Wednesday, December 06, 2006
Leeches, stents, modern medicine, and lawsuits
A flurry of recent research has raised alarm about the safety of a new generation of stents that have quickly become the most commonly used devices for treating clogged arteries, creating widespread concern about how to care for millions of heart-disease patients.
The stents, tiny drug-secreting mesh tubes used to prop coronary arteries open, appear to carry a small but significantly increased risk of causing blood clots, compared with older "bare metal" versions. That may boost the patients' chances of suffering a heart attack or dying, according to the studies, including one released yesterday.
Two such "drug-eluting stents" have resided in a pair of my coronary arteries since last July. So I'm sort of reminded of the story about the guy who slips and falls from the observation deck of the Empire State Building. As he's falling, his cell phone rings. It's his best friend. "Can't talk long right now," says the fellow, "I just fell off the Empire State Building observation deck." In shocked tones, the friend blurts out, "Oh my God, how are you?!?" "Meh," answers the fellow, "So far, so good."
My ex is a physician, and I used to tease her by saying, "While my predecessors as lawyers were doing things like writing the Constitution and the Bill of Rights 200-plus years ago, yours were leeching George Washington to death!" Of course, now leeches are back in medical fashion, if not quite considered to be the panacea they were in Washington's time. This time there's hard science, a substantial body of medical evidence, supporting their use. But anyway, back to the WaPo story:
"This is a public health issue of great importance," the FDA's Daniel Schultz said yesterday. "Our goal is to provide the American public with a coherent, understandable explanation of the risks and benefits associated with these products."
The situation, which has triggered an intense, sometimes bitter debate among cardiologists, illustrates the potential dangers of assuming that new technologies are necessarily superior and of adopting them widely before long-term studies are done, experts said.
"Everybody wants to be perceived as doing the most modern thing for their patients and fear being labeled someone who is old-fashioned and not using the latest and greatest thing," said Spencer King of the American College of Cardiology.
I'm very, very well acquainted with the concept of "informed consent" as a medico-legal matter. (Great term, that: "medico-legal." Nobody really knows what it means, but it makes you sound more knowledgeable to say or write it.) And as they handed me the consent forms to sign, I remember thinking, while flat on my back in the cardiac intensive care unit at Methodist Hospital last year, "These forms pretty much boil down to 'The stuff that we're proposing to do to you might hurt or kill you, but we'll try not to, and if we don't do that stuff, you might be hurt or killed anyway.'" As my cardiologist was running a catheter from an incision in my groin up to my heart, I didn't ask him, "Hey, Doc? For these new drug-eluting stents, how many years of evidence from controlled studies are in yet as to whether they might be more likely than plain stents to cause clots later?" Pretty much whatever answer he might have given me then, I'd still have just asked, "So what would you do if you were me, Doc?" Based on what he knew then, he almost certainly would have said, "I'd want this stent." And that would have been plenty good enough for me.
I don't know what he'd say if asked that question today — which is to say, I have no idea if he's been in that recent "heated debate" among cardiologists, and if so, on which side. Another WaPo story reports that a just-released Duke University study "also showed a marked reduction in the need for repeat angioplasties among patients getting drug-eluting stents — one in 12, compared to one in five for those getting bare-metal stents." Hey, that sounds like a trade-off that might be worth taking, especially if (as seems also to be the case, emphasis on the word seems) the clot risk can be reduced through a medication called clopidogrel.
But I'm not a bit worried that a year ago, my cardiologist prescribed those stents for me based on some desire not to "be perceived as old-fashioned." Wow, that's an insulting notion, and I can't believe it could be even partly true in even a tiny fraction of situations; but I'm absolutely certain it wasn't true of my own cardiologist. Even with all of the science available to modern physicians — even the specialists at cutting-edge teaching hospitals — there's still an element of art in the practice of medicine. And certainly there are lots of judgment calls, in medicine just as in law, and the essence of being a professional means that people outside your profession have to rely upon and trust your judgment.
How much education would I have needed to make an intelligent decision without the benefit of my cardiologist's recommendations and judgment? I've got a decent education in science, and a pretty good understanding of medical language and concepts for a layman. But when I first heard them talking about this, I don't think I had any clue what a "stent" was, much less a "drug-eluting stent." Until they explained it a little, I thought they were saying "drug-eluding stint" — and I was wondering, What kind of time-frame are they talking about my having to dodge drugs during (and how, and why)?
Get away from me with your dirty paper cup full of meds, Nurse Ratched, at least for now! I'm embarked upon one of my drug-eluding stints!
So, Doc, if you're reading this by any chance, you can exhale now. At least one lawyer you installed drug-eluting stents into last year has pretty much admitted that if he keels over from a heart attack tomorrow, his survivors won't have a decent case against you. I trusted your judgment, and was, and am, damned grateful for the benefit of it, along with your technical skills.
Did I read those WaPo articles pretty carefully, knowing that this issue applies to hardware that, for me, is "hard-wear"? Oh, sure. Am I going to lose any sleep over it tonight? Naw. It's not something that would be productive to worry about right now. And I'm almost certain that other factors that I can control — "Put down that cheeseburger, Beldar, and get back on the cross-country ski machine!" — are more likely to determine my future cardiac health.
Life is ultimately a terminal condition. But so far, so good.
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let us not forget the $250K limit of P&S that factors into the lawsuit equation...
(2) dw made the following comment | Dec 6, 2006 6:46:54 PM | Permalink
No limit in a products case. Just ask the Ernst Estate.
(3) DRJ made the following comment | Dec 7, 2006 9:19:24 PM | Permalink
I have family members, also lawyers, who view medical decisions and doctors with the same attitude that you do. If I understand your post - and I certainly might be misreading your point - I don't share your view about the physician/patient roles in medical treatment. I think most patients are well-qualified to grasp the medical research, diagnosis and prognosis if the physician is willing to provide an explanation and has worked on refining his teaching skills in this regard.
As a lawyer, I eventually learned that my clients were almost always able to grasp the legal concepts they needed to make a good decision. It often took more time - sometimes quite a bit of time - to explain the concepts and I wasn't very good at it when I started. But when I invested the time to communicate subjects with my clients, and after I learned how to more effectively communicate those subjects, it paid off because I found that my clients made truly informed decisions. As an added benefit, my clients were virtually always happy with their decisions - even when they didn't turn out well.
As a patient myself and, more important, as the parent of 2 VIP patients with chronic illnesses, I learned that it is possible to bring this philosophy to medicine. Medical knowledge in specific areas is not so complicated that it's impossible for a reasonably intelligent person to understand. The hardest part is the vocabulary so I work hard to educate myself in that area. It is also possible to attend medical seminars (with the physician's authorization) that can greatly enhance your knowledge if you have a chronic condition. I know of several instances where patients who took a personal interest in a disease were able to make breakthroughs that medicine had been unable to accomplish. Lorenzo's Oil is one example; The discovery of H.Pylori as the source of some ulcers is another (although the discovery was made by an ulcer-suffering physician).
I like to think of the patient and physician as a team. The more the patient knows, the better the physician will be.
(4) ncoic6 made the following comment | Dec 11, 2006 11:18:22 AM | Permalink
I had one of those drug-eluting stents inserted last year. I remember, as you, reading the consent forms, and deciding that it beat the heck out of having my ribcage cracked open.
One thing that bothers me a bit is that I am now taking a number of drugs, on a daily basis, that coincidentally are heavily, very heavily, advertised on TV continuously.
In the back of my mind is a little voice cautioning that so much money spent on promotion can't be a good thing. Can it?
ncoic6, the commercial that seriously scares me is the guy in the suspenders standing over the printing presses, as the voice-over announcer talks about him being done in by a clot smaller than a drop of ink. Is it good or bad that drug companies are spending so much money on advertising? I dunno, but that commercial scares me, as I guess it's intended to do.
DRJ, your points are all well made and well taken. Part of the proper exercise of professional judgment is figuring out how much information a patient or client is capable of absorbing, in general and in the particular circumstances of the moment. And part of professional skill is then imparting that amount of information, so that his or her choices can be as well-informed as is practicable under those circumstances. I didn't mean to come off as an opponent of informed consent as a concept. I think it's important for reasons other than legal liability as you point out, people who've understood the decisions they've made are more likely to "own" them, i.e., accept a shared responsibility for them, regardless of the outcome. That's true, and a good thing, even if the information being imparted doesn't actually end up altering the decision that would have been made without all that information. I think we agree more than we disagree. What I was trying to articulate, I suppose, was my distaste for second-guessing and 20/20 hindsight in the litigation context, and my doubt that very many better-informed decisions would in fact have been different than the ones recommended by the professional.
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