quote:The crux of the disagreement, I guess, is whether or not one believes that it's possible to get enough people wearing bracelets of consent that enough would be in amulances in trauma situations that the study could go forward.
Actually, that's only half the disagreement. If an option exists that would allow experimentation with consent with reasonable costs, I'm sure most people would agree that that should be done.
However, there are also people who believe that the experimentation should not occur absent consent, even if there is no alternative. That's the real crux of the disagreement, I think. What life-saving goals are worth what invasion of personal autonomy.
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aspectre, that's a bit of a tricky question because the notion of informed consent didn't come around until the Nuremberg code in 1948. There were certainly many tests conducted on orphans, the mentally handicapped, and prisoners after that (penicillin, as an example, was tested on prisoners to determine the optimum dosage). Things changed in the 60s when thalidamide was tested on pregnant women who were not told that it hadn't been approved and new laws were drawn up requiring doctors to tell patients if they were going to be taking drugs that hadn't been approved. Then we have Beecher's paper in 66 and a shift in attitude from the ends justifying the means to the rights of individuals being worth protecting. Not that things stopped then, the 60s and 70s were full of studies coming to light that used unethical means (things like the Tuskagee study). Heck, the million dollar finings for informed consent violations only happened in 1997.
I think you were looking for a list of drugs that have been approved via questionable means, but I don't know that I can provide that. Certainly many drugs/treatments for trauma patients, strokes, comas, and the like were likely conducted without informed consent.
And it *does* fly in the face of everything I've ever learned in an ethics class. I'm actually being quite a bit of a dick in this thread by hounding Steven and not giving my own views (which are quite in line with his, but he's much more articulate than I am). And I think I owe him an apology for that.
Sorry for badgering you, Steven (Steve?). It was neither fair nor did it really help the thread.
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You did ask some important questions, BtL. I think that did further the discussion.
Transcript of National Bioethics Advisory Committe discussion regarding research on those with limited decision-making abilities (long-winded but has some information regarding the history of treatments without consent -- especially on those with disabilities, e.g., the early radiation studies)
posted
To propose a hypothetical, would people have as much problem with this if the experiment involved either people getting the normal treatment (i.e. saline) in the control condition and real blood (that somehow could be matched to the subject quickly and easily) in the experimental one, but didn't get the subjects' consent to being part of the experiment?
edit: That's not an argument. It's a question that I think might help us identify where the crux of people's problems with this lie.
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(I am so happy that we are having a discussion about this at Hatrack. It is such an important topic.)
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I'd have to determine if that were an "experimental" treatment, and I don't know enough about emergency medicine to decide. Are the parameters for deciding whether to give blood in an ER parameters that could be judged by EMTs in the field?
If so, I'd say that likely isn't experimental treatment. But there's a lot of questions involved.
posted
(Sara - It's good to hear about Kahn and Caplan, not to mention surprising. Do you have links? The others aren't really in the "mainstream" of bioethics, though - especially Shamoo.)
My reply to email from Loyola re: bracelets. (remembering that my email or web submission to their site happened back sometime in February, March or April):
quote:First, I am grateful to see that my email to your site wasn't trashed as I thought it must have been, although I think it's strange you didn't email me about any of the community forums you held.
Second, a number of my coworkers have expressed interest in the bracelet as well, our workplace is right next door to Maywood. Please give me the start date of this study, what the bracelets consist of (are they plastic ones we may need to replace from time to time?), and how long the study will last once it's started.
I sincerely hope the reply to this email is speedier than the reply to my last one.
Stephen Drake Research Analyst Not Dead Yet 7521 Madison St. Forest Park, IL 60130 http://www.notdeadyet.org
It was only today it hit me that they were in possession of my contact info all this time and didn't bother to email me to let me know about community forums.
Just about any interpretation one puts on that doesn't make them look very good.
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quote:Sorry for badgering you, Steven (Steve?). It was neither fair nor did it really help the thread.
BtL,
It's "Stephen" or "Steve" but I don't bother to go around correcting people unless they ask as you have.
In my work, one thing I can't afford to have is a thin skin. Variations on the argument you threw up have been used in all seriousness by ethicists of ill repute in articles defending this practice as well as in comments in the press.
The "straw man" is not a stranger in bioethics.
There are some other arguments that have been used to promote this waiver that are even more interesting and might make for an interesting discussion with Bob Scopatz the traffic safety guy, and might actually serve as an excuse to continue a brief discussion he and I had at KamaCon.
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What I found strange about this whole thing.
This is for emergency services involving major loss of blood.
Like when you, say, slit your wrist?
What happens when you accidently gash your wrist and cut the freaking bracelet?
What are the odds of a temporary bracelet surviving a major auto accident where this service would be required?
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quote:MAYWOOD, Ill. – Loyola University Health System plans to test PolyHeme®, an investigational oxygen-carrying blood substitute designed to increase survival of critically injured and bleeding trauma patients at the scene of injury, beginning July 1, 2004, as part of a national clinical trial.
Got that? If this is true, the study has been going on since July. I submitted my objections to being a participant via the website many months ago.
They emailed me a week ago with an offer for a bracelet.
Are they being this thorough with the rest of the study?
I think this may be grounds for a formal complaint for noncompliance with their own protocol. More tomorrow - I have to talk to some folks about filing a formal complaint and maybe going to the press if this start date is true.
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quote:[January 18, 1999] Some say such notification cannot replace direct consent from patients or their relatives.
"Public notification means nothing," said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "I know people are enamored of it, but it means nothing."
quote:[September 12, 2004] Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said it makes sense to allow some research on people who can't give consent, but there should be a plan to compensate loved ones of study participants who die.
In the 1990s, research on a chemically different blood substitute was halted after recipients died at a higher rate than a control group.
Caplan also said meetings attracting a few hundred people don't seem to be enough to gain community consent, especially if hundreds of thousands are potential participants in the study.
Jeffrey Kahn from a CNN report on the prior study (I don't know if he is active in the discussion regarding PolyHeme).
quote:[February 1999] Given the availability of human blood, it is not clear that the artificial blood research meets the requirement that the research offer similar benefit to standard care, so that subjects could be exposed to this level of research risk without consent. However this point is answered, the subjects were grievously harmed as a result of the research, pointing out the importance and difficulty of protecting the rights of research subjects who do not give their consent.
To do so, we must have even greater confidence that the risks are outweighed by potential benefits. We must not allow community notification to take the place of efforts to find family members who can consent to participation on behalf of their loved ones. And we must create ways to allow members of communities to make clear that they choose *not* to participate in "no-consent" research -- a sort of informed refusal, in advance. The model of advance directives for the end of life, such as living wills, serves as an example for how this could be accomplished. ... There are important benefits to us all from the information gained by medical research. But carrying out research on our fellow citizens is a privilege -- a privilege that rests on trust. This trust is fostered when subjects and potential subjects understand what research entails, and when society believes that the rights and interests of subjects are served.
Some bioethicists have also published in opposition to nonconsensual blood substitute trials both as books and as academic articles. Amazon and Medline searches would probably find them, should you be interested.
[ October 19, 2004, 06:50 PM: Message edited by: Sara Sasse ]
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Ya know, paramedics are not doctors. I don't think they should be the ones to decide whether or not the standard of "conventional techniques would have been ineffective" has been met.
I don't think that any amount of multivariate analysis can correct for unknown/undocumented selection bias. That's my concern -- that the best methodology they could possibly come up with for this trial would still be bad from a scientific methodology point of view.
I understand the "do the best your can" approach to things, but is this truly the best that can be done, or is it simply the best that can be done within a specified cost parameter?
posted
While I am still undecided as to the ethics of the study, as is, not to mention its ability to get meaningful results . . . I have thought quite a bit about BtL and Sara's point as to the lack of a current good treatment alternative.
Too bad I don't live in the study area. I think I would actually be willing to wear a bracelet that said I would participate (at least, after I checked with my personal physician, to be sure there's no reason why I shouldn't).
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See, I think they'd actually have a fairly easy time of getting volunteers if they went out into the community and said "we're going to have this stuff available on ambulances. If you want to have the potentially life-saving treatment, wear this bright orange wrist band.
Oh well, it'd take longer and they'd have to canvass...
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quote:I understand the "do the best your can" approach to things, but is this truly the best that can be done, or is it simply the best that can be done within a specified cost parameter?
Trauma presents itself to you as is, and you take what you get. I have no inkling how one would approach this experiment otherwise.
quote:I don't think that any amount of multivariate analysis can correct for unknown/undocumented selection bias. That's my concern -- that the best methodology they could possibly come up with for this trial would still be bad from a scientific methodology point of view.
I confess you have completely lost me here. If the factors are "unknown/undocumented," how could you use them to stratify the sample? But if they are known, why can't they be controlled for in the analysis?
You may not get the most representative sample, but that's the best you can do without going out an inflicting the trauma yourself. At least the limitations of the sample can be addressed, insofar as they are known. If they are not known, then they cannot be addressed anyway.
Yes?
[ October 20, 2004, 01:21 AM: Message edited by: Sara Sasse ]
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The purposeful stratification of the sample yields better control than post-facto multivariate analysis because you aren't looking at the data and saying "well, we got too few of those to test the influence, so combine with these others."
I am, of course, assuming they'll have small counts in some of the cells of a table of desired trauma types.
I would think they'd at least have an idea going into it of what they'd like to stratify on if they had the chance.
The problem with unknowns isn't that you can ignore them. It's that they have unknown/unknowable effects on your outcome. It's the same as the third-variable problem in correlation analysis. You're trying to make causal attributions between x and y, but you have some unknown "z" in there that's really the cause of all the differences you see between groups.
One such thing is selection bias. Sometimes selection bias is obvious, but in other cases, it's just there and you have no way of knowing whether it had an effect or how big that effect is.
That's why you have to avoid it methodologically.
From what I've heard so far, this study isn't going to be able to do that. If there's discretion in the initial administration of the fake blood, then there's selection bias. That's not questionable, I think. No matter how well they train the paramedics, it's going to end up that the choice of who got the treatment and who didn't was affected by things other than what the study sponsors told them.
Since that's the case, you have to always ask whether the differences between groups at the instant that decision was made might not have affected the outcome.
When the people choosing group assignment know the desired outcome of the study, for example, they almost always bias their choices in favor of having the study come out "positive."
This is not a double blind study, so assignmment bias is almost guaranteed.
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quote: If there's discretion in the initial administration of the fake blood, then there's selection bias.
What discretion is there here that there wouldn't be in any experiment in a basic life support situation? That is, if PolyHeme for some reason seems to be failing, the physician in charge of the case switches the patient to the standard of care (saline). But regardless of how you design the study, that would be the case. You can't not be able to switch from an experimental product to the standard, not when it is the "golden hour." IRBs won't allow it.
If you object to that part, I think you object to all trauma research, which is a more pure scientific stance, but would block all trauma trials of the product. That may be understood to be where you are going, but I'm not sure.
And that really is the only discretion exerted -- otherwise, the assignment is unknown until the bag is opened once the patient has been deemed to require fluids for resuscitation. So paramedics and physicians aren't picking and choosing which patients to assign initially to which treatment group. Any changes after initial assignment are dealt with by "intent to treat" analysis -- you see what happened to the people in each (randomly assigned, as the bag is pre-sealed and unidentified as saline or blood substitute before opening) group, regardless of whetheer they were later changed to a different group. "Intent to treat" is the apporpriate analysis in medical research, as it reflects actual practice.
This is not an uncommon procedure, at least not in the standard medical journals. There is nothing new about this setup at all.
quote:The purposeful stratification of the sample yields better control than post-facto multivariate analysis because you aren't looking at the data and saying "well, we got too few of those to test the influence, so combine with these others."
The only way to get more of a certain type is to create that particular type, and you just can't go around creating the traumas you desire. Instead, you take the traumas that come in, analyze the types separately (if relevant), and see if you have enough power in each type to draw a conclusion for that subgroup. If you do not, then you do not draw the conclusion, and you explain why. This is also standard practice in trauma research.
And there are ways of incorporating small samples into a larger composite sample using ANOVA. This prevents a rejection of the null for the large sample when really the only statistical difference is in a small subset of groups and so the result cannot be generalized.
Ensuring appropriate use of ANOVA is part of the review process.
quote:The problem with unknowns isn't that you can ignore them. It's that they have unknown/unknowable effects on your outcome. It's the same as the third-variable problem in correlation analysis. You're trying to make causal attributions between x and y, but you have some unknown "z" in there that's really the cause of all the differences you see between groups.
You can't stratify on an unknown, though. The question of selection bias is not one of stratification on an unknown, but on a known (or at least, a "knowable")-- namely, the reason why some were selected to receive a treatment preferentially. Comparison of the treatment and control groups afterward tells you whether the randomization worked.
Bob, I understand that this isn't a pure lab rat double-blinded controlled trial. But most of medical research, especially trauma research, just is not feasible to be fit into that model. So you do the best with what you can, and in the analysis of the study, you see if it was good enough. If it wasn't, then you cannot draw a strong conclusions, but you can detail the areas where the conclusion would have to be drawn less strongly, or not at all.
[ October 20, 2004, 09:23 AM: Message edited by: Sara Sasse ]
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posted
I wonder if maybe our different areas of interest have different standards of practice? I don't think you can do double-blinded [from start to finish] trials on basic life support interventions in the field. I don't think it is considered permissible.
[ October 20, 2004, 11:41 AM: Message edited by: Sara Sasse ]
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As far as I can tell, the part that Bob's talking about (the assignment of subjects to either the saline or the PolyHeme condition) is actually double-blind. Neither the subject nor the experimenter decides what group they're going to be in. It stops being double blind after the introduction because the paramedic now knows whether the patient is getting saline or PolyHeme. However, this is both pratically and ethically unavoidable and, unless we are going to suggest that the paramedic's care is going to change based on what fluid replacement is being used, largely ignorable.
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A separate problem from the double-blinding is the issue of stratification. I think these issues may have been conflated.
If you stratify the sample before the study, the measurements and confidence in generalizing to the population is tighter. You can do more. If you don't stratify but instead take what you are presented with, there are specific statistical techniques to determine:
1) whether the subgroups you find are of sufficient size to generalize to a conclusion for just that subgroup
2) whether there is more variation in between the subgroups as compared to within the subgroups, which tests for generalizability from subgroups to the whole sample
3) whether skewed data (e.g. too many more men total than women, or too many men in the treatment group as compared to the control, etc) can be appropriately "normalized" in order to give you sufficient justification for generalization
4) etc
But when you have to deal with skewed data or the like, there are more limitations on the generalizability. So you might not be able to draw a conclusion -- and your chance of this is higher than if you used stratified data, which were designed to provide sufficient generalizability. But that isn't really an option in this sort of case.
[ October 20, 2004, 11:42 AM: Message edited by: Sara Sasse ]
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Sorry to dumb it down, but I guess any new treatment has to have the safety and efficacy proved. If this study is to prove the safety, then that's frequin' sickening.
But if safety has been established, this seems a reasonable way to evaluate efficacy. I wonder if it could be argued that this stuff is actually safer than blood. Apart from blood types, there can be some really weird incompatibilities and fatal reactions with whole blood.
And if they could make this stuff out of AIDS and CJD risk donors, that would offset the cost liabilities. I guess that will have to be a different set of tests down the line, that no one would willingly participate in.
Then there is the risk that if a long shelf life blood substitute exists, people will feel less obligation to donate.
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quote: I wonder if it could be argued that this stuff is actually safer than blood. Apart from blood types, there can be some really weird incompatibilities and fatal reactions with whole blood.
I believe that it has been found to have much much less infectious disease transmissability than whole blood as well as no (? not sure) risk of transfusion reactions. That is part of the excitement about it.
I can't imagine that they can screen out prions, though, although that is just my guess. I'm pretty sure prions are smaller than hemoglobin molecules. [But see the CC article quoted below re: prions. I don't know what that claim is based on, though.]
From a 1999 French article in Critical Care Forum (I can't voch for the veracity of this site, as I am unfamiliar with it):
quote: The viral risks associated with blood transfusions, already reduced by extensive donation screening tests, are greatly minimized during the haemoglobin therapeutic manufacturing process by rigorous viral-inactivation procedures. Some chemically stabilized haemoglobin solutions, such as diaspirin cross-linked haemoglobin (DCLHb or HemAssist™, Baxter Health-care Corporation, Chicago, Illinois, USA) are subjected to ultrafiltration and heat treatment during the manufacturing process to inactivate viruses [4]. Other human haemoglobin-based products are currently being developed, including pyridoxylated and glutaraldehyde polymerised haemoglobin (PolyHeme™, Northfield Laboratories Inc, Evanston, Illinois, USA)... ... Furthermore, infectious agents present in animal blood, such as the bovine spongiform encephalopathy prion, are not as well characterized and therefore are more difficult to detect than those in human blood. ... [But] In addition, the specific purification techniques used may be able to eliminate the protein responsible for bovine spongiform encephalopathy transmission, even though the nature of the protein is unknown. ... [And in further research:] Recombinant technology is also being investigated to engineer oxygen-carrying solutions. These techniques allow flexibility in product design, enabling haemoglobin molecules to be modified to address specific clinical needs. In addition, many of the potential side effects of bovine-sourced products, or indeed the sourcing complications associated with human red blood cells, may be avoided by using recombinant technology. ... The possibility of obtaining haemoglobin from transgenic tobacco plants was recently reported [10].
[4]Farmer M, Ebeling A, Marshall T, et al. Validation of virus inactivation by heat treatment in the manufacture of diaspirin crosslinked hemoglobin. Biomater Artif Cells Immobil Biotechnol 1992;20:429–433.
[10]Dieryck W, Pagnier J, Poyart C, et al. Human haemoglobin from transgenic tobacco. Nature 1997;386:29–30.
(Eventual blood substitute through the extraction of hemoglobin from tobacco leaves? It was in Nature 1997, apparently.)
[ October 20, 2004, 12:49 PM: Message edited by: Sara Sasse ]
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posted
pooka, That's the idea that I was trying to determine with my blood/saline experiement above. I think that there are two separate ethical issues.
First, is it ever right to perform experiments on people without their prior knowledge or consent?
Second, if this is not absolutely wrong, what conditions make it ok or not ok?
If people are ethically opposed in the first condition (which is what many people's remarks seemed to me to be suggesting), then they are not going to agree with this. But they are also not going to agree with nearly all trauma research and research from a host of other situations.
If instead they aren't absolutely opposed to this research (which, despite what it seems that people are saying, I think is the actual truth), then what are the aspects of this situation that they think makes it ok/not ok?
I think that it comes down in large part to a question of risk and of good faith on the part of the peopel doing the testing. If the PolyHeme has been extensively tested and, from this testing, there is a reasonable expectation that it's use in trauma situations carries little risk and the people who are running the experiment are operating in good faith with respect to the subjects of the experiment, I'd most likely not have ethical issues with this being a non-consensual experiment.
However, as a social scientist, I have a definite bias. As most social science experiements lose their validity if the subject know what the research is about, social scientists, by necessity, don't regard informed consent an ethical necessity as long as there is rigorous good faith on the part of the experimenter. It's possible that my ethical standards differ from other peoples and that they affect the way I see this situation. So, I'm interested in where people's objections to this experiment rest.
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posted
I'm not sure it would be feasible to get true informed consent on site at a trauma, regardless.
"Hi. You [or your husband, or daughter, or whoever] is in shock and needs IV fluids or will probably die. We have a study going on where we are comparing a blood substitute that we think is more effective to saline. Mind if we enroll you [or ...] in the study? You might get the new stuff or you might get standard saline, it just depends. Oh, and you have about 30 seconds to decide, so no time for questions."
I mean, you might have more than 30 seconds, but not much more.
The only tenable way to get real informed consent would seem to me to be through a much more extensive public information campaign so that people are really familiar with the study before being put in the crunch. And if you are going to do that extensive a public relations campaign, you might as well have opt-in bracelets, anyway. Otherwise, the "informed consent" you get before starting the protocol would be a joke. Who, if one's loved one or self is dying, can really process this kind of information?
"Informed"? "Consent"? Or just mind-numbed and unthinking desperation?
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:kind of obsessing on the reality of having to wear a bracelet for a year if I want to make absolutely sure I don't end up a guinea pig:
I'll try to write more later, but I haven't had any reply to my email to Loyola. In regard to keeping the community informed, shouldn't there be something on the site announcing the start date??
The more I read about this, the more convinced I am that it's not just paranoia on my part that leads me to believe this "community education" stuff was designed to be a sham. I read the FDA regs and they are incredibly nonspecific about what the information campaign should consist of.
And no plan to evaluate its effectiveness...
Like, if you hired a pollster now to ask what people knew about the study, what would the response be? If the level of knowledge is low, it means the efforts were a failure.
But, as I said, evaluation isn't part of the FDA requirements.
Which leads me to believe it's all a meaningless CYA effort and was designed that way. (Art Caplan seemed to be saying the same thing, but he doesn't have to back up his statements or his reasoning. )
(In case y'all didn't notice, btw, this change in the FDA regs happened during the Clinton administration.)
posted
Caplan and others in the Project on Informed Consent criticized the changes on informed consent in an article in a late 1998 edition of JAMA. That might be a useful resource.
And in reading back through the thread, I picked up on this:
quote:The others aren't really in the "mainstream" of bioethics, though - especially Shamoo.
Adil Shamoo, PhD, is the director of CIRCARE, the Citizens For Responsible Care and Research group. Shamoo himself has published more than 100 articles, including in the American Journal of Bioethics, Neuroscience, and the Cambridge Quarterly of Healthcare Ethics. He was previously the chair of the Department of Biochemistry and Molecular Biology at U Maryland as well as maintaining affiliation with its Center for Biomedical Ethics.
quote: You need to meet some new bioethicists. There is a whole world out there beyond Leon Kass.
Not-so-oddly, I have never met Kass. He has about as much interest in and/or respect for the disability rights perspective as Caplan, Kahn, etc. Living here in the Chicago area for the past 8 years, I don't get a sense of him as a dominant presence, although that may have been true at one time.
I have met George Annas - several years ago. He seemed to appreciate - at the time - both NDY and some points I made during a Q&A during a euthanasia conference at Harvard (we were not part of the conference and protested it). His enchantment with NDY was probably short-lived - and when it comes right down to it, he's probably more in sync with other bioethicists in terms of who he thinks should be heard.
I also have had contact with Jeff Kahn. If memory serves, he actually called me, because we were embarrassing him and his center when they allowed a pro-euthanasia group to co-opt their conference on assisted suicide. (Long story, but he was obviously more upset with me and NDY for highlighting what happened than what Death With Dignity National Center did.)
No direct contact with Caplan, except to see him glaring at us from his seat on a panel discussing Kevorkian. (in spite of the fact that Kevorkian's body count consisted of mostly nonterminally-ill people with disabilities, there were no disability advocates invited.) Everyone on that panel resented our presence and sometimes outspoken behavior - except for Clarence Page, who was also the only minority person on the panel. He ended up writing a column about us. (That's the same event I shouted Mike Wallace down when he made a really outrageous statement, but that's another story.)
And, of course, you already know what kind of an impression I made on Catholic ethicist Kevin O'Rourke.
Edit to add: Peter Singer - how could I forget? I annoyed the heck out of him! (and more annoyance to come next month )
See, Sara, I get to meet all kinds of interesting people.
But not Leon Kass. And it's not likely it will happen, either.
Edit to add: Steven Miles doesn't like me very much, either.
Was up against Glenn McGee once on a now-defunt newstalk show. We did a good job of annoying each other.
Susan Wolf: she also called me in regard to the co-opted conference. I respect her work, but that almost puts her out of the mainstream by definition.
David Mayo: Debated him.
(Hmmm... I have more bioethics contacts in Minnesota than I do in Illinois)
Illinois bioethicists I have met:
Kathryn Montgomery Mark Kuczewski Todd Chambers
Kuczewski's an interesting case - he is carving out a niche for himself in "disability and bioethics" but has a great deal of disdain for disability advocates - not just me or NDY-affiliated people.
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posted
I remember Shamoo and his protests when the big push started for access to legally incompetent people for medical research. That was the first I had heard of him. (he's quoted in the Ervin article I linked to earlier.)
I've actually talked with Vera Hassner Sharav a couple times and exchanged email. She's with the Alliance for Human Research Protection.
posted
I was using "meet" in the Information Age sense. I understand that the above are people you have debated directly, or talked with, or have seen in person, but I get the sense that you are not familiar with the bioethics academic literature or the work that is done behind the scenes.
That is a shame, since the academics who publically debate or otherwise cultivate the popular media are not generally predisposed to nuance or thoughtful critique. You can't get something carefully developed across in a matter of minutes -- you yourself have noted your frustration with trying to get your points across in the short time allotted. What you can get across are brief sound bites. From an academic standpoint, these soundbites have to be short, blunt, and easily understood. That isn't rigorous and it isn't good philosophy.
I understand that from the advocacy side, even getting soundbites across is a step forward. I don't fault that at all, and I've come to respect the different approach you must take in order to have an effect. But from a bioethics standpoint, soundbite-driven media tends to attract people who are happy with soundbites, which is usually people who are happy with the party line. It is also a huge drive to financial gain through selling one's popular books and oneself as a popular lecturer.
On the other hand, you have someone like Shamoo, who is testifying before Congress on your issues, on your side; writing amicus curiae briefs; teaching students at university (some of whom will be going on into positions of power themselves); and who is leaving an intellectual paper trail in his own quiet way. And it's a good, careful, thorough, rigorous path he creates.
That is a friendly ear in which to voice your concerns, and it is connected to someone who does more (quietly, but powerfully) to affect the actual lives of persons than a Big Name talking head. He also may be a good resource for information and further contacts.
I hear your frustration when you rail against bioethicists, as it seems you are exposed to the worst of the lot with distressing regularity. But it troubles me to hear the whole profession tarred with that same brush, as it slanders people who are doing good work, even if they are not media darlings. Just as the media loves the flamboyant aspect of the Gay Pride Parade, so does it love bioethicists who will reflect what America expects to see right back at it.
And I know that Hatrack is a venting place for you, but when you are categorical about sneering at bioethicists and physicians, you are also sneering at me. It does hurt my feelings, even if I do understand, and it makes threads like this uncomfortable for me. (Not weepy, not depressed, not enraged -- just that tired, why-am-I-bothering, burned-out feeling that drives any of us to vent here anyway.) Hatrack should be a good place for you to vent and feel welcome, but that shouldn't have to come at the expense of insulting others here, even unintentionally, as it does belong to all of us. IMHO.
I can see taking an extreme stance in a soundbite, but at Hatrack you don't have to be extreme or radical to get listened to. People here (including me) value you and your thoughts and opinions, and we will listen even if you tone down the rhetoric. Actually, I'd be delighted with the qualification of "some bioethicists," or even "many" or "most." You can rant and rave about most of them all you like, and I'd be happy to join in. Just, please, be clear that the sneer isn't directed at at all of them, okay? Especially when you have at least one known reader here who is doing her best to uphold the stronger standards.
Thanks.
[To clarify: I'm not mad, and I don't mean to take you to task for being irritated at those who are total dipshits. I'm just asking a favor as a friend, along with trying to be helpful to both of us. You for possible contacts, and me for my avoidance of burnout and exhausted passion.]
[And, of course, if any of this is offensive or over the top to you or others, I would of course edit or delete as requested. I have my own doubts about posting it anyway, and it is a bit of a down night for me. Probably fuels the frustration in good part.]
[I am also aware that I sound fantastically whiny. Ew.]
[ October 20, 2004, 07:32 PM: Message edited by: Sara Sasse ]
Posts: 2919 | Registered: Aug 2004
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quote:On the other hand, you have someone like Shamoo, who is testifying before Congress on your issues, on your side; writing amicus curiae briefs; teaching students at university (some of whom will be going on into positions of power themselves); and who is leaving an intellectual paper trail in his own quiet way. And it's a good, careful, thorough, rigorous path he creates.
Sara,
I have admitted before that I'm self-taught in bioethics and have lots of gaps. And I'm probably more aware than you think I am of some of the careful and thoughtful work that goes on.
The trouble is, the Shamoos in the field aren't having an impact. The behind the scenes stuff that is effective are things like Norm Fost helping push the FDA exception along, Art Caplan promoting futility policies, and a whole host of mainstream ethicists pushing the system to remove barriers to ending the lives of people with cognitive disabilities through withholding of treatment.
quote:but when you are categorical about sneering at bioethicists and physicians, you are also sneering at me.
I really don't understand where this comes from. I don't think I've been categorical - at times I've stressed the issue of "mainstream" bioethics. The same with physicians - there's a difference between individual physicians and the medical culture, and attacking the latter often leads to a misinterpretation - usually an honest one - that it's individual physicians being painted with one big brush.
I'm not a proponent of deletion for anything except - to use a real example - anti-semitic remarks (first and only time I used the whistle on this forum).
Meanwhile, I'm still sitting here at ground zero, and reading old articles that feature one of the Loyola docs conflating the presumed consent to "treatment" in emergency situations with presumed consent to be a "research subject." It's vile - and if I did something like that, I'd most likely be called to task for it. Or at least called on to defend it.
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(((Sara))) you did challenge him with the [paraphrase] Pull your head out of your Kass[/paraphrase] remark
We are talking about something that isn't prejudiced against the differently-abled, right?
I understand the specific situation that they contracted to provide community education and failed. That can't be excused.
But the structure of opting-to-not raises another principle. Are some treatments so overwhelmingly beneficial that it is okay to...uh, deceive the patient population in order to bring them to the market? If a physician believes that deceiving the public will ultimately benefit the public, is that okay?
If penicillin had been marketed as mold excrement, how many people would have opted to use it?
I guess my weird take on this is based on the fact that I think many medical procedures are guinea-pig-like in their nature. Most things that are done to hospital patients are things they would not specifically give informed consent for. We trust that all these things are within the standard of care, I think. I'm assuming such a concept exists.
Childbirth for many years involved many standards of care that had no research to back up their benefit and were at best annoying and expensive. Nothing related to pregnancy and children really can be tested because everyone recognizes that such testing would be unethical. So when changes in care occur, it is pretty much a stab in the dark.
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Are you saying that the ambulance goes out into the field with a set of fluid replacement bags that are wrapped in brown paper or something so that when the paramedic decides to give fluids, they "discover" whether it's saline or fake blood they'll be putting into the patient?
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quote: I don't think I've been categorical - at times I've stressed the issue of "mainstream" bioethics. The same with physicians - there's a difference between individual physicians and the medical culture, and attacking the latter often leads to a misinterpretation - usually an honest one - that it's individual physicians being painted with one big brush.
quote: I really question one comment in it, though. It describes the ethics community as "divided" on the wisdom of this study. Here in Chicago, which is swarming with bioethicists, none came forward to criticize the study....
quote:As a result, the public gets no sense of context, and I'm not sure they even want it.
Mainstream bioethics doesn't seem to have much interest in it, either. (yeah, I know, them's fighting words)
quote: I'm charging him with intellectual dishonesty (not using the exact words, phrased a little softer) and letting him off the hook a little by saying that much that I have to say about him specifically can be applied to the field of bioethics as a whole.
quote: So, to be fair, a lot of the complaints I have with Peter Singer can be leveled against mainstream bioethics as well.
quote:Singer and his fellow bioethicists are very happy to have the debate on policy dominated by a small range of people in the professional class - themselves.
These are what I remember in particular about bioethicists, and there are others about what "doctors" do and say. Not just medical culture or a doctor, but "doctors" in general, which means me, too, in my eyes (even if not intended). I know, a lot of this is old stuff. It just adds up. "Mainstream" has to be very narrowly defined in order to be this bad, and that use of mainstream is one I was not using myself, except in trying to understand you. Maybe the semantics here led to confusion?
I have a lot of respect for your skills and knowledge I wouldn't care if you were just some yahoo blowhard, but I do care because I respect and like you.
You talk a lot about being annoying, and I've come to recognize it as something of a useful characteristic in the work you do. Being annoying means being seen, and being seen possibly means having peoples lives be saved. And I know you are under stress. I am, too, and I get it. I also am on the frontlines, just at a different part. And I feel overwhelmed and embittered at times, too, and I come here to destress and vent, too.
I don't think you can see Shamoo's impact from where you are, though, not if you cannot see that he is mainstream. And I realize, it isn't your job to know all the details of various academics lives! But to question whether the community is at all divided on something which is evil, given a limited perspective, triggers (for me) all the past comments about my field. I agree with you that it is true in many cases, just not in all. And it isn't fair to judge the all just by what you see, not when it is something tagged as vile, like this.
This is whining. I can see that quite clearly, actually, and I doubt it is helpful to either of us.
Hmmm. Maybe could you ask me to check for persons with a more sympathetic eye to your cause when it seems that mainstream bioethics is completely clueless? I'd be delighted and honored to try to step up to the plate. Posts: 2919 | Registered: Aug 2004
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quote:(((Sara))) you did challenge him with the [paraphrase] Pull your head out of your Kass[/paraphrase] remark :
I did. I really, really loathe Kass, and I think his influence has altered who is accepted into graduate school and onto faculty in the many Chicagoland universities. But I shouldn't have let that loathing make me snarky about anyone else. (Sorry, Stephen. It was uncalled-for and disrespectful of your skills and experience.)
I shouldn't post when I'm feeling like this.
quote:I must not be clear on this study design.
Are you saying that the ambulance goes out into the field with a set of fluid replacement bags that are wrapped in brown paper or something so that when the paramedic decides to give fluids, they "discover" whether it's saline or fake blood they'll be putting into the patient?
Yeah, that's how it is designed to work. But even if they made opaque bags and tubing, they'd still be able to see the fluid when starting the IV, and so once the bag is opened, the assignment to ttreatment or control is clear.
Hey! We must've been talking at cross purposes. Posts: 2919 | Registered: Aug 2004
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posted
By the way, trauma research can stratify on type of injury without CAUSING the injuries. Yes, you take what comes your way, but you also select cases. For example, the NEXT gun shot wound that comes in get's the stuff. Unless contraindicated.
You set out knowing the general time frame that it will take to collect a certain number of cases of a given type. And you don't allow discretion (other than contraindications or "opt out") in the choice of who receives the treatment.
That way, the assignment is random but you aren't going around creating trauma.
It's simple, but it takes more coordination and planning.
Methodology in medical research "in the field" is problematic. I'm not arguing that it should rise to the level that is obtainable under laboratory conditions -- that would be inconceivable.
But I am arguing that this methodology unnecessarily relies on post-facto statistical analyses rather than careful selection processes at the outset.
I suspect my proposal would cost more money and that's why it isn't done. It might also require closer coordination with the EMS providers, and that's not all that easily accomplished either.
The problems I continue to have with the statistical solutions are: 1) No matter how much apportioning of variance you do after the fact, if you haven't controlled for selection bias, you haven't controlled for it. It doesn't matter what your ANOVA tells you -- that's just working the stats test -- you have unexplained variance that you've folded into some place in the treatment or control. Oops.
2) STandard practices in various fields of scientific study are often in violation of the rules of statistical methodology. Analysis of Variance, for example, has a set of rules that should be met prior to its application. This study doesn't come close, and yet the ANOVA will be used. It's the old "when all I have is a hammer, the entire world looks like a nail" problem in statistical testing. Just because medical journals will publish it doesn't make it valid or reliable.
3) There are ways to control this kind of thing better and rule out some potential confounds. I can see how it makes it tough on practitioners to do the studies better and how it would suck up research dollars to do so. So, I also recognize that my little diatribe isn't going to change anything. Medical studies in naturalistic settings will continue to be performed this way. And the result will be, every once in awhile, the researchers will guess wrong when they apportion the variance by tweaking their stats package. Will that result in deaths? Probably not so many that we'd be able to detect it.
In other words, I'm just being a crank from the sidelines.
But, to me, it raises an issue of reliability. If this is the study that will determine if this product is used nationwide, I think after the rollout, we'll still be using an experimental treatment.
Since the FDA and drug companies have taken it on the chin lately with treatments that made it through clinical trials and then years later were shown to increase the risk of death in selected groups of people, I think there's reason to suspect that the motto of "do no harm" has been sort of chucked out the window for the sake of convenient experimental design rather than scientific rigor.
I think it is perhaps time for the medical community to seriously question the research methods that pass for "standard practice."
Maybe the decision will indeed be "this is the best we can do." But I suspect the answer will be "we need to do better."
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posted
By the way, I'm feeling a little guilty here. I don't mean to pick on you, Sara. Medical research today is much better than it was 50 years ago, and we have some amazing treatments available because of it.
I also think that medical research is vitally important.
I'm not trying to be difficult. I find the methodological stuff fascinating.
Sorry for being so critical of your wonderful profession.
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Bob, They've been doing trauma efficacy studies for some time now and I'm willing to bet they have actually dealt with the issues that you're bringing up. It's not like this study is introducing any new complications into trauma experiments. The methodological issues you are mentioning are either already anticipated or are flaws in all research of this type. As I try to tell people when they start looking at reputable, established, peer-reviewed research, if you came up with your objection off the top of your head, it's reasonable to assume that it has already been investigated. The potential methodological flaws you are bringing up are pretty basic. If we assume that the people doing these experiments for the past 30 years or so aren't completely incompetent, I think they've almost definitely thought of them as well.
posted
I posted and then deleted a really dumb question. Like "I already forgot items mentioned in the first post" dumb. Not like "I don't trust the medical-industrial establishment to always do the right thing" dumb.
P.S. I applaud the thread title change. At least as long as that "other white meat" thread is floating around.
quote:I have a lot of respect for your skills and knowledge I wouldn't care if you were just some yahoo blowhard, but I do care because I respect and like you.
You talk a lot about being annoying, and I've come to recognize it as something of a useful characteristic in the work you do. Being annoying means being seen, and being seen possibly means having peoples lives be saved. And I know you are under stress. I am, too, and I get it. I also am on the frontlines, just at a different part. And I feel overwhelmed and embittered at times, too, and I come here to destress and vent, too.
A couple of points. I obviously haven't been clear about the "annoying" stuff. Being intentionally annoying is almost always done as part of a protest, part of theater - to get attention, as you say. And sometimes people like Clarence Page get it, even though folks like Art Caplan just turn red with agitation (he does that pretty easily though.)
Mostly, though, I annoy people like Singer, Mayo, and others by playing by a different set of rules. I insist on relating to the real world of medicine with our own documented stories of what happens to people in the health care arena. I don't soften my language when one of them is being sloppy or just plain misrepresenting facts. I'm annoying because they don't have a ready answer for charges fairly laid.
And I think that's a place we differ. When it comes to policy, I believe we have far to much elaboration on philosophy and case examples and far too little about what's really going on in the system.
I don't know what to think of "diversity" in bioethics, frankly. In the case of Robert Wendland - a brain-damaged man never argued to be in PVS - 43 bioethicists signed onto a brief supporting the right of surrogates to withhold lifesaving treatment on a "good faith" standard.
In the Schiavo case, there were 55 bioethicists who signed onto the brief supporting Michael Schiavo.
Number of bioethics briefs opposing starvation in either case: 0
It's also harder to find bioethicists speaking out against futile care guidelines. There used to be quite a few, but the voices seem to be dwindling in both numbers and volume.
To use another example, I know for a fact that there are members of the "Aspen Group" that strongly disagree with Ron Cranford's advocacy with the newly classification of "minimally conscious state." Cranford advocates having people in that category thought of as being most like people in persistent vegetative state, and that the laws around cessation of lifesaving treatment should be similar.
They may be troubled by Cranford's advocacy, but they aren't getting their hands dirty publicly countering his agenda.
Who knows? Maybe if enough "good" bioethicists get annoyed at being lumped with the "not so good," maybe they'll be motivated enough to get as sophisticated about media and advocacy as the others. Posts: 4344 | Registered: Mar 2003
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Example (non-Singer one) of confronting someone with being less than honest:
A few years ago, I debated David Mayo, who was and is on the board of directors of both the Hemlock Society (which has now merged with another organization) and Death With Dignity National Center.
At one point, he tried to say that Hemlock was "divided" on Kevorkian. I just looked at him and said something along these lines:
"David, your own surveys show over 80% of your membership is extremely supportive of Kevorkian. As a board member, you authorized the raising and donating of over forty thousand dollars to Kevorkian's defense fund. Not only that, you won't find one single critical word about Kevorkian any issue your organization has put out. Who are you trying to kid here? Shame on you."
Edit to add: For obvious reasons - he's part of the Minnesota Bioethics Center - I suspect Mayo played a significant role in the assisted suicide conference fiasco.
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It was in Nature 1997, apparently.)
