Medical experiments to be done without patients' consent

[Judi Lynn]

Source: Houston Chronicle/Washington Post

May 26, 2007, 11:51PM
Medical experiments to be done without patients' consent
Five-year project aims to improve car crash, cardiac, other treatments
By ROB STEIN
Washington Post

WASHINGTON — The federal government is undertaking the most ambitious set of studies ever mounted under a controversial arrangement that allows researchers to conduct some kinds of medical experiments without first getting the patients' permission.

The $50 million, five-year project, which will involve more than 20,000 patients in 11 sites in the United States and Canada, is designed to improve treatment after car accidents, shootings, cardiac arrest and other emergencies.

The three studies, organizers say, offer an unprecedented opportunity to find better ways to resuscitate people whose hearts suddenly stop, to stabilize patients who go into shock and to minimize damage from head injuries. Because such patients are usually unconscious at a time when every minute counts, it is often impossible to get consent from them or their families, the organizers say.

The project has been endorsed by many trauma experts and some bioethicists, but others question it. The harshest critics say the research violates fundamental ethical principles.



Read more: http://www.chron.com/disp/story.mpl/nation/4839234.html

[IndianaGreen]

1. Josef Mengele is alive and well in Amerika!

One more step towards the Fourth Reich! What's next, euthanizing the mentally ill? We are already using Tasers on them, according to a LBN thread.

[Miss Chybil]

43. Please. Ridiculous and callous comparison.

Trying a different way to resuscitate an unconscious accident victim is hardly comparable to Nazi war crimes. Get a grip.

[undergroundpanther]

48. Ill kill myself before I let Bush's

Fucking asshole euthanasia "team" do it to me. Sooner or later we all ,make the widdle flowers grow.. (I have a "mental illness" and I stand up for GBLT mentally ill people too I hate all authoritarians and bullies.) But may it be said, I REFUSE to die at THE bullies command, I'll destroy thier shit ,as best as I can and fuck them over before they can get me, I'll kill myself fast, I'll be outta here laughing as the assholes from the aether's depriving them of thier sadistic kicks. Corpses can't scream or be tortured.That's why I have no fear concerning suicide. But I ain't leaving until I do damage to thier control games or whatever else.

I know the Bush regime wants to destroy alot of people that his kind don't like.I sometimes feel like I'm walking with a big ass target on my head.But hey, regardless Fuck Them,ALL!! fuck these pigs forever and ever.My last breath will be fuck you aimed at these fascist swine.And them not catching me alive , may my stiff body be seen as a HUGE insulting middle finger in thier faces.I hate this world and the thugs destroying the all the good, sweet,beautiful, innocent and noble things in this miserable world at every turn, I HATE them even more.I will never be tamed,broken or domesticated.

[piesRsquare]

2. I just read the entire article...

...and while the headline seems alarming, what's going on seems pretty "kosher" to me.

Johns Hopkins is overseeing these studies. They're pretty trustworthy.

I used to be an EMT. From what I read in the article, the approach makes sense to me.

[IndianaGreen]

3. Johns Hopkins had that crazy doctor John Money, and his experiments with intersexed children

Pretty bad shit!

[Kindigger]

4. Hmmmm

My father suffered a hemoragic stroke about 3 weeks ago. We were all frustrated, because it seemed the hospital wasn't really doing anything, but watching and waiting.

A doctor had mentioned a drip involving a large amount of sodium that would stop the swelling in his brain, but they weren't going to do it. I was angry, thinking they thought he was too old, not worth the effort or something.

I went to the JH site to research it, and the site said the procedure had been proven to have little benefit. :shrug:

[StarryNite]

30. You are way to trusting.

[Duppers]

52. my hubby is a current cancer patient at Johns Hopkins and

I have the utmost respect for and confidence in the physicians there.

Matter of fact it is THE BEST medical facility in the U.S.

>>
Out of 5,189 hospitals, only 3 percent, 176 in all, are ranked in one or more of the 16 specialties in this year's "America's Best Hospitals." And of those, just 14 qualified for the Honor Roll by ranking at or near the top in at least six specialties—a demonstration of broad expertise.

# 1
Johns Hopkins Hospital, Baltimore
30 points in 15 specialties

# 2
Mayo Clinic, Rochester, Minn.
26 points in 13 specialties
# 3
Cleveland Clinic
23 points in 12 specialties
# 4
Massachusetts General Hospital, Boston
21 points in 11 specialties
# 5
UCLA Medical Center, Los Angeles
20 points in 13 specialties
# 6
New York-Presbyterian Univ. Hosp. of Columbia and Cornell
18 points in 11 specialties
# 7
Duke University Medical Center, Durham, NC
17 points in 10 specialties
# 8
Barnes-Jewish Hospital/Washington University, St. Louis
16 points in 10 specialties
# 9
University of California, San Francisco Medical Center
14 points in 9 specialties
# 10
University of Washington Medical Center, Seattle
13 points in 8 specialties
# 11
Brigham and Women's Hospital, Boston
12 points in 9 specialties
# 12
University of Michigan Hospitals and Health System, Ann Arbor
11 points in 9 specialties
# 13
Stanford Hospital and Clinics, Stanford, CA
8 points in 7 specialties
# 14
University of Pittsburgh Medical Center
7 points in 6 specialties

http://www.usnews.com/usnews/health/best-hospitals/honorroll.htm

[IndianaGreen]

54. Johns Hopkins gets federal funding to conduct research

as do many teaching hospitals. There could be a group at Hopkins with intentions of using emergency patients as guinea pigs in experiments intended to advance trauma medicine in the battlefield, and you (or us) wouldn't know about it.

[Peace Patriot]

5. I don't think Emergency Rooms have to get permission from anyone (if no one is

available, and the patient is comatise) to save a life. I don't understand the distinction between that current power (I think it's current--isn't it?) and having medical researchers there, suggesting new life-saving treatments. If a patient is conscious, I believe that ER's ask them to sign a consent form, or if they are not conscious and a relative is present, they ask the relative to do so. Does this take that right away from CONSCIOUS patients or from the relatives of unsconscious patients? Is that why it is "controversial"?

[demgurl]

15. Actually, that information would be wrong.

I am not sure if they ask for the patient's consent but here is what they say as far as the family is concerned:

"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," said Myron Weisfeldt of the Johns Hopkins University School of Medicine, who is overseeing the project. "Even if there are family members present, they know their loved one is dying. The ambulance is there. The sirens are going off. You can't possibly imagine gaining a meaningful informed consent from someone under those circumstances

It would seem they do not feel getting consent is important in the least since they do not trust the patient's family.

[acmavm]

6. Anybody who thinks this is kosher is crazy. This strips you of the

fundamental right to control over your own body. This IS the first step towards making people unwilling guinea pigs for the pharacological industry. Shit, when I had my strokes they originally put me on medicine that made me horribly ill. Horribly ill. I had to throw a fit to get the doctor's to change it. Let someone else have control and God knows what you'll have to tolerate in the name of medical science.

People act like doctor's are some kind of ethical Gods. Ethics in the medical field have taken a dive drastically the last few years. Not all doctors, but so many of them.

Keep control of your body. Don't hand it over to anyone.

[Kagemusha]

8. It's making unconscious people guinea pigs for the MEDICAL industry.

Hospitals. Doctors. Nurses. Paramedics.

We can wallow in societal ignorance forever or we can learn. It's hard to keep control of your body when you're an unconscious car accident victim. At least in the study described by this article, it is uh, not like paramedics are not trying to save lives with every effort. Someone does, however, need to collect data on things like how effective the competing CPR methodologies work. I have no idea what sodium injection works better for reviving people, but if both save lives and one may be marginally better than the other and we're not sure, that's a legitimate area for study.

I'm not pleased to read that expert types consider previous studies like this to be much less ethical. That is not cool. But take oh, learning hospitals. Now I only know about that stuff from watching a little bit of "ER" but nevermind that. Should we ban them too? You're not guaranteed the best care that exists at any moment in time by going to one. I don't see how governing the issue with absolutes is going to help. The only absolute control would be refusing ALL medical care.

[acmavm]

9. People who volunteer to be part of studies (and there's a whole industry

out there) take their chances in return for being recompenses monetarily. They know what they're doing, and they are willing (sometimes for reasons that would break your heart) to do it.

To just pull this on unsuspecting people is criminal.

[Kagemusha]

10. In general I'd agree with you. But there's nothing I see typical about this one.

Unless someone out there has some kind of hard evidence that varying the techniques is GOING TO KILL PEOPLE, I remain skeptical. It's rather ironic that the only hard evidence might be obtainable solely by this very study. That's a bit of a dilemma, isn't it?

No one volunteers to have their heart stop after a car accident.

[acmavm]

13. So let's just see whether or not some poor unsuspecting fools die

because someone was trying out some new treatment on them? Without their permission?

The one damn thing I do know is that we have the right, guaranteed by the Constitution of the United States to be secure in our bodies. Life, liberty, etc. This includes not having to worry about some government sanctioned experimentation without our knowing about it.

No one, absolutely no one, under any excuse whatsoever has the right to experiment on people without thier foreknowledge. They did that down in Tuskeegee a few decades ago. That worked out well, didn't it?

[Kagemusha]

18. You're not listening so whatever.

I'm sorry I said anything.

[NashVegas]

11. Using Our Fear of Death

to accomplish this. Great people.

[entanglement]

55. Medical ethics didn't exist in the mid 1900s - the infamous Tuskegee syphilis study is an example

of the utter lack of medical ethics of our esteemed medical community. I hope we don't ever go back to those times.

[ikojo]

7. The US is taking on more and more characteristics

of the failed thousand year Reich with each year Bush is in office. Grandpa Prescott taught him well, didn't he?

[Doremus]

12. Hmmm ... no permission = secret?

No permission because the patient is unconscious would be standard procedure I'd think.

If this is controversial, it would have to be for other, unspeakable, reasons.

[hedgehog]

40. If it was a secret, then why is it published in a major newspaper

with no fan fare?

Not everything happens as a result of conspriracy.

[panzerfaust]

14. Difficult question, no obvious answer.

If it stays quiet today (I am on-call) I will later make a more though post, but for now I just want to address some major points.

First, we need to be clear on what is being proposed to be done, and to whom. I will only address the first part of the proposal – which is the treatment of traumatic shock. The second part of the study is apparently going to be looking at cardiac arrests.

My understanding is that to be ‘eligible’ one must be in shock secondary to trauma. The treatment protocol is apparently going to be a comparison of ‘standard’ treatment with probably near-isotonic crystalloid solutions against resuscitation with hypertonic saline solution (HSS) or HSS with dextran.

A few definitions. Tonicity is a measure of the osmotic pressure in a solution. ‘Isotonic’ (in this specific case) is a solution with the same tonicity as normal human blood plasma, ‘hypertonic’ is a solution that is more concentrated than that. ‘Dextran’ is a sugar-based colloid. ‘Colloid’ is a solution which has solute particle sizes of 1-1000 nanometers in diameter, these cross cell membranes poorly. ‘Crystalloid’ is a solution of substances of smaller size than a colloid: the most common crystalloids used in trauma are Lactated Ringers (LR, slightly hypotonic); Normal Saline (NS, slightly hypertonic); Balanced Salt Solutions (BSS: Plasmalyte, Normosol which are isotonic). Crystalloids easily cross cell membranes.

As far as I can tell, the study is not designed to address any of the other pressing and unknown issues in trauma resuscitation - eg: hypotensive vs normotensive resuscitation in penetrating vs blunt trauma; hypothermic vs normothermic resuscitation; scoop-and-run vs stay-and-play, what type of HSS is best (3%, 5%, 7.5%, 20%) … etc

It might surprise you to learn that truly not all that much is solidly known about trauma management. It might surprise you even further to learn that with severe trauma the outcome is very grim. The only way to find out what actually works, is to compare the outcomes of one treatment against another.

In the news article cited, George Annas is quoted as saying of the current study “This just seems like lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible …”

I am going to single out George’s comments to address, as I doubt that I will have time to get much further, and his remarks are cogent and, I expect, widely shared.

I must ask this question: How many times has George struggled in the middle of a dark and stormy night to free someone from a wrecked and burning car, dragged them far enough to be safe, and then tried to resuscitate that person. So like, is this a great time to get on the phone and try to find someone in the victim’s family who has legal authority (assuming there is such a person) to give ‘consent’ as to what form of treatment should be undertaken?

No. It is not. Nor is it ‘laziness’, it is impossible. That is why all states allow ‘implied consent’ in such circumstance: which is exactly the situation (traumatic shock) that we are talking about here.

George further asks "Suppose a 15-year-old child is in the back of a car that is in a terrible accident … The EMTs arrive and say: 'We are doing an experiment with two techniques. We think they are about equal. Is it okay if we flip a coin to see how we treat your son? Or would you rather we just give him the treatment we think is best?' Unless you think all parents would have the EMTs flip a coin, consent here is necessary."

Put the way George phrases it, there is clearly only ONE answer: “Do what you think best.”

This is faith-based medicine.

Further, what if one 23 year old “EMT” (it would actually be a paramedic, not an EMT, if we are talking iv fluids) says “I believe it is best that we tank your child up with Ringers”, but another says “no way Dude” we need to go with HSS, and yet a third says “No. What I know is best is that just scoop him up and get to the hospital right away.” Each believes in what he or she is saying. Which should the parent believe?

The point is, at the current level of medical knowledge, we do not know what is the right answer. A fact that George does not seem to appreciate. But the EMS crew has to do something! George says, well “just do whatever they think is best” – even though they have no way of truly knowing what is best – having only their individual experience to draw on, and that being usually limited to pre-hospital care.

Let’s ask the question another way.

The EMS crew has managed to extract the kid from the vehicle. They now ask “Your child is horribly injured and will not survive. He is unconscious now and not in pain. Do you want us to let him pass peacefully here by the side of the road with you lovingly holding him in your arms, or should we drag him off to the hospital where he will die in agony three weeks from now surrounded by uncaring strangers in terrible pain after suffering through multiple painful and hopeless surgeries?”

Well – that is what this EMT believes. Frankly, do you not think that there is a significant chance that the EMT would be told to just ‘let him pass in peace now without pain.’

The point here being that neither question is framed in a manner that I would accept as meeting professional standards. If it were I asking the question on scene to ‘enroll’ the victim in the study it would be along the lines of “We do not know what is the very best way to treat your child. We do have a protocol that is set up to give your child the best chance we know of of surviving and also to help find out the best way to treat other children. Can we use it?” Most likely will they say yes?

Is the way I would frame the question more or less fair than the way George would frame it? Is either question appropriate to be asking at the scene?

Again the basic point, unappreciated by George, is that we do not know what is the best treatment. There is no answer in the back of the book. If the treatments cannot be compared, then we will never know.

For my own self, if I had a choice of how I was to be treated I would say: A) If I have a head injury then 5-7.5% HSS, and probably with induced hypothermia in the ambulance (I am a believer); B) If I have penetrating chest or abdominal trauma then just get me the hell to the Level-I Trauma Center (survival being inversely proportional to the delay in getting into the ER at a Trauma hospital); C) If I have severe crush injury then low pressure resus with 3-5% HSS (My opinion is that there is less chance of compartment syndromes with HSS, but I also think blunt trauma does better with some fluid); D) If I have exsanguination secondary to long-bone fractures then a tourniquet and off to the Level-I (yes, that is not what the Red Cross teaches); E) If I have (B) or (D) and it is more than 20 minutes to a Level-I then I want low pressure resus with either LR/BSS/3-HSS (and no tourniquet).

But these choices of mine are not evidence-based. They are all simply based on my clinical experience, on the incomplete and contradictory ‘evidence’ in the literature, and, mostly of all, on my opinion.

Since we do not know the answer. Since we do not know if one of the proposed treatments is better/worse/the-same-as any of the others. Since trauma can be expected-but-not-planned. Then my belief is that, as long as the affected communities agree, the protocol can be ethically effected.

It is worth noting that the regions mentioned as participating in the study all have above average EMS services.

Also, remember, that study, or no study, the EMS crew is going to do something. Would it not be nice if that something was evidence-based as being the most useful intervention?

Given that in resuscitation from trauma we do not know what is best, should we try to find out – whilst minimizing the chances of doing harm - or should we remain ignorant and simply continue to base our care on whatever any particular trauma practitioner currently believes is for the best?

[hedgehog]

20. It is often said that the one good side effect of war is the advances we make in medicine.

The truth is that many medical advances have been made when is was impossible to perform the standard procedure of the time. As you said, the key here is that we don't know the best procedure. Do we keep doing something that sort of works sometime, or do we try out something that might work out much better?

For anyone who missed the point in your post, anyone who is in an emergency situation, whether it be a heart attack, stroke or accident, already is taking part in a lottery. Who is the first EMT on the scene, what hospital are you going to, how many hours has your doctor already been working, what training has he or she had? There is no time to give consent or shop around for a doctor. You call 911 and take your chances. As explicitly stated, there is implied consent to whatever procedures the medical community recommends in those first critical minutes and hours. The time for informed consent is before the trauma occurs, when you and your community decide what type of emergency medical care to fund and what type of training and oversight is required. There was a time not so long ago that many communities relied on the local funeral director to serve as a part time ambulance driver. It was only when studies were done showing the better results of starting treatment on-site and in-transit that we started spending money on EMTs and paramedics.

The only consent to be given in this case is whether we as a community trust the medical establishment or not. In this case, the establishment tells us that the procedures have been reviewed and shown not to be harmful, but that no one knows which one is better. Anyone is the study area has an equal shot at either treatment; no one will go without treatment. The concept of informed consent implies that there is information to be be reviewed. In this case, the only thing happening is two equally goo procedures will be reviewed to see if one or the other is actually the better choice. I would expect one of two results from these studies: either changing the procedure will not make much of a difference or else one procedure will clearly be so much better that the study is stopped ahead of time.

[The Backlash Cometh]

16. I think they killed my mother this way.

A stupid stent which they later freely admitted never should have been used, and which now is accepted practice NOT to use.

Beware old people. You are the next guinea pigs because they know no lawyer will find you valuable enough to fight for on a contingency basis.

[hedgehog]

21. I'm sorry for your loss, but the only way that they found out the stent shouldn't be used

is that someone compared outcomes with and without the stent. Sometimes we can glean information from "natural" experiments; for example, when the people taking Vioxx were compared to people not taking Vioxx. I would guess that doctors noticed the differences and passed on anecdotal observations and then someone else organized the data. Sometimes we have to set up a formal experiment to sort out the interlocking effects. This was how HRT was discredited.

[The Backlash Cometh]

22. No offense, but yours has got to be the sickest response I've ever

received from anyone on DU.

[hedgehog]

25. I'm sorry for offending you.

I was trying to point out the need for continual experimenting if medical science is to advance. A lot of people are very suspicious of the medical establishment and with good reason. That is why we are much more conscious of informed consent than we were 20 or 30 years ago. If an experimental stent was used on your mother without informed consent, then you have a right to be enraged. If it was offered in good faith as the best medical science had to offer at that point, then there is no one to direct the anger at. The doctors did the best they could with the information they had at the time. Someone had to gather the data and prove that the stents were causing harm. I don't know if some people just chose to forgo the stints or if there was a study in which people were deliberately selected for alternate treatment. As it happens, I've had family members harmed by accepted medical treatments and others saved by experimental techniques. It's very painful when something goes wrong. The only comfort is the possibility that someone else might be helped in the future.

[panzerfaust]

32. Pat on the back

Your point is valid.

But was a bit awkwardly put the first time.

[hedgehog]

35. It's very hard to discuss medical outcomes because while we

may understand the statistics, we only ever care about one patient at a time. Every year some children are injured by vaccines. While it is true that thousands of others are spared illness or death, how can that be a comfort to the parents of the injured child? All we can do is ensure that if we're all in a lottery, the lottery isn't rigged.

[The Backlash Cometh]

38. This time it will be.

Unless you can promise that people like Barbara Bush would be subjected to the same "lottery" treatment as someone on skidrow.

[panzerfaust]

56. True. The current Measles Epidemic

in which 88 have died so far in Japan is a result of an anti-measles vaccination campaign in that country about ten years ago.

[The Backlash Cometh]

37. God, your opinion and your nom de plume sends chills up my spine.

[The Backlash Cometh]

36. Let's just say, if she had been twenty years younger, the doctor would

have been sued up the ass with a high likelihood of success.

[MilesColtrane]

42. "Someone had to gather the data and prove that the stents were causing harm."

Before corporations and Republicans took over the FDA that was it's job.

And the proof of safety was supposed to happen before the stents were ever sold to hospitals.

Now, apparently, pharma can just throw a bunch of shit onto the market and if people start dying, then they might recall it.

Testing and approval stand in the way of money.

[The Backlash Cometh]

47. I really do believe, that they're hiding information from the public.

It's the Republican way. They hide everything. It's the way things are done in my local area. It's the way this Republican White House operates. So any fool who thinks that people who have this much autonomy will do "the right thing," deserves to end up on one of their tables.

In fact, I'll be as blunt as to say, that they're already doing this kind of "triage," and I'll bet, my mother was an early casualty. With Michael Moore breathing down their neck, no wonder they want to bring light to it in an effort to legitimize it.

[NotGivingUp]

61. INFORMED consent? give me a break!

the american people and its 'doctors' are the most UNINFORMED bunch i know.

[glitch]

17. This should be done like organ donation. Sign up when you get your driver's license

if you are willing to be experimented on.

[Downtown Hound]

19. Lots of scary implications there.

Of course it all sounds kosher on the surface, but once you give up the right to control your own body, who knows where it will lead?

[The Backlash Cometh]

24. You know what they're fucking doing? They're legitimizing mal-practice.

[panzerfaust]

29. WHICH is the malpractice?

Is it: A) Current standard care, or B) one of the study protocols?

Apparently you feel that you know the answer to this question as you so emphatically state that "They're legitimizing mal-practice." Please share your conclusion as to which form of treatment is malpractice, please share also the data upon which that conclusion rests.

Recall too that in the 1950's the 'standard care' for shock was not any type of fluid resuscitation, but the use of vasoconstrictors. Many of these injured people died acutely of lack of organ perfusion or, later, of renal failure – but, at the time, it was believed that the injured body could not handle any extra fluid.

Studies in Viet-Nam taught us about the need to fluid resuscitate the 'third space.' Sadly, en passant, it did not seem to teach us anything at all about having unjust wars in Third-World nations.

The subsequent routine use of overly aggressive fluid resuscitation then brought to light the previously unsuspected problems of lung damage and abdominal compartment syndrome resulting from persistent hypervolemia.

It is good that it is given to you to know that (at least one) of the proposed treatments is malpractice, and I, again, urge you to share this knowledge as those of us who deal with trauma everyday do not know what the right answer is.

[The Backlash Cometh]

33. There is no such thing as protocol in medicine.

When my mother died, the paperwork that should have been written up by the doctor was no where to be found. The F.O.I.A. we sent to the FDA to find out if there were other people inquiring about the stents came back with nothing conclusive. Yet a couple of years later, they reach the decision that there are issues with the stent? How did that happen in a vaccum?

Please. There will be no protocol. Doctors are just going to go 007 with these regulations.

How about you let people make decisions beforehand if they want to be treated as guinea pigs and let them put that information on their driver's license. What happened to CHOICE in America? Do you really believe they're going to treat rich people the same way they treat less fortunate people? What if that pattern can be determined that those without insurance are subject to this shit more than others? Where does you ethics go then?

In a nutshell, the medical community doesn't deserve our trust. THAT's the end game.

Fuck, China puts whatever shit they want in their products and the FDA doesn't catch on until our dogs start dying; and now they want to give doctors 007 certificates. No fucking thank you.

[panzerfaust]

57. I am sorry that you live in such a dark world.

[Missy Vixen]

66. I'm sorry that you have no compassion

for those of us who've buried loved ones as a result of medical "mistakes". My mother died as a result of a drug study.

Those who don't believe the ability to perform experiments on patients without that patient's knowledge would be abused are, frankly, delusional. It is legitimizing malpractice.

Julie

[panzerfaust]

69. If your mother had a drug study performed on her without consent

...that is not "malpractice" that is “battery.” It may even be “assault.” In any case, it is at least a criminal misdemeanor and probably a felony. By any understanding it is a crime, and should be addressed by the criminal legal system.

From that fact that I believe that, when it is not known which of two treatments might be better, when neither is known to cause harm, when each has evidence supporting that it may be of benefit, that it is reasonable to test them against each other; that from this you can conclude that I lack compassion fills me with Shock – though not with Awe.

[undergroundpanther]

50. Murder

Not malpractice. They are legalizing murder. Lets call it what it IS.And to hide the evidence of murder by experiment by calling a crime scene proprietary information.
Kill the proprietary lie, Fuck blood profits..Because you may never find the truth of what happened to your loved one if YOUR loved one gets killed when they didn't have to, because the corporation took advantage while they could not consent. Like a criminal who slips a victim a drug in their drink to make them pass out, and rapes the victim as she lay passed out.. THen the criminal claims the victim consented to "sex" because they did not fight against him or scream. Is that fair? NO..A corporation doing a risky operation on an unconscious person AND a roofie rape are BOTH an excuse to VIOLATE someone else's consent.. In corporate world it's so easy to lie to yourself,and deny.. especially if the criminal can hide his deeds and always claim proprietary information.

Imagine investigating a crime scene and it is declared off limits because to know what killed someone and who and how it might reveal corporate "secrets".Can you imagine corporate property overriding the right for the law to investigate a crime and reveal what happened to a daughter,brother, mother, son,sister, father or friend of YOURS.. Don't you get it? They ARE making it legal for corporations and doctors working for said corporations to get away with murdering people who cannot consent.

We don't need cattle cars and ovens..With American ingenuity as Friendly Fascism.. What better place to hide a death camp ..than IN the local hospital!!People die there already the dumb public will never question a hospital.. THINK about it. Hitler failed among other reasons one of which was because his Death camps were visible by air and it and shocked the people.. The psychopath right has learned well from Hitler's mistakes. Beware..the corporate empire state.We are all expendable ..THIS makes it clearer,. What will it take to wake this nation up??

[The Backlash Cometh]

51. It really is frightening, isn't it?

What happened to this country? I don't understand why they can't see where this is going.

Heck, compared to everything else we've seen, I wouldn't be surprised if someone in the GOP figured out a way to use this "study" to selectively exterminate people they find troublesome. Why not? They've gotten away with everything else.

[panzerfaust]

58. Ummm: We are talking about Salt Water here.

No one is going to make money selling saltwater. Not even with a little sugar added.

It is amazing to me that the study was funded, since there is no way that the biomedical manufacturing companies can possibly profit from this.

You, clearly, state “Not malpractice. They are legalizing murder. Lets call it what it IS.”

Let me paraphrase the question I put to the previous interlocutor: WHICH is Murder?
Is it: A) Current standard care, or B) one of the study protocols?

Again. I would be very interested to both know your opinion on this, and, even-more-so in knowing the data upon which you base your reasoned opinion.

[NotGivingUp]

62. I'm awake and i am so pissed and you are so absolutely right.

our 'medical' system sucks and just keeps getting worse and so many crazy fools just keep going along with it...wake up people!!!

[MadMaddie]

23. What is the difference between this and the notorious syphyllis

studies using black men? "Tuskegee Study of Untreated Syphilis in the Negro Male."


http://www.cdc.gov/nchstp/od/tuskegee/time.htm


Black Americans have a distrust of the medical society because of these types of experiments.

Is it the degree of the experiments? Once the line is crossed it gets easier and easier to justify ones motivations.

So they start with patients who are unconscious, who is the next target group...those mentally impaired? Children in the state foster care systems?

Then a race deemed genetically inferiour....sound familiar?

This should concern everyone...

[hedgehog]

26. The difference is that at Tuskegee the patients were lied to.

There was a cure available and they thought they were getting it. Instead, the disease was allowed to progress untreated just to see what it would look like. Here, there are two treatments. If it is true that no one knows which one is better, then the patients are not being put at risk. The only way to find out if one treatment is better than the other is to try both and check the results. There is no deliberate harm being done to either set of patients. Neither set of patients is being neglected.

[Nikki Stone1]

27. Agreed. This is unethical.

..

[otherlander]

45. MKULTRA comes to mind.

[hedgehog]

28. When we accept trauma care, we give consent to whatever treatment

the doctors involved think best. We transfer our power of consent to the committees overseeing those doctors' work. Sometimes a patient emerges from emergency surgery missing a spleen or a leg. In the case of this study, there are two treatments which can only be judged as having equal results. As far as we know today, it makes no difference to the patient which treatment is used. If one treatment is in fact better than the other, this study will show us that fact.

[panzerfaust]

31. A Bit More Restrictive -

Our 'implied consent' is given only to medical interventions which are currently accepted as 'standard of care', to interventions which are done under an accepted study protocol, or to interventions which are known to be immediately life, organ, or limb, saving. The consent is only valid for the immediately threatening condition.

If you are in a car crash and found unconscious with an obvious deformity of your neck should a Doctor of Chiropractic happen to stop and treat you with neck manipulation – THAT is not something that would be considered a protected act under the doctrine of ‘implied consent’.

Nor, if you were taken to hospital following a wreck, and you were know to be suffering from a seizure disorder, could the neurosurgeon decide to implant a Vagal Nerve stimulator, or do a craniectomy to excise your seizure focus - even if s/he thought this the best treatment for seizure.

On the other hand, if you had suffered an intracranial epidural bleed, s/he could take you directly to the OR (operating room) and cut your head open, as long as the ‘unable to give consent’ provisions of the applicable state law were met.

[hedgehog]

34. I stand corrected. I should have remembered that proviso.

But I think you and I are in agreement that if the case is as stated, that there is no proof that the current techniques are better than the proposed techniques and there is a consensus in the medical community that the new techniques may be better, then it is OK to proceed with the study.

Turn it around; what if you thought the new technique was better; should you use it every time regardless of what everyone else is doing? How could you justify using the old technique? It seems to me the best way to resolve all the issues and to ensure the best patient care, the way to go is a controlled trial. In this case, the group responsible for giving informed consent is the medical community.

We had another example of this a few weeks ago. A family wanted to have their severely retarded child treated to ensure that she wouldn't grow very large. The doctors involved and the family gave consent, but given the unusual purpose and nature of the treatments, it was judged that the approval of a larger medical community should also be obtained.

[panzerfaust]

59. I think that you might be referring to Ashley?

These are a couple of the headlines that turn up:

“Surgeons maimed brain damaged child for convenience of caregivers”

“Mutilation of daughter as disability treatment”

That, I am sure, was a horribly difficult decision for all involved. It was one made by the parents, the surgeons, the hospital ethics committee. I do recall reading recently that the hospital has been censured by the state for the decision.

For those who do not know, the parents had a severely neurologically devastated young girl sterilized by hysterectomy and removal of her ovaries at about age 7 as she was entering a premature puberty.

Their fears were that she would quickly grow too large for them to be able to physically handle (she is unable to move herself), and that menstruation would needlessly frighten her.

The most balanced discussion of this I have seen is in the Telegraph.

The DU Editor won't accept the URL as a link, so here it is as text:
www.telegraph.co.uk/news/main.jhtml;jsessionid=0WL1JYUNPF4OLQFIQMFCFFOAVCBQYIV0?xml=/news/2007/01/05/wash05.xml

The ";" after ".jhtml" seems to break it - you need to enter the whole text up to the ".xml"

The parents view is "Some question how God might view this treatment. The God we know wants Ashley to have a good quality of life and wants her parents to be diligent about using every resource at their disposal (including the brains he endowed them with) to maximize her quality of life.

"Knowingly allowing avoidable suffering for a helpless and disabled child can't be a good thing in the eyes of God."

This was not either an easy, nor a casual decision, for either the parents or the doctors to make. I think that it should be respected.

[HockeyMom]

39. My Mom's Living Will - "I don't want to become a Science Experiment

to see how long they can keep me alive by whatever means". Yes, she actually put that in it.

I guess now it won't matter any more????

[hedgehog]

41. Maybe I shouldn't comment in this thread at all because I do have a bias.

I've worked with both my primary care physician and specialist to try out new treatments over the years. Some worked, some didn't. I went in with informed consent and often proposed the new treatment myself. I've also volunteered to have myself and my kids checked out by medical students. They have to practice on patients sometime. Why should it be only on people at free clinics? I feel it's my responsibility that if I benefit from the system, I assist the system to train new practitioners.

[semillama]

65. no, that's exactly why you should post here

All too often on DU something like this gets posted, and you'll have 2/3's of the posts being people blowing things out of proportion, invoking Godwin's law, posts that clearly show the poster didn't read past the headline, and posts that extrapolate a conspiracy from the actual facts presented. What's needed are posts from people like you and panzerfaust that are from people knowledgeable in the topic being discussed. All too often it is easy to feel like you are being dismissed, but I bet a number of people read the posts of both of you and said to themselves: "Oh, well, then that's all right, then" and didn't bother to post anything.

Sometimes you can't avoid coming off cold, and sometimes the truth hurts. Keep it up.

[panzerfaust]

67. Yes.

However, I do think that the study being discussed can be ethically undertaken only if it has been approved down to the local EMS (Emergency Medical Service) level. Simply because someone at a State EMS level might think it a Good Idea, I do not believe that to be 'good enough' to go.

To adduce a study which, in my belief, was not ethically performed I point to the “ARREST Trial” (Amiodarone for Resuscitation after Out-of-Hospital Cardiac Arrest Due to Ventricular Fibrillation).

This trial, of which one of my former mentors was a lead author, compared a new (and expensive) drug against placebo for the treatment of cardiac arrest caused by ventricular fibrillation. The study showed the drug to be more effective than saltwater in treating V-Fib.

Let me repeat: the comparison was against saltwater, not against what, at the time, was the accepted drug of choice (lidocaine).

I was, and remain, appalled that the study was undertaken in this manner.

A later, ethical, study (ALIVE) did compare amio vs lido (and amio was more effective). This study (thankfully) did not contain a placebo control arm, so the question cannot be answered if lido is truly more effective than placebo. Though I expect that most believe it to be, and it was the drug of choice at the time of the ARREST Study.

If lidocaine is, by even a tiny amount more effective than saltwater, then some people may have needlessly died in the ARREST Trial. Though this is unlikely, given that survial-to-discharge was the same in both groups, it is still, in my opinion, indefensible that the trail drug was not tested against the standard drug.

So, I certainly do not think that one should give blanket approval to community clinical trials: especially to trials in which it truly is not possible to obtain informed consent at the time when treatment must be randomized.

Yet, I do believe that only by undertaking ethically designed trails, will questions of importance to us all be able to be answered.

Many posters on this thread seem to regard doctors as a distinct species from patients. Yet, any day, any doctor, any health care provider, can become a patient.

Certainly I agree with you that making puerile remarks, and ad hominem attacks, does little to advance discourse on this difficult subject.

Also, I too am dismayed that we are the only civilized country which does not offer, at least basic, healthcare to all.

This shames us as a nation.

[Tandalayo_Scheisskopf]

44. Let's cut to the chase on this thing.

While I read Panzerfaust's first response in abject awe(dayum, d00d, I don't know what you do for a living, but I do not think it is working in a McDonald's drive-thru), he made valid points about data and the necessity to compile it to advance trauma care. It read like a very short novel. I think the word gripping is appropriate here.

But what disturbs me here is what is not said, but jumped out at me as I read down. Call it a growing creepy impression:

They are using trauma patients, without their specific consent, to compile data that will be used to advance trauma medicine to be used in wartime, on the battlefield.

I can't put my finger on why this disturbs me, but it does. It's not as if I resent the best trauma care being used on some poor kid, no matter how dumb the war he or she is fighting might be.

Maybe it's because the tail is wagging the dog so hard the dog is in danger of being beaten to death.

[IndianaGreen]

53. The medical experiments at Dachau were to advance battlefield trauma medicine

They are using trauma patients, without their specific consent, to compile data that will be used to advance trauma medicine to be used in wartime, on the battlefield.

I believe we all have reason to be concerned about this, and I wonder who really is funding the Johns Hopkins study.

[panzerfaust]

60. Wendy's. And mostly it goes the OTHER way.

"They are using trauma patients, without their specific consent, to compile data that will be used to advance trauma medicine to be used in wartime, on the battlefield"

It is the reverse. Most trauma research is done where there is the most, and the most unbelievably horrific, trauma and that is in a theater of war. What is learned there is applied here ‘back in the world’.

This has always been true, ranging from looking at anesthesia and asepsis (Crimea), delayed amputation, malarial phrophylaxis (The War Between the States: 'The Civil War' damnyankees call it), to the Hare Traction Splint in WWI (aka "The War to End All Wars), and the use of steel rod/plate fixation of fractures, plasma transfusion, antibiotics, intravenous anesthetics (WW2), rapid battle field air-evac, early blood transfusion (Korea), massive fluid resuscitation, early excision of severe burn wounds, delayed closure of contaminated wounds (all in Viet-Nam).

The DOD is much less worried about the ethics of their studies than is the civilian world.

Two examples.

First the Army is currently studying the effects of a blood-clotting agent called “Activated Factor 7.” The specifics about how it works are not important here, but one of the side effects – increased risk of clotting throughout the vasculature system – is, since this can be as fatal as bleeding to death.

It is not yet known if the risk of using this drug offsets the benefits, and it is being very widely used in Iraq – too widely many, including myself, feel. There is also the undisputed fact that the drug costs about $10,000 per DOSE.

The other is personal.

When I was in the service I was looking over my medical record one day, and discovered that I had, unknowingly, been a subject in a study undertaken when I was in boot camp. I have no idea WHAT the experiment was, and, when I started asking up the chain (of command), my medical record was ‘lost’ by my unit.

I do know that I was 17 at the time. I do know that I came down with a serious pneumonia for which I was hospitalized for two weeks – worse, I thus was ‘set back’ for an extra two weeks in boot camp.

I have often wondered if the two were related. Pneumonia, whilst not unheard of, is uncommon in healthy 17 year olds.

This being Memorial Day, y’all might want to visit a program the LA Times has put up. It is the least (but still heavily) sanitized look into the faces of the wounded.

At least of wounded Americans. No pictures of the shredded Iraqi and Afghan women and children. When a friend of mine was in Afghanistan, he said the 1/3 of the casualties were children.

One Third Were Children.

[Screwfly]

46. Call me cynical

but this experimentation crap sounds like a good way for doctors and hospitals to either weasel out malpractice cases, or keep a dead guy breathing so they can extract as much money as possible from his family or insurance company. At the very least, this program would using a lot of inner city minorities for human guinea pigs since that's where the majority shootings and stabbings in this country occur.

[panzerfaust]

63. Most trauma occurs in car crashes

The current fairly well accepted distribution of cause of 'preventable' death in the US is summarized on About. The data is always subject to being contested, but it is clear that Tobacco, Poor Physical State and Alcohol account for most deaths.

Car Crashes killed 43,000 (Most of these are actually drug/alcohol/testosterone related), whilst Shootings killed 29,000. Stabbings did not make About’s Top Nine list.

In the world as a whole, the top killers are Heart Disease, Stoke, Pneumonia, AIDS, Lung disease (from smoking and unsafe work exposures in mines and other jobs), Diarrhea, TB, Malaria, and trauma.

Worldwide about the same number of people (mostly infants) die of diarrhea as from trauma (all the wrecks and wars put together).

Oddly, though this has led to Trauma Centers being established, there are no proudly proclaimed Diarrhea Centers – though such centers would save many more lives than Trauma Centers ever will.

WHO estimates that most of these infant deaths could be prevented at a cost of about 25 cents per baby.

So, how many babies per iPod?

[undergroundpanther]

49. We are all expendable

To the thugs that think they own and rule us.We are cattle to be used up,days of our lives milked doing work,our bodies to make treatments that benefit THEM.

Nothing the state does when it is as fucked up as the republican machine is to HELP anyone but some rich pig a hidden faceless tyrant.They can do whatever they want.They can harvest organs and call the"treatment" a failure Who would know? Who would care. They will put polyheme (fake blood) in people and kill them,do strange drugs surgeries not proven to help. The medical establishment is not safe, it has abandoned Hippocrates' oath for the poor, The Rich have gone psychopathic and they will not let anything take away their dream of domination and economic stranglehold.Murder is legal if you are a corporation now. If this does not prove corporations are DANGEROUS to human life I don't know WTF is blinding you to reality. We cannot afford to have corporations in control of ANYTHING anymore. Destroy the paper myth,The BIG lie, the FAKE person, the corporation the mother of all frauds. Kill the corporate before it kills you or someone you hold dear.

I am sure the company will not care if you suffer.They have already proven they are a psychopathic institution. Stop bowing down to corporations,Stop serving these paper monsters, stop feeding them with your labor and trust. Let them wither and disappear and let the Ceo's starve in the gutters..Do not let yourself be OWNED by anyone or any paper monster!

[SayWhatYo]

64. How about making it like a donar card thing...

If you opt into being willing to be part of experimental care, then they can just pull your name up in the system.. That way anyone can opt in when they get their license.

[hedgehog]

68. I don't want to be nasty, because my own daughter came up with the same suggestion,

but you have to consider whether paramedics trying to stabilize and revive a trauma victim are going to have time to stop and look for someone's wallet, then flip through it to check a license. It would be a perfect solution, but I don't think it's practical.

[SayWhatYo]

70. Disagreeing with me is hardly considered nasty. :D

Well, I don't think this is referring to anything the paramedics would do, is it? If it's in the hospital then I don't think it's unreasonable to think that they would be able to pull up a person's information fairly quickly. Of course if they do not have ID or cannot be identified, then that's a different story.