Arizona strikes again.

Lawyer says:

Since last week’s news of Arizona’s new organ transplant/medicaid rules, denying certain types of transplants for medicaid patients as a cost-saving measure, I have been thinking about what to write here.

All I have been able to come up with is this:

Shame on you, Arizona government. This change is unacceptable. You are telling your citizens that their lives, which we can likely prolong and improve, are not worth the cost, and they can only get life-saving care if it is not on your dime. There are many things I believe a state should guarantee for all its citizens, but even if I were to strip most of them away, life-saving medical care would always be on the list. What’s worse, you’ve taken people to whom you have already promised such care and kicked them off the waiting list — unless they can raise hundreds of thousands of dollars. The life of a person with abundant resources is not worth more than the life of a working-class husband and father. Shame on you, Arizona.

Patients vs. Proof: Are Clinical Trials Ethical?

NYT had an interesting article last weekend about a promising new melanoma drug that was in clinical trials right now – profiling a pair of cousins in the trial, one who got the drug and one who didn’t get it. And couldn’t get it, despite the fact that it seemed to be helping. What an ethical pandora’s box we have here!The core dilemma:
In order to really know that a drug is both safe and effective, we have to do controlled clinical trials with a lot of patients – and to do these trials, we need a control group. Sick patients who aren’t getting the drug.

If we have a drug that shows great promise, it seems unethical to deny it to half of the patients. But at the same time, we can’t prove that it’s really a good drug without doing so, so ultimately, we get a great benefit as a population by making that “sacrifice” of some patients in the trial. It would be true if people were lab rats – but they’re not. Every patient is somebody’s kid, parent, sibling, etc.

So what can we do??

The regulatory pieces:
Besides just being good science/ arguably the best policy in terms of only spending healthcare dollars on treatments that actually work, companies do these trials because that’s what the FDA requires to approve the drug. And without FDA approval, the company can’t market the drug. If they can’t market it, they can’t make any money off it.

There is, however, an exception: a drug that shows great promise can be offered BY THE COMPANY that made it for “compassionate use,” or “treatment use,” that is, use, prior to approval. But this creates a problem: who would want to be in the study, where they might be in the control group and not get the drug, if it were available outside of the study context? Companies generally have little incentive to offer investigational drugs to non-trial patients, because they need approval to market the drug, and if they can’t market the drug, they can’t make any money, which pays for research and development, so. . . nobody would ever make new drugs.

How can we fix this:

Dad: I think a lot depends on the clinical trial design. Many have cross-over provisions if the patients don’t respond (i.e. if they get placebo). They can then get the “active” drug.   This is difficult in the case of cancer in which the time frames are long and the endpoints are generally  survival based.

Nurse: Although survival is certainly not the only benchmark for a drug’s success, especially in cancer. There’s a lot of discussion in evidence-based medicine about whether interventions increase survival, which is great, but it’s only one piece of the puzzle.

Lawyer: How does that work, though? Do they just put a check in the “didn’t work” box after the patient doesn’t respond in a fixed time-frame?

Why shouldn’t we just allow free access or marketing, as long as it’s clear that we don’t know for sure whether this works, once we’ve been through basic safety trials? In other words, if we think it’s safe, should the FDA, either directly or through the incentives they create, stand in the way of more sick patients being able to get the drug?

Nurse: Well, isn’t part of the FDA’s mandate to protect the public from totally bogus nonsense? I mean, think about supplements not regulated by the FDA and how much confusion that generates.

Dad: Safety has not been demonstrated for this drug. The Phase I trial was only 31 patients. Often, it takes thousands or more to identify serious safety concerns. This happened with Remicade [a drug Dad was instrumentally involved in. Or dare we say, invented.]

Nurse: That’s good to know/remember. This article, with its approach of profiling two specific patients, kind of mirrored (and encouraged) the public reaction to promising advances– as in, they have to have it and they have to have it now– when they may be jumping the gun. The article mentioned a promising breast cancer treatment from years ago that didn’t pan out. That happens, and I think that people may be a little misled and also may be unable to judge well if they are really starved for a crumb of hope.

Lawyer: What do they do with treatments for really rare diseases? Where the prospects of finding thousands of patients in a decent time frame isn’t so good?

Nurse: Also, as medical doctors, (even though they are researchers), shouldn’t they have some level of concern for patients as opposed to solely for data? At some point, shouldn’t we place patients’ well-being or relief of suffering above perfect data?

Dad: Then you would never find out if it really worked, and it would cost everyone a lot of money.

Nurse: Well but that’s where a crossover type design could be helpful. I think it’s inhuman to say to a patient, “we’re sorry, even though you are clearly deteriorating rapidly and your tumors are getting bigger, we refuse to try any other treatment because we might sully our results.”  And sure, it’s great if we prove that the drug increases survival, but if we have a fair amount of evidence (even if it’s not perfect evidence) that it has some beneficial effects, isn’t that good too? Why does death have to be the endpoint? That seems like a problematic element in the design.

Nurse: I wonder if there’s a way to do a retrospective study that would give us some insight– look at previous patients who received the chemo as a control. It’s not perfect, but perhaps it’s necessary from an ethical standpoint.

Lawyer: And don’t we already use lots of treatments that are FDA-approved, but really don’t work very well? They’re just the best we’ve got? I guess the question here is, are these better or worse than existing treatments? If we’re trying to improve, we need to know if we are — or not.

Selling a kidney? Read this!

Nurse: Beyond the stuff of urban legends, there really is a black market for organs– kidneys, especially, since a living donor can give one up and essentially have no ill effects. To be simplistic, the black market thrives because there are more people with kidney failure than there are willing– or cadaverous– donors. Iran has a program that allows the government– and the recipient, through a 3rd party– to pay the donor a “modest sum”. This brought up all kinds of stuff for both of us!

Lawyer: Hmm. The part about the recipients paying the donors was more immediately troubling to me. Access question — who gets the kidneys? Definitely legal issues here — in terms of ownership rights. Comes up in property law — in what way do you own your body/organs?
Nurse: I’d be inclined to say you own your body/organs more than anything else in the world– more than your shirt, more than your house. They are absolutely yours.
Lawyer: We can certainly conceive of different kinds of ownership — ownership that allows you to exclude others (you can’t just TAKE my kidney) or that allows you to give it away, or destroy it after its removal, but NOT sell it. These different sorts of rights can be separated from each other. At the minimum, we could say that you don’t own your body at all — all you have is a right to protect it against unauthorized invasion. So you can’t sell it or rent it out (prostitution, for example), and you can’t even control what happens to your body after you die (though in our society, you can) — see what I’m saying? Different types of legal rights we could or could not grant. Related question about who owns tissue excised from your body during non-elective surgery. (One case I studied involves the spleen removed from a patient with a rare form of leukemia being used for research and subsequent profit without his consent — and the court, though divided, allowing it, and granting him ZERO rights to any of the profits.)
Nurse: Is it ever ethical to pay living organ donors for their organs, as is done in this case (Iran)? There are of course lots of protections in place for the donors, including who can evaluate their suitability. Also, it’s a pretty small payment– but likely enough to be essentially coercive to someone who is hard up. in the article, doctors say they believe donors act out of altruism, but why then include a financial component at all? i can see including care for free, but why cash?
Lawyer: This might be part of the problem, too. . . people who are desperate might actually “under-price” this sort of thing. I’d venture to guess that in a real competitive market for this sort of thing, the value of all the pain and future uncertainty of giving up a kidney would be a lot more than $1200. But I agree — why cash at all? If it’s altruism, pay for their care, pay for some monitoring after the procedure, maybe even pay them for their time — but not for their organs.
Nurse: Normal consent procedures certainly won’t cut it, if you ask me– people frequently sign without understanding, knowing that the procedure is in their best interest. in this case, it’s in someone else’s interest, not their own. that changes the calculus drastically. to truly accept the risk, the donor must have a fairly sophisticated understanding.
Lawyer: How would you accomplish a “super-consent”? Is there such a thing already in place for other types of situations? Research?
Nurse: Research is the closest case I can think of, and research consents are far more extensive than a basic procedure consent. They can be pages and pages and pages, whereas a regular consent form that we’d use in the hospital is one page, with a minimal amount of information written in.
To what extent can the government intervene? it’s illegal to sell your organs, no? why? would a regulated system circumvent the concerns at all?
Lawyer: The government can intervene in that they can make it illegal to sell your organs — basically, if a doctor removes your kidney, you have no claim to payment. Of course, there can be all sorts of other “payment” that doesn’t leave a paper trail… bag of hundred dollar bills, etc. (cf. gestational surrogacy — can’t actually pay someone to do this for you. But you can over-pay them for nutrition during gestation, etc.)
Nurse: People CAN sell plasma and eggs, and both of these donation procedures carry some risk. not as much as nephrectomy, but still.
Lawyer: Is it just about the risk of the procedure itself, or also about possible compromised future health? (I mean, you definitely don’t need all your plasma or eggs, but don’t you need both your kidneys? Need as in, there’s a reason we have 2? Is the second one really just a backup? What are the increased risks of living with a single kidney? Will the health care system have to bear the cost of this risk, especially for the aforementioned patients who are indigent?)
Nurse: You really only need one. The risk of living with one is that you’re screwed if your one kidney fails. Otherwise people can live with a single kidney and have no adverse affects.
Lawyer: A further curiosity: are there really any other organs where we could see this come up? Most of the things we desperately need, we don’t have two of (e.g. liver). So, nurse, is this just, always and forever, about kidneys?
Nurse:  Well. . . for now it is. It is possible to transplant part of a liver from a living donor. I believe it’s somewhat riskier, but in general it’s fairly successful. And like our earlier discussion, things like blood, plasma,and  eggs are certainly part of the discussion.
Lawyer: I am also curious about alternatives. I know there has been work on artificial hearts — what about kidneys? (I mean, obviously, short of lifetime dialysis.)
Nurse: Well, dialysis IS really an artificial kidney.  And as of now, it’s the only other way to do it. And if we wanted to open up a can of worms about cost, both financially and in terms of quality of life, that would be a good one!

Ping-Pong Post: The Toughest of Choices

The New York Times and ProPublica collaborated on a story (more than a story, really) that will appear in this weekend’s magazine about health care decisions made in the immediate aftermath of Hurricane Katrina.

The upshot: some health care professionals administered lethal doses of drugs to patients who seemed almost certain to die anyway in a hospital that was completely cut off from all services. And though the doc in charge was not indicted on criminal charges, she is still facing wrongful death suits. These issues are painful to even consider in the abstract, but then, we didn’t go into nursing and law because they were warm and fuzzy. Some of the issues:

EVACUATING THOSE WITH DO NOT RESUSCITATE  (DNR) ORDERS LAST

Nurse: the most familiar things would be to evacuate the sickest first. the theory behind taking the DNR’s last is that they have the least to lose– typically, patients only have DNR orders if they are very old, very ill, or often, both. But this isn’t always true. Some people who are relatively healthy have DNR orders, not because they are dying, but because if they ever do die suddenly, they want to do it peacefully. When we don’t know the extent to which rescue would be possibly, is it wrong to take spots for people who may recover fully and live for thirty years in favor of those who are currently critically ill and are unlikely to survive a few years anyway? This sounds awfully harsh, but it’s a harsh world out there. But is a DNR order an OK way to decide who those people are? DNR is NOT the same as giving up or withdrawing care. have these people somehow relinquished their right to be save while they remain alive? If this was standard or common practice, it would change the meaning of a DNR order. (incidentally, i believe DNR’s are a good thing in a lot of cases and should be protected. people who are quite ill and have little chance of recovery may not wish to have their death prolonged by violent chest compressions. It can be very, very ugly.)

Lawyer: Yes, I see the concept behind using that classification, but it seems to be the wrong one. They appear to be using it as a shorthand for chance of recovery, in some ways, and you’re right, signing a DNR would be a very different thing if it also meant “Rescue Me Last.” If such a policy were to be instituted, it could only rightly be done with NEW DNRs — that’s not what people who already had them were signing up for.

WHAT IS “THE GREATEST GOOD”?

Nurse: This is what we look for in utilitarian ethics– which seems like a reasonable thing to apply in disaster situatios. but how do we define it? years of life saved? quality of life saved? number of lives saved? we can’t define any of these things in absolute terms. at memorial, they basically flipped the standard triage model on its head– the sickest were last instead of first. (in many models only the already dead or those who seemed unsavable would be passed over in favor of more stable patients).

Lawyer: Okay, I can only really speak to this with my disaster hat on, but in basic disaster medical operations (such as what they teach in CERT training) they teach you to, in initial triage, pass over people you can’t help quickly. Someone may be totally saveable — but if you’d have to stand there with your finger plugging their artery for half an hour while eight other people died, you’re not doing the greatest good. So how sick they are is part of it — but so is how far your effort will go toward helping everyone who needs help.

HASTENING DEATH?

Nurse: These patients got doses of morphine enough to supress their breathing. Is this murder, or is it comfort care? What makes that line? Is it intent? Is it outcome?  Is it ok if the person is dying, and the morphine lets them die without pain (even if it’s slightly sooner?). If the person is not dying, but they almost certainly will– in this case, it could be from dehydration, starvation, lack of treatment, or any number of things– then is it ok? If a person is conscious and lucid, that must change things– can you ask them? If they are capable of consent and you do not ask, that is almost certainly wrong. If you do ask, it may still be wrong. It’s gray. At Memorial, it seems that alert people were given enough morphine to kill them without being asked. Although I recognize the intent was to be compassionate, I find it deeply troubling. What happened is not really palliative care, either– it seems the intent was to end life, and the doses used are way beyond the standards of practice. I have no doubt that some patients really did get “comfort, peace, and dignity” in the words of one of the nurses involved. It cant have been an easy decision, but they went too far, I think. Some of the invovled people said that that’s what they would have wanted done for them. I don’t think we can use that. I frequently do things for people that i wouldn’t want done to me– all kinds of painful, life-sustaining treatment– and I know that a lot of healthcare providers wouldn’t want it done to them either, but that doesn’t mean that others wouldn’t.

Lawyer: Since law school has now started, I wasn’t able to read all, ahem, 18 webpages of this article, so I may be missing some details. And I agree with your line-drawing there. But I’d ask if those patients who seemed certain to die were taking resources from patients who stood a good chance of recovery.

Nurse: The doctor and two nurses who were arrested in the case were not indicted. I don’t think they should be. My concern here is with what is ethical going forward– laws and ethics are not the same thing. I’m glad that healtcare providers were protected here- we need to develop systems to guide and protect them during crisis. The doctor involved, Anna Pou, is now advocating for just this. You go, girl.

Lawyer: What Dr. Pou has been emphasizing is that the rules are different in disasters. We can’t use the same standards, and we can’t use the same systems. There are many laws already in place dictating the “new rules” in disaster situations, and many more in the works — they become active when disasters and emergencies are declared in any number of different ways. (e.g. a governor’s or presidential declaration, an HHS secretary’s declaration of a public health emergency, etc.) The last eight years have been fruitful in this area — but there is still a TON of work to do. I’ll save my treatise on disaster-specific laws for another day, but the take-away here is that legally and ethically, we can’t rely on our usual senses of right and wrong in the midst of a true catastrophe.

No Lie MRI

Lawyer: Last week, Emily Murphy at the Stanford Center for Law & Biosciences broke a story on their blog about a defendant trying to introduce fMRI-based lie detection as evidence in a child abuse case in San Diego.  The accused — a parent — paid a lot of money (don’t know how much) to No Lie MRI for a brain scan hoping to prove that he was telling the truth when he claimed innocence. You can read all about it on their blog.

I don’t know about you, but I was appalled — not only because they were attempting to use a completely unproven method, but because it’s almost certainly outrageously expensive — the parent was essentially buying evidence that most people wouldn’t have the resources for.

Interestingly, the evidence has been withdrawn. Maybe they realized that the academic community isn’t ready to accept this. Maybe something else happened behind the scenes. Either way, this is really a postponement of a court’s consideration of this kind of evidence.  It’s coming. The time to consider it is now.

There are two questions really: does it work now, and could it ever work in the future?

The answer to 1, many neuroscientists and lawyers seem to think, is either maybe or no.

The answer to 2 is open to debate. Could we get there? I go back and forth.

My biggest concern at this point is that non-scientist jurors will not have the tools to understand the evidence. White coats and medical/scientific-looking charts tend to seem more authoritative than might be warranted, and fMRI is a complicated technology. I studied it for years and barely understand the nitty-gritty of it myself. If you’re showing people a picture of a brain, with colors showing activation across time, what they’re seeing has been hugely altered to illustrate some effect, both mathematically and visually.  So even if the technology improves somewhat an/or is tested and the actual broad, relevant scientific community agrees that the technology is accurate enough, I still think we’d need to provide some scientific education to jurors before asking them to consider such complicated evidence.  It’s not as simple as it looks.