INFORMED CONSENT PROCEDURES
NEW ZEALAND JAPAN
INFORMED CONSENT PROCEDURES ARE BROKEN
One of a suite of blog entries about the aftermath of chemotherapy and radiation therapy, including brain damage and eyesight damage; a survivor's account of the aftermath of cns lymphoma, non-Hodgkin's lymphoma of the large B-cell variety, in the author's case cancer of the brain and the spinal cord.
THIS IS A PICTURE OF YOUR GOD:
A HUGH COOK READER.
Informed consent procedures are broken.
I've been thinking of this on and off for some time now, having been through quite a number of informed consent procedures, both in New Zealand and Japan, and they have all been broken in exactly the same way: there is no concept check.
No feedback loop.
No "what is your understanding of what you have just been told?"
Maybe a "Did you understand that?", but, as a trained English teacher, I can tell you straight off that this is the world's most useless question. Does someone understand? Well, if they can explain it to you in their own words, then, yes. Otherwise all you know is that you heard the word "yes".
A broken procedure, then.
Nobody asks you "What do you think you've just been told?"
There's no student-teacher relationship here, even though, in practice, the patient is the student, studying to understand.
Got no money for that. Got no time. If there's any formal teaching of the notion of becoming a patient as being some kind of induction procedure through which the patient should be guided and assisted, I've never seen any evidence of it.
Done as it is, on the quick and on the cheap, look at this and sign here, informed consent procedures, as they currently exist, are, in my considered opinion, not very far removed from the realms of the farcical.
As a rule, the whole thing becomes reduces to a legal formality, often with the "we have a legal requirement to do this" message being explicitly communicated to the patient in as many words, sometimes by someone who doesn't hide the fact that they don't entirely buy into the concept.
So the hospital runs in accordance with the law, with what the legislators had in mind. Sort of. Sometimes.
The informed consent form I signed on behalf of my wife when she was struggling in labor in a Japanese hospital and needed drugs, that was just floated into my field of vision for a legally required sign-off, the woman being in no state to sign anything for herself. No explanation, no nothing.
The informed consent procedure which I did to have intravenous iodine injected for a CT scan, well, the Japanese doctor explained, in English, the key points of the Japanese-language documentation I was going to sign.
But skipped part of it.
The part that I could read very easily, my reading level in the Japanese language at least adequate for this part, the part which says, okay, and, one more thing, sometimes, on occasion, this stuff kills you stone dead.
(The risk, from memory, was something like one in twenty thousand.)
The doctor chose to skate over that one in untranslated silence.
So, as a patient, you're at the mercy of staff who, often, see informed consent procedures as just one more paperwork hassle, or doctors who really do not want to level with you about the ugly downside of what might possibly happen to you.
But the informed consent procedure is the point at where you are, or should be, consolidating your idea of exactly what you are getting into?
And if you feel you were misinformed then the downside may be quite big.
And, as I have said, there is no feedback loop. The message was given to you, you signed to acknowledge receipt of the message, as the law requires, then it was over, done.
A broken procedure because nobody ever checked that the message was received.
Messages signed for are not necessarily messages that have been heard, interpreted and completely understood.
My thoughts on this matter were sharpened up by an informed consent procedure I went through before a cataract operation last year.
It looked bulletproof.
This place, they give you the documentation to take away, and it's about four pages of stuff, all the horrible things that can go wrong with cataract surgery, which, while it generally has a good outcome, is not risk-free surgery.
Off the top of my head, the negative outcomes that I can remember at this point, some months after reading and signing, are:
1. A cataract operation on one eye may, in rare cases, cause infection in both eyes, with permanent blindness the result.
2. The intraocular lens implanted to replace the natural lens (which is removed when the cataract is removed) may decenter, causing subsequent visual problems. (I don't think they go back and operate again to try to put it right. The eye is not the kind of organ on which you want to do repeat operations if you can possibly avoid it.)
3. You may be disappointed by the result, because successful cataract surgery may reveal a problem at the back of the eye, a problem which was masked by the cataract: macular degeneration, a downgrading of a light-sensitive area at the back of the eye known as the macula. Cataract surgery is typically for the old my maternal grandmother, for example, had cataract surgery on both eyes at age 94 and, as you get older, your risk of having macular degeneration increases. Surgery was a success but, sorry, your outcome is disappointing.
At this stage, I do not remember if the informed consent procedure made it clear that cataract surgery messes up the production of tear film, so you end up using eye drops after the operation until the natural production of tear film recovers.
The bottom line, though, which emerged very clearly from the informed consent procedure documentation, which was thorough, honest and up-front about the risks, was that cataract surgery does have a potential downside, and you should be ready for this.
Thinking this was, at last, one informed consent procedure which had the level of clarity, honesty, thoroughness and detail that I thought was appropriate, I signed the informed consent form and mailed it back to the place which was going to do the operation.
Bulletproof for me.
But not for my parents' friend who had her surgery at the same place.
Same place, same form, same procedure.
And the friend went into surgery totally ignorant of the risks for one simple reason: she could not see well enough to read the informed consent procedure.
Given that she's over eighty years of age, you would have thought that, as a fully grown adult, she would have done the logical thing and would have asked someone to read the form to her. But she never did. And nobody eve checked. There was never any feedback loop. No "what is your concept of your medical outcomes?" question. No student-teacher interaction.
The law was satisfied. She got the information and she signed to acknowledge receipt. But she went into her operation minus the key concept: the outcome may be negative.
The outcome was negative: intolerable glare to the point where she cannot watch TV.
In my case, some months after cataract surgery on both eyes, I still find the world a bit glaring, to the point where, for preference, I will wear sunglasses outside, but this woman has the glare very bad.
Finally she sat down with the top guy at this place and he was, it seems, reassuring. Improvement can be expected, I gather. The operation was a success, and I believe it's been indicated to her that her long-term outcome will be satisfactory.
But the point, no feedback loop, that's the key point. The procedure is broken.
Of course, truly informing the patient is a source of friction for the system.
To do it properly would mean the patient becoming seen as a student, the provider-patient relationship a teacher-student relationship.
But that is what you become, when you become a patient, if you take on the role seriously. You become, to a lesser or greater extent, a student of your own condition.
I think the pharmaceutical industry understands this.
Back in Japan, I taught at a regular basis for a couple of years at a pharmaceutical research laboratory, teaching English to high-level research scientists, the people who work on developing the new drugs that may one day save my life. Or yours.
The pharmaceutical industry has, and, on the grounds of historical misbehavior, deserves, a bad image. It's an industry which, from time to time, has catastrophically misbehaved, and, giving the pressures of the marketing environment, may reasonably be expected to misbehave again in the future.
That said, despite the kind of sinful behavior which has been documented in the past and will continue to surface in the future, having seen this industry from the inside, and having got to know some of the people working inside it, having met them as human beings, my own take on the industry is essentially positive.
Yes, people do mess up, particularly on the marketing side, hiding things they should not, and playing fast and loose with the truth.
But, that said, having acknowledged the fact that a pharma essentially exists to make a buck, my take on the pharmaceutical industry as a whole is that it is, essentially, an ethical industry, most definitely so at the level where the researchers are at work.
I came to the classroom in Japan one afternoon, late afternoon, the sun sinking over the gritty urban environment visible from the seventh-floor window, and my students had something to show me. It was a photo, and they were very happy to be showing it to me.
The photo was of a British woman, a bit overweight, red-faced, homely, smiling, looking happy.
She was looking happy for her child, who was too young to understand what was going to happen, who was too young to have the concept of death, far less to understand that the mother had an entirely incurable cancer for which there was no treatment, no hope, no cure.
So this entirely ordinary British woman was facing her death, and her way of facing it was to leave, for her child, her smile.
And why were my students so happy?
Well, because the woman lived. She got a new drug invented by the very corporation for which my students worked, and it saved her life. And they were radiant.
All these years of work amongst the molecules, the work of their lifetimes, the work to which they have dedicated the supremacies of their intelligence, the work which they do day by day, week by week, year by year, infinitely patient, giving their lives to this: it paid off.
I don't want to sound hokey, but the mood in that room was radiant. There is no other word for it.
So, though the bad pharma is a reality, and though the bad pharma shenanigans which feature in the currently playing movie, THE CONSTANT GARDENER, do have a basis in real life, my concept of the industry, written from having seen it from the inside, is that it remains, nevertheless, an essentially ethical enterprise.
And it's an enterprise which, when it interacts with the public via drug information websites, takes on the teaching role, takes it seriously and does a good job.
Of course, the websites are skewed in the direction of happy smiles. The side effect warnings may be clear and up front, but you're going to be seeing them on a site which is, typically, going to have its fair share of entirely irrelevant calendar-type photography: smiling couple on beach, smiling couple with dog on beach ... the beach doesn't really have anything to do with the drug, but your visual residue, after visiting the site, is going to be, in part, that of having had a day at the beach.
The best "happy couple with a dog on a beach" was on a site promoting a drug which, while useful, could cause serious heavy-duty psychological side effects. The effects were documented, reasonably prominently, but the romping dog on the beach was the star of the site.
I've recently been clicking around a site which may end up being of direct relevance to me, rituxan.com, a promo site for a drug called rituximab.
First thing you see, top left, is a photo of a beach with two people standing on it, looking, to my eye, as if they are signaling to some kind of hallelujah in the sky.
On the right, a lone figure in a landscape, arms outstreched in a kind of "embracing a universe of joy" gesture.
So the photos, here, are doing the selling.
Perched up above the photos, a very clear "what's this?" message, telling you this site is "has information you need about non-Hodgkin's lymphoma and treatment with Rixutan," this Rixutan being another name for rituximab.
The site is divided into two slices, left side for the general public, right side for health professionals.
Right on the front page, on the left, in the part for the general reader, making no effort to hide it, they put the big possible negative: death.
"Fatal Infusion Reactions: Deaths within 24 hours of RITUXAN infusion have been reported. These fatal reactions followed an infusion reaction complex which included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation or cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first infusion."
So there it is.
What I'd call a standard pharmaceutical drug information site.
Basically, the concept, regardless of the corporation, seems to be the same.
I would break it down like this:
1. Really mellow photographs, the kind of thing you would have on your calendar in the kitchen, beach almost compulsory, dog optional, sky is nice and a lot of sky is better than a little. People should, of course, be smiling. Hand-in-hand is nice, and two people in a photo is probably better than one.
2. The big bad downside is featured somewhere reasonably prominently, if only because you're on public display, so you have the motivation to come clean and be honest. Your doctor might skip over the fact that this stuff can and does kill people, but if you are the Good Pharma (either the real thing or just faking it, makes no difference) you have to do a "let me level with you, buddy" thing up front.
3. For people who want to go into the technical details, a typical pharmaceutic industry site will have, somewhere, at least some data relating to stuff like clinical trials, the stuff that a doctor might be interested in. Quite possibly tagged with some kind of warning that you're not entitled to access this documentation unless you are in fact a medical health professional, but you can still click and read.
Obviously these sites are biased in the direction of optimism. The real stories we see with real faces attached, they're the faces of the survivors, the ones who are (genuinely, I believe) keen to share their experiences because, hey, it worked for them.
If you drill down to the actual clinical trials data and start looking at the statistical outcomes, you may find a landscape where the beaches do not look quite so pretty, where the dog is not in a good mood.
In summary, then, any pharmaceutical industry site designed to promote a drug is going to be engineered in the direction of glossy, designed to give you a feel-good feeling after having visited it, and your dominant visual residues are going to be of beaches, big skies, smiles or something similar. Nothing medical, certainly.
That said, having seen a whole bunch of these sites, I have to say I've never yet seen a bad one. Every single one has been well-designed and, if you choose to drill down deep, as informative as you could reasonably expect.
So, for the patient who is ready to take on the role of student, one way to get around the informed consent problem the problem of actually being informed about what you're theoretically consenting to would be to study up in advance of the procedure.
And then, ideally, in a face-to-face setting with your qualified medical services provider, you would concept-check your understanding of the consequences of the drug you are consenting to take.
"Excuse me, but do I am I right in understanding that this drug sometimes kills people outright?"
Your doctor or nurse may not be keen on exploring the death, disaster and downside issues as fully as you would like to. May not want to go there. But your friendly pharmaceutical industry site, whatever your concept of the industry is, Good Pharma or Bad Pharma, they will lay it out on the line for you.
Obviously I'm stressing the importance of interaction. There's no point in forming a concept of your treatment unless you go check it with someone who is qualified to confirm, refute or refine your concept.
A website can't check the concept that you form by studying that. For concept-checking, the face-to-face is necessary, the doctor or nurse functioning, effectively, as the teacher, the student coming in with homework to be checked.
But, as a starting point, a drug information site is, in my view, the place to begin, if you have serious questions about a drug which may be really important in your life. Because, while the calendar graphics are trying to sell you a feel-good message (and are succeeding, since nobody was ever made unhappy by looking at a photo of a sunny beach) the information on these sites is solid.