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A Constitutional Right to Drugs:

Today, in Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, a divided panel of the U.S. Court of Appeals for the D.C. Circuit held that the Due Process Clause protects "the right of a mentally competent, terminally ill adult patient to access potentially life-saving . . . drugs, upon a doctor's advice, even where that medication carries risks for the patient" and has not been approved for commercial sale by the Food & Drug Administration, but where the FDA has determined that the drug is safe enough for broad ("post Phase I") testing on human subjects.

According to the majority opinion, written by Judge Judith Rogers and joined by Chief Judge Douglas Ginsburg, this right "can be inferred from the [Supreme] Court's conclusion in Cruzan v. Director, Missouri Department of Health that an individual has a due process right to refuse life-sustaining medical treatment." The right at issue here, according to Judge Rogers, implicates the same fundamental issue "the patient's right to make the decision about her life free from government interference." Judge Thomas Griffith dissented.

Orin Kerr has more thoughts here.

UPDATE: In reference to Eugene's post above, it is worth noting that the D.C. Circuit explicitly rejected relying on the "line of cases beginning with Griswold v. Connecticut, and continuing through Eisenstadt v. Baird, Roe v. Wade, and [Planned Parenthood of Southeastern Pa. v.] Casey," and instead relied on the "more restrictive" approach embodied by the right-to-die cases, particularly Washington v. Glucksberg. Under the latter approach, the Due Process Clause only protects as fundamental those rights that are "objectively, deeply rooted in this Nation's history and tradition," and are "implicit in the concept of ordered liberty, such that neither liberty nor justice would exist" were they not protected as such. Because the majority found the right claimed met this test, it did not have to consider whether the abortion cases -- what the majority opinion termed the "personal dignity and autonomy" line of cases -- also support the claim.

I see at least two possible reasons for the Court's approach. First, by relying on the "more restrictive" Glucksberg approach -- an approach that some of the more conservative justices have endorsed -- the opinion is not staking out as bold a claim. Second, should the Roberts Court revisit, and perhaps even restrict or reverse, some of the abortion precedents, the D.C. Circuit's holding would remain secure. Avoiding any reliance on the abortion cases would also seem to insulate the opinion from at least some potential criticism for being "activist."

MDJD2B (mail):
Pragmatically, this will interfere with the ability of medical scientific community to validate the effectiveness of new drugs for serious illnesses.

At present, testing involves three stages. First is phase I toxicity studies, which determine the maximum dose of the drug that gan be given without unacceptable complications. Second is phase II effectiveness studies, in whihc the drug is given without any controls. Finally, arephase III studies, in which the drug is compared with the best standard treatment (some oversimplification here) in randomized trials. The large numbers of patients in the phase III trials also uncover unusual complications, though not rare ones.

Premature release of the drugs will allow availability of drugs whose good effects in phase II trials are a fluke, or which, though effective, are less effective than standard treatments. The majority of drugs, at least in the cancer area, that undergo phase II trials never reach market because of such considerations. If patients who are appropriate candidates for clinical trials programs are allowed access to the drugs outside the contesxt of the trials, it will be more difficult to validate the effectiveness of new drugs and to determine their appropriate role in treatment fo disease.

Presumably, pharmaceutical companies can refuse to provide drugs despite this putative right. If they do so, they might have tort liability. Furthermore, their ability to make a good financial return on these drugs will be dependent on thier ability to get the drugs approved as early as possible, so they can enjoy the longest possible window of patent protection.

Alternativelyl, we will freeload on Europe and Japan (and, increasingly, India) to learn which drugs are really appropriate to use in life threatening illnesses.
5.2.2006 5:11pm
jvarisco (www):
How is this consistent with Raich?

When did drug regulations come about? Was it much after they became commercially available and standardized? By this reasoning can someone sue to be operated on by a non-AMA accredited doctor?
5.2.2006 5:21pm
Richard Bellamy (mail):
How does one distinguish a "potentially life-saving . . . drug" from any other drug that has gone through Phase I trials? Don't you not know that until after the Phase II trials?

Have there been Phase I trials for marijuana? Cocaine? Meth?

They would all be found non-life threatening in relatively small doses, I would assume.
5.2.2006 5:33pm
lisamarie (mail):
MDJD2B,
I don't think things would turn out as you fear. Roughly, I would divide patients into two groups. The first group consists of patients who are willing to try an untested drug, either because they have run out of clinical options and have no viable treatments left that can help them, or because they believe doing so advances therapeutic knowledge (such as people who participate in trials even though they have not necessarily run out of therapeutic options). The second group is people who are willing to take a drug only after the risk has been defined by adminstering the drug to other people and observing its effects. Even if a small minority of the terminally ill wish to take an untested drug, you will still have the second group, who would never consider doing so. They will drive the demand for clinical trials of drug efficacy. Even if a small population of patients takes a drug outside of the trial setting, this does not mean that rigorous trials are not possible. You can still recruit people who wish to expand their own options as well as the options of others like them by participating in a research study (I have done so myself). Also, I think it's problematic to look at it simply in terms of "the ability of medical scientific community to validate the effectiveness of new drugs." That view turns patients into mere guinea pigs who exist to make sure drugs work, while depriving most of them of the possible benefits of those drugs. People who live with serious illness are pretty well equipped to decide whether trying a drug is worth it. Allowing them to do so may result in some of them trying stuff that doesn't work. But not letting them choose is worse.
5.2.2006 6:34pm
MDJD2B (mail):
Also, I think it's problematic to look at it simply in terms of "the ability of medical scientific community to validate the effectiveness of new drugs." That view turns patients into mere guinea pigs who exist to make sure drugs work, while depriving most of them of the possible benefits of those drugs.

No-- it doesn't turn people into guinea pigs. It balances the interests of the people who need treatment now and those who will need it later. And prevents harm to desperate people who are not aware that most of these drugs do not make it to the market, but get put on the shelf for ineffectiveness or harmfulness. Until the uccess o fhte drugs have been validated in clinical trials, they are no different from snake oil, except that snake oil isn't intrinsically harmful.

People who live with serious illness are pretty well equipped to decide whether trying a drug is worth it.

It is appropriate for the government to protect vulnerable people whose hope for escape from an impossible situation may lead them to hurt themselves.
5.2.2006 7:20pm
Dilan Esper (mail) (www):
Anyone else not surprised that Judge Douglas Ginsburg would concur in an opinion granting people the right to take drugs?
5.2.2006 7:23pm
Rich Rostrom (mail):
Why only "terminally ill" people? Why not someone who is at risk of or suffering from a permanent major disability, such as blindness? Or someone whose condition is not yet "terminal", but is at high risk of becoming terminal? Who decides?

Who decides whether the treatment is "potentially lifesaving"?

Also, the analogy to refusing treatment doesn't work, because the refusal's costs and consequences are certain, whereas a treatment's cost (and effect) are uncertain. The restriction on treatment to that which the FDA has approved is intended to prevent desperate patients from squandering money on ineffective treatments.

The FDA has been (legitimately) accused of delaying the availability of valuable treatments. But abolishing the FDA's authority to approve opens the gate to a host of problems. Reform the FDA, yes. Applying the Constitution should be right out.

Asserting a constitutional right to bypass the FDA is very dangerous. It could lead to a "right" to have state or private third-party-payers fund anything a patient says he wants and some doctor is willing to prescribe. Given the expanded treatment mandates imposed by many states on health-care plans, I can see a lot of ways to exploit this.
5.2.2006 8:10pm
Anderson (mail) (www):
You took the words right out of my mouth, Dilan.
5.2.2006 8:37pm
Wild Pegasus (mail) (www):
Prof. Barnett looks to be getting his wish, although I think the correct legal ground is to strike down the regulation as outside of Congress' enumerated powers. Congress may have the power to regulate interstate commerce, but that can't possibly mean that it can prohibit the sale of a product anywhere in the US.

- Josh
5.2.2006 9:22pm
ScottS (mail):
Asserting a constitutional right to bypass the FDA is very dangerous. It could lead to a "right" to have state or private third-party-payers fund anything a patient says he wants and some doctor is willing to prescribe. Given the expanded treatment mandates imposed by many states on health-care plans, I can see a lot of ways to exploit this.

Yet again, a questionable resort to the slippery slope. Just as the substantive due process rights to use contraception or get an abortion do not demand government funding of those activities (nor require private parties to cooperate in the exercise of those rights), letting terminally ill patients choose whether to use experimental drugs does not logically demand that the government subsidize their choices. As Professor Volokh explained in the related post, the D.C. Circuit is dealing with a question of negative rather than positive liberty.
5.2.2006 10:02pm
MarkM:
No-- it doesn't turn people into guinea pigs. It balances the interests of the people who need treatment now and those who will need it later.

People can disagree over where the precise balance lies and that seems to me what the D.C. court is doing. Ethical standards exist in scientific research to prevent exactly this guinea pig mentality. Without those ethical standards, no doubt science would advance even more rapidly but the moral cost would be too high. And so it is with using the force of law to prevent patients with little to lose from obtaining potentially life-saving drugs.

Until the uccess o fhte drugs have been validated in clinical trials, they are no different from snake oil, except that snake oil isn't intrinsically harmful.

Doctors advise any number of treatment options that are not always supported by rigorous double-blind clinical trials -- if only because such studies are infeasible or would take too long to do. One of the most basic rights people have is to make informed choices on the available evidence. We live in an imperfect world in which the information we have at a given point in time may fall short of current scientific standards. That does not mean we should treat that information as useless or wrong.
5.2.2006 10:43pm
MDJD2B (mail):
Doctors advise any number of treatment options that are not always supported by rigorous double-blind clinical trials -- if only because such studies are infeasible or would take too long to do.

But good physicians try to base decisions on evidence to the greatest possible extent. And there is a tendency to require higher standards of evidence for new treatments than for oplder treatments. This is because (1) placing medicine on aas scientific basis as possible has to start somewhere, and (2) the newer treatments tend to be under patent, and to involve major pecuniary interest on the part of corporations and others that may run counter to patients' interests.

One of the most basic rights people have is to make informed choices on the available evidence.

From where does this putative right originate? And if it exists, is there a right to make uninformed choices based on pure hype? And why is it so basic? And how does it balance against the interests-- and rights-- of future victims to advance medical knowledge so that their lives may be saved?

Combine your "basic right" with current commercial speech doctrine and you have the dangerous possibility of commercial vendors hawking unproven treatments that will both increase suffering from side effects and persuade people not to undergo effective treatment.
5.2.2006 10:58pm
lisamarie (mail):
If future victims have a right to advance medical treatment so their lives can be saved, does that allow them to draft unwilling participants into clinical trials in order to advance science?
5.3.2006 2:38am
MDJD2B (mail):
If future victims have a right to advance medical treatment so their lives can be saved, does that allow them to draft unwilling participants into clinical trials in order to advance science?

Of course not. But neither do people have a right to use unproven substances outside of the trials. There is a difference between being required to ingest a drug and being allowed to ingest it, but only in the context of a clinical trial. I don't think this difference is too subtle.
5.3.2006 9:53am
lisamarie (mail):
I think the different "rights" we're talking about are getting a little confused. As I see it, if a drug company wants to sell me an unproven substance, they have a right to do that. If I want to take it, I have a right to do that. If the company wants to withhold the drug except when someone is enrolled in a clinical trial, they have a right to do that. But someone who wants more proof of a drug's efficacy than is available at the time does not have a "right" to demand that the drug be withheld from others until it's tested to their satisfaction. People who don't want to take untested drugs don't have to. But they have no right to block treatment for others who are willing to do so, just because they'd rather those people participated in a clinical trial so they can get more information.
5.3.2006 12:21pm
MDJD2B (mail):
As I see it, if a drug company wants to sell me an unproven substance, they have a right to do that.

As I understand it, they do not have a legal right to sell a drug without demonstrating its safety and efficacy. If you believe that the law contravenes some natural or human right, that's another issue.

If I want to take it, I have a right to do that.

Again speaking of legal rights, this depends on the specifics of the law. If the drug is medical marijuana or an opiate, you do not have a legal right to take these drugs unless percribed by someone with a license to do so.

If the company wants to withhold the drug except when someone is enrolled in a clinical trial, they have a right to do that.

Again, they have an obligation NOT to release drugs without appropriate clinical testing, with some exceptions for compassionate release. In my practice, medical this has generally occurred between demonstration of its efficacy and its formal release for sale, but never when the drug was still in preliminary stages of testing.

But someone who wants more proof of a drug's efficacy than is available at the time does not have a "right" to demand that the drug be withheld from others until it's tested to their satisfaction. People who don't want to take untested drugs don't have to. But they have no right to block treatment for others who are willing to do so, just because they'd rather those people participated in a clinical trial so they can get more information.

I think you're right here about getting a little confused. Who is the "someone" you speak about? If it is Congress, they have exercised this right for many years. And not because they have a platonic wish to search for truth, but because they want to protect credulous members the public from ingesting dangerous drugs. I suppose they could do what they do for cigarettes, and just require a warning label for unproven substances that are potentially dangerous, but they chose not to do this for substances whose health benefits people actively promote.

If you are talking about hypothetical "someones" without governmental authority, then I agree that Prof. volokh or I should not be able to do this by fiat. But we are, I think, not talking about the drug vigilantes, but about the limits of authority of legitimate government authorities.

If you or I want to drink antifreeze, I suppose we have the right (I strongly recommend against it). But the government certainly has the legal authority under the commerce clause of Article I of the US Constitution to prevent the sale of antifreeze for the puropose of curing cancer.

And, finally, I agree that neither I nor the Pfizer company should be able to kidnap terminal cancer patients, put them in cages, and force them to participate in clinical trials. But, if I may analogize, requiring that people who drive cars wear seat belts is not the same thing as shoving someone into a car and forcing him to put on his seat belt and drive.
5.3.2006 2:01pm
lisamarie (mail):
I should have been clearer. I believe the "right" of Congress to regulate which medications I may take is a violation of my right to control my own body and maintain my own health as I see fit. You seem to be arguing that paternalistic drug regulation is justified in order to protect vulnerable sick people from bad decisions they might otherwise make. But have you ever actually asked these people if they want this protection? As a chronically ill person who has participated in the experimental drug testing process, I can tell you that I do not wish anyone to regulate me for my own good, nor do I need it. I am prefectly capable of judging which risks I'm willing to take, and I would never presume to tell other people they're not fit to do the same. I can tell you from experience that no one, no matter how highly trained or educated they are, is truly qualified to make these choices for another person, and having your choices delegated to another person in that manner leaves the people who need the most options frustrated, powerless, and without choices.
5.4.2006 3:49pm
msk (mail):
MDJB2B and a few others ask us to deny rights to existing people because a few imaginary future people have a slim chance to benefit, if they ever are conceived and live to eventually get ill, and if today's experiment is not a total flop (or an unnecessary treatment for an artificially created syndrome).


"Balance the needs of people who need treatment now against the needs of [purely hypothetical future patients]," they suggest.

This is further confused by our general failure to realize you can only say someone was terminally ill after he is dead. So long as the patient is still requesting treatment, he believes he has a chance, and in many cases he lives on for years -- more than 30 lively, productive extra years in some cases of persons who had been officially declared hopeless.

Anyone can say, "No, you have less than an hour to live," -- if they plan to cause your death.

Those who advocate experimenting on "the terminally ill" have already made a decision that the experiment ends when the patient is dead, which needs to be soon. If physicians become dedicated to using you up "for the greater good of society" can you trust them to tell anyone the truth about anything?

The flaw in a lot of research is that experimenters propose to work only on people who are already seriously ill. If the individual's illness was the result of misdiagnosis (and consequent mistreatment) to begin with, that must skew results.

Studies that enroll anyone with a particular set of symptoms ignore many hundreds of variables. Age, gender, eating habits, the full array of medicines ingested prior to enrollment, environmental factors such as water quality, and how the patient is treated from day to day in terms of hydration, ambient temperature, secondary infections -- all could dramatically impact the performance of the new test drug.

Hypothetically, agents for one monster drug company could sabotage tests by another company. "They were all dying anyway," could curtail or bias investigations.

If studies enroll only people who are already ill or suddenly injured, the vast number of uncontrolled variables weakens the predictive value of that small population sample. People who are already ill are more easily "persuaded" or can now be "enrolled" while unconscious. Thus, you can conduct a flawed experiment no fully-informed person would ever want in on.

Default diversity (anyone who comes through the door, 8 or 80, fat, thin, healthy or unhealthy) weakens the predictive power of medical data because what saves a man may be the jumbo cheeseburger in his system, not the new emergency procedure. Policy at the highest levels of the research community has gone bassackwards, and the "sacrifice" of certain patients "for the greater good" can rapidly degenerate into a sort of local hit list.

Policy may be made in DC, but the shot goes into your own arm, right where you live.

I happily volunteered in several past experiments. Now, speaking as an "expendable," it is cold comfort to me that if a future experiment disables or kills me, and my survivors later discover I was unwittingly made an experimental subject, recently developed NIH policies allow the drug company to exclude my unfavorable outcome from the data -- supposedly out of consideration for the survivors' feelings.

Going back to the original question: Only in a hypothetical world can we assume most doctors would tell you what's available, if you ask.
5.4.2006 4:32pm
Paul Parry (mail) (www):

How does one distinguish a "potentially life-saving . . . drug" from any other drug that has gone through Phase I trials? Don't you not know that until after the Phase II trials?

Usually, but not always. Gleevec is a prime example -- the Phase I trial showed remarkable responses in 31 of 31 patients. Yet patients who didn't qualify for Phase II or III trials were not allowed to use it until it was approved three years later. And three years is blazingly fast compared to most drug approvals. Drugs whose phase I trials don't study and/or demonstrate the potential to be life-saving probably won't meet the threshold. "Potentially life-saving" is a high threshold, and courts are likely to defer to the FDA's judgement on that definition.

Asserting a constitutional right to bypass the FDA is very dangerous.

No one's talking about bypassing the FDA (NORML and a few salivating bloggers excepted). The FDA will need to provide an avenue of access that balances this right with its compelling government interests. This could be accomplished with some changes to existing regulations, or through a new level of limited conditional approval.

The current "compassionate use" system is a strawman that everyone can point to, say it exists, wash their hands, and walk away. But it doesn't work in reality for many patients -- this ruling will force that to change.
5.5.2006 1:08am
Wikstrom (mail):
MDJD2B quote :
["If you or I want to drink antifreeze, I suppose we have the right (I strongly recommend against it). But the government certainly has the legal authority under the commerce clause of Article I of the US Constitution to prevent the sale of antifreeze for the puropose of curing cancer."]

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Nonsense. But that is the core issue of all this.

The Federal Government has absolutely zero "legal authority" under the U.S. Constitution to dictate what citizens may ingest, inhale, or inject. The ever popular figleaf of the 'Commerce Clause' grants no authority whatsoever for that action. But that most Federal government politicians, bureaucrats & legal bureaucrats-in-black-costumes ... vigorously act contrary to the supreme-law-of-the-land {Constitution} is hardly a newsflash.


"...a law repugnant to the Constitution is void.."

{Marbury vs. Madison}
5.5.2006 4:51pm