I don’t even want to imagine the creative titles law students might come up with for a note on this topic, but it is a question worth asking/answering: how should the FDA regulate fecal transplants? Check out the NY Times article on the treatment here – apparently, it works!
Last spring I had the chance to work as a research assistant for Marc Rodwin, a Lab Fellow at Harvard’s Edmond J. Safra Center for Ethics, reading through hundreds (perhaps thousands) of pages of Congressional hearing transcripts from the 1960s and 1970s relating to the federal regulation of drugs. In reading the final version of the article that I helped to research, Independent Clinical Trials to Test Drugs: The Neglected Reform, forthcoming in Volume 6 of the Saint Louis University Journal of Health Law & Policy (also available online), two things occurred to me about the way academics and to some extent policymakers approach regulatory law, especially in the life sciences.
First, it struck me that in the general discourse about health policy, we are often surprisingly oblivious to history. Although the first U.S. law requiring safety or efficacy testing for new drugs was passed a mere 75 years ago, the intervening decades have been prolific when it comes to proposals and debate. What Rodwin’s article does, and I think is valuable both to support his own proposition and to advance the scholarship of others, is to frame his contemporary proposal with a close historical look at similar proposals and the debate surrounding them. What becomes clear, whether the topic is independent clinical testing, the “drug lag,” or the scope of patent protection and marketing exclusivity, is that our “new” ideas about how to improve the system are often anything but. The idea that we ought to know the history of our subject is not particularly groundbreaking, of course, but it’s plain we could be doing more. I’ve found that even the little history I’ve read–all those hearings, of course, but also wonderful books like Daniel Carpenter’s Reputation and Power and Philip J. Hilts’s Protecting America’s Health, and under-utilized resources like FDA’s Oral History Transcripts–has proved endlessly valuable even in thinking about cutting edge ideas like those I’m privileged to be exposed to as a participant in the Petrie-Flom Center’s Health Law Policy and Bioethics Workshop.
Second, it occurred to me that when we think and write about health policy, we might benefit from distinguishing–at least for ourselves–between two distinct projects: the practical endeavor of proposing “realistic” policy changes that take account of and purport to improve on our imperfect and historically contingent regulatory regime, on the one hand, and the more theoretical work of contemplating an ideal system, a “castle in the sky.” Folks who think deeply and write about these issues obviously engage in both: Rodwin’s article, for example, plainly takes the present framework as its starting point, but does so with the larger theoretical question in mind. I just wonder if we might be more explicit in articulating how proposed incremental changes fit into a broader project of making the regulatory scheme look more like our hypothetical ideal. The history of regulatory law is so littered with incremental changes that have had unanticipated consequences elsewhere in the system that I would love to see more authors lay out explicitly what they hope the system will look like, and justify their incremental proposals as part of that broader vision.
Due to the string of December holidays and some traveling by the round-up author, this post belatedly summarizes tweets from the end of 2012 to the beginning days of the new year. The round-up will resume a regular schedule following the conclusion of this week. Read below for this (extended) round-up:
Frank Pasquale (@FrankPasquale)posted an article about China’s growing obesity problem, one that shocks those who remember the Great Famine of 1958-61 and which is still largely minimized by government officials. The total number of obese individuals in China has risen from 25% in 2002 to 38.5% in 2010, according to the World Health Organization. (1/1)
Frank Pasquale (@FrankPasquale) also tweeted this blog post on the possibilities of cyborgs, a potential reality that a recent BBC article notes may not be too distant. Such an invention could potentially result in direct mental control of machines, augmented intelligence, augmented learning, and mood modification, among other benefits, postulates the article author. (1/1)
Frank Pasquale (@FrankPasquale) additionally posted a piece addressing the idea of love between humans and robots. (1/3)
Alex Smith (@AlexSmithMD) announced the release of PREPARE, an online advanced care planning tool meant for individuals to foster communication skills and prepare for decision-making rather than make premature plans. The project in part is meant to help empower individuals rather than have them tied to the medical establishment. (1/4)
Dan Vorhaus (@genomicslawyer) included a blog post on crowd-funding personalized bioscience, particularly summarizing companies aiming to contribute outside the genetics realm. This includes sequencing the gut microbiome and noting biomarker concentrations through the blood. (1/7)
Michelle Meyer (@MichelleNMeyer)posted an article decrying the paternalistic attitudes surrounding the release of genetic information to patients. Not only does this article claim that “People are smarter & more resilient [re #genetic info] than ethic debates give them credit for”, as Meyer references from the article, but it also recognizes that the complexities of the genome do not make it less necessary for doctors to figure out how to discuss it with the public. (1/7)
Michelle Meyer (@MichelleNMeyer)also posted about the Supreme Court’s decision regarding a case on government funding of embryonic stem cell research. SCOTUS declined to hear an appeal to stop the research, which opponents claimed was in violation of the 1996 Dickey-Wicker law. (1/7)
Daniel Goldberg (@prof_goldberg) posted about a recent study on the influence of body weight and gender on courtroom judgments. The Yale Rudd Center for Food Policy and Obesity found that only an obese female was punished when in consideration along with a lean male, an obese male, and a lean female. Goldberg notes in his tweet that the results are “unreal but sadly [unsurprising]”. (1/8)
Alex Smith (@AlexSmithMD) retweeted an article lamenting the continued fall of fellowship trained geriatricians, which noted that the decrease in numbers is surprising considering that a boost from the Affordable Care Act raises a geriatrician’s annual salary by 12 percent through 2015. (1/9)
Arthur Caplan (@ArthurCaplan) shared a link on a sperm donor custody case in Kansas where the sperm provider thought he had absolved any connection to the child that his sperm would create, but is now being called upon to pay child support. While similar cases have not received as much media attention, the concept – being responsible financially as a result of having genetic ties to a child – has come up in cases involving fathers who were deceased yet were called to pay through their estate, and even in a similar sperm donor case in Pennsylvania in 2011. (1/10)
Frank Pasquale(@FrankPasquale) posted an article discussing the recent move by various healthcare centers requiring their health practitioners (doctors and nurses alike) to get a flu vaccine – possibly at the risk of their job. Should this be grounds for termination, or should the healthcare providers have the same choice to abstain from vaccination as does a patient? (1/13)
Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.