Changesurfer Radio – Kids, Medical Ethics, and ER

James Hughes

Thank you. Thank you. Thank you.

James Hughes

And the author of a book, Do We Still Need Doctors? Welcome, John Lentos.

Dr. John Lantos

Thank you. Great to be here.

James Hughes

John and I, in the spirit of full disclosure, used to work together in the bioethics program there. He's also faculty in the McLean Center for Clinical Bioethics. And he... Hasn't

Dr. John Lantos

been the

James Hughes

same since you left. I know. I'm hard to replace. But John is a very well-known... perhaps the leading pediatric ethicist, I'll say that for you, in the country. And I know that you haven't followed the most recent episodes, but I think for many listeners, their principal exposure to pediatric ethics is probably the television show ER, and I'm a fan of that. This week, Doug Ross, the pediatric attending on ER, will be leaving as a result of several of his experiences ethical infractions, and I wanted to just run them past you and see what a trained pediatric ethicist thinks about these situations. Okay. He's been treating a child with a progressive neurological disease. And the first thing that he did was break a clinical protocol by giving a drug that was being tested for one purpose to this child with a progressive disease. And the attendings, the other attendings who found out about it, thought that this would result in the hospital losing funding for many years and might do serious damage to everyone there. Is that something that physicians have faced?

Dr. John Lantos

It is. I mean, I think the thing... People should know is that Doug had an alternative if he wanted to use a drug like that. For people who want to use unapproved drugs without sanctions, there's something called compassionate use, which is permission from the hospital to use an unapproved drug. It has to be approved by the Institutional Review Board. It's the same committee that oversees human subjects research. But the idea is that the doctor thinks it's a drug that's clinically appropriate for the situation that the patient's in, that there's enough evidence to suggest that it might help, that nothing else is known to help better, but that it's not officially part of a research protocol. And Usually that can be obtained in an emergency situation in a matter of hours or in a non-emergent situation in a day or two. So Doug's rashness in taking the law into his own hands I think is consistent with his behavior throughout the series.

James Hughes

He often pits himself against authority in a way that he doesn't look into the alternatives of what he could have done. That's right. He thinks he's defending his patients' interests. And it seems also peculiar for him to, for the show, to portray clinical trials as being so rigid because in reality, clinical trials seem much more flexible and perhaps too flexible for physicians to admit patients on a more haphazard basis. Do you think that that's true?

Dr. John Lantos

In some ways, the process of doing a clinical trial, the administrative oversight is similar to the administrative oversight for drugs in general, prescription drugs in general in the United States. That is to say... There's a lot of upfront bureaucratic red tape in order to get a trial approved or a drug approved. The Institutional Review Board carefully scrutinizes the protocol, goes over the informed consent form with a fine-tooth comb, makes all sorts of somewhat picky and minute changes in exactly what's to be said and what's to be done. But then, in general, if the protocol is approved, there's almost no subsequent oversight of how it's carried out, except that which the investigators choose to show the Institutional Review Board. They're mandated to report every adverse event or side effect, but they can decide what counts as an adverse event or a side effect. Similar to what happens after a drug is approved, the FDA carefully scrutinizes the evidence to show that the drug is effective in some defined clinical circumstance. There has to be evidence from randomized controlled trials, usually trials done in the United States. They often don't accept European data as valid for reasons that are beyond me. But then once a drug is approved for any indication, it's available and physicians can write prescriptions for it for any other indication, whether it's been proven beneficial or not, and there's sort of no post-licensing oversight.

James Hughes

And that's in contrast to Europe where drugs are approved for very specific purposes relatively rapidly.

Dr. John Lantos

I'm not too familiar myself with what happens post-approval, but they definitely manage to get drugs approved more quickly in Europe than they do in the United States. Whether they curtail their use after they're approved in a more rigorous manner, I really don't know.

James Hughes

Now, another one of the situations that Doug Ross on ER has faced, which is a much more serious infraction, which is that the resolution for his having broken the clinical protocol was that he wasn't to prescribe narcotics without a co-signature by his other attendings. And that actually takes us back to last year when he... did a rapid detox on an infant. Did you catch that?

Dr. John Lantos

That one I saw.

James Hughes

That one you saw. Well, what did you think of that, the rapid detox situation? I mean, often pediatricians find themselves in a conflict between being the advocate of the best interests of patients vis-à-vis the negligence of parents, and that seemed to be that kind of a situation. I

Dr. John Lantos

don't know, it's complicated, although I think to a certain extent what Doug represents best is the...

Dr. John Lantos

hubris that some doctors have in thinking that they know what's best in every situation and that any sort of collective decision making or the input of other

Dr. John Lantos

involved parties represents a questioning of their authority or of their omniscience. In most cases, not all cases, there are mechanisms for doing that sort of thing, even the rapid detox. And even if it was the right thing to do, the way Dr. Ross did it unsupervised in the ER when he'd never done it before, seemed to me to put the patient at risk. I'm surprised he got off so easy.

James Hughes

So in this situation, he is sending this child home with a fatal neurological condition. The genetics attendings who have been supervising the child's care don't want to go through the procedure to do a home care to allow the patient to die at home, and the mother would prefer the child to die at home. Doug sees this again as a situation where he has to step in and act like God, and he forges the signature of a fellow physician. Obviously, forgery takes us out of the realm of the ethical and into the realm of the clearly illegal, but what alternatives would he have here with a patient where some attendings don't want to release a child into home care, but the parent clearly wants the child to have home care?

Dr. John Lantos

It seems like in that case the alternatives are really with the parent. They should insist on the obligations of the genetics doctors to help them institute a palliative care plan that they see as preferable. If people, certainly if competent adults choose to die at home rather than in the hospital, They are not only allowed but encouraged. If parents choose to have their children who are acknowledged to be dying, if parents choose to have them die at home, they should similarly be both allowed and encouraged and assisted in that plan. So in that one, I think Doug actually was right. The genetics attendings were wrong, but it was the parents' ultimate responsibility to insist that the plan take place.

James Hughes

Now, the particular situation that he, the thing that he signed off on with forging another doctor's signature was to get a patient-controlled analgesia unit. And it struck me that, in general, patient-controlled analgesia is where the patient themselves gives the timed and controlled doses to themselves on the basis of their own perception of pain. In this case, it was a parent looking on a child that's totally noncommunicative and giving that child PCA doses, which presumably aren't going to be able to be fatal for the child, but it seems a very different application of that technology. Is PCA used in that way?

Dr. John Lantos

No. Certainly not often. I'm not sure if it's ever used that way. It's important to realize, as you said, that patient-controlled doesn't mean entirely patient-controlled. Whosoever writing the orders can specify maximums for each dose that is delivered when somebody presses the button, and for a four-hour maximum.

Dr. John Lantos

It seems to me it certainly could be used in that way with the parents deciding when and how much to administer without putting the child at significant risk. It's also interesting just as a conceptual problem to think about what significant risk would be for a child who's acknowledged to be dying and thought likely to die within a matter of days when the most dangerous complication of intravenous narcotics is that someone would stop breathing and die.

James Hughes

Right. So why didn't they just give her a big set of syringes to inject him with, is that what you're saying?

Dr. John Lantos

Well, I mean, I think it represents sort of, you know, the general narcotics phobia that our society has and somehow a fear that...

Dr. John Lantos

Addiction is worse than pain, even for someone for whom death is imminent, which is completely irrational, but widespread.

James Hughes

And it's not just narcotics phobia. Physicians are under a drug war-based surveillance by the FDA and the DEA to make sure that they don't prescribe narcotics.

Dr. John Lantos

Yeah, well, it's interesting that physicians seem to have internalized an even more rigorous standard than the standard that you are alluding to that is itself pretty rigorous. But a lot of physicians won't even do things that they're allowed to do under that law. Some because they clearly don't understand the law and are afraid that appropriate palliative care is illegal. but others even understand the law and just don't seem able or willing to follow widely agreed upon practice guidelines for pain management and palliative care.

James Hughes

This situation, obviously physician-assisted suicide isn't something that you often face with children, is it? But the issue of pain control and Americans' inability to grapple with pain control is central to the physician-assisted suicide debate.

Dr. John Lantos

For some people it seems to be the key issue. That would be for people who... accept the fact that assisted suicide would be appropriate in situations where patients have intractable pain, but just insist that most, if not all, pain is not intractable, that is, can be controlled with appropriate non-lethal doses of narcotics or other pain medications.

Dr. John Lantos

So the question would be whether appropriate pain medications are being used enough in the current situation, and if not, they should be.

James Hughes

One of the articles, now to shift away from ER to the real world of what you've been writing about, One of the articles that you wrote earlier in your career which became quite famous was an article about the application of growth hormones to kids and the ethical problem of determining when it's appropriate to increase the height of children. Can you talk a little bit about that?

Dr. John Lantos

It's an interesting problem. Growth hormone is a

Dr. John Lantos

natural hormone that Most people make, the pituitary gland makes it, and without growth hormone, people don't grow. Some children are born completely growth hormone deficient, and their final adult height will be two and a half or three feet.

Dr. John Lantos

When this syndrome was discovered, growth hormone deficiency, it was before drug companies knew how to manufacture growth hormone. So they used to get it from animals, particularly cows and pigs who were being slaughtered. And it was very difficult to get enough. the government which ran the program set very rigorous standards for what would count as growth hormone deficiency. And the standards pretty much matched the supply of growth hormone to this somewhat arbitrarily defined demand. What happened then in the mid-80s was drug companies using recombinant DNA technology figured out how to synthesized growth hormone, and suddenly the lid was off. The supply was potentially unlimited. It was still expensive, $20,000 a year, but for people who had money or if other mechanisms to pay were available, any kid could get it. So suddenly the question became whether treatment of people who were short for other reasons with growth hormone first of all, would work, would make them taller, and second of all, if it did, whether it was appropriate to be sort of fiddling with Mother Nature

Dr. John Lantos

in some of the more overblown and futuristic scenarios, offering parents the choice of determining how tall they wanted their children to be.

Dr. John Lantos

We tried to analyze it from the perspective of models of health and disease and to ask whether and in what sense short stature could be considered a disease with the idea that treatment of disease was the proper province of physicians and other sorts of biologic enhancements were not. We ended up deciding that short stature in general should not be considered a disease. Doctors shouldn't be prescribing growth

James Hughes

hormone. A lot of the problems that people of short stature have, lack of social promotion, lack of success in love or whatever, are problems of social discrimination and therefore more properly social change problems rather than medical problems. Is that part of the perspective?

Dr. John Lantos

Yeah, I mean the argument... that short stature is either a disease or a disability usually rested on the sorts of data that you're talking about. People who are short do worse in school, they have more divorce, they have lower self-esteem, they make less money, and that therefore short stature is a significant disability. and growth hormone can alleviate the sequelae of this disability and so should be an entitlement, essentially.

Dr. John Lantos

One of the ironies was that growth hormone was used much more widely for little boys than for little girls. Little boys, in general, seem to suffer more stigma from being short, although little girls in general are shorter and end up shorter. And if you looked at the social data, would also suffer from many of the social sequelae that are thought to be associated with short stature. They earn less money, they're promoted less often, and all the other things that go along with short stature. So if the goal was to reduce those sorts of inequalities, the prescribing patterns by gender should have been the reverse.

James Hughes

Right. In fact, being a woman has this equalized, so we should be prescribing androgen to girls to...

Dr. John Lantos

Or sex selection prenatally, perhaps. I mean, if you're going to get into that sort of biological social engineering, the sky's the limit, I guess.

James Hughes

Now, the counterargument would seem to be that we do see a role for cosmetic surgery for people who have traumatic accidents to their face, their arms, their legs, whatever. And we acknowledge that the psychological burdens of living with disfigurement are a medical problem. How is that different from being short?

Dr. John Lantos

I think both draw on some sort of biologic or perhaps aesthetic norm. And to a certain extent... push the boundaries of what would be considered a disease. I guess the question there would be whether the sorts of cosmetic surgery that adults can seek or consent to are appropriate for children as well. You know, adults can alter their facial appearance whenever they want. They have to pay for it.

Dr. John Lantos

And the payment is an interesting kicker here, too. In the end, I ended up arguing that growth hormone was much more like cosmetic surgery and therefore should be treated more like a luxury good than like an entitlement, whereas health care for

Dr. John Lantos

real diseases should be more of an entitlement than a consumer good.

James Hughes

So you didn't argue that it was unethical for a doctor to prescribe a growth hormone for kids, but you argued that it was not necessary that a national health care plan, Medicaid, Medicare, something would be obligated to cover it.

Dr. John Lantos

That's right. And I thought the ethical problem would really be more for the parents, deciding whether they would subject their kids to three or four injections a week for... two or three years.

James Hughes

And the evidence is actually quite minimal now that it really improves stature over the long term.

Dr. John Lantos

Yeah, in some sense the debate has disappeared because it doesn't work, although something else that does work will come along soon.

James Hughes

Right. genetic therapy or whatever. And finally, I wanted to touch on the topic of your research for the last couple years, the neonatal intensive care unit studies, the debate over what kind of resources we put into the remediation and the taking care of sick babies, many of whom have problems as a result of, well, some of whom have problems as a result of poor nutrition or drug abuse or whatever of their mothers has been very hotly debated. Some parents, some people believe that these kids are an unnecessary expenditure of resources on kids who are not going to have good outcomes. And you've been looking into that question. What are some of the findings of your neonatal intensive care studies?

Dr. John Lantos

Yeah. Well, one of the first things we did was to try to address the issue of

Dr. John Lantos

useless expenditures, that is, expenditures directed towards people who would ultimately go on to die or whose care, at least retrospectively, appeared to be futile. We compared the neonatal intensive care unit And we found some interesting things there. If you're going to critique resource allocation because resources are being directed towards patients who ultimately will not benefit from them, the adult intensive care units are much more problematic than the neonatal intensive care unit. And the reason for that is that most neonates who die, die very early in their course. That is to say, 600 gram babies are very sick at birth. If they live for two or three days, most of their problems improve. So the ones who die, to put it most callously, die pretty cheaply. In adult intensive care units, exactly the opposite occurs. The longer you stay in the unit, the more likely you are to die.

Dr. John Lantos

and the people who are going to get out tend to get out in a day or two because they have a relatively easily reversible sort of problem. So we didn't think neonatal intensive care units should be critiqued along those lines. The issue of whether resources would be better spent on preventive care than crisis intervention, I think, has all neonatal intensive care units, but our healthcare system in general, And I think it's clear that it would be better spent on prenatal care and drug treatment programs and better nutrition and all those things. The evidence comes from almost every other industrialized country which has those sorts of programs in place and has a much lower incidence of prematurity and low birth weight than we do, and so much less need for neonatal intensive care. But... I don't think it's fair to single out neonatal intensive care for that failing.

James Hughes

Especially since in our regime, if we were to cut neonatal intensive care, for instance, at the behest of managed care, those managed care forces don't have very much incentive to turn around and start conducting expensive public health campaigns that may not redound to their profit.

Dr. John Lantos

Right. No system, not just managed care, but there's no central pot of money labeled infant mortality reduction that can either be allocated to the neonatal intensive care units or to the prenatal care programs and other preventive programs. Actually, most of the evidence shows that prenatal care by itself is not...

Dr. John Lantos

The most powerful factor in affecting infant mortality, the most powerful is ready accessibility to contraception, family planning, and abortion.

James Hughes

Family planning.

Dr. John Lantos

Right, allowing women or couples to control their reproductive lives and so not have babies until they're ready to.

James Hughes

Well, that takes us into adolescent ethics, and we don't have time to do that. So I'm going to get a rain check from you that we can come back and do more adolescent ethics later on, which since the population that you're talking to here is young adults and many parents out in the community, I'm sure they're interested in that.

Dr. John Lantos

I'd be happy to.

James Hughes

Great. Can people email you, John? Sure. At jlantos, L-A-N-T-O-S, at medicine.bsd.uchicago.edu. And the website for the McLean Center for Clinical Medical Ethics, which I happen to have actually constructed at one point, is ccme-mac4.bsd.uchicago.edu. And there will be links back to that from the Event Horizon website. Thanks a lot for joining us, John.

Dr. John Lantos

Pleasure.

James Hughes

You've been listening to Change Surfer Radio. Change Surfer Radio is produced at WHUS-FM at the University of Connecticut in Storrs. If you want to learn more about radical democratic transhumanism, or you want to share your thoughts about this show with me, Dr. J, email me at jhughes, J-H-U-G-H-E-S, at changesurfer.com. Also check out past and future shows and myriad relevant links at the website. www.changesurfer.com