, "How do you feel to know that people would rather commit suicide than come to you for help?  What does that mean to you personally?"

To my psychiatrist readers (do I have any?), do you have any training like CPE, where you are asked to examine your personal feelings and consider how they affect your judgments and your treatment of patients?  Does it include your judgments about suicide?  How do you feel about yourself when one of your patients commits suicide?   How do you feel about that patient, and the next patient with suicidal ideation?  Can you acknowledge those feelings?  Is shame part of your own experience?  Where have you put your shame?  Your feelings are just that, feelings.  Can you use them to inform your understanding of your patients?

I posted a facebook status last week with a link to Dr. Steinberg's article, asking, "Do patients with any other disease face such disrespect from their doctors?"  I am going out on a limb here.  But I wonder if many psychiatrists have not yet dealt with their feelings about their patients' dying.  When oncologists did, the treatment of cancer patients changed.  Now, who even remembers that cancer once was shamed?

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