Showing posts with label costs and benefits. Show all posts
Showing posts with label costs and benefits. Show all posts

Trading Symptom Relief for Side Effect Relief

Why do people stop taking their psych medication?


Psychiatrists spend a lot of time on this question. They used to call it noncompliance. Then they figured out that the word fed the power struggle between doctor and patient. Now they call it nonadherence. Me, I am not convinced that the word change reflects an attitude shift on doctors' parts, i.e., that they have changed their attitudes toward noncompliant patients, have abandoned the power struggle themselves, and instead want to partner with their patients. I suspect the word change is a cosmetic shift designed to change the patient's attitude.

Psychiatric Times regularly publishes articles on why patients don't take their meds and best practices for improving adherence. Suboptimal adherence is pervasive among individuals with chronic health conditions, including psychiatric disorders... However, many mental health practitioners ascribe nonadherence to the mental illness itself.

Antidepressants and Suicide: A History

Do antidepressants prevent suicide, or do they cause it?

Yes.

Well, maybe.

It's a no-brainer, right?  People who commit suicide are depressed.  Take away the depression, and how better than with an anti-depressant, and you decrease the risk of suicide.

So what's with the question?  Here is the story:

History of Antidepressants

Return to the Chemistry Experiment

What is it like, this chemistry experiment, you ask.  Somebody did ask, honest.

Prozac Monologues strives to be journalism, not journaling.  I write for education (mine first, then yours), not for therapy.  So when the story turns to the Chemistry Experiment, a topic I write about so often, it gets its own label, I have tried to season my prose only lightly with my personal story.

But the Chemistry Experiment has been excruciatingly personal these last several weeks.  And nowadays, the personal story is one way that journalists frame their reporting.  So here goes.

Looking Under the Hood - A Better Depression Diagnosis?

Corrected July 7, 2013

Maybe my writer's block is an Ecclesiastes issue.  There is nothing new under the sun.

But finally, there is.  No, not the DSM.  Keep reading.

The DSM. Sigh.

But regarding the DSM, and it makes no difference at all which edition, you have to wonder when somebody who is suicidal, losing weight, irritated at the drop of a hat and can't sleep gets the same diagnosis as somebody else who is immobile, gaining weight, couldn't be bothered about anything anymore and sleeps the night and day away.  It's all depression -- the DSM's junk drawer.

Finally, somebody thought to sort the junk drawer, by looking inside the brains of these two sorrowful souls, both taking the same meds for God's sake.

PET Scans - Looking Under the Hood

Helen Mayberg and her team at Emory University School of Medicine used PET scans to look under the hood (to use John McManamy's favorite metaphor).  PET scans use a radioactive tracer to determine where glucose is being used in the brain, i.e., what part of the brain is busy.

Homicide and Firearms - Some Facts

While I was researching this post, a Facebook friend posted this  picture.  I commented, giving information I discovered and found surprising.  The stats are below, under domestic violence.  A friend of my friend then commented, Dearest Willa......useless, worthless statistics.  Lies, damn lies and statistics.  Go back to class and learn forgiveness, and while you're at it....drop dead!

Well.  That was disturbing.  To my knowledge, I do not know the person who called me Dearest Willa, said I need to learn forgiveness, and then told me to drop dead.  It occurs to me that facts have power, if they evoked this response.

My facts come from the Centers for Disease Control, Bureau of Justice and Federal Bureau of Investigation, from reports and data bases that count people who died and how they died.  That is all these sources did -- they counted.  They made no policy recommendations.

I make no policy recommendations in this series, either.  I am reporting their numbers.  I do hope they are not useless numbers.  I offer them to you to help you weigh the costs and benefits of gun ownership.

How Many Killed Since Newtown?

Technical difficulties have delayed my research on homicide and firearms.  I can't figure out how to make the story not tedious.  So I will skip it.  Maybe next week...

Until then, here is a resource to keep you up to date.  Slate Magazine and the Twitter feed @GunDeaths are crowd sourcing data to answer the question:

How Many People Have Been Killed by Guns Since Newtown?

The answer is not easy to find.  Coroners do not publish this information in real time.  Perhaps you noticed that my statistics last week were from 2009 and 2010.  The tally is collected only at the end of the year, and it is not official for some months after.  Suicides, in particular, are underreported, even in official statistics.  They get caught up in investigations that take months beyond the reporting date.  Eventually the numbers for 2011 will be corrected, when these investigations are completed.  Meanwhile, the smaller number has been published in places that will not be corrected and will nonetheless be repeated (including Prozac Monologues, if I try to publish the most current sources.)


Guns and Death, Death and Guns

I have a friend, a young mother of two toddlers, whose New Years resolution is to get her license to carry.  This series is for her.  Live long and prosper, dear one!

My Next Series -- Facts About Firearms

I have a plan.  No, not that kind of plan.  Well, yes, I do.  But that is not the plan I mean right now.  I plan to do a series about firearms.  It is my intent to provide facts, just facts.  There are a lot of facts out there about firearms.  A lot of nonsense is disguised as facts.  But genuine facts are available, and more useful than our impressions for making sound decisions.

I am not going to write about my opinions about firearms, because, well really, who cares about my opinions.

Keeping Track of How People Die

Firearms are a cause of death, which means that the US Centers for Disease Control keeps track of them.  Wait, wait -- it doesn't keep track of the firearms, just the deaths.

Dopamine and Dementors



Dementors are among the foulest creatures that walk this earth. They infest the darkest, filthiest places, they glory in decay and despair, they drain peace, hope, and happiness out of the air around them... Get too near a Dementor and every good feeling, every happy memory will be sucked out of you. If it can, the Dementor will feed on you long enough to reduce you to something like itself...soulless and evil. You will be left with nothing but the worst experiences of your life.
-- Remus Lupin to Harry Potter
Harry Potter and the Prisoner of Azkaban

Been there?

While we wait with bated breath for the final episode of the Harry Potter movie series, here is a post on the neuroscience of Harry's worst nightmare.

Dementors, you see, are dopamine depleters.  They are not to be messed with.

Neither is any other kind of dopamine depletion.  Here is one clinical case, an experiment conducted on one highly-functional, never-a-whiff-of-mental-disturbance 21-year-old who received a dopamine depleting drug over the course of 25 hours.

The Future is Bright -- For Whom?

The Future is Bright for Psychopharmocology Breakthroughs --

Okay, I'll bite.

I subscribe to an online journal Psychiatric Times.  Or at least, I have access to the articles for which there is no charge.  I don't get paid for this, you know.  Anyway, I get emails that link to the articles of the week.

So that was the subject line on the email dated 4/21/11, The Future is Bright for Psychopharmocology Breakthroughs.

This I'd like to know about.

Inside the email was a link to Novel Treatment Avenues for Bipolar Depression: Going Beyond Lithium, by Roger S. McIntyre and Danielle S. Cha.

This I'd really like to know about.

The article was not what I had been led to believe.  But I learned a lot, will share some of that with you, and explore the miscommunication at the end. 

Weighing Costs and Benefits Part V -- Down and Dirty Algorithm

SE + NE + $$$ + STG + TR = STC.

E#PT X NSR = STB.

STB TO STC = ODDS OF SUCCESS


There it is, the Prozac Monologues Down And Dirty Algorithm, to weigh your costs and benefits for medication or any other treatment for any mental illness, or any other medical condition, for that matter.  Click on the first and second lines.  They will take you to the posts that develop the formula.

Can you believe we finally made it?

We started with the:

Manifesto of a Lab Rat. 


I am a Lab Rat.  Yes, I am.

The Manifesto begins there.


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

What I mean by free-range lab rat is this: 

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

Your doctor tells you to weigh your costs and benefits, but gives you no way to do so, other than insufficient information + gut + desperation = noncompliance, if you don't come up with the same answer as your doctor.

What we need is an algorithm: logical rules that we can apply to objective data to solve a problem.

This algorithm does not exist.

So as an interested party, a very interested party, given that my body is the test tube, I decided that my contribution to this chemistry experiment would be the algorithm.

The problem we want to solve is this:

Do I Want To Put These Chemicals Inside My Body?

This task has continued over several posts this fall, interspersed with a few sick leaves and vacation days.  Click on costs and benefits to follow the whole development.  (The first post is at the bottom, dated August 19, 2010).

What To Do With The Algorithm

The resulting algorithm can be applied not only to the chemicals you put in your body, but any other form of treatment as well, talk therapy, aerobic exercise, yoga, Chinese medicine, acupuncture, even aroma therapy, should you choose.

You can compare the results of the cost/benefit analysis of different treatments, and do the same with various combinations, when you can find the numbers.  Which admittedly, you cannot for any of these that do not get Blue Cross Blue Shield reimbursement.

There are numbers out there for talk therapy and aerobic exercise.  But doctors do not usually use the word therapy for anything other than chemicals or electro-convulsive therapy (ECT) or any of those new-fangled electrical interventions.  That is the context in which you are told to weigh your costs and benefits.

For the most part, I have used antidepressants as examples.  One out of every ten people in the United States is taking them right now.  So this would be the most common application, among psychotropic medications.

It was helpful to look at chemicals as I developed this algorithm, because they are the form of treatment with the greatest costs and greatest variety of costs:





dizziness and confusion,





insomnia and fatigue,



weight gain, irritability, sexual dysfunction,  irritability.




So this is what you do when you use the algorithm to weigh your costs and benefits -- you compare two numbers, STC (Short Term Costs) and STB (Short Term Benefits).

And how do we get those numbers?

Remember,

SE + NE + $$$ + STG + TR = STC.
E#PT X NSR = STB.

The abbreviations increase the confusion quotient, and thus make it look scientific.  Here is a translation:

Side Effects (SE) plus Not Effective (NE) plus Money ($$$) plus Stigma (STG) plus [lack of] Trust (TR) are your costs (STC).  These costs are based on the reasons people give for discontinuing their medication.

Efficacy Given The Number of Present Trial (E#PT) times How Many Would Not Experience Spontaneous Remission Unless They Took the Medication (NSR) are your benefits (STB).

Did you like my illustrated tour of the previous posts?

And Where Are We Supposed To Get Our Data?

They ought to be provided to you by your doctor, who has told you to weigh your costs and benefits.  Except for money, stigma and trust -- you have to come up with your own odds that you will quit taking your medication because you can't afford it, you are afraid for your reputation, or you do not trust your doctor.

They ought to be provided to your doctor by the drug reps.

But they are not.

So you have to do your own research.

I think the algorithm would make a fabulous app.  The numbers could be regularly updated, from the latest research by scientists not funded by the companies that sell these chemicals.

I claim copyright, by the way. 

Long Term Costs And Benefits Are Missing

Notice that I refer to short term costs and benefits.  Some will object that I left out good reasons to take meds: the difference that meds make to how quickly another episode occurs (relapse rate), how long various approaches take to work (time to remission), how medications affect things like brain mass, suicide risk.

Others will object that I left out good reasons not to take them: the possibility that medication might accelerate the natural progression of the disease, the possibility that the diagnosis is off and you will flip into mania or hypomania, liver damage, the consequences of weight gain, such as heart disease and diabetes, suicide risk.

Someday I will do a post or two on that suicide risk issue.  There is a lot to say about that.

Well, this algorithm is complicated enough and took five posts already.  This one has that i-Pod potential.  The one that includes all those other issues will take more gigabytes.

STC versus STB give you the odds.

Once more I repeat, they do not give you your decision.  There are additional personal factors that influence or even override logical rules, objective data, and problem solving.

Personal Factors:

You have used up your sick leave, your vacation time and your family leave for this year and next, and your boss will fire you if you don't start taking meds.

Your wife has issued a similar ultimatum.

You can't get out of the loony bin any other way.

You are desperate.

You have the knife to the wrist.

Like I said, it is your decision.  I am merely your humble servant.  Who does occasionally buy a Powerball ticket.

How Does The Algorithm Work?

Let me give you a personal example.

When I first took Prozac, Eli Lilly's website said that it had helped 70% of the 55,000,000 who had already taken it.  I didn't know anything about spontaneous remission or the effect of which trial this was.  So STB = 70.

Meanwhile, none of the side effects (SE) reported went above the 15% range; the odds that it would not be effective (NE) were 30 out of 100; it was already generic, and I could afford it ($$$); stigma (STG) was not an issue for me; and I had total trust (TR) in my doctor.  So STC was 15 + 30 + 0 + 0 + 0 = 45.

That meant (with the information I had) that the odds for Prozac were 70 to 45 in favor.  And I could put off therapy.  No brainer.

Next up -- actually, five keep trying's later, we had moved on to a psychiatrist who prescribed Effexor.  Crazy Meds says: for deep, despairing clinical depression that needs to respond to the standard tweaking of the three most popular neurotransmitters, Effexor XR (venlafaxine hydrochloride) often pulls people out of the abyss.  By then, the deep, despairing abyss -- that would be me.

My doc said I get good results from Effexor.  She didn't say how good results translated to a number,.  (That's case studies, by the way -- not research.)  But she did tell me to weigh my costs and benefits.  By then I knew that most antidepressants have about the same effectiveness level, which I took to be around 40%.  I didn't know it mattered that I was on my sixth go round.  Odds for benefit, STB = 40%

She also gave me the usual side effects, because I asked.  Since insomnia was a major issue for me, and we had run through a number of sleep aids, she said that the insomnia risk (SE) was 15%.  Not effective odds (NE) would come in at 60 out of 100.  Since she didn't ever answer phone calls, and I knew I couldn't stop this med without help tapering off, and I was wary of her by now, I grilled her on how to discontinue without her help.  Trust, lack thereof, (TR) was in the 40% range.  STC was 15 + 60 + 40 = 115.

With Effexor, my odds were 115 to 40 against.  Not so good this time.  However, desperation overcame gut instinct.  So I kept trying.

The rules of the algorithm work, but the results are only as good as the objective data.  What if I knew then what I know now?  Without going into the whole story, and by tweaking numbers actually available: 

Prozac -- 

STB = 40 (E#PT) X .8 (NSR) = 32.
STC = 30 (SE) + 60 (NE) + 0 ($$$) + 0 (STG) + 20 (TR) = 110. 

110 to 32 against.  I still had issues with therapy (nothing to do with any therapist I have ever known, by the way).  And being over-educated, I am on the compliant side.  So I would have given it a shot. 

Effexor --

STB = 10 (E#PT) X .8 = 8.
STC = 34 (SE) + 92 (NE) + 0 ($$$) + 0 (STG) + 95 (TR) = 221.

221 to 8 against.

The numbers for Effexor come from the STAR*D study, and were available at the time I started taking it.  But I didn't know that.  STAR*D's original conclusion was that after two antidepressants have been tried, subsequent results are dismal, and more research for better medications should be a priority.

Since then, a jillion articles have been written about how STAR*D was a lousy research design that cooked the books in way favor of the chemicals at every step, starting with the selection of subjects.  Click here for my posts that reference STAR*D.  But Google it for for what the scientists say.

Anyway, 221 to 8 against -- I would have given it a pass.  Even I could tell the books were cooked.  And I got so much better after I went off it.

And So The Manifesto Of A Lab Rat Concludes

Of course, your results may vary.  Just remember, it's your test tube.




flair from Facebook
Photo "Tired Man" by graur codrin
Photo "Angry Father" by Akapl616.  Permission is granted to copy
under the terms of the GNU Free Documentation License
i-Pod family photo by Matthieu Riegler, licensed under
the Creative Commons Attribution 3.0 Unported license.png
photo of Warren G. Harding in public domain
photo of woman pointing taken by David Shankbone,
used by permission under the Creative Commons 
Attribution-Share Alike 3.0 Unported licence and modified
photo of prozac by Tom Vasco and is licensed under
photo of effexor by Parhamr who has placed it in the public domain
photo of John LeCompte of Evanescence by Samuel Lang,
permission to copy and modify granted under GNU Free Documentation License

Weighing Costs and Benefits Part IV: Costs

Some people quit taking meds that their doctors believe will relieve their symptoms of mental illness.  Why?

Because the meds don't work, because they can't afford them, because the meds make them sick.

Manifesto:

For any of these reasons, people who quit are making intelligent decisions in their own best interests.

On The Other Hand 

Sometimes the meds do work.  Sometimes people have decent health insurance with good drug coverage.  Sometimes the side effects are not as bad as the disease.  In that case, those who quit their meds are stupid.

Let's just get that right out front.

Moving On To The Costs

Today my series on weighing costs and benefits turns to the costs.  The costs do not tell you whether you should try a medication.  They simply give you the odds.  It is up to you to decide how you want to play the odds.  I calculate the odds based on the numbers of those who quit.  Those who consume have the best information about costs, what actually happens when they put these chemicals in their own particular test tubes.

How Many Of Us Are Noncompliant?

Out of 100 prescriptions that providers write, 10 consumers never consume.  They don't show up at the pharmacy at all.

28 consumers quit within the first month.  That includes those first 10.

50 quit within 60 days.

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

That leaves 22 compliant consumers.

How Do Noncompliant Consumers Explain Their Decision?

10 out of the 78 don't.  Providers failed to close the sale.  Providers would be interested to know why these 10 are pharmacy no shows, because it might help them improve their pitch.  Their assumptions are that it was because the consumers didn't understand, or the providers didn't establish trust, or that good old back up -- stigma.  But often, consumers don't report their decision.

We could invent reasons, which might be fun, top ten list, that sort of thing.  The drinking buddy said, Buck it up.  Real men don't get depressed.  The transmission fell out of the car on the way to the drug store.  My favorite -- the primary care physician said, Are you kidding?  With your blood glucose and lipid levels?  Does this so-called doctor even own a blood pressure cuff?  However, all this speculation is just that.  These 10 do not give us information about the costs of taking the medication, because they never take it.

So now we have 68 consumers who quit after they tried the meds.  AK Ashton et. al. actually asked them why.

30 (out of the 90 who actually filled the prescription) say they quit because they could not tolerate the side effects.

30 say the medication was not effective.

That already adds up to 70 nonconsumers, counting the nonstarters and leaving eight who quit for other reasons.  I will suggest some of these other reasons, and you will have to come up with the odds yourself that any of them might put you among these 8.  (They may have reasons similar to the 10 who never started.)

And by the way, these numbers vary by how many different medications the consumer has already consumed, which primarily affects the efficacy number.  They also vary by which medication is currently being considered, primarily effecting the side effect number.

We don't have all the numbers we need.  Somebody needs to be collecting this data.  A consumer group, looking at real world data over the course of a year, not the guys with 6-8 weeks of information, seeking FDA permission and doctors' cooperation to sell pills.  But the algorithm itself will work for whatever the numbers turn out to be. 

Let's Start With Side Effects

30 of the 68 who consumed and quit say they quit because of side effects.  The clinical trials, lasting eight weeks or so, report much lower numbers.  The numbers the providers give you are from the clinical trials.

The common belief among providers is that they could improve compliance by giving consumers more information up front about side effects.  Small isolated studies sometimes confirm this over the short haul.  But this belief does not stand up to more research and more time.

Up front discussion of side effects can give the consumer strategies for dealing with insomnia, reducing nausea, preventing falls when they get out of bed.  These are the side effects we notice immediately.  Maybe they are tolerable if you have social supports to get you through the roughest first weeks.  Sometimes your body does  acclimate, and the immediate side effects become less bothersome.

But sometimes these strategies don't work.  Social supports wear out.  Mom has to go home and stop helping you with the kids.  You run out of sick leave.  The body does not adjust.  And sometimes these side effects are indications that you are taking the wrong medication!

But the major side effects appear later.  Which are the most bothersome?  The results: weight gain (31%), erectile dysfunction (25%), failure to reach orgasm (24%) and fatigue (21%).

Weight gain -- a few pounds in the first few months are not a problem.  You hardly notice.  But over the months, when you are moving from overweight to obese, you get a reality check on what this medication really costs.  Morbid obesity takes 8-10 years off your life.

Tell that to your psychiatrist when you complain and he/she says you have to weigh your costs and benefits.  Your doctor may not even know about how serious the health risks of obesity are.  Obesity even increases the risk of dementia.  But psychiatrists treat psychological problems with pharmacology.  They do not treat your heart, pancreas or liver.

Then there are the sexual side effects.  When you started the medication, you weren't getting much anyway.  That was one of the symptoms -- loss of interest in formerly pleasurable activities.  But six months later when you're not getting any, you (and your partner) recalculate your costs and benefits.

Hence, these noncompliance numbers go up over time.

Side Effects In The Algorithm

The major competition between makers of psychotropic medications has always been on this side effect issue.  It turns out, we just won't keep taking stuff that makes us feel worse.  So sometimes you can find studies that pit one against the other and get real numbers about side effects.

STAR*D found that in just 8 weeks, a combo of lithium/sertraline (Zoloft) got an intolerable rate of 45%, 2-5 times any other treatment.  Effectiveness rate -- 9%.  I wonder how many of the 91% who didn't get better would have been better off if they had taken nothing at all.

Or to put a finer point on it, did lithium/sertraline make matters worse?  They didn't test against placebo, so we don't know.

If the odds of harm are five times the odds of help, I will give it a pass.  That is like rolling the dice, looking for one particular number.  Only it's not dice; it is my body.  That is my personal decision, made after my eighth trial.  It is up to you how you play the odds.

For the sake of the algorithm, SE means the odds that you will quit taking this medication within a year because of side effects.

Efficacy -- What If It Just Doesn't Work?

We already discussed effectiveness in detail on September 2, Weighing Costs and Benefits Part II: Benefits.  Go back there for the details.  It makes more sense if you know the back story.  In summary:

Efficacy for Number of Present Trial (E#PT) means how many people got better with this med after they tried a number of others that didn't work.  Non-Spontaneous Recovery Rate (NSR) means how many people would not have gotten better if they had simply waited for the depression to go away on its own.  Efficacy for Number of Present Trial times Non-Spontaneous Recovery Rate equals Short Term Benefit (STB).  Those are the odds that it will work.

Or, E#PT X NSR = STB.

The abbreviations are there to make me look smart.  Which, as a matter of fact, I am.  Some days, I can make the smart parts of my brain connect  again and actually work smart.

Another way of looking at it: STB is a number between 1 and 100.  That many times out of a 100 are the odds that you have come up a winner.

So then the odds that the medication will not work are 100 minus Short Term Benefit.  We will call that Not Effective (NE)100 - STB = NE.  You have wasted your time, and are more discouraged than ever.  Bummer.

Now you may have noticed, the algorithm calculates the Short Term Benefit for eight to twelve weeks.  And the Short Term Cost refers to one year.  Why the difference?  Because you will likely be one of the early quitters (50%) if you don't get relief by twelve weeks.  And if you do get relief by then, you are likely to keep taking the medication for a year.  It may quit working for you eventually.  But you are probably good to go for a year.  Hence, twelve weeks for STB and twelve months for STC are probably equivalent measures.

Efficacy -- What About Those Who Quit Before They Gave The Medication An Adequate Trial?

I did not consider how many reported that they discontinued because the medication was ineffective, the 30 out of 90 that Ashton, et al, discovered in their survey.  This number is not helpful, because some of these 30 quit before the full 60 days needed to determine efficacy.

Instead, I used the efficacy numbers reported from the clinical trials.  As a result, those 8% discussed below is a larger group.  It would include the early quitters, because some of them might have gotten better if they had been more patient.

But these numbers are for illustration purposes only.  The algorithm is designed to be general, so that you can insert whatever the numbers turn out to be.

If you quit simply because the medication does not work faster than it works, and for no other reason, then you go into the stupid category.  Just to get that right out front.

Other Costs

8% (plus) quit taking the medication primarily for other reasons.  I expect that money, stigma and trust are the the big ones, with stupid in there, too, as stated above.

Money

Let's face it.  These medications cost money.  There are two costs to consider.  The first is the pills themselves.  The provider may provide you with samples, if yours is the newest wonder drug being promoted this week.  The samples likely last for two or three weeks.  This is good, if it helps you determine early on that there is no way you can tolerate the medication, even long enough for some of the side effects to become less troublesome.

On the other hand, it does not help you determine whether the medication will be effective.  That takes more time and your own money, a lot of it, if yours is the newest wonder drug being promoted this week, which you can count on, if you have failed to prove your provider a genius by getting better with his/her first or second choice.

If you have a good drug benefit, cost of medication may not be a major issue.  I now get my generics for free.  I represent a very, very small portion of the U.S. population.

I used to have insurance with a high deductible and mediocre drug benefits.  After the samples ran out, I paid $120 for a two month supply from a company that required I buy from them by mail order.  By the time the pills arrived, I had already discovered I couldn't tolerate the med.  I never even opened their bottle.  Meanwhile, I had to pay through the nose at my local pharmacy for the two weeks it took me to taper off.

In addition to the medications, you will pay for medical management, trips to the provider who will monitor your condition and tweak the chemistry experiment.

Again, these costs will vary by insurance plans and whether you have insurance at all.  With my current insurance, I pay $5/visit.  In my previous plan, I paid $40.  If I had no insurance at all, the cost would be $135.  And I see my doc every six weeks on average.

I cannot assign a number to the odds that you will quit a medication because of how much money it will cost you.  That is your call. Out of 100, what are the odds that you will quit because you cannot afford it?  We will call that $$$ in the algorithm.

Stigma

Okay, if you have made it this far through the Costs and Benefits series, you ought to be motivated enough to resist those who shame you (including yourself) for relying on a pill, for being weak, for being sick... whatever garbage they throw at you and you throw at yourself.  Please let's get over it.  I hope your stigma number is low.  But again, that is your call.  Out of 100, what are the odds you will quit for reasons of stigma? -- STG.

Trust

Next, out of 100, what are the odds that you will quit because you cannot find a provider you trust with your body, or because you think the pharmaceutical industry is corrupt? -- TR.

Stupid

Stupid is a side note.  Providers prescribe the medication because they already believe that the benefits outweigh the costs.  So they expect the stupid category is a large proportion of the noncompliers.   Only they call it confused.

Stupid is irrelevant to the algorithm, which is designed to weigh costs and benefits.  So stupid (or confused) is not in there.  Like stigma, stupid can be fixed.  But it is not a cost.  It is a prior condition.

Down And Dirty Costs

So now we simply add the odds of each of these costs together:

Side Effects plus Not Effective plus Money plus Stigma plus Trust (lack thereof) equals Short Term Costs.

SE + NE + $$$ + STG + TR = STC.

So How Do You Decide?

STC versus STB give you the odds.  Once more I repeat, they do not give you your decision.

We will look at a couple other issues and pull this all together in our next installment.  Whew.  My brain is about to explode.

Flair from Facebook
Clipart from Microsoft
Photo of die by Roland Scheichder, in the  public domain
Photo "Solution" by Salvatore Vuono
Photo "Angry Father" by Akapl616.  Permission is granted to copy
under the terms of the GNU Free Documentation License
Photo of "Tired Man" by graur codrin
Photo "Aces" by Felixco, Inc.
Photo "Loneliness" by graur razvan ionut 
Photo of Pristiq by Tom Varco.  Permission is granted to copy
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Mademoiselle Zizi Feints at Fainting, by John Sloan

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.

Flair from Facebook
Cartoon from Microsoft images
Counseling photo in public domain
Andreasen photo used by permission
Book cover from Amazon.com

The Chemistry Experiment: Muppets Version

When your doctor, pen poised over prescription pad, tells you to weigh your costs and benefits, you will have next to no information with which to do so.  Over the last several and coming weeks, we are constructing an algorithm to help you comply with your doctor's instruction to make this calculation.  But remember, the best this algorithm can do is give you the odds.

After you calculate your odds, you may decide to proceed with this chemistry experiment and put the chemicals at issue inside your body, your own personal test tube.   At that point, you no longer have odds.  You have results.  Your doctor may not expect this, but once you have results, you will weigh your costs and benefits again.  You will make a new decision, this time with new information.

This is a good thing.  This is what people who conduct experiments do.  They use the information they have gained from one experiment to move on to the next.

This week's post is brought to you from the laboratory of Dr. Bunsen Honeydew, with the aid of his assistant Beaker. My thanks to Beaker in particular, for his contribution to science.



photo by Linda Bartlett, in public domain

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-adherenceNon-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.

drawing of dictionary in public domain
Adam and Eve by Albrecht Durer, in public domain
photo of Warren G. Harding in public domain
photo of woman pointing taken by David Shankbone,
used by permission under the Creative Commons 
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