Thursday, September 18, 2014

When Medical Research Ethics Fall Short



A short while ago I was asked my opinion about a promising new treatment for depression being evaluated at a prominent research hospital.  I looked at the description on the hospital’s website, and it did indeed look interesting. I called the study coordinator for more details.

He told me the therapy involved adding energy to parts of the brain that might be involved in depression, and evaluating the results over a period of several months.  After my experience with TMS (which adds magnetic energy to the brain) I felt the idea sounded promising enough to be worth exploration.

Patients who enrolled in the study would go to the hospital twice a week for the duration of the study, which would be 2-3 months.  Then we got to the “fine print.” Half the participants would get the therapy, and half would get a placebo (a treatment that does nothing.)  Hearing that, I asked if the people in the placebo group would have the option to come back after the study sessions, and get the real treatment.

“No,” he said, “we don’t have funding for that.”  Wrong answer, I thought to myself.

When scientists construct a study that tests a new therapy for depressed people, they have an ethical duty to their subjects, and the structure of this study falls far short of what I’d find acceptable, as an ethical advisor.  I was surprised it made it past the hospital’s review board.  I was tempted to raise the question with them, but I didn’t.

If you’re testing a therapy that might help gifted kids read faster, this design might have been ethically ok, because volunteers in such a study would not be described as “suffering.”  People who enroll in a depression study are certainly suffering.  Asking a population that lives in pain to volunteer for research while withholding possible pain relief from half of them is morally wrong. Period.  There’s not much room for discussion about that, in my opinion.

We’ve gone down this road with autism pharmaceutical studies, where policies have evolved to the point where people who get a benefit from experimental medications can continue to take them after the study is complete.

Anyone who signs up for a study like this does so in hopes of gaining a benefit.  They don’t sign up to be “control patients” who get a sham treatment for purposes of comparison.  No one would knowingly do that.

“We thought they’d sign up to get the money,” the study coordinator told me in a weak voice.  Two hundred dollars for eighteen sessions, each of which takes 3-4 hours out of your day?  Let’s get real.  That’s two bucks an hour; an inducement that I found insulting at the suggestion.

“We had a really strong placebo response,” he told me, in a further effort to justify the flawed study design.  I’m aware of that effect, and it wasn’t surprising to hear him say that.  Basically, what he was saying was that patients who received a sham treatment reported almost as much benefits as patients who got the “real thing,” and the researchers wanted to separate people who truly got better from those who just imagined they were better.

That’s a real and valid concern in medical research where the power of positive thinking can make people think they are better even when they didn’t receive any medical value from a treatment.  We often see placebo responses that are similar to the real thing.  So how should researchers tell them apart?

One good way – in a psychiatric treatment like this – is to double the length of the study and give each subject both therapies. The subjects can be told they will be tested with two possible treatments, one of which is a placebo.  Half the group gets placebo first, half gets the actual treatment first.  Each group gets the other treatment after an appropriate “cooling off” period.  That way, the placebo effect can be compared in the same individuals.

The alternative would be to offer the actual therapy to the placebo patients after the study has run, and after announcing they were in the placebo group.  That would be ethically incorrect if it came as a surprise, but it would be OK if people were told they might be in a placebo group at the outset.

“Those are good ideas,” the coordinator told me, “But we didn’t have money to do what you suggest.”  How does one answer that?  Is it better to run an ethically flawed study in hopes of a strong result? Or is it better to hold off until an ethically sound study can be funded?  Now we have a different ethical question – one of benefiting the few versus benefiting the many.

The design of this study did not have the potential to harm participants directly but it could increase suffering for those who discovered they were in the placebo group.  It certainly subjects half the study participants to hardship for no real benefit.  Is it OK to do that to twenty people in hopes of developing a beneficial therapy for thousands?

I think the answer is no, when we place the study in context.  This is a well-funded research hospital, and when we consider the costs to save the twenty initial subjects from possible pain, that cost is trivial in the broader scheme of things.  The study should be properly designed and funded, or not done at all.  Getting funding is the researcher’s job.  You don’t save money at the expense of your subjects, unless there is no possible alternative, and a huge comparative benefit.

This study is not a “one or many” example where one person is sacrificed to avoid the sure death of a thousand.  That’s the stuff of action movies, not medical science.  This is considerably more pedestrian but still important to the patients who trudge to the hospital for three months, and get nothing for their depression but a thanks for helping science.

The final argument - That's the way we've always done these studies - is just disappointing.  Two hundred years ago, unsuspecting animals and sometimes people were dissected while alive, in the name of what was then legitimate science.  Ever hear of "Anti-vivisection societies?" That was what got them going.  Ethics evolve, and this is an example where evolution is called for today. 


As someone who has served on several medical research ethics boards I found it troubling that a major hospital would design a study with such obvious (to me, at least) ethical flaws.   What do you think?  Am I missing something here?

John Elder Robison is an autistic adult and advocate for people with neurological differences.  He's the author of Look Me in the Eye, Be Different, Raising Cubby, and the forthcoming Switched On. He serves on the Interagency Autism Coordinating Committee of the US Dept of Health and Human Services and many other autism-related boards. He's co-founder of the TCS Auto Program (A school for teens with developmental challenges) and he’s Neurodiversity Scholar in Residence at the College of William & Mary.  The opinions expressed here are his own.

Sunday, September 14, 2014

Fall is the season for Fairs

One of the things I love about fall is the fairs and carnivals.  The biggest of them all – where I live at least – is the Big E in West Springfield, Massachusetts.  It’s two weeks and three weekends of action, and I take thousands of photos there every year.

One of my favorite places is the circus tent, where I see things like this:



Professional cat catchers stand ready to rescue a leaping feline



Playing with fire under the circus tent


Motorcycles and acrobatics, fifty feet off the floor. With no safety net.


They've always got a full house, so get there early


You will never guess what came out of that little box






I love the brilliant colors, the lights, and the patterns.  And I admire the skill of the performers.

My next favorite place is the concert stage.  I've only been to two shows so far this year, but both were great.  Does anyone know who these performers are?









And we can't forget the horses and all the other animals  . . .





What are you favorite images of the fair?

The photos above were shot with Nikon Df and D3s cameras, and 28-70 and 70-200 2.8 lenses.  An SB910 flash was used for some shots.  ISO ranges from 400 to 3200.  All images (c) 2014 John Elder Robison


Friday, August 29, 2014

A Briefcase Full of Dreams

Where were you in ’78? I was 21 years old, trying to make a place for myself in a world of adults.  My clients were musicians, but the people who paid me were businessmen, and I had to make a good impression.

That meant button up shirts, a nice pen in my pocket, and the ultimate professional accessory . . .  a real leather briefcase.  Fifty dollars was a lot of money for me then, but I must have chosen well ‘cause it’s still in good shape today . . .


Outside – quiet and conservative.



Inside – rock and roll passes and sound engineer business cards told the rest of the story.  No corporate drone here! 
  • A card from M Kluczynski, president of Britro, Pink Floyd’s sound company;
  • Backstage passes from Phoebe Snow, Duke Ellington, Talking Heads, The New Riders of the Purple Sage, Roxy Music;
  • A faded pass for the James Montgomery Band says Manager;
  • A pass for the Return of KISS at Madison Square Garden says Crew;
  • Stickers for Sola power supplies and MXR special effects.

Underneath, I had a receipt book so I could get money, diagrams of amplifiers I might have to fix, schematics for things I'd just thought up, and bills I struggled to pay.  It was a hand to mouth living in those days, but it was a fun time, too.  It was a time of sadness, excitement, discovery, and adventure.  I probably should have died a dozen times over, but I'm still here.  There aren't any pictures from those days because there wasn't any time for photos. I had to work! And work I did.   

Those shows were the stuff of dreams for a sixteen year old failure and a high school dropout.  Yet they all came true, five short years later. But like all dreams, they changed and evolved.  

Ten years later, I’d left music behind and I was an electronics executive

Ten years later, I’d left electronics behind and I was restoring and fixing cars

Ten years later I was photographing performers and thinking about writing a book


I could never have predicted any of that, when I bought that briefcase.  I remembered it all when my mother and my wife Maripat found it stored away, and brought it back to life for my birthday.  It just goes to show . . . . you really never know . . .

Tuesday, August 12, 2014

Robin Williams, and thoughts on suicide

Midnight, in the graveyard at Bruton Parish Church in Virginia


This morning I awoke to the news that comedian Robin Williams had killed himself, at 63.  He’s the latest of a long line of creative people to take his own life.   Every time a performer or artist kills himself I ask if this is an unavoidable hazard of the arts, or if something might be done about it.

News sources say Williams was “wrestling with depression” when he did himself in.  I myself have wrestled with depression, as have many people around me.  The question of why some of us choose suicide, successfully and without warning, is one that has yet to be answered.

Most of the people who commit suicide don’t announce their intentions.  Some research suggests they may not even have such intentions until the fateful moment.  I don’t have any wisdom to offer in that regard; it’s perhaps one of those things where the only ones who know the answers are dead.

I know I’m a part of two communities at risk.  The suicide rate among people with autism is shockingly high – near 2%  http://jerobison.blogspot.com/2014/05/what-happens-to-autistic-people-when-we.html

Some researchers speculate that autism isolates us, and isolation is painful.  Autistic people are often subject to bullying, marginalization, and other painful things.  I can understand how some of us are overwhelmed by that mix.

It's easy to start feeling we have nothing to look forward too except more psychic pain, and if we feel that way suicide may seem like a good choice.  I do not feel that way right now, but I have been there before, and I can't think of anything that magically "snapped me out of it.  From my experience, I can see how this state of mind would become unsustainable after a certain period of time.  Yet it's a quiet despair, and I don't think most people noticed when I was feeling that way.

That's the danger of those kind of feelings - no one knows. We don't show much outward sign, and if we don't get better on our own . . .

When I was alone as a young adult I used to feel terrible pain and despair, almost every night.  I'm all too aware that those feelings can return any time, should something bad enough happen.  We're a vulnerable population in that respect.  Some people say sadness strengthens and shapes us; others say it kills us.  I guess it's situational.

Another study – this one dating from 1999 – found a similarly high rate among writers, sculptors, actors and other artists:  http://www.amsciepub.com/doi/abs/10.2466/pr0.1999.84.1.291?journalCode=pr0

Are artists susceptible because we are sensitive to perceived criticism?  Are artists isolated by difference?  I don’t know.  I know many writers who are absolutely devastated by attacks on their work.  I’ve felt that myself, with some of the one-star reviews on Amazon.  Does that lead to suicide?  I don’t think anyone knows.

I know many writers and artists who seem to experience greater highs and lows than the average person.  Maybe the highs bring us our gifts, but the lows can take us out.  That's another unanswered question.

As a person who is often out there before the public, I know well the pressure to put on a happy face even when I'm crying inside.  That puts a tremendous strain on the psyche, and it sometimes hammers you hard when you're alone after the show.  When people look to you with certain expectations - whether you're a comedian like Robin, or a singer, or a speaker on disability - you are always feeling you must live up to an imaginary standard and it can be very hard.  At the same time, you offer your inner thoughts - even if couched as comedy - and it stings when they're rejected.  Is too much of that the straw that breaks the camel's back?  Those of us who are living may never learn that particular answer.

I don't feel sad today - I am not writing from a place of despair - but I am well familiar with how that feels.  It's heartbreaking to read stories like this one, and realize it could be any of us, tomorrow, with a few little disasters to put us over the edge.

The suicide rate for people with severe psychiatric disorders – mania, psychosis, schizophrenia, major depression – is even higher – near 10%.  The 1999 study draws that comparison.   I think of my parents, locked in the wards of the Northampton State Hospital 40 years ago. I remember seeing them among the other inmates and I understand.  They were a desert of lost people.

Is there anything we might do to reduce rates of suicide in these groups?  I wasn't personally acquainted with Robin Williams, but the news of his death reminds me how sad it is that we can be so silently alone and in pain - even when we are loved by millions as he was.  And our sadness can be such a crushing burden that we take our own lives rather than carry on, even as observers of our lives imagine things to be so good.  And it can happy to any of us - rich or poor, famous or unknown.


I’d be interested in your thoughts.


John Elder Robison is an autistic adult and advocate for people with neurological differences.  He's the author of Look Me in the Eye, Be Different, Raising Cubby, and the forthcoming Switched On.  He's co-founder of the TCS Auto Program high school in Springfield, MA and Neurodiversity Scholar in Residence at the College of William & Mary in Williamsburg, VA.