Class Two/Students
From Cyberlaw
Contents |
Where do bioethicists come from?
The question that Matt Bray posed to kick off last class still hasn't been answered:
If a market-based approach to biotechnology regulation leaves test subjects open to exploitation, and the political process also proves to be inefficient at generating regulations that fit the norms and preferences of a majority of society, how should we go about tackling bioethics problems?
In our small group we started to address the question of who (or what) should be trusted with the articulation and resolution of bioethics problems, but we didn't come to anything like a resolution or consensus. Should this authority rest with the government? Industry? The academy? A hybrid group composed of members of all or several of these segments? Should policy questions be decided by a direct democratic process (e.g., a referendum)?
We generated a number of different possibilities and I'd like to continue this discussion. Personally I'm predisposed toward having academics play a very prominent, perhaps controlling, role in developing science/bioethics policy guidelines. While I recognize there are substantial problems with this proposal I'm sufficiently concerned about the epistemic competency of other groups (politicians and the general public specifically) to wonder if some sort of regulatory body, operating within general guidelines that have been politically ratified, isn't the best of a number of admittedly imperfect options. But that's just me, and I'd like to hear what other people have to say.
I initially thought I would post some sort of poll. Then I learned that polls are evil. So no poll, just contribute your thoughts and suggests below if you feel like it.
DVorhaus 00:25, 15 February 2006 (EST)
Regarding Outsourcing Clinical Trials
Laurieburlingame 10:46, 16 February 2006 (EST)
Although I haven’t yet watched the show on Outsourcing Clinical Research that Gary sent us, I wanted to suggest the movie- Constant Gardener to anyone in the class who has not yet seen it. This movie portrays a case in which a large US pharmaceutical company performs clinical research in a poor African country. The individuals who are given the test drug are not even informed that they are receiving it, i.e. there is no consent at all let alone informed consent. Unfortunately, several people die as a result of taking this drug. The government knows all about these trials and the associated deaths, but are more than willing to let them continue because if they did not allow the trials, many individuals would be without any form of health care as the companies also provided basic health care services to the region. Hence, it appears as though the government was employing a utilitarian calculus. I found the movie disturbing, but it does raise many interesting issues, so I would highly recommend it to the class.
- Public service announcement: ELaB (Ethics, Law and Biotechnology Society) is going to be screening The Constant Gardener on campus in the next few weeks. I don't have an exact date yet but it will be before Spring Break. I'll send an email out to the list when I have a specific date/time. DVorhaus 15:07, 16 February 2006 (EST)
- Two articles (jumping off from my small group's discussion, see notes under Class Two): Here's a NYT article about the academy stepping up to deal with stem cells...but excluding stem cell researchers to avoid looking "political" and an oped about about cloning. - BEL (Brenda)
Summary of Outsourcing Clinical Trials to India Video Clip
I thought I would just summarize the pros and cons associated with outsourcing clinical research that were mentioned in the video clip of India. I’m sure that there are others that were not explored in the clip and I’m not sure that we would necessarily place them in the same categories, but I thought it would be interesting to at least lay them out as a starting point for debate.
On the pro side, the Indian physicians noted that this gave them an opportunity for new learning and improvement of their clinical skills. Also, the physicians noted that they were able to spend more time with patients enrolled in the clinical trials (if patients are not enrolled in the trials, they get 3-4 minutes of the physicians time/visit), which could lead to better health outcomes for the patients. Interestingly, there was the suggestion that India had a better test population because a) the large population size and b) fact that most of the individuals were not currently on any other forms of medication due to lack of health coverage. Finally, officials noted that trials could be completed in less time in India due to less strict regulations (of course this can also be viewed as a con but the overall tenor of the clip was quite positive).
On the con side, there was fear that the patients would lie about their health status so that they could obtain access to health care by enrolling in the clinical trials. Then, there was the fear that the poorest individuals in the world were being used to test drugs that they would no longer have access to once the clinical trials were over due to high drug costs. Hence, the poor are taking all of the risks associated with clinical trials, while the benefits are being reaped by individuals in more wealthy nations.
As mentioned above, the clip seemed to portray this development as a positive one, at least when viewed from the point of view of the Indian government and health care workers. Although they did mention that the Indian government was imposing some safety checks into the trials, they did not mention if these checks would be as rigid as those imposed by the FDA. However, if the companies hope to have these drugs eventually cleared for the US market, it seems as though they would need to adhere to FDA standards, but I'm not at all sure about this. Does anybody have any thoughts about that? Laurieburlingame 08:51, 20 February 2006 (EST)
Whose Politics?
The Annas/Elias piece in Nature is an interesting one, and alongside the Cohen/Kristol piece in the Weekly Standard, it certainly helped me identify the particular element of the “political” in bioethical inquiries that I find so discomforting. Annas and Elias describe Bush’s Presidential Committee on Bioethics (“PCB”) as a body that has become “virtually irrelevant to the rest of the world.” But why irrelevant? The authors cite “narrow[ness] and self-absor[ption]”—the focus on an “ideological, domestic political agenda.” The PCB was “born” with its pro-life, pro-market bent, and has consequently been doomed to fail in producing “thoughtful” reports that face the “tough ethical-policy issues.” Annas and Elias note that even those who are not troubled by a “political” bioethics body are in fact wary of the politically “extreme and isolated” PCB.
If the words of Cohen and Kristol can be taken as representative voices of a political/ideological constituency—a move that is specious but will do for present purposes—then they seem to correspond well with that “narrow” constituency that Annas/Elias claim gave birth to the PCB. Upon confronting the earnest expression of these views by those who hold them, I certainly recoil at the thought of suppressing them. Admittedly, I disagree considerably with the substance proffered by Cohen and Kristol; but my intuitions of liberal democracy militate against dismissing them entirely from public bioethics discourse.
Now of course, Annas and Elias did not say that the constituency purportedly driving the PCB should be suppressed in any way; but to a certain degree, the characterization of this constituency as one of pure ideology or religion is a subtle suggestion that their voices are inimical to the public/global bioethics debate. A notion of excluding religious views from government-facilitated debate is arguably found in the Establishment Clause, and is certainly embodied in the writings of Rawls, as described in the Cynthia Cohen article. However, as Cynthia Cohen so astutely argues, principles of liberty are insufficient to distinguish between religiously-derived views and views that can be justified by “public” or “secular” reason. Seemingly, says Cynthia Cohen, there may be *many widely-held feelings about life, health and family in American culture (roughly speaking of course) that can be traced to western religious traditions. And the corollary: there may be academics out there with ideas so bizarre that one can only assume they were handed down from some deity, for the lack of any other means to reconcile such views with a reasonable understanding of the world.
So what’s the solution? Or perhaps first, what’s the problem? It’s not that the PCB is political, and it’s not that it takes account of (or even finds authority in) religious or ideological viewpoints. It is that the PCB takes account of only one political/ideological constituency. Diversity of opinion is the key to the democratic value of any government-constituted bioethics commission. That diversity includes the Cohen/Kristol camp, as well as Annas/Elias; and it can no more justifiably shut out all those who adhere to a single doctrinal view of human rights than it can shut out those who renounce belief of ensoulment at conception. Such an embrace of diversity would preclude the dismissal of a particular approach to bioethics as "irrelevant" solely because it lies outside a strong consensus of world opinion.
Believe that it can’t be done? Take a look at the New York State Task Force on Life and the Law... I think it is significant move in that direction.
Of course bioethics is political. What needs remedy is the form in which the politics of bioethics is conducted.
- EDD (Evan)
Which is our Default on Biotechnology: Safety or Progress?
It strikes me that we need to discuss our default stance towards biotechnology. In our last class, we focused on the potential benefits of biotechnology and they're certainly admirable:
- More than 325 million people worldwide have benefited from medicines made through biotechnology
- More than 288 biologic drugs and vaccines have been approved1
- More than 60% of biologic drug approvals have occurred since 1998
- Biotechnology provides drugs for HIV/AIDS, cancer and rare genetic disorders
- Biotechnology has led to the development of "golden rice" enriched with Vitamin A and "pharma foods" to help prevent or cure disease.
Still, biotechnology products - both food and drugs - are highly controversial, in part because their long-term safety is unproven.
At the same time, however, their lack of safety is also unproven. In the years since the first biotech food product came on the market (the FlavrSavr® tomato in 1994), there hasn’t been a single documented case of an illness caused by biotechnology foods. Moreover, hundreds of studies have confirmed the safety of biotech crops and food.
None of this evidence, however, is conclusive. There may very well be dangerous unexpected consequences of modifying genetic data in such a calculated manner. Mutations, crop-mixing, resistance, and other concerns are very real. Not to mention our favorite "unknown unknowns."
The question, in my mind, comes down to our default preferences. Do we favor progress/innovation and run with the assumption that biotechnology is safe, tackling problems as they arise? Or do we favor safety and slow down the relentless march of progress until we can feel confident that it won't unleash widespread harm that outweighs its benefits?
We're law students, so we're supposed to be risk-averse, but I suspect many of us in this class would lean towards progress/innovation. I think I do as well. I think of all the disruption caused by the industrial revolution at the turn of the century and the technology revolution in the second half of the 20th century. Both have caused significant social disruption that we are still attempting to deal with, but most of us believe they are a net positive for our society, and we would all be worse off without them. We must be vigilant and careful as we embrace change, but I think our default preference should be to move the ball forward.
Dsclar 16:04, 16 February 2006 (EST)
Full on Frankenstein
I would like to advocate for progress. Total unlimited progress. While I may have qualms with how medical research is conducted on test subjects, or how drugs and therapies are patented, restricted, and marketed, I have no qualms whatsoever with the advancement of medical knowledge. I want to meet a cloned human. I want new organs grown in incubators with human-animal hybrids. I want new forms of life to be invented at the DNA level. I want nerve cell/microchip combination technologies to advance to the point where humans and robots become indistinguishable. There's a lot that's scary about biotechnology, and I think most of the fear is unnecessary. I remember a few years back, scientists developed a safe method to irradiate food. It would've ushered in a new age, free of e. coli and salmonella infections. You could have eaten raw hamburger right out of the package, drank a glass of raw eggs, and never got sick. But the entire country became afraid of radiation, like some sort of 1960s B movie. And irradiated food never reached the shelves.
I don't buy the current round of biotech fear-mongering as anything more than a political move. If Republicans were really concerned about the lives of unwanted fertilized embryos, they would outlaw fertility clinics. If there ever was a cloned human being, and I guess it's almost certainly inevitable, I don't envy him. But I hope the law would treat him like a normal human being.
I imagine a lot of the fear of new horizons in biotechnology such as cloning, human-animal hybrids, gene therapy and selection, abortion, comes from people's insecurity about the value of human life. Back in the day, a human was a human, and that human's life had value. But these days, lots of things can be human, and not all of those things have value. It's up to us to come up with a new justification for human dignity, to say what belongs in the club with us special people and what deserves to be discarded or exploited. Without a good definition of humanity, we risk either stagnation or damnation. We must walk the line between Nazi and Christian Scientist. Gordon, 12:33 February 19, 2006
But Frankenstein’s Monster tried to kill him…
While I agree with Gordon that many scientific innovations have been squelched for unjustifiable political reasons, I am going to have to disagree with his desire for total unlimited progress.
My classmate desires absolute freedom for scientists to discover new processes and innovations. No panel of academics setting guidelines, no government body intervening in laboratory protocols, and certainly no politicians legislating knee-jerk reactions in response to politically popular issues (federal stem cell funding anyone?). While I too would like to see biotechnology unfettered by political fear-mongering, I also believe that there should be limits to what may be done in the name of scientific progress.
There is a fear about the consequences of scary sounding scientific experiments, and it is true that much of this fear may be unfounded. However, this harks back to the unknown unknowns discussion from last week. If we don’t know the ramifications of a particular innovation, then we should proceed carefully. I am not suggesting that we must know the outcome of all experiments before they begin—that would be silly. Some of the best scientific discoveries were the results of experimental accidents and we cannot possibly plan for such results. However, there are many current technologies that require prudence, such as human cloning and human-animal hybrids. For example, I agree with Gordon that the law should treat a cloned human fairly but it would be irresponsible to put the cart before the horse. This is a foreseeable issue and one that can be considered and possibly even legislated before such an experiment is ever conducted. I argue that science should progress. Rapidly. But with reasonable limitations and self-restraint. In fact, Wikipedia notes that the novel Frankenstein was actually a warning about how the irresponsible uses of technology can bring about undesirable consequences.
This brings us back to the heart of last week’s group discussion. I am not sure who should regulate biotechnology (I lean toward the scientific community). As Gordon notes, a universally accepted definition of humanity is important when trying to set defensible limitations on what may be done in the arena of human cloning and other such technologies. However, in the absence of such consensus, going full on Frankenstein does not strike me as the best strategy. User:Ashley 20 February 2006 (EST)
Interesting Quote
I read an article in the Washington Post the other day regarding companies hiring ethics committees to review their internal procedures, the goal of which was to obtain ethical clearances for their operating procedures. In this article, I came across what I felt was a very interetsing quote from an individual that invests in biotech. companies. He stated: “There is, I think, a misunderstanding that if you set up an ethics panel there are some sorts of ground rules, like principles of accounting, and everyone knows what those rules are. In the field of ethics, there are no ground rules. . . . It all depends on who you pick." Therefore, he was arguing that companies can essentially buy ethical support for all sorts of positions that they take. This seems as though it can apply more broadly, for example, to the President's Council on Bioethics. What do people think about this quote? Do we need to develop more nuanced rules for bioethics? If so, how would such rules be articulated? How would we determine if they were being adhered to? Laurieburlingame 09:06, 20 February 2006 (EST)
- [NOTE: Here's the full text of the article to which Laurie refers -- Gary]
- I think the concern that companies (or government bodies or research institutions or even individuals) can cherry-pick arguments/advocates that support their desired position or outcome is a very real one. It's certainly not limited to bioethics but it is particularly problematic for bioethics (ethics in general I suppose) because, as Laurie/the Washington Post says, there aren't any ground rules. I know there have been attempts to establish such ground rules, and to pursue other lines of action designed to standardize and legitimize these bioethical panel recommendations (such as developing some sort of bioethicist accreditation program) but I'm not sure that any of them have been all that successful. Although I think that developing standardized guidelines is generally a good idea I'm somewhat skeptical that there are any universal rules of ethics that will be specific enough to really inhibit the production of agenda- or viewpoint-motivated ethical recommendations. I think that if there is a solution to be found it probably lies in forcing both the ethicists and their employers (companies or otherwise) to be far more open about their relationships with each other, including any possible conflicts of interest. DVorhaus 14:50, 20 February 2006 (EST)
- I think that my colleague makes a very good point about the need to have greater disclosure and increased transparency regarding the conflicts of interest that exist between potential ethics panels and the companies that are sponsoring/funding the panel. I know that in light of some of the recent fears regarding funded-research, some journals have mandated disclosure of the funding sources so that individuals can tell if such research is truly independent. Since I also think it would be very difficult to develop bioethics standards per se, at least aside from settting some baseline rules, I wonder if it would be possible to require multiple groups of bioethicists to review the conclusions of company-sponsored bioethics reviews? Of course the difficulty here is deciding where these outside reviewers would come from and what their review would be based on. Laurieburlingame 14:51, 23 February 2006 (EST)
