CyberBullying

January 31, 2011

Another day, another fantastic talk. Today, Professor John Palfrey from the Berkman Center (which you absolutely must check out, if just to see all the awesome work they’re doing) gave a talk on the potential pragmatic and constitutional issues with current legislative trends in cyberbullying.

As many of my friends know, I find bullying an incredibly important topic. (This is no doubt influenced by both my firsthand experience of it and more general reading on the psychological effects this sort of experience can have. And I’ll just say, its effect cannot be understated.) But, with that said, there are hugely important questions about the chilling effects legislation can have if not created carefully.

So, I’ll just list a few tidbits to chew on below:

- One of the most interesting questions posed was something like this: Depending on how you define bullying, are there certain types that are in fact speech we want to protect? Thinking of the LGBT community, the use of “outing” as a political tool, way to expose hypocrisy, etc. has been seen by some to be hugely important. In the world of defamation, a complete defense to the accusation is that what you said is, in fact, true. That of course won’t work in some of these bullying situations — where it might be the very truth of it (the “outing” if we expand its meaning a bit to encompass all disclosures of truthful information the person doesn’t want disclosed) that can be, in some cases, so traumatic. So, where do we protect the free speech/ right to speak the truth versus the fact that, in the eyes of some, it might be classified as bullying?

As a response, there was some discussion that we might see a difference between outing someone who is already in the public eye versus the privacy that might be differently due to a child. But, in general, I think the fact that this was a hard question remained.

- Another interesting issue that I haven’t thought about before has to do with potential due process concerns. In some legislation, we give wide-reaching powers to school administrators to visit fairly severe punishments on students accused of cyberbullying. And, even before that punishment is enforced, the school administrators can demand the students to comply with questioning with no lawyers, no guarantee of a fair hearing on the matter, no nothing really. What should we do about that?

As Professor Palfrey pointed out, what’s interesting about the internet is that there is an expectation of a lot of private ordering to deal with what are in essence legal issues. For instance, think about the DMCA takedown requirements. There’s no judge that says whether or not a certain video should be taken down. The alleged copyright holder sends a demand, it’s taken down, the person putting it up gets notice and can explain why it shouldn’t be taken down, but a judge isn’t deciding in that process (granted, litigation can ensure later down the line but let’s be realistic about how often the average YouTuber is going to have the financial means to go down that road.)

The point is: we already expect a lot of private ordering to resolve issues on the internet. Granted, in the case of cyberbullying you’re empowering public school administrators, but the same questions of due process and general justice remain.

That’s good for now. Would love to hear people’s thoughts. There are plenty more notes I took from the talk and you can find them all here. I just can’t write about them all because, alas, law school beckons.

Current Controversies in Food and Drug Law

January 18, 2011

I recently attended a panel on “Current Controversies in Food and Drug Law” and thought I’d jot down a few notes to share with those of you back home (who, obviously, are dying to learn more about the strage exciting world of food and drug law.)

Panelists
Peter Hutt - Current HLS Professor (former FDA general counsel, teaches a Food and Drug Law course every winter)
Mark Raza - Senior Counsel at FDA’s Office of the Chief Counsel
Kirsten Mayer - Ropes and Gray counsel with all sorts of medical and science-related clients

Each panelist had a chance to stand up and discuss in a few minutes what they took to be some of the biggest challenges the FDA currently faces, and while I am not mean an expert I’ll try and lay out a few of the concerns raised:

- Hutt brought up some economic incentive difficulties based on the duration of patents coupled with the significant amount of time it takes to get through FDA approvals. [from my understanding the issue is: patents run for either 14 or 20 years. You file for a patent fairly early in the game (long before you’ve even gone through clinical trials, let alone gotten approval to actually market and sell. So, by the time you get through all the FDA hurdles for approval, you typically only have 11 or 12 years left on the patent — which for a lot of companies isn’t enough time to fully recoup costs and make the sort of profit that incentives companies to invest in the R&D to begin with. So, unless you have a blockbuster, it isn’t worth it for a lot of companies.)

- Raz, changing gears, talked about biosimilars and the regulatory difficulties there (a topic on which the FDA had a two-day meeting back in September). As a bit of background, biosimilars are what they sound like — they are (if I understand correctly — and I’m sure Chris will read this and correct me if I’m wrong) basically molecularly identical to some drug that was already approved, but they are created by another lab, under non-identical conditions, at a time after the original patent has expired. One of the big questions is what sort of testing should these biosimilars have to go through before getting FDA approval. On one hand, they’re basically the same as something already on the market (think of a certain active ingredient in both a name brand drug and some generic) so it seems redundant. On the other hand, we don’t know how much other factors come into how that drug will actually perform. So for instance, with different manufacturing processes they might have different impurities or slight differences at some level — and that in turn may have a profound effect on how that drug is digested in the body.

- Mayer went last and it turns out her issues ended up dominating the rest of the discussion: Off-label marketing. So, in a few sentences what is that all about? Well, from what I understand it goes like this: The FDA approves a drug for a specific use. The manufacture of that drug is then allowed to promote (market) the use of that drug to doctors and the like for just that use. However, it turns out that a drug might be approved to deal with one condition but actually is really great to use in another as well. How do we know this? Well, the drug company might be sponsoring studies to explore that or doctors have recognized relationship in underlying pathology between the condition it was approved for and another condition and then decided to conduct trials of their own (this sometimes happens at university hospitals for people who are basically out of options and are willing to try anything), etc. The issue is: even if it turns out the drug is really useful for another condition, the manufacturer cannot promote/market the use of the drug for that other condition. It is criminal to do so. But, notwithstanding the serious criminal penalties (let alone the absolutely enormous fines companies have paid for doing so) they still do promote off-label use in some cases. Mayer brought up the argument that such off-label marketing prosecution may (1) have some pragmatic issues but more interestingly (to me) (2) may run afoul of Free Speech protection.

So, having not taken ConLaw I will say just a few sentences and see if others have thoughts on all this. The argument seems to be as follows: It’s granted that while we have freedom of speech not all speech is protected (can’t yell “fire” in theatre, can’t slander someone and expect that to be protected, etc.) The government argues that there is no First Amendment issue because 1) the regulations prohibit the promotion by manufacturers of off-label marketing, so for the manufacturer to do so would be an unlawful activity and 2) the speech (which I guess is just the marketing tactics) are just used to establish intent — the intent to commit the unlawful activity. [I think that’s right… though it is a bit confusing to me]

The issue with that line of arguments however is that the promotion of off-label use isn’t prohibited, period. In fact, anyone but the manufacturer can promote the use of the drug in an off-label way. As Mayer points out, if the NYtimes wants to write a bit piece on the virtues of the off-label use of x drug, it can do so under the law. So, it cannot be that the speech itself is an illegal activity; it’s only the speech itself coming from the manufacturer that’s prohibited — and that seems to be a First Amendment issue.

What this made me think of was the Citizens United case. The more we think of companies through the personhood metaphor, the more these free speech for the company issues come up.

Anyway, I must run and do actual class readings but just thought I’d lay out a few of the things I heard. If I can better clarify the last argument in the future, I’ll be sure and do so… and soon!

New Doodles and Zittrain’s “Minds for Sale” part one!

November 19, 2009

Unhappy-girl I’ve added two more doodles to the Artsy Stuff > Computer Doodles section. I’ll add them here, too!

I’m also hoping to send out my write up about the really interesting talk I went to last night. Jonathan Zittrain from Harvard’s Berkman Center gave his “Minds for Sale” talk. Info here.

Long story short – I think most of the problems he expressed aren’t unique to cloud computing (or technology at all). Generally speaking, there’s a danger when people agree to do work when they don’t understand the overarching goal of the project or even who they’re working for.

Simple example: Someone puts an ad in the paper: “Will hire someone to flier cars in x shopping center.” You know that’s a heavily Persian area and so you aren’t surprised that the ads are in Farsi. You accept the job, get your $20 and continue on your merry way.

Turns out those little fliers were actually filled with hate speech, threatening to kill Muslims and Muslim supporters.

You didn’t really care (or perhaps better said, you didn’t really think to care) when you took the job what the flier said. And, especially because it was in Farsi, you didn’t have ready access to figuring it out for yourself. But, if the ad would have said “Will pay someone to distribute Muslim hate speech on cars!” you certainly would have declined.

awesome-guy-with-dorky-glasses Now taking that to the land “o” the Internets, things like Amazon’s Mechanical Turk allows people to post simple jobs (like, “what words best describe this picture”) for something like $.01/job. The “turks” have no idea what the larger scope of the project might be and it’s possible if they did, they’d never support it.

So the worry seems to be that things like Mechanical Turk at least have the potential to make people complicit in activities they never would have supported otherwise. But, because you’re just turning one little cog, you might be.

Food for thought…