Thursday, September 28, 2006

Responsible Risk Management

Originally posted 20 Apr 2006.

Risk of harm is omnipresent. One could address the issue of risk by focusing on obvious issues like the threat of terrorism, crime, global warming, hurricanes, etc. but let me approach the topic from a different angle. I wish to recount two separate stories that were reported in the media awhile back but have remained vivid in my mind whenever I think about the issue of risk management and responsible governance.

The first story is the sad story of a man who was decapitated by a malfunctioning elevator. CNN reported this story a few years back and I kept it on file because I found it interesting. The story is here

The story notes that elevators and escalators kill about 30 and injure about 17,100 people each year in the United States. I'd like to think my interest in such stories is not based on some subconscious morbid interest in human suffering but rather an interest in how pervasive (and sometimes unimaginable) risk of harm is and how complex the challenges of mitigating such risks can be. When one hears a story like the elevator tragedy (or a story about a child abduction, threat of terrorism, etc.) one can't help but feel that more should be done to mitigate the particular risk in question. But the reality is that there are an infinite number of risks that we are susceptible to, and thus we face tough and complex decisions when the reality is we can't eliminate *all* risk of harm. How do we prioritise the efforts to mitigate different kinds of risk? And whose responsibility is it to protect us from different types of risk?

The second story I would like to recount is from 2 years ago. It was a nice summer evening and I was watching the Canadian national news when two stories were reported (independently) one after the other. The first story was about a woman from Ontario who was paralyzed by West Nile virus and was suing the Ontario government for not doing enough to protect citizens. The second story was about protestors in a Western province who were protesting the government's decision to spray fields in an attempt to guard against the dangers of West Nile virus. The irony! The government can't seem to win- your damned if you do and damned if you don't.

These kinds of concerns (and the ones brought more vividly to the fore by 9/11 and hurricane Katrina) show that any humane society must take a responsible approach to the prevention of harm (and risk of harm). I have been led to these concerns by my work on genetics where genetic diseases can vary widely in terms of their risk of harm, prevalence and severity of disadvantage. These considerations ought to impact how stringent we believe the duty to mitigate genetic disadvantage is. But keeping the discussion more general for now, I think the following four considerations are central questions that any responsible approach to risk management must address and consider:

1. How probable is the risk of harm? The greater the probability of harm (all else being equal) the greater the case for intervention.

2. How severe and pervasive is the disadvantage in question? The greater the harm (all else being equal) the greater the case for intervention.

3. What is the likelihood that intervention will have the desirable effect (i.e. prevent or reduce the risk of harm)? The greater the likelihood that intervention will make a difference (all else being equal) the greater the case for intervention.

4. What is the cost of intervention? The cheaper the cost of intervention (all else being equal) the greater the case for intervention.

Thinking about these considerations in the context of environmental policy, the war on terror, healthcare, crime prevention, etc. will help ensure that we take a responsible approach to risk management. These considerations highlight the importance of getting the input of experts with specialised knowledge. But responsible risk management does not prescribe autocratic rule by knowledge elites. Nor does it lead us to embrace a crude or simplistic cost-benefit analysis (CBA). I like the purposeful approach taken by CBA but I think we need to embrace a more nuanced version of it if we are to make it a component of an attractive normative theory. How do we do this? One way would be to incorporate a democratic mechanism in the cost/benefit metric. Rather than simply positing a monetary value to everything we could permit informed citizens to play a role in terms of ranking the importance of various goods (e.g. better education vs. better healthcare vs. greater economic stability vs. safer streets, etc.). So one way of fostering a responsible approach to risk management is to foster democratic accountability and reflective deliberation (in addition to accumulating reliable facts).

At a minimum an informed and reflective citizenry must appreciate how enormous the task of minimizing risk is. Such a citizenry will not demand the government make protection from risk X or Y a top priority simply because they read a story about someone suffering from X, or witness a gripping amateur video showing someone being harmed by Y. An informed and reflective citizenry (and government) should ensure that other considerations (like the 4 points highlighted above) are part of the public debate.

And responsible journalists should ensure that the stories they report to the public are balanced and placed in an appropriate context. So the quality of the media is *vital* to ensuring responsible risk management. The sad reality is that many citizens are more afraid of being harmed by terrorists when the reality is that the greatest threat to their health is often themselves (e.g. their diet, lack of exercise, etc.). Reporting on how we are losing the war against obesity [update: kudos to the Guardian for reporting this] might not make for exciting news reports but it would serve a very useful societal function.

Finally, responsible risk management must also recognise that a division of labour is required. Certain responsibilities fall to the government in terms of enforcing formal regulations (e.g. covering food preparation) and policies/law (e.g. criminal law, etc.), but some responsibility should (and must) fall to us as individuals. As individuals we can do many things to reduce our own health risks- wear seatbelts, quit smoking, limit the intake of alcohol, exercise, eat well, etc. So the next time you feel inclined to slam the government for not doing enough to protect your safety ask yourself if you yourself are doing enough to protect yourself. Would you "re-elect" yourself as your own personal "Health Minister"? If not, put pressure on yourself to be more proactive about promoting your health!


Tuesday, September 26, 2006

Chinese Cancer Therapy

The CTV has this interesting story about Gendicine, the world's first commercially approved gene therapy that is available in China. Here is a snippet from the story:

A revolutionary anti-tumour drug in China is attracting terminally ill cancer patients from around the world, including Canada.

The world's first "gene therapy" drug, named Gendicine, was officially licensed by the Chinese government in late 2003 after clinical trials found it noticeably improved the survival rate of patients with head and neck cancer, which are common in China.

Injected directly into the tumour, Gendicine is designed to destroy cancerous genes. The key ingredient is the p53 gene, described as a tumour-suppressing gene and which is mixed with a common virus.

....Experts openly question the Chinese government's willingness to approve new cancer drugs that are still in their experimental stages in North America.

As one Wall Street Journal article on Endostar noted: "The hurdles to getting Endostar approved for general use in the U.S. are high. It has only been tested in China, and it's not clear whether those trials meet U.S. and European standards. The results of the trials have yet to be published in any Western peer-reviewed medical journals. The exact mechanism by which Endostar inhibits tumors from building a blood supply is unknown."

The Genesis of Gendicine has an interview with the chairman and founder of Shenzhen SiBiono GeneTech.

World-wide there are over 1000 gene therapy clinical trials. See the useful charts here.

Here are some of the numbers of gene therapy trials by country:

USA: 776; UK: 136; Germany: 73; Switzerland: 42; France: 19; Belgium: 19;

Australia: 17; Canada: 13; China: 4

797 of the gene therapy trials are for cancer diseases, 102 are for monogenic diseases, and 106 are for vascular diseases.



Thursday, September 21, 2006

Some Reflections on Publishing

Now that I am somewhat settled in Oxford I have a chance to post something on the blog. Oxford is a beautiful city and the weather these past 2 weeks has been great.

I have had a few conversations with people here about the upcoming RAE that will take place in the UK in 2008 (see ). And this has motivated me to write this brief post on academic publishing.

My first three academic appointments were in UK departments and thus the RAE played a formative role in shaping the publication strategies I pursued in the early stages of my career. Since leaving the UK in 2003 I have been in a tenure-track position in Canada (though now I am back in the UK for this year). There are many parallels between the two systems but there are also important differences. So I offer some thoughts on publishing which might be useful to those considering a job in academia or those in the early stages of their academic career.

The motto “publish or perish” is very much alive in the competitive academic job market. From the pressures of the RAE (in the UK) to those of landing that first job, getting tenure and applying for promotion, academics must continuously give serious consideration to implementing an effective publication strategy that will permit them to fulfil the important intellectual services they are employed to perform.

Given how important publishing is to academia, those entering the field (recent PhDs and junior faculty) will no doubt want sage advice concerning how best to develop their research programmes. I do not pretend to offer such sage insights. Instead, I offer some reflections on my own experiences (and thus one should take them for what they are worth). Furthermore, I don’t think one can make universal prescriptions on this subject because a lot depends on the
research expectations and culture of one’s institution, discipline and country.

When I worked in the UK between 1999 - 2003 I received explicit advice on what journals and publishers to target so as to maximise the RAE submission of the department. When on the tenure stream in North America this is a bit different. Junior faculty members need to know what the research expectations are for getting tenure in their particular institution and make long-term plans to meet those demands in the years to come. An attractive feature of the tenure system is that you are given a set number of years (e.g. 6 or 7) to develop your research programme. This can be contrasted with the publication expectations with the RAE. In the latter a lot really depends on *when* you enter the job market relative to the next RAE. If the RAE is just 1 year down the road, permanent jobs will most likely go to those who have the necessary number of publications in print before the submission deadline. If you enter the job market immediately after the RAE cycle things will look very different.

The stakes involved in publishing for an RAE submission and for tenure can also be different. If you don’t get tenure you lose your job. If you have a poor RAE submission your whole department suffers in terms of the funding it will receive (and you probably won’t land a permanent job in the first place). So the motto of “publish or perish” will mean slightly different things for those in different countries, disciplines and institutions (e.g. research

Scholars in research institutions will inevitably have to grapple with the difficult issue of weighing the importance of “quantity” of publications with “quality” of publications. For example, is it better for an academic to publish 3 articles on the same specialised topic rather than investing their energies in tackling new problems (with the result that, at least in the short
term, that they might have a lower publication output)? How much weight should be placed on intellectual breadth versus impact of specialisation?

There are no easy answers to these kinds of questions. And the weight placed on these different variables will no doubt depend on *who* is asking these questions (i.e. the academic her or himself, a tenure or hiring committee, etc.) Departments, administrators, and individual scholars will have different (in some cases conflicting) visions of what the priorities of higher education
are and thus what research is important /outdated/ irrelevant/ ill- conceived / “pie in the sky”, etc.

From the perspective of the academic her or himself, I don’t think it is wise to attempt to answer these questions purely (or even primarily) by considerations of career advancement. Rather the answers should come via reflections on one’s own intellectual curiosity and their determination of what research is the most important for them to invest their finite time and energies in. Ideally, an academic’s intellectual aspirations and judgement will cohere with the likely judgements of those charged with evaluating an academic's performance. But of course we do not live in an ideal world. So a prudent scholar will give due consideration to the constraints they face in the real life of academia (e.g. time constraints imposed by tenure, the RAE, etc.).

One useful source which academics can utilise when contemplating where to publish their work is the ISI Web of Knowledge Journal Citation Reports (subscription needed) which ranks the impact of journals by discipline (e.g. Political Science, Law, etc.) and specialisation (e.g. Ethics, etc.). These rankings are of course controversial and should be taken with a grain of salt, but it is important (especially for junior scholars) to be aware of them.

Knowing the impact factor of a journal can be very useful. The primary goal of publishing is the dissemination of knowledge. And publishing in a high impact journal will help optimise the dissemination of one’s work. The impact factor and rankings of the journals fluctuate from year to year. Here are the impact ratings for the top journals listed in the ISI category for “Ethics”:

Rankings in Ethics (with impact factor):

1. American Journal of Bioethics 2.50
2. Hastings Center Report 1.70
3. Bioethics 1.37
4. Journal of Medical Ethics 1.31
5. Philosophy and Public Affairs 1.24
6. Kennedy Institute of Ethics Journal 0.82
7. Journal of Law, Medicine and Ethics 0.81
8. Ethics 0.80
9. Business Ethics Quarterly 0.78
9. Journal of Agricultural and Environmental Ethics 0.78

The internet itself is also a great tool and can help researchers get a realistic sense of what the publication output of their peers is. Take a look at the web pages of junior academics in your field hired in institutions you would like to work at (or those recently tenured or promoted to full professor, etc.). How much have they published? Where have they published? Google them
and see what comes up. Are they presenting at important conferences you should consider presenting at? How much teaching experience do they have? Perhaps they have applied for research grants that you should also consider applying for.

The internet provides us with a multitude of information that can help a junior academic get a sense of where they are in the larger pool of job candidates and the things they need to do to improve their job prospects.