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Unethical human experimentation on preemies

I'll give the moral of this story right at the outset. If somebody asks you to sign your baby up for a "study" when you're being wheeled into the delivery room, telling you only that it is a way to "help" your baby, don't sign.

Tell them, "I am in no position right now to give informed consent to my child's being enrolled in any study. Just give my child the best treatment possible, and we can discuss this later when I can ask questions and get full information."

This story is outrageous:


[I]n reality, the study was much more than that. It was a national, government-funded experiment on 1,316 extremely premature infants in which their fate may as well have rested with the flip of a coin.

[snip]

The government-backed study is called SUPPORT, which stands for “Surfactant, Positive Airway Pressure, and Pulse Oximetry Randomized Trial.” The experiment was conducted at 23 academic institutions from 2005 through 2009 under the National Institutes of Health, part of the Department of Health and Human Services.

All three women now say they never would have agreed to take part if they had known the NIH-funded study’s true nature—to randomly manipulate preemie oxygen levels. They discovered that just last year.

It gets even worse:

Doctors say babies are at risk of complications even when born at 37 weeks, now considered early term. The stated goal of SUPPORT was to identify the best oxygen level for extremely preterm infants—generally those born before 25 weeks, and so especially in distress.

Medical personnel routinely give supplemental oxygen to babies who are born with immature lungs. Too much oxygen can cause severe eye damage, including a blood vessel disease and blindness called retinopathy. Too little oxygen can lead to brain damage and death.

The NIH-funded experiment used the test babies in an attempt to find the sweet spot for preemies yet to be born: the lowest level of oxygen that would preserve vision, yet be sufficient to prevent brain damage and death.

To get the answer, researchers arbitrarily assigned infants to either a high-oxygen or low-oxygen group. Because, researchers say, all oxygen levels fell within the generally accepted range, they argue the babies received the same “standard of care” as babies not in the study. None of the consent forms mentioned a risk of death from the oxygen experiment.

But it turns out there were key differences in how researchers treated babies in the study compared with those not in the study.

Normally, medical personnel constantly adjust oxygen as preemies’ conditions change, based on their individual needs. But the SUPPORT study was designed to keep infants in their randomly assigned range, despite a baby’s individual needs.

And in a decision that one government source says shocked seasoned researchers when they learned of it, the babies’ oxygen monitors intentionally were altered to provide false readings. The reason: so medical staff wouldn’t be tempted to adjust oxygen out of the babies’ study-assigned range. (emphasis added)

Yes, you read that right. But this was all said to be "within standard of care" by the sophistical logic that the oxygen levels given to the babies all lay within the range that is the "standard of care." Obviously, the real standard of care is to vary the oxygen levels within that range, based on knowledgeable medical assessment of the best treatment of the patient as an individual. But these babies weren't individuals to the researchers. They were variables in a study.

I can only imagine how the nurses and doctors must have felt if they learned later that their instruments were deliberately tampered with by higher-ups to give false readings.

If you wonder if this is part of a larger trend, read Wesley J. Smith's blog Human Exceptionalism regularly, as I do, and ask yourself this: Does it or does it not seem that scientists are increasingly impatient at limitations on their ability to experiment on and make use of human beings? Embryonic stem-cell research is an obvious example. But so too is the move toward "presumed consent" in organ donation laws. Then there is this interesting article about bioethicists promoting experimentation in hospitals without patient consent. Then there is this one, from the UK. Oh, and this proposal for allowing people to "consent" ahead of time to being experimented on when they are dying.

Perhaps in the preemie study the scientists were more willing to experiment without true informed consent from the parents because of special disdain for the lives of preemies. That may be true. But the phenomenon of pushing for more and more experimentation on human subjects without informed consent affects other ages and stages of human development. It may be that what we are seeing here is a general disregard for all merely individual human lives, even those previously considered "sufficiently valuable." This disdain comes from a toxic combination of scientific hubris and decades of attacks on human exceptionalism.

May God help us to negotiate our way through these shoals for ourselves and our loved ones.

HT for main story link: Sage McLaughlin

Comments (33)

I keep thinking that I've gotten beyond the point of true shock, and I keep being proven wrong. This could have happened to two of our precious granddaughters . . . horrifying.

>But so too is the move toward "presumed consent" in organ donation laws.


Is that really all that objectionable? It doesn't seem comparable to the other stuff you are talking. Most people don't think about organ donation at all, and that causes a lot of people to die. An opt out system provides everyone with the ability to make their own choices, but also guarantees that more people that do not care one way or the other end up in the system. Given that the dead aren't exactly using their organs that policy seems far better.

and that causes a lot of people to die.

Dunsany, could you try thinking and re-reading and editing what you write once in a while? No, the disease or damage that happens to a person is what is killing him, not someone else's situation with their own organs. You don't have a claim on anyone else's organs unless they have given you such a claim, and not until then. Before that, they remain someone else's, so if you are dying of bad kidneys, the state of someone else's kidneys isn't killing you, it is the state of YOUR OWN kidneys that is killing you.

Given that the dead aren't exactly using their organs that policy seems far better.

Deaf, deaf, deaf, deaf.....Lydia has made it perfectly clear to anyone with eyes or ears that THEY DON'T WAIT FOR YOU TO DIE!!!! They only wait for you to be close enough to death that they can *get away with pretending* you are dead without anyone picking a bone about it. (To coin a phrase - no pun unintended.) Oh, sure, sometimes they take the organs of dead people, when they have to. But what they really want is the organs of a freshly almost-dead person because they are in better condition that way. And the language in which the protocols are written are all nicely crafted to smear the difference to a de minimus gap, and then the protocols are winked at sometimes anyway. In practice, you are basically betting your life on a shake of the dice by signing up for organ donation, and the trend is getting worse much faster than anyone dreamed. In THAT environment, no, a presumption in favor of donation is not a good idea.

it seems one might well ask- if 'consent' is becoming a fuzzier and fuzzier (and inconvenient, apparently...) concept in one area of modern ethics, how viable will it actually be as a criterion for ethical behavior in other areas of modern ethics? More pointedly, if one can actually take someone's life without his consent, what meaningful application could 'consent' possibly have for any other behavior?

Most people don't think about organ donation at all, and that causes a lot of people to die.

Yeah, I didn't think about it at all today (until I read that sentence) so somebody probably died.

>nd re-reading and editing what you write once in a while? No, the disease or damage that happens to a person is what is killing him, not someone else's situation with their own organs.

Tony, I'm not playing your pseudo-intellectual semantic games. You know very well that I meant that people's lives are saved by such policies. Spare me your idiocy. If you ever decide to get into real philosophy you will learn that no one looks kindly on such nonsense.

>Deaf, deaf, deaf, deaf.....Lydia has made it perfectly clear to anyone with eyes or ears that THEY DON'T WAIT FOR YOU TO DIE!!!! They only wait for you to be close enough to death that they can *get away with pretending* you are dead without anyone picking a bone about it. (To coin a phrase - no pun unintended.) Oh, sure, sometimes they take the organs of dead people, when they have to. But what they really want is the organs of a freshly almost-dead person because they are in better condition that way. And the language in which the protocols are written are all nicely crafted to smear the difference to a de minimus gap, and then the protocols are winked at sometimes anyway. In practice, you are basically betting your life on a shake of the dice by signing up for organ donation, and the trend is getting worse much faster than anyone dreamed. In THAT environment, no, a presumption in favor of donation is not a good idea.


This is just nonsensical conspiracy theory BS. It belongs on Alex Jones.

You know very well that I meant that people's lives are saved by such policies.

Your position right now is "We should presume that somebody wants their organs removed, even if they didn't say so."

Here's the problem: What if they would have said no?

This is just nonsensical conspiracy theory BS...

Do you even read the things you're criticizing? Like, how long have you been reading Lydia's long and fairly meticulous documentation of organ donation disasters? How often have the writers here shown that the meaning of consent is getting stretched to the point of absurdity, to the extent that in Belgium children can decide to be euthanized without their parents' consent? You really don't think this is any reflection at all of changing attitudes in the world, to the extent that the things Tony said, combined with the weight of research, *just might* make sense?

Dunsany2 (are you different from Dunsany without a number?), let me put the organ issue more suavely: It is entirely legitimate for people to have _concerns_ about their treatment in connection with organ donation--to be concerned, for example, that their treatment prior to death will be _influenced_ by their consent for organ donation. That influence can concern all sorts of things, even intentional _over_-hydrating so as to keep kidneys in better shape. Also, informed people have reason to be concerned that the process of death itself will be different if they have consented. For example, a slow and natural death will be less likely to be permitted, because it is more gradual and might not keep organs as fresh. There is also the possibility of distress and confusion for loved ones. Notice that these considerations are _aside from_ the concern that organs will be taken when one is not really dead--a real concern the justification for which, as MarcAnthony says, I have meticulously documented. And which has nothing to do with conspiracies but rather with the biological difficulties in getting usable organs. But if you choose to think that only a wingnut would even have that concern, then content yourself with the earlier concerns, which are also real, understandable, and documentable.

These sorts of things are entirely understandable reasons why consent is supposed to be important. To make consent presumed is to make light of any concern for _informed_ consent. This is why I included that issue in my list: There is an increasing disdain for informed consent, because the elites are supposed to know better than hoi polloi what hoi polloi should be consenting to. This is highly distasteful and problematic.

Thanks, Lydia. I haven't looked at this study closely, but if this is so, then it's unconscionable, to say the least. I'm surprised it made it past an ethics committee. An ethics committee should have caught this, but maybe that's another issue - who's in charge of the ethics committee to allow or disallow such studies in the first place? (By way of background, I say this as someone who is currently undertaking clinical research, and I'm familiar with how clinical research works.)

I was pretty astonished as well. I've had some indirect contact with human experimentation protocols, and there has indeed (in the past) been a pretty lynx-eyed committee that is very solicitous about informed consent. I don't know how something this obviously unethical slipped through.

I'm no expert on this but it seems the problem here is that no one knows what the ideal level is. Your assumption is that individual doctors and nurses 'tweaking' the oxygen up and down based on their subjective feelings may be wiser than just choosing a high or low level and sticking with it no matter what.

But that too might be dangerous. I could easily imagine a worse of both world's result where the staff overshoots in both directions first causing eye damage and then causing brain damage as they try to 'correct' themselves to a better spot.

Absent an experiment like this how would this information be discovered? You could keep careful track of every case and then build models that looked at the 'tweaking' doctors compared to those who stuck with just a high or low setting....perhaps using some type of Big Data to discover the relationship but isn't that just as much of an 'experiment on humans' too?

Boonton do you not even begin to see the unethical nature of

a) not getting true informed consent from the parents, and

b) falsifying the medical outputs of sensitive medical equipment so that the doctors and nurses could not treat the patient individually according to *their best medical judgement*?

The wildly unethical nature of this seems obvious. I cannot imagine any parent agreeing *if fully informed* to having their child in a study where this was done. Which is why they didn't tell them or the doctors and nurses!

Right now, the best medical judgement is that the tweaking *is* best for the patients. Presumably the doctors have *some* evidence on which to base that. Of course it is logically and physically _possible_ that that isn't best, but that isn't what the medical personnel on the ground believe, based upon their experience.

If one wanted to test that, one could much more readily get parents to sign up for a responsible study that really did just _keep records_ of what tweaking was done and then record outcomes. That would not make any actual difference to the patient as compared with normal medical practice.

As for comparing that to those that were fixed at a high or low level rather than tweaked, I would say good luck getting non-deceived parents to agree to having their children in either group. I certainly wouldn't. And if that means we can't get all the data we would like to get in some "ideal world of data," too bad. Deception of human subjects or their guardians to gain phony consent to a study is wicked and should be vigorously punished when uncovered.

1. I agree parents need to be fully informed. But you're making an assumption here.

2. "Best medical judgement"? OK that's fine but what does that have to do with anything? Can you show me that 'best medical judgement' works better than choosing a setting and sticking with it? If not you just have a 3-sided coin: high-oxygen, low-oxygen and 'tweak up and down based on the hunches of whoever is on staff' and no obvious way to know which is the safest and best for the patient.


"Presumably the doctors have *some* evidence on which to base that."

Why? Based on their past experience? "Before I did high oxygen and that baby went blind, then I did low and that one got brain damaged...so now I'm trying a bit of both switching around every half hour"....sounds like your still 'experimenting' on the babies but you've covered it up and disguised it (in addition to making it very ineffective).

If a doctor has absolutely no evidence either way, he is just going to use his hunches. That's fine, if you began doing clinical studies at the beginning of the universe you still wouldn't be a quarter of the way towards being able to 'know' the best answer to all medical cases. Without clear knowledge a 'hunch' is acceptable but just because the hunch is made very sincerely by a doctor who wants very badly to help the patient doesn't mean we can pretend it should have a privileged position above other possible treatments.

"As for comparing that to those that were fixed at a high or low level rather than tweaked, I would say good luck getting non-deceived parents to agree to having their children in either group. I certainly wouldn't."

Sounds like a coin toss to me. More than a few things in life are messed up by people who aren't patient and start 'tweaking' up and down. I see no reason why you as a parent should feel safer with a tweaking doctor versus a 'set it here and leave it there' doctor.

But you're making an assumption here.

Nope, I'm not. We have multiple interviews with parents who definitely say that they were _not_ informed of this. That isn't an assumption. It's a conclusion. We also *know* that the doctors were deceived, which should *never* happen.

"If a doctor has absolutely no evidence either way, he is just going to use his hunches." Why think a thing like that? They aren't just randomly tweaking the oxygen. For example, they might tweak it up in response to respiratory distress in the child. Then tweak it back down when the breathing evens out because if possible we don't want to be giving a lot of oxygen because of the vision issues. Even as a layman I can envisage a way that this would work that would not be some kind of random, evidence-free behavior, as if the doctors and nurses are monkeys randomly varying oxygen levels! Good grief.

" I see no reason why you as a parent should feel safer with a tweaking doctor versus a 'set it here and leave it there' doctor."

Yeah, fine, you can enter your preemie in such a study. You can read the story to find out what kind of fairy tales they had to tell the parents to get them to enroll, and it wasn't laying all that out, that's for sure. There isn't time when you're being wheeled to the surgery room for a C-section.

You're being very dense, here. Very dense indeed. The ethics violations here are glaring, and for some reason you want to go to the mat to defend this study. Talk about a lost cause. I'm not even sure why you're trying to die on this hill, but this thing is a _huge_ violation of informed consent and medical ethics.

""If a doctor has absolutely no evidence either way, he is just going to use his hunches." Why think a thing like that? They aren't just randomly tweaking the oxygen. For example, they might tweak it up in response to respiratory distress in the child."

No of course the tweaking is not random, but that still tells us nothing about its effectiveness. Clearly 'respiratory distress' here could not be extreme since no baby was denied oxygen. So does increasing the oxygen to relieve wheezing or coughing and then turning it back down avoid both brain damage and eye damage? Perhaps but we have no evidence to know that. To make it even worse no doctor is going to stay 24-7 with a premie, if you opt for tweaking you're opting for tweaking by whoever is on staff, not just the highly experienced doctor you trust. The doc covering the 3AM shift may not be as good at tweaking as the daytime one.

My point here is that between the 3 options, there's no obvious right choice unless you have some information beyond what you just presented. It's totally possible the tweaking itself ends up causing worse outcomes than setting high or low, although in the short term it 'feels' right because it seems to relieve some types of distress.

It's funny that you keep harping on your theory, Boonton, that the intelligent tweaking is no better rather than acknowledging the extremely unethical nature of lying to the parents and deceiving the doctors. I think that's just the topic you want to talk about instead, huh? I disagree with you in any event and would reflect it in my decision as a parent. I simply say that it's manifestly unethical for the parents not to be given the opportunity to decide whether they agree with you or not. And for the medical equipment to be set to give falsified readings to medical professionals.

That the respiratory distress couldn't be acute is a pretty uninformed statement, I would say. Some of these babies do die because they can't breathe well enough. Lack of sufficient lung function is a gigantic cause of death in these preemies.

Theory? There's no theory here. You've presented 3 possible courses of treatment (set high, set low, or 'tweak') and zero evidence that one works better than the others. This is no different than if you came home one day and saw a white, blue and red pill on your kitchen table. Which one is most likely to help your headache? Absent any additional information all 'theory' can say is flip a coin (or 3 sided coin....of course this analogy is imperfect since you would probably not trust any of the unknown pills and throw them away whereas with a premie you must decide to do something with the oxygen level).

Absent informtion you've just fed adjectives into the argument. It's not just 'tweaking'....it's 'professional' tweaking, or it's 'intelligent tweaking', or it's 'medical judgement' tweaking. Yet you're still trying to sneak in an assumption here that the 'tweaking' is any of these. If the tweaking is based one experience, then your back to experimenting since the experienced doctor got that way by 'learning' on lots of premies along the way. If the tweaking is just guessing based on whether or not the baby seems distressed or not then it's not really 'expert' or even 'medical judgement'. That's not to say it may not be the best anyway, but it could very likely not.

To me this sounds a lot like the thermostat battle I wage and loose all year long. My position is set it to room temp. and the heat will kick on when it's cold, the air when it's hot. My stance is 'set it and leave it' will let the system operate most efficiently. Everyone else, though, is convinced that they must fight the cold by 'turning the heat up' and the hot by 'turning the air up'...which leads me to suspect office building designers are pretty smart to put plenty of thermostates on the walls connected to nothing so people can relieve their 'tweak itch' without messing anything up.

"rather than acknowledging the extremely unethical nature of lying to the parents "

I acknowledged that in the first sentence I wrote here. My only quibble is that you should be fully honest with the parents. We have no idea if tweaking by the doctor is 'intelligent' or just 'random' and no idea if it produces better or worse outcomes.

Regarding the medical equipment, I'm skeptical that there was no provision made for actual cases of respiratory distress. I'd be pretty surprised if there was absolutely no way for the staff to give the premies more oxygen (what if an oxygen line got kinked and the levels dropped to zero?).

Regarding the medical equipment, I'm skeptical that there was no provision made for actual cases of respiratory distress. I'd be pretty surprised if there was absolutely no way for the staff to give the premies more oxygen (what if an oxygen line got kinked and the levels dropped to zero?).

So you're defending this? Because of some vague idea you've made up in your head that somehow "provision was made" for something or other? If you are going to defend tampering with medical equipment to deceive medical personnel so they will literally think the oxygen levels are different than they are, you're hopeless.

But in general, you've just been defensive about this whole thing from the get-go. I have no idea why, really. I seriously don't. Maybe it's just some kind of knee-jerk. This ought to be a place where politics wouldn't even matter. I wouldn't care if this were decried by what I regarded as a left-wing source. The whole thing cries out for major, major punishment of everyone who authorized this multi-layered deception.

Lydia, you also have provided no evidence that anesthesiologists know what they're doing in prescribing and adjusting dosage levels in response to physiological readings. Therefore it's obviously rational to assume that nothing much underlies their judgment on such matters, and participate in a study which set those dosages at an arbitrary level irrespective of his judgment, and gave him false readings of your vital signs to boot.

At least, that's what I think you're being asked to buy into. None so blind as will not see, and so forth.

Having watched my prematurely born son nearly expire in front of my eyes from having been born with underdeveloped lungs just six months ago, it is unimaginable to me that someone would defend an experiment of this sort on the grounds that it's safe to assume that the NICU staff who saved his life really didn't much know what they were doing when they closely monitored and adjusted his oxygen levels in response to his vital signs. If I discovered the equipment in that delivery room had been tampered with to deceive them on that most vital detail, there would be...trouble.

It's strange to say I'm being 'defensive' when my first statement was that I agree parents should be fully informed. It's also strange to say I'm defending putting premies in danger when I point out that I don't buy Lydia's description of the experiment (i.e. absolutely no way to really tell if the baby wasn't getting oxygen and no way to provide more if that was the case).

In clinical studies modern ethics requires that the groups either get a proposed treatment that people reasonably think will help them or absent that get the 'standard of care' if they are very sick, (in other words, you don't get a placeabo if you're dealing with a serious cancer...you either get the new treatment or the best old treatment). This is, of course, better than what used to happen in the past but it still leaves the individual facing some measure of risk. If the new treatment works better you'll make out better, if it works less you will make out worse. If the person who is subject to the experiment can estimate his odds of coming out better is no less than his odds of coming out worse then it's ethical.

That would mean for your argument to work you have to show that the babies subjected to the 'normal tweaking' had *more* reason to expect that would work better than a policy of 'set low or high then leave it there'. Clearly that would be the case for setting the level very high or very low and leaving it, but within some range it would cease to obviously be the case. At the point where it becomes a toss up whether or not treatment A, B or C works better the study is ethical IMO.

As for 'tampered' equipment, what if it turns out that tweaking ends up causing the most damage? What if it turns out that while there's a tremendous temptation for staff to 'tweak' given that it *seems* to provide for short term relief the reality is that it causes by far the most damage? In that case what should our response be if it turns out that 'playing with the thermostat' isn't just useless but positively dangerous? I suspect the answer would be to remove the thermostat entirely or make it so that only one doctor can change it. Nonetheless, for purposes of the study I'm not sure it's unethical to deceive the staff if you have just as much reason to think 'tweaking' is harmful rather than helpful but I would say there would have to be some provision for someone who knows to always be around and some provision for the tampering to be overridden if it was obvious that he needed oxygen.

Note I'm just working with the facts as you present them to me. I haven't read the study myself so I'm simply relying on you to convey the story in an unbiased and true manner. I'm 100% open to the possibility that there were unethical aspects of the study. I think parents should know exactly what is being studied, how it's being studied and what reason researchers think the study has the potential to benefit their children. I'm not so much open to a blanket assertion that it's unethical to 'play the office building thermostat trick' on medical staff. If the 'trick' prevents harm then it's hard to see how it is unethical simply because it hurts the hubris of those who thought their 'judgement' was helpful rather than harmful. Is that a long term solution if it turns out tweaking is harmful? I don't think so but we haven't gotten there yet.

A summary of the study can be found at http://clinicaltrials.gov/show/NCT00233324

Of interest is the section called 'arms' which indicates what type of treatment each group was supposed to receive.

The study had 4 arms, two sets were targetted 85-89% oxygen saturation and the other group was targetted for 91-95%. This was achieved by either using intubation or CPAP which is why there was 4 arms rather than 2.

Unfortunately clinicaltrials.gov just provides a high level summary so we don't have results or details.

What's interesting about this is:

1. Since the babies had a targetted oxygen satuation level, there had to be a way to add more or less oxygen. Even the 'low' group still had an 85% target so if a premie fell below that there would have to be some way to add oxygen. This seems to contradict Lydia's description of babies needing oxygen and the staff unable to provide it because the machines were tampered with. Clearly someone or something had to be keep track of the actual oxygen level and applying more or less as needed.

2. The parents consent was obtained *before* delievery. The description provided of a mother in labor being asked to sign a form for some fuzzy 'study' as she is wheeled toward the delievery room doesn't appear to be true either.

3. Lydia's argument now is even tougher. We had one set of babies held from 85-89% and another from 91-95%. Unless she can show it's obvious that babies do better at above 95% or below 81% or they do better shuttling between the first range and then the second one I don't see how she can assert it was better to be in the study than not.

Does this mean we should trust the study was done ethically? Of course not. But since Lydia's description now appears far from accurate which means she is an untrustworthy source or has relied upon one.

This seems to contradict Lydia's description of babies needing oxygen and the staff unable to provide it because the machines were tampered with.


Boonton, you're turning into a nuisance. I never said that _no_ adjustment was possible. I have known all along that they could turn it up or down but *only within the target range*. The tampering stopped them from going out of that target range ("target" for their experimental group) even when clinically the medical personnel would otherwise have wanted to do so. The tampering made them think that they had adjusted it to a level to which they had not adjusted it. I have always understood this aspect and have never said anything to contradict it. You are just attributing a position to me that I have never held. And you're doing it to defend the study.

Which is crazy. As for whether the study was done ethically, you pretend to have acknowledged the problem with informed consent but are now acting like it is in doubt whether the study was done ethically??? Despite the fact that your silly "discoveries" don't address that issue at all and that we have documented evidence on that issue from the parents themselves?

Besides, you think it's ethical to tamper with the equipment, and I don't. The study could _not_ be ethical while they were doing that.

And, yes, the babies might very well do better shuttling between the lower and the higher ranges of the study. The doctors obviously think that they do, which is why the equipment had to be tampered with. You just make stuff up. "Uh, I dunno, I think maybe this doesn't make a difference. Just because. Because I'm pretty sure the people who made up this study knew more about what was best for the patients than the doctors actually treating them. And the difference between those ranges doesn't sound like a lot to me."

What silliness.

2. The parents consent was obtained *before* delievery. The description provided of a mother in labor being asked to sign a form for some fuzzy 'study' as she is wheeled toward the delievery room doesn't appear to be true either.

Are you nuts?

"before delivery" means before the baby is fully delivered - completely out.

Most premature births occur as a crisis - nobody expected the baby to be born 2 months early, but here she is all of a sudden deciding to come anyway for any of 100 reasons. So it's not like the mother and father are sitting around in the waiting room filling out paperwork before they decide to start labor and delivery or something - the birth process is already underway typically. If they are lucky, and the parents are on the ball enough, they get to the hospital early enough that the doctors can manage to STOP the labor before the deliver process gets very far, and THEN they might have some time on their hands...IF. Otherwise, which is a lot of the cases, the labor is already in full swing and there is nothing they can do but make it as close to a stable, healthy delivery as possible, and get ready to treat the baby in the NICU immediately. In either case, the parents are in crisis mode before the consent paperwork is put in front of them, and in the typical case there is little time.

But we already know it cannot be true consent if the doctors cannot explain the risks and alternatives correctly.

Ah, yes, I didn't notice Boonton airily saying that the story from the mother "doesn't appear to be true." I can't fully figure out how he thinks reading the study protocols tells him that. Did they contain a credible ex post facto rebuttal of the mother's claim? No? Yeah, I didn't think so.

Tony answers very well the absurdity of claiming that the stories in the article must be false because parental consent was obtained before delivery. Perhaps Boonton is under the impression that preemie babies are delivered by a scheduled C-section three weeks in advance and that the protocols mean they had to sit down and have a non-deceptive, detailed, informative discussion with all the mothers ahead of time. In which case, the mothers interviewed in the main story are just lying, I guess. Because Boonton says so. Because researchers would never do anything unethical. Or something.

I think we should articulate what exactly makes a medical study ethical. I agree informed consent is required. I think what also is required is that those who participate at least have a chance of being better off because they did.

Consider this example. Say I did a study that consisted of dropping 50 people out a one-story window and another 50 out a two-story window and counting how many more deaths and serious injuries happened between the two groups. Might this produce some useful info? Sure, not much but a bit. Would it be ethical? I'd say no. If you participated there would be 0 chance you'd enjoy any benefit from it. You're either going to get hurt, or get really, really hurt.

Compare now a study where 50 people get a new BP pill and 50 get the standard pill and a year latter we see which group had fewer heart attacks. We don't know if the new pill works better than the old or worse. If you volunter you might get the current pill...which we know does something...or the new pill which may make you worse or better off. Could you loose? Yes but you could also win so IMO the study isn't unethical. Sadly sometimes we have to take risks to succeed.

So here we have:

Treatment A: move around 10 points of oxygen

Treatment B: move around only 5 points

You tell us treatment A works better than B therefore the study must be unethical. How do you presume to tell us this? Argument from authority. Doctors are gods, if doctors think A works better then A must work better.

Yet anyone with even a smattering of experience with the medical profession or the history of medicine knows this is absolutely false. History is filled with examples of doctors insisting something worked when it didn't. For example, the doctor who discovered stomach ulcers were caused by bacteria once tried to convince another doctor to not remove a patient's stomach...begged him to just try antibiotics to see if that would cure the ulcer. His efforts were failed even though it would have been the most trivial thing in the world to try.

"Just because. Because I'm pretty sure the people who made up this study knew more about what was best for the patients than the doctors actually treating them. And the difference between those ranges doesn't sound like a lot to me."

Err sorry but you're the one tossing around accusations that people behaved unethically. If you're going to bear witness against your neighbor it's YOUR obligation to have your facts right. I'm no expert on premie oxygen levels but it certainly seems plausible to me to think that A.vs.B is a tossup given what we know. For you to claim unethical behavior you must demonstrate that B is clearly an inferior treatment hence it would be unethical to subject any babies to it.

On delivery: I never said the mothers lied about how they were approached for consent. I remind you again I began my comments by agreeing such a study has to very clearly tell parents what is being studied, how it's being studied, and why it may help or hurt their children. But we do have some problems here:

1. If there's no clear difference between what we know about A.vs.B, the claim that premies were put at risk becomes harder to swallow. A mother could have declined the study and still had a doctor who decided to only vary the oxygen 5 pts.

2. The premies were randomized based on sealed envelopes in the delivery room. In other words according your depiction of the events, mother went into early labor. She was approached by researchers who explained the study and got her consent (to what detail they explained we don't know and should investigate). When the baby was delivered, the staff opened a sealed envelop which told them which of the 4 arms the baby would be assigned too. It sounds like a good portion of the medical staff, including the doctors in the delivery room were well aware of the study and well aware that it consisted of letting the premie vary by only 5 pts. These sound like the same people you're telling us have this godlike 'medical judgement'. Clearly when they learned a study was being done that let premies vary by just 5 pts, they weren't shocked and didn't leap to the conclusion that it was obvious a wider variation was more likely to prevent harm.

to what detail they explained we don't know and should investigate

Actually, we have a pretty good idea, because we have their testimonies. I linked a story that shows that I did not make up and am not "throwing around" accusations.


A mother could have declined the study and still had a doctor who decided to only vary the oxygen 5 pts.

Except that that isn't what doctors normally do, so probably not.

Look, at this point, you're just making stuff up, so you're not worth answering anymore. In fact, you've pretty much been making stuff up all along. YOu haven't even acknowledged the silliness of your attempting (above) to pretend that it was some kind of "gotcha" that "consent" was obtained before delivery. In other words, you really don't even know how to read this story or what's being described.

Nothing is made up here Lydia. I provided you with the two different treatments, A and B (actually B could be divided into two subgroups). You've provided no evidence that A is better than B, but you have provided reasons why that might be the case. I've provided no evidence that B is better than A, but I've provided reasons why that might be the case.

Absent any evidence which is the better treatment, then which one to use is essentially a tossup. Doing A is no more or less ethical than doing B unless and until there's actual evidence to say one is an inferior treatment.

Now I've proposed a way to evaluate whether a study is ethical. Namely does it offer the possibility of help to those who participate. If A and B are a tossup, a baby might be helped with B therefore it wouldn't be unethical for him to be in the study.

You can talk all you want about 'tampered machines' but something is wrong with your narrative. Clearly some variation had to have been possible and accurate measurements had to have been possible otherwise the staff couldn't have kept the babies within the assigned range. Likewise clearly the staff, esp. doctors in the delivery room, were engaged with the study so if your're asserting their 'medical judgement' matters then their own judgement seems to have been that they didn't know themselves whether A or B was better.


Suppose we went to the doctors and study organizers and proposed this to them: We are going to magically turn you into a premie. Without knowing the results of the study, we will only let you choose to be a premie born to a mother who participated or one who didn't. Which will it be?

I strongly suspect you're going to get a 50-50ish breakdown there, or at least you're not going to get an overwhelming majority opting not to be a study premie. Leaving aside the issue of properly informed consent, if it that was the case would you be willing to reconisder your opinion about the study's ethical status?

Sweet sunshine. Boonton, kindly take your spidery cogitations to some hipster Twitter account; spare us this facepalm-fest.

And while we are discussing what makes an ethical or unethical study, consider this statement very carefully:

"But this was all said to be "within standard of care" by the sophistical logic that the oxygen levels given to the babies all lay within the range that is the "standard of care." Obviously, the real standard of care is to vary the oxygen levels within that range"

So some doctors use aspirin for headaches, others motrin. Since both are the 'standard of care' this would seem to imply it would be unethical to even do a study where one group used aspirin and the other motrin. After all, the true 'standard of care' is to use both as needed! Of course the really useful studies are ones where a 'standard of care' is compared against some new promising treatment since that is just about the only way the standard could ever hope to get better. Yet if it's even unethical to conduct studies *within* the standard of care then exactly what studies could ever be done ethically?

IMO the standard is only useful in that it's a baseline for the ethical requirement that those in the study have a chance to benefit personally from it. In other words it would be unethical only to have a study designed to give everyone in it something bad just to provide knowledge that would only benefit others (i.e. dropping people out of different windows to see what types of injuries happen)


The crazy thing, Boonton, is that you don't even seem to _understand_ what was done with the oxygen machines to falsify the readings as to how much oxygen was being given. I could explain it _again_, but I don't think you'd understand it even then, so I'm not going to bother. And the comparison to a study comparing Motrin and aspirin is laughable.

Lydia, that's a moot point. You yourself said it was unethical because it wasn't the 'standard of care'. If the machines were not 'rigged', if the staff was just under strict orders to not vary the machine outside the assigned range that would still fall within your objections to the study.

So once again I challenge you to show how one could do any study ethically.

I said that it is weaseling and sophistical to claim that the treatment of the preemies in the study _was_ the standard of care. Whether going outside of standard of care for a patient is ever ethical under any circumstances whatsoever is a question I did not address and that is too broad to address. It would in any event always be unethical to abandon standard of care by deceiving the medical personnel actually treating the patient on vital questions like how much oxygen the patient is receiving, which was what was done here. It is also, of course, utterly unethical to depart from standard of care without obtaining full informed consent--something you pretend to agree with but then constantly waver on by pretending that maybe, somehow, this study was ethical in that regard anyway, testimonial evidence to the contrary notwithstanding. You are so incredibly careless that I do not know why I bother to answer your careless comments.

So a very famous study consisted of having psychology students present themselves to mental hospitals with a set of symptoms. After they were admitted they did not fake any symptoms but did not reveal the ruse to the staff. Very interestingly, the hospitals did not do a very good job diagnosing the fact that these 'patients' were not mentally ill either before or after admission. It was a real challenge to the psychology profession which claimed to have objective diagnostic criteria, but the entire study was premised on deceiving the medical professionals.

So:

1. I haven't disagreed with you in terms of informed consent. I doubt there are many studies that suffer from 'too much informed consent'. However there's no 'testimony' offered here. Testimony is a continuous statement offered in a controlled setting (often but not always under oath). You have a news article that features edited statements from parents. We do not have a copy of the consent form, we do not have any statements from those who conducted the verbal explanation of the study to the parents. So by all means investigate the consent aspect of the study and go to town on shoddy practices. But be honest, if no one knows what is the best treatment option, then there's risk no matter what a parent or doctor chooses to do. Don't pretend that 'medical judgement' is known to be the best course and the study needlessly increased patient risk by ignoring that.

2. In terms of being unethical, sorry the only standard here that matters is to the patient. Unless you can show that altered meters are reasonably expected to harm the patient, there is no ethical problem with deceiving staff. Consider, suppose the results show that 'tweaking' was actually very harmful to the babies. By what ethical standard could you say it's ok to harm children for the sake of staff to avoid 'offense' at being deceived? If tweaking is very harmful then the machines should all be designed to make tweaking impossible or very difficult.

3. So a lot depends on how meters were altered. Clearly the meters could not have simply been total fictions since the babies were kept within a narrow range. So whatever system was used still had to connect somehow to the 'true reading'. As luck would have it, the study has actually been published so you can read it at http://www.nejm.org/doi/pdf/10.1056/NEJMoa0911781. It's somewhat technical but it seems like the meters would revert to true readings if the oxygen level fell below 85% or above 96% so babies were not suffocating without oxygen while staff saw meters telling them the baby was at a safe 90% or so.


4. The actual results are interesting as well. Basically the lower oxygen group had less eye damage but a slight increase in death risk. The high oxygen group had a higher risk of blindness but slightly lower death risk. That's a striking result since the trend in the recent past has been for 'medical judgement' to lean towards less oxygen to avoid eye damage. That means 'judgement' has been causing deaths to increase (unintentionally of course but that's the 'price' being imposed nonetheless).


Knowing the results it's interesting to ask again if you could be beamed into the mind of a mother about to give birth would you choose to participate or not? Informed consent in that case would not be an issue since you're now better informed than anyone ever could have been. If you had participated and gotten the high group, you'd have less risk of death than the low group or those who didn't participate. On the other hand you may have ended up in the low group with a lot less risk of blindness but slightly more risk of death.

To be honest I would view it as a bit of a toss up. I could understand why some would say yes and others no. Why some would want to go in the high group and others into the low group. Yet that belies the claim that the study itself is unethical. If you can't even be sure whether or not it was better off to be in the study or not how exactly could it have been unethical?

Now compare that to one of the most infamous unethical studies; the Tuskegee syphilis experiment. Pretty simple there how to choose if I 'beamed' you into the mind of a patient. Participate and essentially get no treatment for syphilis as it destroys your mind and body vs don't participate and get treatment for syphilis. Pretty easy to see that participating offered no chance of benefit at all.

Another 'study' to consider is the guy who figured out bacteria causes ulcers. He demonstrated it by drinking the bacteria himself, getting ulcers, then cured them with antibiotics. Clearly that would be an unethical study to do on others since the best they could hope for is to get better after being made sick. The only thing that saves it ethically is that he did it on himself so he presumably has the authority to take responsibility for harming his body (he also scored a Noble Prize for himself).

I think the 'standard of care' is totally irrelevant here to whether a study is ethical or not. The standard of care is really just the current educated guess by the medical community of what works. It's openly acknowledged in medical schools that the standard is subject to drastic revision and students are indeed taught to expect that over time most of what they learn the standard says will turn out to be wrong.

Since the standard is unreliable and subject to constant change it doesn't make sense to use it as an ethical yard stick. Instead IMO the better metric is to ask from *only* the POV of those participating in the studies, is there a reasonable chance that those assigned to each arm might end up better off?

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