David Sclar

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Crystallizing the Week 8 (Sandel) Debate

Dsclar 19:06, 3 April 2006 (EDT)

Our class discussion often covers a lot of ground. It can be confusing to keep track of what exactly we're wrestling with. The purpose of this post is to clarify the central arguments that ran through my mind during today's discussion.

Those who would oppose genetic selection during birth (including selecting for or against deafness, sex, or sexual orientation) believe it will be harmful in some way. Dan asked us all, "Why will it be harmful?"

I can see two good reasons: 1) Unknown harmful effects. If we are flawed beings and we are given powerful tools to manipulate our genetics then we may cause more harm than good in the long term. 2) The impact on children. Children whose parents have genetically manipulated them will be affected because their parents will have sent a message that their love is not unconditional. Given that it was augmented by manipulation, it could be decreased just as easily if the child doesn't turn out as the parents would ideally hope. Children will be greatly harmed by this knowledge.

But I see two good counterarguments: 1) As I asked in a previous posting, why not favor progress? If we can't be sure whether the long-term effects will be beneficial or harmful, why not lean towards using the tools we have available, balanced by our best judgment, to achieve goals that we deem valuable? With good judgment, we're likely to have net socially beneficial results. 2) Where do you draw the line on the manipulation of children? We seek to augment our children's lives through disease-preventing vaccines, not to mention more mundane techniques such as piano lessons and other forms of "manipulation" when they are too young to consent for themselves. What makes genetic trait selection somehow distinct or worse. It's not just a distinction based on disease/non-medical, as demonstrated by vaccines example.

I won't argue here for either side, but I simply raise the difficult conflicts that I believe remain unresolved after our discussion.

Excess Patents: Why I'm Now Interested in Patent Law

Dsclar 14:30, 20 March 2006 (EST) Ok, I admit it: I thought patent law was pretty boring. Lots of scientific diagrams that make no sense except to those in a small community with specific knowledge.

Michael Crighton's op-ed on excess patents changed my perspective and captured my gut reaction to the Metabolite case. Something just seems wrong here. And to me it's on a larger policy level that feels far more familiar than the details of amino acid deficiencies.

The purpose of patents, as I understand them, is to encourage innovation that will ultimately benefit society. Unfortunately, as Crighton's op-ed points out, the recent rush of excessive patents frequently cost the public dearly allowing their owners to artificially inflate prices on material that ought to be in the public realm - including genes, very basic business processes, and the use of correlations.

I think that patents should be far more limited in scope. Patenting a gene adds about as much to the public realm as purchasing a domain name on the Internet. Only the costs are much greater if the owner chooses to hold out on allowing use of that gene. Moreover, we haven't tolerated such behavior with domain names.

This is just one example of how patents are damaging to our society and keep critical resources out of the public realm. I'm convinced that the incentives to find correlations and develop new business processes - including fame and efficiency/cost-savings - are quite sufficient to drive their development.

Instead, we have a game of excess patenting that a few of us are playing at the expense of everyone else.

I acknowledge that this is just a gut reaction someone without an extensive background in patent law, but in my opinion, Michael Crighton is on to something, and he has my attention.

Wrestling With Industry Funding and Academic Science

Dsclar 16:20, 8 March 2006 (EST)

After Professor Sheldon Krinsky’s visit to our class, I was rather concerned about the corporate influence on academic science. I recently spoke about my concerns with a lawyer practicing in the health care industry, and she gave me some clarification and some increased confidence in the system.

First, she clarified that from her perspective, the risk of flawed science generally comes not so much at the level of study design or results, but more at the level of interpreting and scrutinizing the results. While Professor Krinsky did suggest that positive study outcomes are directly associated with corporate funding, I recall that our class discussed some rather plausible alternatives to the suggestion that the studies were biased by their funding source. (For instance, industry may only fund research when it has conducted preliminary research of its own and can confidently expect positive outcomes.) The attorney I spoke with was more deeply concerned with the level of scrutiny that review committees, such as those at the NIH, apply in reviewing study results. As we discussed in class, these committees are frequently comprised of scientists with consulting arrangements with industry that may bias their review or cause them to approve more excessive claims of efficacy and safety. The attorney with whom I spoke felt that this was a problem, and that it was exhibited by the insufficient review of studies of COX-II inhibitors (such as Vioxx) before they went on the market.

However, there is reason to believe that the story of COX-II inhibitors is the exception not the rule. There are many levels of review of clinical trial results. In the attorney’s opinion, while bias may exist, it will be countered by the scale of review – the many sets of eyes that may notice deficiencies in study results and raise questions. Not to mention, of course, professionalism and ethical standards.

This gives me some comfort and renewed confidence in our system. While some unsafe and inefficient drugs will probably slip through review – and we should attempt to minimize the number of such drugs – the majority will be caught before being they are put on the market.

It’s not a perfect system, but it’s one that satisfies the need for funding of academic science while the influence of funding sources is largely mitigated – again, by the scale of review as well as professionalism and ethics.


If Not Outrage, What Upholds Our Standards?

Dsclar 15:39, 16 February 2006 (EST):
What then can we rely on to stem the pressure for human experimentation? If the most ambitious of human rights codes - the Nuremberg Code - and related laws are ineffective, what will protect us? Certainly not a private sector driven by the profit motive in the form of shareholder value. I would have suggested public opinion, but Professor Nesson seems to feel it's inadequate. Isn't public opinion - manifested by election results and, in the most extreme cases, revolution - the ultimate bearer of our standards and the finger in the dam of unchecked human experimentation?:

  • On February 8, Professor Nesson wrote:

Outrage is not sufficient to stem the pressure for human experimentation. The Nuremberg Code, if left for compliance to agents of institutions and companies that benefit from such experimentation, will be no more effective as a constraint than leaving issues of surveillance and torture to a lawyer chosen by a president who believes such practices are necessary to accomplish his mission. Law and codes, viewed from this perspective, are impediments to doing what must be done, used by an opposition consisting of political opponents, plaintiffs lawyers and rabble-rousing media, collectively seen as “enemy”.

  • I agree that public opinion is the "ultimate bearer of our standards", I just worry that it is, in some situations, capable of finding itself unmoored from the realities to which it is responding or reacting. I think that public opinion has a (very important) role to play in developing policy surrounding issues like human experimentation, but I don't think it can be the only voice. I know we continue to struggle with this question but I think that, some way or another, we're going to come to the conclusion that a hybridized approach which combines some elements of governmental authority, raw public opinion, expert knowledge, etc. is going to be necessary to manage such complex issues. By the way, I think this is what happens already but that it is often a de facto conglomeration of individuals and bodies promulgating rules and policies and not a principled, well-defined attempt at merging different groups of decision-makers to create a coherent response to a problematic or contested social issue. DVorhaus 14:35, 20 February 2006 (EST)