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Medical Self-Defense and a Right of the Terminally Ill to Use Experimental Medical Treatments:

So far, the excerpts from my Medical Self-Defense, Prohibited Experimental Therapies, and Payment for Organs article have focused on the established constitutional right to abortion-as-self-defense, and the established common-law, statutory, and possibly constitutional right to lethal self-defense. Now I turn to the places where my medical self-defense arguments would make a difference; I will soon turn to the most controversial item — the impropriety and unconstitutionality of the ban on compensation for organ transplants — but for now I start with a right of the terminally ill to use experimental medical treatments:

Let us turn to Ellen, who is terminally ill. Existing therapies, doctors say, are useless. An experimental drug offers some hope, and FDA Phase I tests suggest that it's safe; but it is banned by federal drug law, because it has not yet been shown effective.

Ellen's right to medical self-defense should exempt her — and the doctors and pharmaceutical companies whose assistance she needs — from the ban. Alice may kill her viable fetus to protect her life, and may enlist her doctor's help to do so. Katherine may kill her attackers, whether guilty humans, morally innocent (for instance, insane or mistaken) humans, or morally innocent animals. Ellen should have at least an equal right to ingest potentially life-saving medicines, without threatening anyone else's life.

This is not a general autonomy argument, premised on the theory that all people should be free to ingest whatever they choose into their body. Rather, it's an argument specifically focused on the right to self-defense, a right supported both by the Court's caselaw (Roe and Casey) and by the longstanding acceptance of the right to lethal self-defense.

What justification can the government have for limiting Ellen's rights? Ellen's use of experimental drugs might jeopardize what little time she has, and cost her money that may prove wasted. Yet if people may protect their lives even by taking a viable fetus's life or an attacker's life, they should be as free to risk their own short remaining spans in trying to lengthen those spans. [Footnote: Compare cases such as In re Guardianship of Browning, 568 So.2d 4, 14 (Fla. 1990), which conclude that where a patient has an incurable disease, the state's interest in preserving his life isn't compelling enough to trump the patient's right to refuse treatment (a right protected by Cruzan v. Director, 497 U.S. 261, 278 (1990)). If the state may not use the interest in preserving life to trump the patient's right to end his life through refusing treatment, it should be even less able to use the interest in preserving life to trump the patient's right to try to prolong his life through experimental treatment.] Paternalistic government interests suffice where no constitutional rights are involved, but they shouldn't justify blocking a person's right to protect her own life.

Terminally ill patients' right to use experimental drugs might also interfere with randomized clinical drug studies. It's possible that so many patients will insist on getting a not fully tested but promising drug that researchers will be unable to scientifically test the drug's effectiveness. If people can just buy the drug, they may not want to enroll in a study in which they might get a placebo instead of the drug.

Yet even if the need-to-test argument justifies some limits on the use of experimental drugs even by the terminally ill, it doesn't mean that people lack medical self-defense rights — it merely means that these rights may sometimes be trumped by a strong enough justification. Moreover, the argument justifies limiting medical self-defense only when such limits are really necessary for conducting clinical studies, and when no other alternatives will do. For instance, if the studies require 200 patients, and there are 10,000 who seek the experimental therapy, there's little reason to constrain the self-defense rights of all 10,000. Likewise, if the drug is being studied now only on people who suffer from a particular kind or stage of a disease, it shouldn't be legally barred to those who would fall outside those studies in any event. If we must strip people of self-defense rights to save many others' lives in the future, this tragic constraint should be imposed on as few people as possible and to as small an extent as possible.

There is one difference between Alice and Ellen: Ellen's experimental therapy is much less likely to be successful than Alice's therapeutic abortion would be. Yet there's no reason why self-defense rights should be limited to sure self-defense. Lethal self-defense is allowed even though it is often not completely reliable — even if Katherine tries to use lethal force, she may be overcome by the home invader. Similarly, imagine a woman who is sure to die without an abortion, but who may still die even with one. Her abortion-as-self-defense right should remain even if the therapeutic abortion will increase the chance of survival only by a fairly small (or uncertain) amount. [Footnote: At most, some people might reach a different result if the fetus is likely to survive the woman's death: As between a 100% chance of maternal survival and fetal death and a 100% chance of maternal death and fetal survival, they would choose allowing the woman to abort; but as between a 10% chance of maternal survival coupled with sure fetal death and a 100% chance of fetal survival coupled with sure maternal death, they would choose protecting the fetus. Yet even they would justify this conclusion by saying the woman's right to self-defense is trumped by the need to protect a viable fetus's life — not by claiming that the woman's right vanishes because her defensive tactics aren't certain to succeed.]

The D.C. Circuit's decision in Abigail Alliance [which reached the same result I argue, but which was a 2-1 decision that might yet be overturned on en banc review or by the Supreme Court] rested in part on the traditionally recognized right to defend one's own life; yet it didn't cite the close analogy to abortion-as-self-defense, or discuss the state constitutional protections for the right to self-defense. These analogies, I think, substantially add to the case the Abigail Alliance panel made.

Finally, some might respond that courts generally shouldn't recognize unenumerated constitutional rights. The right to abortion — even abortion-as-self-defense — ought not have been constitutionalized, they'd argue, and ought not be broadened by analogy. Lethal self-defense ought to be seen as a legislatively trumpable common-law or statutory right, not a constitutional right. Let's stick with judicial minimalism on unenumerated rights, and leave matters to the democratic process.

This is a plausible argument, but not one the Supreme Court has adopted. The Court has continued to endorse abortion rights and family rights. It has recognized rights to sexual autonomy and to refuse unwanted medical treatment. There's little profit in reprising the whole unenumerated rights/Ninth Amendment/substantive due process debate here. My point is simply that the Court's process for recognizing unenumerated rights by analogy remains active, and there is a strong case for using this process to recognize a right to medical self-defense.

And regardless of whether medical self-defense should be recognized as a constitutional right, the arguments given above should offer a strong moral case for the legislature's respecting such a right. American legal traditions properly recognize people's rights to protect their lives, even when that requires killing. The law ought to do the same when a dying person simply seeks an opportunity to risk slightly shortening her life in order to have the chance of substantially lengthening it.

I'd love to hear people's thoughts on this. One request, though: I realize — as the last three paragraphs make clear — that there's a hot and eminently legitimate debate about whether courts should recognize unenumerated constitutional rights; and the previous posts in this post chain have drawn many comments focused on that very debate. I'd like to ask that we set aside that general issue for the comments to this post and the coming ones, simply because it has already been dealt with in such detail (and already with some repetition) in the comments. Naturally, the specific issue of whether this unenumerated right should be recognized (among many other issues) remains entirely fair game.

Omar Bradley (mail):
I tend to agree. I also think that for the most part, states would recognize such rights. As I think Eugene posted in an earlier thread, some 46 of 50 states already have Self Defense statutes or Constitutional provisions. A number of states have recently passed stand your ground laws. Obviously, this is a somewhat new issue, but I think that if it received backing in the various sates, the vast majority would support it. Does anyone know if attempts have been made?

And further, regardless of the status of such constitutional rights, I just don't see some big push to prosecute people in such situations. Before Roe, were there loads of prosecutions of women who got abortions to save their lives? My understanding is that even the states that banned it offered life exceptions. I know Texas did.

Have people been prosecuted for seeking life saving treatmnent(as opposed to suicide or assisted suicide which isn't life saving but life ending treatment and is thus totally different)? Has anyone been convicted?

Also, at least in the state context, is there really a difference between "unenumerated rights" and the police power. The legal doctrine of the police power is fairly well developed going back to the sic uetere principle and all that and many commentators and even Judges and Justices and SC cases(Cooley, Teidemann, Holmes, Story, Holden v Hardy, etc...)have written about it.

Or are they merely two sides of the same coin? IOW, there may or may not be a constitutitional right to self defense, but an effort by a state to bar an attempt to procure the life saving treatment Eugene described or to act in lethal self defense to save one's life would nonetheless exceed exceed the sic utere doctrine/Holden v Hardy "reasonable relation" test and also the principles from the Jacobson v MA case from 1905 or so. Of course, it seems to me that the sic utere/reasonable relation police power test and the reational basis due process test are pretty much the same thing in many regards.

Thus, it seems that whether a right is protected by the due process clause or whether the power of the state to abridge it prevented through the police power, the result is the same. I guess though that the difference between having a right to X and the state not being able to legislate against X is really semantic.

It's like in the debate over the Bill of Rights when Hamilton in 84 asks "it's said we need to secure the freedom of the press. what for? who ever heard of any such doctrine that gives the Govt power over the Press to begin with? Why provide for something the govt has no power over? It can only lead to abuse by implication" Or words to that effect.

Similarly, maybe the question isn't why recognize the right to self defense, but where was the govt given power to act in this area in the first place? And if they weren't, then there's no need for the right.

If they were, at least on the state level it seems that it would be the police power which gives them the power to legislate in this area and thus the sic utere/reasonable relation test would apply and in my view, at least, the regulations that Eugene mentioned don't pass that test, at least most of them. The organs stuff and some others I'm not so sure, but I think experimental cures/drugs and lethal self defense definitely would be ok.

Where does the police power and whether or not state attempts to ban self defense exceed it fall into this issue?
11.8.2006 8:55pm
Andrew Hyman (mail) (www):
Saying that 46 out of 50 states have done one thing cannot logically justify doing ANOTHER thing. How many of those states have constitutional provisions that allow lethal self-defense against other people who are NOT morally culpable? Such stretching of the self-defense principle has no logical limits. Any behavior that enhances one's own interests can in some sense be regarded as self-defense.

Quite apart from the very strong constitutional arguments against transferring authority in this area to the Supreme Court, is it really wise as a matter of policy to confide all of this line-drawing to 5 lawyers, instead of to the 300 million people who will have to live with the results? I think not.
11.8.2006 9:17pm
Sean M:
Professor Volokh,

Partly, I'm wondering if there is a type of argument you are ignoring that justifies these clinical trial requirements: fraud on the public.

In other words, it's not just /safety/ that these drugs are testing for (as, you point out, even if the drug is unsafe and shortens her life, it would be reasonable to say she should try nonetheless).

However, the FDA wants to prevent the public from being swindled by drug makers or just quacks who want to peddle "experimental" drugs that are just sugar pills. The terminally ill are especially vulnerable to these claims and are as likely as not to be unsophisticated to separate the wheat from the chaff when evaluating claims, given their desperation.

Can the ban, then, be justified by the broader need to protect this especially vulnerable group? Especially seeing as they might sell their entire lives to pay for these "experimental" drugs?

Also: This right may commit you to medical marijuana. Not that this is bad, but it's an angle to consider.
11.8.2006 9:32pm
Arbusto Spectrum:
Prof. Volokh-
you phrased this issue as "the right to use" experimental treatments. Though there are a number of issues that one might come up with to justify such a prohibition, they would all almost certainly be outweighed by the potential benefit relative to the potential damage, at least in the case of a terminal patient with no other alternative. So yes, I think that one can make a very strong medical self defense argument, and in fact, it is absurd that the government would attempt to limit one's efforts in that regard.

However, the flip side of this coin is whether there should be a "right to sell" experimental untested treatments; unless I missed it, you didn't express a view on that point. There are much stronger arguments against this right. For example, if a pharmco could sell drugs to the public after successful completion of a phase i trial, they would have little incentive to do phase ii or iii trials, i.e. prove that it works. so, it would seem that the commercial aspect of this would have to be limited in some way to incentivize the inventor to prove that his or her invention actually works. This could be done by either (i) prohibiting the sale of the experimental drug and requiring it be donated, which is probably not a realistic solution, or (ii) requiring that any sales proceeds from the drug be invested in conducting phase ii and phase iii trials, which might be more workable. Then, of course, one gets into the difficult question of insurance coverage and whether the public should be forced to pay, through the medicare program, the cost of such experimental drugs....
Consumer protection should be able to be handled through disclosure laws. Caveat emptor

And, Sean, there is nothing wrong with being committed to marijuana, medical or not.
11.8.2006 10:51pm
John Thacker (mail):
For example, if a pharmco could sell drugs to the public after successful completion of a phase i trial, they would have little incentive to do phase ii or iii trials, i.e. prove that it works.

"Little incentive" is, I think, stretching it. For one, as you allude to a bit letter, I reckon that insurance companies would be loath to provide remuneration for drugs that had not undergone Phase II or Phase III trials. In addition, quite a few doctors and patients would prefer to take a drug that had actually been proven to work according to a more rigorous trial.

Consider the following arguement, which I consider parallel to yours: "Since companies can sell 'herbal supplements' and 'homeopathic remedies' without FDA approval for effectiveness (so long as they have a disclaimer), they have little incentive to research real drugs." Seems false, doesn't it? Sure, many companies do hock snake oil, or at the very least "untested" medicines. But insurance, doctors, and patients demand tested medicines.
11.8.2006 11:07pm
logicnazi (mail) (www):
I'm still wondering what happens when it isn't life on the line but severe injury or suffering. It would seem the same arguments would apply as one generally has a right of self defense against severe bodily injuring or great suffering. For example I think it is generally understood that one could use lethal force to defend oneself from rape or even extreme torture even if one was guaranteed not to have permanent bodily damage.

If this is the case how does your argument not entail that the medical right of self-defense applies to treatments for depression or emotional suffering as well? If so and my doctor certifies that I am extremely unhappy how does this argument not establish my right to use mood enhancing drugs?
11.9.2006 2:24am
Robert Jackson (mail):
The problem I have with these arguments is that you have made a leap from negative liberties to positive liberties.

It may be true that you have a right to self-defense because you have a right to bodily integrity that the government may not encroach upon, e.g., the government may not chop off your arm. Likewise, the government may not tell you that you may not chop off your arm, e.g., your doctor notifies you that unless your arm is chopped off, you will die from gangrene within the next year. But the right to be free from government interference is different from a right to government succor. Indeed, Harris v. McRae, which dealt with taxpayer subsidy of abortions, noted that the government is not obligated to pay for your abortion, even if you have the right to choose to have or not to have one.

A further argument in this vein, which I made awhile back in a seminar paper in law school, is that you do not have a right to any particular level of technological advancement or scientific progress. So abortion rights are always contingent in that sense. While one may say that a woman can always use a hanger or imbibe some form of plant life that functions as an abortifacient, that only proves the point that a woman's capacity to abort her fetus is dependent on the background level of technology and scientific development, i.e., the environment, which the government need not sustain or promote in any particular form. You may have a right to an abortion, but you do not have a right to the existence of abortion clinics. If no doctors wish to perform the procedure and no one wishes to fund the building of facilities where it may be performed, you're just going to have to resort to a hanger. You can't go to court to compel Congress to build an abortion clinic. (You can, however, lobby Congress to pass a law that authorizes the expenditure.)

I suppose the counter-argument is that these life-saving drugs already exist. Congress has already subsidized their creation. Why doesn't the right attach to the drugs once they exist? The answer could be phrased two ways, as I see it. One, the drugs do not "exist" until they complete the process that Congress has established for them to reach market. Two, you don't have a right to the drugs (if you did, you could go to court to compel Congress to fund research of a cure for your disease), you have a right to the drugs to the extent they are available. They haven't been made available yet.

One critique of my answer is that is it status quo neutral -- it takes the present regime as beyond normative critique rather than critically evaluating its inequities. And Volokh certainly is making a normative critique when he writes: "The law ought to do the same when a dying person simply seeks an opportunity to risk slightly shortening her life in order to have the chance of substantially lengthening it." But given that we are talking about an unenumerated right that the people may enact, or give substance to, via their state legislative bodies, the question is why we are focusing on an abstract, individualistic conception of "self-defense" rather than empirics. Let us evaluate the state legislatures, let us review public opinion polls, and let us look to ballot initiatives to see whether local and state governments have dealt with the issue. If the people simply do not care about, or want, this individual right for themselves would they find themselves in Ellen's position, or have crafted a compromise that they collectively think best protects the common good, why even have this debate (or why abandon common sense in the having of it)? Perhaps most people reject the abstract conception of individuality underlying this right to self-defense because it is incoherent or illogical, or vitiates other values that lead to human flourishing, such as respect for private property. Far more of us are liable to own private property (e.g, the food we bought for lunch) than to become terminally ill. Should a hungry person be able to steal my lunch because he is hungry and it is self-defense against the ravages of hunger? Should a homeless person be able to break into my home and sleep in my bed to fend off the frost of winter? Should a lonely sex maniac be able to snatch up my daughter to sate his sick urges? How far does the right of self-defense go to intrude upon the rights and privileges and privacy and security of others? To be more germane, let us say I own a pharmaceutical company. Can Volokh break in at night to steal a chemical compound under research and development at my firm and violate my patent in order to mass produce my compound so that he has enough of it to ingest for the rest of his life? It seems, notwithstanding the quote below, that even Thomas Aquinas would reject so broad a conception of self-defense -- and that's saying something.


Since, however, there are many who are in need, while it is impossible for all to be succored by means of the same thing, each one is entrusted with the stewardship of his own things, so that out of them he may come to the aid of those who are in need. Nevertheless, if the need be so manifest and urgent, that it is evident that the present need must be remedied by whatever means be at hand (for instance when a person is in some imminent danger, and there is no other possible remedy), then it is lawful for a man to succor his own need by means of another's property, by taking it either openly or secretly: nor is this properly speaking theft or robbery.
-- Thomas Aquinas



Very provocative, Volokh. But even if you awoke tomorrow biologically fused to a gifted violinist, you would still be wrong.
11.9.2006 3:42am
John Thacker (mail):
The problem I have with these arguments is that you have made a leap from negative liberties to positive liberties.

I believe that you have misread his argument, for I do not believe that Professor Volokh is doing so at all. He is not arguing for a positive right to the drug, but rather a negative right of not having the government forcibly prevent a person who wishes to buy and a person who wishes to sell a drug from voluntarily engaging in trade. That's quite simply a negative liberty, not a positive one, and I believe it vitiates many of your otherwise good examples.

I do agree that there are those who would argue for a positive right to a drug, in which case your private property arguments would apply. However, it's a straw man as far as Professor Volokh's argument is concerned.

You may have a right to an abortion, but you do not have a right to the existence of abortion clinics. If no doctors wish to perform the procedure and no one wishes to fund the building of facilities where it may be performed, you're just going to have to resort to a hanger. You can't go to court to compel Congress to build an abortion clinic.

While I certainly agree, there is a large difference between compelling Congress to build an abortion clinic and forcibly preventing someone from purchasing a pharmaceutical from a company that wishes to sell it anyway, without any sort of subisidy.

The answer could be phrased two ways, as I see it. One, the drugs do not "exist" until they complete the process that Congress has established for them to reach market. Two, you don't have a right to the drugs (if you did, you could go to court to compel Congress to fund research of a cure for your disease), you have a right to the drugs to the extent they are available. They haven't been made available yet.

The furst argument of yours, I reckon, is far more injurious to private property than Professor Volokh's. A piece of property does not "exist" until Congress permits it to? That sounds very dangerous to me and certainly sets the stage for all sorts of expropriation.

The second argument is a non sequitur. The premise does not conflict with Professor Volokh's argument. He, unlike some, does not argue for a positive right to a drug nor the right to compel research. He simply argues for the negative right of non-interference with a voluntary transaction. The drug is "available" in the sense that a company exists that desires to sell it, and another person desires to purchase it.

Certainly purchasing some things is illegal, but that's a denial of a negative liberty and should be admitted as such. Framing the right to voluntary exchange of a particular good as a positive right is, in my opinion, extremely dangerous to the concept of liberty and private property.
11.9.2006 7:55am
Arbusto Spectrum:

Sure, many companies do hock snake oil, or at the very least "untested" medicines. But insurance, doctors, and patients demand tested medicines.

Snake oil sales are doing very well... Patients and doctors have a preference for tested medicines, but if you take away the requirement that they be fully tested and put everyone on a level playing field where pivotal phase iiis are optional, you will find a lot more products being hawked on the basis of much less data, complete with customer testimonials, and a lot fewer for which the inventors are willing to pay $200mm to run an expensive trial that might show the product don't hunt.... (statistically, 50% likelihood)
11.9.2006 8:49am
John Thacker (mail):
Snake oil sales are doing very well.

Yes they are. And so are licensed drugs. Thus, I believe it is inaccurate to say that allowing drugs to be sold after Phase I will prevent drugs from being tested on Phase II.

I believe that allowing drugs to be sold after Phase I will get us a better quality of snake oil/unlicensed drugs. They will be drugs that are still intended to go to Phase II or Phase III instead of pure snake oil remedies-- which are already so popular.
11.9.2006 10:06am
Robert Jackson (mail):
John Thacker,
Unfortunately, there is nothing to your defense of Volokh but rhetoric, and it fails because I suspect Volokh has a greater understanding of the relevant regulatory framework than you do. Pharmaceutical companies submit their raw materials (i.e., API) to the regulatory process before there is actually a drug, i.e., a saleable product. And they submit to the regulatory process through the evolution of their product because it provides them with some protection from suit and permits them to avail themselves of patent protection in the end. In other words, there is no "drug" without the regulatory process. The "drug" is what is patented and permitted to be sold on the market. The government cannot "interfere" with the sale of the drug -- it is the regulatory process that makes the drug saleable (and, more importantly, profitable, because no company, or very few companies, would underwrite the R&D costs without the guarantee of patent protection). Just look at the market failure with regard to vaccines. To simplify, the government subsidizes all drugs that get to market: there is no voluntary transaction in the state of nature with regard to experimental drugs because the government's regulatory process and its patent regime is what makes the transaction possible. Your attack on my position is thus the only straw-man on this thread.

I believe that allowing drugs to be sold after Phase I will get us a better quality of snake oil/unlicensed drugs.

This only proves my point.
11.9.2006 11:28am
Arbusto Spectrum:

Yes they are. And so are licensed drugs. Thus, I believe it is inaccurate to say that allowing drugs to be sold after Phase I will prevent drugs from being tested on Phase II.

I didn't say it would prevent Phase II/III trials; perhaps I overstated the case, but I still believe that it would dramatically reduce the incentive to proceed with II/III trials. 50% of drugs crap out in Phase IIIs, and if you add that to the number that crap out in Phase IIs, I am not so convinced that allowing post-phase I sales would actually increase the quality. But that is just my opinion.
11.9.2006 12:06pm
Ken Arromdee:
Patients and doctors have a preference for tested medicines, but if you take away the requirement that they be fully tested and put everyone on a level playing field where pivotal phase iiis are optional, you will find a lot more products being hawked on the basis of much less data, complete with customer testimonials, and a lot fewer for which the inventors are willing to pay $200mm to run an expensive trial that might show the product don't hunt.

Well, there's always the pseudo-libertarian argument: if people aren't willing to pay for drugs that had expensive trials conducted, obviously they don't believe the extra value from having a trial is worth the increase in price. So only allowing the public to buy drugs with a built-in trial cost that they would not voluntarily choose to pay is a distortion of the market.

(Incidentally, isn't paying for trials a public good? While naively one might note that the cost is borne by the buyers of the drug, that only applies when the trial is successful. If the trial is unsuccessful, the exclusion of the drug from the market benefits all consumers of drugs for that condition.)
11.9.2006 1:01pm
MadMan (mail):
As between a 100% chance of maternal survival and fetal death and a 100% chance of maternal death and fetal survival, they would choose allowing the woman to abort; but as between a 10% chance of maternal survival coupled with sure fetal death and a 100% chance of fetal survival coupled with sure maternal death, they would choose protecting the fetus. Yet even they would justify this conclusion by saying the woman's right to self-defense is trumped by the need to protect a viable fetus's life — not by claiming that the woman's right vanishes because her defensive tactics aren't certain to succeed.]

Prof.-

I think this point which you bracketed has to be the major turning point of your argument relating self-defense of abortion or lethal self-defense to "medical self-defense" and I don't think it works. After all, in the secnario above, the only factor that changed was the odds of the act of self-defense working. We would not allow someone to employ lethal self defense if there was not at least a "reasonable belief" that killing that person would end the danger (or at least a component of the danger). [You get credible information (enough to allow you to form a "reasonable belief") on your blackberry that one (but not which one) of the 10 people you are sitting down to lunch with is about to kill you. Can you shoot everyone at the table? There's a 10% chance each time that killing the person will save your life.] You admit there's an argument in the above abortion scenario. You're asking the state to play the game of creating rules that balance risk, why cant the state say that we only let you take the drug if the benefits substantially outweigh the risks [We know the drug works for some people and the risk of dying is comparatively smaller].
Would Ellen's "rights" be different if people died during phase I trials?
11.9.2006 2:00pm
John T (mail):
Just look at the market failure with regard to vaccines.

Ah. You mean the one where the government buys most vaccines at government-negotiated low rates, resulting in companies not wanting to produce them? It's not a market failure at all; it's a failure of government price controls. (And an excellent reason to opposed government-negotiated low prices with Medicare.)

Pharmaceutical companies submit their raw materials (i.e., API) to the regulatory process before there is actually a drug, i.e., a saleable product

Hmm. People will buy it after Phase I, hence it is saleable. Who's using ridiculous rhetoric here?

there is no voluntary transaction in the state of nature with regard to experimental drugs because the government's regulatory process and its patent regime is what makes the transaction possible.

If it were not possible, there would be no need to ban it. Clearly it is possible and often desired by both parties. The government imposes the regulatory regime such that it is illegal to sell without going through it, but it must forcibly prevent company A from selling to drug user B.

It may well be a good idea to require the regulatory process (though I personally doubt it), but it is rather crazy to suggest that it is impossible to have a "saleable product" or a transaction without Phase II and Phase III. The drug exists; people wish to buy it. A transaction is clearly possible.
11.9.2006 3:05pm
bob (www):
The need-to-test argument doesn't seem to hold up unless an individual can compel the company to provide the drug in question. In all other cases of potentially hazardous treatment (experimental surgery, for example), the individual must find the resources for the treatment (doctors, facilities, medications, etc.). If a drug company didn't have enough subjects to run controlled experiments, it would presumably deny the requests of patients unwilling to participate.
11.9.2006 4:47pm
John Thacker (mail):
Robert Jackson:

I don't care if you support a regulatory framework. But I can't possibly see how you're worried about "private property" when you want to prevent people from freely engaging in transactions. Your "the regulation creates the product" theory justifies all sorts of interference into private property, including "the food we bought for lunch" (FDA-inspected and regulated, hence "created"), and our houses (zoning regulations and regulatory easements for utilities).

Your reframing of the right to freely buy and sell our products as "positive rights" is incredibly injurious to the idea of private property, as is your apparent insistence that whenever there is a regulatory framework (particularly one that can be claimed to encourage the product of the product) that property rights are inherently limited.

Your position may be a consistent and coherent one, but it is hardly about a distinction between positive and negative rights or about defending private property.
11.9.2006 6:05pm
Robert Jackson (mail):
John Thacker,

Whether I "support" it or not, our taxpayer dollars pay for the drug regulatory framework because it provides the public with minimally safe drugs and incentivizes pharmaceutical innovation, research, and development: it is not a "ban".

The regulatory framework creates the incentive to create the drug because submitting the drug to the process guarantees minimal insurance from lawsuit and a power of monopoly (i.e., a patent) to recoup the R&D costs. Without such incentives, the drugs wouldn't get made, as in the vaccine market where companies won't make vaccines because vaccines require human testing and human testing means exposure to lawsuits that negate profits. As you seem to fail to understand, there is no transaction in the abstract -- the incentives of the regulatory framework are what create the transaction.

You also seem not to understand that API is not a drug. It's just raw materials. At certain stages of the regulatory process there isn't something that qualifies as a drug. Reprocessed uranium is not a nuclear warhead; that isn't rhetoric.

Just to point out how absurd your position is, I say that I support the patent system and your reply is that I must not support private property.

And if you don't think that asking for a redistribution of income from all other taxpayers funding the drug regulatory framework that provides them with safe drugs to you for your experimental medical care counts as a positive liberty, then you don't know what a positive liberty is.

I would also note that Volokh recognizes that the right to self-defense is not the absolute that you are advocating for: "The self-defense right, like other rights, isn't absolute. Modest regulations (informed consent requirements, waiting periods, and the like) that don't substantially interfere with the right should be permissible. The right may well be limited to situations where self-defense is necessary to avoid threat of death, or perhaps of very serious injury. The right is inherently limited to cases where it doesn't directly infringe the rights of others who are not threatening the person's life."

Other taxpayers who have sunk tax dollars into the drug regulatory regime and companies already reliant on the patent system count as other who are not threatening your life. Thus, according to Volokh, the right could be limited in exactly the way I have implied above. If you still disagree, take your disagreement up with Volokh.
11.9.2006 7:23pm