I just read the D.C. Circuit's opinion that recognized "the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient." I'm sure others will say plenty about the usual unenumerated rights debates; but I wanted to raise a question that I didn't see discussed in the D.C. Circuit decision — why isn't Roe v. Wade (as preserved in Casey v. Planned Parenthood) strong precedential support for that decision?
Roe concluded that the Constitution secures a right to an abortion, but it may be more accurate to say that it secured two different, though related, rights. First, it secured a right to an abortion during the first two trimesters (Casey has since cut this back to before viability); the government is entitled, especially after Casey, to regulate such abortions, but it can't prohibit them. This right vindicates the woman's right to choose not to bear a child.
Second, though, Roe held that even after viability — when the state is generally entitled to protect fetal life, and thus to ban most abortions — the woman still has a right to an abortion "when it is necessary to preserve the life or health of the mother." This right does not vindicate the woman's right to choose not to bear a child, since absent the threat to the woman's life, she can no longer get an abortion. Its purpose must be to vindicate the woman's right to protect her own life and health, even using a medical procedure that will kill the now-viable fetus.
Now of course those who strongly oppose Roe and Casey might not want to see them extended; one error, they'd reason, doesn't require others.
But if one accepts this second abortion right that I discussed above, or one is at least willing to accept it as binding precedent, why doesn't this precedent strongly point towards recognizing terminally ill patients' right to get potentially life-saving medication? (Note, by the way, that this is a right in the negative liberty sense of freedom from government prohibition, not a positive entitlement to government funding to the medication.) If pregnant women are entitled to protect their lives or even just their health using medical procedures, why don't others patients have an equal entitlement?
True, the government may have an important interest — which is generally absent as to abortions, which tend not to be dangerous as a rule — in protecting a patient's life and health against the potential dangers of experimental drugs. Yet surely this interest is extremely weak when the patient is already terminally ill, and the risks of doing nothing probably far outweigh the risks of trying something.
So can it be that a person has a constitutional right to get potentially life-saving treatment, but only when that potentially life-saving treatment involves the killing of a viable fetus that she is carrying?
I put the question (and much of this post) in an intentionally provocative way, to make it more fun to read; but I should stress that it is a real question, not just a rhetorical one, and there may well be important arguments that I'm missing. Please do let me know what those arguments might be.
Related Posts (on one page):
- Terminally Ill Patients' Right to Get Potentially Life-Saving Medication:
- A Constitutional Right to Drugs:
"the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient."
--then what legal reasoning could require a doctor's advice? Of course, "terminally ill" is suspect too, given the logic of Roe. Goodbye, FDA!
I was, by the way, reading the blog as procrastination from grading this exam question:
"Should the FDA be required to approve *prescription* drugs at all, since uninformed patients cannot use them without a prescription?"
Any thoughts?
Only if you exclude the one being killed from the definition of the "patient". Abortions are generally lethal, not just dangerous, to one of the patients.
Otherwise interesting in that we have to find the right to live in an opinion creating the right to die.
Stenberg v. Carhart, the partial birth abortion case, seems to be even stronger support, since it held that a medical procedure cannot be banned even if most doctors view it as unnecessary, and other procedures are available, as long as a respectable minority of physicians view it as the best method of treatment.
I also agree with Houston Lawyer that it is ironic that we have to rely on cases recognizing the right to take life to establish a right to save it.
But a patient having a fundamental constitutional right to experimental treatment would seem to imply, if not in this decision than in a future one, that it is not ethical to give placebo to patients when there is a treatment that may possibly be better. How, then, will it be possible to determine whether or not a drug actually works?
The pool of available patients is not unlimited, and in some diseases there is a very limited pool of available patients, so that it is necessary to manage the learning process by rationing patients among the different trial phases (and competing drug trials) to ensure there are enough patients available for trials to achieve their purposes. The folks upstream may need the water to survive, but if they do, will there be any fish?
We would seem to have a classic Prisoner's Dilemma situation in the way uncertainty is managed, because in this situation uncertainty can be resolved only for a society cooperative enough to be able to put on an organized experiment. A society where everyone does what is individually best in these matters would seem to one that is unable, as a community, to learn or improve. Such a society may lose badly as a result.
It is sometimes necessary to regard a society of people as forming a connected whole rather than merely being an amalgamation of atomistic individuals. The Constitution is not a suicide pact, and rights theories must, accordingly, necessarily have limits.
Isn't the drug company still free to only allow access to its drug as part of a study in which some will receive the placebo? Presumably, whenever FDA approval is important enough (to achieve wide prescription by doctors and thus a much larger market), a drug company would withold open access to the drug until it could conclude the necessary studies.
It seems that unless willing patients (AND the prescribing doctors) are willing to blidly throw themselves at any new drug, this limitation on gov't intervention shouldn't destroy drug company incentives to control release of new drugs in a way which ensures enough takers for placebo studies.
I have almost no specialized knowledge of this field, so I'm sure I'm missing quite a bit here. Could someone explain a little more clearly ReaderY's concern?
What you're saying (correct me if I'm wrong, and assuming for argument's sake as you do that the rights in question are real) is that it may be neccessary to violate the rights of a small group of individuals slightly in order to preserve those of a larger group to a greater degree sometime in the future. Then the society as a 'connected whole' is just a way of denoting people not present (far away or not yet extant...) for consideration of their rights too. But this is no abrogation of individual rights; it's just an abstraction of them to complicated situations. The idea that the society is more than the sum of its parts certainly cannot be upheld by adding up and counting the (individual!) rights of its members as your example does.
Like many bad ideas, federal regulation of what medicines (as opposed to intoxicants) you could obtain is part of the Progressive Era's "mother knows best" approach to government. That isn't to say that the motivations weren't positive, and the results were generally positive as well, when you consider how freely opiates were used in drugs intended for children, but once the federal government got into that sphere of influence, it is rather hard to stop its sphere from enlarging.
Prof. Volokh,
One distinction is that, unlike the putatively protected late abortion, these drugs do not demonstrably protect life or health.
The appropriate analogy would be to a new abortion procedure that either failed to renmove the fetus much of the time or that produced a higher mortality rate in the population seeking late abortions than either (a) letting the pregnancy proceed or, alternatively, (b) using standard abortion procedures.
Legal protection of the right to seek efficacious treatments can only extend to efficacious treatments. But a drug that has not gone at least through successful phase II trials (and i would argue for phase II trials, because there are a lot of positive results in small phase II trials that subsequently don't pan out) is, in essence, just a putative drug. There is no reason prior to successful testing to think that such a substance will protect life or health. Indeed, there is more reason to think it will be injurious to life and health, becasue most drugs don't make it past phase II testing.
So, granting, arguendo, that there substantive due process right to buy successful drugs, the government may still have the power to reasonably determine which treatments are effective.
1. referencing Roe is likely to provoke strong reactions from my colleagues, as well as the public and the legislature;
2. if Roe is counteracted somehow, any dependent decisions may be called into question;
3. others?
How does your argument handle the case of [i]terminally[/i] ill patients? Surely the government interesting in preventing preventing the use of ineffective treatments is rooted in the desire to keep patients alive and healthy. Isn't this interest very weak when the patient is terminally ill?
Your arguments seem to justify coerced human experimentation (e.g., Nazi Germany) by implication, and experimentation by neglect (e.g. the Tuskogee syphillis project) directly, for the greater good of society. The only difference I can see is the random/non-random distinction. Is this enough to take this type of forced human experimentation out of the realm of the criminal and make it respectable?
Or did I miss other distinctions?
A corollary issue would be: would it be considered ethical for pharamaceutical firms or the government to ration/prohibit lifesaving treatment for the greater good, or for personal enrichment?
Your argument, with respect the pool of available patients misses a fundamental point in drug research: the profit motive. Research decisions, at least insofar as it concerns pharmaceutical companies, are based in large measure on the potential for profit. If the pool of available patients is small/limited, a pharmaceutical company will more than likely choose not to go down the path of drug development and testing, thereby making your smaller/limited populations argument irrelevant.
The weak government interest in extending the life of the terminally ill is counterbalanced by the weak interest of the terminally ill (as well as other people) of being able to use putative treatments that do not help them. the stronger interest is that of all people in developing treatments that cure and alleviate disease, and the interest of government in facilitating this. I appreciate the utilitarian nature of this argument.
If, instead of a placebo, the standard drug is used in the "control", then there is a valid comparison in which the control group is not given a "drug" known to be ineffective.
I'm not sure how often these alternative approaches are used.
If, instead of a placebo, the standard drug is used in the "control", then there is a valid comparison in which the control group is not given a "drug" known to be ineffective.
I'm not sure how often these alternative approaches are used.
Mr. Schaffer is correct. In phase III trials of drugs used for serious conditions like cancer, the control group is given the best standard treatment while the experimenrtal group is given usually standard drugs plus the new agent. Placebo trials are now used mostly when there is a subjective endpoint like relief of psychiatric symptoms or else endpoints with a known placebo effect like hypertension. In many years of treating cancer, participating in phase II and III trials and reading many more, I cannot remember encountering a placebo trial used in cancer treatment.
My 75 year old aunt was diagnosed with metastatic cancer last year, and at some point she will probably die of it (if something else doesn't kill her first), although apparently not within the next year or two based upon current treatment techniques and prognosis.
Given the life expectancy of a cancer patient today with metastatic cancer (5-7 years?), and the average life expectancy of an otherwise healthy 75 year old (5-7 years?), I have no idea what "terminally ill" and "potentially lifesaving" would mean.
Taken to a not very distant logical conclusion, this is an argument for the FDA regulation of selective use of certain fruits and the concentrates thereof, and peppers including capsicum, and the concentrates thereof. There are a number of other naturally occuring substances that treat conditions that, according to the FDA, are less effective than something they happened to review (because they only review drugs submitted to them via a rather expensive protocol).
My question is whether ceding that level of control to the FDA is really what you believe to be in your own, or in general, "best interest".
Given a hypo: a terminal patient, no viable treatment regime. What is wrong with letting them call in a shaman to wave a dead chicken and feed the dying? What if feeding them involved including something not FDA approved? Tell me, what exactly is wrong with that? Now, if you put aside Raisch, do you still agree?
It's one thing to say something probably ought to be allowed and another to assert a Constitutional right. Of course, it's kinda hard to see where the FDA fits into the 10th Amendment anyway.
We can't, and don't want to stop good words, prayer, chicken waving, etc.
The fruit and diet question is intermediate. You have to eat, and if you eat carrots instead of potatoes, it would seem unreasonable, at least at first blush, for the government to say otherwise. However, the use of dietary supplements instead of standard therapy has been extensively advobated by
quackssome practitioners of alternative or whatever. Indeed, I have read somewhere (can't vouch for the truth) that Steve McQueen's colon cancer was potentially curable, but he used coffee ground enemas and a macrobiotic diet instead of medical care. If he didn't, I have certainly seen others who have.So I would NOT put Raich aside, and I would say that regulation of medical treatment is a reasonable government endeavor, converded by state police power and by the Commerce clause. As yu=ou correctly point out, there is no bright line, but rather a continuum from medicine to dietary regimens to prayer. Regulation has to be governed by prudential considerations. Government must balance between individual autonomy on the one hand and public safety and advancement of medicine on the other hand. I would look at several factors. Some that jump to mind are (1) whether the promoter of the putative treatment has a pecuniary interest, (2) the scientific basis of the putative treatmenmt, (3) wheher the putative treatment is being advanced as an alternative or a supplement to medical treatment, (4) the weight of evidence for the efficacy (or lack) of the putative teatment (the Daubert factors, applied in another area than admission of expert evidence), (5) the likely intrinsic harm of the putative treatment, and (6) whther the putative treatment is likely to impact adversely on medical care (for example, the all-grape diet that has been advocated by some
quacksalternative medicine practitioners for cancer treatment is likely to cause malnutrition. In my ideal world, regulation of unproven treatment would involve balancing, and would be very fact-dependent. I have no problem with pepper extract or shamans in circumstances in which there is no alternative treatment.New York v. U.S. (1992).
I would agree with you, but I am sure that the Court (at least, as it was until a few months ago) would have had no problem finding that their authority to regulate the doctor/patient relationship comes out of Congress' authority to regulate interstate commerce.
nutspractitioners of alternative health care advocate an all-grape diet (1) would not get through Congress and (2) would not meet rational basis scrutiny.The issue at hand would still be alive if a woman were to desire that the termination be done with a drug that is not approved by the F.D.A.
I think Eugene is trying to apply an equivalence between killing a fetus, and using unapproved drugs. Roe does not address this. Noone seems to be arguing that the patients in this case don't deserve treatment, just whether or not they should ba allowed to use post phase I medication.
Wickard v. Filburn (1942), because a person growing their own wheat was reducing effective demand for wheat that crossed state lines. (By the same reasoning, the federal government has authority to prohibit masturbation, because it reduces effective demand for the services of legal prostitutes in Nevada.)
Some years ago, the New York Bar Association argued that the federal government had authority under the Interstate State Commerce clause to prohibit handgun possession, on the grounds that even if a particular handgun hadn't ever crossed state lines, the metals that went into certainly had, or the ore from which the metals were smelted. They didn't mention the coal used to smelt the iron ore, but that was probably just an oversight.
Now, I can certainly agree that there are irrational bases out there. A ban on the sale of artichokes because of fear that it will lead to an increase in bestiality would seem pretty clearly irrational. A ban on women wearing halter tops and short skirts to prevent rape is probably factually wrong about causality, but is it truly "irrational"? I can see how a rational person might well think that:
1. Rapists are men who lack self-control about their impulses. This is an assumption, and I think accurate.
2. Rapists commit the crime of rape at least partly because of sexual desires or rage. This is an assumption, and I think largely accurate.
3. Rapists who see women dressed in a sexually provocative are likely to lose self-control. This is an assumption, and while it might be true some of the time, much of the time it seems not to be true. Rapists attack women who are dressed quite modestly, and many rapes involve substantial premeditation--hardly indicative of someone has just lost control.
Still, there's nothing irrational about the reasoning, and even the assumptions may be true often enough that you can't call such a law irrational.
So I ask again: what defines "irrational" in a precise sense, other than "I think these legislators are crazy."
Nevertheless, the logic of Professor Volokh is outstanding and he has an interesting point.
Wrong. While there are certainly cases that save lives and improve health, the state gives great deference to the validity of these decisions to the doctor treating the woman (see partial birth abortion bans) and the woman herself. Thus, any many, many cases abortion is not necessary to maintain the life or health of the mother, but the state believes, essentially, these decisions are best left to individual women and their doctors.
If a woman and her doctor can decide to end the life of a viable fetus because her health could conceivably be impacted negatively, why isn't the case even stronger when there is no fetus at all? Why give deference only in a situation where life is taken? The opposite should be true.
Since the constitutional basis of Roe v. Wade is imaginary, one can imagine that it is a precedent for all kinds of other imaginary rights that courts can/may/must ram down the throats of an unwilling public.
In the Blue State in which I live, women are not allowed to get abortions after 24 weeks gestation. Period. End of discussion. None of the hospitals I have worked at (many in medical administration) would violate the law in this regard.
Women who wanted 3rd trimester abortions were advised to seek them in Kansas and Colorado, apparently the only states where the laws allowed this and a practitioner was willing to do this.
The procedure is too dangerous at that late period to be done outside a hospital and if someone were to try, and were discovered (e.g., as a result of a complication), he would be subject to professional discipline.
You have no idea what you're talking about. Any regulation post-viability must have a "health" exemption. Since pregnancy always jeopardizes a woman's health to some extent, an abortion can always be obtained.
You are right that the practical obstacle is finding a willing physician. But that is not a legal obstacle, that's an obstacle created by physicians' ethical concerns.
Or they have a right to have their treatment paid for?
Given the recent Texas case, where a woman was to have life saving treatment removed because some ethics committe thought she'd be better off dead, you had better be very clear about your definition.
As for abortion, as MaryAnnGlendon has pointed out, most European laws recognize the interest of the state into preserving the life of the fetus, but it is not an absolute right to stop abortion. The problem with the American law is that by not regulating it, it assumes the woman will talk it over with her normal physician. Alas, what usually happens is that she panics, the boyfriend or parents pressure her, and the only counseler she talks to is at the abortion clinic. Now, some of these clinics actually do counsel. But alas too many do not, and even oppose a "cooling off" period .
ANDREA CLARK CASE
The following definitions are applicable to this article:
You have no idea what you're talking about. Any regulation post-viability must have a "health" exemption. Since pregnancy always jeopardizes a woman's health to some extent, an abortion can always be obtained.
No, Hans, it is you who don't know what you're talking about. I quote relevant sections of the NY Penal Code:
Any restriction of abortion in the third trimester MUST have a health exception. The law you quote is unconstitutional.
Quoting Roe:
But after viability, delivery is as safe as abortion. After viability, abortion is rarely if ever necessary to preserve either the life or the health of the mother. So if the question becomes: is deliberate destruction of fetal life warranted by "appropriate medical judgment," the answer is, "almost never." (I say this with a little expertise-- I am board certified in OB/GYN as well as GYN oncology.) This does not require that mothers consent to cesarean section or any other measures to facilitate fetal survival-- just that the doctor (or, in NY, the mother-- I didn't quote the statute on first degree abortion) may not deliberately kill the fetus.
This, at least is one interpretation of Roe after viability, and it is the interpretation that presumably animates legislation in almost every state. To my knowledge, nobody has challenged a third-trimester law successfully. I don't know if there have been any challenges to such laws at all.
So thhe question is not open/shut. Statutes prohibit post-viability abortions in most states, they are conscientiously enforced, and their susceptibility to constitutional challenge is unclear. I appreciate that you would overturn such a law, but I think it's doubtful that many courts would agree with you.
Allan
I doubt that the law you cite is "conscientiously enforced." Can you name a single abortion provider who has been prosecuted under this law?
I am unaware of anyone trying to challenge New York Penal Code 125.40-- the third trimester abortion law. This to me is signal evidence of its strength. Many New Yorkers and many hospital boards, not to mention the NYC municipal Health and Hospitals Corporation, which runs the city hospitals, as well as many private people, likely are not philosphically opposed to late abortion. These people live in a real world of running hospitals, and having to pay lawyers if they want to overturn laws. It is almost inconceivable that there would not have been a challenge if serious people thought that the New York or local Federal courts-- which are by no means hostile to abortion-- would find these laws unconstitutional.
The language of the relevant SCOTUS opinions could be extended either to sustain or overturn these laws. I do not have the time to research the matter sufficiently to reach a satisfactory first-hand conclusion. But I strongly surmise that the consensus of even those people who have a serious stake in the issue and want to allow abortions after viability believe that the NY law would be sustained.
As for conscientious enforcement, there are different ways to enforce laws. Again, remember that we are speaking of serious people who are fiduciaries of the institutions that they run. they frequently speakwith appropriate regulatory bodies, and their trustees and officers often are lawyers. It is not necessaryfor the state to arrest people to enforce the law. If you are breaking the law-- say, disturbing the peace-- and a policeman tells you to move on, the law has been enforced without a trial. If you ask the cop if you can pee on the side of the road and he says no, he has enforced the law without a trial. Similarly, it is far more likely than not that operators of hospitals and abortion clinics have a sense regarding whether and how the state would respond to defiance of 125.40 and similar statutes in other states.
"It is not necessary for the state to arrest people to enforce the law."
This is specious. Two positions are possible here: Either the law is broken and enforced (in which case people should be arrested, according to teh statute), or it's not broken and therefore the law doesn't need to be enforced. And maybe but "enforcement" you just mean investigation and monitoring. But does the state of New York or any city have even a single officer devoted to the investigation of crimes commited under this statute? Can you cite the investigation of even a single abortion provider for violation of the statute?
"The language of the relevant SCOTUS opinions could be extended either to sustain or overturn these laws."
No, you are absolutely incorrect (see above). Though a future decision may change the law, the law today is clear.