Seattlest Pix 09Nov24
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Hollywood's fascination with all the terrible things Westerners do in Africa has always been a little cloying. Did anyone actually need to see Blood Diamond to get the point? Then there was The Constant Gardener, which melodramatized the all too real phenomenon of American and European drug companies finding it more expedient (if more ethically questionable) to do research on poorly educated and ill informed Third World subjects. Turns out, Hollywood could just as well have set their cameras on good old Seattle.
On Monday, a friend of Seattlest forward us this troubling article from The Seattle Times. According to health reporter Carol Ostrom:
Suppose you happen to be in a serious car wreck. Or maybe you get shot or suffer cardiac arrest. If you live in King County, it might also mean that in that life-or-death moment, you will become part of an experiment — without your consent.
Turns out, the UW studies--part of the Resuscitation Outcomes Consortium (ROC)--are making use of a conveniently placed loophole in federal law to carry out research on emergency victims without having to go through the normal process of consent. EMTs in ambulances, at the prompting of computers, will test new treatments on trauma and heart attack patients. One tests the effectiveness of a stronger version of the saline solution given to trauma victims with crashing blood pressure. The other tests whether it's better to be given CPR for three minutes before applying defibrillators to heart attack victims. Additionally, they will be testing something called (according the Resuscitation Outcomes Consortium's website) an "impedance threshold device (ITD), which enhances venous return and cardiac output by increasing the degree of negative intrathoracic pressure during decompression," not that we entirely understand what that means.
Neither issue here is particularly galling in and of itself--the research may in fact lead to better treatment for trauma and cardiac arrest victims. What's so troubling is that a patient in an emergency situation will--without their knowledge or consent--be given treatment without advice or information from a medical professional of a level higher than an EMT, if at all. Normally, clinical research subjects are supposed to grant informed consent, which means that they have to both demonstrate they understand the procedure and its risks and agree to undergo them. According to the website of the American Medical Association, in a normal clinical environment (not a test), the doctor (specifically stating the doctor, "not a delegated representative"), needs to inform the patient of his or her diagnosis, the nature and purpose of the treatment, its risks and benefits, and those of both refusing the treatment or of any potential alternatives. So how has it come to be that an EMT is now performing treatments at computerized direction with no concern over consent, to the effect that defibrillation to restart a stopped heart could be delayed for up to three excruciatingly long minutes?
Precisely, it's located in the Code of Federal Regulations, Title 21, Chapter 1, Subchapter A, Section 50.24 (who wouldn't have trouble finding that?). This section of the code, on "Exception from informed consent requirements for emergency research," stipulates that standard informed consent practices may be waived if the subjects are in a life threatening situation, or are unconscious or can't give consent, their representatives can't be found, or if the researchers couldn't figure out who to seek consent from before starting.
In that last case, the researchers are supposed to seek "community consultation and public disclosure" about what they're going to be doing, so that people are more or less aware that should they get in a terrible car wreck, in addition to being charged exorbitant fees for ambulance service, they may have the added benefit of being a lab rat. According to Carol Ostrom, the UW "contacted media outlets, placed information in newsletters and on the online classified-ad site Craigslist, created Web sites and bought bus ads."
There is, theoretically, a way to protect yourself from being a lab rat--er, test subject: According to Ostrom's article, you can simply contact the ROC (800-607-2926 for the cardiac arrest study, or 800-607-1879 for the trauma study--thanks due to Ms. Ostrom) to get a little bracelet for free that says "No Research Study." It's the equivalent of British patients whose National Health Service has gotten so bad they have to write in magic market which leg not to amputate. Thing is, Seattlest's friend requested one Monday, and she's still to hear a peep. That said, although we didn't document the UW's page on opting out, according to sources they did take the time to update it since Ostrom's article appeared. A new section has been added to discourage you from even bothering. A special note for the ladies--you better like your medic-alert bracelet, because "You will have to wear this bracelet during the time the study is being conducted – through 2009." And anyway: "Even if you wear this bracelet there is no guarantee that under emergency circumstances the bracelet will be read by those providing care for you. You might still get the enrolled in the study." But don't worry, if they do accidentally treat you like a bunny rabbit at a make-up factory, afterwards, they'll just delete the data they collected on you from the study, making your unwilling sacrifice utterly useless.
There's nothing you can do, kids, it's Chinatown.
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So, say you've developed a new technique that's only applicable in situations where a patient's heart has stopped and/or they've been subjected to extreme trauma. How do you go about getting opt-in volunteers for a study on that?
I'm not saying that there isn't an ethical concern here, but what's the alternative? Never developing any new techniques to deal with trauma, because there isn't a way to study them that doesn't either involve lack of consent or further endangering the patient by waiting for an authorized representative to consent on their behalf?
Good question: when confronted by the need for medical experimentation and the perceived lack of other alternatives, what are we supposed to do? The law authorizing this exists for precisely this reason.
In some European countries, I understand, with an integrated medical system, it's perfectly easy to keep track of who agrees to what study. That would one way of doing it (and achieving that level of integration would, of course, mean that everyone in the US had health insurance). But of course the group in charge of these studies can't make that happen for the US, so in a sense it's completely stupid to discuss.
Or is it? I think it fair to point out that if someone else has the capacity to do it in a more ethical fashion, maybe it should be done there. Who suffers? Med students? American medical manufacturers? I don't know. I see the point in favor of these sorts of studies from beginning to end, and it makes a certain sense. Unfortunately, as with any real issue, there's not a clear-cut solution. The question to my mind is, do people want to be guinea pigs and lab rats? If no, why should we have to? That's also a very simple and rather straight-forward sounding proposition, I think. So it's a tough issue. Fundamentally, I think it needs at this point to turn on a couple factors:
One, what has ROC done to inform the public? Was is enough, or was it--like so many things involving public information--a close hewing to the rules and otherwise really going through the motions.
Two, do we the public, as we find out more about the study, have real representation to ensure our safety? In other words, I'm no doctor, but to my mind a stopped heart needs to be restarted. There's a very low survival rate for people defibrillated outside of hospitals, which is why they're testing to see whether two methods of increasing oxygenation could have better outcomes. I don't if that makes sense, or if the normal method of immediately defibrillating makes sense. So who does? Obviously, I doubt that the doctors here intend to do anyone harm, but why should we trust them out of hand, with no real consultation besides some posters and a post on Craigslist? Who's looking out for us? Universal healthcare and an integrated healthcare computer system may be out of reach, but public representatives out to ensure our well-being are not, and insofar as I understand, we have no public health representatives directly engaged with ROC/UW, no one we can go to besides the study's progenitors themselves, who are able to do it following the letter or the law and standard scientific practice. In short, we have no more rights than do lab rats, save that occasionally PETA or SETA will go apeshit on their behalf.
I think you are confusing EMT's with Paramedics. While there are EMT's on many ambulances in King County, it is the much more extensively trained paramedics that are administering these treatments. No offense meant to EMT's, but it's important to make the distinction, since paramedics are trained to administer medications, perform advanced cardiac life support, intubate, etc.. and all in a moving ambulance!
Fair enough, though most of the guidelines I saw, including the one I cited from the AMA, stress that a physician be the one to communicate the treatment to a patient. In this case, EMT or paramedic--and I apologize for the error--it is not a doctor who appears to be making the call. It seems to me that the crucial issue is that regardless of whether it's an EMT or a more trained paramedic, it is not a doctor making the call, except from a long distance of via some method of communication. A doctor's responsibilities are far in excess of temporary emergency medical personnel. Regardless of training, it doesn't seem like it should be their job.
So who cares whether it is a 'doctor' who is making the call, paramedics and EMTs are actually the experts in out-of-hospital emergency medical treatment therefore they should be the ones 'making the call'.
Also as an academic in the ambulance field I feel that it would be unethical of me not to perform research on patients who are suffering cardiac arrest considering they only have a 3% long-term chance of surving neurologically intact! I need to improve that.
However the fact the the patient is unconscious and needs immediate treatment means that researchers cannot ask their consent and don't have time to ask a legal representative. But everybody needs to know that all studys are required to be approved by an ethics committee who would not let the study take place without ensuring that: the benefits to the patient outweigh the risks, community consultation has taken place, the patients or their families are informed asap, information about the study is publically available and their is no known or likely reason why patients would refuse the treatment.
Research is important (how do you think that defibrillation became common practice?)and researchers and medical personnel have an ethical obligation to improve their treatments.