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In Search of Facts

Whether The American Constitution Society seeks "to revitalize and transform the legal debate, to counter the narrow conservative vision of American law that lacks appropriate regard for the ways in which the law affects people's lives" or is in fact the least necessary organization in legal education, the Columbia chapter has had a blog since October, and I've singularly failed to mention it. They use Blogger, but if they had an RSS feed I'd be linking to them.

Today, however, there's a column by "Liz" (full disclosure--I have no idea who this is) that's gotten me a bit confused, and so I'm going to "fisk" it. However, unlike your normal fisking, I'm going to start up front by saying I don't really know enough about genetics to make heads or tails of this. This isn't an argument. The questions asked below aren't rhetorical, they're real, and if any of my readers have some medical/scientific knowledge, please fill me in.

After some introductory text, the article starts as follows:

A little background. Last November, the New England Journal of Medicine published a study about BiDil, the aforementioned drug. BiDil treats heart disease and has been tested in the past, unsuccessfully, in a diverse community. When researchers went back and analyzed the data, they discovered that while the drug was ineffective overall, it was fabulously successful in treating folks that were identified as African American. In fact, when the researchers initiated a study whose only participants self-identified as being African American, they had to stop it prematurely, because the drug was so effective they felt it would be wrong to withhold it from the control group.

In a slight gripe with the CLSCACS Blog, it would have been nice to link to the report. I'm pretty certain it's the report here, though again, this isn't my forte.
The FDA, which falls under the umbrella of the Department of Health and Human Services, is responsible for certifying all prescription drugs as being safe and effective before they are put on the market; there is no real question that everything they do constitutes state action. Thus, if they choose to label something on the basis of race, shouldn’t this action be strictly scrutinized? If so, the approval of BiDil solely for African Americans must advance a compelling government interest by the least restrictive means necessary. No doubt, the treatment of heart failure serves a compelling government interest. Even more so if we look at BiDil’s story through the lens of affirmative action. African Americans suffer from a variety of health problems at disproportionately high rates due to a variety of environmental factors. BiDil’s approval for African Americans may just be one step towards righting past health care wrongs. Still, despite the fact that this drug will help African Americans suffering from heart disease in the short term, allowing the FDA to slap a race-based label on the drug may not be least restrictive means of putting it on the market and is probably not a good thing for the African American community in the long term.

Now, here's where I would have expected to see something saying that a less restrictive means of determining who the drug would help, and who it wouldn't, actually exists. Here's what follows:
For years, scientists, researchers and other academics have been shouting that race is a social construct. In fact, the preliminary sequencing of the human genome told us that regardless of whether or not our physical characteristics (a.k.a., " phenotype" to geneticists) identify us as black, white or Asian, we are pretty much genetically identical to one another.

One would have thought that "pretty much" and "identical" here was begging the question, since there would seem to be a difference due to the experiment. Even the National Human Genome Research Institute source that the ACS quotes approvingly below doesn't say that genetics have no role in disease:
What about health disparities? Are genetic differences between populations likely to have a role in health status, both in the US and around the world? In many instances, the causes of health disparities will have little to do with genetics, but rather derive from differences in culture, diet, socioeconomic status, access to health care, education, environmental exposures, social marginalization, discrimination, stress and other factors. Yet it would be incorrect to say that genetics never has a role in health disparities. This is most obvious in the unequal distribution of disease-associated alleles for certain recessive disorders, such as sickle cell disease or Tay-Sachs disease, but has also been noted recently for certain nonmendelian disorders, such as Crohn disease.

The question of whether genetics will explain a substantial proportion of health disparities for most common diseases is largely unanswered and will be clarified only by further research studies of many populations. Given that the frequency of many genetic variants is not equal in all parts of the world6, however, genetic variations conferring disease susceptibility are expected to be unequally distributed, at least in some cases.

But again, I don't know enough to evaluate that statement. Liz continues:
And yet, here we have a drug company implying that African American heart failure patients are physically (read: genetically) different from white heart failure patients. How can they do this? Were the social construct theorists wrong?

I can't find anything that says a drug company is stating there's a physical or genetic difference between African American and white heart failure patients. I couldn't find any of the application documents on the FDA website, although I did find this: a 2003 report stating that the FDA was now requiring reporting on race and ethnicity in drug trials. But relevant to any evaluation would be: is the drug company implying that the difference stated exists? Or are they claiming that only for this group do they know that a reasonable chance of successful treatment exists? The two would seem to be very different statements. (Again, there's a frustrating lack of linking to sources.)
No. The reality is that BiDil’s efficacy likely has little to do with race as commonly perceived. "African American" is just filling in as a proxy for the genetic markers that code proteins which ultimately lead to the ways in which the human body interacts with the drug. Anyone may have these genetic characteristics.

Again, no support for this is offered. Does anyone have some? (Again, the only source cited by the ACS, Dr. Frances Collins, seems to disagree. See the third paragraph in the document linked above and here.)

Skipping ahead some, we come to this:

Nevertheless, BiDil’s makers and the FDA should not be permitted to shortcut the drug approval process by referring to BiDil’s efficacy within one community. The drug company should be required to find out what exactly is making the drug so effective in the African American community. The FDA should compel BiDil’s makers to research what exactly "race" is serving as a proxy for and approve the drug for all individuals with such characteristics, whatever their ancestry. . . .The last thing we need is the FDA’s stamp of approval on dubious biological differences between races. This could open up a whole can of worms. For starters, how do we decide who qualifies as African American? Is it a phenotypic designation? More research is needed to identify how people self-select their racial identity. Again, it would be wrong to deny sick patients an effective drug. Therefore, the FDA should approve BiDil for African Americans only so long as it takes to develop a test to identify all the individuals who could be treated by BiDil, whatever their race.

Now, so far, so good. The report then quotes this statement from Francis Collins (The source being here, and they forgot to state that he's the Director of the National Human Genome Research Institute, which is why he's persuasive):
In the words of Francis Collins, "a true understanding of disease risk requires a thorough examination of root causes. ‘Race’ and ‘Ethnicity’ are poorly defined terms that serve as flawed surrogates for multiple environmental and genetic factors in disease causation, including ancestral geographic origin, socioeconomic status, education and access to health care. Research must move beyond these week and imperfect proxy relationships to define the most proximate factors that influence health."

Now, here's my question: can you actually make a case that, even if this deserved strict scrutiny, it wouldn't pass? First, to even bring a case, you're going to have to have someone who's disadvantaged by the FDA denying access to BiDil to them. This would seem to have to be a non-African American with heart disease who can prove that he would be helped by the drug. After all, for strict scrutiny to be applied, there has to be some group who's being disadvantaged, and you're going to be hard pressed to show that someone's disadvantaged by a drug that's not going to work on him.

(Or I suppose you could say that the disadvantage of "disproving" the social-science theory of race through the FDA approval is more disadvantageous to African-Americans than lack of access to the drug, but this too seems like one heck of a tough sell.)

But then you're going to have to prove that drug approval solely for African-American's isn't the least restrictive means to accomplish what even Liz says is a compelling government interest. To do this, it would seem to me that you'd have to show either that (a) self-identified race (because the NEJM study did correlate with something, whether we say there's such a thing as race or not) is not a reasonable proxy for who this drug is going to work for; or (b) the development of a test for whatever genetic markers do determine the drug's usefulness will be cheap enough that it doesn't crowd out other research. I'd also think you'd want to show that the side-effects for non-effective use (i.e. if you give BiDil to non-African Americans) are non-negligible, and that the money spent developing a genetic test wouldn't be more usefully spent on other heart disease (or even disease-treating) programs with a wider applicability.

In other words, given the high priority that health gets for compelling government interests, and the fact that no less restrictive means seems available, why even bother trying to apply strict scrutiny to it, as any attempt to do so is likely to merely find that it passes muster?

Looking at some of the cited literature, it doesn't seem that there's much fear that scientists aren't trying to uncover the exact genetic nature of what race is a proxy for anyway. For instance, this study, cited in the NEJM work, spends the last two paragraphs arguing that just such research is needed.

Now, I suppose there could be some fear that, even were a test for genetic markers developed that allowed BiDil to be used on those who do not self-describe as African Americans, the manufacturers wouldn't want to sell to them. The only reason I can see for this, really, is that the cost of the test outweighed the value of the medicine, taken in aggregate. (i.e. If you tested every caucasian heart patient, you'd get a higher cost from testing and false positives/negatives than you saved by handing out the medicine.) But again, if that were the case the action would seem to pass strict scrutiny as well.

Otherwise, one is left with the curious situation of a drug manufacturer refusing to sell to non-African Americans though they possess a test which would make it profitable for them to do so. But this seems a curious concern.

So I'm assuming that there is a large amount of the science I'm simply not understanding. As it stands, I can't see why Liz is so concerned.


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» Race-Based Drugging from Letters of Marque
Quite shockingly, I agree with Anthony Rickey on something, and it's not about cheese, either. Anthony takes on another Columbia blogger, Liz, on the subject of race-based FDA approval. Oddly enough, this scenario showed up -- in slightly mutated form,... [Read More]


They have an Atom feed (http://columbiaacs.blogspot.com/atom.xml)... if your reader supports it...
Yeah, Atom doesn't help me. My personal aggregator reads it, but the sidebar on the main page doesn't, and ATOM does some pretty lousy things to the Continuum, too.
Liz is concerned because she cares about critical race theory. I think it leads her astray a bit. In her defense, there is an argument on strict-scrutiny grounds, which you identify pretty well. It is true, as critical race theorists might say in reference to genetics, that there's no "black" gene or "Hispanic" gene, etc., that race, in a strict sense, appears as the result of genetic physical differences (skin color, facial structure &c.), but that race _as we commonly conceive it_ appears as a result of something else: Namely, how we think about those physical differences. (The great triumph of many an critical studies undergrad is the realization that when you think about things, the way you think about them is important to the way you think about them. I was one myself, so I'm not trying to be too critical.) So there's no "black" heart disease drug in the same sense that there's no "black" sickle-cell propensity; there is rather a drug responsive to or a propensity stemming from a peculiar genetic trait that may be predominantly found in members of one race, but is not identical with that race. Not everyone in the race will have the trait, and probably vice versa. So you could argue against the program on (related to least-restrictive analysis) the lines of: since there is a more precise criterion you could use for who gets the drug (assuming, of course, that there is) that does _not_ make use of a facial racial classification, failure to use that and the decision to use the race-based one is unconstitutionally discriminatory. Which I think you identify.
TtP: Yes, but this is what's confusing me: If there is no cheap way to identify who has the genes necessary--assuming it's genetic as opposed to some other factor that tracks with racial self-identification--then the strict scrutiny action fails. Assuming there is a cheap way of doing this, given the very low marginal cost of prescription drugs, why are the manufacturers of BiDil not going to petition the FDA as fast as their profit-grubbing little fingers can file the form? The entire concern only makes sense if you think that for some reason the manufacturers have a test (or could easily develop it), but would for some reason stick to the race-based restriction. This, to me, seems a bit odd.
Liz here. The author. I confess to know nothing about Critical Race Theory, so I have no idea what one of the other commentors was talking about, but I do want to thank Three Years of Hell for reading the blog of such an obviously unimportant organization. BiDil's makers would likely make money on any test they develop and that the FDA regularly approves drugs for all adults, but then labels them with an efficacy breakdown by race- allowing Doctors to use their professional judgment when prescribing. That what makes BiDil's case that much more interesting...
Liz: Please don't take offense at the comment--I found Professor Bainbridge's commentary on the ACS to be amusing, which is why I quote it. The point was I was remiss in not mentioning you guys before. Heck, I make fun of the Federalists all the time. (On the other hand, they do have an RSS feed.
I dont know what an RSS feed is!
Liz: Disclaiming any knowledge is cute, but just. (I blame Anthony for starting it with the I'm-not-a-geneticist rap.) "For years, scientists, researchers and other academics have been shouting that race is a social construct." is what I'm talking about. You obviously know something about it. Anthony: Yeah, any strict scrutiny action would fail, no doubt. The FDA's only going to label the drug as more effective for certain racial groups, not deny it to all but blacks (huh---well, I'm _assuming_ that's the case; they might construe their mandate to be that, if they can prove it "safe and effective" for Class A, but not for Classes B through Z, then only approve it for sale to Class A, but that, I think, is doubtful). So it's just an informational thing. And despite whether you think it's a good or bad idea, it's not unconstitutional for the Bureau of Overburdensome Statistics to break down, say, economic stats by race. That is, you need actual discriminatory _treatment_, not merely classification, before it becomes a constitutional concern. TtP
Okay, so I honestly did not know that the whole race as a social construct thing was linked up to critical race theory. But enough of that. It is discriminatory in that the FDA is essentially saying that white heart failure patients who would also respond positively to an increase in nitric oxide in their bloodstream (the dumbed down version of what BiDil does) are not approved to take the drug.
Liz, A) If you want to know what an RSS feed is, check out the link at the top of the post. Or just click here. It's one of my entries on RSS feeds, and explains what they are, how they differ from ATOM, what they do, why you should have one, and how to get one. If you need help making one, you have only to ask. B) Somehow I doubt that this is what the FDA is saying. What they're "essentially" saying is, of course, a matter of dispute, but I'll leave that to the socio-linguists. We can't go any further without some facts, which would need some hyperlinked material, which is mostly what I'm wondering about. Your claim seems to be that the FDA wants to license the makers of BiDil to only sell the product to people who self-identify as a particular race. TtP seems to be saying that he thinks the FDA would license it for sale to anyone, but recommend that it only be given by doctors to African Americans. That would be the first factual dispute, and if you have some information on which has been requested by the makers of BiDil, and which the FDA is considering, it would be helpful. I personally can't find any primary sources. But even supposing the FDA only licensed it for sale to African Americans, your point still eludes me. In order for the action to fail strict scrutiny, you have to hypothesize two things: (a) there exists a group of white heart disease patients (and is this a heart disease drug, or a heart failure medication?) who would respond to BiDil; and (b) that this group can actually be identified. You can't even bring a case without showing that there is an actual person who's been denied the medication who would benefit from it. Even supposing you could--a matter for which you've put forward no evidence, and indeed the studies you failed to link to don't seem to support it--you'd have to prove that it was possible to distinguish a white heart disease patient who would and would not respond to BiDil in a manner that was both (a) harmless, i.e. you won't accidentally do harm by prescribing the wrong medication to folks it won't help, and (b) cost-effective, i.e. you won't save lives by putting research elsewhere. Otherwise you'd seem to make the "least restrictive means" bit of strict scrutiny without much problem. Now, you seem to be assuming that all these things are true, which is why I called this post a request for facts. It seems that if these things were true, we wouldn't have a case at all, since the makers of BiDil are likely to want to sell to the largest pool possible. But given that you seem to think there is a way to make a case out of this, I'm wondering if there are facts which might rebut that assumption. You didn't seem to formally propose that the FDA force the makers of BiDil to research a method of testing who the drug will work for and who it won't, only that BiDil only be allowed solely to African Americans until a less restrictive means of doing so is available. But again, I'm wondering why bother? If you're not going to mandate the research, one assumes that the makers of BiDil will apply for a broader license as soon as is feasible anyway--they have zero incentive not to do so.
I'm still not convinced that this even gets strict scrutiny. Assuming the science is right, this is rational discrimination--something the constitution doesn't prohibit. The court has ruled this way in other equal protection contexts (gender/handicap) and I see no reason why this would be any different in the race context. Liz says on ACSBlog that: "The biological differences that lead to different treatment for women under the law are physiologically related to gender- in this case the physiological differences are not actually related to race as legally perceived." I don't know what that means. Maybe she could clarify. I think this is exactly what the science is saying. Maybe the science is wrong, which obviously makes the entire argument moot. Certainly the physiological differences between men and women are greater than the physiological differences between african americans and whites. But I don't know why that matters. It's still a physiological, rational difference. In any case, I agree that there is no way this fails strict scrutiny, even if it is judged under that standard.
I had a misconception about what Liz was saying. Frankly I'm surprised that the FDA would have the power to approve for some people and not for others, unless the category was something like "people with a prescription." I would think it'd be in excess of their jurisdiction (izzat the right word? I don't wanna say "mandate" again but maybe...). Say... thalidomide. The situation there looks similar to the one here; two classes of people, one who might get some benefit from the drug, one who really really shouldn't take it for any reason. But the FDA, were it to loosen restrictions on thalidomide, wouldn't approve it for sales only to men and non-pregnant women; they'd approve it for prescribed use and rely on doctors. No? Publius: Oi. "Rational" discrimination sounds... tricky. Keep in mind that while the Court's perception of some prejudices as more irrational than others (and therefore gender- ostensibly get less review than race-based classifications), the concept of irrationality doesn't inform the analysis _once the Court has set the level of review_. That is, since the Court concluded racism was thoroughly irrational, racial classifications get strict scrutiny. (Or that's at least what the Court said it was doing.) But you can't challenge the scrutiny by showing that your racial prejudices are, in fact, rational. I.e., once step one is decided, you have to argue at step two; you can't relitigate the purpose of strict scrutiny.
TtP: In partial defense of Publius, my conception was that strict scrutiny only applied to racial classification that discriminated to disadvantage against a discrete group, if not minority. (I.e. in affirmative action, you can show that if one hadn't hired X minority person, Y non-minority person would have been hired.) What I'm wondering is what the evidence of disadvantage here. Certainly saying, "The FDA does not approve prescription of this medication to non-African Americans will be damaging if and only if you can prove that there's a (for instance) white person who would benefit from the drug. Liz assumes this is true, but there seems no evidence for it yet; further, if there were evidence for it, there seems no reason the FDA would so limit the precribing power of doctors (assuming that's what they're doing). So: a) if you have to show harm to get to strict scrutiny, which was certainly my impression (since it all rests on Carolene Products infamous footnote), where's the harm here?; and then, b) if you did, you're still going to pass strict scrutiny. Which makes the whole thing a bit moot.
TtP, I'm not saying that the analysis should get strict scrutiny, and then since the discrimination is rational, get bumped back out of strict scrutiny. I'm saying that the court changes it's level of review based on whether the discrimination is being drawn rationally. It's not clear from the opinions that rationality informs the analysis, but I think everyone is pretty much in agreement on this point. See 111 Yale L.J. 1141, 1159. I think this is most clearly extrapolated from the Section 5 cases (Garret, Kimel). And I don't understand why rational discrimination is tricky. We separate men's and women's bathrooms because discriminating bathrooms based on gender is rational. We don't allow employers to discriminate based on gender because it is irrational to think that a man could do a better job as a lawyer than a woman. Race discrimination is obviously per se irrational because of its "social construct" quality, having little to do with genetic differences. Unless, however, these genetic differences have some significance in the area of heart medicine. Then race isn't a complete social construct, and there are rational reasons for differentiating in the area of medicine. Liz's concern as I understand it is a slippery slope argument that racists (wherever they are) are going to use this as ammunition to start taking down the black man.
Huh. Prehaps. Prehaps. On the point about strict scrutiny: My point was that there's a two-step analysis that the courts do. First, they ask, What kinds of classifications deserve heightened scrutiny? Second, they ask what kind of classification is at stake here? Now, the rationality of a particular _kind_ of classification informs the first analysis, but the rationality of a specific classification itself doesn't really get discussed in the second. It's simply "racial" or "sex-based" or "economic" or what have you, and then it proceeds from there; there's never any notion of treating objectively race-based classifications differently depending on their rationality. That only happens in rationality review. I think you kind of identify this when you say that racial classifications are _per se_ irrational. Well (make it absolutely clear I'm playing devil's advocate... heh, here), what if they're not? What if a really good argument, in the sense of logically unimpeachable, for treating blacks differently can be made? My feeling is that it shouldn't be entertained by the courts, which should keep to its 1) compelling? 2) necessary? analysis of strict scrutiny. You're right, they're "per se" irrational, but not necessarily because they actually _are_ irrational, but because _we say they are_. Anthony: You certainly have to show harm, but is it your understanding that in the absence of harm there's no unconstitutionality, or that there's no standing? (As if it mattered.)
Agreed. There is the two-step analysis, but you seem to be saying that the first step is automatic, i.e. if race, then strict scrutiny. That's what I'm disputing. I think there is more in the question than automatic strict scrutiny. Gender is the perfect example because there are clearly two different levels of scrutiny based on whether you're discriminating based on biological differences (bathrooms) or not (employment). And you say "what if there were a rational reason for treating blacks differently"--remember "rationality" informs whether the two people being discriminated are different enough to warrant the distinction being drawn, not the reason for the discrimination (the second prong). I can't think of any rational difference between blacks and whites other than in this example, so I don't buy the slippery slope argument.
The first step isn't automatic so much as it's prescribed. The Supreme Court occasionally tinkers with its formulations, but for lower courts the analysis is much less involved. Indeed it usually is "race, then strict." And it's not a slippery-slope argument; I'm not worried at all about where it might lead, or anything like that. My point is perhaps subtler, but here goes: When we hear people say there are good reasons to treat people differently according to race, especially when presented as legal arguments, our reaction isn't to _disagree_, strictly speaking, but rather to shut our ears. We just don't take those arguments seriously. (I think your reaction that "I can't think of any rational difference" is indicative of this tendency.) If you really can't think of such an argument, you suffer from a failure of imagination, but you're in good company. Give you a dumb example: Say some functionary at a public college (state action) supposes, upon chancing through the refectory one day, that since all the black students are sitting at the same tables and all the Latinos at another &c. &c., it stands to reason that black students are more comfortable in their exclusive company and that therefore the mandatory freshman English sections should be segregated by race. You can imagine all sorts of arguments for and against this, but if such a proposal were serious, no one would take those arguments for it seriously. Indeed, our first reaction would be pretty much like a district court's doctrine: facially according to race? then getouttahere. Now, you might say that's because such a classification is patently irrational. But of course it's _not_: Black educators have been wondering openly about the virtues of all-black private schools for years now, to say nothing of the experience of the nation's historically black colleges and universities. The point is that there exist reasons and arguments in favor of the policy; if our inquiry were really whether it's irrational, we would pay attention to those reasons and arguments. _But we don't_. The fact that it's openly race-based ends our inquiry. [You say "remember "rationality" informs whether the two people being discriminated are different enough to warrant the distinction being drawn, not the reason for the discrimination"---I'm sorry, but I'm not following you. Isn't the "reason for the discrimination" just another way of saying why one draws the distinction?] Hmm. Long-winded even for me. I'll stop now.
To answer in a different way, an old joke: Three baseball umpires, returning after an outing. Says proudly the first, a rookie ump: "I called it like I saw it." Says the seasoned pro: "I called it the way it really was." Says the grizzled veteran: "It wasn't anything, until I called it." Thus endeth the lesson. TtP

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