quote: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.)
I'm taking it then that we agree Hatrack isn't (or shouldn't) be about theater. I like that there is an attempt here -- even if not elsewhere on the web -- to be accurate, clear, and thoughtful, and to work to get facts about the world straight. Sure, we all have different opinions, but ideally we all work together to make sense of things, and we do so by expecting ourselves and others to give accurate information especially when opinions differ.
quote:I don't soften my language when one of them is being sloppy or just plain misrepresenting facts.
I do, here, or at least I try to. I do that because Hatrack is a different sort of community with a different structure, and we can speak at any length and in any level of detail about anything, and we can be sure of having an attentive and involved audience. Also, I know that when passions are involved on matters of grave import, it is sometimes difficult to see anything but the error and injustice, and I make allowances for others as well as myself.
quote: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.
Why do you think we differ on this? Or are you speaking of the soundbite bioethicists?
quote: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
But there was Wesley Smith, attorney and anti-euthanasia advocate, who was very involved in opposing the case. He is not just a lawyer but also a consultant for the International Task Force on Euthanasia and Assisted Suicide and author of Forced Exit: The Slippery Slope From Assisted Suicide to Legalized Murder and Culture of Death: The Assault on Medical Ethics in America. I suppose you could define the field of bioethics to exclude him, but I'm not clear on what grounds: he publishes articles and texts in the field and he is active in grassroots work. He does bioethics, he is a bioethicist. Just not one of the bad ones, unless you define bioethicists as those who disagree with you, in which case one would be assuming the conclusion.
And Stan Dundon from the Dept of Philosophy at California State University has been highly critical of the brief:
quote:In a fairly substantial piece I am writing on Robert Wendland I state that the Amici Curiae brief submitted to the California Supreme Court supporting his extubation was badly written due to its adversarial legal setting and poorly informed by traditional Catholic medical ethics in spite of several “Catholic” institutional undersigners. My review of the Court's decision notes that it saw this case as a request to kill a conscious patient who was not even sick, who was making limited progress, and who would be likely to suffer distress, since he was conscious, from the prolonged process of dehydration. I suggest further that the Court may very well been aware that claiming that such an action was a legitimate "letting die" of a dying patient would sound like nonsense to objective observers.... My judgment of the case, as framed by the Court's language, is obviously negative about the Amici Curiae brief and completely in agreement with the Court.
I'm not disagreeing that there are problems with the vast majority of academic bioethicists, especially on disability issues. That is obvious. I've been glad to have my own biases and preconceptions challenged here by you and some of your work. I'm just asking for the expression of frustration to be directed at "most" not "all."
quote:They may be troubled by Cranford's advocacy, but they aren't getting their hands dirty publicly countering his agenda.
That is, the mass media is not covering any such objections well. There is a difference.
quote: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.
Stephen, I couldn't give a rat's patootie about whether you lump all bioethicists together in your work outside of Hatrack. I'm sure it might well be necessary and effective. I'm just asking you not to do it here, where it is not necessary.
What is the difficulty with adding a clarifying "most" to the claims about physicians and bioethicists? I can't see where it would detract from your effect here, except that I would not be braced so much for the wince-inducing comment while reading these threads.
(I am getting super-sensitive about this, I know. But in reading back through some of the earlier stuff when I was posting as ClaudiaTherese, I found you to be much more clear about not necessarily including me in expressing the frustration. Perhaps it didn't seem as important anymore, given that we know each other better now?I don't know.)
Of course, I could always just not read the threads. It would make less of Hatrack for me, but if this is a sticking point, it is the obvious concession to make. We both come here drained and exhausted from our outside work, and we both look for a place (I think) to let down our hair and relax among friends, and we both have our attentions caught by similar topics. I can't engage in that if I read (unintentional, I understand) slams against everyone in either of my professions, because that does include me.
Growl about "many" or "most" all you want though. That wouldn't bother me in the slightest, especially given that it is a fair assessment.
[ October 21, 2004, 11:31 AM: Message edited by: Sara Sasse ]
Posts: 2919 | Registered: Aug 2004
| IP: Logged |
quote: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.
I was sloppy in my wording and unclear. I meant to say not just trauma research in general but research on basic life support measures in the field.
quote: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 don't think this can be done in the field, though. Paramedics have enough going on with following the medical protocol for treatment -- I don't think it would work to have them consult back to find out "if we need another cardiac case for the study."
I think that's why it was designed so crudely. Anything too sophisticated in that environment tends to backfire. (e.g., they recently simplified the basic CPR protocol because it was a way of decreasing error in the field)
Regarding, say, therapies initiated in the ED, I can definitely see your point.
quote:By the way, I'm feeling a little guilty here. I don't mean to pick on you, Sara. ... Sorry for being so critical of your wonderful profession.
Not at all! I'm cool with criticizing a specific incident, action, or person. You raise thoughtful questions.
I am reminded, though, that I tend to have trouble with "all" in the implied or colloquial sense in many areas of my life. This literalism has been a sticking point between me and my husband -- he says something like, "Americans believe blah-blah-blah," and even if it is generally true, I perseverate on insisting that this is not "all" Americans. We've come to joke about it between us, but it has been a definite issue in the past.
It seems to be more than a pet peeve, as I don't seem to be able to get past it. I know for sure it is a clanging bell in my mind even in cases where that literal a meaning of the phrase is not intended by the speaker.
I'm sorry about this, Stephen. perhaps it is just me. Could you indulge me as a friend by using "many," "most," or "nearly all" (but just in those cases where it is indeed appropriate, that is) and I'll find something nice to do as a thank you back? Posts: 2919 | Registered: Aug 2004
| IP: Logged |
I'd forgotten about Dundon. He contacted me a couple years ago asking thoughts from both me and Diane on his own thinking about the case. But it still comes as too little too late, frankly.
Wesley is kind of a special case. I've known him for about 8 or 9 years. But, while they were still posting, mainstream bioethicists on an email list I'm on were pretty clear as viewing Wesley as an outsider - a "spoiler," even.
My point, not made clearly, is that if colleagues of Cranford's are truly alarmed or object to his advocacy, then they have to be as public as he is or that opposition is nonexistent, for all practical purposes. It's weird - futility policies seem to have taken the quiet, backdoor approach. OTOH, the issues around ending the lives of people with cognitive disabilities are being handled through a very public discourse - with people like Jon Eisenberg, Peter Singer, Ron Cranford and others working to shape public perceptions.
I don't know what to say to you. I type on the fly not always taking the time to type every thought perfectly. If I had to do that, I'd probably be unable to post about my work stuff here any more, except for cutting and pasting things I've already written. That gets deadly dull.
I don't know how much I'll be on for the next week or two anyway. I have to leave town for a workshop on Saturday and I'll be gone for a week. Don't know how much time I'll have while I'm there. And I have a lot of stuff to get ready right now.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
posted
Sara is *that* why I butt heads with your husband? It suddenly makes sense! (And I mean butting heads in the nicest sense because I enjoy a good discussion, but now I see where the disagreements probably often originate.)
I'll try to post something later. Your last reply came in while I was typing. My office computer is crashed and I need to completely reformat the hard drive, which I don't have time for right now.
So for the past few days I've been having to type from a public room in the office, people going in and out - right now there's a radio going. All very distracting and not very pleasant when I'm already sleep-deprived.
I think maybe I better avoid posting until this situation gets better.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
quote:Wesley is kind of a special case. I've known him for about 8 or 9 years. But, while they were still posting, mainstream bioethicists on an email list I'm on were pretty clear as viewing Wesley as an outsider - a "spoiler," even.
I'm coming to realize that I might understand you much better if I knew what sort of person you'd qualify as a bioethicist (who counts? what qualifies one as a bioethicist?) and what you mean to include in referring to "mainstream bioethics" (what characteristics make for "mainstream" as opposed to "fringe" or "outsider"? Is it having a degree of some sort, or being well-published in the field, or being affiliated with a university, or being covered in popular media, or some mix?)?
I promise, I don't have any intent to critique the criteria. I think the semantics may get in the way of understanding, and I'd like to understand you better.
quote:I don't know what to say to you. I type on the fly not always taking the time to type every thought perfectly. If I had to do that, I'd probably be unable to post about my work stuff here any more, except for cutting and pasting things I've already written. That gets deadly dull.
Yeah, I get that. I guess my plea would be to remember me as a fellow Hatrack eye when you speak about physicians or ethicists as a whole. Like I said, just a "many" or a "most" (or even an "it seems") when you speak about the whole bunch of them together would set my heart a'flutterin.'
quote:I don't know how much I'll be on for the next week or two anyway. I have to leave town for a workshop on Saturday and I'll be gone for a week. Don't know how much time I'll have while I'm there. And I have a lot of stuff to get ready right now.
I hear you. I think I've likely made this venue uncomfortable for you, though, and that wasn't my intent, although it is a logical consequence of witchy whining about my feelings in public like this. Looking back, if I wanted to be effective and respectful, this should have been dealt with over email instead at a public forum, with a great deal more good humor and less self-indulgence, and in a short "hey, could you do this" format rather than beating it into the ground in agonizing detail.
I think it's called "social skills." I promise to work on it. Really, I will, and I'll be creative about addressing the issues in myself.
quote:Sara is *that* why I butt heads with your husband? It suddenly makes sense! (And I mean butting heads in the nicest sense because I enjoy a good discussion, but now I see where the disagreements probably often originate.)
AJ, I have no idea. I'm guessing you mean over at GreNME, where I'm not following things carefully, or really following at all lately. It might well be that you and he get stuck at an impasse if you have the same perseveration over categoricals that I do. Dave calls it "seeing the leaf instead of the tree." I, on the other hand, can't make sense of a categorical that isn't true for all members of the group.
Once when I was about four, my mother assigned me the aftenoon chore of "picking up all the sticks in the yard so that your brother can mow tomorrow." [actually, I might have told this story here before -- can't remember. But it's illustrative.] Although intially happy about the task, I ended up at sundown sitting in the grass and crying. I'd cleared all the sticks and twigs and little tiny dried hard bits of grass from around me in a few yards' width circle, but I'd run out of time with most of the yard left. I panicked and stressed out because no one could have picked up all the sticks in the whole yard, but I felt like I was supposed to and failed.
Actually, that's developmentally appropriate literalism for a four-year old. It isn't developmentally appropriate for a thirty-four-year-old, but -- even though I work around it -- looks like I'm still stuck in the same place. There is definitely a strong personal component to this for me.
quote:So for the past few days I've been having to type from a public room in the office, people going in and out - right now there's a radio going. All very distracting and not very pleasant when I'm already sleep-deprived.
Sounds quite nightmarish, I'm sure even moreso than you have conveyed.
quote:I think maybe I better avoid posting until this situation gets better.
Well, consider Hatrack a free space now, should it be helpful. I'll go and work on my own issues for awhile, staying witht he fluff til I get my head back in order. Plenty of real work stuff to do for the serious side.
Take care, Stephen.
Posts: 2919 | Registered: Aug 2004
| IP: Logged |
posted
See, underneath everything right now is a very real personal rage I am trying to deal with.
When this study starts, I will have to deal with the daily reminder of the power that Loyola, the FDA and a handful of bioethicists who helped make it all happen now have over my life.
Don't know if anyone who has met me ftf noticed, but I don't wear anything in the way of jewelry - no ring, nothing on my neck, no even a wristwatch. I don't like wearing nonclothing items.
This will feel very much like a slave bracelet.
I deal with emotionally powered issues on a daily basis, but I usually maintain a comfortable distance from them.
That's not working for me right now. And I know I need to cultivate some distance emotionally to figure out a constructive response that will cause discomfort and embarrassment to the offending parties.
That probably explains a lot of my tone right now. This particular issue isn't something I deal with, since you can't fight every battle you believe in. But this is me and my backyard, so now I have to put up or shut up.
Shutting up is not an option.
But I also need to get a grip.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
posted
Stephen, I know what you mean about the bracelets. Earlier in the thread, when people were saying they would volunteer for an opt-in study I thought, “I would too, but not if it involved wearing something on my wrist.” I just don’t think I could do it.
Posts: 9866 | Registered: Apr 2002
| IP: Logged |
posted
sndrake, I'm going to try to express what I'm getting from you here. I may or may not do a good job.
It seems to me that your objection to this issue is part of a wider objection to the actions of people who are considered medical authorities. These people have in other instances shown that not only can't they be trusted to operate in good faith but that, in terms of at least your community, they aren't even aware of what would be involved in good faith (i.e. They say these people are like this, when the reality is very different.) Because of their authority, they have been able to act very irresponsibly in specific cases and influence the general thinking of our society towards a prejudiced view. They have power to subject people to things that these people don't necessarily want and they have shown that they often use this power inappropriately.
In this case, the high-handed way the researchers have gone about this, the lack of genuine efforts to present and test their ideas with the public, and their negligence in responding to you have led you to believe that these people are not at all concerned about doing things to you that you don't want, which confirms your suspicions that people should almost never be allowed to perform experiements on other people without their consent. Since this affects you personally and because these people are an outgrowth of those people in authority who have treated you and others like as less than human and try to convince the public at large that this is the right way to handle your community, it provokes a lot of understandable anger.
Is that more or less accurate?
Posts: 10177 | Registered: Apr 2001
| IP: Logged |
posted
Very interesting thread. I had no idea non-consent experimentaion was even legal in the US anymore, though I can see how trauma treatment presents special problems.
quote: Don't know if anyone who has met me ftf noticed, but I don't wear anything in the way of jewelry - no ring, nothing on my neck, no even a wristwatch. I don't like wearing nonclothing items.
Shutting up is not an option.
sndrake. I'm with you here, Steve: I almost never wear jewelry as well. It would bug me immensely to wear that just to keep out of an experiment. I am afraid to check if similar experiments ar underway in Atlanta.
As far as shutting up, keep on fighting for what you believe in, Steve, here at hatrack and elsewhere. You have changed some of my views on euthanasia, and I'm sure you have had an wider impact as well. Keep up the good work!
Posts: 6316 | Registered: Jun 2003
| IP: Logged |
quote: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.
I was trying to avoid a direct slam on medical research in general here, but you've left me in a position where I feel I need to point out a few things:
1) My undergraduate degree is in Psychobiology. I read a great deal of medical research and know a bit about methodological flaws.
2) I am a scientist practicing in a field with flawed data sources and necessary reliance on quasi-experimental designs in naturalistic studies. And I'm considered one of the best methodologists in that field by people who don't already hate me for criticising them. Though it is NOT medical research, it is public safety research and the two are closely allied -- we share journal space on some issues.
3) What happens A LOT in medical and other areas of research when we get into naturalistic environments is an approach that Sara alluded to -- doing the best we can. That's okay except when it ISN'T. What we are often doing is the best we can given the research budget and time frame. That's a completely different animal than "the best we can."
Case in point: There's a potential that this treatment is dangerous. SUre, maybe not much of one, but some chance. The ideal would be to go slowly and use it on as few people as possible in the process of proving its basic safety.
Stratification of samples is a way of reducing the required number of subjects. Post-hoc analysis does not do this. Reliance on post-hoc analysis leads to researchers "hedging their bets" by requiring larger Ns.
You might wish to argue that a larger N is by default a better proof of the stuff's safety. Not so! IF crucial contraindicating conditions are not discovered or tested because they didn't show up in the treatment/control populations in sufficient numbers to be testable, you can't use the post-hoc analytic method to find them.
It's possible that people might worry about this after the fact, but I suspect that worrying and doing something about it are two different things once the research budget is expended and the trial period is over.
Is this sounding at all familiar?
Do I need to continue?
I'm not a medical researcher, granted. But I suspect that the techniques of naturalistic studies in medicine cause some serious concern for those who worry about reliability and prediction of rare but serious side effects/contraindicating conditions even within the medical research community.
I'm being simplistic and basic right now because I haven't gotten my copy of the methods section from the research proposal.
I'll be more specific if and when I can be.
Posts: 22497 | Registered: Sep 2000
| IP: Logged |
posted
Bob, I wasn't trying to get into a pissing match here (edit: not that you were/are either. I'm just trying to say that I wasn't trying to disagree with your credentials or authority, both of which are greater than mine). I don't really know much at all about the statistical methodologies used in medical research, but I do know about those used in psych research and about methodology in general. The problems you brought up seem to be very basic to me. Perhaps they aren't actually recognized in medical research of this type, but I would be greatly suprised and discomfitted by this. As I said, I have no atual evidence that they are recognized, so, if you do look it up, I'd be interested in seeing what is said.
posted
Reply from Loyola (anyone want to translate this?)
quote:We have not had any community meetings in Forest Park yet. We have been in the towns of Hillside, Northlake, and Berwyn. They will be the first to enroll patients along with Loyola's Lifestar. We will be starting this study on November 1st 2004. Request for bracelets can be directed to this email address. The bracelets are plastic. Length of study is not known. Please provide name, address and number of bracelets required with request. Thanks, (Name deleted) Clinical Research Nurse
OK - there are a number of possible interpretations here. One is that the study will only start in the three towns named on November 1, along with "Lifestar" (?). Forest Park will be "enrolled" (gotta love the language) only after a community forum is held.
OR it could be that it's starting and there will be no community forum until after the study has already begun.
One thing is clear - there were no forums *before* the decided to do the study. I wonder if they have a list of how many information sessions they held before approving the study.
Ya know, these studies almost depend on the ignorance of the population. The kinds of trauma they're looking at aren't that frequent. The best way to make sure that they have full access to as many qualified "enrollees" as possible is to have people ignorant. They know the numbers who would wear bracelets to volunteer would never be sufficient to meet their needs.
(This isn't helping my anger issues, btw. And I don't even have a "happy place" to retreat to. )
btw, in the interests of preserving relationships, I took a golden opportunity to turn some of this hostile energy toward a listserv I'm on that's heavily populated with psychologists in the dev. disabilities field. Kinda stomped on one of the psychologists, but he was stomping on a woman with autism who says things annoying to applied behavior specialists.
quote:Bob, I wasn't trying to get into a pissing match here (edit: not that you were/are either. I'm just trying to say that I wasn't trying to disagree with your credentials or authority, both of which are greater than mine). I don't really know much at all about the statistical methodologies used in medical research, but I do know about those used in psych research and about methodology in general. The problems you brought up seem to be very basic to me. Perhaps they aren't actually recognized in medical research of this type, but I would be greatly suprised and discomfitted by this. As I said, I have no atual evidence that they are recognized, so, if you do look it up, I'd be interested in seeing what is said.
MrSquicky, you'd be surprised how often the basic principles are violated. Even in Psych experiments. But, as I said, I'm keeping my comments basic because I don't have a copy of their methodology.
The design as I understand it so far simply cannot be a double blind study. In such a case it is flat impossible to control for selection bias unless you have a strict "no discretion" policy for assigning people to treatment and control. I personally can't imagine any medical director of pre-hospital care signing off on taking away the discretion of the paramedics who are dealing with the patient in the field.
Hence, selection bias.
I don't think the study design can deal with this.
I'm reserving judgement, though, because I don't have the methods section yet.
Maybe they are more clever than I am and have come up with the perfect way to ensure random assignment and overcome the need to allow paramedics to make medical decisions in the field, or rather accounted for that in the way that they will collect and analyze the data.
I'll be very surprised if they have figured that out, but I'll be the first to come back here and say how much I admire them if they convince me.
By the way, no worries, I really don't want to compare credentials. It's just that you seemed to be implying that I was coming at this from an uninformed perspective. I prefer to think of it as coming at these things from "first principles." That's where I've seen the screw ups most frequently in my own field. People who know how to make a stats package sing, but don't remember what the conditions are for applying it, or that the data have to be collected in appropriate ways in the first place.
As you say, they've probably thought of it. I hope so.
Posts: 22497 | Registered: Sep 2000
| IP: Logged |
Hillside goes to Gottlieb, Berwyn goes to MacNeal. Not sure which hosp serves Northlake. Their selection of communities makes no sense to me.... unless perhaps we're looking at transfers from those other hospitals TO Loyola (or direct via Lifestar because of urgency) because of a patient's specific needs (i.e. burn unit).
Posts: 4515 | Registered: Jul 2004
| IP: Logged |
By LINDSEY TANNER AP Medical Writer Published November 4, 2004, 7:09 AM CST
CHICAGO -- Loyola University Medical Center has joined a nationwide study of a potentially revolutionary artificial blood product that's being tested in trauma patients without prior consent, authorities said Wednesday.
Doctors say the product called Polyheme could transform trauma care if it saves lives by quickly replacing blood loss at the scene or en route to the hospital.
After months of preparation, including efforts to give local residents a chance to refuse participation, Loyola began the study Monday by equipping its medical helicopter with Polyheme. Hospital spokesman Stephen Davidow said in coming weeks Polyheme will be used in as many as six ambulances in three Chicago suburbs.
Because trauma patients often are unconscious or in shock, they are unable to give the consent required for experimental treatment. As a result, the Polyheme researchers are being allowed to bypass the consent rules under a 1996 federal exemption that applies to emergency, potentially lifesaving research.
Polyheme's maker, Northfield Laboratories, is the second Illinois company to test a blood substitute without obtaining prior patient consent. The first, Baxter Laboratories, halted research on its own artificial blood in 1998 after the deaths of more than 20 patients who received the product.
While there's evidence that Polyheme can be safely used in hospital patients, the study is "bringing it closer to the time of insult and injury by testing it in the field," said co-researcher Dr. Mark Cichon, director of Loyola's emergency medical services. He said there hasn't been a similar advance since World War I research on saline fluids that are now standard procedure for trauma victims.
"If the study proves that this is a safe product, it will in some ways revolutionize what we are doing for trauma patients," Cichon said.
Ambulances do not carry human blood, which has a short shelf life. Instead, patients get an intravenous saline solution to restore fluid volume and blood pressure. But unlike blood, the fluid does not contain tissue-nourishing oxygen, so patients risk organ damage.
Polyheme has that blood-like ability and is made by extracting oxygen-carrying hemoglobin from human red blood cells. It can be used in patients with any blood type and lasts longer than blood.
Loyola hopes to test Polyheme on about 20 patients, and results will be compared with 20 patients given saline fluids, Cichon said.
Davidow said as of Wednesday, no patients had been tested because none had met the study qualifications.
Criteria include severe blood loss, and participants must be older than 18. People excluded include pregnant women, people with severe brain injuries and those who require cardiopulmonary resuscitation to maintain their heartbeat.
More than 700 patients nationwide are expected to participate in Polyheme research at more than 20 centers. Loyola is the 16th center to join and the only hospital in Illinois involved, according to a Northfield spokesperson.
posted
The articles says the drug was widely used in Africa. Wonder how many uneducated African women died so we could find out multiple doses could cause fatal liver damage.
This is just sick.
Posts: 2283 | Registered: Dec 2003
| IP: Logged |
posted
How do you think we find out the side effects of drugs and which ones actually work?
This was a medical error. Her doctors should have been monitoring her liver enzymes more dilligently. It's not clear if the protocol for the study had an instruction for monitoring and standards for dealing with and adverse liver event, but the presence of the liver problems in the disclaimer make me think it did.
Yes, this is a tragedy. Yes, this woman is likely dead because someone screwed up. No, this isn't an indictment of the clinical trial process as a whole.
quote:Yes, this is a tragedy. Yes, this woman is likely dead because someone screwed up. No, this isn't an indictment of the clinical trial process as a whole.
Yeah, but it's one more piece of evidence pointing to a system that could do with a lot more oversight and accountability. The issue of informed consent raises its head here, as well as the more obvious routine medical competency questions.
I didn't post anything about it (at least I can't find anything), but there's been some press coverage devoted to the way in which universities have abandoned ethics in their research contracts with pharmaceutical companies. The pharmaceutical companies, as part of the contract, have the right to prevent publication and sharing of data - and they exercise that option regularly for research findings that aren't what they're wanting to find.
These contracts played a role in the delayed findings of potential dangers in Vioxx and in the use of some anti-depressants in children.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
posted
Wow, what a great discussion! I'm sorry I didn't follow this thread all along.
As for this particular study, the main reason I would opt out is that once you get to the hospital where whole blood is available, they continue treatment with polyheme anyway. That's very wrong, in my view. I would certainly opt out for that reason.
As for the informed consent question, it hinges on trusting them to work against their own interests by publicizing the study as widely as possible and making the process of opting out as easy as possible, which clearly we can't trust them to do. The task of mailing out bracelets will clearly be given last priority behind every other task. I wonder if they even have the bracelets made yet, and how many they made up?
Posts: 6246 | Registered: Aug 2004
| IP: Logged |
posted
The issue of trusting medical professionals in general is also an interesting one, to me. Obviously many doctors like Sara, and my doctors Joey and Bob, are awesome and excellent. But from working at a hospital for a number of years, and from my 2 year experience with my father's illness and death, and other experiences, I've come to know that you MUST take ownership yourself of your own treatment. It's not a failing of any individual, but rather the system as a whole. There is just not any way that a huge system such as a hospital can care individually about a single patient in the way that you care about your own father. And they will not be straight with you about mistakes they make.
My father had a reaction to heparin. It was causing coaggulation all over his body. They ignored the signs of this. Fever spikes to 107 were dismissed as post surgery fever. Or the machine not reading right. His increasing difficulty in breathing from blood clots in his lungs was called ARD, Adult Respiratory Dysfunction (basically means the patient can't breathe for unknown reasons). His O2 saturation was in the 80s and the resident on duty said to keep him from getting so much oxygen, that "80s, 90s, it's not that different" (which caused Dr. Bob to say he needed to go back to med school.) The night of my father's surgery he was alert and strong, and in the next two weeks he declined rapidly, and nearly died. We managed to save him when we insisted on them consulting a medical pulmonary specialist. I had to threaten with lawyers and so on to make them do it. They still were not going to do it. Finally I got a friend who was a retired surgeon at that hospital to talk to the resident, and then he agreed to call in the consulting doc. The consulting doc immediately diagnosed the problem and saved my father's life.
Oh wow, I need to post this whole story someday. There's so much more. It needs to be written down. One CPU nurse nearly killed my father of a morphine overdose on Thanksgiving day when she didn't want to be disturbed by restive patients. She wrote "morphine" on the chart 4 or 5 times, but didn't write the dose she gave. When I pointed out that his blood pressure was reading 30, she said the machine wasn't reading right. If this were a rare thing it might be of little concern. But it's not rare. Something is wrong that needs to be fixed. Hospitals are being stressed to the breaking point by all the changes in the payment system over the past 20 years.
Here are some of the huge red flags I saw that were systemwide.
1) Whenever a measurement machine gave alarming data, they dismissed it as a faulty reading. Even when the data was consistent with other signs and symptoms. 107 fever, for instance. 85 oxygen saturation. 30 blood pressure. They would take the reading 10 times, and if 9 readings were alarming but 1 looked a bit better, they'd write down the least alarming number. (You'd better believe that 30 blood pressure never made it onto my father's chart.)
2) They ordered so many tests and never looked at the results unless and until I asked them what the result had been and what it indicated to them. I've found this to be true even in good doctor's offices. They order tests and then they never look at the results until I ask.
3) The doctor in charge of the case, when things were stabilized finally and gradually improving, got rotated out. To me this is a huge problem! If the project engineer on a project gets changed midstream it throws the whole project into confusion and delays. The arguments that claim one doctor can just pick up and carry on for another are exceedingly weak! I don't know how to fix this but it MUST BE FIXED!
posted
The situation that happened here is exactly the kind of situation that can occur whenever a drug with potentially bad side effects is administered. The fact that this was a clinical trial added nothing to the mix:
1.) The drug was known to cause liver problems. 2.) The doctor failed to either adequately test or to adequately respond to the test results. 3.) The drug-induced liver problems killed the patient.
Nothing in this series of events depends on this being a clinical trial. There are many approved drugs with potential liver effects. I've taken several, and been stuck monthly to test for the problems.
In fact, had this drug already been on the market, it's likely the woman's family would never know about this. Because it was a clinical trial, the adverse event was reported to NIH, which is the source of the information.
This death was caused by breakdowns in the way medicine was practiced in this case, not by the way clinical trials are administered.
Edit: To be clear, I'm not saying there aren't problems with the clinical trial system. I am saying the death in this incident was not caused by any risk present in clinical trials that is not present in standard medical practice.
posted
As for what I would recommend a patient do, it is this.
1) Don't even go to the hospital unless the thing you have is life threatening. There is a fair chance (not miniscule by any means) that they will kill you in the hospital. So just don't go there, never have surgery, unless what you have already is life threatening and worth the risk.
2) Never leave a loved one who is sick or incapacitated alone in the hospital without someone who loves them looking out for them. If the nurse comes in and calls them by the wrong name, for instance, they could correct that mistake before a wrong drug was given.
3) Check the labels on all medicines and IV bags to be sure they are actually for the right patient. Know what treatment the patient is supposed to get, understand the reason for each medicine and procedure and what is expected to be accomplished.
4) Know what tests are ordered and why, and what we expect to learn from them. Check back and ask about the results and what we discovered or ruled out. Ask all these things. Good caregivers love for the patient and family to be involved and interested. Those who are less good prefer that there be no questions asked.
5) Know what all the machines are, what the readings mean, and how they are supposed to read. Nurses are all overworked. Help them out whenever you can by monitoring the patient's condition more frequently than they can. You improve the level of care greatly this way, while easing the burden on the nurses.
6) Read and study online about the patient's condition, the treatment options, all the drugs being given, etc. Check drugs for interactions. Read the side effects of drugs. Often a question like, "We're seeing x symptom. Might this be a side effect of y drug?" could trigger a doctor to make an association that might otherwise be missed.
Diagnosis is extremely tricky. Doctors have dozens of patients at any one time. You just have the one. Obviously you have more time to ponder and observe and figure out what is going on, though of course they have much more knowledge and experience. If you work together you can pool your time with their knowledge and improve the level of care that the patient receives.
Good doctors, though always pressed for time, are delighted when people take so much interest.
Posts: 6246 | Registered: Aug 2004
| IP: Logged |
posted
While I'm going off on a tangent about medical and hospital care, I want to talk about hospice as well.
The hospice people were great but the whole focus of the hospice system alarmed me because they were all about "how can we kill this patient as quickly as possible?" It was just weird, when I asked if he didn't need fluids they gave me a brochure about how death of dehydration is so much more pleasant than other deaths. If I could have gotten him to drink and swallow, in those first couple of days, he might have revived. Partly the problem was that his morphine was oral drops, and I think it deadened his throat muscles so they wouldn't work.
Of course, by that point he was going to die of the cancer in his liver eventually anyway, but the doctor from looking at the CAT scan thought he had a couple of more months on that.
So how do you decide? It seems to me that life is a terminal disease, and the fact that we're going to die eventually doesn't stop us from taking care of people.
The hospice people were great, and yet, they weren't wanting him to get better. They were wanting him to go as quickly and with as little trouble as possible. That didn't feel right to me in my guts. At one point my father asked my mother to call 911. She didn't. A few days later a much weaker father looked at me in desperation and said "Help, help help! Quick, quick, quick!" ... and I ... made soothing noises and did nothing. How was that a help?
I don't know what I think about hospice. Something about it felt very wrong to me.
Posts: 6246 | Registered: Aug 2004
| IP: Logged |
posted
I've had cases where I was having a bad reaction to a drug, reported it, and was dismissed. When I presented them with research I had done, it was still dismissed. I finally refused the medication, and (surprise!), the reaction went away. At that point, they implied that the reaction had been all in my head...
What I want to know is, if Polyheme is contraindicated in pregnant women, what steps are in place to make sure they don't get it? Are they going to track down every woman who is pregnant or may become pregnant, inform them of the risks, and provide them with an opt-out bracelet? Are they going to administer a pregnancy test before they give the treatment to any woman of childbearing age? Because you can't always tell by looking, and if the patient is unconscious and no one on the scene knows she's pregnant, how are they going to know?
quote: In a potential blow to the future of an Evanston-based biotech company, a clinical trial showed Tuesday that its key product, an experimental blood substitute, performed worse than standard treatments in patients who suffered traumatic injuries.
In a trial of 712 patients, Northfield Laboratories Inc. reported 13.2 percent of the 349 who had been given Northfield's product died, compared with deaths of 9.6 percent in the control group of 363 who received either saline solution in the ambulance or blood in the hospital.
"No matter how they slice it, it's a disaster," said Martin Shkreli, a hedge-fund manager at New York-based Elea Capital, which invests in health-care companies and sold its Northfield shares earlier this year. "If you look at the absolute number of deaths, it kills more patients than saline does."
Well, nice to know a hedge fund manager gets that this is a "disaster," but I guess it's a little too much to ask for some comment on the ethical implications of nonconsensual research in which more people died than in the "control" group.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
posted
Wow - I would think this would be opening them up to all kinds of legal backlash if the families of those who got the "substitute" knew about this. Or was it such a blind study that they have no way of knowing if their loved one was given the real blood or the blood substitute, and thus have no recourse?
quote:Or was it such a blind study that they have no way of knowing if their loved one was given the real blood or the blood substitute, and thus have no recourse?
I don't know the specifics, but I can almost guarantee there's a way to determine which patients got which blood.
Oh, and I'd be surprised if there aren't lawyers looking into this right now.
Posts: 26071 | Registered: Oct 2003
| IP: Logged |
posted
Just who are lawyers supposed to go after? This was all sanctioned by the FDA. The feds signed away these people's rights.
Good luck suing the feds for damages.
The policy allowing for this type of consent waiver should have been challenged long ago, but neither the self-proclaimed constitutional watchdogs at the ACLU or the ACLJ (roughly "left" and "right" wing counterparts) have gone anywhere near this issue.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
quote:Just who are lawyers supposed to go after? This was all sanctioned by the FDA. The feds signed away these people's rights.
FDA approval is not a protection from many torts. And, of course, if their submission to FDA was at all inaccurate, the lawyers will start to get some real leverage.
The lawsuit will not be about any constitutional violations but about battery, product liability, and negligence.
Which means it will have no real precedential value for rights. But a big verdict could stop this kind of thing just as effectively.
Posts: 26071 | Registered: Oct 2003
| IP: Logged |
Gould hopes the FDA will review Northfield's data carefully, considering that the trial was complicated and involved a complex group of patients who had suffered traumatic injuries that were treated by emergency workers under intense pressure at accident scenes or while being transported by ambulance.
"This was a logistically complex study with many variables and a high incidence of protocol violations," Gould said. "We believe that there is an unmet medical need for a hemogloblin-based, oxygen-carrying red-blood-cell substitute, and that Polyheme is that product."
Okaaay...Let me get this straight. Gould wants the FDA to understand and make exceptions for this product because it was used in emergency settings where protocol violations may have happened? The very same settings that Northfield chose and actively sought? Is one to believe that Northfield didn't already know, and accepted, the fact that protocol violations would inevitably happen given that they occur in "controlled" settings as well? Actually, I'm quite curious as to what these protocol violations might have been since this 3.6% difference between the experimental group versus control shows a marked 'inferiority'. (Northfield promised the FDA a 3.8% increase in lives saved in the experiemental group as the FDA required that to show superiority. I would say this is ironic, except that people died because of this.)
Posts: 32 | Registered: Aug 2006
| IP: Logged |
quote:Originally posted by Anshi: Is one to believe that Northfield didn't already know, and accepted, the fact that protocol violations would inevitably happen given that they occur in "controlled" settings as well?
Protocol violations are a different matter if one is talking about experimental conditions as opposed to working with known and tested entities. The results are different, the reasons are different -- it really is a matter of apples and oranges. I can probably explain this better (if you are interested) if you explain first what it is about the protocol violations (experimental or controlled) that bothers you.
quote:Actually, I'm quite curious as to what these protocol violations might have been since this 3.6% difference between the experimental group versus control shows a marked 'inferiority'. (Northfield promised the FDA a 3.8% increase in lives saved in the experiemental group as the FDA required that to show superiority. I would say this is ironic, except that people died because of this.)
I do not know the specifics. I can identify a potential situation where these results would be skewed because of systematic protocol violations in the study -- skewed enough to make the treatment look like it is more harmful than saline when it really isn't.
The reports state that the company claims they identified approximately 20% of the sample suffered from protocol violations. These were not specified in the news articles I've seen, which means the violations could have biased the experimental group or the control group, or (most likely) some mix of the two.
For example, if the decision-makers involved were believers in the superiority of the experimental substance, then it is possible that (if they could determine which was which) they would have steered the most fragile patients towards that treatment. Sicker and more deathly ill people in the experimental group --> unequal distribution of risk --> experimental substance appears to be less effective, because the group it was used on is sicker overall to begin with.
That's more than enough possibility to cover a 7% skew.
Alternatively, the random allocation might not have resulted in balanced groups, even if the protocol was followed exactly. Until we have the summary analysis of group variances (a necessity before any randomized controlled trial can be analyzed at all), we just don't know. Again, more than enough possibility to cover a 7% skew.
---
Mind you, it's entirely possible that this blood substitute does work less effectively than saline. I just can't for the life of me see how this conclusion is justified by any of the information we have so far, and I'm puzzled that this conclusion is being drawn so readily.
posted
I had a discussion with my pharmtech sister in law last night about this stuff. She told me that the hospital she works at opted out of the study when they were "advised" that any patient given Polyheme instead of lactated ringers in the field were required to STAY on Polyheme for a minimum of 24 hours before bing given whole blood, regardless of treatments given. If the patient has to go into surgery, they do so under Polyheme and not whole blood. She also said that Polyheme doesn't have the clotting abilities needed (at least I think that's what she said), and that this difference alone might account for the increase in deaths.
Posts: 4515 | Registered: Jul 2004
| IP: Logged |
It might well be. Might. There really is no telling, though, given what has been released so far. Cause for concern to look further? Yes. Might be bad? Yes. Might be entirely misleading? Equally yes.
Posts: 14017 | Registered: May 2000
| IP: Logged |
Thanks for adding a bit of detail. I hope we hear more about this.
I personally would be surprised if there isn't a lawsuit over this, even though the FDA approved the non-consent protocol. If there were "protocol violations," then the EMS providers & crews and the ED staff are going to be in deep doo even if the manufacturer and hospital are in the clear regarding the lack of prior consent. Seems like the manufacturer might also be implicated if their experimental protocol was too hard to follow.
This just sounds like it could get very ugly.
Of course, maybe this might convince health care providers to henceforth shy away from participating in studies where consent is waived.
Posts: 22497 | Registered: Sep 2000
| IP: Logged |
posted
Bob, I note that you foreshadowed this issue above.
quote:Originally posted by Bob_Scopatz: The design as I understand it so far simply cannot be a double blind study. In such a case it is flat impossible to control for selection bias unless you have a strict "no discretion" policy for assigning people to treatment and control. I personally can't imagine any medical director of pre-hospital care signing off on taking away the discretion of the paramedics who are dealing with the patient in the field.
Hence, selection bias.
I don't think the study design can deal with this.
I'm reserving judgement, though, because I don't have the methods section yet.
posted
Just for clarification, my commentary on the lawsuit potential is pretty much unrelated to the scientific analysis - which is a sad commentary on my profession.
When the powerline scare was in full swing, and the studies started pointing toward more strongly to the "no effect on cancer" conclusion, the tort theory was that fear of the powerlines - justified or not - was lowering property values. The idea was then that all the studies would be admissible regardless of the Daubert gatekeeping function that empowers federal district judges to exclude junk science, because it was knowledge of the studies that led to the harm.
Fortunately that didn't happen here. But the connection between causation in a scientific sense and causation in a legal sense is, sadly, often tenuous.
Posts: 26071 | Registered: Oct 2003
| IP: Logged |
posted
Since this isn't the first such study involving a blood substitute and a consent waiver that resulted in an unexpectedly high death rate, it's possible to extrapolate from the past here.
There are *no* lawsuits from the prior study, as far as I know.
I suspect it would be difficult to find all the "subjects" and a judge that would allow them to sue as a group. One trouble, I imagine, is that most of the people who died in the study, would have died no matter what kind of treatment they received. How do you prove just who died as a result of the specific experimental treatment?
Here's an article an editor put together put together from editing some of my email to a listserv - and this was before any of the mainstream media had connected the dots between the discontinued blood substitute study and its special status as one that involved a waiver of informed consent. (Chicago Trib reporter Jeremy Manier broke the connection in the mainstream media after I called him linking the two items - but he never acknowledged my role in print.):
quote:Easing of FDA rules may have led to deaths Media hasn't put 2 and 2 together, says Steve Drake
Last April 1, an Associated Press article that was not a joke began, "A pharmaceutical company abruptly halted its study of a blood substitute in U.S. emergency room patients after discovering they were dying at a higher rate than expected."
"This news was of interest to me because of another story, from November 5, 1996," says Steve Drake of Not Dead Yet. On that day, the New York Times's Gina Kolata had reported on the U.S. Food and Drug Administration's easing of requirements that informed consent be obtained for enrollment in trials of experimental medical procedures.
"For the first time in a half century, new federal regulations allow investigators to enroll patients in some medical research studies without their consent," wrote Kolata. "The Food and Drug Administration regulations, which took effect on Friday, apply only in carefully circumscribed situations. The patients must have a life-threatening condition, like a severe head injury, and must be unable to say whether they want to be part of a study. They would be selected only if it was not feasible to obtain consent from a relative."
"TV coverage of this FDA change at the time indicated that experimental use of artificial blood would be one of the first applications of this rollback of the Nuremberg Code," said Drake. In her article, Kolata explains that this Code "dates back to the Nuremberg trials of Nazi doctors after World War II, when American judges were agonizing over rules that might prevent doctors from ever again using human subjects in horrendous experiments.
"The judges wrote a code of ethics, the Nuremberg Code, whose first principle was that no one should ever be forced to take part in a medical experiment," wrote Kolata.
"The voluntary consent of the human subject is essential," says the Nuremburg Code.
"The leader of the group of bioethicists who quietly lobbied and won the FDA changes," says Drake, "was Norman Fost, the first recipient of the funded chair at Princeton that Peter Singer will now hold." (See "Peter Singer appointment draws warning," D.R. Nation, September/ October). At the time of the FDA change, Fost was Director of the Center for Clinical Ethics at the University of Wisconsin.
"We are seeing a worldwide trend in the use of 'nonconsenting subjects,'"says Drake. "A few years ago, most of the European community signed onto a new set of research guidelines that allows incapacitated people (people with mental retardation, in 'persistent vegetative states' or in comas) to be 'enlisted' in research not of direct benefit to the subjects."
"No press coverage seems to have put the earlier story together with the April 1 news," says Drake, "but it seems highly likely that the people in the artificial blood experiment gone bad were 'enrolled' in this research project without their consent--and that a number of people may have died as a result of getting the artificial blood."
"Given that the subjects are now dead (and evidently do not have next of kin), it is unlikely there's worry of lawsuits regarding wrongful deaths in this scenario," says Drake. "Convenient, isnt it?
"Is there going to be a re-evaluation of the wisdom of this exception to the requirement of informed consent?" asks Drake. "Or is it still ethical, due to the fact that the press hasn't caught on and there will probably be little danger of litigation resulting from the deaths of unwitting participants?"
"One would think that the early termination of studies involving nonconsenting subjects would have been newsworthy--yet it received scant attention from the press," Drake continues. "No coverage of the discontinued study tied it to the FDA informed consent exemption."
"According to investigative reports from a couple of years ago, the FDA's own data indicate that about half the medical researchers they have monitored (after the fact) had significant problems in terms of documenting informed consent or giving enough information so that consent could be truly informed," Drake adds. "It seems we are giving further powers to a group that has a s____y track record of obeying already existing rules." (edited for PG Compliance)
To me, there is something worse than the fact that some patients will (unknowingly and with no choice in the matter) get blood substitute. It is that NO patients will get whole blood! I believe (and EMTs or similar can correct me if I am mistaken) that the standard of care in ambulances includes whole (O neg) blood. But because of this study, that will not be available to ANY patients.
[Addit: The web site says saline, not plasma, and claims this is standard for hemorrhagic shock. I will have to look more.]
EMT Standards of care vary widely by region. In certain isolated, rugged, rural environments, standards of care include more advanced life saving procedures for EMTs that would otherwise require Paramedics to do, such as blood transfusions and tracheotomies. Where I had my license in the northern California pacific region, I believe we could do saline only, but definetly NOT whole blood. Whole blood is probably not even carried by Paramedics in regions where lifeflight is available (most of California), or hospitals are relatively nearby. Some very remote regions may allow it, but supplies and storage would be a real logistical issue for any emergency vehicle.
Posts: 9912 | Registered: Nov 2005
| IP: Logged |
Printer-friendly view of this topic
![[Smile]](smile.gif)
![[Wink]](wink.gif)
![[Cry]](graemlins/cry.gif)
