Abigail Alliance: A Right to Life Denied
An interesting debate has broken out amongst bloggers about the recent DC Circuit decision, Abigail Alliance v. Eschenbach. The Court was asked to consider whether the liberty protected by the Due Process Clause includes the right of a terminally ill patient (with noremaining approved treatment and with the approval of their physician) to seek access to investigational medications that the FDA admits are safe and promising enough for substantial human testing. The drugs in question have passed Phase I testing, but have not yet been subjected to Phase II or III testing. In a recent en banc decision the Court overturned the three judge panel who originally ruled in favor of Abigail Alliance. Judge Judith Rogers’s dissent (in the en banc decision) is worth quoting:
In the end, it is startling that the oft-limited rights to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one’s own body even if it results in one’s own death or the death of a fetus have all been deemed fundamental rights covered, although not always protected, by the Due Process Clause, but the right to try to save one’s life is left out in the cold despite its textual anchor in the right to life.
Historically, substantive due process, whether implicated by the 5th, 14th, or even the 9th Amendment, has been a point of contention amongst conservatives and classical liberals. While it’s true that when a court deems a right fundamental, it removes the issue from the democratic process, it is precisely the role of the court to do just that. Fundamental rights should not be left to the whim of the tyranny of the majority. The courts have come up with all sorts of doctrinal tests to identify fundamental rights; rights are considered fundamental if they are “implicit in a concept of ordered liberty” or part of “our Nation’s history and traditions” or “rooted in common law”. Yet, the process of figuring out what rights are fundamental remains complicated because rights can be defined broadly or narrowly. For example, many judges may agree that a right to privacy is both implicit in a concept of ordered liberty and part of our Nation’s history and traditions. Yet, the scope of the right to privacy is still very much undefined. (Does the right to privacy encompass a right to abortion? What about bestiality?)
In the case of Abigail Alliance, the rights issue can be framed one of two ways. Volokh Conspiracy’s Jonathan Adler is right on target when he claims that the rights issue can be framed as broadly, as the “right to save one’s life” or as narrowly as “a right to access experimental and unproven drugs in an attempt to save one’s life.” While it’s true that conservatives should worry about the creation of new fundamental rights, Rogers is right to claim (in her dissent), “Were it impermissible to draw any inferences from a broader right to a narrower right, nearly all the Supreme Court’s substantive due process case law would be out of bounds.”
I believe even the narrower right of “a right to access experimental and unproven drugs in an attempt to save one’s life” has an anchor in our Nation’s history and the Constitution. As Rogers (and Judge Douglas Ginsburg) argues, for most of our Nation’s history individuals were free to take whatever drugs they wanted without a prescription. Cato’s Roger Pilon points out in a Wall Street Journal editorial (“New Right to Life”, Aug. 13, 2007), it was only in 1951 that Congress created a category of prescription drugs. It wasn’t until 1962 that Congress began requiring drug companies to conduct extensive tests to ensure drug “efficacy”. Georgetown law professor (and Volokh blogger) Randy Barnett makes a strong case for the 9th Amendment in another Wall Street Journal editorial (In “Re: Life or Death”, Dec. 9, 2006). Barnett writes, “If the right to preserve one’s life is not among the natural rights retained by the people when they established the government, then none are.” Considering many of the Framers wrote the Constitution with John Locke in mind, I couldn’t agree with Professor Barnett more. Governments were instituted in order to secure natural rights. In the words of Pilon, “the Framers would be appalled to see federal bureaucrats standing between dying patients and the medicines that might save them.”
No obviously related posts.
Welcome!
Great subject. If I had no other alternatives, I’d like to think the .gov wouldn’t get in the way.
Welcome,
So should we then allow anyone who is in critical need of the possible medication to be assured of not only being in a clinical trial, but of being in the non-control group?
To be perfectly callous adding additional people to the testing may not make sense, though I would have no problem with a person attempting to get a drug, I would not say they have a right to it.
Now if the drug is legal in a differnt country I would also have no problem with them going to another country to get it with their own finances assuming they also use it in the other country and do not attempt to import it here.
Welcome Legal Bitch! Good opening post. Just some background for people not in the pharmaceutical industry. FDA clinical trials are divided up into three phases:
Phase I is typically where you assess the drug’s safety. Typically you’re look for a Maximum Tolerated Dose (MTD) to learn what dosing level to use for further trials. These trials will generally be with a smaller number of patients.
Phase II is where you’re starting to look at dosing and efficacy of the drug. These are still smaller scale trials, but generally a good bit larger and more costly than phase I.
Phase III trials are the largest, sometimes encompassing thousands of patients. This is basically where you’re doing your large scale studies of efficacy, side effects, adverse reactions, and other safety measures. They take the longest and cost the most.
I agree that patients should be able to take whatever they feel will help them, as long as they are informed of the risks, and are aware that a drug that has passed Phase I may not actually help them at all.
Nice argument: I came in skeptical and you essentially convinced me, which is saying a lot. That said, as always, the devil remains in the details. Why should Phase I testing be a bright dividing line? Ed raises an excellent point, as if there’s a right to be in the non-control group, then the efficacy of ALL pharmaceutical testing is destroyed. Further, once someone takes not-entirely-approved drugs and thereafter dies (which they will, mortality after all being the common condition of humanity), you have to know the plaintiffs’ bar will step out of the shadows to sue the drug companies, the insurers, the doctors, the hospitals, the FDA and/or anyone else connected by even the most tenuous stretches of the imagination. Maybe that’s OK, but it’s also generally the result of judicial rather than legislative remedies to perceived problems.
I don’t think your post does the rights question justice. Mr. Adler was certainly right to note that the issue can be framed broadly or narrowly. Interestingly, it seems like you presume that the case was incorrectly decided under a broad reading of the concept of the ‘right to life’, which I don’t think is true. The original Constitution and Bill of Rights were designed to protect the individual’s freedoms against the interference of government, not to ensure that the individual could make any demands it pleased of the government. Liberty does not mean the freedom to do anything, nor does the ‘right to life’ allow the individual to take action in violation of the law to continue their lives.
The FDA does not create safety standards frivolously, and given the number of prescription medications that have been found to have either undisclosed or improperly cited side effects, it is difficult to sustain the argument that there is no significant difference between a trial medication and a marketable drug. But further, your argument that because ‘in our Nation’s history’ people were allowed to buy medications freely, they should be able to access trial medications now, misses the point of that standard. It is not designed to say that anything Americans were able to do in the past is an acceptable practice at present (because, for example, child labour was once an accepted practice that was regulated – by the Court, to be fair – out of existence). Once the law changes, it is no longer enough to claim that such freedoms were enjoyed in the past.
Most significantly, however, your post dangerously blurs the difference between the right to preserve life and the right to extend life. No agent of the federal government was trying to kill the patient at issue in this case, no government bureaucrat is endangering the life of this (admittedly terminally-ill) person. The right to life guaranteed in the Due Process clause ought protect that patient’s life against the threat of government violence (small or large), but not allow them to require the FDA to provide an experimental drug.
Sebastian, do you know anything about what testing pharma companies perform before they go to the FDA?
I mean, surely these companies invest in drugs which are known to have some effect (and thus make money).
Yes. Pre-clinical studies are done first in animals. What kind of animals depends on the drug. But typically starting with rodents, and moving up to dogs, and sometimes primates. They have to be tested in animals before going into people. Typically, once you can not kill rodents, you won’t kill other animals either, but you’ll notice side effects in higher order animals that you wouldn’t notice in rodents. Rats can have a lot of CNS disruption and still run around doing rat-like things, whereas those types of effects tend to show up in dogs.
Mr. Ford,
I don’t really see how right-to-life issues don’t come into play when a government agent tells a person they can’t take something they believe will save their lives.
I think the FDA process is fine, but I think if someone wants access to something for their own treatment, if they know and understand the risks, understand that the drug may never help them, I don’t think the government ought to have the power to stop in and say “No, and it’s for your own good.”
I don’t believe they have the right to force anyone to give them that drug, but I do think they have a right not to have the government interfering in that decision.
Even if I were to grant your premise, which I’m not sure that I do, I don’t think your argument follows in this case. Medical treatment is one of the areas of a person’s life where control is regularly ceded to outside professionals because of the complexity of issues involved. Even in the case of a drug that has already been approved by the FDA, we still don’t allow individuals to unilaterally access those medications, regardless of how well they may personally understand the risks involved. Here, the asymmetry of information is even more pronounced, because the drugs haven’t even been tested to the point where anyone can be said to fully know and understand the risks involved. At that point, when the individual cannot be making a fully informed decision, and there are legitimate barriers in place to prevent individuals from taking possibly dangerous drugs, the side effects of which cannot necessarily be known by the patient’s physicians, there is certainly no “right” to access.
You’re last comment, though, is particularly interesting in this case, because the government is both the interfering agent and the agent that would theoretically be giving the patient access to the medication. The government isn’t stopping a doctor from prescribing something that is generally available, it is preventing someone from accessing experimental medicines. If they don’t have the right to force the government or anyone else to give them the drug, then the case was decided correctly: there is no ‘right’ to access here.
The fact that the risks aren’t fully known is itself a risk. What I’m suggesting is that, if someone were selling “magic water” that someone believed would save their life, as long as that someone had disclosed to them that “magic water may kill you”, “magic water may have no effect on your disease at all”, and in fact, “we really have no idea at all what magic water will do to you if you take it”, and they still want to take it, that’s their choice as a free person. That is, in fact, very similar to the agreement that people sign when they enter into a clinical trial.
What I’m suggesting is, not that the FDA ought to compel someone into a clinical trial against trial protocols, or that FDA force a pharmaceutical company to manufacture an experimental drug for anyone who claims they think it will face their lives. I’m against that kind of compulsion.
But I do think there is a fundamental right for people to control their own medical treatment, especially for life and death matters, even to the point where the patient becomes gravely mistaken.
I am not against the FDA process as a whole, because it’s primarily aimed at preventing fraud on the part of drug makers. But I am against using it to make choices for people, even if the choices people would ultimately make might be bad for them.
I should be more clear as to my general libertarian ideas on how to construct a drug regulatory scheme that respects people’s right to make choices about their health care, even bad ones.
I do believe the FDA ought to have the power to prevent a drug company from marketing a product to treat a certain condition until it’s been through the approval process. That would mean they can’t sell it to you and say “This will treat cancer, and is safe.” Doctors couldn’t tell you that either.
But I do think if someone wants an experimental drug, and can find a willing seller of it, provided the risks are quite clearly spelled out to the person, that transaction ought to be allowed. Practically, this isn’t going to happen, because the drug maker won’t want the liability. But in theory, I don’t think the government ought to interfere, as long as there’s no fraud involved.
Now, when it comes treatment like antibiotics, it can get a little different, and there’s now public health reasons for the government to restrict access.
I’m not generally a fan of government action to protect people from themselves. People have the right to make poor choices for themselves, provided those choices only have negative consequences for them individually, and not society as a whole.
“the Framers would be appalled to see federal bureaucrats standing between dying patients and the medicines that might save them.”
Isn’t that exactly what Britain’s NHS system does? It’s where we’re headed under socialized medicine. We can’t have the medicine’s to save ourselves nor the guns to protect ourselves – sometimes a gun is mighty powerful medicine.
“Most significantly, however, your post dangerously blurs the difference between the right to preserve life and the right to extend life. No agent of the federal government was trying to kill the patient at issue in this case, no government bureaucrat is endangering the life of this (admittedly terminally-ill) person. The right to life guaranteed in the Due Process clause ought protect that patient’s life against the threat of government violence (small or large), but not allow them to require the FDA to provide an experimental drug.”
Hard to square that with Roe v. Wade. In Roe, no government official was trying to force someone to get pregnant. The government was simply blocking the ability to end that state. The ruling (if I may distill down Harry Blackmun’s usual 110 printed pages) was that this was a sufficiently private life decision that the state may not insert its judgment (except during last trimester, anyway) into the decisionmaking, which is left to woman and doctor.
If a person is dying, I’d tend to classify their decision, with their doctor, to try a medication as an even more private decision.
Phrased otherwise, I cannot see *any* valid governmental concern here. Given that the person is dying, it cannot worsen their lot. It would harm no one else. At most, they might waste their money. OK, it’s their money, and I don’t see a governmental interest in preventing them from spending it. (Not to mention that the drug companies might just give it for free in this situation — might yield some useful data.
Legal,
A warm and hearty welcome! I’m glad that you were discovered by Bitter to come and save the day for this blog.
I’m glad that Bitter is going to stick around too.
You will find your posts linked daily, Monday through Friday, on The Liberty Sphere in a section entitled, ‘Second Amendment News Roundup.’ This section deals mainly with gun rights issues, but there’s lots about politics and the law there too.
I’m looking forward to reading your posts. Your first is a good one!
Martyn
The Liberty Sphere
http://www.thelibertysphere.blogspot.com
OK, it’s their money, and I don’t see a governmental interest in preventing them from spending it. (Not to mention that the drug companies might just give it for free in this situation — might yield some useful data.
Clinical trial drugs are always provided for free, since they aren’t marketable drugs yet. But clinical protocols have requirements about the types of patients they’ll take. Typically, for Phase I, you test on healthy patients, because sick patients can complicate matters.
For cancer drugs, you often do test on terminal patients in Phase I trials, but you’ll want a terminal patient that still has good hepatic and renal function, so you know the data you’re getting on the drug is worth something.
So drug companies, even in a less restrictive regulatory regime, are still going to be picky about who they give the drugs to, and who they don’t. Without the scale up of full blown production facilities for the drug, making it in the quantities needed for phase I and phase II tends to be very costly.
It is protocol that if you accept someone into trials, and the drug shows efficacy, even if your study was just measuring safety, you keep giving it to them, so we’re not totally heartless as an industry, but during the trial phase, you really have to ensure you’re using your resources wisely, and getting data that helps advance the compound through the FDA process.