Whatever you do Don’t go for your wallet. Never drive a new expensive car without wearing a really nice suit. Don’t, under any circumstances, drive in a white neighborhood after dark. You will now need 4 pieces of photo identification, two witnesses, an affidavit, and an accurate count of the number of bubbles in a bar of soap if you want to vote. Now if you want your vote counted, you’ll have to find someone other than Al Gore to defend your constitutional rights. You always hang your sack to the left. Boxers never briefs. Bid Whist over Bridge. Oh shit! Wait a minute, you’re in Maine. Fuck it - find the Somalis and lay low.

Welcome to the tribe,

X

Why do I need to hang my sack to the left?

I don't mean to say, in case this needs to be said, that I have the personal or the historical experience, here. Obviously.

But as far as being mere flesh to be used for whatever purposes Our Betters might have? Oh yes, indeed. An experience I suspect many will increasingly have.

No authoritarians were tortured in the writing of this post.

It's to provide balast. When you're strolling, or resting said "sack" on someone's neck or shoulder after a "most awesome" dunk (the kind where you hang and swing from the rim). Also, it's easier to grab on the left while standing, walking, talking shit, or just keeping the left hand warm on those cold winter nights while the right hand aimlessly surfs channels.

So, can I get a waiver on this one?

No authoritarians were tortured in the writing of this post.

But, you will need to figure out the bubbles thing. There will be a test later.

First of all, let me say that after puzzling through the preceding comments I do not want to ever hear any grumblings from the male caucus here when discussions of female anatomical matters take place.

But onto the main point of the experimental emergency medical fluid/blood substitute situation...I'm sorry, but of all the medical things going on today I can't say I find this the most objectionable. Yes it would be ideal to make this an "opt-in" scenario but dammit we are talking about emergencies here. By definition unexpected.

It's rather like saying everybody should have a living will, and a regular will for that matter, and have filled out an organ donor card and carry it on one's person at all times. Yeah, yeah, right, I'll get right on that chief...maybe next week? Hell, right now I got other things on my mind and what are the odds anyway? (Misc. other fatalistic remarks and moving away from the speaker on the Group W bench if he persists in nagging about the subject.)

The comparison to the obscenity that was the Tuskeegee Experiment seems entirely around the bend. That was a refusal to give treatment which was known to work. A complete dehumanization of the patient in the most literal sense, treating them as an experimental object like a test tube or Bunsen burner, to be used as needed and then discarded.

The project under discussion here is an increased amount of treatment, if anything. The most horrifying prospect to any EMT, with the possible exception of a massive burn, is uncontrolled bleeding. Ideally every ambulance would also be a rolling blood bank but we all know that isn't the case and isn't likely to be, with the supply of blood donors not only not growing but shrinking as additional whole categories of people are barred from donating.

(Yes some of those categories are stupid--the recent announcement that the policy of excluding gay men will be continued, despite the fact that ALL blood is screened for HIV and other STDs regardless of source, being a prime example--but that doesn't help our EMT with a guy who just went through a plate glass window or somesuch.)

If that patient is me, or my family member, and the choice is giving them this experimental substance versus watching them bleed out, to death or--worse IMHO--brain damage, then dammit, use the stuff. It may not work because the damage to the body was too severe. It may not work because the substance is flawed in some way, or there are some as yet unknown categories of people who will react badly to it. From the description given it sounds like the people getting it are most likely going to die anyway without it. It doesn't really look like that tough a choice to me.

Some percentage of people in any population will react badly to damn near anything. Vaccinations for example. This is a tragedy but it is not the result of Mengele-type heartless sadistic evil on the part of doctors. We do not advocate the abolition of vaccinations because of these few reactions, because the overall benefit to society as a whole is so great. That too took experimentation on humans and in the early days when ignorance was vast, some of the results were grim. We do what we can with what we have.

Get me universal healthcare first so the schmuck who went through the window can wake up and be happy he's alive, rather than drowning in despair because he and his family are going to be bankrupted by the cost of healing him. Then we can quibble about these other matters.

And about that bubble thing?....never mind Xeno, this is probably one of those Men's Mysteries which we of the XX persuasion are forbidden to know. :)

This is a surprise? I'm a biomedical scientist, and I have to tell you most people have no idea what MDs are doing to them. Or how much money they're making off of it.

Every off-label prescription encouraged by pharmaceutical companies is an experiment, and the results are simply noted in the anecdotal way of sales. No other criteria matters unless it effects sales.

No, xan, this is a really bad idea. But I'm with you on the universal healthcare. It's just the entire American Medical Association and the global pharmaceutical industries that are against us.

No Hell below us
Above us, only sky

I'm sorry but Xan is right and gets the official Voice of Reason stamp here.

How do you guys think that CPR was tested? This is exactly the same.

See the link for a long list of trials performed by EMS since 1974. Many of these things we now consider absolutely critical to meet the minimal standards of care in an emergency. I don't know how you guys think these things got figured out, but this is how.

http://www.nhtsa.dot.gov/people/injury/e...

Sure it would be nice to figure out a way for people to opt in or opt out, but it just isn't realistic.

The comparison to Tuskegee is nothing less than OBSCENE.

Off-label medicine uses are hardly new, absolutely unpreventable by any means I can think of, and morally defensible under the "well hell, ain't nothing else working on my symptom, what the hell else can we try that might possibly work?" situation. To continue the sometimes-vaccinations-hurt-or-kill-people analogy from above, once any pharmaceutical moves from the carefully controlled setting of the research study out into the wild ecosystem of the general public, there are going to be people for whom a given drug should work but doesn't, and others for whom a medicine designed for one problem works just great on something seemingly unrelated. Quirks of metabolic differences, misdiagnosis with the best of intentions (hey, even House has to go through at least 45 minutes of fuckups every week before he figures out what's really going on and he's the best there is, right?), failure to do just one more test (possibly because it's expensive and the patient's "insurance" or pocketbook fails to cover it) that would reveal the true problem....you know the possibilities better than I do.

This is one area in which (girds loins to make controversial statement) some of Newt Gingrich's proposed "healthcare reforms" make at least theoretical sense. (ouch, pain. I mean this in a very limited way, and must go wash my keyboard with lye after writing these words.)

If all these off-label uses of medicines, correlated with the patient's data on everything from symptoms to full DNA analysis and other test results, age, sex, racial background, environmental exposure history, etc etc etc, went into a database, statistical analysis would I suspect produce an explosion of new and useful information.

This drug works, or works best, in premenopausal women who have lived for at least 20 years in areas of high average rainfall and easy access to fresh ocean seafood, of which the patient is a frequent consumer. That drug is most likely to work in elderly men with a history of low sun exposure, heavy consumption of over the counter multivitamins, frequent aspirin use due to a history of headaches, and >10 lifetime sexual partners. This other drug works great in prepubescent children but becomes useless thereafter.

Etc. No one doctor, or even a Mayo Clinic sized treatment center, is going to see a large enough patient universe to make these correlations--but the data is out there in those big racks o'charts rotating on the wall of every doctor's office in the land.

My point being I guess that we both agree treatment without full consent is going on all the time. There was a story just a few days ago (I forget where of course) about just how finely-tuned the system Big Pharma has to push their latest shit has gotten: doctors will get letters asking why they are depriving their patients of the benefits of NeoFizzyOla(tm), of which they (BP's sales reps) have left ample quantities of free samples (a month's worth, for a drug that has to be taken for months/years/lifetime) and telling the patient to take generic aspirin instead. They know the doctor is doing this because they have databases tied to pharmacy sales.

A ban on that sort of datamining would be swell. A ban on TV--well, all media, but TV is the worst--advertising to the general public is long overdue. Some form of government encouragement, perhaps by tinkering with reimbursement rates, to get drug companies to come up with cures for diseases, not the lifestyle-enhancement, if-baldness-lasts-more-than-four-hours-call-your-doctor crap they are fixated on now, would seem doable.

I still don't see how you get consent for emergency treatments though. Lambert's opt-in system would be great for other situations but hopelessly cumbersome for situations in which survival has a ten minute window.

Any EMTs out there who can weigh in with greater expertise on the matter? I've had some good friends work in the field but have not done so myself. That, ew, blood 'n' needles thing, ick.

(I fear I am not the person you want around in a medical emergency; I am liable to freak out and start applying tourniquets, leeches, and similar devices which were state of the art circa 1862 but not held in such high regard today for some reason. :)

Repeating this quote:

“We will never know the best way to treat people unless we do this research. And the only way we can do this research, since the person is unconscious, is without consent,”

We've set up a whole international process and we're now training EMTs in applying the protocols for this.

So that's a process that's being put in place for research where "the only way you can do the research... is without informed content." Tell me how that doesn't treat the patient as "treating them as an experimental object like a test tube or Bunsen burner, to be used as needed and then discarded." Oh, because "it's for their own good?" Fine--when I'm conscious.

It isn't so much this study that bugs me, but the precedent it sets. What's the next study? You can bet they picked the one that was simplest and would cause the least outcry to get people trained in the protocols.

Re "opt in." Xan, I think you're misreading the nature of the study and the post.

I don't mind an EMT or a doctor using their best judgment in an emergency situation on my behalf, and I'm not demanding "opt in" in that situation. (Given the corrupting influence of Big Pharma, there are other issues here, but it's a separate thread.)

However, when an institution is doing a study, and treating me as a randomly selected experimental subject, hell yeah I'm demanding opt in. And what about the EMT? When the EMT is pushing the plunger, does the EMT really want to not do their for that patient? Or does the EMT want to start thinking of patients as subjects too?

As far as the comparison between Tuskegee being over the top: Fuck no. The common thread is lack of informed consent. Period. Or do think that medical establishments are so constituted that they will always do good without checks?

Er, any other recent processes you can think of where well-known ethical guidelines and protocols, developed internationally over many years, were abandoned because of an "emergency"?

As to the pragmatic aspects of carrying a card: I just don't agree it's hard. Death is just as unexpected as any other emergency. The hospital looks in the wallet, the card is there. If it's not, they don't harvest the corneas. And if there's no way to get informed consent, they shouldn't be doing the study. Or, er, have you heard the idea that "it will save lives" on other contexts that might make you less than trustful?

No authoritarians were tortured in the writing of this post.

You can avert your eyes, Xan, but the other question I was going to ask Xenophon was why he thought one hand would be enough?

No authoritarians were tortured in the writing of this post.

I have really big hands.

I rarely laugh out loud at a comment.... What a gift!

No authoritarians were tortured in the writing of this post.

Suppose that the case were different. Suppose that a new drug was approved for the market -- a substitute for some existing drug. A hospital might approach that skeptically -- they might say "Ok, this is less expensive.... it has FDA approval..... let's just double check for ourselves and give it to a randomly selected 10% of our patients for a few months. If the outcomes look good, we can make its use policy."

Would people object to that? or compare it to Tuskegee?

The only difference here is the particular set of regulatory badges given. To believe that that's all that important one must accept the regulatory process as reliably producing scientifically important results which, on its face and empirically, it does not (except in the grossest terms of a few narrow issues).

The simple fact is that the craft of medical practice, properly conducted, is continuous experimentation. Here we have practitioners who are being completely transparent about the particular experiments they are running by policy. If you feel threatened by this, shouldn't your main complaint be about the absense of consumer choice in providers, for most people?

To compare this thing to Tuskegee is obscene -- an insult to the Tuskegee victems. In the Tuskegee experiments, patients were actively deceived and known-needed treatments were deliberately withheld. In Tuskegee, patients were brutally assualted by their treating physicians who, additionally, violated their oaths by ordering treatments that it was known would cause harm. There is no comparison with Tuskegee.

-t

I don't know where you get information on how the real world works but this sort of thing happens all the time in the emergency treatment.

Several examples:

Standard treatment for any possibility of a neck injury was complete immobilization (collar, spine board, the whole bit) until spinal injury was ruled out. Work in Australia over the last couple of years is changing the protocol where instead of assuming a spinal and treating the patient accordingly the emergency personnel on scene instead do a risk assessment and only treat for a spinal injury if a threshold of risk is reached. The end result is that a few people that might have injuries due to a freak situation might slip through but the vast majority of people who didn't need immobilization are spared the discomfort and pain of up to several hours on a board. The effectiveness of this system was established by deliberately deciding not to board people that would have been done automatically.

The CPR standards have been changed: more chest compressions, less breathing. How do you think the effectiveness of the change in method was tested?

There are numerous examples. Virtually all procedures in emergency treatment were developed by testing on real, live people. If you feel so strongly about it, I suggest that you ensure that you, nor anyone in your family, be on the receiving end of CPR, artificial blood products, most first aid and a host of other life-savign measures.

Any EMTs out there who can weigh in with greater expertise on the matter?

I've done my time in an ambulance, and I can tell you this. Paramedics, EMTs, firefighters, and other emergency first responders routinely get updates on emergency medical treatment. Standards change, new techniques are spread around, comparisons of new ways with old ways are done all the time. How do people think that new improved methods arrive, divine inspiration? Hell no, it's usually trial and error while covered in blood. If we get a 1% increased survival rate, that's a major achievement.

The issue is that people are being experimented on without their consent. This one is tricky because there is no new drug it's just a change in protocols. Dextran and saline are already used it’s just that the mix is being changed. But, in the past, even experimentation with protocols was limited to people like soldiers or police officers. Those individuals who were in harm’s way and had previously signed a consent form. The majority of our medical innovations and treatment protocols for trauma have been worked out in combat where consent is not necessary. When the FDA scaled back its testing polices in the 90’s we really screwed the pooch. Much of which we are beginning to see now if the increase in drug recalls. It used to take ten years for a new drug to reach market now it’s less than two. Drugs are being tested in the open market. That is wrong. Treatment protocols should not be tested without consent, let alone drugs. It may happen all the time but it isn’t legal without consent. This is so dangerous it’s not funny. What happens next is a scenario like this – “well, lets give the poor person, nigger, spic, chink, gook, gang banger, illegal, the questionable treatment we’ll give the soccer mom the tried and true.” If they die, oh well, we know it doesn’t work.

The issue is not testing on "real, live people." That this level of distortion enters the discussion so soon is a tipoff to me that some people must have a real stake in this.

The issue is denying a random subset of helpless, unconscious people the treatment that their caregiver would determine is the best without their consent. Exactly like Tuskegee, for the commenter who thought the comparison was "obscene."

That sets about the rottenest precedent I can imagine. Whoever would have imagined that the right to informed consent would be taken away from those who need protection the most--the helpless and unconscious? Just amazing.

Oh, and for those who are saying "emergency! emergency!" -- can you think of any other examples where powers assumed in emergencies turned out to be vaster and of more far reaching implications than anyone imagined at the time?

We need to start considering the idea that Our Betters have one cast of mind, whereever they are to be found. Experimenting on the helpless is about as sick an aspect of the authoritarian mindset as I can see. So what if the implementation is in medicine? It's the same everywhere.

No authoritarians were tortured in the writing of this post.

Hi:

I found your link from the WaPo story blog links.

The story as it was reported was OK as far as it went. The problem is that the issues are far more complex and involved than what was included in the story.

In real life in the field (pre-hospital), the vast majority of resuscitation is done by using pre-set algorithms - a set of treatment instructions. In the hospital setting, physicians can - and do - make treatment adjustments based on their assessment and professional judgment.

The study is using an already accepted treatment alternative as the "experimental" component. Hypertonic solutions are standard IV solutions with a greater concentration of salts and sometimes of sugars. Even though IV bags look pretty much the same, their slat and sugar ingredients vary by concentration and type (there are sodium salts, potassium salts and magnesium salts, for instance which are commonly used for various therapeutic reasons).

The hypertonic solutions are used to try to draw excess fluid away from the heart, lungs and kidneys - where they tend to overload and cause organ failure and collapse.

Changing how long CPR is performed before shocking a heart in a lethal rhythm is already done in hospitals where a physician is running a code.

The difference in the studies is that patients would be assigned to either the standard or the hypertonic/extended CPR group - only if they met the clinical criteria.

No experimental drugs are being administered. No suspect treatments are involved.

The problem is in the consent. All of the patients who would be eligible will be unconscious at that time. In most cases, their ID will not be known. And in the few cases where it is known, there are often no close family members present. There are only between 4 to 6 minutes to resuscitate a stopped heart and get back brain function.

Trust me on this - I used to try to track family down as part of a former position in a trauma center.

It is essential that wherever possible, patients have full information and make informed choices and give informed consent.

But this case is more similar to that of an already dead person. Currently, only 5% of trauma patients in full cardiac and respiratory arrest survive with current treatment protocols. The change in the treatment has a high likelihood of improving the survival rates, and the risks are minimal.

I would invite you to read the post I wrote about this issues and read more about the studies at the trauma outcomes Consortium website. Then contact your nearest trauma center and speak to the trauma director. Get involved and get educated about the specifics.

Make a fully informed decision.

Sorry to say Lambert you make little sense here.

As was pointed out more eloquently by others here, every time a doctor treats a patient in an emergency situation it is an "experiment" since nothing exactly like that has ever happened before or will again. Despite this, we as MDs need to have "evidence based medicine" to guide us as to the best practice to follow in a given situation. It would be nice to have prior informed consent, but as I and others pointed out the quoted study is actually a very minimal refinement of currently accepted practice and a "reasonable" physician wouldn't expect it to cause harm, but just wouldn't know if it happened to "work".

Your hyperbole just serves to trivialize an important issue. In particular, your insistence of comparing these very minor types of clinical trials that "tweak" existing emergency care guidelines to Tuskegee is insulting and the rhetorical equivalent of pulling out the "Nazi" card. It insults the poor people who were actually criminally mistreated in the syphilis situation. This wasn't a clinical trial but rather criminal negligence and to put this hypertonic saline trial into that boat is to trivialize the original crime.

I don't imagine that I will change your mind because you are obviously either being willfully ignorant or intentionally provocative, but it seems to me that you are doing exactly as you accuse typical Fox News commentators of doing by spewing vile, hateful BS.

I'm afraid I don't really have time to respond to reasonage like this right now:

But it seems to me that you are doing exactly as you accuse typical Fox News commentators of doing by spewing vile, hateful BS.

But for now I refer you to the definition of Hate: To a Republican, being held accountable. Sounds like you've got some issues with challenges to your authority...

NOTE By contrast, n=1 is speaking from experience. Interesting argument, to which I will return.

No authoritarians were tortured in the writing of this post.

Look in the mirror, you were wrong, just fess up and admit it. I know its hard, but it will make you a better person. You didn't think of all the ramifications of what you said, you made a faulty analogy and your sticking to it as you sink in the quicksand.

Also, your definition of hate seems to be fully appropriate to this situation (except the part about being a Rethuglican). I am holding YOU accountable for accusing an entire profession of dedicated people as being no better than a crew of nasty racists and YOU aren't happy about being held accountable.

What is that they say "de Nile, not just the name of a river".