Wednesday, January 31, 2007

Neuroscience and Ethics

The latest issue of The American Journal of Bioethics has an interesting in-focus piece entitled "Neuroscience and Ethics: Intersections" by Antonio Damasio. You can download the article for free here. Here is a small sample:

The words neuroscience and ethics, placed together in the same sentence, conjure up two different ideas. One idea has to do with the fact that modern neuroscience has not only opened the way for new treatments of brain disease but also made possible a variety of unexpected applications of neuroscientific progress at the level of the individual and the culture at large. The goal of treating brain diseases is clearly laudable, provided it follows time-honored ethical medical practices, but it is legitimate to wonder about some of those other applications, debate them, and establish the ethical framework for the related practices. This is an important endeavor and it is currently underway in the new discipline of neuroethics.

The other idea evoked by combining the words neuroscience and ethics has to do with the possibility of using new scientific facts to help us understand the neural underpinnings of moral behavior. While these two ideas are different and are cultivated by distinct experts, it is apparent that they are related (Roskies 2002). The ethical questions we ask and the just guidelines we hope to formulate depend on the boundaries of what constitutes ethical behavior, and the setting of those boundaries, may come to be influenced by new knowledge regarding how the brain operates in health and disease. The comments in this essay focus on the second idea.

Cheers,
Colin

Saturday, January 27, 2007

PGD paper

I am writing this post on my return train journey from Exeter to Oxford. I just spent the last three days at an excellent interdisciplinary conference on “Governing Genomics”, organized by Egenis. I’ve been to Exeter a few times before for various conferences in the past, and it is a very beautiful campus.

This morning I presented my paper on regulating the non-medical uses of PGD. I actually presented this same paper just last week to a group of philosophers at the James Martin advanced research seminar at Oxford, so it was a nice contrast to receive back-to-back feedback from a group of philosophers and then a group of (primarily) non-philosophers. Receiving feedback from scholars in different disciplines, with different interests and expertise, is useful for a whole host of reasons. It exposes you to different ways of looking at an issue, or new dilemmas or hard cases or possible solutions that you might not have entertained.

The goal of my paper is to explore a normative framework for addressing the issue of regulating non-medical uses of PGD. And in this blog I will outline some of the preliminary thoughts that motivated me to develop the position I take in the paper, though I will not (at least now) get to the real details and heart of my argument. But writing this blog has been useful to me nonetheless as it has compelled me to make explicit some of the more general concerns explored in the paper.

Firstly, what is PGD? Preimplantation genetic diagnosis involves screening embryos before they are implanted in a women’s uterus. Parents who undergo IVF can have their embryos screened for a variety of genetic disorders. This screening process involves removing one or two cells from a three-day old (eight-celled) embryo. You can do this without jeopardizing the integrity of the embryos. Once they are tested, a more informed decision can be made concerning which, if any, of those embryos should be implanted. You can learn more about PGD here.


Some believe that even permitting the medical uses of PGD is controversial (see here ). But in my paper I focus on a much more controversial (and thus, for a philosopher, more interesting!) range of issues- regulating the non-medical uses of PGD. Currently it is possible to utilize PGD to screen for the gender of embryos though this is banned in both Canada and the United Kingdom. And one could envision, as science progresses further, new screening capabilities becoming possible, testing not only for the likelihood of developing disease, or gender, but for complex phenotypes like behavioral characteristics. What should we be willing to say about this prospect? Do we want to permit parents to have these new discretionary powers to influence the phenotypes of their offspring? This raises fundamental questions about the scope and limits of reproductive freedom. And it is important that we start thinking about these issues now so we are prepared to meet the ethical and legal challenges that lay ahead in the years to come.

It is of course worth noting that we currently give parents a vast amount of discretionary power to influence the life prospects of their children and potential offspring. Not only are we free to decide if we want to have children in the first place, how many, and when; but expecting mothers can pursue environmental interventions (e.g. diet, abortion) that have a profound impact on a child’s (and potential child's) wellbeing. And once a child is born parents have a vast degree of discretionary power to influence the physical, intellectual and moral development of their children.

This parental freedom is of course limited by a principle of no harm. If the actions or omissions of a parent threaten the safety and wellbeing of a child (or potential child) the state may legitimately intervene. But beyond satisfying the minimalist requirement of a duty of no harm, parents are free to influence the development of a whole variety of phenotypes. Lets call this state of affairs the “status quo”. And the interesting question is: will the status quo equip us to address the complex ethical and legal concerns which the genetic revolution raises? I think it will not. Before I say why let me outline what I anticipate those who defend the status quo will argue.

At this stage one might be inclined to say that regulating the non-medical uses of PGD should simply be subject to the same standards (i.e. the “status quo”) that we invoke in the larger case of reproductive and parental freedom. In other words, non-medical uses of PGD should be permitted provided they do not pose a significant risk of perceptible damage to an identifiable individual. So, for example, they should be prohibited if and only if such screening technologies pose a significant risk of harm to the prospective mother or the embryos that are implanted.

Those liberals and libertarians inclined to take this stance will thus want the discussion to end there. If something like Mill’s liberty principle has not been contravened, then we should permit liberty to reign unabated. End of debate.

But this is not my stance. And it’s not for a variety of reasons. One reason is that, while I would probably be inclined to defend the status quo in the pre(genetic) revolutionary context, I would not defend it in the post-revolutionary context. The reason is that my defense of the status quo is, in large part, pragmatic rather than principled. I do not believe, by virtue of giving birth to a person, that one is (unconditionally) morally entitled to play such a formative role in influencing the development of their offspring.

So if the status quo is defensible (and I’m open to the possibility that it may not be) it is not defensible by reference *solely* to a principle of no harm or the autonomy of parents. Rather, it’s that society could not (without huge expense, invasion of privacy, and other bad consequences etc.) regulate what goes in the family to ensure parents satisfy more than a duty of no harm. Parents are morally required to do a lot more than satisfy the principle of no harm. They are obligated to *love* their children, which goes way beyond the duty of no harm. But to legally compel parents to love their children is not something the state could effectively do and it would probably do a good deal of harm when trying to compel parents to love their children. (note: though there might be non-coercive measures, like creating incentives, that could better secure these goals without those costs. So the state could take the cultivation of parental love to be a goal, its just not something to be achieved through coercion).

This is worth pointing out because a prohibition on non-medical uses of PGD (as well as prenatal genetic modification) is interesting because it may prove to be an effective way to limit parental discretionary power in a way does not have all the negative costs of trying to limit that freedom after a child is born. Rather than trying to police the family we could simply prohibit fertility clinics from offering PGD to parents who undergo IVF. So for me there is no principled defense of the status quo. Rather, given a number of background considerations- about the way the family functions, and the limits of what can be achieved through state coercion, etc. something like the status quo is probably a reasonable position to take in the pre-revolutionary context. But possibly not in the post-revolutionary context.

So, what do I argue then? In the paper I defend a normative framework that I think can help us grapple with the different concerns that arise in case of permitting non-medical uses of PGD. That normative framework is not the standard philosophical arguments one encounters in ethics and political philosophy (e.g. Kantian ethics, utilitarianism, virtue ethics, etc.), but rather it’s the theory deliberative democracy. Recall my post on the rise of deliberative democracy. There are of course many versions of the ideal of deliberative democracy. But I focus on the specific version advanced by Gutmann and Thompson in their excellent (second book) entitled Why Deliberative Democracy?

I won’t go through all the details of why I think this normative theory is useful for the particular debates concerning non-medical uses of PGD, but let me just briefly highlight two important parts of the theory that are vital for this particular policy issue.

Firstly, deliberative democracy is a “second-order” social theory rather than a “first-order” theory. First-order theories seek to win a philosophical argument; they attempt to resolve moral disagreement by showing that rival principles should be rejected. So libertarians will argue that concerns of equality, or the fact that there is popular opposition to gender selection for family balancing, are not legitimate grounds for overriding reproductive freedom. Conversely, some feminists might be inclined to argue that reproductive freedom does not include the freedom to have a child of a particular kind, thus a ban on gender selection is not liberty-restricting and thus a ban should be imposed because it protects equality. And procedural democrats might be inclined to invoke the fact that there is popular opposition to these uses of PGD as a justification for a ban. All of these kinds of debates are first-order arguments. The aim is to show that liberty, equality, or the aggregation of preferences should win the day in terms of determining if we should permit non-medical uses of PGD like gender selection.

This can be contrasted with a second-order theory like deliberative democracy. Deliberative democracy is a second-order theory in that it seeks to find a reasonable balance between the conflicting values and principles that arise in the debate among first-order theories. So rather than championing a principle of liberty, equality, or democracy, deliberative democracy is a *pluralistic public ethic*, one that seeks to give due attention to a diverse range of substantive and procedural values. This makes it very useful when tackling the issue of regulating non-medical uses of PGD. For a diverse range of values and principles arise in this context. And the real challenge we face is determining what would constitute a reasonable balance between respect for reproductive freedom, equality and democratic law-making.

So the idea of exploring a second-order analysis of the stakes involved in debates over gender selection and other uses of PGD is, I think, a novel and important endeavor to pursue. It gives us a much more inclusive normative framework than the standard liberal strategy of invoking Mill’s harm principle.

The second distinctive feature of deliberative democracy that I think is very important when examining the issue of PGD is Gutmann and Thompson’s emphasis on the idea of “provisionality”. This means that the principles of deliberative democracy are both morally and politically provisional. They must be open to revision in light of new moral insights and empirical discoveries. And this is vital for ensuring we implement a fair and humane regulation of new genetic technologies like PGD. The amount of weight we place on protecting reproductive freedom vs equality or some other aim needs to be influenced by the background context of the society in question (e.g. its level of patriarchy, health of its democratic practices, etc.) and by key considerations concerning these new technologies (e.g. their price, how accurate the tests are for screening complex phenotypes, etc.). So we need a *flexible* normative framework, one that incorporates the requirements of provisionality. Again, this makes deliberative democracy an attractive normative framework to invoke.

So where does all of this get us? Should we permit parents to utilize PGD for non-medical purposes like gender selection? Well that’s ultimately up to us as a society (not me) to decide. But, for what it’s worth, here is a brief summary of my two cents worth (the complete paper gives the longer answer).

A second-order analysis of these issues will take us away from thinking in terms of false dichotomies like: “Should X (e.g. gender selection) be permitted or prohibited?”. Taking the prescriptions of deliberative democracy seriously will lead us to measures that seek to *reasonably balance* the diverse stakes that arise in this context. And this will likely lead us to consider less restrictive measures (e.g. perhaps a ban on selection of gender for first child, or a requirement that you already have two children of the same sex, etc.) rather than outright bans on gender selection.

Furthermore, given the lack of empirical evidence concerning the likely societal impact permitting these technologies would have on our society (e.g. impact on equality, gender balance, etc.) we should take a provisional attitude. So what we decide now, concerning what constitutes a proper balance between respect for liberty vs respect for equality, is not the end of the dialogue and debate. We need to revisit these issues as new screening technologies become possible, as the price for PGD falls, and in light of empirical evidence concerning what actually motivates parents to pursue these technologies.

Putting all this together suggests, at least to me, that those who currently propose outright bans on the non-medical uses of PGD like gender selection really face an uphill battle. And that the current prohibition on gender selection, in both the UK and Canada, is not justified. And I think we owe those parents whose reproductive freedom we are infringing a compelling justification for why their liberty is being curtailed. To fail to do so is, I believe, to fail to satisfy the moral requirements of deliberative democracy.

Cheers,
Colin

Wednesday, January 24, 2007

PD and The Fox Foundation


Parkinson's disease is a brain disorder that impairs or destroys neurons in the brain. The symptoms of PD include shaking, slowness of movement and difficulty with balance. The National Parkinson Disease Foundation website contains a wealth of information on PD. Here are some of the facts of the disease listed on the website.

What is Parkinson disease?

Parkinson disease is a brain disorder. It occurs when certain nerve cells (neurons) in a part of the brain called the substantia nigra die or become impaired. Normally, these cells produce a vital chemical known as dopamine. Dopamine allows smooth, coordinated function of the body's muscles and movement. When approximately 80% of the dopamine-producing cells are damaged, the symptoms of Parkinson disease appear.

Who gets Parkinson disease?

Parkinson disease affects both men and women in almost equal numbers. It shows no social, ethnic, economic or geographic boundaries. In the United States, it is estimated that 60,000 new cases are diagnosed each year, joining the 1.5 million Americans who currently have Parkinson disease. While the condition usually develops after the age of 65, 15% of those diagnosed are under 50.

The Michael J. Fox Foundation was established by the actor in 2000 and is dedicated to finding a cure for PD within a decade. I was curious to see learn more about the Foundation and took a look at their website here. They funded nearly $70 million dollars in PD research between 2000-2005. Michael J. Fox has a moving message on the website which captures the challenges the Foundation faces in terms of finding a cure and their determination to employ an effective strategy to overcome these obstacles. Here is Fox's inspiring message:

Welcome and thanks for checking in.

I can pretty much tell the latest news story on the research front by the tone of your letters and emails. Cheerful when there's good news, deflated when we get news that doesn't meet our expectations. It's like a Parkinson's barometer.

As someone with PD, I share the ups and downs, not to mention the ons and the offs. But I'm essentially optimistic and remain convinced that a cure is within reach.

The fact is given the nature of science today, there is so much cutting-edge research being done in so many areas — and so many variables — that it's not always apparent where the next breakthrough will come from. That's why we always use the strategy of betting on several horses at once — you just don't know which one will get fired up in the home stretch and win the race.

With that in mind, the Foundation is pushing ahead on several fronts at once — drug development, cell replacement therapy, genetic discoveries. We are looking for ways around the roadblocks and we're willing to take risks.

So hang in there — we're sure to make it across the finish line.

Thanks again for all of your support.

The latest news update on the Foundation website details their latest effort to help with the laudable aim of finding a cure for PD. Here is a brief excerpt from that update:

The Michael J. Fox Foundation for Parkinson’s Research today announced $4.6 million in total funding to 10 industry research teams under its Therapeutics Development Initiative. The Foundation launched the program in 2006 as a key element in its strategy to ‘de-risk’ preclinical Parkinson’s disease research for biotech and pharmaceutical companies, thus expanding and catalyzing industry investments in the development of improved PD treatments and a cure.

“No matter how much capital a pharmaceutical or biotech company may have, every investment of that capital is a bet — and, by definition, may not pay off,” said Deborah W. Brooks, president and CEO of The Michael J. Fox Foundation. “Our goal with the Therapeutics Development Initiative is to add our resources to companies’ own, making Parkinson’s a more attractive bet and helping to push PD research further out the drug development pipeline toward the clinic and patients.”

Cheers,
Colin

Friday, January 19, 2007

Clinical Trials (Useful Info)



Those who have been following my blog over the past few months know that I have been predominately preoccupied with the issue of genetics and justice.

In order to develop a useful normative framework for addressing the myriad of concerns which arise out of the genetic revolution, normative theorists must have an appreciation of the empirical realities that face the aspiration to directly mitigate genetic disadvantage. So normative theorists must have an *informed* view concerning where the science actually is, where it might take us in the next few decades, and the kinds of obstacles and challenges facing the aspiration to develop safe and effective treatments for genetic disadvantage.

Suppose, for example, a report comes out (as frequently occurs and I sometimes link to such stories) that a novel gene therapy has proved successful in treating mice for a particular disease. How do we go from treating mice to treating human beings for these same diseases? Not only are human beings biologically different than mice (though we are much more similar than one might have thought, hence the importance of the mouse genome) but there are a range of ethical concerns that arise in the context of conducting experimental therapies on human beings that do not arise in the case of testing on mice. These kinds of concerns are important if one wishes to develop, as I hope to, an informed theory of genetic justice. Concerns about safety and informed consent, etc. complicate the story of how stringent the duty to directly mitigate different kinds of genetic disadvantage is.

To help illustrate the complexity of these kinds of concerns I thought it would be useful to note this informative website which I happened to come across while looking up information on gene therapies for cancer. It is the website of the M. D. Anderson Cancer Center at the University of Texas. And it contains a wealth of useful information about clinical trials for cancer, why they are important, and how these trials progress through different phases to test the safety and efficacy of novel treatments for cancer.

More details concerning clinical trials more generally are available from the Clinicaltrialsgov web site here.

Appreciating the diverse concerns that arise with respect to clinical trials for gene therapies is essential if one wishes to develop a normative theory that takes the duty to prevent harm seriously. The empirical realities of our biology, and limited knowledge, scarcity, indeterminacy, etc. must inform the normative principles and theories we champion.

Cheers,
Colin

Thursday, January 18, 2007

Genetic Privacy Legislation



Knowledge about our genetic susceptibility to disease could empower individuals to pursue lifestyle changes and medical interventions that will improve their expected lifetime acquisition of what John Rawls calls "natural primary goods" (e.g. health). But in the wrong hands this same information could be very damaging to an individual's employment prospects and thus it could negatively impact a person's expected lifetime acquisition of their social primary goods (e.g. income, self-respect). This illustrates the potential pros and cons of the genetic revolution. Genetic privacy is a very important issue that we need to address to ensure that advances in genetic knowledge do not impose unfair disadvantages on individuals.

This story in the NY Times is encouraging. President Bush urges Congress to pass (long-stalled) legislation barring employers and insurance companies from discriminating based on the results of genetic tests. Details about the legislation are available here.

Cheers,
Colin

Monday, January 15, 2007

The NG Question of the Year

The journal Nature Genetics is running a'Question of the Year' website, which they will update monthly, here. This year they are asking geneticists what they would do if the capacity to sequence the equivalent of a full human genome for $1,000 were available today. Here are two of the first round of responses to this question:

Francis S. Collins (National Human Genome Research Institute): where to begin?
The real question is, "What wouldn’t we do?" At the National Human Genome Research Institute, we'd be like kids in a candy shop—there are so many exciting possibilities from which to choose. Bearing in mind our mission of using genomic research to improve human health, we'd probably take most of our current annual spending on DNA sequencing, about $120 million, and devote it to sequencing 100,000 human samples for $100 million. About 75,000 of those samples would come from obtaining the complete genome sequences of 2,500 affected individuals for each of 30 common, complex diseases, such as asthma, arthritis, diabetes, various types of cancer, heart disease, stroke, Alzheimer’s disease and depression. This would enable us to systematically find both the common and the rare genetic variations that contribute to the risk of developing these diseases. The remaining genomes to be sequenced would be those of 25,000 people who have made it to the age of 100 in relatively good health and retaining the capacity for independent function. The aim of that endeavor would be to see what's special about the genomes of healthy centenarians, and then to use that information to explore the genetics of good health and longevity in all humans.

George Church (Harvard Medical School): the Personal Exome Project
If the equivalent of a complete human genome could be sequenced for only $1,000, then we should sequence all exons (also known as the 'exome') for $10—a bargain that the world could not afford to ignore ($60 billion for 6 billion people). The exome is the 1% of the genome most easily interpreted and most likely to cause noticeable phenotypes. Even if we never get to $10, it is likely that the exome is already, in 2006, 'affordable' for the global middle class: $4,000 (e.g., using polonies)—an amount recoverable over a lifetime at $50/year in healthcare savings. Association studies based on 'pathway sequences' for a million early adopters could benefit the rest of us in a way that is out of reach with current 'common variant' and/or 'linkage disequilibrium' methods. Pathway sequence studies look for associations between a disease and any 'obviously deleterious alleles' (e.g., protein-truncating alleles or changes in highly conserved amino acids) anywhere in the pathways potentially relevant to the disease (which can include dozens of loci unlinked genetically but well-linked conceptually). This would crank up the already high motivation to work out the social components of sharing integrated genome and phenome data with trusted researchers—and at a million, the statistics would be awesome. This would permit broadening the number of hypotheses simultaneously testable (i.e., combinations of alleles and environments). This might transform personal genomic medicine from a luxury to a birthright.


For an examination of some of the potential ethical and legal implications of a $1000 Genome, see this In-Focus article by John A. Robertson in AJOB, August 2003.

Cheers,
Colin

Friday, January 12, 2007

Armstrong and the Fight Against Cancer


Lance Armstrong makes a passionate plea for Americans to take the fight against cancer seriously here. It's a moving appeal. Here is a brief excerpt:


It is time to hold our leaders accountable. It remains to be seen if the change in power on Capitol Hill will affect the fight against cancer. In two years we will elect a new president. We cannot predict the actions of any of our elected officials, but we can say for sure that when it comes to cancer their silence is unacceptable.

Patient people may accept the status quo, but the status quo isn't working for us. Instead, we need to stubbornly hold our leaders accountable and we need the courage to ask tough questions of our elected officials. Few issues facing our government are more personal or more critical than the health of our citizens. What are we going to do to effectively fight cancer? Millions of Americans with cancer are asking.

I'm not known for my patience. When it comes to cancer, I hope you aren't either.


Cheers,
Colin

Thursday, January 11, 2007

The Allen Brain Atlas

The latest issue of Nature has a fascinating article entitled "Genome-wide atlas of gene expression in the adult mouse brain" which details the research of The Allen Brain Atlas. Here is an excerpt from the Nature article:

The mammalian central nervous system (CNS) contains an enormous variety of cell types, each with unique morphology, connectivity, physiology and function. A characterization of the full complement of neural cell types is essential to understand functional circuit properties and their relation to higher cognitive functions and behaviours. The phenotypic properties of different neuronal and non-neuronal cells are largely the product of unique combinations of expressed gene products; therefore, gene expression profiles provide an informative modality to define cellular diversity in the brain. However, histological data are typically generated for one gene at a time, and data are neither systematically produced and analysed nor consolidated in an easily accessible format. Consequently, a limited set of established cellular markers dominates the current literature, and expression patterns of many genes remain uncharacterized.

...The Allen Brain Atlas project has taken a global approach to understanding the genetic structural and cellular architecture of the mouse brain by generating a genome-scale collection of cellular resolution gene expression profiles using ISH. Highly methodical data production methods and comprehensive anatomical coverage via dense, uniformly spaced sampling facilitate data consistency and comparability across >20,000 genes. The use of an inbred mouse strain with minimal animal-to-animal variance allows one to treat the brain essentially as a complex but highly reproducible three-dimensional tissue array. Image-based informatics methods for signal detection and three-dimensional registration of ISH data to a de novo age-matched annotated reference atlas have been developed to allow automated signal quantification across the anatomical structures in the reference atlas, or its associated grid-based coordinate system. These methods enable global analysis and mining for detailed expression patterns in the brain. The entire Allen Brain Atlas data set and associated informatics tools are available through an unrestricted web-based viewing application.


Cheers,
Colin

Wednesday, January 10, 2007

Gene Patents: A Snapshot


*Originally posted May 15th, 2006*

Like my previous post on Google Alerts for "Gene Therapy", I recently signed up (about 2 or 3 weeks ago) for weekly Google Alerts for "Gene Patents". So I get an email linking me to every news item posted on the web that addresses gene patents. And if this week's list of posts is any indication of the volume of links I am likely to get I will certainly have my work cut out for me trying to keep abreast of these developments! Today I received my weekly update that contained 21 news items. Here is a snap shot of some of the diverse issues that arise with genomic intellectual property:

This story reports that Inovio Biomedical Corporation has been granted two patents with broad claims regarding electroporation of nucleic acids in muscle. Here is a brief blurb from the report:

"SAN DIEGO--(BUSINESS WIRE)--May 15, 2006--Inovio Biomedical Corporation (AMEX:INO) announced today that it has acquired, under a license with Sphergen SARL, rights to several patent families relating to the use of electroporation technology. The rights Inovio has licensed include two patents with broad claims regarding electroporation of nucleic acids in muscle (U.S. Patent No. 6,939,862) and tumor tissue (U.S. Patent No. 6,528,315). This intellectual property acquisition enhances the breadth of Inovio's patent portfolio directed to the use of electroporation technology to deliver therapeutic biopharmaceuticals. The license also includes grants of rights to know how, future improvements, and provisions for exclusivity in applications to human medicine."


There is also this story which reports that the Federal Appeals Court has ruled in Cardium's Favor Over Boston Scientific and Arch Development on Patents for the Treatment of Heart Disease.

Via msn Money comes this report about the first quarter financial report of Corautus Genetics and an update on its therapeutic development program. Here is a quote from the CEO which summarizes why one of the trials (treating severe angina) has been cancelled.

"The Data Monitoring Committee ("DMC") recommended the termination of enrollment in the trial after review of summary information on 220 patients with three month data related to the primary endpoint of an increase in exercise treadmill time (ETT) of 60 seconds over baseline. The DMC also reviewed summary ETT information on 135 patients with 6 month follow up data and 26 patients with 12 month follow up data. Mr. Otto continued, "While the results of this interim primary endpoint review was disappointing, we and our GENASIS trial steering committee believe the analysis of the complete trial database will offer important additional insights regarding any potential application of the VEGF-2 therapeutic in this difficult patient population. We are actively continuing to gather blinded results from patients on all efficacy endpoints including, SPECT nuclear scans, angina class and frequency, angina medication consumption, electrocardiographic (ECG) changes indicating ischemia and major adverse cardiac events (MACE), as well as exercise tolerance times all of which will be analyzed."


And finally there is this encouraging story about crop scientists who have isolated two soybean lines that grow without the primary protein linked to soy allergies in children and adults. And they have released this information without any patents so that these two lines can be incorporated as quickly as possible. 6 - 8 % of children are allergic to soy-based products. Here is a brief blurb from the story:

"Crop scientists at the University of Illinois at Urbana-Champaign and the USDA-Agricultural Research Service's Donald Danforth Plant Science Center in St. Louis screened more than 16,000 soybean lines kept in the USDA's National Soybean Germplasm Collection. The findings will appear later this year in the journal Crop Science.

The two soybean lines (PI 567476 and PI 603570A) contain virtually identical genetic mutations that do not contain the leading allergy-causing P34 protein, which consists of 379 amino acids, said Theodore Hymowitz, emeritus professor of plant genetics in the crop sciences department at the U. of I.

"We are releasing this information with no patents so that companies and breeders involved with soybeans can incorporate these two lines as quickly as possible," Hymowitz said. Companies in Japan, Canada and across the United States have been following the research effort, he added".


Cheers,
Colin

Friday, January 05, 2007

Hybrid Embryo Research (UK)

This important BBC News report notes that UK scientists pursuing cures for degenerative diseases like Alzheimer's might have their work stopped because of popular opposition to "hybrid embryos". These are embryos that are more than 99% human but have a small (non-human) animal component. Reuters UK also has the story here.

Cheers,
Colin

Gene Therapy, Liver Disease and Nanoparticles

This article in the Sept. 2006 issue of the journal Cancer Gene Therapy is the first demonstration that nanoparticles could be used for delivery of therapeutic genes with anti-tumor activity into human liver tumors. The title of the article is "Gene Therapy of Liver Tumors With Human Liver-specific Nanoparticles" and here is the abstract:

The development of safe and efficient liver-specific gene delivery approaches offers new perspectives for the treatment of liver disease, in particular, liver cancer. We evaluated the therapeutic potential of hepatotropic nanoparticles for gene therapy of liver tumor. These nanoparticles do not contain a viral genome and display the hepatitis B virus L antigen, which is essential to confer hepatic specificity. It has not been shown whether a therapeutic effect could be obtained using L nanoparticles in a human liver tumor xenograft model. Rats bearing human hepatic (NuE) and non-hepatic tumors were injected with L nanoparticles containing a green fluorescent protein (GFP) expression plasmid. GFP expression was observed only in NuE-derived tumors but not in the non-hepatic tumor. The potential for treatment of liver tumors was analyzed using L nanoparticles containing the herpes simplex virus thymidine kinase gene, in conjunction with ganciclovir pro-drug administration. The growth of NuE-derived tumors in L particle-injected rats was significantly suppressed, but not of the non-hepatic tumor control. In summary, this is the first demonstration that nanoparticles could be used for delivery of therapeutic genes with anti-tumor activity into human liver tumors. This intravenous delivery system may be one of the major advantages as compared to many other viral vector systems.

Cheers,
Colin

Wednesday, January 03, 2007

Cancer and Time




The lifetime risk (for all races) of being diagnosed with cancer is currently 45.67% for males and 38.09% for females. And the lifetime risk of dying from cancer is 23.56% for males and 19.93% for females (see stats here).

These staggering statistics mean that someone in your immediate family will most likely die from cancer. For those robbed of a love one the tragic costs of cancer are all to clear. But cancer also has some hidden costs that are worth emphasising and addressing.

Via Bioethics News I came across this article in the Washington Post entitled "Cancer's Unrecognized Toll: Time". Here is a brief excerpt from the story:

The hours spent sitting in doctors' waiting rooms, in line for the CT scan, watching chemotherapy drip into veins: Battling cancer steals a lot of time _ at least $2.3 billion worth for patients in the first year of treatment alone.

So says the first study to try to put a price tag to the time that people spend being treated for 11 of the most common cancers.

Even more sobering than the economic toll are the tallies, by government researchers, of the sheer hours lost to cancer care: 368 hours in that first year after diagnosis with ovarian cancer; 272 hours being treated for lung cancer, 193 hours for kidney cancer.

....Cancer is more than the just the dollars and cents for the medicines and the treatments and the doctors. It's also the lost opportunities for the patients," added Dr. Len Lichtenfeld of the American Cancer Society, who praised the research for attempting to quantify that often overlooked reality.

How much a disease costs society plays an important role in policy-making, such as how much to invest in medical research, but it's hard to calculate the value of a patient's time spent getting care.


The actual study addressed in the Washington Post story is available in the latest issue of Journal of the National Cancer Institute (here).

Cheers,
Colin

Tuesday, January 02, 2007

Word of the Year (2006)



Merriam-Webster's #1 Word of the Year for 2006 is "Truthiness", a term coined in a hilarious comedy skit by Stephen Colbert (see the skit here, well worth a look if you haven't seen it already!).

Truthiness means "truth that comes from the gut, not books". There is an insightful piece on "The Truth of Truthiness" on CBS News here.

Lets hope the year 2007 is a year with less "truth from the gut" and more "enlightenment". Recall Kant's definition of enlightenment: "man's emergence from his self-incurred immaturity". The era of "truthiness" is a stark reminder of the prevalence of our immaturity.


Cheers,
Colin